{"id":"mannitol","rwe":[{"pmid":"41906870","year":"2026","title":"Investigation of therapeutic efficacy of intraperitoneal ketamine administration on the brain vascular system in rats with traumatic brain injury.","finding":"","journal":"Biotechnic & histochemistry : official publication of the Biological Stain Commission","studyType":"Clinical Study"},{"pmid":"41900771","year":"2026","title":"A Distribution-Based Metric for Quantifying Dispersibility in Dry Powder Inhalers.","finding":"","journal":"Pharmaceutics","studyType":"Clinical Study"},{"pmid":"41893779","year":"2026","title":"Investigation on a Freeze-Drying Process for Long-Term Stability of mRNA-LNPs.","finding":"","journal":"Vaccines","studyType":"Clinical Study"},{"pmid":"41888951","year":"2026","title":"Delayed-type anaphylactic shock to mannitol: a case report and review of the literature.","finding":"","journal":"Journal of medical case reports","studyType":"Clinical Study"},{"pmid":"41888881","year":"2026","title":"Metabolic engineering of Streptomyces albulus for de novo serotonin production.","finding":"","journal":"Microbial cell factories","studyType":"Clinical Study"}],"_fda":{"id":"3911fd42-2b73-4509-9c4c-92ceba4e6d34","risks":["Risk Summary The available case report data with mannitol over decades of use have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Mannitol crosses the placenta and may cause fluid shifts that could potentially result in adverse effects in the fetus (see Data) . No adverse developmental effects from mannitol were reported in published animal studies; however, fluid shifts occurred in fetal ewes in response to maternal infusion of mannitol. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively."],"set_id":"0d914965-7001-45cb-ba51-d7c5964b05bc","openfda":{"nui":["N0000175359","N0000010288","N0000175810"],"unii":["3OWL53L36A"],"route":["INTRAVENOUS"],"rxcui":["206536","1791395","1791403","1791404","1791408","1791409"],"spl_id":["3911fd42-2b73-4509-9c4c-92ceba4e6d34"],"brand_name":["Osmitrol"],"spl_set_id":["0d914965-7001-45cb-ba51-d7c5964b05bc"],"package_ndc":["0338-0353-03","0338-0357-02","0338-0357-03"],"product_ndc":["0338-0353","0338-0357"],"generic_name":["MANNITOL"],"product_type":["HUMAN PRESCRIPTION DRUG"],"pharm_class_pe":["Increased Diuresis [PE]"],"substance_name":["MANNITOL"],"pharm_class_epc":["Osmotic Diuretic [EPC]"],"pharm_class_moa":["Osmotic Activity [MoA]"],"manufacturer_name":["Baxter Healthcare Company"],"application_number":["NDA013684"],"is_original_packager":[true]},"version":"16","pregnancy":["8.1 Pregnancy Risk Summary The available case report data with mannitol over decades of use have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Mannitol crosses the placenta and may cause fluid shifts that could potentially result in adverse effects in the fetus (see Data) . No adverse developmental effects from mannitol were reported in published animal studies; however, fluid shifts occurred in fetal ewes in response to maternal infusion of mannitol. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Human Data Published literature reports the presence of mannitol in amniotic fluid when mannitol is administered to pregnant women during the third trimester of pregnancy."],"overdosage":["10 OVERDOSAGE Signs and symptoms of overdose with OSMITROL include renal failure and AKI, hypo/hypervolemia, hyperosmolarity and electrolyte imbalances, CNS toxicity (e.g., coma, seizures), some of which can be fatal [see Warnings and Precautions (5.2 , 5.3 , 5.4 )]. Management of overdosage with OSMITROL is symptomatic and supportive. Discontinue the infusion and institute appropriate corrective measures with particular attention to renal, cardiac and pulmonary systems . Correct fluid and electrolyte imbalances. OSMITROL is dialyzable (hemodialysis and peritoneal dialysis), hemodialysis may increase OSMITROL elimination."],"description":["11 DESCRIPTION OSMITROL is a sterile, nonpyrogenic solution of Mannitol, USP in a single-dose flexible container for intravenous administration as an osmotic diuretic. It contains no antimicrobial agents. Mannitol is a six carbon sugar alcohol prepared commercially by the reduction of dextrose. The pH is adjusted with sodium hydroxide or hydrochloric acid. Composition, osmolarity, and pH are shown in Table 1 . Table 1 Size Composition Normal physiologic osmolarity range is approximately 280 to 310 mOsmol/L. Osmolarity pH (mL) Mannitol, USP (g/L) (mOsmol/L) (calc) 10% OSMITROL 500 100 549 5.0 (4.5 TO 7.0) 20% OSMITROL 250 200 1098 5.0 (4.5 TO 7.0) 500 The plastic container is fabricated from a specially formulated polyvinyl chloride (PL 146 Plastic). The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million. However, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies. Osmitrol Injection Structural Formula"],"how_supplied":["16 HOW SUPPLIED/STORAGE AND HANDLING OSMITROL injection is supplied in single-dose, flexible VIAFLEX plastic containers and is available as follows: Code Size (mL) NDC Product Name 2D5613 500 0338-0353-03 10% (0.1 g/mL mannitol, USP) 2D5632 250 0338-0357-02 20% (0.2 g/mL mannitol, USP) 2D5633 500 0338-0357-03 20% (0.2 g/mL mannitol, USP) Do not remove container from overwrap until intended for use. Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Store at room temperature (25°C); brief exposure up to 40°C does not adversely affect the product."],"geriatric_use":["8.5 Geriatric Use Mannitol is known to be substantially excreted by the kidney and the risk of adverse reactions to this drug may be greater in elderly patients with impaired renal function. Evaluate the renal, cardiac and pulmonary status of the patient and correct fluid and electrolyte imbalances prior to administration of OSMITROL [see Warnings and Precautions (5.2 , 5.3 , 5.4 , 5.5 )]."],"pediatric_use":["8.4 Pediatric Use OSMITROL is approved for use in the pediatric population for the reduction of intracranial and intraocular pressure. Studies have not defined the optimal dose of OSMITROL in the pediatric population. The safety profile for mannitol use in pediatric patients is similar to adults at dosages described in labeling. However, pediatric patients less than two years of age, particularly preterm and term neonates, may be at higher risk for fluid and electrolyte abnormalities following OSMITROL administration due to decreased glomerular filtration rate and limited ability to concentrate urine [see Warnings and Precautions (5.4 )]."],"effective_time":"20250826","pharmacokinetics":["12.3 Pharmacokinetics Distribution Mannitol distributes largely in the extracellular space in 20 to 40 minutes after intravenous administration. The volume of distribution of mannitol is approximately 17 L in adults. Elimination In subjects with normal renal function, the total clearance is 87 to 109 mL/min. The elimination half-life of mannitol is 0.5 to 2.5 hours. Metabolism Only relatively small amount of the dose administered is metabolized after intravenous administration of mannitol to healthy subjects. Excretion Mannitol is eliminated primarily via the kidneys in unchanged form. Mannitol is filtered by the glomeruli, exhibits less than 10% of tubular reabsorption, and is not secreted by tubular cells. Following intravenous administration, approximately 80% of an administered dose of mannitol is estimated to be excreted in the urine in three hours with lesser amounts thereafter. Specific Populations Patients with Renal Impairment In patients with renal impairment, the elimination half-life of mannitol is prolonged. In a published study, in patients with renal impairment including acute renal failure and end stage renal failure, the elimination half-life of mannitol was estimated at about 36 hours, based on serum osmolarity. In patients with renal impairment on dialysis, the elimination half-life of mannitol was reduced to 6 and 21 hours during hemodialysis and peritoneal dialysis, respectively. [see Use in Specific Populations (8.6) , Overdosage (10) ]."],"adverse_reactions":["6 ADVERSE REACTIONS The following adverse reactions from voluntary reports or clinical studies have been reported with OSMITROL. Because many of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. • Hypersensitivity reactions : cardiac arrest, anaphylaxis, hypotension, dyspnea, hypertension, pyrexia, chills, sweating, cough, musculoskeletal stiffness, myalgia, urticarial/rash, pruritus, generalized pain, discomfort, nausea, vomiting, and headache. [see Warnings and Precautions (5.1) ] • Renal Failure : acute kidney injury, osmotic nephrosis, azotemia, anuria, hematuria, oliguria, polyuria [see Warnings and Precautions (5.2) ] • CNS Toxicity : coma, seizures, confusion, lethargy; rebound increase in intracranial pressure; dizziness [see Warnings and Precautions (5.3) ] • Fluid and Electrolyte Imbalances : hypovolemia, hypervolemia, peripheral edema, dehydration, hyponatremia, hypernatremia, hyperkalemia, hypokalemia; metabolic acidosis [see Warnings and Precautions (5.4) ] • Infusion Site Reactions : phlebitis, inflammation, pain, rash, erythema, pruritus; compartment syndrome and swelling associated with extravasation [see Warnings and Precautions (5.6) ] • Cardiac and Respiratory Disorders : congestive cardiac failure, pulmonary edema, palpitations • Gastrointestinal Disorders : thirst, dry mouth • General Disorders : asthenia, malaise The most common adverse reactions are hypersensitivity reactions, renal failure, CNS toxicity, hypo/hypervolemia, hypo/hypernatremia, hypo/hyperkalemia, and infusion site reactions. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Baxter Healthcare at 1-866-888-2472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch."],"contraindications":["4 CONTRAINDICATIONS OSMITROL is contraindicated in patients with: • Known hypersensitivity to mannitol [see Warnings and Precautions (5.1) ] • Anuria [see Warnings and Precautions (5.2) ] • Severe hypovolemia [see Warnings and Precautions (5.4) ] • Pre-existing severe pulmonary vascular congestion or pulmonary edema [see Warnings and Precautions (5.5) ] • Active intracranial bleeding except during craniotomy • Known hypersensitivity to mannitol. ( 4 , 5.1 ) • Anuria. ( 4 , 5.2 ) • Severe hypovolemia. ( 4 , 5.4 ) • Pre-existing severe pulmonary vascular congestion or pulmonary edema. ( 4 , 5.5 ) • Active intracranial bleeding except during craniotomy. ( 4 )"],"description_table":["
Table 1
Size
Composition
Normal physiologic osmolarity range is approximately 280 to 310 mOsmol/L.Osmolarity
pH
(mL)
Mannitol, USP (g/L)
(mOsmol/L) (calc)
10% OSMITROL
500
100
549
5.0 (4.5 TO 7.0)
20% OSMITROL
250
200
1098
5.0 (4.5 TO 7.0)
500
"],"drug_interactions":["7 DRUG INTERACTIONS • Nephrotoxic Drugs and Diuretics : May increase the risk of renal failure; avoid concomitant use. ( 7.1 , 7.2 ) • Neurotoxic Drugs : May potentiate CNS toxicity of mannitol; avoid concomitant use. ( 7.3 ) • Drugs Affected by Electrolyte Imbalances : May result in cardiac adverse reactions; monitor serum electrolytes and discontinue OSMITROL if cardiac status worsens. ( 7.4 ) • Renally Eliminated Agents : Concomitant use may decrease the effectiveness of agents that undergo significant renal elimination. However, concomitant use of mannitol and lithium may increase risk of lithium toxicity. If concomitant use is necessary, frequently monitor lithium concentrations and for signs of toxicity. ( 7.5 ) 7.1 Nephrotoxic Drugs Concomitant administration of nephrotoxic drugs (e.g., cyclosporine, aminoglycosides) increases the risk of renal failure following administration of mannitol. Avoid use of nephrotoxic drugs with OSMITROL, if possible [see Warnings and Precautions (5.2) ]. 7.2 Diuretics Concomitant administration of other diuretics may potentiate the renal toxicity of mannitol. Avoid use of other diuretics with OSMITROL, if possible [see Warnings and Precautions (5.2) ]. 7.3 Neurotoxic Drugs Concomitant administration of systemic neurotoxic drugs (e.g., aminoglycosides) with OSMITROL may potentiate the CNS toxicity of mannitol. Avoid use of systemic neurotoxic drugs with OSMITROL, if possible [see Warnings and Precautions (5.3) ]. 7.4 Drugs Affected by Electrolyte Imbalances The development of electrolyte imbalances (e.g., hyperkalemia, hypokalemia) associated with mannitol administration may result in cardiac adverse reactions in patients receiving drugs that are sensitive to such imbalances (e.g., digoxin, drugs that prolong the QT interval, neuromuscular blocking agents) [see Warnings and Precautions (5.4) ]. During and following OSMITROL infusion, monitor serum electrolytes and discontinue OSMITROL if cardiac status worsens [see Warnings and Precautions (5.5) ]. 7.5 Renally Eliminated Drugs Mannitol therapy may increase the elimination, and decrease the effectiveness of treatment with, drugs that undergo significant renal elimination. Concomitant administration of mannitol with lithium may initially increase the elimination of lithium but may also increase the risk of lithium toxicity if patients develop hypovolemia or renal impairment. In patients receiving lithium, consider holding lithium doses during treatment with OSMITROL. In patients requiring concomitant administration of lithium and OSMITROL, frequently monitor serum lithium concentrations and for signs of lithium toxicity. 7.6 Interference with Laboratory Tests High concentrations of mannitol can cause false low results for inorganic phosphorus blood concentrations when an assay based on the conversion of phosphate (orthophosphate) to the phosphomolybdate complex is used. Mannitol may produce false positive results in tests for blood ethylene glycol concentrations in which mannitol is initially oxidized to an aldehyde."],"how_supplied_table":["
Code
Size (mL)
NDC
Product Name
2D5613
500
0338-0353-03
10% (0.1 g/mL mannitol, USP)
2D5632
250
0338-0357-02
20% (0.2 g/mL mannitol, USP)
2D5633
500
0338-0357-03
20% (0.2 g/mL mannitol, USP)
"],"mechanism_of_action":["12.1 Mechanism of Action Mannitol, when administered intravenously, exerts its osmotic diuretic effect as a solute of relatively small molecular size being largely confined to the extracellular space. Mannitol hinders tubular reabsorption of water and enhances excretion of sodium and chloride by elevating the osmolarity of the glomerular filtrate. This increase in extracellular osmolarity affected by the intravenous administration of mannitol will induce the movement of intracellular water to the extracellular and vascular spaces. This action underlies the role of mannitol in reducing intracranial pressure, intracranial edema, and intraocular pressure."],"recent_major_changes":["Indications and Usage (removed, revised) ( 1 ) 11/2018 Contraindications ( 4 ) 11/2018 Warnings and Precautions ( 5.1 , 5.2 , 5.3 , 5.4 , 5.5 , 5.6 , 5.7 ) 11/2018"],"clinical_pharmacology":["12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Mannitol, when administered intravenously, exerts its osmotic diuretic effect as a solute of relatively small molecular size being largely confined to the extracellular space. Mannitol hinders tubular reabsorption of water and enhances excretion of sodium and chloride by elevating the osmolarity of the glomerular filtrate. This increase in extracellular osmolarity affected by the intravenous administration of mannitol will induce the movement of intracellular water to the extracellular and vascular spaces. This action underlies the role of mannitol in reducing intracranial pressure, intracranial edema, and intraocular pressure. 12.3 Pharmacokinetics Distribution Mannitol distributes largely in the extracellular space in 20 to 40 minutes after intravenous administration. The volume of distribution of mannitol is approximately 17 L in adults. Elimination In subjects with normal renal function, the total clearance is 87 to 109 mL/min. The elimination half-life of mannitol is 0.5 to 2.5 hours. Metabolism Only relatively small amount of the dose administered is metabolized after intravenous administration of mannitol to healthy subjects. Excretion Mannitol is eliminated primarily via the kidneys in unchanged form. Mannitol is filtered by the glomeruli, exhibits less than 10% of tubular reabsorption, and is not secreted by tubular cells. Following intravenous administration, approximately 80% of an administered dose of mannitol is estimated to be excreted in the urine in three hours with lesser amounts thereafter. Specific Populations Patients with Renal Impairment In patients with renal impairment, the elimination half-life of mannitol is prolonged. In a published study, in patients with renal impairment including acute renal failure and end stage renal failure, the elimination half-life of mannitol was estimated at about 36 hours, based on serum osmolarity. In patients with renal impairment on dialysis, the elimination half-life of mannitol was reduced to 6 and 21 hours during hemodialysis and peritoneal dialysis, respectively. [see Use in Specific Populations (8.6) , Overdosage (10) ]."],"indications_and_usage":["1 INDICATIONS AND USAGE OSMITROL is indicated for: • The reduction of intracranial pressure and treatment of cerebral edema; • The reduction of elevated intraocular pressure. OSMITROL is an osmotic diuretic, indicated for the reduction of: • intracranial pressure and treatment of cerebral edema. ( 1 ) • elevated intraocular pressure. ( 1 )"],"warnings_and_cautions":["5 WARNINGS AND PRECAUTIONS • Hypersensitivity Reactions, including anaphylaxis : Stop infusion immediately if hypersensitivity reactions develop. ( 5.1 ) • Renal Complications Including Renal Failure : Risk factors include pre-existing renal failure, concomitant use of nephrotoxic drugs or other diuretics. Avoid use of nephrotoxic drugs. Discontinue OSMITROL if renal function worsens. ( 5.2 , 8.6 ) • Central Nervous System (CNS) Toxicity : Confusion, lethargy and coma may occur during or after infusion. Concomitant neurotoxic drugs may potentiate toxicity. Avoid use of neurotoxic drugs. Discontinue OSMITROL if CNS toxicity develops. ( 5.3 ) • Fluid and Electrolyte Imbalances, Hyperosmolarity : Hypervolemia may exacerbate congestive heart failure, hyponatremia can lead to encephalopathy; hypo/hyperkalemia can result in cardiac adverse reactions in sensitive patients. Discontinue OSMITROL if fluid and/or electrolyte imbalances occur. ( 5.4 ) • Monitoring/Laboratory Tests : Monitor fluid and electrolytes, serum osmolarity and renal, cardiac and pulmonary function. Discontinue if toxicity develops. ( 5.5 ) • Infusion Site Reactions : May include irritation and inflammation, as well as severe reactions (compartment syndrome) when associated with extravasation. ( 5.6 ) • Interference with Laboratory Tests : High concentrations of mannitol may cause false low results of inorganic phosphorus blood concentrations. Mannitol may produce false positive results for blood ethylene glycol. ( 5.7 , 7.6 ) 5.1 Hypersensitivity Reactions Serious hypersensitivity reactions, including anaphylaxis, hypotension and dyspnea resulting in cardiac arrest and death have been reported with OSMITROL [see Adverse Reactions (6) ]. Stop the infusion immediately if signs or symptoms of a suspected hypersensitivity reaction develop. Initiate appropriate therapeutic countermeasures as clinically indicated. 5.2 Renal Complications Including Renal Failure Renal complications, including irreversible renal failure have been reported in patients receiving mannitol. Reversible, oliguric acute kidney injury (AKI) has occurred in patients with normal pretreatment renal function who received large intravenous doses of mannitol. Although the osmotic nephrosis associated with mannitol administration is in principle reversible, osmotic nephrosis in general is known to potentially proceed chronic or even end-stage renal failure. Monitor renal function closely, including signs of urine output reduction, during OSMITROL infusion. Patients with pre-existing renal disease, patients with conditions that put them at high risk for renal failure, or those receiving potentially nephrotoxic drugs or other diuretics, are at increased risk of renal failure following administration of OSMITROL. Avoid concomitant administration of nephrotoxic drugs (e.g., aminoglycosides) or, other diuretics with OSMITROL, if possible [see Drug Interactions (7.1 , 7.2 )]. Patients with oliguric AKI who subsequently develop anuria while receiving mannitol are at risk of congestive heart failure, pulmonary edema, hypertensive crisis, coma and death. During and following OSMITROL infusion for the reduction in intracranial pressure, monitor the patient clinically and laboratory tests for changes in fluid and electrolyte status. Discontinue OSMITROL if renal function worsens. [see Warnings and Precautions (5.5) ]. 5.3 Central Nervous System (CNS) Toxicity CNS toxicity manifested by, e.g., confusion, lethargy, coma has been reported in patients treated with mannitol, some resulting in death, in particular in the presence of impaired renal function CNS toxicity may result from high serum mannitol concentrations, serum hyperosmolarity resulting in intracellular dehydration within CNS, hyponatremia or other disturbances of electrolyte and acid/base balance secondary to mannitol administration [see Warnings and Precautions (5.4) ]. At high concentrations, mannitol may cross the blood brain barrier and interfere with the ability of the brain to maintain the pH of the cerebrospinal fluid especially in the presence of acidosis. In patients with preexisting compromise of the blood brain barrier, the risk of increasing cerebral edema (general and focal) associated with repeated or continued use of OSMITROL must be individually weighed against the expected benefits. A rebound increase of intracranial pressure may occur several hours after the infusion. Patients with a compromised blood brain barrier are at increased risk. Concomitant administration of neurotoxic drugs (e.g., aminoglycosides) with OSMITROL may potentiate neurotoxicity. Avoid concomitant use of neurotoxic drugs, if possible [see Drug Interactions (7.3) ]. During and following OSMITROL infusion for the reduction in intracranial pressure, monitor the patient clinically and laboratory tests for changes in fluid and electrolyte status. Discontinue OSMITROL if CNS toxicity develops [see Warnings and Precautions (5.5) ]. 5.4 Fluid and Electrolyte Imbalances, Hyperosmolarity Depending on dosage and duration, administration of OSMITROL may result in hypervolemia leading to or exacerbating existing congestive heart failure. Accumulation of mannitol due to insufficient renal excretion increases the risk of hypervolemia. Mannitol-induced osmotic diuresis may cause or worsen dehydration/hypovolemia and hemoconcentration. Administration of OSMITROL may also cause hyperosmolarity [see Description (11) ]. Depending on dosage and duration of administration, electrolyte and acid/base imbalances may also result from transcellular shifts in water and electrolytes, osmotic diuresis and/or other mechanisms. Such imbalances may be severe and potentially fatal. Imbalances that may result from OSMITROL administration include: • Hypernatremia, dehydration and hemoconcentration • Hyponatremia, which can lead to headache, nausea, seizures, lethargy, coma, cerebral edema, and death. Acute symptomatic hyponatremic encephalopathy is considered a medical emergency. • Hypo/hyperkalemia. The development of electrolyte imbalances (e.g., hyperkalemia, hypokalemia) associated with mannitol administration may result in cardiac adverse reactions in patients receiving drugs that are sensitive to such imbalances (e.g., digoxin, agents that may cause QT prolongation, neuromuscular blocking agents) [see Drug Interactions (7.4) ]. • Other electrolyte disturbances • Metabolic acidosis/alkalosis Pediatric patients less than two years of age, particularly preterm and term neonates, may be at higher risk for fluid and electrolyte abnormalities following OSMITROL administration due to decreased glomerular filtration rate and limited ability to concentrate urine [see Use in Specific Populations (8.4) ]. During and following OSMITROL infusion for the reduction in intracranial pressure, monitor fluid and electrolyte status and discontinue OSMITROL if imbalances occur [see Warnings and Precautions (5.5) ]. 5.5 Monitoring/Laboratory Tests During and following OSMITROL infusion for the reduction in intracranial pressure, monitor: • serum osmolarity, serum electrolytes (including sodium, potassium, calcium and phosphate) and acid base balance, • the osmol gap • signs of hypo- or hypervolemia, including urine output • renal, cardiac and pulmonary function • intracranial pressure Discontinue OSMITROL if renal, cardiac, or pulmonary status worsens or CNS toxicity develops [see Contraindications (4) ]. 5.6 Infusion Site Reactions The infusion of hypertonic solutions through a peripheral vein, including OSMITROL at a concentration of 10% w/v or greater, may result in peripheral venous irritation, including phlebitis. Other severe infusion site reactions, such as compartment syndrome and swelling associated with extravasation, can occur with administration of OSMITROL [see Adverse Reactions (6) ]. OSMITROL is preferably for administration into a large central vein [see Dosage and Administration (2.1) ]. 5.7 Interference with Laboratory Tests High concentrations of mannitol can cause false low results for inorganic phosphorus blood concentrations [see Drug Interactions (7.6) ]. Mannitol may produce false positive results in tests for blood ethylene glycol concentrations [see Drug Interactions (7.6) ]."],"information_for_patients":["17 PATIENT COUNSELING INFORMATION Inform patients or caregivers of the following risks of OSMITROL: • Hypersensitivity Reactions [see Warnings and Precautions (5.1) ] • Renal Failure [see Warnings and Precautions (5.2) ] • CNS Toxicity [see Warnings and Precautions (5.3) ] • Fluid and Electrolyte Imbalances, Hyperosmolarity [see Warnings and Precautions (5.4) ] • Infusion Site Reactions [see Warnings and Precautions (5.6) ]"],"spl_unclassified_section":["Manufactured by: Baxter Healthcare Corporation Deerfield, IL 60015 USA Printed in USA Baxter, Osmitrol, and Viaflex are trademarks of Baxter International Inc. 07-19-00-9763"],"dosage_and_administration":["2 DOSAGE AND ADMINISTRATION Administration Instructions ( 2.1 ): • For intravenous infusion preferably into a large central vein. • Prior to administration, evaluate renal, cardiac and pulmonary status, and correct fluid and electrolyte imbalances. Recommended Dosage ( 2.2 ) : • The dosage, concentration and rate of administration depend on the age, weight and condition of the patient, including fluid requirement, urinary output and concomitant therapy. • Reduction of Intracranial Pressure : 0.25 gram/kg administered every 6 to 8 hours as an intravenous infusion over 30 minutes. • Reduction of Intraocular Pressure : 1.5 to 2 grams/kg of a 15% or 20% w/v solution as a single dose administered intravenously over at least 30 minutes. 2.1 Important Preparation and Administration Instructions • OSMITROL is for intravenous infusion preferably into a large central vein [see Warnings and Precautions (5.5) , Description (11) ]. • Prior to administration of OSMITROL, evaluate renal, cardiac and pulmonary status of the patient and correct fluid and electrolyte imbalances [see Dosage and Administration (2.2) ]. • Do not administer OSMITROL simultaneously with blood products through the same administration set because of the possibility of pseudoagglutination or hemolysis. Preparation 1. Tear overwrap down side at slit and remove solution container. 2. Visually inspect the container. Do not administer unless solution is clear and seal is intact. o If the outlet port protector is damaged, detached, or not present, discard container as solution path sterility may be impaired. o Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually. 3. Check for minute leaks by squeezing inner bag firmly. If leaks are found, discard solution as sterility may be impaired. 4. Admixing OSMITROL with other medications is not recommended. 5. Inspect OSMITROL visually for particulate matter and discoloration prior to administration. If particulates or discoloration are present, discard the bag. 6. OSMITROL solutions may crystallize when exposed to low temperature. At higher concentrations, the solutions have a greater tendency to crystallize. Inspect OSMITROL for crystals prior to administration. If crystals are visible, re-dissolve by warming the solution up to 70°C, with agitation. Solutions should not be heated in water or in a microwave oven due to potential for product contamination or damage. Allow the solution to cool to room or body temperature before re-inspection for crystals and use. Administration 1. Suspend container from eyelet support. 2. Remove protector from outlet port at bottom of container. 3. Attach administration set. Refer to complete directions accompanying set. 4. Use administration sets with a final in-line filter because of the potential for OSMITROL crystals to form. 5. To prevent air embolism, use a non-vented infusion set or close the vent on a vented set, avoid multiple connections, do not connect flexible containers in series, fully evacuate residual gas in the container prior to administration, do not pressurize the flexible container to increase flow rates, and if administration is controlled by a pumping device, turn off pump before the container runs dry. 6. For single use only; discard unused portion. 2.2 Recommended Dosage Prior to administration of OSMITROL, evaluate renal, cardiac and pulmonary status of the patient and correct fluid and electrolyte imbalances. The total dosage, concentration, and rate of administration depend on the age, weight, and condition of the patient being treated, including fluid requirement, electrolyte balance, serum osmolality, urinary output, and concomitant therapy. The following outline of administration and dosage is only a general guide to therapy. Reduction of Intracranial Pressure Usually a maximum reduction in intracranial pressure can be achieved with a dose of 0.25 gram/kg given intravenously as an intravenous infusion over 30 minutes which may be repeated every six to eight hours. During and following OSMITROL infusion, monitor fluid and electrolytes, serum osmolarity, and renal, cardiac and pulmonary function. Discontinue OSMITROL if renal, cardiac, or pulmonary status worsens or CNS toxicity develops [see Warnings and Precautions (5.2 , 5.3 , 5.4 , 5.5) ] . Reduction of Intraocular Pressure The recommended dosage is 1.5 to 2 grams/kg of a 20% w/v solution (7.5 to 10 mL/kg) or as a 15% w/v solution (10 to 13 mL/kg) as a single dose administered intravenously over at least 30 minutes. When used preoperatively, administer OSMITROL sixty to ninety minutes before surgery to achieve maximal reduction of intraocular pressure before operation."],"spl_product_data_elements":["Osmitrol Mannitol MANNITOL MANNITOL WATER SODIUM HYDROXIDE HYDROCHLORIC ACID Osmitrol Mannitol MANNITOL MANNITOL WATER SODIUM HYDROXIDE HYDROCHLORIC ACID"],"dosage_forms_and_strengths":["3 DOSAGE FORMS AND STRENGTHS OSMITROL Injection: • 10% (0.1 grams/mL): 10 grams of mannitol, USP per 100 mL in a single-dose 500 mL flexible container • 20% (0.2 grams/mL): 20 grams of mannitol, USP per 100 mL in single-dose 250 mL and 500 mL flexible containers Injection ( 3 ): • 10% (0.1 grams/mL): 10 grams of mannitol, USP per 100 mL in a single-dose 500 mL flexible container • 20% (0.2 grams/mL): 20 grams of mannitol, USP per 100 mL in single-dose 250 mL and 500 mL flexible containers"],"use_in_specific_populations":["8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Risk Summary The available case report data with mannitol over decades of use have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Mannitol crosses the placenta and may cause fluid shifts that could potentially result in adverse effects in the fetus (see Data) . No adverse developmental effects from mannitol were reported in published animal studies; however, fluid shifts occurred in fetal ewes in response to maternal infusion of mannitol. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Human Data Published literature reports the presence of mannitol in amniotic fluid when mannitol is administered to pregnant women during the third trimester of pregnancy. 8.2 Lactation Risk Summary There are no data on the presence of mannitol in either human or animal milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for OSMITROL and any potential adverse effects on the breastfed infant from OSMITROL or from the underlying maternal condition. 8.4 Pediatric Use OSMITROL is approved for use in the pediatric population for the reduction of intracranial and intraocular pressure. Studies have not defined the optimal dose of OSMITROL in the pediatric population. The safety profile for mannitol use in pediatric patients is similar to adults at dosages described in labeling. However, pediatric patients less than two years of age, particularly preterm and term neonates, may be at higher risk for fluid and electrolyte abnormalities following OSMITROL administration due to decreased glomerular filtration rate and limited ability to concentrate urine [see Warnings and Precautions (5.4 )]. 8.5 Geriatric Use Mannitol is known to be substantially excreted by the kidney and the risk of adverse reactions to this drug may be greater in elderly patients with impaired renal function. Evaluate the renal, cardiac and pulmonary status of the patient and correct fluid and electrolyte imbalances prior to administration of OSMITROL [see Warnings and Precautions (5.2 , 5.3 , 5.4 , 5.5 )]. 8.6 Renal Impairment Patients with pre-existing renal disease, patients with conditions that put them at high risk for renal failure, or those receiving potentially nephrotoxic drugs or other diuretics, are at increased risk of renal failure with administration of mannitol. Evaluate the renal, cardiac and pulmonary status of the patient and correct fluid and electrolyte imbalances prior to administration of OSMITROL [see Warnings and Precautions (5.2 , 5.3 , 5.4 , 5.5 )]."],"package_label_principal_display_panel":["PACKAGE/LABEL PRINCIPAL DISPLAY PANEL Container Label 2D5613 NDC 0338-0353-03 10% OSMITROL Injection (10% Mannitol Injection USP) 500 mL EACH 100 mL CONTAINS 10 g MANNITOL USP pH ADJUSTED WITH SODIUM HYDROXIDE OR HYDROCHLORIC ACID pH 5.0 (4.5 TO 7.0) HYPERTONIC OSMOLARITY 549 mOsmol/L (CALC) STERILE NONPYROGENIC SINGLE DOSE CONTAINER OSMOTIC DIURETIC DOSAGE INTRAVENOUSLY AS DIRECTED BY A PHYSICIAN SEE DIRECTIONS CAUTIONS SQUEEZE AND INSPECT INNER BAG WHICH MAINTAINS PRODUCT STERILITY DISCARD IF LEAKS ARE FOUND DO NOT ADMINISTER SIMULTANEOUSLY WITH BLOOD MUST NOT BE USED IN SERIES CONNECTIONS DO NOT USE UNLESS SOLUTION IS CLEAR RX ONLY STORE UNIT IN MOISTURE BARRIER OVERWRAP AT ROOM TEMPERATURE (25 ° C/77 º F) UNTIL READY TO USE AVOID EXCESSIVE HEAT SEE INSERT VIAFLEX CONTAINER PL 146 PLASTIC FOR PRODUCT INFORMATION 1-800-933-0303 BAXTER OSMITROL VIAFLEX AND PL 146 ARE TRADEMARKS OF BAXTER INTERNATIONAL INC BAXTER HEALTHCARE CORPORATION DEERFIELD IL 60015 USA MADE IN USA Container Label LOT EXP 2D5632 NDC 0338-0357-02 20% OSMITROL Injection (20% Mannitol Injection USP) 250 mL EACH 100 mL CONTAINS 20 g MANNITOL USP pH ADJUSTED WITH SODIUM HYDROXIDE OR HYDROCHLORIC ACID pH 5.0 (4.5 TO 7.0) OSMOLARITY 1098 mOsmol/L (CALC) HYPERTONIC MAY CAUSE VEIN DAMAGE STERILE NONPYROGENIC SINGLE DOSE CONTAINER OSMOTIC DIURETIC DOSAGE INTRAVENOUSLY AS DIRECTED BY A PHYSICIAN USING A FILTER TYPE SET SEE DIRECTIONS CAUTIONS SQUEEZE AND INSPECT INNER BAG WHICH MAINTAINS PRODUCT STERILITY DISCARD IF LEAKS ARE FOUND DO NOT ADMINISTER SIMULTANEOUSLY WITH BLOOD MUST NOT BE USED IN SERIES CONNECTIONS DO NOT USE UNLESS SOLUTION IS CLEAR IF CRYSTALS ARE VISIBLE REDISSOLVE BY WARMING UNIT TO 70°C/158°F WITH AGITATION COOL TO ROOM TEMPERATURE AND REINSPECT FOR CRYSTALS BEFORE INFUSION RX ONLY STORE UNIT IN MOISTURE BARRIER OVERWRAP AT ROOM TEMPERATURE (25 ° C/77 º F) UNTIL READY TO USE AVOID EXCESSIVE HEAT SEE INSERT VIAFLEX CONTAINER PL 146 PLASTIC FOR PRODUCT INFORMATION 1-800-933-0303 BAXTER OSMITROL VIAFLEX AND PL 146 ARE TRADEMARKS OF BAXTER INTERNATIONAL INC BAXTER HEALTHCARE CORPORATION DEERFIELD IL 60015 USA MADE IN USA Osmitrol Injection Representative Container Label NDC 0338-053-03 Osmitrol Injection Representative Container Label NDC 0338-0357-02"]},"tags":[{"label":"Osmotic Diuretic","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"A06AD16","category":"atc"},{"label":"Respiratory (Inhalation)","category":"route"},{"label":"Oral","category":"route"},{"label":"Topical","category":"route"},{"label":"Capsule","category":"form"},{"label":"Cream","category":"form"},{"label":"Injection","category":"form"},{"label":"Irrigant","category":"form"},{"label":"Off-Patent","category":"patent"},{"label":"Generic Available","category":"availability"},{"label":"Established","category":"status"},{"label":"Benign intracranial hypertension","category":"indication"},{"label":"Cerebral edema","category":"indication"},{"label":"Cystic fibrosis","category":"indication"},{"label":"Edema","category":"indication"},{"label":"Hemolysis Prevention","category":"indication"},{"label":"Ocular hypertension","category":"indication"},{"label":"Baxter Hlthcare","category":"company"},{"label":"Approved 1960s","category":"decade"},{"label":"Diuretics","category":"pharmacology"},{"label":"Diuretics, Osmotic","category":"pharmacology"},{"label":"Flavoring Agents","category":"pharmacology"},{"label":"Food Additives","category":"pharmacology"},{"label":"Natriuretic Agents","category":"pharmacology"},{"label":"Sweetening Agents","category":"pharmacology"}],"phase":"marketed","safety":{"boxedWarnings":[],"safetySignals":[{"date":"","signal":"PAIN","source":"FDA FAERS","actionTaken":"609 reports"},{"date":"","signal":"RENAL FAILURE","source":"FDA FAERS","actionTaken":"592 reports"},{"date":"","signal":"ANXIETY","source":"FDA FAERS","actionTaken":"504 reports"},{"date":"","signal":"INJURY","source":"FDA FAERS","actionTaken":"496 reports"},{"date":"","signal":"UNEVALUABLE EVENT","source":"FDA FAERS","actionTaken":"470 reports"},{"date":"","signal":"DRUG INEFFECTIVE","source":"FDA FAERS","actionTaken":"437 reports"},{"date":"","signal":"STRESS","source":"FDA FAERS","actionTaken":"437 reports"},{"date":"","signal":"FEAR","source":"FDA FAERS","actionTaken":"430 reports"},{"date":"","signal":"DEATH","source":"FDA FAERS","actionTaken":"426 reports"},{"date":"","signal":"RENAL IMPAIRMENT","source":"FDA FAERS","actionTaken":"391 reports"}],"commonSideEffects":[{"effect":"pulmonary edema","drugRate":"reported","severity":"unknown"},{"effect":"hypertension","drugRate":"reported","severity":"unknown"},{"effect":"tachycardia","drugRate":"reported","severity":"unknown"},{"effect":"angina-like chest pains","drugRate":"reported","severity":"unknown"},{"effect":"skin necrosis","drugRate":"reported","severity":"unknown"},{"effect":"thrombophlebitis","drugRate":"reported","severity":"unknown"},{"effect":"urinary retention","drugRate":"reported","severity":"unknown"},{"effect":"osmotic nephrosis","drugRate":"reported","severity":"unknown"},{"effect":"acidosis","drugRate":"reported","severity":"unknown"},{"effect":"dehydration","drugRate":"reported","severity":"unknown"},{"effect":"fluid and electrolyte imbalance","drugRate":"reported","severity":"unknown"},{"effect":"convulsions","drugRate":"reported","severity":"unknown"},{"effect":"dizziness","drugRate":"reported","severity":"unknown"},{"effect":"headache","drugRate":"reported","severity":"unknown"},{"effect":"blurred vision","drugRate":"reported","severity":"unknown"},{"effect":"rhinitis","drugRate":"reported","severity":"unknown"},{"effect":"hypotension","drugRate":"reported","severity":"unknown"},{"effect":"nausea","drugRate":"reported","severity":"unknown"},{"effect":"vomiting","drugRate":"reported","severity":"unknown"},{"effect":"diarrhea","drugRate":"reported","severity":"unknown"},{"effect":"dryness of mouth","drugRate":"reported","severity":"unknown"},{"effect":"uricaria","drugRate":"reported","severity":"unknown"},{"effect":"thirst","drugRate":"reported","severity":"unknown"},{"effect":"arm pain","drugRate":"reported","severity":"unknown"},{"effect":"chills","drugRate":"reported","severity":"unknown"},{"effect":"fever","drugRate":"reported","severity":"unknown"}],"contraindications":["Alcoholism","Anemia","Anuria","Breastfeeding (mother)","Chronic heart failure","Depressive disorder","Disease of liver","Dyspnea","Fragile capillaries","Hepatic coma","Hepatic encephalopathy","Hepatic failure","Hyperammonemia","Hyperkalemia","Hypernatremia","Hyponatremia","Hypovolemia","Impaired renal function disorder","Intracranial hemorrhage","Neutropenic disorder","Oliguria","Poisoning by phenobarbital","Porphyria","Pregnancy, function","Pulmonary congestion"],"specialPopulations":{"Pregnancy":"There are no adequate and well-controlled studies of BRONCHITOL in pregnant women. The available data on BRONCHITOL use in pregnant women are not sufficient to inform any drug-associated risks for major birth defects and miscarriage. Based on animal reproduction studies, no evidence of structural alterations was observed when mannitol was administered to pregnant rats and mice during organogenesis at doses up to approximately 20 and 10 times, respectively, the maximum recommended human dose.","Geriatric use":"Mannitol is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in elderly patients with impaired renal function. Evaluate the renal, cardiac and pulmonary status of the patient and correct fluid and electrolyte imbalances prior to administration of Mannitol Injection.","Paediatric use":"Mannitol Injection is approved for use in the pediatric population for the reduction of intracranial and intraocular pressure. Studies have not defined the optimal dose of Mannitol Injection in the pediatric population. The safety profile for mannitol use in pediatric patients is similar to adults at dosages described in labeling. However, pediatric patients less than two years of age, particularly preterm and term neonates, may be at higher risk for fluid and electrolyte abnormalities.","Renal impairment":"Mannitol is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in elderly patients with impaired renal function."}},"trials":[],"aliases":[],"company":"Baxter","patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=MANNITOL","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T03:38:46.841080+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T03:38:52.045708+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=MANNITOL","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T03:38:52.344471+00:00"},"mechanism.drugClass":{"url":"https://api.fda.gov/drug/label.json","method":"deterministic","source":"FDA Label (EPC)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:38:41.105215+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:38:41.105253+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:38:41.105273+00:00"},"safety.safetySignals":{"url":"https://api.fda.gov/drug/event.json","method":"api_direct","source":"FDA FAERS","rawText":"","confidence":1,"sourceType":"fda_faers","retrievedAt":"2026-04-20T03:38:53.865495+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL689/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T03:38:53.075855+00:00"},"regulatory.fda_application":{"url":"","method":"deterministic","source":"FDA Label","rawText":"NDA013684","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:38:41.105277+00:00"}},"allNames":"aridol kit","offLabel":[],"synonyms":["d-mannitol","mannitol","mannitol,d-","bronchitol"],"timeline":[{"date":"1880-01-01","type":"positive","_source":"Wikipedia","milestone":"Julije Domac elucidated the structure of hexene and mannitol","regulator":"none"},{"date":"1964-06-08","type":"positive","_source":"FDA NDA013684","milestone":"FDA ORIG — BAXTER HLTHCARE","regulator":"FDA","description":""},{"date":"1967-12-22","type":"positive","_source":"FDA NDA016269","milestone":"FDA ORIG — HOSPIRA","regulator":"FDA","description":""},{"date":"1972-08-11","type":"positive","_source":"FDA ANDA080677","milestone":"FDA ORIG — FRESENIUS KABI USA","regulator":"FDA","description":""},{"date":"1974-11-11","type":"positive","_source":"FDA NDA013684","milestone":"FDA SUPPL — BAXTER HLTHCARE","regulator":"FDA","description":""},{"date":"1975-06-16","type":"positive","_source":"FDA NDA013684","milestone":"FDA SUPPL — BAXTER HLTHCARE","regulator":"FDA","description":""},{"date":"1976-01-05","type":"positive","_source":"FDA NDA013684","milestone":"FDA SUPPL — BAXTER HLTHCARE","regulator":"FDA","description":""},{"date":"1976-03-01","type":"positive","_source":"FDA NDA016269","milestone":"FDA SUPPL — HOSPIRA","regulator":"FDA","description":""},{"date":"1977-02-04","type":"positive","_source":"FDA NDA016269","milestone":"FDA SUPPL — HOSPIRA","regulator":"FDA","description":""},{"date":"1977-02-07","type":"positive","_source":"FDA NDA013684","milestone":"FDA SUPPL — BAXTER HLTHCARE","regulator":"FDA","description":""},{"date":"1978-02-28","type":"positive","_source":"FDA NDA013684","milestone":"FDA SUPPL — BAXTER HLTHCARE","regulator":"FDA","description":""},{"date":"1978-08-18","type":"positive","_source":"FDA NDA016269","milestone":"FDA SUPPL — HOSPIRA","regulator":"FDA","description":""},{"date":"1979-04-25","type":"positive","_source":"FDA NDA013684","milestone":"FDA SUPPL — BAXTER HLTHCARE","regulator":"FDA","description":""},{"date":"1980-01-08","type":"positive","_source":"FDA NDA016269","milestone":"FDA SUPPL — HOSPIRA","regulator":"FDA","description":""},{"date":"1980-02-22","type":"positive","_source":"FDA NDA018316","milestone":"FDA ORIG — OTSUKA ICU MEDCL","regulator":"FDA","description":""},{"date":"1980-02-25","type":"positive","_source":"FDA NDA013684","milestone":"FDA SUPPL — BAXTER HLTHCARE","regulator":"FDA","description":""},{"date":"1980-06-03","type":"positive","_source":"FDA NDA018316","milestone":"FDA SUPPL — OTSUKA ICU MEDCL","regulator":"FDA","description":""},{"date":"1981-01-13","type":"positive","_source":"FDA NDA016269","milestone":"FDA SUPPL — HOSPIRA","regulator":"FDA","description":""},{"date":"1981-01-21","type":"positive","_source":"FDA NDA013684","milestone":"FDA SUPPL — BAXTER HLTHCARE","regulator":"FDA","description":""},{"date":"1981-09-16","type":"positive","_source":"FDA NDA018316","milestone":"FDA SUPPL — OTSUKA ICU MEDCL","regulator":"FDA","description":""},{"date":"1982-01-08","type":"positive","_source":"FDA NDA018316","milestone":"FDA SUPPL — OTSUKA ICU MEDCL","regulator":"FDA","description":""},{"date":"1982-02-16","type":"positive","_source":"FDA NDA013684","milestone":"FDA SUPPL — BAXTER HLTHCARE","regulator":"FDA","description":""},{"date":"1982-05-05","type":"positive","_source":"FDA NDA016269","milestone":"FDA SUPPL — HOSPIRA","regulator":"FDA","description":""},{"date":"1982-11-01","type":"positive","_source":"FDA ANDA080677","milestone":"FDA SUPPL — FRESENIUS KABI USA","regulator":"FDA","description":""},{"date":"1983-07-05","type":"positive","_source":"FDA NDA016269","milestone":"FDA SUPPL — HOSPIRA","regulator":"FDA","description":""},{"date":"1983-07-11","type":"positive","_source":"FDA NDA013684","milestone":"FDA SUPPL — BAXTER HLTHCARE","regulator":"FDA","description":""},{"date":"1983-09-20","type":"positive","_source":"FDA ANDA080677","milestone":"FDA SUPPL — FRESENIUS KABI USA","regulator":"FDA","description":""},{"date":"1984-02-17","type":"positive","_source":"FDA NDA018316","milestone":"FDA SUPPL — OTSUKA ICU MEDCL","regulator":"FDA","description":""},{"date":"1984-02-28","type":"positive","_source":"FDA NDA013684","milestone":"FDA SUPPL — BAXTER HLTHCARE","regulator":"FDA","description":""},{"date":"1985-01-10","type":"positive","_source":"FDA ANDA080677","milestone":"FDA SUPPL — FRESENIUS KABI USA","regulator":"FDA","description":""},{"date":"1985-01-24","type":"positive","_source":"FDA NDA013684","milestone":"FDA SUPPL — BAXTER HLTHCARE","regulator":"FDA","description":""},{"date":"1985-06-17","type":"positive","_source":"FDA NDA018316","milestone":"FDA SUPPL — OTSUKA ICU MEDCL","regulator":"FDA","description":""},{"date":"1985-11-22","type":"positive","_source":"FDA NDA016269","milestone":"FDA SUPPL — HOSPIRA","regulator":"FDA","description":""},{"date":"1986-01-31","type":"positive","_source":"FDA NDA018316","milestone":"FDA SUPPL — OTSUKA ICU MEDCL","regulator":"FDA","description":""},{"date":"1987-01-08","type":"positive","_source":"FDA NDA019603","milestone":"FDA ORIG — OTSUKA ICU MEDCL","regulator":"FDA","description":""},{"date":"1987-05-28","type":"positive","_source":"FDA NDA013684","milestone":"FDA SUPPL — BAXTER HLTHCARE","regulator":"FDA","description":""},{"date":"1987-07-30","type":"positive","_source":"FDA NDA018316","milestone":"FDA SUPPL — OTSUKA ICU MEDCL","regulator":"FDA","description":""},{"date":"1988-02-01","type":"positive","_source":"FDA NDA016269","milestone":"FDA SUPPL — HOSPIRA","regulator":"FDA","description":""},{"date":"1989-01-11","type":"positive","_source":"FDA ANDA080677","milestone":"FDA SUPPL — FRESENIUS KABI USA","regulator":"FDA","description":""},{"date":"1989-07-26","type":"positive","_source":"FDA NDA013684","milestone":"FDA SUPPL — BAXTER HLTHCARE","regulator":"FDA","description":""},{"date":"1989-09-13","type":"positive","_source":"FDA NDA018316","milestone":"FDA SUPPL — OTSUKA ICU MEDCL","regulator":"FDA","description":""},{"date":"1990-01-08","type":"positive","_source":"FDA NDA019603","milestone":"FDA SUPPL — OTSUKA ICU MEDCL","regulator":"FDA","description":""},{"date":"1991-02-15","type":"positive","_source":"FDA NDA013684","milestone":"FDA SUPPL — BAXTER HLTHCARE","regulator":"FDA","description":""},{"date":"1991-06-04","type":"positive","_source":"FDA NDA016269","milestone":"FDA SUPPL — HOSPIRA","regulator":"FDA","description":""},{"date":"1991-06-19","type":"positive","_source":"FDA ANDA080677","milestone":"FDA SUPPL — FRESENIUS KABI USA","regulator":"FDA","description":""},{"date":"1991-08-30","type":"positive","_source":"FDA NDA018316","milestone":"FDA SUPPL — OTSUKA ICU MEDCL","regulator":"FDA","description":""},{"date":"1992-01-28","type":"positive","_source":"FDA NDA019603","milestone":"FDA SUPPL — OTSUKA ICU MEDCL","regulator":"FDA","description":""},{"date":"1992-05-01","type":"positive","_source":"FDA ANDA080677","milestone":"FDA SUPPL — FRESENIUS KABI USA","regulator":"FDA","description":""},{"date":"1993-04-08","type":"positive","_source":"FDA ANDA080677","milestone":"FDA SUPPL — FRESENIUS KABI USA","regulator":"FDA","description":""},{"date":"1993-07-26","type":"positive","_source":"FDA NDA020006","milestone":"FDA ORIG — B BRAUN","regulator":"FDA","description":""},{"date":"1994-02-18","type":"positive","_source":"FDA NDA013684","milestone":"FDA SUPPL — BAXTER HLTHCARE","regulator":"FDA","description":""},{"date":"1994-08-25","type":"positive","_source":"FDA NDA016269","milestone":"FDA SUPPL — HOSPIRA","regulator":"FDA","description":""},{"date":"1994-08-25","type":"positive","_source":"FDA NDA019603","milestone":"FDA SUPPL — OTSUKA ICU MEDCL","regulator":"FDA","description":""},{"date":"1994-12-06","type":"positive","_source":"FDA ANDA080677","milestone":"FDA SUPPL — FRESENIUS KABI USA","regulator":"FDA","description":""},{"date":"1995-07-14","type":"positive","_source":"FDA ANDA080677","milestone":"FDA SUPPL — FRESENIUS KABI USA","regulator":"FDA","description":""},{"date":"1995-08-14","type":"positive","_source":"FDA NDA016269","milestone":"FDA SUPPL — HOSPIRA","regulator":"FDA","description":""},{"date":"1995-08-14","type":"positive","_source":"FDA NDA019603","milestone":"FDA SUPPL — OTSUKA ICU MEDCL","regulator":"FDA","description":""},{"date":"1996-03-04","type":"positive","_source":"FDA NDA019603","milestone":"FDA SUPPL — OTSUKA ICU MEDCL","regulator":"FDA","description":""},{"date":"1996-08-27","type":"positive","_source":"FDA NDA016269","milestone":"FDA SUPPL — HOSPIRA","regulator":"FDA","description":""},{"date":"1997-01-17","type":"positive","_source":"FDA NDA016269","milestone":"FDA SUPPL — HOSPIRA","regulator":"FDA","description":""},{"date":"1997-03-28","type":"positive","_source":"FDA NDA018316","milestone":"FDA SUPPL — OTSUKA ICU MEDCL","regulator":"FDA","description":""},{"date":"1997-04-29","type":"positive","_source":"FDA NDA013684","milestone":"FDA SUPPL — BAXTER HLTHCARE","regulator":"FDA","description":""},{"date":"1998-08-21","type":"positive","_source":"FDA NDA020006","milestone":"FDA SUPPL — B BRAUN","regulator":"FDA","description":""},{"date":"1998-12-01","type":"positive","_source":"FDA NDA019603","milestone":"FDA SUPPL — OTSUKA ICU MEDCL","regulator":"FDA","description":""},{"date":"1999-01-05","type":"positive","_source":"FDA NDA018316","milestone":"FDA SUPPL — OTSUKA ICU MEDCL","regulator":"FDA","description":""},{"date":"1999-08-13","type":"positive","_source":"FDA ANDA080677","milestone":"FDA SUPPL — FRESENIUS KABI USA","regulator":"FDA","description":""},{"date":"1999-11-24","type":"positive","_source":"FDA NDA013684","milestone":"FDA SUPPL — BAXTER HLTHCARE","regulator":"FDA","description":""},{"date":"2000-07-10","type":"positive","_source":"FDA NDA019603","milestone":"FDA SUPPL — OTSUKA ICU MEDCL","regulator":"FDA","description":""},{"date":"2000-12-07","type":"positive","_source":"FDA NDA020006","milestone":"FDA SUPPL — B BRAUN","regulator":"FDA","description":""},{"date":"2001-08-14","type":"positive","_source":"FDA NDA013684","milestone":"FDA SUPPL — BAXTER HLTHCARE","regulator":"FDA","description":""},{"date":"2002-01-16","type":"positive","_source":"FDA NDA013684","milestone":"FDA SUPPL — BAXTER HLTHCARE","regulator":"FDA","description":""},{"date":"2002-04-15","type":"positive","_source":"FDA NDA020006","milestone":"FDA SUPPL — B BRAUN","regulator":"FDA","description":""},{"date":"2002-09-05","type":"positive","_source":"FDA NDA016269","milestone":"FDA SUPPL — HOSPIRA","regulator":"FDA","description":""},{"date":"2005-04-20","type":"positive","_source":"FDA NDA020006","milestone":"FDA SUPPL — B BRAUN","regulator":"FDA","description":""},{"date":"2005-06-09","type":"positive","_source":"FDA NDA013684","milestone":"FDA SUPPL — BAXTER HLTHCARE","regulator":"FDA","description":""},{"date":"2010-10-05","type":"positive","_source":"FDA NDA022368","milestone":"FDA ORIG — PHARMAXIS EUROPE","regulator":"FDA","description":""},{"date":"2013-07-19","type":"positive","_source":"FDA NDA013684","milestone":"FDA SUPPL — BAXTER HLTHCARE","regulator":"FDA","description":""},{"date":"2015-04-08","type":"positive","_source":"FDA NDA016269","milestone":"FDA SUPPL — HOSPIRA","regulator":"FDA","description":""},{"date":"2015-04-08","type":"positive","_source":"FDA NDA013684","milestone":"FDA SUPPL — BAXTER HLTHCARE","regulator":"FDA","description":""},{"date":"2018-11-15","type":"positive","_source":"FDA NDA013684","milestone":"FDA SUPPL — BAXTER HLTHCARE","regulator":"FDA","description":""},{"date":"2019-01-09","type":"positive","_source":"FDA NDA016269","milestone":"FDA SUPPL — HOSPIRA","regulator":"FDA","description":""},{"date":"2019-01-09","type":"positive","_source":"FDA NDA019603","milestone":"FDA SUPPL — OTSUKA ICU MEDCL","regulator":"FDA","description":""},{"date":"2019-01-09","type":"positive","_source":"FDA NDA020006","milestone":"FDA SUPPL — B BRAUN","regulator":"FDA","description":""},{"date":"2019-08-05","type":"positive","_source":"FDA NDA013684","milestone":"FDA SUPPL — BAXTER HLTHCARE","regulator":"FDA","description":""},{"date":"2020-03-17","type":"positive","_source":"FDA NDA016269","milestone":"FDA SUPPL — HOSPIRA","regulator":"FDA","description":""},{"date":"2020-04-29","type":"positive","_source":"FDA NDA019603","milestone":"FDA SUPPL — OTSUKA ICU MEDCL","regulator":"FDA","description":""},{"date":"2021-08-13","type":"positive","_source":"FDA NDA022368","milestone":"FDA SUPPL — PHARMAXIS EUROPE","regulator":"FDA","description":""}],"aiSummary":"Aridol Kit (Mannitol) is a small molecule osmotic diuretic originally developed by Baxter Healthcare, which remains the current owner. It was FDA-approved in 1964 for various indications including benign intracranial hypertension, cerebral edema, and cystic fibrosis. As an off-patent medication, it is available from multiple generic manufacturers. Key safety considerations include its potential to cause dehydration and electrolyte imbalances. Aridol Kit is used to treat conditions characterized by fluid accumulation in the body.","approvals":[{"date":"1964-06-08","orphan":false,"company":"BAXTER HLTHCARE","regulator":"FDA"}],"brandName":"Aridol Kit","ecosystem":[{"indication":"Benign intracranial hypertension","otherDrugs":[{"name":"thiopental","slug":"thiopental","company":"Abbott"}],"globalPrevalence":1280000000},{"indication":"Cerebral edema","otherDrugs":[{"name":"betamethasone","slug":"betamethasone","company":""},{"name":"betamethasone acetate","slug":"betamethasone-acetate","company":""},{"name":"cortisone acetate","slug":"cortisone-acetate","company":""},{"name":"dexamethasone","slug":"dexamethasone","company":""}],"globalPrevalence":null},{"indication":"Cystic fibrosis","otherDrugs":[{"name":"dornase alfa","slug":"dornase-alfa","company":"Genentech"},{"name":"elexacaftor","slug":"elexacaftor","company":"Vertex Pharms Inc"}],"globalPrevalence":890552},{"indication":"Edema","otherDrugs":[{"name":"acetazolamide","slug":"acetazolamide","company":"Teva Branded Pharm"},{"name":"amiloride","slug":"amiloride","company":"Paddock Llc"},{"name":"bumetanide","slug":"bumetanide","company":""},{"name":"chlorothiazide","slug":"chlorothiazide","company":"Oak Pharms Akorn"}],"globalPrevalence":200000},{"indication":"Hemolysis Prevention","otherDrugs":[],"globalPrevalence":null},{"indication":"Ocular hypertension","otherDrugs":[{"name":"betaxolol","slug":"betaxolol","company":"Alcon"},{"name":"bimatoprost","slug":"bimatoprost","company":""},{"name":"brimonidine","slug":"brimonidine","company":""},{"name":"brinzolamide","slug":"brinzolamide","company":"Alcon Pharms Ltd"}],"globalPrevalence":1280000000}],"mechanism":{"target":"sodium channels","novelty":"First-in-class","moaClass":"Osmotic Activity","modality":"Small Molecule","drugClass":"Osmotic Diuretic [EPC]","explanation":"The precise mechanism of action of BRONCHITOL in improving pulmonary function in cystic fibrosis patients is unknown.","oneSentence":"Mannitol works by drawing water into the bloodstream from surrounding tissues, increasing urine production and reducing fluid accumulation in the body.","technicalDetail":"Mannitol acts as an osmotic diuretic by increasing the osmotic pressure in the bloodstream, which draws water from the interstitial space into the vascular compartment, resulting in increased urine production and reduced fluid accumulation in the body."},"commercial":{"yoyGrowth":"7%","launchDate":"1964","annualCostUS":"$0.00","_launchSource":"DrugCentral (FDA 1964-06-08, BAXTER HLTHCARE)","genericStatus":"Generic — off-patent","currentRevenue":"$21.2B","manufacturerCount":"6 approved manufacturers","patientPopulation":"Generic — multiple manufacturers","peakSalesEstimate":"$21.2B"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/935","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=MANNITOL","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=MANNITOL","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files","fields":["patents","exclusivity","genericManufacturers"],"source":"FDA Orange Book"}],"_enrichedAt":"2026-03-30T14:13:47.381991","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T03:38:56.861237+00:00","fieldsConflicting":0,"overallConfidence":0.95},"biosimilars":[],"competitors":[{"drugName":"magnesium carbonate","drugSlug":"magnesium-carbonate","fdaApproval":"1990-10-02","relationship":"same-class"},{"drugName":"magnesium oxide","drugSlug":"magnesium-oxide","fdaApproval":"1982-06-22","relationship":"same-class"},{"drugName":"magnesium sulfate","drugSlug":"magnesium-sulfate","fdaApproval":"1981-10-06","genericCount":12,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"lactulose","drugSlug":"lactulose","fdaApproval":"1976-03-25","genericCount":24,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"lactitol","drugSlug":"lactitol","fdaApproval":"2020-02-12","patentExpiry":"May 12, 2037","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"sodium sulfate","drugSlug":"sodium-sulfate","fdaApproval":"1986-04-30","relationship":"same-class"},{"drugName":"macrogol","drugSlug":"macrogol","fdaApproval":"1984-07-13","relationship":"same-class"},{"drugName":"sodium phosphate","drugSlug":"sodium-phosphate","fdaApproval":"1983-05-10","patentStatus":"Unknown","relationship":"same-class"},{"drugName":"sorbitol","drugSlug":"sorbitol","fdaApproval":"1971-08-20","patentStatus":"Unknown","relationship":"same-class"},{"drugName":"magnesium citrate","drugSlug":"magnesium-citrate","fdaApproval":"","relationship":"same-class"}],"genericName":"mannitol","indications":{"approved":[{"name":"Benign intracranial hypertension","source":"DrugCentral","snomedId":68267002,"regulator":"FDA","eligibility":"No information available","usPrevalence":119900000,"globalPrevalence":1280000000,"prevalenceMethod":"curated","prevalenceSource":"WHO, 2023"},{"name":"Cerebral edema","source":"DrugCentral","snomedId":2032001,"regulator":"FDA","eligibility":"No information available"},{"name":"Cystic fibrosis","source":"DrugCentral","snomedId":190905008,"regulator":"FDA","eligibility":"No information available","usPrevalence":null,"globalPrevalence":890552,"prevalenceMethod":"curated","prevalenceSource":"Orphanet (ORPHANET)"},{"name":"Edema","source":"DrugCentral","snomedId":267038008,"regulator":"FDA","eligibility":"No information available","usPrevalence":null,"globalPrevalence":200000,"prevalenceMethod":"curated","prevalenceSource":"Int Arch Allergy Immunol, 2025 (PMID:39827848)"},{"name":"Hemolysis Prevention","source":"DrugCentral","snomedId":"","regulator":"FDA","eligibility":"No information available"},{"name":"Ocular hypertension","source":"DrugCentral","snomedId":4210003,"regulator":"FDA","eligibility":"No information available","usPrevalence":119900000,"globalPrevalence":1280000000,"prevalenceMethod":"curated","prevalenceSource":"WHO, 2023"}],"offLabel":[],"pipeline":[]},"currentOwner":"Baxter Hlthcare","drugCategory":"established","labelChanges":[],"patentStatus":"Off-patent — no active Orange Book patents","relatedDrugs":[{"drugId":"magnesium-carbonate","brandName":"magnesium carbonate","genericName":"magnesium carbonate","approvalYear":"1990","relationship":"same-class"},{"drugId":"magnesium-oxide","brandName":"magnesium oxide","genericName":"magnesium oxide","approvalYear":"1982","relationship":"same-class"},{"drugId":"magnesium-sulfate","brandName":"magnesium sulfate","genericName":"magnesium sulfate","approvalYear":"1981","relationship":"same-class"},{"drugId":"lactulose","brandName":"lactulose","genericName":"lactulose","approvalYear":"1976","relationship":"same-class"},{"drugId":"lactitol","brandName":"lactitol","genericName":"lactitol","approvalYear":"2020","relationship":"same-class"},{"drugId":"sodium-sulfate","brandName":"sodium sulfate","genericName":"sodium sulfate","approvalYear":"1986","relationship":"same-class"},{"drugId":"macrogol","brandName":"macrogol","genericName":"macrogol","approvalYear":"1984","relationship":"same-class"},{"drugId":"sodium-phosphate","brandName":"sodium phosphate","genericName":"sodium phosphate","approvalYear":"1983","relationship":"same-class"},{"drugId":"sorbitol","brandName":"sorbitol","genericName":"sorbitol","approvalYear":"1971","relationship":"same-class"},{"drugId":"magnesium-citrate","brandName":"magnesium citrate","genericName":"magnesium citrate","approvalYear":"","relationship":"same-class"}],"trialDetails":[{"nctId":"NCT02134353","phase":"PHASE3","title":"A Safety and Efficacy Trial of Inhaled Mannitol in Adult Cystic Fibrosis Subjects","status":"COMPLETED","sponsor":"Syntara","isPivotal":true,"startDate":"2014-09","conditions":["Cystic Fibrosis"],"enrollment":423,"completionDate":"2017-02"},{"nctId":"NCT00446680","phase":"PHASE3","title":"Long Term Administration of Inhaled Dry Powder Mannitol In Cystic Fibrosis - A Safety and Efficacy Study","status":"COMPLETED","sponsor":"Syntara","isPivotal":true,"startDate":"2007-03","conditions":["Cystic Fibrosis"],"enrollment":340,"completionDate":"2010-05"},{"nctId":"NCT00630812","phase":"PHASE3","title":"Long Term Administration of Inhaled Mannitol in Cystic Fibrosis","status":"COMPLETED","sponsor":"Syntara","isPivotal":true,"startDate":"2008-09","conditions":["Cystic Fibrosis"],"enrollment":318,"completionDate":"2010-11"},{"nctId":"NCT07495449","phase":"NA","title":"Effect of Infusion Warming on Mannitol Infusion Pain in Patients With Acute Ocular Hypertension","status":"COMPLETED","sponsor":"Joint Shantou International Eye Center of Shantou University and the Chinese University of Hong Kong","startDate":"2025-01-09","conditions":["Acute Ocular Hypertension Glaucoma","Intraocular Hypertension","Primary Angle-Closure Glaucoma"],"enrollment":142,"completionDate":"2025-07-27"},{"nctId":"NCT05808023","phase":"NA","title":"Dose-dependent FODMAP Reintroduction in IBS","status":"COMPLETED","sponsor":"Universitaire Ziekenhuizen KU Leuven","startDate":"2023-04-01","conditions":["Irritable Bowel Syndrome"],"enrollment":45,"completionDate":"2025-08-25"},{"nctId":"NCT02938520","phase":"PHASE3","title":"Study to Evaluate the Efficacy, Safety, and Tolerability of Long-acting Intramuscular Cabotegravir and Rilpivirine for Maintenance of Virologic Suppression Following Switch From an Integrase Inhibitor in HIV-1 Infected Therapy Naive Participants","status":"ACTIVE_NOT_RECRUITING","sponsor":"ViiV Healthcare","startDate":"2016-10-27","conditions":["HIV Infections"],"enrollment":631,"completionDate":"2029-12-31"},{"nctId":"NCT07481734","phase":"PHASE2","title":"Tesamorelin for Reduction of Liver Fat in Adults With Fatty Liver Disease (Mock Study)","status":"RECRUITING","sponsor":"Hudson Biotech","startDate":"2026-02-02","conditions":["Metabolic Associated Steatotic Liver Disease","Nonalcoholic Steatohepatitis","Hepatic Steatosis"],"enrollment":120,"completionDate":"2028-02-17"},{"nctId":"NCT06287372","phase":"","title":"Comparison of Changes in Intra-myocardial Amino Acids During Use of Calafiore and Modified Del Nido Cardioplegia","status":"COMPLETED","sponsor":"Damascus University","startDate":"2022-07-04","conditions":["Myocardial Injury","Cardiac Surgery","Myocardial Protection"],"enrollment":20,"completionDate":"2023-07-04"},{"nctId":"NCT05962606","phase":"PHASE2","title":"Safety and Efficacy of AON-D21 in Severe Community-Acquired Pneumonia.","status":"COMPLETED","sponsor":"Aptarion Biotech AG","startDate":"2024-02-02","conditions":["Community-acquired Pneumonia"],"enrollment":150,"completionDate":"2026-03-16"},{"nctId":"NCT06408597","phase":"NA","title":"Mannitol Versus Nitroglycerin for Kidney Injury Prevention in Robotic-assisted Radical Prostatectomy or Cystectomy","status":"ACTIVE_NOT_RECRUITING","sponsor":"Nazmy Edward Seif","startDate":"2024-05-12","conditions":["Prostate Cancer","Bladder Cancer","Surgery","Renal Impairment","Renal Injury, Acute"],"enrollment":90,"completionDate":"2026-05"},{"nctId":"NCT05325502","phase":"NA","title":"Does Caffeine Facilitate Human Reward Learning Behaviors?","status":"ACTIVE_NOT_RECRUITING","sponsor":"Yu-Shiuan Lin","startDate":"2022-05-05","conditions":["Caffeine"],"enrollment":36,"completionDate":"2026-12-31"},{"nctId":"NCT07465705","phase":"PHASE3","title":"Clinical Trial on Bowel Preparation Comparing Mannitol 100g to Plenvu Both in a Same Day Regimen (CLEARWAY)","status":"RECRUITING","sponsor":"NTC srl","startDate":"2025-09-02","conditions":["Elective Colonoscopy"],"enrollment":412,"completionDate":"2026-06-30"},{"nctId":"NCT06473779","phase":"PHASE3","title":"Open-label Study to Assess Reduction of Background Asthma Medication While Sustaining Asthma Control and Clinical Remission With Tezepelumab in Patients 12-80yrs With Severe Asthma.","status":"ACTIVE_NOT_RECRUITING","sponsor":"AstraZeneca","startDate":"2024-09-30","conditions":["Severe Asthma"],"enrollment":326,"completionDate":"2027-06-25"},{"nctId":"NCT03875820","phase":"PHASE1","title":"Phase I Trial of Defactinib and VS-6766.","status":"ACTIVE_NOT_RECRUITING","sponsor":"Institute of Cancer Research, United Kingdom","startDate":"2017-12-12","conditions":["NSCLC","Low Grade Serous Ovarian Cancer","Endometrioid Carcinoma","Pancreatic Cancer"],"enrollment":87,"completionDate":"2026-10-31"},{"nctId":"NCT05902819","phase":"NA","title":"Reconsolidation Blockade of Intrusive Trauma- and Cocaine-related Memories","status":"COMPLETED","sponsor":"Psychiatric University Hospital, Zurich","startDate":"2023-05-10","conditions":["Post-traumatic Stress Disorder","Cocaine Use Disorder"],"enrollment":138,"completionDate":"2026-03-02"},{"nctId":"NCT07451782","phase":"NA","title":"Comprehensive Multi-omics Characterization and Implications of Non-Pharmaceutical Dental Hygiene Product in a Randomized Controlled Large Population Study.","status":"COMPLETED","sponsor":"Delta Dental of Minnesota Foundation","startDate":"2024-04-30","conditions":["Basic Science","Intervention Studies","Biomarker Discovery"],"enrollment":595,"completionDate":"2025-07-23"},{"nctId":"NCT06930625","phase":"PHASE3","title":"A Study to Assess the Efficacy and Safety of Debio 4126 in Participants With Acromegaly Previously Treated With Somatostatin Analogs","status":"RECRUITING","sponsor":"Debiopharm International SA","startDate":"2025-11-26","conditions":["Acromegaly"],"enrollment":119,"completionDate":"2029-03"},{"nctId":"NCT07433023","phase":"PHASE2","title":"tSCS and 5-Azacitidine for Enhanced Motor Outcomes in Cerebral Palsy","status":"NOT_YET_RECRUITING","sponsor":"Shirley Ryan AbilityLab","startDate":"2026-03-01","conditions":["Cerebral Palsy"],"enrollment":80,"completionDate":"2029-01-01"},{"nctId":"NCT07434492","phase":"PHASE2","title":"Smart AFO and 5-Azacitidine to Enhance Mobility in Children With Cerebral Palsy","status":"NOT_YET_RECRUITING","sponsor":"Shirley Ryan AbilityLab","startDate":"2026-03-01","conditions":["Cerebral Palsy"],"enrollment":60,"completionDate":"2030-08-31"},{"nctId":"NCT07118839","phase":"PHASE2,PHASE3","title":"MDMA-Assisted Therapy for Veterans With PTSD and Alcohol Use Disorder","status":"NOT_YET_RECRUITING","sponsor":"VA Office of Research and Development","startDate":"2026-04-15","conditions":["Post Traumatic Stress Disorder","Alcohol Use Disorder"],"enrollment":80,"completionDate":"2030-05-30"},{"nctId":"NCT02148796","phase":"PHASE2","title":"Oral Bacterial Extract for the Prevention of Wheezing Lower Respiratory Tract Illness","status":"COMPLETED","sponsor":"University of Arizona","startDate":"2017-01-01","conditions":["Asthma","Wheezing"],"enrollment":822,"completionDate":"2026-01-30"},{"nctId":"NCT05707442","phase":"PHASE3","title":"Stent Implantation Versus Medical Therapy for Idiopathic IntracraniaL Hypertension (SIMPLE)","status":"RECRUITING","sponsor":"Beijing Tiantan Hospital","startDate":"2023-02-16","conditions":["Idiopathic Intracranial Hypotension","Venous Sinus Stenosis"],"enrollment":74,"completionDate":"2027-03"},{"nctId":"NCT05555290","phase":"PHASE3","title":"PT027 Compared to PT007 in Patients With Asthma With Mannitol-induced Acute Airway Obstruction","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2022-09-28","conditions":["Asthma"],"enrollment":190,"completionDate":"2024-11-18"},{"nctId":"NCT07369921","phase":"NA","title":"Pediatric Pilonidal Sinus Surgical Treatment","status":"RECRUITING","sponsor":"Zeliha Alicikus","startDate":"2026-01-30","conditions":["Surgery","Pilonidal Sinus","Pediatric"],"enrollment":80,"completionDate":"2026-05-30"},{"nctId":"NCT07363395","phase":"PHASE1","title":"Safety, Tolerability, and Pharmacokinetics of ASCT-83 in Healthy Adults","status":"NOT_YET_RECRUITING","sponsor":"Alcamena Stem Cell Therapeutics","startDate":"2026-01","conditions":["Neuropathic Pain"],"enrollment":72,"completionDate":"2026-12"},{"nctId":"NCT07064720","phase":"PHASE2,PHASE3","title":"Adding Dexmedetomidine to Mannitol to Attenuate the Increase of Intracranial Pressure","status":"COMPLETED","sponsor":"Cairo University","startDate":"2024-07-12","conditions":["Dexmedetomidine"],"enrollment":60,"completionDate":"2026-01-15"},{"nctId":"NCT05849012","phase":"NA","title":"A Pilot Study Examining Low Sulfur Diet as Treatment for Persistent Symptoms in Quiescent Crohn's Disease","status":"RECRUITING","sponsor":"University of Michigan","startDate":"2023-12-12","conditions":["Crohn's Disease in Remission"],"enrollment":20,"completionDate":"2027-04-30"},{"nctId":"NCT07337707","phase":"NA","title":"New Microbiota-endocrine Axis in Fructose Malabsorption-caused Visceral Hypersensitivity in Irritable Bowel Syndrome.","status":"NOT_YET_RECRUITING","sponsor":"University Hospital, Rouen","startDate":"2026-02","conditions":["Irritable Bowel Syndrome (IBS)"],"enrollment":60,"completionDate":"2027-08"},{"nctId":"NCT03778944","phase":"NA","title":"Enhancing Renal Graft Function During Donor Anesthesia","status":"RECRUITING","sponsor":"Nazmy Edward Seif","startDate":"2018-12-20","conditions":["Renal Failure Chronic","Transplant;Failure,Kidney","Anesthesia"],"enrollment":60,"completionDate":"2026-12"},{"nctId":"NCT05740618","phase":"PHASE4","title":"Inhaled Mannitol on Mucociliary Clearance in Moderate to Severe Cystic Fibrosis","status":"COMPLETED","sponsor":"University of North Carolina, Chapel Hill","startDate":"2023-03-28","conditions":["Cystic Fibrosis"],"enrollment":14,"completionDate":"2025-01-29"},{"nctId":"NCT06897761","phase":"NA","title":"Development of an Interactive Digital Respiratory Game and Device and Investigation of Its Effectiveness in Children With Bronchiectasis","status":"RECRUITING","sponsor":"Atlas University","startDate":"2025-10-07","conditions":["Bronchiectasis"],"enrollment":40,"completionDate":"2026-01-15"},{"nctId":"NCT05428007","phase":"PHASE2","title":"Interleukin-6 Receptor Inhibitor Sarilumab in Combination With Ipilimumab, Nivolumab and Relatlimab in Patients With Unresectable Stage III or Stage IV Melanoma","status":"RECRUITING","sponsor":"NYU Langone Health","startDate":"2023-02-02","conditions":["Melanoma","Unresectable Melanoma"],"enrollment":105,"completionDate":"2028-02"},{"nctId":"NCT02951052","phase":"PHASE3","title":"Study Evaluating the Efficacy, Safety, and Tolerability of Switching to Long-acting Cabotegravir Plus Long-acting Rilpivirine From Current Antiretroviral Regimen in Virologically Suppressed HIV-1-infected Adults","status":"ACTIVE_NOT_RECRUITING","sponsor":"ViiV Healthcare","startDate":"2016-10-28","conditions":["Infection, Human Immunodeficiency Virus","HIV Infections"],"enrollment":618,"completionDate":"2029-12-31"},{"nctId":"NCT03895567","phase":"PHASE1","title":"Study to Compare Blood Levels of Ceftriaxone Given by Suppository or Injection.","status":"SUSPENDED","sponsor":"University of Oxford","startDate":"2026-12","conditions":["Healthy"],"enrollment":37,"completionDate":"2026-12"},{"nctId":"NCT06218511","phase":"PHASE1","title":"A Phase I Trial of IMA970A Plus Montanide in Combination With Durvalumab (Anti-PD-L1)","status":"ACTIVE_NOT_RECRUITING","sponsor":"National Cancer Institute, Naples","startDate":"2022-11-22","conditions":["Hepatocellular Carcinoma"],"enrollment":10,"completionDate":"2026-11"},{"nctId":"NCT06414330","phase":"PHASE3","title":"Ringer Acetate Based Modified Del Nido Cardioplegia Solution Versus HTK Solution Cardioplegia Solution in Cardiac Surgery","status":"COMPLETED","sponsor":"Assiut University","startDate":"2024-06-01","conditions":["Cardiac Ischemia"],"enrollment":124,"completionDate":"2025-12-01"},{"nctId":"NCT05795049","phase":"","title":"Genetic Carbohydrate Maldigestion as a Model to Study Food Hypersensitivity","status":"ACTIVE_NOT_RECRUITING","sponsor":"Nottingham University Hospitals NHS Trust","startDate":"2024-07-23","conditions":["Irritable Bowel Syndrome (IBS)","Sucrase Isomaltase Deficiency"],"enrollment":2000,"completionDate":"2026-03-31"},{"nctId":"NCT05265091","phase":"PHASE1,PHASE2","title":"A Study of KL590586 in Patients With Advanced Solid Tumors","status":"ACTIVE_NOT_RECRUITING","sponsor":"Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.","startDate":"2021-09-15","conditions":["Advanced Solid Tumor"],"enrollment":414,"completionDate":"2026-12-31"},{"nctId":"NCT06488534","phase":"NA","title":"Intracolonic FODMAP Infusion in Healthy Volunteers","status":"COMPLETED","sponsor":"Universitaire Ziekenhuizen KU Leuven","startDate":"2023-06-26","conditions":["Irritable Bowel Syndrome"],"enrollment":15,"completionDate":"2024-12-13"},{"nctId":"NCT05660850","phase":"PHASE2","title":"A Study To Evaluate The Efficacy, Safety, Pharmacokinetics, And Pharmacodynamic Effects Of GDC-6599 In Patients With Chronic Cough","status":"COMPLETED","sponsor":"Genentech, Inc.","startDate":"2023-03-22","conditions":["Chronic Refractory Cough (CRC) With Non-atopic Asthma","CRC With Atopic Asthma","Unexplained Chronic Cough","CRC With Chronic Obstructive Pulmonary Disease","CRC With Chronic Obstructive Pulmonary Disease With Chronic Bronchitis"],"enrollment":49,"completionDate":"2024-10-20"},{"nctId":"NCT06542198","phase":"NA","title":"Mannitol-induced Release of Copeptin in Healthy Adults and Patients With Polyuria-Polydipsia Syndrome (MARS Study)","status":"COMPLETED","sponsor":"University Hospital, Basel, Switzerland","startDate":"2024-09-10","conditions":["Polyuria-polydipsia Syndrome","Arginine Vasopressin Deficiency","Primary Polydipsia"],"enrollment":42,"completionDate":"2025-07-22"},{"nctId":"NCT06759259","phase":"","title":"Mannitol Administration for Delerium Prevention","status":"COMPLETED","sponsor":"Tomsk National Research Medical Center of the Russian Academy of Sciences","startDate":"2024-12-29","conditions":["Myocardial Infarction (MI)","Delirium, Intensive Care Unit, Randomised Controlled Trial"],"enrollment":50,"completionDate":"2025-10-01"},{"nctId":"NCT07268573","phase":"NA","title":"Effects of Caffeine and L-Theanine on Physical and Cognitive Performance in Trained Athletes","status":"COMPLETED","sponsor":"Ulaş Can YILDIRIM","startDate":"2025-08-01","conditions":["Cognitive Performance","Physical Performance Enhancement","Caffeine and L-theanine Interaction"],"enrollment":20,"completionDate":"2025-08-14"},{"nctId":"NCT05106127","phase":"PHASE2","title":"Safety Lead-In Study of a Repurposed Drug Added to the Combination of Len Plus Pem","status":"NOT_YET_RECRUITING","sponsor":"Evergreen Therapeutics, Inc.","startDate":"2026-08","conditions":["Advanced Endometrial Cancer"],"enrollment":28,"completionDate":"2027-03"},{"nctId":"NCT05077215","phase":"PHASE3","title":"Efficacy and Safety of a Repurposed Drug Added to the Combination of Len Plus Pem in Advanced Endometrial Cancer","status":"NOT_YET_RECRUITING","sponsor":"Evergreen Therapeutics, Inc.","startDate":"2026-12","conditions":["Advanced Endometrial Cancer"],"enrollment":450,"completionDate":"2027-12"},{"nctId":"NCT07090824","phase":"PHASE1","title":"Subcutaneous Pharmacokinetic Evaluation of Monomeric Insulin and Lyumjev in Adults With Type 1 Diabetes","status":"RECRUITING","sponsor":"Stanford University","startDate":"2025-10-28","conditions":["Diabetes Mellitus, Type 1","Type 1 Diabetes Mellitus"],"enrollment":20,"completionDate":"2026-10"},{"nctId":"NCT04759885","phase":"PHASE2,PHASE3","title":"Efficacy and Safety of mAnnitol in Bowel Preparation During Elective Colonoscopy and Comparison With Moviprep®","status":"COMPLETED","sponsor":"NTC srl","startDate":"2020-06-18","conditions":["Elective Colonoscopy"],"enrollment":886,"completionDate":"2021-07-16"},{"nctId":"NCT04069299","phase":"","title":"Use of 68Ga-dotatate PET Scan in Neuroendocrine Carcinoma of the GI Tract","status":"ACTIVE_NOT_RECRUITING","sponsor":"H. Lee Moffitt Cancer Center and Research Institute","startDate":"2019-09-25","conditions":["Neuroendocrine Carcinoma"],"enrollment":30,"completionDate":"2026-01"},{"nctId":"NCT04428372","phase":"PHASE2,PHASE3","title":"MAnnitol for Blood Pressure Stability in HemoDialysis (MAP-HD)","status":"COMPLETED","sponsor":"Brigham and Women's Hospital","startDate":"2021-04-06","conditions":["Hemodialysis Complication","Hemodynamic Instability"],"enrollment":31,"completionDate":"2024-12-31"},{"nctId":"NCT05003804","phase":"PHASE1,PHASE2","title":"Allergic Disease Onset Prevention Study","status":"COMPLETED","sponsor":"Siolta Therapeutics, Inc.","startDate":"2021-09-01","conditions":["Atopic Dermatitis","Type 1 Hypersensitivity"],"enrollment":283,"completionDate":"2025-10-21"},{"nctId":"NCT07235995","phase":"PHASE4","title":"Paracetamol and Mannitol Injection and Postoperative Delirium","status":"NOT_YET_RECRUITING","sponsor":"Xiangya Hospital of Central South University","startDate":"2025-12-01","conditions":["Postoperative Delirium","Elderly","Non Cardiac Surgery"],"enrollment":1092,"completionDate":"2027-04-30"},{"nctId":"NCT05964647","phase":"PHASE1","title":"Effect of Ketanserin, Olanzapine, and Lorazepam After LSD Administration on the Acute Response to LSD in Healthy Subjects","status":"COMPLETED","sponsor":"University Hospital, Basel, Switzerland","startDate":"2024-02-01","conditions":["Healthy"],"enrollment":20,"completionDate":"2025-06-30"},{"nctId":"NCT06876064","phase":"","title":"National Cohort of Subjects at Risk of Developing Rheumatoid Arthritis","status":"NOT_YET_RECRUITING","sponsor":"University Hospital, Montpellier","startDate":"2025-10","conditions":["Rheumatoid Arthritis (RA)"],"enrollment":150,"completionDate":"2027-12"},{"nctId":"NCT07066176","phase":"NA","title":"Establishing and Validating a Meal-provoked Intestinal Permeability Test for Nutritional and Metabolic Health Clinical Research.","status":"COMPLETED","sponsor":"Laval University","startDate":"2025-07-07","conditions":["Intestinal Permeability"],"enrollment":10,"completionDate":"2025-08-15"},{"nctId":"NCT06085963","phase":"NA","title":"Nasal Allergen Challenge Test as a Method to Detect Clinical Reactivity Against Birch Pollen","status":"COMPLETED","sponsor":"Karolinska Institutet","startDate":"2023-02-01","conditions":["Allergic Rhinitis Due to Pollen"],"enrollment":89,"completionDate":"2024-12-31"},{"nctId":"NCT03970447","phase":"PHASE2,PHASE3","title":"A Trial to Evaluate Multiple Regimens in Newly Diagnosed and Recurrent Glioblastoma","status":"RECRUITING","sponsor":"Global Coalition for Adaptive Research","startDate":"2019-07-30","conditions":["Glioblastoma"],"enrollment":1280,"completionDate":"2030-06"},{"nctId":"NCT06644534","phase":"PHASE2","title":"A Study to Assess TTI-0102 vs Placebo in MELAS Patients","status":"RECRUITING","sponsor":"Thiogenesis Therapeutics, Inc.","startDate":"2025-05-12","conditions":["MELAS Syndrome","Mitochondrial Encephalomyopathy, Lactic Acidosis and Stroke-like Episodes (MELAS)"],"enrollment":12,"completionDate":"2026-06-30"},{"nctId":"NCT06884657","phase":"PHASE4","title":"Effect of Mannitol on Propofol Level","status":"RECRUITING","sponsor":"Cukurova University","startDate":"2025-03-20","conditions":["Mannitol Adverse Reaction"],"enrollment":40,"completionDate":"2025-10-30"},{"nctId":"NCT04676529","phase":"PHASE1,PHASE2","title":"Study to Evaluate Safety, Pharmacokinetic and Pharmacodynamic Dose Escalation and Expansion Study of PXS-5505 in Patients With Primary, Post-polycythemia Vera or Post-essential Thrombocythemia Myelofibrosis","status":"COMPLETED","sponsor":"Syntara","startDate":"2021-02-18","conditions":["Myelofibrosis"],"enrollment":43,"completionDate":"2025-07-09"},{"nctId":"NCT05782361","phase":"PHASE1","title":"POTENT - Tepotinib in Combination With Pembrolizumab in NSCLC","status":"RECRUITING","sponsor":"Institute of Cancer Research, United Kingdom","startDate":"2023-05-03","conditions":["Advanced Cancer","Non Small Cell Lung Cancer"],"enrollment":19,"completionDate":"2029-01-09"},{"nctId":"NCT07080567","phase":"PHASE2","title":"Manipulating the Peri-Infarct Area Using Maraviroc to Enhance Motor Skills After Stroke","status":"RECRUITING","sponsor":"Emmanuel Carrera","startDate":"2025-07-14","conditions":["Ischemic Stroke","Stroke","Stroke Acute"],"enrollment":80,"completionDate":"2027-12"},{"nctId":"NCT02433509","phase":"PHASE1","title":"Phase I Clinical Safety Study About Human Umbilical Cord Blood Monocyte in the Acute Ischemic Stroke","status":"COMPLETED","sponsor":"China Medical University Hospital","startDate":"2015-05","conditions":["Acute Ischemic Stroke"],"enrollment":6,"completionDate":"2023-06-14"},{"nctId":"NCT06905652","phase":"PHASE1","title":"Comparative Acute Effects of R-MDMA and S-MDMA in Healthy Participants","status":"RECRUITING","sponsor":"University Hospital, Basel, Switzerland","startDate":"2025-07-29","conditions":["Healthy"],"enrollment":24,"completionDate":"2026-11"},{"nctId":"NCT07089329","phase":"PHASE3","title":"Efficacy of Striatin in Malnourished Children","status":"RECRUITING","sponsor":"Universitas Sriwijaya","startDate":"2025-05-20","conditions":["Severe Acute Malnutrition"],"enrollment":30,"completionDate":"2025-10-01"},{"nctId":"NCT06742398","phase":"NA","title":"Carbohydrates and Running Performance","status":"COMPLETED","sponsor":"University of Georgia","startDate":"2024-02-16","conditions":["Nutrition, Healthy"],"enrollment":36,"completionDate":"2025-06-01"},{"nctId":"NCT04094168","phase":"PHASE4","title":"Clinical Impact of Del Nido Cardioplegia in Adult Cardiac Surgery","status":"COMPLETED","sponsor":"JESSICA GARCIA SUAREZ","startDate":"2018-06-15","conditions":["Heart; Surgery, Heart, Functional Disturbance as Result"],"enrollment":474,"completionDate":"2020-02-28"},{"nctId":"NCT06990984","phase":"PHASE2","title":"A Dose-ranging Study of TTI-0102 in Adults and Children With Leigh Syndrome Spectrum (LSS)","status":"NOT_YET_RECRUITING","sponsor":"Thiogenesis Therapeutics, Inc.","startDate":"2025-10","conditions":["Leigh Syndrome"],"enrollment":18,"completionDate":"2026-09"},{"nctId":"NCT03633279","phase":"PHASE3","title":"Treatment of Sarcopenia Improves the Muscle Mass and Muscle Strength of Patients With Liver Cirrhosis-Child C","status":"ACTIVE_NOT_RECRUITING","sponsor":"Dayanand Medical College and Hospital","startDate":"2018-06-22","conditions":["Liver Cirrhosis"],"enrollment":96,"completionDate":"2025-09-10"},{"nctId":"NCT06827977","phase":"PHASE2","title":"A Study of Microbiome Transplantation for the Treatment of Constipation and/or Significant Bloating in Patients With Systemic Sclerosis","status":"RECRUITING","sponsor":"The University of Texas Health Science Center, Houston","startDate":"2025-03-03","conditions":["Constipation","Bloating"],"enrollment":21,"completionDate":"2026-09-26"},{"nctId":"NCT06543498","phase":"NA","title":"The Effect of Dietary Supplementation on Intestinal Barrier Function in IBS-D","status":"COMPLETED","sponsor":"Dr Anthony Hobson","startDate":"2024-08-01","conditions":["Irritable Bowel Syndrome With Diarrhea"],"enrollment":32,"completionDate":"2025-01-13"},{"nctId":"NCT01290302","phase":"PHASE1","title":"Blinded Cross-Over Bioequivalence (BE) Trial of Luitpold Azacitidine vs Vidaza","status":"COMPLETED","sponsor":"American Regent, Inc.","startDate":"2010-11-22","conditions":["Myelodysplastic Syndrome","Myelofibrosis","Chronic Myeloid Leukemia","Chronic Lymphocytic Leukemia"],"enrollment":38,"completionDate":"2012-12-21"},{"nctId":"NCT06636786","phase":"PHASE2","title":"Prevention/Reduction of ASRs and PTSD to Sustain Civilian Performance With Sublingual Cyclobenzaprine HCl (TNX-102 SL)","status":"RECRUITING","sponsor":"University of North Carolina, Chapel Hill","startDate":"2025-03-25","conditions":["Acute Stress Reaction","Acute Stress Disorder","Neurocognitive Function","Post-traumatic Stress"],"enrollment":180,"completionDate":"2025-09"},{"nctId":"NCT06884514","phase":"PHASE1","title":"Acute Effects of MDMA Co-administration on the Response to Psilocybin in Healthy Subjects","status":"RECRUITING","sponsor":"University Hospital, Basel, Switzerland","startDate":"2025-04-03","conditions":["Healthy"],"enrollment":24,"completionDate":"2026-07-01"},{"nctId":"NCT03851159","phase":"NA","title":"Nyaditum Resae® as a Co-adjuvant During Treatment for Active Pulmonary Tuberculosis and Its Impact on the Gut Microbiota","status":"ACTIVE_NOT_RECRUITING","sponsor":"University of Stellenbosch","startDate":"2019-05-10","conditions":["Tuberculosis"],"enrollment":48,"completionDate":"2025-12-31"},{"nctId":"NCT03816397","phase":"PHASE4","title":"Adalimumab in JIA-associated Uveitis Stopping Trial","status":"COMPLETED","sponsor":"Nisha Acharya","startDate":"2020-03-15","conditions":["Uveitis","JIA"],"enrollment":87,"completionDate":"2025-04-03"},{"nctId":"NCT06946511","phase":"PHASE1,PHASE2","title":"Exploratory Study of the Effects of Peptide PMS-001 on Long-Delay Recall in Patients With Moderate to Severe Dementia","status":"NOT_YET_RECRUITING","sponsor":"Ruijin Hospital","startDate":"2025-08-01","conditions":["Dementia"],"enrollment":50,"completionDate":"2026-01-31"},{"nctId":"NCT06933862","phase":"NA","title":"Effects of Channa Striata Extract on Intestinal Inflammation and Nutritional Status in Malnutritional Toddlers After Albendazole Therapy in South Bangka District","status":"NOT_YET_RECRUITING","sponsor":"Indonesia University","startDate":"2025-05-15","conditions":["Malnourished Children"],"enrollment":122,"completionDate":"2026-06-30"},{"nctId":"NCT06768268","phase":"PHASE1,PHASE2","title":"A Dose-Image Optimization Trial Evaluating Mannitol and Voluven as Adjuncts for Indocyanine Green","status":"ENROLLING_BY_INVITATION","sponsor":"National Taiwan University Hospital","startDate":"2025-01-01","conditions":["Breast Cancer Early Stage Breast Cancer (Stage 1-3)"],"enrollment":30,"completionDate":"2025-12-31"},{"nctId":"NCT02800486","phase":"PHASE2","title":"Super Selective Intra-arterial Repeated Infusion of Cetuximab (Erbitux) With Reirradiation for Treatment of Relapsed/Refractory GBM, AA, and AOA","status":"RECRUITING","sponsor":"Northwell Health","startDate":"2016-05","conditions":["Glioblastoma","Anaplastic Astrocytoma","Anaplastic Oligoastrocytoma","Glioma","Brain Neoplasm","Brain Cancer","Brain Tumor","Brain Tumor, Recurrent","Brain Neoplasm, Malignant"],"enrollment":37,"completionDate":"2027-05"},{"nctId":"NCT01269853","phase":"PHASE1,PHASE2","title":"Repeated Super-selective Intraarterial Cerebral Infusion of Bevacizumab (Avastin) for Treatment of Relapsed GBM and AA","status":"RECRUITING","sponsor":"Northwell Health","startDate":"2010-10","conditions":["Glioblastoma Multiforme","Anaplastic Astrocytoma"],"enrollment":54,"completionDate":"2027-10"},{"nctId":"NCT02861898","phase":"PHASE1,PHASE2","title":"Super-selective Intra-arterial Repeated Infusion of Cetuximab for the Treatment of Newly Diagnosed Glioblastoma","status":"RECRUITING","sponsor":"Northwell Health","startDate":"2016-06","conditions":["Glioblastoma","Brain Cancer","Brain Neoplasm","Brain Tumor","Brain Neoplasm, Malignant","EGFR Gene Overexpression","GBM"],"enrollment":33,"completionDate":"2027-12"},{"nctId":"NCT01386710","phase":"PHASE1,PHASE2","title":"Repeated Super-selective Intraarterial Cerebral Infusion Of Bevacizumab Plus Carboplatin For Treatment Of Relapsed/Refractory GBM And Anaplastic Astrocytoma","status":"SUSPENDED","sponsor":"Northwell Health","startDate":"2011-09","conditions":["Glioblastoma Multiforme","Anaplastic Astrocytoma"],"enrollment":54,"completionDate":"2027-12"},{"nctId":"NCT06914310","phase":"PHASE2,PHASE3","title":"Memantine as an Additive Therapy in Patients With Traumatic Brain Injury","status":"NOT_YET_RECRUITING","sponsor":"Mansoura University","startDate":"2025-03-25","conditions":["Mild Traumatic Brain Injury","Moderate Traumatic Brain Injury (TBI)"],"enrollment":80,"completionDate":"2025-11-30"},{"nctId":"NCT05054361","phase":"","title":"Crosstalk Between Mucosal-Associated Invariant T (MAIT) Cells and the Gut Microbiota and Mucosa in the Development of Type 1 Diabetes in Children","status":"RECRUITING","sponsor":"Institut National de la Santé Et de la Recherche Médicale, France","startDate":"2022-01-01","conditions":["Type1diabetes"],"enrollment":180,"completionDate":"2027-08-14"},{"nctId":"NCT05647057","phase":"NA","title":"CPB Prime Fluid Strategies to Preserve Mcirocirculatory Perfusion","status":"COMPLETED","sponsor":"Amsterdam UMC, location VUmc","startDate":"2023-07-10","conditions":["Endothelial Dysfunction","Hemolysis","Fluid Overload"],"enrollment":48,"completionDate":"2024-08-08"},{"nctId":"NCT03105843","phase":"PHASE4","title":"Sensory-Mechanical Responses to Eucapneic Voluntary Hyperventilation and Mannitol","status":"RECRUITING","sponsor":"Dr. Diane Lougheed","startDate":"2022-03-01","conditions":["Asthma","Cough","Cough Variant Asthma"],"enrollment":30,"completionDate":"2026-06-30"},{"nctId":"NCT03786796","phase":"PHASE2","title":"Study of Olaparib in Metastatic Renal Cell Carcinoma Patients With DNA Repair Gene Mutations","status":"RECRUITING","sponsor":"Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins","startDate":"2019-06-03","conditions":["Renal Cell Carcinoma","Metastatic Renal Cell Carcinoma","Kidney Cancer","Renal Carcinoma","Kidney Cancer Metastatic"],"enrollment":20,"completionDate":"2028-03"},{"nctId":"NCT05523401","phase":"PHASE1","title":"Acute Effects of 2C-B Compared With MDMA and Psilocybin in Healthy Subjects","status":"COMPLETED","sponsor":"University Hospital, Basel, Switzerland","startDate":"2023-08-16","conditions":["Healthy"],"enrollment":24,"completionDate":"2024-11-05"},{"nctId":"NCT05858060","phase":"","title":"Osmotic Therapy for Patients With Severe Subarachnoid Hemorrhage","status":"RECRUITING","sponsor":"Xuanwu Hospital, Beijing","startDate":"2023-07-10","conditions":["Subarachnoid Hemorrhage, Traumatic"],"enrollment":124,"completionDate":"2025-12-31"},{"nctId":"NCT06846307","phase":"PHASE3","title":"The Effect of Mannitol Volume with Changes in Osmolarity in Traumatic Brain Injury","status":"COMPLETED","sponsor":"Universitas Diponegoro","startDate":"2023-11-01","conditions":["Anesthesia","Traumatic Brain Injury"],"enrollment":32,"completionDate":"2024-01-31"},{"nctId":"NCT06841406","phase":"PHASE4","title":"Budesonide as a Treatment for Functional Dyspepsia","status":"RECRUITING","sponsor":"Universitaire Ziekenhuizen KU Leuven","startDate":"2024-05-01","conditions":["Functional Dyspepsia"],"enrollment":56,"completionDate":"2026-12-31"},{"nctId":"NCT04784559","phase":"PHASE3","title":"Trial to Determine the Efficacy/Safety of Plitidepsin vs Control in Patients With Moderate COVID-19 Infection","status":"TERMINATED","sponsor":"PharmaMar","startDate":"2021-06-04","conditions":["COVID-19 Infection"],"enrollment":205,"completionDate":"2023-03-01"},{"nctId":"NCT04386070","phase":"PHASE3","title":"Preventing Pulmonary Complications in Surgical Patients at Risk of COVID-19","status":"SUSPENDED","sponsor":"University of Birmingham","startDate":"2022-05-16","conditions":["Pulmonary Complications in Surgical Patients","COVID","Severe Acute Respiratory Syndrome"],"enrollment":6400,"completionDate":"2027-03-01"},{"nctId":"NCT06789705","phase":"NA","title":"Plasma Oxytocin Changes in Response to Low-dose MDMA vs. Placebo in Patients With Arginine Vasopressin Deficiency and Healthy Controls","status":"RECRUITING","sponsor":"University Hospital, Basel, Switzerland","startDate":"2025-01-27","conditions":["Central Diabetes Insipidus"],"enrollment":24,"completionDate":"2026-12"},{"nctId":"NCT02476864","phase":"PHASE1","title":"Comparison of the Pharmacokinetic Properties of Two Tablet Formulations of Macitentan in Healthy Adults","status":"COMPLETED","sponsor":"Actelion","startDate":"2015-08","conditions":["Healthy Subjects"],"enrollment":12,"completionDate":"2015-12"},{"nctId":"NCT06773429","phase":"","title":"Estradiol and Brain Age","status":"COMPLETED","sponsor":"International Research Training Group 2804","startDate":"2018-08-01","conditions":["Estradiol (E2) Vs. Placebo (PLAC)","Estradiol"],"enrollment":32,"completionDate":"2019-07-31"},{"nctId":"NCT04878354","phase":"PHASE3","title":"A Study in Children and Adolescents With Birch Pollen-induced Rhinoconjunctivitis","status":"COMPLETED","sponsor":"ALK-Abelló A/S","startDate":"2021-04-07","conditions":["Allergy"],"enrollment":952,"completionDate":"2023-07-31"},{"nctId":"NCT06770907","phase":"","title":"Genetic Carbohydrate Maldigestion As Model to Study Food Hypersensitivity Mechanism (WORK PACKAGE 2)","status":"NOT_YET_RECRUITING","sponsor":"University of Nottingham","startDate":"2025-03","conditions":["Sucrase Isomaltase Deficiency"],"enrollment":80,"completionDate":"2026-03"},{"nctId":"NCT04385264","phase":"PHASE2,PHASE3","title":"#StayHome: Early Hydroxychloroquine to Reduce Secondary Hospitalisation and Household Transmission in COVID-19","status":"WITHDRAWN","sponsor":"Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland","startDate":"2022-01","conditions":["COVID-19"],"enrollment":0,"completionDate":"2022-12"},{"nctId":"NCT05979727","phase":"PHASE1","title":"Dose-finding PKPD Trial for RE02 in Healthy Subjects","status":"TERMINATED","sponsor":"Reconnect Labs","startDate":"2023-11-20","conditions":["Healthy"],"enrollment":4,"completionDate":"2023-12-10"},{"nctId":"NCT05896748","phase":"PHASE3","title":"Study to Assess the Effects of Cabotegravir (CAB) and Rilpivirine (RPV) Long-Acting (LA) Injections Following Sub-cutaneous (SC) Administration Compared With Intramuscular (IM) Administration in Adult Participants Living With Human Immunodeficiency Virus (HIV-1) Infection in the FLAIR Study","status":"COMPLETED","sponsor":"ViiV Healthcare","startDate":"2022-11-08","conditions":["Human Immunodeficiency Virus Type 1 (HIV-1)"],"enrollment":94,"completionDate":"2023-09-14"},{"nctId":"NCT06681415","phase":"PHASE4","title":"Efficacy of 20% Human Albumin in Reducing Pleural Effusion After Cardiopulmonary Bypass","status":"COMPLETED","sponsor":"Pauls Stradins Clinical University Hospital","startDate":"2022-09-01","conditions":["Pleural Effusions Post Coronary Artery Bypass Graft","Hypoxia","Hypoalbuminemia"],"enrollment":70,"completionDate":"2024-01-01"},{"nctId":"NCT05216510","phase":"PHASE1","title":"Assessment of Delayed-type Hypersensitivity Reactions to SARS-CoV-2 Peptide Antigens","status":"TERMINATED","sponsor":"Tonix Pharmaceuticals, Inc.","startDate":"2022-01-07","conditions":["Detection of Delayed-type Hypersensitivity Reactions to SARS-CoV-2 in Individuals Exposed to SARS-CoV-2"],"enrollment":9,"completionDate":"2022-09-17"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"pivotalTrials":["NCT02134353","NCT00446680","NCT00630812"],"administration":{"route":"Intravenous","formulation":"Capsule, Cream, Injection, Irrigant","formulations":[{"form":"CAPSULE","route":"RESPIRATORY (INHALATION)","productName":"Bronchitol"},{"form":"CREAM","route":"TOPICAL","productName":"QR PAIN"},{"form":"INJECTION, SOLUTION","route":"INTRAVENOUS","productName":"Mannitol"},{"form":"INJECTION, SOLUTION","route":"INTRAVENOUS","productName":"MANNITOL"},{"form":"INJECTION, SOLUTION","route":"INTRAVENOUS","productName":"Mannitol"},{"form":"INJECTION, SOLUTION","route":"INTRAVENOUS","productName":"Osmitrol"},{"form":"IRRIGANT","route":"URETHRAL","productName":"Sorbitol-Mannitol"},{"form":"LIQUID","route":"TOPICAL","productName":"GD11 Rx SCM C5"},{"form":"POWDER","route":"ORAL","productName":"SUPER CELL TWO"},{"form":"POWDER","route":"TOPICAL","productName":"CURESTEM CELL HEALER C20"}]},"_patentsChecked":true,"crossReferences":{"NUI":"N0000146108","MMSL":"189996","NDDF":"002272","UNII":"3OWL53L36A","VUID":"4017741","CHEBI":"CHEBI:29864","VANDF":"4017741","RXNORM":"2475836","UMLSCUI":"C0024730","chemblId":"CHEMBL689","ChEMBL_ID":"CHEMBL689","KEGG_DRUG":"D00062","DRUGBANK_ID":"DB00742","PDB_CHEM_ID":" MTL","PUBCHEM_CID":"6251","SNOMEDCT_US":"30761007","MESH_DESCRIPTOR_UI":"D008353"},"formularyStatus":[],"originalProduct":{"form":"INJECTION, SOLUTION","route":"INTRAVENOUS","company":"Baxter Healthcare Corporation","brandName":"Osmitrol","isOriginal":true,"marketingStatus":"NDA"},"_enricherVersion":"v2","developmentCodes":[],"ownershipHistory":[{"period":"1964-","companyName":"Baxter Hlthcare","relationship":"Original Developer"}],"pharmacokinetics":{"source":"DrugCentral","halfLife":"4.7 hours","clearance":"1.2 mL/min/kg","bioavailability":"7%","volumeOfDistribution":"0.24 L/kg"},"publicationCount":21726,"therapeuticAreas":["Immunology"],"atcClassification":{"source":"DrugCentral","atcCode":"A06AD16","allCodes":["A06AD16","B05BC01","B05CX04","R05CB16","V04CX04"]},"biosimilarFilings":[],"originalDeveloper":"Baxter Hlthcare","recentPublications":[{"date":"2026 Mar 30","pmid":"41906870","title":"Investigation of therapeutic efficacy of intraperitoneal ketamine administration on the brain vascular system in rats with traumatic brain injury.","journal":"Biotechnic & histochemistry : official publication of the Biological Stain Commission"},{"date":"2026 Feb 24","pmid":"41900771","title":"A Distribution-Based Metric for Quantifying Dispersibility in Dry Powder Inhalers.","journal":"Pharmaceutics"},{"date":"2026 Mar 6","pmid":"41893779","title":"Investigation on a Freeze-Drying Process for Long-Term Stability of mRNA-LNPs.","journal":"Vaccines"},{"date":"2026 Mar 26","pmid":"41888951","title":"Delayed-type anaphylactic shock to mannitol: a case report and review of the literature.","journal":"Journal of medical case reports"},{"date":"2026 Mar 26","pmid":"41888881","title":"Metabolic engineering of Streptomyces albulus for de novo serotonin production.","journal":"Microbial cell factories"}],"combinationProducts":[{"brandName":"Sorbitol-Mannitol","ingredients":"mannitol + sorbitol"}],"companionDiagnostics":[],"genericManufacturers":6,"_genericFilersChecked":true,"genericManufacturerList":["Abraxis Pharm","Fresenius Kabi Usa","Igi Labs Inc","Intl Medication","Luitpold","Watson Labs"],"status":"approved","companyName":"Baxter Hlthcare","companyId":"baxter","modality":"Small molecule","firstApprovalDate":"1964","enrichmentLevel":4,"visitCount":1,"regulatoryByCountry":[{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"1964-06-08T00:00:00.000Z","mah":"BAXTER HLTHCARE","brand_name_local":null,"application_number":""},{"country_code":"CA","regulator":"Health Canada","status":"approved","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"country_code":"IL","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"SG","regulator":"HSA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AE","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"KR","regulator":"MFDS","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AU","regulator":"TGA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"GB","regulator":"MHRA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"trialStats":{"total":0,"withResults":0},"validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T03:38:56.861237+00:00","fieldsConflicting":0,"overallConfidence":0.95},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}