{"id":"hyoscyamine","rwe":[],"_fda":{"id":"347830a8-8833-26b7-e063-6294a90a1f17","set_id":"01f97804-a6cb-ce6d-e063-6394a90ae220","openfda":{"upc":["0351525011515"],"unii":["F2R8V82B84"],"route":["ORAL"],"rxcui":["1046770"],"spl_id":["347830a8-8833-26b7-e063-6294a90a1f17"],"brand_name":["Hyoscyamine ER"],"spl_set_id":["01f97804-a6cb-ce6d-e063-6394a90ae220"],"package_ndc":["75929-057-10"],"product_ndc":["75929-057"],"generic_name":["HYOSCYAMINE SULFATE"],"product_type":["HUMAN PRESCRIPTION DRUG"],"substance_name":["HYOSCYAMINE SULFATE"],"manufacturer_name":["Pharma Packaging Solutions, LLC dba Tjopack LLC"],"is_original_packager":[true]},"version":"3","warnings":["WARNINGS In the presence of high environmental temperature, heat prostration can occur with drug use (fever and heat stroke due to decreased sweating). Diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy. In this instance, treatment with this drug would be inappropriate and possibly harmful. Like other anticholinergic agents, hyoscyamine sulfate may produce drowsiness, dizziness, or blurred vision. In this event, the patient should be warned not to engage in activities requiring mental alertness such as operating a motor vehicle or other machinery or to perform hazardous work while taking this drug. Psychosis has been reported in sensitive individuals given anticholinergic drugs including hyoscyamine sulfate. CNS signs and symptoms include confusion, disorientation, short-term memory loss, hallucinations, dysarthria, ataxia, euphoria, anxiety, fatigue, insomnia, agitation and mannerisms, and inappropriate affect. These CNS signs and symptoms usually resolve within 12 to 48 hours after discontinuation of the drug."],"pregnancy":["Pregnancy – Pregnancy Category C Animal reproduction studies have not been conducted with hyoscyamine sulfate. It is also not known whether hyoscyamine sulfate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Hyoscyamine sulfate should be given to a pregnant woman only if clearly needed."],"overdosage":["OVERDOSAGE The signs and symptoms of overdose are headache, nausea, vomiting, blurred vision, dilated pupils, hot dry skin, dizziness, dryness of the mouth, difficulty in swallowing, and CNS stimulation. Measures to be taken are immediate lavage of the stomach and injection of physostigmine 0.5 to 2 mg intravenously and repeated as necessary up to a total of 5 mg. Fever may be treated symptomatically (tepid water sponge baths, hypothermic blanket). Excitement to a degree which demands attention may be managed with sodium thiopental 2% solution given slowly intravenously or chloral hydrate (100-200 mL of a 2% solution) by rectal infusion. In the event of progression of the curare-like effect to paralysis of the respiratory muscles, artificial respiration should be instituted and maintained until effective respiratory action returns. In rats, the LD 50 for hyoscyamine is 375 mg/kg. Hyoscyamine sulfate is dialyzable."],"description":["DESCRIPTION Hyoscyamine sulfate extended-release tablets contain 0.375 mg of hyoscyamine sulfate in a formulation designed for oral b.i.d. dosage. Hyoscyamine sulfate is one of the principal anticholinergic/antispasmodic components of belladonna alkaloids. The empirical formula is (C 17 H 23 NO 3 ) 2 •H 2 SO 4 •2H 2 O and the molecular weight is 712.85. Chemically, it is benzeneacetic acid, ɑ-(hydroxymethyl)-, 8-methyl-8-azabicyclo [3.2.1.] oct-3-yl ester, [3(S)-endo]-, sulfate (2:1), dihydrate with the following structure: Each tablet also contains as inactive ingredients: calcium phosphate dibasic, ethylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose and stearic acid. Hyoscyamine Sulfate Chemical Structure"],"precautions":["PRECAUTIONS General Use with caution in patients with: autonomic neuropathy, hyperthyroidism, coronary heart disease, congestive heart failure, cardiac arrhythmias, hypertension, and renal disease. Investigate any tachycardia before giving any anticholinergic drugs since they may increase the heart rate. Use with caution in patients with hiatal hernia associated with reflux esophagitis. Information For Patients Like other anticholinergic agents, hyoscyamine sulfate may produce drowsiness, dizziness, or blurred vision. In this event, the patient should be warned not to engage in activities requiring mental alertness such as operating a motor vehicle or other machinery or to perform hazardous work while taking this drug. Use of hyoscyamine sulfate may decrease sweating resulting in heat prostration, fever or heat stroke; febrile patients or those who may be exposed to elevated environmental temperatures should use caution. Tablets may not completely disintegrate and may be excreted by some patients. Drug Interactions Additive adverse effects resulting from cholinergic blockade may occur when hyoscyamine sulfate is administered concomitantly with other antimuscarinics, amantadine, haloperidol, phenothiazines, monoamine oxidase (MAO) inhibitors, tricyclic antidepressants or some antihistamines. Antacids may interfere with the absorption of hyoscyamine sulfate. Carcinogenesis, Mutagenesis, Impairment Of Fertility No long-term studies in animals have been performed to determine the carcinogenic, mutagenic or impairment of fertility potential of hyoscyamine sulfate; however, 40 years of marketing experience with hyoscyamine sulfate shows no demonstrable evidence of a problem. Pregnancy – Pregnancy Category C Animal reproduction studies have not been conducted with hyoscyamine sulfate. It is also not known whether hyoscyamine sulfate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Hyoscyamine sulfate should be given to a pregnant woman only if clearly needed. Nursing Mothers Hyoscyamine sulfate is excreted in human milk. Caution should be exercised when hyoscyamine sulfate is administered to a nursing woman. Geriatric Use Reported clinical experience has not identified differences in safety between patients aged 65 and over and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. To report SUSPECTED ADVERSE REACTIONS, contact Wallace Pharmaceuticals at 1-800-619-6344 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch."],"how_supplied":["HOW SUPPLIED Hyoscyamine Sulfate Extended-Release Tablets, 0.375 mg are white, capsule-shaped tablets. They are coded “AP” on one side and “115” on the other. Bottles of 100 tablets NDC 75929-057-10 Store at controlled room temperature 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F). Please refer to current USP. Dispense in tight, light-resistant containers as defined in USP/NF with a child-resistant closure. KEEP OUT OF REACH OF CHILDREN Also available as: Dosage Strength Package Size NDC Hyoscyamine Sulfate Tablets, USP 0.125 mg 100 75929-055-10 Hyoscyamine Sulfate Sublingual Tablets 0.125 mg 100 75929-056-10 Distributed by: Wallace Pharmaceuticals Inc. Somerset, New Jersey 08873-4120 ©2018 Mylan Pharmaceuticals Inc WALLACE and are trademarks of Wallace Pharmaceuticals Inc., a Mylan company IN-1151-03 Rev. 3/2018 Printed in USA 70011278 Wallace Pharmaceuticals Inc. Logo"],"geriatric_use":["Geriatric Use Reported clinical experience has not identified differences in safety between patients aged 65 and over and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. To report SUSPECTED ADVERSE REACTIONS, contact Wallace Pharmaceuticals at 1-800-619-6344 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch."],"effective_time":"20250506","nursing_mothers":["Nursing Mothers Hyoscyamine sulfate is excreted in human milk. Caution should be exercised when hyoscyamine sulfate is administered to a nursing woman."],"adverse_reactions":["ADVERSE REACTIONS All of the following adverse reactions have been reported with hyoscyamine sulfate. Adverse reactions may include dryness of the mouth; urinary hesitancy and retention; blurred vision; tachycardia; palpitations; mydriasis; increased ocular tension; loss of taste; headache; nervousness; drowsiness; weakness; fatigue; dizziness; insomnia; nausea; vomiting; impotence; constipation; bloated feeling; abdominal pain; diarrhea; allergic reactions or drug idiosyncrasies; urticaria and other dermal manifestations; ataxia; speech disturbance; some degree of mental confusion and/or excitement (especially in elderly persons); short-term memory loss; hallucinations; and decreased sweating."],"contraindications":["CONTRAINDICATIONS Glaucoma; obstructive uropathy (for example, bladder neck obstruction due to prostatic hypertrophy); obstructive disease of the gastrointestinal tract (as in achalasia, pyloroduodenal stenosis); paralytic ileus, intestinal atony of elderly or debilitated patients; unstable cardiovascular status in acute hemorrhage; severe ulcerative colitis; toxic megacolon complicating ulcerative colitis; myasthenia gravis."],"drug_interactions":["Drug Interactions Additive adverse effects resulting from cholinergic blockade may occur when hyoscyamine sulfate is administered concomitantly with other antimuscarinics, amantadine, haloperidol, phenothiazines, monoamine oxidase (MAO) inhibitors, tricyclic antidepressants or some antihistamines. Antacids may interfere with the absorption of hyoscyamine sulfate."],"how_supplied_table":["
Dosage StrengthPackage SizeNDC
Hyoscyamine Sulfate Tablets, USP 0.125 mg10075929-055-10
Hyoscyamine Sulfate Sublingual Tablets 0.125 mg10075929-056-10
"],"general_precautions":["General Use with caution in patients with: autonomic neuropathy, hyperthyroidism, coronary heart disease, congestive heart failure, cardiac arrhythmias, hypertension, and renal disease. Investigate any tachycardia before giving any anticholinergic drugs since they may increase the heart rate. Use with caution in patients with hiatal hernia associated with reflux esophagitis."],"clinical_pharmacology":["CLINICAL PHARMACOLOGY Hyoscyamine sulfate inhibits specifically the actions of acetylcholine on structures innervated by postganglionic cholinergic nerves and on smooth muscles that respond to acetylcholine but lack cholinergic innervation. These peripheral cholinergic receptors are present in the autonomic effector cells of the smooth muscle, the cardiac muscle, the sinoatrial node, the atrioventricular node, and the exocrine glands. At therapeutic doses, it is completely devoid of any action on autonomic ganglia. Hyoscyamine sulfate inhibits gastrointestinal propulsive motility and decreases gastric acid secretion. Hyoscyamine sulfate also controls excessive pharyngeal, tracheal, and bronchial secretions. Hyoscyamine sulfate is absorbed totally and completely by oral administration. Once absorbed, hyoscyamine sulfate disappears rapidly from the blood and is distributed throughout the entire body: the half-life of hyoscyamine sulfate is 2 to 3½ hours. Hyoscyamine sulfate is partly hydrolyzed to tropic acid and tropine but the majority of the drug is excreted in the urine unchanged within the first 12 hours. Only traces of this drug are found in breast milk. Hyoscyamine sulfate passes the blood brain barrier and the placental barrier. Hyoscyamine sulfate extended-release tablets releases 0.375 mg hyoscyamine sulfate at a controlled and predictable rate for 12 hours. The mean peak plasma concentration occurred at 4.20 hours. The mean (±SEM) apparent plasma elimination half-life is 7.47 hours (±0.60). Tablets may not completely disintegrate and may be excreted by some patients."],"indications_and_usage":["INDICATIONS AND USAGE Hyoscyamine sulfate extended-release tablets are effective as adjunctive therapy in the treatment of peptic ulcer. They can also be used to control gastric secretion, visceral spasm and hypermotility in spastic colitis, spastic bladder, cystitis, pylorospasm, and associated abdominal cramps. May be used in functional intestinal disorders to reduce symptoms such as those seen in mild dysenteries, diverticulitis, and acute enterocolitis. For use as adjunctive therapy in the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and functional gastrointestinal disorders. Also used as adjunctive therapy in the treatment of neurogenic bladder andmneurogenic bowel disturbances (including the splenic flexure syndrome and neurogenic colon). Hyoscyamine sulfate extended-release tablets are indicated along with morphine or other narcotics in symptomatic relief of biliary and renal colic; as a “drying agent” in the relief of symptoms of acute rhinitis; in the therapy of parkinsonism to reduce rigidity and tremors and to control associated sialorrhea and hyperhidrosis. May be used in the therapy of poisoning by anticholinesterase agents."],"information_for_patients":["Information For Patients Like other anticholinergic agents, hyoscyamine sulfate may produce drowsiness, dizziness, or blurred vision. In this event, the patient should be warned not to engage in activities requiring mental alertness such as operating a motor vehicle or other machinery or to perform hazardous work while taking this drug. Use of hyoscyamine sulfate may decrease sweating resulting in heat prostration, fever or heat stroke; febrile patients or those who may be exposed to elevated environmental temperatures should use caution. Tablets may not completely disintegrate and may be excreted by some patients."],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Dosage may be adjusted according to the conditions and severity of symptoms. Adults And Pediatric Patients 12 Years Of Age And Older 1 to 2 tablets every 12 hours. Do not crush or chew tablets. Do not exceed 4 tablets in 24 hours."],"spl_product_data_elements":["Hyoscyamine ER hyoscyamine sulfate HYOSCYAMINE SULFATE HYOSCYAMINE capsule shape AP;115"],"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - Hyoscyamine ER .375 mg NDC 75929-057-10 100 tablets Hyoscyamine Sulfate Extended-Release Tablets 0.375 mg Rx only Each tablet contains 0.375 mg hyoscyamine sulfate, USP. USUAL DOSAGE: Adults and pediatric patients 12 years of age and older: 1 to 2 tablets every 12 hours. See package insert for full prescribing information. Dispense in tight, light-resistant containers as defined in USP/NF with child-resistant closure. KEEP OUT OF REACH OF CHILDREN. Store at controlled room temperature 20º-25ºC (68º-77ºF); excursions permitted to 15º-30ºC (59º-86ºF). Please refer to current USP. Distributed by: Wallace Pharmaceuticals Inc. Somerset, NJ 08873-4120, USA For medical inquiries call 1-800-619-6344 ©2018 Mylan Pharmaceuticals Inc. LB-115103-03 REV 3/2018 Bottle1"],"carcinogenesis_and_mutagenesis_and_impairment_of_fertility":["Carcinogenesis, Mutagenesis, Impairment Of Fertility No long-term studies in animals have been performed to determine the carcinogenic, mutagenic or impairment of fertility potential of hyoscyamine sulfate; however, 40 years of marketing experience with hyoscyamine sulfate shows no demonstrable evidence of a problem."]},"tags":[{"label":"hyoscyamine","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"Muscarinic acetylcholine receptor M4","category":"target"},{"label":"CHRM4","category":"gene"},{"label":"CHRM3","category":"gene"},{"label":"CHRM2","category":"gene"},{"label":"A03BA03","category":"atc"},{"label":"Oral","category":"route"},{"label":"Capsule","category":"form"},{"label":"Elixir","category":"form"},{"label":"Active","category":"status"},{"label":"Cholinesterase Inhibitors Toxicity","category":"indication"},{"label":"Dysuria","category":"indication"},{"label":"Excessive salivation","category":"indication"},{"label":"Gastrointestinal Radiography Adjunct","category":"indication"},{"label":"Muscarine Toxicity","category":"indication"},{"label":"Peptic ulcer","category":"indication"},{"label":"Adjuvants, Anesthesia","category":"pharmacology"},{"label":"Anti-Arrhythmia Agents","category":"pharmacology"},{"label":"Anti-Asthmatic Agents","category":"pharmacology"},{"label":"Bronchodilator Agents","category":"pharmacology"},{"label":"Cardiovascular Agents","category":"pharmacology"},{"label":"Central Nervous System Agents","category":"pharmacology"},{"label":"Cholinergic Agents","category":"pharmacology"},{"label":"Cholinergic Antagonists","category":"pharmacology"},{"label":"Muscarinic Antagonists","category":"pharmacology"},{"label":"Mydriatics","category":"pharmacology"},{"label":"Neurotransmitter Agents","category":"pharmacology"},{"label":"Parasympatholytics","category":"pharmacology"},{"label":"Peripheral Nervous System Agents","category":"pharmacology"},{"label":"Respiratory System Agents","category":"pharmacology"}],"phase":"marketed","safety":{"boxedWarnings":[],"safetySignals":[{"date":"","signal":"NAUSEA","source":"FDA FAERS","actionTaken":"884 reports"},{"date":"","signal":"DIARRHOEA","source":"FDA FAERS","actionTaken":"759 reports"},{"date":"","signal":"PAIN","source":"FDA FAERS","actionTaken":"739 reports"},{"date":"","signal":"FATIGUE","source":"FDA FAERS","actionTaken":"687 reports"},{"date":"","signal":"DRUG INEFFECTIVE","source":"FDA FAERS","actionTaken":"600 reports"},{"date":"","signal":"DIZZINESS","source":"FDA FAERS","actionTaken":"574 reports"},{"date":"","signal":"HEADACHE","source":"FDA FAERS","actionTaken":"574 reports"},{"date":"","signal":"ABDOMINAL PAIN","source":"FDA FAERS","actionTaken":"518 reports"},{"date":"","signal":"VOMITING","source":"FDA FAERS","actionTaken":"518 reports"},{"date":"","signal":"DYSPNOEA","source":"FDA FAERS","actionTaken":"480 reports"}],"commonSideEffects":[{"effect":"Excessive dryness of the mouth","drugRate":"reported","severity":"unknown"},{"effect":"Blurred vision","drugRate":"reported","severity":"unknown"},{"effect":"Urinary difficulty","drugRate":"reported","severity":"unknown"},{"effect":"Tachycardia","drugRate":"reported","severity":"unknown"}],"contraindications":["Achalasia of esophagus","Acute exacerbation of asthma","Acute hepatitis","Acute nephropathy","Alcoholism","Anemia","Anemia due to enzyme deficiency","Angle-closure glaucoma","Atony of colon","Autonomic dysreflexia","Benign prostatic hyperplasia","Bladder outflow obstruction","Bleeding","Blood coagulation disorder","Body fluid retention","Brain damage","Breastfeeding (mother)","Cardiovascular event risk","Chronic heart failure","Chronic idiopathic constipation","Chronic lung disease","Chronic obstructive lung disease","Cirrhosis of liver","Complete trisomy 21 syndrome","Conduction disorder of the heart"],"specialPopulations":{"Pregnancy":"This product should be given to pregnant woman only if clearly needed. Hyoscyamine crosses the placenta. It is also not known whether this product can cause fetal harm when administered to pregnant woman or can affect reproduction capacity.","Geriatric use":"Reported clinical experience has not identified differences in safety between patients aged 65 and over and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.","Paediatric use":"This product is not recommended for use in children under twelve years of age. Infants and young children are especially susceptible to the toxic effects of anticholinergics. Close supervision is recommended for infants and children with spastic paralysis or brain damage since an increased response to anticholinergics has been reported in these patients and dosage adjustments are often required.","Hepatic impairment":"In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy."}},"trials":[],"aliases":[],"patents":[],"pricing":[{"market":"United States","source":"CMS National Average Drug Acquisition Cost (NADAC)","asOfDate":"2024-01-03","unitCost":"$0.1597/EA","priceType":"NADAC","sourceUrl":"https://data.medicaid.gov/dataset/4j6z-xnwq","annualCost":"$58","description":"HYOSCYAMINE 0.125 MG ODT","retrievedDate":"2026-04-07"}],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=Hyoscyamine","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-19T23:59:41.869322+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-19T23:59:47.715718+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=Hyoscyamine","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-19T23:59:48.072901+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-19T23:59:40.632669+00:00"},"indications.approved":{"url":"","method":"ai_extraction","source":"FDA Label + AI","aiModel":"featherless","rawText":"","confidence":0.9,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:00:30.745188+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-19T23:59:40.632701+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":"2026-04-19T23:59:49.667215+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL1331216/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-19T23:59:48.804123+00:00"}},"allNames":"(-)-atropine","offLabel":[],"synonyms":["hyoscyamine hydrobromide","hyoscyamine","(-)-Atropine","(-)-Hyoscyamine","L-Hyoscyamin","L-Hyoscyamine","l-Atropine","hyoscyamine sulfate"],"timeline":[{"date":"1869-01-01","type":"positive","source":"DrugCentral","milestone":"YEAR INTRODUCED approval"}],"approvals":[{"date":"1869-01-01","orphan":false,"company":"","regulator":"YEAR INTRODUCED"}],"brandName":"(-)-Atropine","ecosystem":[{"indication":"Cholinesterase Inhibitors Toxicity","otherDrugs":[{"name":"pralidoxime","slug":"pralidoxime","company":"Baxter Hlthcare Corp"}],"globalPrevalence":null},{"indication":"Dysuria","otherDrugs":[{"name":"flavoxate","slug":"flavoxate","company":""},{"name":"phenazopyridine","slug":"phenazopyridine","company":"Able"},{"name":"secbutabarbital","slug":"secbutabarbital","company":"Meda Pharms"}],"globalPrevalence":null},{"indication":"Excessive salivation","otherDrugs":[{"name":"glycopyrronium bromide","slug":"glycopyrronium-bromide","company":"Shionogi Inc"}],"globalPrevalence":null},{"indication":"Gastrointestinal Radiography Adjunct","otherDrugs":[{"name":"glucagon","slug":"glucagon","company":""},{"name":"metoclopramide","slug":"metoclopramide","company":"Baxter Hlthcare Corp"},{"name":"silicon dioxide","slug":"silicon-dioxide","company":""}],"globalPrevalence":null},{"indication":"Muscarine Toxicity","otherDrugs":[],"globalPrevalence":null},{"indication":"Peptic ulcer","otherDrugs":[{"name":"algeldrate","slug":"algeldrate","company":"Sanofi Aventis Us"},{"name":"almasilate","slug":"almasilate","company":""},{"name":"chlordiazepoxide","slug":"chlordiazepoxide","company":"Valeant Pharm Intl"},{"name":"dexlansoprazole","slug":"dexlansoprazole","company":"Takeda Pharms Usa"}],"globalPrevalence":64000000},{"indication":"Sinus bradycardia","otherDrugs":[],"globalPrevalence":null},{"indication":"Urinary Tract Irritation","otherDrugs":[{"name":"flavoxate","slug":"flavoxate","company":""},{"name":"pentosan polysulfate","slug":"pentosan-polysulfate","company":"Janssen Pharms"},{"name":"phenazopyridine","slug":"phenazopyridine","company":"Able"},{"name":"secbutabarbital","slug":"secbutabarbital","company":"Meda Pharms"}],"globalPrevalence":null}],"mechanism":{"target":"Muscarinic acetylcholine receptor M4","targets":[{"gene":"CHRM4","source":"DrugCentral","target":"Muscarinic acetylcholine receptor M4","protein":"Muscarinic acetylcholine receptor M4"},{"gene":"CHRM3","source":"DrugCentral","target":"Muscarinic acetylcholine receptor M3","protein":"Muscarinic acetylcholine receptor M3"},{"gene":"CHRM2","source":"DrugCentral","target":"Muscarinic acetylcholine receptor M2","protein":"Muscarinic acetylcholine receptor M2"},{"gene":"CHRM5","source":"DrugCentral","target":"Muscarinic acetylcholine receptor M5","protein":"Muscarinic acetylcholine receptor M5"},{"gene":"CHRM1","source":"DrugCentral","target":"Muscarinic acetylcholine receptor M1","protein":"Muscarinic acetylcholine receptor M1"}],"modality":"Small Molecule","drugClass":"hyoscyamine","explanation":"","oneSentence":"","technicalDetail":"As a competitive antagonist of the muscarinic acetylcholine receptor M4, -)-Atropine (Hyoscyamine) inhibits the action of acetylcholine, leading to decreased parasympathetic activity and increased sympathetic activity."},"commercial":{},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/1402","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=Hyoscyamine","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=Hyoscyamine","fields":["publications"],"source":"PubMed/NCBI"}],"_enrichedAt":"2026-03-30T11:58:45.471934","_validation":{"fieldsValidated":1,"lastValidatedAt":"2026-04-20T00:00:30.867261+00:00","fieldsConflicting":1,"overallConfidence":0.8},"biosimilars":[],"competitors":[{"drugName":"atropine","drugSlug":"atropine","fdaApproval":"1960-09-15","genericCount":1,"patentStatus":"Off-patent — generic available","relationship":"same-class"}],"dataSources":[{"url":"https://data.medicaid.gov/dataset/4j6z-xnwq","name":"CMS National Average Drug Acquisition Cost (NADAC)","fields":["pricing"],"retrievedDate":"2026-04-07"}],"genericName":"hyoscyamine","indications":{"approved":[{"id":"hyoscyamine-peptic-ulcer","name":"Peptic Ulcer","dosing":null,"approvals":[],"diseaseId":"","eligibility":"Patients with peptic ulcer","pivotalTrial":null,"restrictions":[],"patientPopulation":"Patients with peptic ulcer","diagnosticRequired":null,"brandNameForIndication":"(-)-Atropine"},{"id":"hyoscyamine-gastric-secretion-control","name":"Gastric Secretion Control","dosing":null,"approvals":[],"diseaseId":"","eligibility":"Patients with conditions requiring control of gastric secretion, visceral spasm, and hypermotility","pivotalTrial":null,"restrictions":[],"patientPopulation":"Patients with conditions requiring control of gastric secretion, visceral spasm, and hypermotility","diagnosticRequired":null,"brandNameForIndication":"(-)-Atropine"},{"id":"hyoscyamine-functional-intestinal-disorder","name":"Functional Intestinal Disorders","dosing":null,"approvals":[],"diseaseId":"","eligibility":"Patients with functional intestinal disorders","pivotalTrial":null,"restrictions":[],"patientPopulation":"Patients with functional intestinal disorders","diagnosticRequired":null,"brandNameForIndication":"(-)-Atropine"},{"id":"hyoscyamine-irritable-bowel-syndrome","name":"Irritable Bowel Syndrome","dosing":null,"approvals":[],"diseaseId":"","eligibility":"Patients with irritable bowel syndrome or functional gastrointestinal disorders","pivotalTrial":null,"restrictions":[],"patientPopulation":"Patients with irritable bowel syndrome or functional gastrointestinal disorders","diagnosticRequired":null,"brandNameForIndication":"(-)-Atropine"},{"id":"hyoscyamine-neurogenic-bladder-and-bowel-d","name":"Neurogenic Bladder and Bowel Disturbances","dosing":null,"approvals":[],"diseaseId":"","eligibility":"Patients with neurogenic bladder or neurogenic bowel disturbances","pivotalTrial":null,"restrictions":[],"patientPopulation":"Patients with neurogenic bladder or neurogenic bowel disturbances","diagnosticRequired":null,"brandNameForIndication":"(-)-Atropine"},{"id":"hyoscyamine-biliary-and-renal-colic","name":"Biliary and Renal Colic","dosing":null,"approvals":[],"diseaseId":"","eligibility":"Patients with biliary or renal colic","pivotalTrial":null,"restrictions":[],"patientPopulation":"Patients with biliary or renal colic","diagnosticRequired":null,"brandNameForIndication":"(-)-Atropine"},{"id":"hyoscyamine-acute-rhinitis","name":"Acute Rhinitis","dosing":null,"approvals":[],"diseaseId":"","eligibility":"Patients with acute rhinitis","pivotalTrial":null,"restrictions":[],"patientPopulation":"Patients with acute rhinitis","diagnosticRequired":null,"brandNameForIndication":"(-)-Atropine"},{"id":"hyoscyamine-parkinsonism","name":"Parkinsonism","dosing":null,"approvals":[],"diseaseId":"","eligibility":"Patients with parkinsonism","pivotalTrial":null,"restrictions":[],"patientPopulation":"Patients with parkinsonism","diagnosticRequired":null,"brandNameForIndication":"(-)-Atropine"},{"id":"hyoscyamine-anticholinesterase-poisoning","name":"Anticholinesterase Poisoning","dosing":null,"approvals":[],"diseaseId":"","eligibility":"Patients with anticholinesterase poisoning","pivotalTrial":null,"restrictions":[],"patientPopulation":"Patients with anticholinesterase poisoning","diagnosticRequired":null,"brandNameForIndication":"(-)-Atropine"}],"offLabel":[{"name":"Diarrhea","source":"DrugCentral","drugName":"Hyoscyamine"},{"name":"Irritable bowel syndrome","source":"DrugCentral","drugName":"Hyoscyamine","evidenceCount":13,"evidenceLevel":"moderate"},{"name":"Neurogenic bladder","source":"DrugCentral","drugName":"Hyoscyamine"},{"name":"Urinary incontinence","source":"DrugCentral","drugName":"Hyoscyamine","evidenceCount":6,"evidenceLevel":"emerging"}],"pipeline":[]},"drugCategory":"active","labelChanges":[],"relatedDrugs":[{"drugId":"atropine","brandName":"atropine","genericName":"atropine","approvalYear":"1960","relationship":"same-class"}],"trialDetails":[{"nctId":"NCT07309393","phase":"NA","title":"Impact of Sugammadex Versus Neostigmine on Early Postoperative Pulmonary Function","status":"RECRUITING","sponsor":"Shanghai Pulmonary Hospital, Shanghai, China","startDate":"2025-12-31","conditions":["Residual Neuromuscular Block"],"enrollment":240,"completionDate":"2026-06-30"},{"nctId":"NCT07494799","phase":"","title":"Efficacy of Different Interventions for Progressive Myopia After Orthokeratology Lens Wear","status":"NOT_YET_RECRUITING","sponsor":"Tianjin Medical University Eye Hospital","startDate":"2026-04-01","conditions":["Progressive Myopia, Pediatric Myopia, Orthokeratology-related Myopia Progression"],"enrollment":3890,"completionDate":"2027-04-01"},{"nctId":"NCT05065424","phase":"PHASE4","title":"Premedication for Less Invasive Surfactant Administration Study (PRELISA)","status":"COMPLETED","sponsor":"University of Texas Southwestern Medical Center","startDate":"2022-04-06","conditions":["Respiratory Distress Syndrome, Newborn"],"enrollment":58,"completionDate":"2026-03-02"},{"nctId":"NCT07475585","phase":"NA","title":"Effects of Auricular Point Pressing With Pellets in Children With Insufficient Hyperopia Reserve","status":"NOT_YET_RECRUITING","sponsor":"Fangbiao Tao","startDate":"2026-03-30","conditions":["Myopia","Ear Acupressure Pellets","Hyperopia Reserve","Low-concentration Atropine Eye Drops","Eye Axis"],"enrollment":380,"completionDate":"2027-07-30"},{"nctId":"NCT04699357","phase":"NA","title":"The Effect and Safety of Different Doses of Atropine on Myopic Progression of Highly Myopic Children: Multi-centered Randomized Clinical Trial","status":"COMPLETED","sponsor":"Shanghai Eye Disease Prevention and Treatment Center","startDate":"2021-07-04","conditions":["High Myopia"],"enrollment":219,"completionDate":"2024-09-01"},{"nctId":"NCT07268586","phase":"PHASE4","title":"Intravenous Atropine in Reducing Reperfusion Arrhythmias, Conduction Abnormalities and Hypotension in Inferior ST-elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention","status":"COMPLETED","sponsor":"Ain Shams University","startDate":"2025-08-01","conditions":["Myocardial Infarction"],"enrollment":158,"completionDate":"2026-02-28"},{"nctId":"NCT02858310","phase":"PHASE1,PHASE2","title":"E7 TCR T Cells for Human Papillomavirus-Associated Cancers","status":"COMPLETED","sponsor":"National Cancer Institute (NCI)","startDate":"2017-01-27","conditions":["Papillomavirus Infections","Cervical Intraepithelial Neoplasia","Carcinoma In Situ","Vulvar Neoplasms","Vulvar Diseases"],"enrollment":224,"completionDate":"2025-07-02"},{"nctId":"NCT07456488","phase":"PHASE2","title":"The Effect of 0.01% Atropine Eye Drops on Axial Length and Refraction in Myopic Children Compared to a Control Group","status":"RECRUITING","sponsor":"Liaquat National Hospital & Medical College","startDate":"2025-07-13","conditions":["Focus on Axial Length"],"enrollment":60,"completionDate":"2026-04-30"},{"nctId":"NCT07449247","phase":"PHASE1,PHASE2","title":"PROTECT-Study: Prospective Research on Optimizing Atropine Concentration Escalation for Children's Myopia Prevention","status":"NOT_YET_RECRUITING","sponsor":"Tianjin Medical University Eye Hospital","startDate":"2026-03-30","conditions":["Pre-myopia"],"enrollment":233,"completionDate":"2027-06-30"},{"nctId":"NCT07095894","phase":"PHASE3","title":"A RCT of Spectacles With Aspherical Lenslets or 0.05% Atropine for Myopia Control","status":"NOT_YET_RECRUITING","sponsor":"Jaeb Center for Health Research","startDate":"2026-03-01","conditions":["Myopia"],"enrollment":348,"completionDate":"2029-06-01"},{"nctId":"NCT07148596","phase":"","title":"Changes of Ciprofol Dosage and Bispectral Index Required for Loss of Consciousness in Patients of Different Ages","status":"COMPLETED","sponsor":"General Hospital of Ningxia Medical University","startDate":"2025-09-01","conditions":["Ciprofol"],"enrollment":125,"completionDate":"2025-12-07"},{"nctId":"NCT04923841","phase":"NA","title":"Myopia Control Using Bright Light Therapy, Myopic Defocus and Atropine","status":"ACTIVE_NOT_RECRUITING","sponsor":"The Hong Kong Polytechnic University","startDate":"2021-09-09","conditions":["Myopia"],"enrollment":579,"completionDate":"2026-12-31"},{"nctId":"NCT06358755","phase":"NA","title":"Combination Effect of Optical Defocus and Low Dose Atropine in Myopia Control","status":"ACTIVE_NOT_RECRUITING","sponsor":"The Hong Kong Polytechnic University","startDate":"2024-07-12","conditions":["Myopia"],"enrollment":112,"completionDate":"2027-01-31"},{"nctId":"NCT07434635","phase":"PHASE4","title":"APPRAISE: Assessment of Pain and Posterior Synechiae Reduction With Atropine, an Investigation of Post-Surgical Eyes","status":"RECRUITING","sponsor":"University of California, San Francisco","startDate":"2026-02","conditions":["Eye Disorders"],"enrollment":62,"completionDate":"2029-02"},{"nctId":"NCT07409935","phase":"PHASE4","title":"A Comparative Study Between Combination of Propofol and Dexmedetomidine Versus Propofol Alone in Anesthesia for Rigid Bronchoscopy by Using the Patient State Index Monitor","status":"COMPLETED","sponsor":"Cairo University","startDate":"2024-04-01","conditions":["Patients Undergoing Rigid Bronchoscopy"],"enrollment":50,"completionDate":"2025-10-01"},{"nctId":"NCT07406399","phase":"PHASE4","title":"Low Concentration Atropine Combined With Soft Contact Lens in Controlling Myopia Progression in Children With High Myopia","status":"COMPLETED","sponsor":"Beijing Tongren Hospital","startDate":"2023-06-30","conditions":["High Myopia","Low Concentration Atropine","Soft Contact Lens","Children"],"enrollment":120,"completionDate":"2026-01-30"},{"nctId":"NCT07028827","phase":"PHASE3","title":"Atropine Eyedrops for Myopia Progression in Children and Adolescents (MODERATO STUDY)","status":"RECRUITING","sponsor":"Ocus Innovation Ireland Limited","startDate":"2025-09-01","conditions":["Myopia"],"enrollment":234,"completionDate":"2027-12-31"},{"nctId":"NCT07394036","phase":"PHASE2","title":"Effect of Ipratropium Bromide on EILO","status":"NOT_YET_RECRUITING","sponsor":"Cook Children's Health Care System","startDate":"2026-03-16","conditions":["Exercise-Induced Laryngeal Obstruction","Dyspnea During Activity"],"enrollment":50,"completionDate":"2029-03-30"},{"nctId":"NCT05470881","phase":"PHASE1","title":"Phase I Clinical Trial to Evaluate the Safety and Tolerability of Ophtalmic Solution PRO-201","status":"COMPLETED","sponsor":"Laboratorios Sophia S.A de C.V.","startDate":"2022-08-20","conditions":["Myopia"],"enrollment":29,"completionDate":"2022-12-26"},{"nctId":"NCT06783296","phase":"NA","title":"Efficacy and Safety of Renal Denervation on Isolated Diastolic Hypertension","status":"NOT_YET_RECRUITING","sponsor":"Shanghai 10th People's Hospital","startDate":"2026-01-01","conditions":["Hypertension","Renal Denervation Therapy"],"enrollment":124,"completionDate":"2028-07-31"},{"nctId":"NCT01391962","phase":"PHASE2","title":"Sunitinib or Cediranib for Alveolar Soft Part Sarcoma","status":"COMPLETED","sponsor":"National Cancer Institute (NCI)","startDate":"2011-07-18","conditions":["Sarcoma, Alveolar Soft Part"],"enrollment":34,"completionDate":"2026-01-16"},{"nctId":"NCT07367178","phase":"PHASE2","title":"Study of Sacituzumab Govitecan With Atropine to Improve Tolerability in Advanced TNBC and HR+/HER2- Breast Cancer","status":"NOT_YET_RECRUITING","sponsor":"MedSIR","startDate":"2026-07","conditions":["Breast Cancer","Advanced HR+/HER2- Breast Cancer","Advanced Triple-Negative Breast Cancer"],"enrollment":30,"completionDate":"2028-01"},{"nctId":"NCT04766554","phase":"NA","title":"Cerebral Oxygen Saturation Monitoring In Cardiac Surgery (COSMICS)","status":"COMPLETED","sponsor":"Instituto Nacional de Cardiologia de Laranjeiras","startDate":"2021-05-19","conditions":["Cardiac Disease","Cognitive Dysfunction"],"enrollment":326,"completionDate":"2024-08-20"},{"nctId":"NCT06366087","phase":"PHASE1","title":"Sublingual Atropine Bioequivalence by Route of Administration (SABER)","status":"COMPLETED","sponsor":"Biomedical Advanced Research and Development Authority","startDate":"2024-04-15","conditions":["Atropine Bioequivalence"],"enrollment":46,"completionDate":"2024-05-22"},{"nctId":"NCT06450132","phase":"PHASE4","title":"Changes in Eye Shape With Myopia Management Interventions","status":"ACTIVE_NOT_RECRUITING","sponsor":"Ohio State University","startDate":"2024-08-01","conditions":["Myopia"],"enrollment":75,"completionDate":"2026-07-31"},{"nctId":"NCT07364370","phase":"NA","title":"Myopia Progression Control Using Atropine 0.05% After Pediatric Cataract Surgery And Intraocular Lens Implantation Surgery","status":"NOT_YET_RECRUITING","sponsor":"Cairo University","startDate":"2026-02","conditions":["Pediatric Cataract","IOL Implantation","Myopia Progression"],"enrollment":50,"completionDate":"2027-12"},{"nctId":"NCT06579287","phase":"PHASE2","title":"A Study of SHJ002 Sterile Ophthalmic Solution for Myopia Control","status":"ACTIVE_NOT_RECRUITING","sponsor":"Sunhawk Vision Biotech, Inc.","startDate":"2025-01-22","conditions":["Myopia, Progressive"],"enrollment":140,"completionDate":"2026-12"},{"nctId":"NCT06948409","phase":"","title":"NMBA Reversal and Postoperative Urinary Retention","status":"ACTIVE_NOT_RECRUITING","sponsor":"Beth Israel Deaconess Medical Center","startDate":"2025-06-08","conditions":["Neuromuscular Blocking Agents","Urinary Retention After Procedure","Urinary Retention Postoperative","Neuromuscular Blockade Reversal Agent","Neuromuscular Blockade","Costs","Atropine","Sugammadex","Glycopyrrolate","Neostigmine","Anesthesia"],"enrollment":70000,"completionDate":"2026-06-01"},{"nctId":"NCT07358689","phase":"PHASE2","title":"Toripalimab Combined With Platinum-based Chemotherapy With or Without H1 Receptor Antagonist in the Perioperative Treatment of Resectable Non-small Cell Lung Cancer","status":"NOT_YET_RECRUITING","sponsor":"Tianjin Medical University Cancer Institute and Hospital","startDate":"2026-01-30","conditions":["NSCLC"],"enrollment":120,"completionDate":"2029-01-01"},{"nctId":"NCT06865677","phase":"PHASE2","title":"Sacituzumab Govitecan for Relapsed Ovarian, Endometrial, and Cervical Carcinomas","status":"TERMINATED","sponsor":"National Cancer Institute (NCI)","startDate":"2025-06-09","conditions":["Recurrent Platinum Resistant Epithelial Ovarian Carcinoma","Recurrent Epithelial Endometrial Carcinoma","Recurrent Epithelial Cervical Carcinoma"],"enrollment":2,"completionDate":"2025-07-01"},{"nctId":"NCT05560542","phase":"NA","title":"Intrathecal Dexamethasone and Atropine on Morphine Induced Post-operative Nausea and Vomiting on Caesarean Section","status":"COMPLETED","sponsor":"Assiut University","startDate":"2022-10-01","conditions":["Morphine Adverse Reaction"],"enrollment":150,"completionDate":"2025-10-01"},{"nctId":"NCT03918915","phase":"PHASE3","title":"The Safety and Efficacy of SYD-101 in Children With Myopia","status":"COMPLETED","sponsor":"Sydnexis, Inc.","startDate":"2019-04-24","conditions":["Nearsightedness","Near Sightedness","Near-sightedness"],"enrollment":852,"completionDate":"2025-05-01"},{"nctId":"NCT07345078","phase":"NA","title":"Study on the Treatment of Post-stroke Dysphagia and Stroke-associated Pneumonia With Bronchoscopy","status":"COMPLETED","sponsor":"The First People's Hospital of Zunyi","startDate":"2019-09-01","conditions":["Stroke Associated Pneumonia","Non Severe Ischemic Stroke","Dysphagia"],"enrollment":50,"completionDate":"2021-09-30"},{"nctId":"NCT07329777","phase":"PHASE3","title":"Atropine in the Treatment of Myopia Study in Malaysia","status":"RECRUITING","sponsor":"IDB VisionCare SDN BHD","startDate":"2025-09-17","conditions":["Myopia Progression"],"enrollment":144,"completionDate":"2029-09"},{"nctId":"NCT05826119","phase":"NA","title":"Intravenous Administration of Magnesium Sulfate in Laparoscopic Hysterectomy Cases","status":"COMPLETED","sponsor":"Ondokuz Mayıs University","startDate":"2024-01-20","conditions":["Laparoscopic Hysterectomy","Magnesium Sulfate","General Anesthesia"],"enrollment":60,"completionDate":"2024-06-15"},{"nctId":"NCT05062031","phase":"NA","title":"Myopia Control in Children: Comparison of Defocus Incorporated Multiple Segments® Lenses Versus Atropine 0.05% Eyedrops","status":"ACTIVE_NOT_RECRUITING","sponsor":"Fondation Ophtalmologique Adolphe de Rothschild","startDate":"2021-10-19","conditions":["Myopia"],"enrollment":242,"completionDate":"2026-02"},{"nctId":"NCT07271875","phase":"PHASE3","title":"Neuromuscular Blocking Agents on Gastrointestinal Function Following Colorectal Surgery","status":"NOT_YET_RECRUITING","sponsor":"Xijing Hospital","startDate":"2026-01-01","conditions":["Postoperative Gastrointestinal Dysfunction (POGD)","Postoperative Ileus","Colorectal Surgery"],"enrollment":560,"completionDate":"2027-12-31"},{"nctId":"NCT07253428","phase":"NA","title":"Emergence Agitation","status":"ACTIVE_NOT_RECRUITING","sponsor":"Ain Shams University","startDate":"2025-10-30","conditions":["Emergence Agitation","Nasal Surgery"],"enrollment":486,"completionDate":"2026-01-31"},{"nctId":"NCT06449430","phase":"NA","title":"Use of Propofol as a Sedative Agent Versus Spinal Analgesia With Bupivacaine in External Cephalic Version","status":"RECRUITING","sponsor":"Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia","startDate":"2024-07-06","conditions":["Pregnancy Complications"],"enrollment":270,"completionDate":"2027-11-30"},{"nctId":"NCT04641702","phase":"PHASE4","title":"Comprehensive Esophageal Diagnostics Study","status":"RECRUITING","sponsor":"Emory University","startDate":"2021-03-17","conditions":["Achalasia"],"enrollment":80,"completionDate":"2026-12-31"},{"nctId":"NCT04903470","phase":"NA","title":"Defecation Patterns in Constipated Patients","status":"RECRUITING","sponsor":"The California Medical Innovations Institute, Inc.","startDate":"2022-12-19","conditions":["Constipation by Outlet Obstruction"],"enrollment":130,"completionDate":"2026-12-30"},{"nctId":"NCT00608725","phase":"NA","title":"Pathophysiology of Orthostatic Intolerance","status":"ACTIVE_NOT_RECRUITING","sponsor":"Satish R. Raj","startDate":"1996-12","conditions":["Tachycardia","Postural Orthostatic Tachycardia Syndrome"],"enrollment":260,"completionDate":"2029-12"},{"nctId":"NCT04393103","phase":"PHASE2,PHASE3","title":"Role of Intralipid in Management of Organophosphorus Poisoning","status":"WITHDRAWN","sponsor":"Amani Hassan Abdel-Wahab","startDate":"2024-04-01","conditions":["Organophosphorus Poisoning"],"enrollment":0,"completionDate":"2025-01-01"},{"nctId":"NCT06282848","phase":"NA","title":"Pharmacological and Non-pharmacological Treatment Effects on Children With Different Predicted Myopia Progression Rate","status":"RECRUITING","sponsor":"The Hong Kong Polytechnic University","startDate":"2024-01-01","conditions":["Myopia"],"enrollment":80,"completionDate":"2026-12"},{"nctId":"NCT07176949","phase":"NA","title":"Early-Onset Myopia Intervention Project","status":"RECRUITING","sponsor":"Shanghai Eye Disease Prevention and Treatment Center","startDate":"2025-06-01","conditions":["Myopia","Pre-myopia"],"enrollment":508,"completionDate":"2028-05-31"},{"nctId":"NCT06431841","phase":"PHASE4","title":"Atropine and Spectacle Combination Treatment (ASPECT): 12-month Results of a Randomized Clinical Trial for Myopia Control","status":"ACTIVE_NOT_RECRUITING","sponsor":"Hospital San Carlos, Madrid","startDate":"2022-02-23","conditions":["Myopia"],"enrollment":111,"completionDate":"2026-06-30"},{"nctId":"NCT00992901","phase":"EARLY_PHASE1","title":"Role of Neural and Hormonal Regulation Factors on Insulin Secretion After Gastric Bypass Surgery","status":"RECRUITING","sponsor":"The University of Texas Health Science Center at San Antonio","startDate":"2009-10","conditions":["Post Bariatricsurgery","Hypoglycemia"],"enrollment":160,"completionDate":"2027-08"},{"nctId":"NCT02823665","phase":"EARLY_PHASE1","title":"The Effects of Bariatric Surgeries on Glucose Metabolism","status":"RECRUITING","sponsor":"The University of Texas Health Science Center at San Antonio","startDate":"2015-07","conditions":["Post Bariatric Surgery","Gastric Bypass","Sleeve Gastrectomy","Hypoglycemia After Gastric Bypass"],"enrollment":200,"completionDate":"2027-08"},{"nctId":"NCT07164092","phase":"PHASE2,PHASE3","title":"Efficacy of Topical Atropine Eye Drops for Control of Myopia Progression Among Children Attending Mansoura University Ophthalmic Center","status":"NOT_YET_RECRUITING","sponsor":"Mansoura University","startDate":"2025-09","conditions":["Myopia"],"enrollment":45,"completionDate":"2027-09"},{"nctId":"NCT06523504","phase":"PHASE1,PHASE2","title":"Atropine (0.02%, 0.04%) Combined With Defocus DIMS for Moderate and High Myopia Control","status":"RECRUITING","sponsor":"Ruihua Wei","startDate":"2024-02-01","conditions":["Myopia"],"enrollment":410,"completionDate":"2026-03-31"},{"nctId":"NCT07129889","phase":"NA","title":"Auricular Acupressure Reduces Rebound Effects After Discontinuation of Atropine","status":"NOT_YET_RECRUITING","sponsor":"Ningbo Eye Hospital","startDate":"2025-12-02","conditions":["Myopia"],"enrollment":180,"completionDate":"2027-06-30"},{"nctId":"NCT07120165","phase":"","title":"Effectiveness of Myopia Control Interventions : A Comparison of Myopia Control in European Children, Adolescents and Young Adults With Defocus Incorporated Multiple Segments (DIMS) and Highly Aspherical Lenslets (HAL) Spectacles, Atropine, Lenses and Combined Treatments","status":"COMPLETED","sponsor":"Centre Hospitalier Universitaire de Saint Etienne","startDate":"2024-10-20","conditions":["Myopia"],"enrollment":114,"completionDate":"2025-05-07"},{"nctId":"NCT04315558","phase":"PHASE2","title":"Revefenacin in Acute Respiratory Insufficiency in COPD","status":"COMPLETED","sponsor":"University of California, Los Angeles","startDate":"2020-11-01","conditions":["COPD","Acute Respiratory Failure"],"enrollment":21,"completionDate":"2025-01-01"},{"nctId":"NCT07092046","phase":"NA","title":"Minimal Flow Anesthesia and Infection Risk","status":"ACTIVE_NOT_RECRUITING","sponsor":"Ankara City Hospital Bilkent","startDate":"2025-07-01","conditions":["Minimal Flow Anesthesia","General Anaesthesia","Inhalation Anesthesia","Infection Risk","Anesthesia Circuit","Microbial Colonization","Anesthesia Equipment Bacterial Contamination"],"enrollment":140,"completionDate":"2026-01"},{"nctId":"NCT06209281","phase":"PHASE3","title":"A Phase III Clinical Study of the Efficacy and Safety of Two Low-concentration Atropine Sulfate Eye Drops","status":"ACTIVE_NOT_RECRUITING","sponsor":"Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.","startDate":"2022-05-13","conditions":["Myopia"],"enrollment":526,"completionDate":"2025-12"},{"nctId":"NCT06209320","phase":"PHASE3","title":"A Study of the Efficacy and Safety of Two Low-concentration Atropine Sulfate Eye Drops","status":"ACTIVE_NOT_RECRUITING","sponsor":"Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.","startDate":"2022-03-15","conditions":["Myopia"],"enrollment":777,"completionDate":"2025-08"},{"nctId":"NCT03909165","phase":"PHASE4","title":"Efficacy, Safety, and Pharmacokinetics of Sugammadex (MK-8616) for Reversal of Neuromuscular Blockade in Pediatric Participants Aged Birth to <2 Years (MK-8616-169)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2019-07-23","conditions":["Neuromuscular Blockade"],"enrollment":145,"completionDate":"2023-09-21"},{"nctId":"NCT07064434","phase":"NA","title":"Sacral Canal Block for Hip Replacement the Efficacy and Safety of Controlled Intraoperative Hypotension","status":"RECRUITING","sponsor":"General Hospital of Ningxia Medical University","startDate":"2024-11-01","conditions":["Postoperative Pain"],"enrollment":80,"completionDate":"2025-10-30"},{"nctId":"NCT06912048","phase":"NA","title":"Understanding Individual Variability in Neuronal Signal Transmission to Target Organs in Health and Disease","status":"RECRUITING","sponsor":"University of Ulm","startDate":"2025-05-14","conditions":["Autonomic Function"],"enrollment":52,"completionDate":"2027-05"},{"nctId":"NCT03911271","phase":"PHASE2","title":"Low-dose Atropine for the Prevention of Myopia Progression in Danish Children","status":"COMPLETED","sponsor":"Line Kessel","startDate":"2019-05-30","conditions":["Myopia"],"enrollment":97,"completionDate":"2024-04-23"},{"nctId":"NCT03094052","phase":"PHASE2","title":"Incidence and Severity of Diarrhea in Patients With HER2 Positive Breast Cancer Treated With Trastuzumab and Neratinib","status":"COMPLETED","sponsor":"University of California, San Francisco","startDate":"2018-10-09","conditions":["HER2-positive Breast Cancer","Breast Adenocarcinoma","Stage II Breast Cancer AJCC v6 and v7","Stage IIA Breast Cancer AJCC v6 and v7","Stage IIB Breast Cancer AJCC v6 and v7","Stage III Breast Cancer AJCC v7","Stage IIIA Breast Cancer AJCC v7","Stage IIIB Breast Cancer AJCC v7","Stage IIIC Breast Cancer AJCC v7"],"enrollment":11,"completionDate":"2022-10-31"},{"nctId":"NCT05331664","phase":"PHASE4","title":"Dropless Pars Plana Vitrectomy Study","status":"RECRUITING","sponsor":"Massachusetts Eye and Ear Infirmary","startDate":"2022-07-25","conditions":["Rhegmatogenous Retinal Detachment"],"enrollment":168,"completionDate":"2027-01-30"},{"nctId":"NCT07033442","phase":"NA","title":"Effects Of Anaesthesia on Intraocular Pressure in Robotic Prostate Surgery","status":"COMPLETED","sponsor":"Ataturk Training and Research Hospital","startDate":"2015-07-23","conditions":["Anaesthesia","Intraocular Pressure","Trendelenburg Position","Robot Assisted Laparoscopic Radical Prostatectomy","Total Intravenous Anesthesia","Inhalation Anesthesia"],"enrollment":60,"completionDate":"2015-12-24"},{"nctId":"NCT07030153","phase":"","title":"Association of Genetic Variants With Myopia","status":"RECRUITING","sponsor":"Beijing Visionly Plus Eye Hospital","startDate":"2025-07-01","conditions":["Myopia"],"enrollment":1000,"completionDate":"2028-12-31"},{"nctId":"NCT06135896","phase":"PHASE2","title":"Tripegfilgrastim Trial to Reduce the Risk of Severe Neutropenia in Patients With Unresectable Pancreaticobiliary Cancers","status":"RECRUITING","sponsor":"National Cancer Center, Korea","startDate":"2024-01-16","conditions":["Unresectable Pancreatic Cancer","Unresectable Bile Duct Carcinoma","Unresectable Biliary Tract Carcinoma"],"enrollment":98,"completionDate":"2026-06-30"},{"nctId":"NCT06200194","phase":"PHASE2","title":"Early Intervention for Premyopic Children","status":"ACTIVE_NOT_RECRUITING","sponsor":"National Yang Ming Chiao Tung University Hospital","startDate":"2024-10-06","conditions":["Myopia","Preschool"],"enrollment":240,"completionDate":"2026-07"},{"nctId":"NCT07016737","phase":"PHASE3","title":"Immunochemotherapy ± Salvage Chemoradiation for Local Recurrence of Esophageal Squamous Cell Carcinoma After Definitive Chemoradiotherapy","status":"ENROLLING_BY_INVITATION","sponsor":"Ye jinjun","startDate":"2024-08-01","conditions":["Esophageal Squamous Cell Carcinoma (ESCC)"],"enrollment":79,"completionDate":"2029-09-01"},{"nctId":"NCT05666219","phase":"PHASE4","title":"Reversal of Complete Heart Block With Aminophylline in Inferior Wall Myocardial Infarction Patients","status":"WITHDRAWN","sponsor":"National Institute of Cardiovascular Diseases, Pakistan","startDate":"2022-12-19","conditions":["Complete Heart Block","Inferior Wall Myocardial Infarction"],"enrollment":0,"completionDate":"2025-01-17"},{"nctId":"NCT05644873","phase":"NA","title":"Intravenous Administration of Magnesium Sulfate in Hysterectomy Cases","status":"COMPLETED","sponsor":"Ondokuz Mayıs University","startDate":"2023-11-15","conditions":["Abdominal Hysterectomy","General Anesthesia","Magnesium Sulfate"],"enrollment":48,"completionDate":"2024-04-30"},{"nctId":"NCT06982092","phase":"PHASE1","title":"Using Diaphragm Ultrasonography, Sugammadex Recovers Diaphragmatic Function More Effectively Than Neostigmine.","status":"COMPLETED","sponsor":"Ain Shams University","startDate":"2024-08-26","conditions":["Perioperative Diaphragmatic Function"],"enrollment":60,"completionDate":"2025-01-15"},{"nctId":"NCT06922097","phase":"NA","title":"Treating Intraoperative Bradycardia in Non-cardiac Surgery Patients With Atropine at Heart Rates Below 60 Versus 30 Beats Per Minute and Norepinephrine Requirements","status":"RECRUITING","sponsor":"University of Hamburg-Eppendorf","startDate":"2025-04-07","conditions":["Intraoperative Bradycardia"],"enrollment":186,"completionDate":"2026-02"},{"nctId":"NCT03140358","phase":"PHASE3","title":"The Use of Atropine 0.01% in the Prevention and Control of Myopia (ATOM3)","status":"ACTIVE_NOT_RECRUITING","sponsor":"Singapore National Eye Centre","startDate":"2017-04-21","conditions":["Myopia"],"enrollment":300,"completionDate":"2025-12-31"},{"nctId":"NCT06970574","phase":"NA","title":"Comparative Study Between Intrathecal (Dexmedetomidine Versus Fentanyl)","status":"COMPLETED","sponsor":"Sohag University","startDate":"2022-07-10","conditions":["Cholecystitis"],"enrollment":60,"completionDate":"2023-07-10"},{"nctId":"NCT05786950","phase":"NA","title":"Neural Respiratory Drive of Patients With Chronic Obstructive Pulmonary Disease","status":"COMPLETED","sponsor":"The First Affiliated Hospital of Guangzhou Medical University","startDate":"2023-01-01","conditions":["Chronic Obstructive Pulmonary Disease"],"enrollment":44,"completionDate":"2024-09-01"},{"nctId":"NCT06683911","phase":"","title":"Opioids Continue to Play a Primary Role in the Management of Perioperative Pain Due to Opioid-Free Anesthesia in Open Heart Surgery.","status":"COMPLETED","sponsor":"Ankara City Hospital Bilkent","startDate":"2024-04-03","conditions":["Undergoing Open-Heart Surgery"],"enrollment":98,"completionDate":"2025-04-03"},{"nctId":"NCT06074185","phase":"PHASE2","title":"Treating Respiratory Emergencies in Children Study","status":"COMPLETED","sponsor":"Oregon Health and Science University","startDate":"2024-02-19","conditions":["Asthma in Children"],"enrollment":44,"completionDate":"2025-03-11"},{"nctId":"NCT05667454","phase":"PHASE3","title":"MAD Trial: Myopia Atropine Dose","status":"RECRUITING","sponsor":"Erasmus Medical Center","startDate":"2022-12-19","conditions":["Progressive Myopia"],"enrollment":550,"completionDate":"2029-04-01"},{"nctId":"NCT06918418","phase":"PHASE4","title":"A Comparative Study of Adding Ipratropium to Salbutamol for the Treatment of Asthma Attack in Children","status":"COMPLETED","sponsor":"Children's Hospital and Institute of Child Health, Multan","startDate":"2024-01-01","conditions":["Asthma Exacerbation","Children"],"enrollment":60,"completionDate":"2024-07-15"},{"nctId":"NCT05724550","phase":"NA","title":"Diaphragm Function After Reversal of Rocuronium-induced Neuromuscular Blockade With Sugammadex or Neostigmine in Children","status":"COMPLETED","sponsor":"Seoul National University Hospital","startDate":"2023-02-22","conditions":["Neuromuscular Block, Residual"],"enrollment":73,"completionDate":"2024-06-08"},{"nctId":"NCT06436768","phase":"NA","title":"Efficacy and Safety of Sugammadex in Thoracoscopy Thymectomy for Chinese Adults With Myasthenia Gravis","status":"COMPLETED","sponsor":"Beijing Tongren Hospital","startDate":"2024-06-01","conditions":["Reversal of Neuromuscular Blockade"],"enrollment":62,"completionDate":"2025-03-05"},{"nctId":"NCT06275542","phase":"NA","title":"Ability to Maintain Saturation Levels Without Oxygen Supplementation as a Extubation Criteria Without TOF Monitoring Equipment","status":"ENROLLING_BY_INVITATION","sponsor":"University of Surabaya","startDate":"2024-04-01","conditions":["Anesthesia Intubation Complication"],"enrollment":240,"completionDate":"2026-01-01"},{"nctId":"NCT06389110","phase":"PHASE3","title":"Study to Evaluate the Efficacy of Alleance® (Atropine Sulfate 0.01%) as a Treatment to Delay Myopia and Axial Ocular Elongation in Children.","status":"RECRUITING","sponsor":"Laboratorios Sophia S.A de C.V.","startDate":"2025-03-15","conditions":["Myopia","Myopia, Progressive"],"enrollment":123,"completionDate":"2027-10-30"},{"nctId":"NCT05411159","phase":"NA","title":"Effect of Opioid-free Anesthesia on PostOperative Nausea and Vomiting in Patients Undergoing Video-assisted Thoracoscopic Surgery","status":"COMPLETED","sponsor":"Beijing Chao Yang Hospital","startDate":"2022-06-07","conditions":["Postoperative Nausea and Vomiting","Opioid Use","Thoracic Diseases"],"enrollment":168,"completionDate":"2024-11-30"},{"nctId":"NCT04252989","phase":"","title":"Atropine 0.01% Eyedrops for Evolutive Myopia Treatment in Children","status":"RECRUITING","sponsor":"Centre Hospitalier Universitaire de Saint Etienne","startDate":"2019-12-18","conditions":["Myopia","Children"],"enrollment":50,"completionDate":"2027-12"},{"nctId":"NCT03865160","phase":"PHASE2,PHASE3","title":"Low-dose Atropine for Myopia Control in Children","status":"ACTIVE_NOT_RECRUITING","sponsor":"University Eye Hospital, Freiburg","startDate":"2021-10-19","conditions":["Myopia, Progressive"],"enrollment":302,"completionDate":"2027-11"},{"nctId":"NCT06836999","phase":"NA","title":"Deep Sedation in Catheter Ablation of Atrial Fibrillation","status":"NOT_YET_RECRUITING","sponsor":"The First Affiliated Hospital of Dalian Medical University","startDate":"2025-03-03","conditions":["Atrial Fibrillation","Atrial Fibrillation, Paroxysmal or Persistent","Deep Sedations","Conscious Sedation"],"enrollment":1334,"completionDate":"2027-12-31"},{"nctId":"NCT06764667","phase":"NA","title":"Comparison of Spinal Anesthesia Adjuvant and Quadratus Lumborum Block on the Opioid Requirement and Perioperative Pain of Laparoscopic Kidney Transplant Donor","status":"RECRUITING","sponsor":"Indonesia University","startDate":"2025-02-10","conditions":["Laparoscopic Donor Nephrectomy","Perioperative Pain Management"],"enrollment":60,"completionDate":"2026-01-31"},{"nctId":"NCT06667037","phase":"NA","title":"Orthokeratology and 0.01% Atropine Sequential Treatment for Myopia Control","status":"RECRUITING","sponsor":"Zhongshan Ophthalmic Center, Sun Yat-sen University","startDate":"2024-09-21","conditions":["Myopia"],"enrollment":194,"completionDate":"2027-03-31"},{"nctId":"NCT05379855","phase":"NA","title":"A-eyedrops on Ocular Alignment and Binocular Vision","status":"RECRUITING","sponsor":"Eye & ENT Hospital of Fudan University","startDate":"2024-03-02","conditions":["Exotropia","Exophoria","Myopia"],"enrollment":339,"completionDate":"2027-02-01"},{"nctId":"NCT05662371","phase":"NA","title":"Influence of Nociception Level Monitor (NOL) Guided Analgesic Delivery on Robot-assisted Colorectal Surgery","status":"RECRUITING","sponsor":"University of Southern Denmark","startDate":"2023-08-01","conditions":["Opioid Use, Unspecified","Pain, Postoperative"],"enrollment":60,"completionDate":"2025-12-31"},{"nctId":"NCT06824025","phase":"EARLY_PHASE1","title":"Comparison of Nebulized Neostigmine/Atropine Versus Lignocaine in Treating Acute Post-dural Puncture Headache Following Subarachnoid Block in Parturient Undergoing Elective Cesarean Section. A Randomized, Clinical Trial.","status":"NOT_YET_RECRUITING","sponsor":"Minia University","startDate":"2025-02-20","conditions":["Post-Dural Puncture Headache"],"enrollment":111,"completionDate":"2027-01-05"},{"nctId":"NCT06657079","phase":"PHASE1,PHASE2","title":"A Combination of an Inhaled Budesonide and Ipratropium in Patients at Risk of Developing ARDS","status":"COMPLETED","sponsor":"Damanhour University","startDate":"2024-05-01","conditions":["ARDS","Prevention and Control"],"enrollment":119,"completionDate":"2025-01-01"},{"nctId":"NCT06794450","phase":"PHASE1,PHASE2","title":"Recovery Times of Half Dose Sugammadex and Neostigmine for Rocuronium-induced Neuromuscular Blockade","status":"RECRUITING","sponsor":"Universitas Padjadjaran","startDate":"2024-11-05","conditions":["Neuromuscular Blocking Agents","Reversal of Neuromuscular Blockade","Recovery Time"],"enrollment":60,"completionDate":"2025-02"},{"nctId":"NCT06787638","phase":"PHASE1","title":"Effects of Neostigmine-dose on Diaphragmatic Dynamics","status":"NOT_YET_RECRUITING","sponsor":"Aswan University Hospital","startDate":"2025-01-25","conditions":["Diaphragm Ultrasound"],"enrollment":50,"completionDate":"2026-04"},{"nctId":"NCT06765603","phase":"PHASE2","title":"Evaluating the Efficacy of the Combination of Multi-zonal Contact Lens and Atropine for Controlling Myopia Progression","status":"NOT_YET_RECRUITING","sponsor":"Singapore National Eye Centre","startDate":"2025-02-01","conditions":["Myopia"],"enrollment":180,"completionDate":"2029-12-31"},{"nctId":"NCT03942419","phase":"PHASE3","title":"Microdosed Atropine 0.1% and 0.01% Ophthalmic Solutions for Reduction of Pediatric Myopia Progression","status":"TERMINATED","sponsor":"Eyenovia Inc.","startDate":"2019-06-03","conditions":["Myopia"],"enrollment":438,"completionDate":"2024-11-20"},{"nctId":"NCT06708156","phase":"PHASE3","title":"The Effectiveness and Safety of Two Low-concentration Atropine Sulfate Eye Drops (0.01%/0.02%) for Delaying the Pediatric Myopia Progression","status":"RECRUITING","sponsor":"Oupushifang Pharmaceutical Technology Co., Ltd.","startDate":"2024-06-15","conditions":["Myopia","Myopia Progression"],"enrollment":606,"completionDate":"2027-12-31"},{"nctId":"NCT05164367","phase":"EARLY_PHASE1","title":"Pharmacokinetics of Atropine Oral Gel","status":"COMPLETED","sponsor":"University of Utah","startDate":"2022-10-01","conditions":["Cerebral Palsy","Sialorrhea"],"enrollment":10,"completionDate":"2024-12-10"},{"nctId":"NCT04016246","phase":"PHASE3","title":"Respiratory Effect of the LISA Method with Sedation by Propofol Versus Absence of Sedation.","status":"ACTIVE_NOT_RECRUITING","sponsor":"University Hospital, Grenoble","startDate":"2019-10-07","conditions":["Respiratory Distress Syndrome in Premature Infant"],"enrollment":233,"completionDate":"2026-10"},{"nctId":"NCT06034379","phase":"NA","title":"Electronic Spectacles Versus Low Dose Atropine in Young Myopes","status":"RECRUITING","sponsor":"Kubota Vision Inc.","startDate":"2023-10-01","conditions":["Myopia"],"enrollment":45,"completionDate":"2025-12"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{"route":"Oral","formulation":"Capsule, Elixir","formulations":[{"form":"CAPSULE","route":"ORAL","productName":"Vilamit MB"},{"form":"CAPSULE","route":"ORAL","productName":"URO-SP"},{"form":"CAPSULE","route":"ORAL","productName":"URIBEL"},{"form":"CAPSULE","route":"ORAL","productName":"URIMAR-T CAPS"},{"form":"CAPSULE","route":"ORAL","productName":"UrNeva"},{"form":"CAPSULE","route":"ORAL","productName":"Uro-MP"},{"form":"CAPSULE","route":"ORAL","productName":"UroAv-B"},{"form":"CAPSULE","route":"ORAL","productName":"Ustell"},{"form":"ELIXIR","route":"ORAL","productName":"Donnatal"},{"form":"ELIXIR","route":"ORAL","productName":"Hyoscyamine Sulfate"},{"form":"ELIXIR","route":"ORAL","productName":"Hyosyne"},{"form":"ELIXIR","route":"ORAL","productName":"Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide"},{"form":"ELIXIR","route":"ORAL","productName":"Phenohytro"},{"form":"ELIXIR","route":"ORAL","productName":"QUADRAPAX"},{"form":"ELIXIR","route":"ORAL","productName":"RE-PB HYOS ELIXIR"}]},"crossReferences":{"NUI":"N0000189428","MMSL":"20634","NDDF":"001727","UNII":"PX44XO846X","VUID":"4018400","CHEBI":"CHEBI:17486","VANDF":"4018398","RXNORM":"1047802","UMLSCUI":"C0596004","chemblId":"CHEMBL1331216","ChEMBL_ID":"CHEMBL1331216","KEGG_DRUG":"D00147","DRUGBANK_ID":"DB00424","PUBCHEM_CID":"174174","SNOMEDCT_US":"372757002","SECONDARY_CAS_RN":"306-03-6","MESH_DESCRIPTOR_UI":"D064692"},"formularyStatus":[],"_enricherVersion":"v2","_offLabelChecked":true,"developmentCodes":[],"ownershipHistory":[],"publicationCount":619,"therapeuticAreas":["Gastroenterology"],"atcClassification":{"source":"DrugCentral","atcCode":"A03BA03","allCodes":["A03BA03","A03CB31"]},"biosimilarFilings":[],"recentPublications":[],"companionDiagnostics":[],"genericManufacturerList":[],"status":"active","companyName":"University of Kansas Medical Center","companyId":"university-of-kansas-medical-center","modality":"Small molecule","firstApprovalDate":"","aiSummary":"","enrichmentLevel":3,"visitCount":1,"regulatoryByCountry":[{"country_code":"OTHER","regulator":"YEAR INTRODUCED","status":"approved","approval_date":"1869-01-01T00:00:00.000Z","mah":"","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":"US","regulator":"FDA","status":"approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"pricingByCountry":[{"country_code":"Un","currency":"USD","price_amount":"58.00","price_per":"year","price_type":"NADAC","annual_cost_usd":null,"reimbursement_status":null}],"trialStats":{"total":1,"withResults":1},"validation":{"fieldsValidated":1,"lastValidatedAt":"2026-04-20T00:00:30.867261+00:00","fieldsConflicting":1,"overallConfidence":0.8},"verificationStatus":"verified","dataCompleteness":{"mechanism":false,"indications":true,"safety":true,"trials":true,"score":3}}