{"id":"glycopyrrolate","rwe":[],"_fda":{"id":"b3bf6c1b-89c3-44ad-b505-9f2384e15a9b","set_id":"02541cfd-b209-49b9-a73f-13ef18dce06d","openfda":{"unii":["V92SO9WP2I"],"route":["INTRAMUSCULAR","INTRAVENOUS"],"rxcui":["238212","1731582","1731590"],"spl_id":["b3bf6c1b-89c3-44ad-b505-9f2384e15a9b"],"brand_name":["Glycopyrrolate"],"spl_set_id":["02541cfd-b209-49b9-a73f-13ef18dce06d"],"package_ndc":["71288-414-01","71288-414-03","71288-414-02","71288-414-04","71288-415-05","71288-415-06","71288-415-20","71288-415-21"],"product_ndc":["71288-414","71288-415"],"generic_name":["GLYCOPYRROLATE"],"product_type":["HUMAN PRESCRIPTION DRUG"],"substance_name":["GLYCOPYRROLATE"],"manufacturer_name":["Meitheal Pharmaceuticals Inc."],"application_number":["ANDA212802"],"is_original_packager":[true]},"version":"6","warnings":["WARNINGS This drug should be used with great caution, if at all, in patients with glaucoma. Exposure to excessive amounts of benzyl alcohol has been associated with toxicity (hypotension, metabolic acidosis), particularly in neonates, and an increased incidence of kernicterus, particularly in small preterm infants. There have been rare reports of deaths, primarily in preterm infants, associated with exposure to excessive amounts of benzyl alcohol. The amount of benzyl alcohol from medications is usually considered negligible compared to that received in flush solutions containing benzyl alcohol. Administration of high dosages of medications containing this preservative must take into account the total amount of benzyl alcohol administered. The amount of benzyl alcohol at which toxicity may occur is not known. If the patient requires more than the recommended dosages or other medications containing this preservative, the practitioner must consider the daily metabolic load of benzyl alcohol from these combined sources (see PRECAUTIONS, Pediatric Use ). Glycopyrrolate injection may produce drowsiness or blurred vision. The patient should be cautioned regarding activities requiring mental alertness such as operating a motor vehicle or other machinery or performing hazardous work while taking this drug. In addition, in the presence of fever, high environmental temperature and/or during physical exercise, heat prostration can occur with use of anticholinergic agents including glycopyrrolate (due to decreased sweating), particularly in children and the elderly. Diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy. In this instance treatment with glycopyrrolate injection would be inappropriate and possibly harmful."],"pregnancy":["Pregnancy TERATOGENIC EFFECTS Reproduction studies with glycopyrrolate were performed in rats at a dietary dose of approximately 65 mg/kg/day (exposure was approximately 320 times the maximum recommended daily human dose of 2 mg on a mg/m 2 basis) and rabbits at intramuscular doses of up to 0.5 mg/kg/day (exposure was approximately 5 times the maximum recommended daily human dose on a mg/m 2 basis). These studies produced no teratogenic effects to the fetus. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Single-dose studies in humans found that very small amounts of glycopyrrolate passed the placental barrier. NONTERATOGENIC EFFECTS Published literature suggest the following regarding the use of glycopyrrolate during pregnancy. Unlike atropine, glycopyrrolate in normal doses (0.004 mg/kg) does not appear to affect fetal heart rate or fetal heart rate variability to a significant degree. Concentrations of glycopyrrolate in umbilical venous and arterial blood and in the amniotic fluid are low after intramuscular administration to parturients. Therefore, glycopyrrolate does not appear to penetrate through the placental barrier in significant amounts. In reproduction studies in rats, dietary administration of glycopyrrolate resulted in diminished rats of pup survival in a dose-related manner."],"overdosage":["OVERDOSAGE To combat peripheral anticholinergic effects, a quaternary ammonium anticholinesterase such as neostigmine methylsulfate (which does not cross the blood-brain barrier) may be given intravenously in increments of 0.25 mg in adults. This dosage may be repeated every five to ten minutes until anticholinergic overactivity is reversed or up to a maximum of 2.5 mg. Proportionately smaller doses should be used in pediatric patients. Indication for repetitive doses of neostigmine should be based on close monitoring of the decrease in heart rate and the return of bowel sounds. If CNS symptoms (e.g., excitement, restlessness, convulsions, psychotic behavior) occur, physostigmine (which does cross the blood–brain barrier) may be used. Physostigmine 0.5 to 2 mg should be slowly administered intravenously and repeated as necessary up to a total of 5 mg in adults. Proportionately smaller doses should be used in pediatric patients. To combat hypotension, administer IV fluids and/or pressor agents along with supportive care. Fever should be treated symptomatically. Following overdosage, a curare-like action may occur, i.e., neuromuscular blockade leading to muscular weakness and possible paralysis. In the event of a curare-like effect on respiratory muscles, artificial respiration should be instituted and maintained until effective respiratory action returns."],"description":["DESCRIPTION Glycopyrrolate Injection, USP is a synthetic anticholinergic agent. Each 1 mL contains: Glycopyrrolate, USP 0.2 mg Water for Injection, USP q.s. Benzyl Alcohol, NF 0.9% (preservative) pH adjusted, when necessary, with hydrochloric acid and/or sodium hydroxide. For Intramuscular (IM) or Intravenous (IV) administration. Glycopyrrolate is a quaternary ammonium salt with the following chemical name: 3[(cyclopentylhydroxyphenylacetyl)oxy]-1,1-dimethyl pyrrolidinium bromide. The molecular formula is C 19 H 28 BrNO 3 and the molecular weight is 398.34. Its structural formula is as follows: C 19 H 28 BrNO 3 MW 398.34 Glycopyrrolate occurs as a white, odorless crystalline powder. It is soluble in water and alcohol, and practically insoluble in chloroform and ether. Unlike atropine, glycopyrrolate is completely ionized at physiological pH values. Glycopyrrolate Injection, USP is a clear, colorless, sterile liquid; pH 2.0 to 3.0. The partition coefficient of glycopyrrolate in a n-octanol/water system is 0.304 (log 10 P= -1.52) at ambient room temperature (24°C). Structural formula"],"precautions":["PRECAUTIONS General Investigate any tachycardia before giving glycopyrrolate injection since an increase in the heart rate may occur. Use with caution in patients with: coronary artery disease; congestive heart failure; cardiac arrhythmias; hypertension; hyperthyroidism. Use with caution in patients with renal disease since the renal elimination of glycopyrrolate may be severely impaired in patients with renal failure. Dosage adjustments may be necessary (see Pharmacokinetics – Renal Impairment ). Use glycopyrrolate with caution in the elderly and in all patients with autonomic neuropathy, hepatic disease, ulcerative colitis, prostic hypertrophy, or hiatal hernia, since anticholinergic drugs may aggravate these conditions. The use of anticholinergetic drugs in the treatment of gastric ulcer may produce a delay in gastric emptying due to antral statis. Information for the Patient Because glycopyrrolate injection may produce drowsiness or blurred vision, the patient should be cautioned not to engage in activities requiring mental alertness and/or visual acuity such as operating a motor vehicle or other machinery, or performing hazardous work while taking this drug (see WARNINGS ). The patient also should be cautioned about the use of this drug during exercise or hot weather since overheating may result in heat stroke. The patient may experience a possible sensitivity of the eyes to light. Drug Interactions The concurrent use of glycopyrrolate injection with other anticholinergics or medications with anticholinergic activity, such as phenothiazines, antiparkinson drugs, or tricyclic antidepressants, may intensify the antimuscarinic effects and may result in an increase in anticholinergic side effects. Concomitant administration of glycopyrrolate injection and potassium chloride in a wax matrix may increase the severity of potassium chloride-induced gastrointestinal lesions as a result of a slower gastrointestinal transit time. Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term studies in animals have not been performed to evaluate carcinogenic potential. Studies to evaluate the mutagenic potential of glycopyrrolate have not been conducted. In reproduction studies in rats, dietary administration of glycopyrrolate resulted in diminished rates of conception in a dose-related manner. Other studies in dogs suggest that this may be due to diminished seminal secretion which is evident at high doses of glycopyrrolate. Pregnancy TERATOGENIC EFFECTS Reproduction studies with glycopyrrolate were performed in rats at a dietary dose of approximately 65 mg/kg/day (exposure was approximately 320 times the maximum recommended daily human dose of 2 mg on a mg/m 2 basis) and rabbits at intramuscular doses of up to 0.5 mg/kg/day (exposure was approximately 5 times the maximum recommended daily human dose on a mg/m 2 basis). These studies produced no teratogenic effects to the fetus. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Single-dose studies in humans found that very small amounts of glycopyrrolate passed the placental barrier. NONTERATOGENIC EFFECTS Published literature suggest the following regarding the use of glycopyrrolate during pregnancy. Unlike atropine, glycopyrrolate in normal doses (0.004 mg/kg) does not appear to affect fetal heart rate or fetal heart rate variability to a significant degree. Concentrations of glycopyrrolate in umbilical venous and arterial blood and in the amniotic fluid are low after intramuscular administration to parturients. Therefore, glycopyrrolate does not appear to penetrate through the placental barrier in significant amounts. In reproduction studies in rats, dietary administration of glycopyrrolate resulted in diminished rats of pup survival in a dose-related manner. Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when glycopyrrolate injection is administered to a nursing woman. As with other anticholinergics, glycopyrrolate may cause suppression of lactation (see ADVERSE REACTIONS ). Pediatric Use Due to its benzyl alcohol content, glycopyrrolate injection should not be used in neonates, i.e., patients less than 1 month of age. Safety and effectiveness in pediatric patients have not been established for the management of peptic ulcer. Dysrhythmias associated with the use of glycopyrrolate intravenously as a premedicant or during anesthesia have been observed in pediatric patients. Infants, patients with Down's syndrome, and pediatric patients with spastic paralysis or brain damage may experience an increased response to anticholinergics, thus increasing the potential for side effects. A paradoxical reaction characterized by hyperexcitability may occur in pediatric patients taking large doses of anticholinergics including glycopyrrolate injection. Infants and young children are especially susceptible to the toxic effects of anticholinergics. Benzyl alcohol, a component of this drug product, has been associated with serious adverse events and death, particularly in pediatric patients. The “gasping syndrome,” (characterized by central nervous system depression, metabolic acidosis, gasping respirations, and high levels of benzyl alcohol and its metabolites found in the blood and urine) has been associated with benzyl alcohol dosages >99 mg/kg/day in neonates and low-birth-weight neonates. Additional symptoms may include gradual neurological deterioration, seizures, intracranial hemorrhage, hematologic abnormalities, skin breakdown, hepatic and renal failure, hypotension, bradycardia, and cardiovascular collapse. Although normal therapeutic doses of this product deliver amounts of benzyl alcohol that are substantially lower than those reported in association with the “gasping syndrome,” the minimum amount of benzyl alcohol at which toxicity may occur is not known. Premature and low-birthweight infants, as well as patients receiving high dosages, may be more likely to develop toxicity. Practitioners administering this and other medications containing benzyl alcohol should consider the combined daily metabolic load of benzyl alcohol from all sources. Geriatric Use Clinical studies of glycopyrrolate injection did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly 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 therapy."],"how_supplied":["HOW SUPPLIED Glycopyrrolate Injection, USP is a clear, colorless solution and is supplied as follows: NDC Glycopyrrolate Injection, USP (0.2 mg per mL) Package Factor 71288- 414 -03 0.2 mg per 1 mL Single-Dose Vial 25 vials per carton 71288- 414 -04 0.4 mg per 2 mL Single-Dose Vial 25 vials per carton 71288- 415 -06 1 mg per 5 mL Multi-Dose Vial 25 vials per carton 71288- 415 -21 4 mg per 20 mL Multi-Dose Vial 10 vials per carton Storage Conditions Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. For single-dose vials only, discard unused portion. Sterile. The container closure is not made with natural rubber latex. To report SUSPECTED ADVERSE REACTIONS, contact Meitheal Pharmaceuticals Inc. at 1-844-824-8426 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . For Product Inquiry call 1-844-824-8426. Brands listed are the trademarks of their respective owners. meitheal ® Mfd. for Meitheal Pharmaceuticals Chicago, IL 60631 (USA) ©2025 Meitheal Pharmaceuticals Inc. Mfd. by Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd. Nanjing, China 210061 Revised: November 2025 8E3AAM9-02"],"geriatric_use":["Geriatric Use Clinical studies of glycopyrrolate injection did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly 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 therapy."],"pediatric_use":["Pediatric Use Due to its benzyl alcohol content, glycopyrrolate injection should not be used in neonates, i.e., patients less than 1 month of age. Safety and effectiveness in pediatric patients have not been established for the management of peptic ulcer. Dysrhythmias associated with the use of glycopyrrolate intravenously as a premedicant or during anesthesia have been observed in pediatric patients. Infants, patients with Down's syndrome, and pediatric patients with spastic paralysis or brain damage may experience an increased response to anticholinergics, thus increasing the potential for side effects. A paradoxical reaction characterized by hyperexcitability may occur in pediatric patients taking large doses of anticholinergics including glycopyrrolate injection. Infants and young children are especially susceptible to the toxic effects of anticholinergics. Benzyl alcohol, a component of this drug product, has been associated with serious adverse events and death, particularly in pediatric patients. The “gasping syndrome,” (characterized by central nervous system depression, metabolic acidosis, gasping respirations, and high levels of benzyl alcohol and its metabolites found in the blood and urine) has been associated with benzyl alcohol dosages >99 mg/kg/day in neonates and low-birth-weight neonates. Additional symptoms may include gradual neurological deterioration, seizures, intracranial hemorrhage, hematologic abnormalities, skin breakdown, hepatic and renal failure, hypotension, bradycardia, and cardiovascular collapse. Although normal therapeutic doses of this product deliver amounts of benzyl alcohol that are substantially lower than those reported in association with the “gasping syndrome,” the minimum amount of benzyl alcohol at which toxicity may occur is not known. Premature and low-birthweight infants, as well as patients receiving high dosages, may be more likely to develop toxicity. Practitioners administering this and other medications containing benzyl alcohol should consider the combined daily metabolic load of benzyl alcohol from all sources."],"effective_time":"20251118","nursing_mothers":["Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when glycopyrrolate injection is administered to a nursing woman. As with other anticholinergics, glycopyrrolate may cause suppression of lactation (see ADVERSE REACTIONS )."],"pharmacokinetics":["Pharmacokinetics The following pharmacokinetic information and conclusions were obtained from published studies that used nonspecific assay methods. DISTRIBUTION The mean volume of distribution of glycopyrrolate was estimated to be 0.42 ± 0.22 L/kg. METABOLISM The in vivo metabolism of glycopyrrolate in humans has not been studied. EXCRETION The mean clearance and mean T 1/2 values were reported to be 0.54 ± 0.14 L/kg/hr and 0.83 ± 0.13 hr, respectively post IV administration. After IV administration of a 0.2 mg radiolabeled glycopyrrolate, 85% of dose recovered was recovered in urine 48 hours postdose and some of the radioactivity was also recovered in bile. After IM administration of glycopyrrolate to adults, the mean T 1/2 value is reported to be between 0.55 to 1.25 hrs. Over 80% of IM dose administered was recovered in urine and the bile as unchanged drug and half the IM dose is excreted within 3 hrs. The following table summarizes the mean and standard deviation of pharmacokinetic parameters from a study. *0 to 8 hr Group t 1/2 (hr) V ss (L/kg) CL (L/kg/hr) T max (min) C max (mcg/L) AUC (mcg/L•hr) (6 mcg/kg IV) 0.83 ± 0.27 0.42 ± 0.22 0.54 ± 0.14 – – 8.64 ± 1.49* (8 mcg/kg IM) – – – 27.48 ± 6.12 3.47 ± 1.48 6.64 ± 2.33* SPECIAL POPULATIONS Gender Gender differences in pharmacokinetics of glycopyrrolate have not been investigated. Renal Impairment In one study glycopyrrolate was administered IV in uremic patients undergoing renal transplantation. The mean elimination half-life was significantly longer (46.8 minutes) than in healthy patients (18.6 minutes). The mean area-under-the-concentration-time curve (10.6 hr-mcg/L), mean plasma clearance (0.43 L/hr/kg), and mean 3-hour urine excretion (0.7%) for glycopyrrolate were also significantly different than those of controls (3.73 hr-mcg/L, 1.14 L/hr/kg, and 50%, respectively). These results suggest that the elimination of glycopyrrolate is severely impaired in patients with renal failure. Hepatic Impairment Pharmacokinetic information in patients with hepatic impairment is unavailable. Pediatrics Following IV administration (5 mcg/kg glycopyrrolate) to infants and children, the mean T 1/2 values were reported to be between 21.6 and 130.0 minutes and between 19.2 and 99.2 minutes, respectively."],"adverse_reactions":["ADVERSE REACTIONS Anticholinergics, including glycopyrrolate injection, can produce certain effects, most of which are extensions of their pharmacologic actions. Adverse reactions may include xerostomia (dry mouth); urinary hesitancy and retention; blurred vision and photophobia due to mydriasis (dilation of the pupil); cycloplegia; increased ocular tension; tachycardia; palpitation; decreased sweating; loss of taste; headache; nervousness; drowsiness; weakness; dizziness; insomnia; nausea; vomiting; impotence; suppression of lactation; constipation; bloated feeling; severe allergic reactions including anaphylactic/anaphylactoid reactions; hypersensitivity; urticaria, pruritus, dry skin, and other dermal manifestations; some degree of mental confusion and/or excitement, especially in elderly persons. In addition, the following adverse events have been reported from post-marketing experience with glycopyrrolate: malignant hyperthermia; cardiac arrhythmias (including bradycardia, ventricular tachycardia, ventricular fibrillation); cardiac arrest; hypertension; hypotension; seizures; and respiratory arrest. Post-marketing reports have included cases of heart block and QTc interval prolongation associated with the combined use of glycopyrrolate and an anticholinesterase. Injection site reactions including pruritus, edema, erythema, and pain have also been reported. Glycopyrrolate is chemically a quaternary ammonium compound; hence, its passage across lipid membranes, such as the blood-brain barrier is limited in contrast to atropine sulfate and scopolamine hydrobromide. For this reason the occurrence of CNS-related side effects is lower, in comparison to their incidence following administration of anticholinergics which are chemically tertiary amines that can cross this barrier readily. To report SUSPECTED ADVERSE REACTIONS, contact Meitheal Pharmaceuticals, Inc. at 1-844-824-8426 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch ."],"contraindications":["CONTRAINDICATIONS Known hypersensitivity to glycopyrrolate or any of its inactive ingredients. In addition, in the management of peptic ulcer patients, because of the longer duration of therapy, glycopyrrolate injection may be contraindicated in patients with the following concurrent conditions: glaucoma; obstructive uropathy (for example, bladder neck obstruction due to prostatic hypertrophy); obstructive disease of the gastrointestinal tract (as in achalasia, pyloroduodenal stenosis, etc.); paralytic ileus, intestinal atony of the elderly or debilitated patient; unstable cardiovascular status in acute hemorrhage; severe ulcerative colitis; toxic megacolon complicating ulcerative colitis; myasthenia gravis."],"description_table":["
C19H28BrNO3 MW 398.34
"],"drug_interactions":["Drug Interactions The concurrent use of glycopyrrolate injection with other anticholinergics or medications with anticholinergic activity, such as phenothiazines, antiparkinson drugs, or tricyclic antidepressants, may intensify the antimuscarinic effects and may result in an increase in anticholinergic side effects. Concomitant administration of glycopyrrolate injection and potassium chloride in a wax matrix may increase the severity of potassium chloride-induced gastrointestinal lesions as a result of a slower gastrointestinal transit time."],"how_supplied_table":["
NDCGlycopyrrolate Injection, USP (0.2 mg per mL)Package Factor
71288-414-03 0.2 mg per 1 mL Single-Dose Vial 25 vials per carton
71288-414-04 0.4 mg per 2 mL Single-Dose Vial 25 vials per carton
71288-415-06 1 mg per 5 mL Multi-Dose Vial 25 vials per carton
71288-415-21 4 mg per 20 mL Multi-Dose Vial 10 vials per carton
"],"general_precautions":["General Investigate any tachycardia before giving glycopyrrolate injection since an increase in the heart rate may occur. Use with caution in patients with: coronary artery disease; congestive heart failure; cardiac arrhythmias; hypertension; hyperthyroidism. Use with caution in patients with renal disease since the renal elimination of glycopyrrolate may be severely impaired in patients with renal failure. Dosage adjustments may be necessary (see Pharmacokinetics – Renal Impairment ). Use glycopyrrolate with caution in the elderly and in all patients with autonomic neuropathy, hepatic disease, ulcerative colitis, prostic hypertrophy, or hiatal hernia, since anticholinergic drugs may aggravate these conditions. The use of anticholinergetic drugs in the treatment of gastric ulcer may produce a delay in gastric emptying due to antral statis."],"teratogenic_effects":["TERATOGENIC EFFECTS Reproduction studies with glycopyrrolate were performed in rats at a dietary dose of approximately 65 mg/kg/day (exposure was approximately 320 times the maximum recommended daily human dose of 2 mg on a mg/m 2 basis) and rabbits at intramuscular doses of up to 0.5 mg/kg/day (exposure was approximately 5 times the maximum recommended daily human dose on a mg/m 2 basis). These studies produced no teratogenic effects to the fetus. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Single-dose studies in humans found that very small amounts of glycopyrrolate passed the placental barrier."],"storage_and_handling":["Storage Conditions Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. For single-dose vials only, discard unused portion. Sterile. The container closure is not made with natural rubber latex. To report SUSPECTED ADVERSE REACTIONS, contact Meitheal Pharmaceuticals Inc. at 1-844-824-8426 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . For Product Inquiry call 1-844-824-8426. Brands listed are the trademarks of their respective owners. meitheal ® Mfd. for Meitheal Pharmaceuticals Chicago, IL 60631 (USA) ©2025 Meitheal Pharmaceuticals Inc. Mfd. by Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd. Nanjing, China 210061 Revised: November 2025 8E3AAM9-02"],"clinical_pharmacology":["CLINICAL PHARMACOLOGY Glycopyrrolate, like other anticholinergic (antimuscarinic) agents, inhibits the action 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 smooth muscle, cardiac muscle, the sinoatrial node, the atrioventricular node, exocrine glands and, to a limited degree, in the autonomic ganglia. Thus, it diminishes the volume and free acidity of gastric secretions and controls excessive pharyngeal, tracheal, and bronchial secretions. Glycopyrrolate antagonizes muscarinic symptoms (e.g., bronchorrhea, bronchospasm, bradycardia, and intestinal hypermotility) induced by cholinergic drugs such as the anticholinesterases. The highly polar quaternary ammonium group of glycopyrrolate limits its passage across lipid membranes, such as the blood-brain barrier, in contrast to atropine sulfate and scopolamine hydrobromide, which are highly non-polar tertiary amines which penetrate lipid barriers easily. With intravenous injection, the onset of action is generally evident within one minute. Following intramuscular administration, the onset of action is noted in 15 to 30 minutes, with peak effects occurring within approximately 30 to 45 minutes. The vagal blocking effects persist for 2 to 3 hours and the antisialagogue effects persist up to 7 hours, periods longer than for atropine. Pharmacokinetics The following pharmacokinetic information and conclusions were obtained from published studies that used nonspecific assay methods. DISTRIBUTION The mean volume of distribution of glycopyrrolate was estimated to be 0.42 ± 0.22 L/kg. METABOLISM The in vivo metabolism of glycopyrrolate in humans has not been studied. EXCRETION The mean clearance and mean T 1/2 values were reported to be 0.54 ± 0.14 L/kg/hr and 0.83 ± 0.13 hr, respectively post IV administration. After IV administration of a 0.2 mg radiolabeled glycopyrrolate, 85% of dose recovered was recovered in urine 48 hours postdose and some of the radioactivity was also recovered in bile. After IM administration of glycopyrrolate to adults, the mean T 1/2 value is reported to be between 0.55 to 1.25 hrs. Over 80% of IM dose administered was recovered in urine and the bile as unchanged drug and half the IM dose is excreted within 3 hrs. The following table summarizes the mean and standard deviation of pharmacokinetic parameters from a study. *0 to 8 hr Group t 1/2 (hr) V ss (L/kg) CL (L/kg/hr) T max (min) C max (mcg/L) AUC (mcg/L•hr) (6 mcg/kg IV) 0.83 ± 0.27 0.42 ± 0.22 0.54 ± 0.14 – – 8.64 ± 1.49* (8 mcg/kg IM) – – – 27.48 ± 6.12 3.47 ± 1.48 6.64 ± 2.33* SPECIAL POPULATIONS Gender Gender differences in pharmacokinetics of glycopyrrolate have not been investigated. Renal Impairment In one study glycopyrrolate was administered IV in uremic patients undergoing renal transplantation. The mean elimination half-life was significantly longer (46.8 minutes) than in healthy patients (18.6 minutes). The mean area-under-the-concentration-time curve (10.6 hr-mcg/L), mean plasma clearance (0.43 L/hr/kg), and mean 3-hour urine excretion (0.7%) for glycopyrrolate were also significantly different than those of controls (3.73 hr-mcg/L, 1.14 L/hr/kg, and 50%, respectively). These results suggest that the elimination of glycopyrrolate is severely impaired in patients with renal failure. Hepatic Impairment Pharmacokinetic information in patients with hepatic impairment is unavailable. Pediatrics Following IV administration (5 mcg/kg glycopyrrolate) to infants and children, the mean T 1/2 values were reported to be between 21.6 and 130.0 minutes and between 19.2 and 99.2 minutes, respectively."],"indications_and_usage":["INDICATIONS AND USAGE In Anesthesia Glycopyrrolate Injection is indicated for use as a preoperative antimuscarinic to reduce salivary, tracheobronchial, and pharyngeal secretions; to reduce the volume and free acidity of gastric secretions; and to block cardiac vagal inhibitory reflexes during induction of anesthesia and intubation. When indicated, Glycopyrrolate Injection may be used intraoperatively to counteract surgically or drug-induced or vagal reflexes associated arrhythmias. Glycopyrrolate protects against the peripheral muscarinic effects (e.g., bradycardia and excessive secretions) of cholinergic agents such as neostigmine and pyridostigmine given to reverse the neuromuscular blockade due to non-depolarizing muscle relaxants. In Peptic Ulcer For use in adults to reduce symptoms of a peptic ulcer as an adjunct to treatment of peptic ulcer when rapid anticholinergic effect is desired or when oral medication is not tolerated. Limitations of Use Glycopyrrolate Injection is not indicated as monotherapy for the treatment of peptic ulcer because effectiveness in peptic ulcer healing has not been established."],"nonteratogenic_effects":["NONTERATOGENIC EFFECTS Published literature suggest the following regarding the use of glycopyrrolate during pregnancy. Unlike atropine, glycopyrrolate in normal doses (0.004 mg/kg) does not appear to affect fetal heart rate or fetal heart rate variability to a significant degree. Concentrations of glycopyrrolate in umbilical venous and arterial blood and in the amniotic fluid are low after intramuscular administration to parturients. Therefore, glycopyrrolate does not appear to penetrate through the placental barrier in significant amounts. In reproduction studies in rats, dietary administration of glycopyrrolate resulted in diminished rats of pup survival in a dose-related manner."],"pharmacokinetics_table":["
*0 to 8 hr
Groupt1/2 (hr)Vss (L/kg)CL (L/kg/hr)Tmax (min)Cmax (mcg/L)AUC (mcg/L•hr)
(6 mcg/kg IV)0.83 ± 0.270.42 ± 0.220.54 ± 0.14––8.64 ± 1.49*
(8 mcg/kg IM)–––27.48 ± 6.123.47 ± 1.486.64 ± 2.33*
"],"information_for_patients":["Information for the Patient Because glycopyrrolate injection may produce drowsiness or blurred vision, the patient should be cautioned not to engage in activities requiring mental alertness and/or visual acuity such as operating a motor vehicle or other machinery, or performing hazardous work while taking this drug (see WARNINGS ). The patient also should be cautioned about the use of this drug during exercise or hot weather since overheating may result in heat stroke. The patient may experience a possible sensitivity of the eyes to light."],"spl_unclassified_section":["meitheal ® Rx Only NOT FOR USE IN NEONATES CONTAINS BENZYL ALCOHOL"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION NOTE: CONTAINS BENZYL ALCOHOL ( see PRECAUTIONS ). Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. For single-dose vials only, discard unused portion. Glycopyrrolate injection may be administered intramuscularly, or intravenously, without dilution, in the following indications. Adults PREANESTHETIC MEDICATION The recommended dose of glycopyrrolate injection is 0.004 mg/kg by intramuscular injection, given 30 to 60 minutes prior to the anticipated time of induction of anesthesia or at the time the preanesthetic narcotic and/or sedative are administered. INTRAOPERATIVE MEDICATION Glycopyrrolate injection may be used during surgery to counteract drug-induced or vagal reflexes and their associated arrhythmias (e.g., bradycardia). It should be administered intravenously as single doses of 0.1 mg and repeated, as needed, at intervals of 2 to 3 minutes. The usual attempts should be made to determine the etiology of the arrhythmia, and the surgical or anesthetic manipulations necessary to correct parasympathetic imbalance should be performed. REVERSAL OF NEUROMUSCULAR BLOCKADE The recommended dose of glycopyrrolate injection is 0.2 mg for each 1 mg of neostigmine or 5 mg of pyridostigmine. In order to minimize the appearance of cardiac side effects, the drugs may be administered simultaneously by intravenous injection and may be mixed in the same syringe. PEPTIC ULCER The usual recommended dose of glycopyrrolate injection is 0.1 mg administered at 4-hour intervals, 3 or 4 times daily intravenously or intramuscularly. Where more profound effect is required, 0.2 mg may be given. Some patients may need only a single dose, and frequency of administration should be dictated by patient response up to a maximum of four times daily. Glycopyrrolate injection is not recommended for the treatment of peptic ulcer in pediatric patients (see PRECAUTIONS, Pediatric Use ). Pediatric Patients (see PRECAUTIONS, Pediatric Use ) PREANESTHETIC MEDICATION The recommended dose of glycopyrrolate injection in pediatric patients is 0.004 mg/kg intramuscularly, given 30 to 60 minutes prior to the anticipated time of induction of anesthesia or at the time the preanesthetic narcotic and/or sedative are administered. INFANTS (1 month to 2 years of age) may require up to 0.009 mg/kg. INTRAOPERATIVE MEDICATION Because of the long duration of action of glycopyrrolate injection if used as preanesthetic medication, additional glycopyrrolate injection for anticholinergic effect intraoperatively is rarely needed; in the event it is required the recommended pediatric dose is 0.004 mg/kg intravenously, not to exceed 0.1 mg in a single dose which may be repeated, as needed, at intervals of 2 to 3 minutes. The usual attempts should be made to determine the etiology of the arrhythmia, and the surgical or anesthetic manipulations necessary to correct parasympathetic imbalance should be performed. REVERSAL OF NEUROMUSCULAR BLOCKADE The recommended pediatric dose of glycopyrrolate injection is 0.2 mg for each 1 mg of neostigmine or 5 mg of pyridostigmine. In order to minimize the appearance of cardiac side effects, the drugs may be administered simultaneously by intravenous injection and may be mixed in the same syringe. PEPTIC ULCER Glycopyrrolate injection is not recommended for the treatment of peptic ulcer in pediatric patients (see PRECAUTIONS, Pediatric Use ). Diluent Compatibilities Dextrose 5% and 10% in water, or saline, dextrose 5% in sodium chloride 0.45%, sodium chloride 0.9%, and Ringer's Injection. Diluent Incompatibilities Lactated Ringer's solution Admixture Compatibilities PHYSICAL COMPATIBILITY This list does not constitute an endorsement of the clinical utility or safety of co-administration of glycopyrrolate with these drugs. Glycopyrrolate injection is compatible for mixing and injection with the following injectable dosage forms: atropine sulfate, USP; Antilirium ® (physostigmine salicylate); Benadryl ® (diphenhydramine HCl); codeine phosphate, USP; Emete-Con ® (benz-quinamide HCl); hydromorphone HCl, USP; Inapsine ® (droperidol); Levo-Dromoran ® (levorphanol tartrate); lidocaine, USP; meperidine HCl, USP; Mestinon ® /Regonol ® (pyridostigmine bromide); morphine sulfate, USP; Nubain ® (nalbuphine HCl); Numorphan ® (oxymorphone HCl); procaine HCl, USP; promethazine HCl, USP; Prostigmin ® (neostigmine methylsulfate, USP); scopolamine HBr, USP; Stadol ® (butorphanol tartrate); Sublimaze ® (fentanyl citrate); Tigan ® (trimethobenzamide HCl); and Vistaril ® (hydroxyzine HCl). Glycopyrrolate injection may be administered via the tubing of a running infusion of normal saline. Admixture Incompatibilities PHYSICAL INCOMPATIBILITY Since the stability of glycopyrrolate is questionable above a pH of 6.0 do not combine glycopyrrolate injection in the same syringe with Brevital ® (methohexital Na); Chloromycetin ® (chloramphenicol Na succinate); Dramamine ® (dimenhydrinate); Nembutal ® (pentobarbital Na); Pentothal ® (thiopental Na); Seconal ® (secobarbital Na); sodium bicarbonate (Abbott); Valium ® (diazepam); Decadron ® (dexamethasone Na phosphate); or Talwin ® (pentazocine lactate). These mixtures will result in a pH higher than 6.0 and may result in gas production or precipitation."],"spl_product_data_elements":["Glycopyrrolate Glycopyrrolate glycopyrrolate glycopyrronium benzyl alcohol hydrochloric acid sodium hydroxide water Glycopyrrolate Glycopyrrolate glycopyrrolate glycopyrronium benzyl alcohol hydrochloric acid sodium hydroxide water"],"clinical_pharmacology_table":["
*0 to 8 hr
Groupt1/2 (hr)Vss (L/kg)CL (L/kg/hr)Tmax (min)Cmax (mcg/L)AUC (mcg/L•hr)
(6 mcg/kg IV)0.83 ± 0.270.42 ± 0.220.54 ± 0.14––8.64 ± 1.49*
(8 mcg/kg IM)–––27.48 ± 6.123.47 ± 1.486.64 ± 2.33*
"],"package_label_principal_display_panel":["Principal Display Panel – Glycopyrrolate Injection, USP 1 mL Container Label NDC 71288- 414 -01 Rx Only Glycopyrrolate Injection, USP 0.2 mg per mL CONTAINS BENZYL ALCOHOL For Intramuscular or Intravenous Use 1 mL Single-Dose Vial Principal Display Panel – Glycopyrrolate Injection, USP 1 mL Container Label","Principal Display Panel – Glycopyrrolate Injection, USP 1 mL Carton NDC 71288- 414 -03 25 x 1 mL Single-Dose Vials Rx Only Glycopyrrolate Injection, USP 0.2 mg per mL NOT FOR USE IN NEWBORNS CONTAINS BENZYL ALCOHOL For Intramuscular or Intravenous Use Principal Display Panel – Glycopyrrolate Injection, USP 1 mL Carton","Principal Display Panel – Glycopyrrolate Injection, USP 2 mL Container Label NDC 71288- 414 -02 Rx Only Glycopyrrolate Injection, USP 0.4 mg per 2 mL (0.2 mg per mL) CONTAINS BENZYL ALCOHOL For Intramuscular or Intravenous Use 2 mL Single-Dose Vial Principal Display Panel – Glycopyrrolate Injection, USP 2 mL Container Label","Principal Display Panel – Glycopyrrolate Injection, USP 2 mL Carton NDC 71288- 414 -04 25 x 2 mL Single-Dose Vials Rx Only Glycopyrrolate Injection, USP 0.4 mg per 2 mL (0.2 mg per mL) NOT FOR USE IN NEWBORNS CONTAINS BENZYL ALCOHOL For Intramuscular or Intravenous Use Principal Display Panel – Glycopyrrolate Injection, USP 2 mL Carton","Principal Display Panel – Glycopyrrolate Injection, USP 5 mL Container Label NDC 71288- 415 -05 Rx Only Glycopyrrolate Injection, USP 1 mg per 5 mL (0.2 mg per mL) NOT FOR USE IN NEWBORNS CONTAINS BENZYL ALCOHOL For Intramuscular or Intravenous Use 5 mL Multi-Dose Vial Principal Display Panel – Glycopyrrolate Injection, USP 5 mL Container Label","Principal Display Panel – Glycopyrrolate Injection, USP 5 mL Carton NDC 71288- 415 -06 25 x 5 mL Multi-Dose Vials Rx Only Glycopyrrolate Injection, USP 1 mg per 5 mL (0.2 mg per mL) NOT FOR USE IN NEWBORNS CONTAINS BENZYL ALCOHOL For Intramuscular or Intravenous Use Principal Display Panel – Glycopyrrolate Injection, USP 5 mL Carton","Principal Display Panel – Glycopyrrolate Injection, USP 20 mL Container Label NDC 71288- 415 -20 Rx Only Glycopyrrolate Injection, USP 4 mg per 20 mL (0.2 mg per mL) NOT FOR USE IN NEWBORNS CONTAINS BENZYL ALCOHOL For Intramuscular or Intravenous Use 20 mL Multi-Dose Vial Principal Display Panel – Glycopyrrolate Injection, USP 20 mL Container Label","Principal Display Panel – Glycopyrrolate Injection, USP 20 mL Carton NDC 71288- 415 -21 10 x 20 mL Multi-Dose Vials Rx Only Glycopyrrolate Injection, USP 4 mg per 20 mL (0.2 mg per mL) NOT FOR USE IN NEWBORNS CONTAINS BENZYL ALCOHOL For Intramuscular or Intravenous Use Principal Display Panel – Glycopyrrolate Injection, USP 20 mL Carton"],"carcinogenesis_and_mutagenesis_and_impairment_of_fertility":["Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term studies in animals have not been performed to evaluate carcinogenic potential. Studies to evaluate the mutagenic potential of glycopyrrolate have not been conducted. In reproduction studies in rats, dietary administration of glycopyrrolate resulted in diminished rates of conception in a dose-related manner. Other studies in dogs suggest that this may be due to diminished seminal secretion which is evident at high doses of glycopyrrolate."]},"tags":[],"safety":{"boxedWarnings":[],"safetySignals":[{"date":"","signal":"DYSPNOEA","source":"FDA FAERS","actionTaken":"3008 reports"},{"date":"","signal":"DEATH","source":"FDA FAERS","actionTaken":"1519 reports"},{"date":"","signal":"COUGH","source":"FDA FAERS","actionTaken":"1436 reports"},{"date":"","signal":"DEVICE DELIVERY SYSTEM ISSUE","source":"FDA FAERS","actionTaken":"1432 reports"},{"date":"","signal":"PRODUCT DOSE OMISSION ISSUE","source":"FDA FAERS","actionTaken":"1339 reports"},{"date":"","signal":"ASTHMA","source":"FDA FAERS","actionTaken":"1292 reports"},{"date":"","signal":"WRONG TECHNIQUE IN DEVICE USAGE PROCESS","source":"FDA FAERS","actionTaken":"1236 reports"},{"date":"","signal":"DEVICE USE ISSUE","source":"FDA FAERS","actionTaken":"1093 reports"},{"date":"","signal":"DRUG INEFFECTIVE","source":"FDA FAERS","actionTaken":"1057 reports"},{"date":"","signal":"CHRONIC OBSTRUCTIVE PULMONARY DISEASE","source":"FDA FAERS","actionTaken":"995 reports"}],"drugInteractions":[],"commonSideEffects":[{"effect":"Dry mouth","drugRate":"","severity":"common","organSystem":""},{"effect":"Constipation","drugRate":"","severity":"common","organSystem":""},{"effect":"Blurred vision","drugRate":"","severity":"common","organSystem":""},{"effect":"Urinary retention","drugRate":"","severity":"common","organSystem":""},{"effect":"Vomiting","drugRate":"","severity":"common","organSystem":""},{"effect":"Tachycardia","drugRate":"","severity":"common","organSystem":""},{"effect":"Drowsiness","drugRate":"","severity":"common","organSystem":""},{"effect":"Decreased sweating","drugRate":"","severity":"common","organSystem":""},{"effect":"Flushing","drugRate":"","severity":"common","organSystem":""},{"effect":"Nausea","drugRate":"","severity":"common","organSystem":""},{"effect":"Headache","drugRate":"","severity":"common","organSystem":""},{"effect":"Dizziness","drugRate":"","severity":"common","organSystem":""},{"effect":"Weakness","drugRate":"","severity":"common","organSystem":""},{"effect":"Nervousness","drugRate":"","severity":"common","organSystem":""},{"effect":"Mental confusion","drugRate":"","severity":"common","organSystem":""},{"effect":"Insomnia","drugRate":"","severity":"common","organSystem":""},{"effect":"Agitation","drugRate":"","severity":"common","organSystem":""},{"effect":"Dysgeusia","drugRate":"","severity":"common","organSystem":""},{"effect":"Bloated feeling","drugRate":"","severity":"common","organSystem":""},{"effect":"Urinary hesitancy","drugRate":"","severity":"common","organSystem":""}],"contraindications":["Achalasia of esophagus","Alcoholism","Anemia","Angle-closure glaucoma","Atony of colon","Autonomic dysreflexia","Benign prostatic hyperplasia","Bladder outflow obstruction","Bleeding","Brain damage","Breastfeeding (mother)","Chronic heart failure","Chronic lung disease","Complete trisomy 21 syndrome","Depressive disorder","Disease of liver","Disorder of coronary artery","Disturbance of salivary secretion","Drowsy","Drug AND/OR toxin-induced diarrhea","Dyspnea","Gastric ulcer","Gastrointestinal obstruction","Hepatic coma","Hepatic encephalopathy","Hepatic failure","Hiatal hernia","Hyperammonemia","Hypertensive disorder","Hyperthyroidism","Kidney disease","Myasthenia gravis","Myocardial dysfunction","Neutropenic disorder","Paralytic ileus","Peptic reflux disease","Poisoning by phenobarbital","Porphyria","Pregnancy, function","Pyloric obstruction","Retention of urine","Severe chronic ulcerative colitis","Sleep apnea","Spastic paralysis","Substance abuse","Suicidal thoughts","Tachyarrhythmia","Thrombocytopenic disorder","Toxic megacolon","Ulcerative colitis","Urinary tract obstruction"],"specialPopulations":{},"discontinuationRates":[],"seriousAdverseEvents":[{"effect":"Anaphylaxis","drugRate":"","severity":"serious"},{"effect":"Respiratory depression","drugRate":"","severity":"serious"},{"effect":"Acute glaucoma","drugRate":"","severity":"serious"},{"effect":"Mechanical intestinal obstruction","drugRate":"","severity":"serious"},{"effect":"Heat prostration","drugRate":"","severity":"serious"},{"effect":"Chest pain","drugRate":"","severity":"serious"},{"effect":"Hypertension","drugRate":"","severity":"serious"},{"effect":"Cycloplegia","drugRate":"","severity":"serious"},{"effect":"Increased ocular tension","drugRate":"","severity":"serious"},{"effect":"Throat irritation","drugRate":"","severity":"serious"}]},"trials":[],"_chembl":null,"aliases":["Glycopyrrolate","Parasympathetic blockade","Robinul","Foster+GLyco 25","Foster+GLyco 50"],"patents":[{"type":"Formulation","number":"10940110","applicant":"SUMITOMO PHARMA AMERICA INC","territory":"US","tradeName":"LONHALA MAGNAIR KIT","expiryDate":"2029-02-26"},{"type":"Formulation","number":"10744277","applicant":"SUMITOMO PHARMA AMERICA INC","territory":"US","tradeName":"LONHALA MAGNAIR KIT","expiryDate":"2036-12-07"},{"type":"Formulation","number":"10376661","applicant":"SUMITOMO PHARMA AMERICA INC","territory":"US","tradeName":"LONHALA MAGNAIR KIT","expiryDate":"2035-09-14"},{"type":"Formulation","number":"9789270","applicant":"SUMITOMO PHARMA AMERICA INC","territory":"US","tradeName":"LONHALA MAGNAIR KIT","expiryDate":"2030-10-30"},{"type":"Formulation","number":"11278683","applicant":"SUMITOMO PHARMA AMERICA INC","territory":"US","tradeName":"LONHALA MAGNAIR KIT","expiryDate":"2026-08-16"},{"type":"Formulation","number":"9604018","applicant":"SUMITOMO PHARMA AMERICA INC","territory":"US","tradeName":"LONHALA MAGNAIR KIT","expiryDate":"2033-05-16"},{"type":"Formulation","number":"8479730","applicant":"NOVARTIS PHARMACEUTICALS CORP","territory":"US","tradeName":"SEEBRI NEOHALER","expiryDate":"2028-10-11"},{"type":"Formulation","number":"9168556","applicant":"SUMITOMO PHARMA AMERICA INC","territory":"US","tradeName":"LONHALA MAGNAIR KIT","expiryDate":"2032-09-01"},{"type":"Formulation","number":"10688518","applicant":"SUMITOMO PHARMA AMERICA INC","territory":"US","tradeName":"LONHALA MAGNAIR KIT","expiryDate":"2036-11-12"},{"type":"Formulation","number":"9265900","applicant":"SUMITOMO PHARMA AMERICA INC","territory":"US","tradeName":"LONHALA MAGNAIR KIT","expiryDate":"2028-12-07"},{"type":"Formulation","number":"8182838","applicant":"NOVARTIS PHARMACEUTICALS CORP","territory":"US","tradeName":"SEEBRI NEOHALER","expiryDate":"2028-10-20"}],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=Glycopyrrolate","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T01:31:25.064755+00:00"},"patents":{"url":"","method":"deterministic","source":"FDA Orange Book","rawText":"","confidence":1,"sourceType":"fda_orange_book","retrievedAt":"2026-04-20T01:31:25.064424+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T01:31:31.466512+00:00"},"regulatory.us":{"url":"","method":"api_direct","source":"FDA Drugs@FDA","rawText":"","confidence":1,"sourceType":"fda_drugsfda","retrievedAt":"2026-04-20T01:31:23.699443+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=Glycopyrrolate","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T01:31:32.232007+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T01:31:22.654341+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T01:31:22.654383+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":"2026-04-20T01:31:33.802103+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL1201335/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T01:31:32.710595+00:00"},"regulatory.fda_application":{"url":"","method":"deterministic","source":"FDA Label","rawText":"ANDA212802","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T01:31:22.654393+00:00"}},"offLabel":[],"timeline":[],"_dailymed":{"setId":"a338ef22-c243-4075-b02d-bcd5b590104a","title":"GLYCOPYRROLATE TABLET [REMEDYREPACK INC.]"},"ecosystem":[],"mechanism":{"target":"Muscarinic acetylcholine receptor M1, Muscarinic acetylcholine receptor M2, Muscarinic acetylcholine receptor M3"},"_scrapedAt":"2026-03-28T00:22:01.962Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"references":[],"_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T01:31:38.931881+00:00","fieldsConflicting":0,"overallConfidence":0.95},"biosimilars":[],"competitors":[],"dataSources":[{"url":"https://drugcentral.org","name":"DrugCentral","fields":["indications","contraindications","safety","target","drugInteractions"],"retrievedDate":"2026-04-07"}],"indications":{"approved":[{"name":"Chronic obstructive lung disease","diseaseId":"chronic-obstructive-lung-disease","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Excessive salivation","diseaseId":"excessive-salivation","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"General anesthesia","diseaseId":"general-anesthesia","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Hyperhidrosis of axilla","diseaseId":"hyperhidrosis-of-axilla","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Peptic ulcer","diseaseId":"peptic-ulcer","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Vagal Reflex Bradycardia","diseaseId":"vagal-reflex-bradycardia","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"}],"offLabel":[],"pipeline":[]},"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT07489911","phase":"","title":"Fixed Triple Inhaled Combination in Asthmatic Patients in a Real-life Setting (STRENGTH)","status":"RECRUITING","sponsor":"Chiesi Slovenija, d.o.o.","startDate":"2024-11-04","conditions":"Asthma, Asthma Patients, Asthma Bronchiale","enrollment":200},{"nctId":"NCT06712563","phase":"","title":"Pooled Analysis of Single-arm Studies of Budesonide/Glycopyrronium/Formoterol (BGF) in Routine Care Setting","status":"RECRUITING","sponsor":"AstraZeneca","startDate":"2025-04-17","conditions":"Pulmonary Disease, Chronic Obstructive","enrollment":2000},{"nctId":"NCT05116930","phase":"PHASE2","title":"Neostigmine and Glycopyrrolate for the Treatment of Headache After Dural Puncture","status":"RECRUITING","sponsor":"Mayo Clinic","startDate":"2021-11-19","conditions":"Post-Dural Puncture Headache","enrollment":18},{"nctId":"NCT06786767","phase":"","title":"Fixed Triple Inhaled Combination in Asthmatic Patients in a Real-life Setting","status":"COMPLETED","sponsor":"Chiesi Bulgaria","startDate":"2025-02-01","conditions":"Asthma, Asthma Patients, Asthma Bronchiale","enrollment":281},{"nctId":"NCT06531798","phase":"PHASE4","title":"Post-marketing Phase 4 Safety & Tolerability Study of Breztri aerosphereTM in Indian Patients With Chronic Obstructive Pulmonary Disease","status":"RECRUITING","sponsor":"AstraZeneca","startDate":"2025-12-19","conditions":"Moderate to Severe COPD","enrollment":150},{"nctId":"NCT05862545","phase":"","title":"Outcomes in Real-life After Initation of Treatment With Trixeo (Budesonide / Glycopyrronium / Formoterol)","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2023-06-01","conditions":"Chronic Obstructive Pulmonary Disease","enrollment":250},{"nctId":"NCT07069829","phase":"","title":"Study of Clinical and Patient-reported Outcomes in Adults With Moderate to Severe COPD Treated With Breztri/Trixeo","status":"RECRUITING","sponsor":"AstraZeneca","startDate":"2025-12-15","conditions":"Chronic Obstructive Pulmonary Disease","enrollment":1400},{"nctId":"NCT06067828","phase":"PHASE3","title":"A Study to Evaluate the Effect of Budesonide, Glycopyrronium, Formoterol Fumarate (BGF) Metered Dose Inhaler (MDI), Budesonide and Formoterol Fumarate (BFF) MDI and Placebo MDI on Exercise Parameters in Participants With Chronic Obstructive Pulmonary Disease (COPD).","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2023-10-24","conditions":"Chronic Obstructive Pulmonary Disease","enrollment":171},{"nctId":"NCT05222529","phase":"PHASE2","title":"Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Glycopyrronium (Bromide) in Children (6 to Less Than 12 Years) With Asthma","status":"RECRUITING","sponsor":"Novartis Pharmaceuticals","startDate":"2022-08-29","conditions":"Asthma","enrollment":42},{"nctId":"NCT07016412","phase":"PHASE2","title":"A Phase IIb Ensifentrine-glycopyrrolate Fixed-dose Combination Dose Ranging Study in Subjects With COPD","status":"RECRUITING","sponsor":"Verona Pharma plc","startDate":"2025-07-31","conditions":"Chronic Obstructive Pulmonary Disease","enrollment":480},{"nctId":"NCT07282886","phase":"PHASE2","title":"VENTURI (VENTilation Using Respiratory Imaging)","status":"NOT_YET_RECRUITING","sponsor":"University of Alabama at Birmingham","startDate":"2026-03-15","conditions":"Asthma","enrollment":20},{"nctId":"NCT06545500","phase":"PHASE2","title":"A Phase IIb Study of Glycopyrrolate Inhalation Solution Over 1 Week in Subjects With COPD","status":"COMPLETED","sponsor":"Verona Pharma plc","startDate":"2024-08-16","conditions":"Chronic Obstructive Pulmonary Disease","enrollment":46},{"nctId":"NCT04320342","phase":"PHASE3","title":"A Study Comparing Efficacy, Safety and Tolerability of the Fixed Dose Triple Combination CHF 5993 With the Fixed Dose Dual Combination CHF 1535 in Subjects With COPD","status":"COMPLETED","sponsor":"Chiesi Farmaceutici S.p.A.","startDate":"2022-04-28","conditions":"COPD, COPD Exacerbation","enrollment":3433},{"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","enrollment":70000},{"nctId":"NCT06112353","phase":"PHASE4","title":"Neuromuscular Blockade Comparison for GI-2 Recovery After Bowel Resection","status":"RECRUITING","sponsor":"University of California, Irvine","startDate":"2024-04-17","conditions":"Intestinal Disease","enrollment":128},{"nctId":"NCT07340008","phase":"NA","title":"Analgosedation With Ketamine, Nalbuphine, or Dexmedetomidine for Suture Removal in Children After Cleft Surgery","status":"RECRUITING","sponsor":"University Medical Centre Ljubljana","startDate":"2025-09-01","conditions":"Orofacial Clefts, Cleft Lip and Palate, Alveolar Ridge Defect","enrollment":60},{"nctId":"NCT07132983","phase":"PHASE2","title":"A Phase II Study to Assess the Pharmacokinetics, Pharmacodynamics, and Safety of Single Inhaled Doses of Ensifentrine-glycopyrrolate Fixed Dose Combination, Ensifentrine, and Glycopyrrolate in Subjects With Chronic Obstructive Pulmonary Disease","status":"COMPLETED","sponsor":"Verona Pharma plc","startDate":"2025-10-06","conditions":"Chronic Obstructive Pulmonary Disease","enrollment":33},{"nctId":"NCT06368427","phase":"","title":"Change in Patient-repOrted Outcomes in COPD Patients Newly Initiated on TRIXEO AEROSPHERE in Real worlD","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2024-04-30","conditions":"Chronic Obstructive Pulmonary Disease (COPD)","enrollment":10},{"nctId":"NCT06110403","phase":"PHASE1, PHASE2","title":"Impact of Long-acting Bronchodilator- -Corticoid Inhaled Therapy on Ventilation, Lung Function and Breathlessness","status":"RECRUITING","sponsor":"University Hospital, Lille","startDate":"2023-09-29","conditions":"Copd","enrollment":35},{"nctId":"NCT07273851","phase":"NA","title":"Comparison of Propofol and Ketofol as Induction Agents for Electroconvulsive Therapy","status":"COMPLETED","sponsor":"Fauji Foundation Hospital","startDate":"2025-07-01","conditions":"Major Depressive Disorder","enrollment":80},{"nctId":"NCT05985343","phase":"PHASE4","title":"The Impact of Sugammadex on Ileus After Abdominal Wall Reconstruction","status":"COMPLETED","sponsor":"Clayton Petro","startDate":"2024-01-15","conditions":"Hernia, Ventral, Ileus","enrollment":184},{"nctId":"NCT03081156","phase":"PHASE4","title":"The Effect of BEVESPI AEROSPHERE ® Therapy on Exercise Tolerance in COPD","status":"COMPLETED","sponsor":"William Stringer, md","startDate":"2017-03-27","conditions":"Pulmonary Disease, Chronic Obstructive","enrollment":52},{"nctId":"NCT05256901","phase":"PHASE4","title":"Sugammadex vs Neostigmine Reversal in Pediatric Appendectomy","status":"TERMINATED","sponsor":"Emory University","startDate":"2023-07-19","conditions":"Appendicitis, Surgery","enrollment":22},{"nctId":"NCT02129660","phase":"PHASE2","title":"Comparator Study of the Effect of Glycopyrrolate and Glycopyrronium in Subjects With Axillary Hyperhidrosis","status":"COMPLETED","sponsor":"Journey Medical Corporation","startDate":"2014-04","conditions":"Hyperhidrosis","enrollment":105},{"nctId":"NCT04027972","phase":"EARLY_PHASE1","title":"Pharmacokinetics of Neostigmine and Glycopyrrolate","status":"COMPLETED","sponsor":"James J. Peters Veterans Affairs Medical Center","startDate":"2020-03-09","conditions":"Spinal Cord Injuries, Constipation, Fecal Incontinence","enrollment":13},{"nctId":"NCT06351852","phase":"EARLY_PHASE1","title":"Transdermal Administration by a Novel Wireless Iontophoresis Device","status":"COMPLETED","sponsor":"James J. Peters Veterans Affairs Medical Center","startDate":"2022-03-22","conditions":"Spinal Cord Injuries, Constipation, Fecal Incontinence","enrollment":2},{"nctId":"NCT06398899","phase":"NA","title":"Sugammadex v.s. Neostigmine/Glycopyrrolate","status":"COMPLETED","sponsor":"National Taiwan University Hospital","startDate":"2024-05-01","conditions":"Head and Neck Surgery, Chronic Sinusitis, Chronic Otitis Media","enrollment":124},{"nctId":"NCT05887375","phase":"PHASE4","title":"Sugammadex vs Neostigmine/Glycopyrrolate on Urinary Retention After Spine Surgery","status":"ENROLLING_BY_INVITATION","sponsor":"University of Missouri-Columbia","startDate":"2023-08-03","conditions":"Spine Surgery, Reversal of Neuromuscular Blockade, Urinary Retention Postoperative","enrollment":118},{"nctId":"NCT06075095","phase":"PHASE3","title":"A Study to Investigate the Effect on Lung Function of an Approved COPD Treatment (BGF, With HFA Propellant) Compared to BGF Formulated With a Next-Generation Propellant in Participants 40 to 80 Years of Age With COPD","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2024-01-11","conditions":"COPD (Chronic Obstructive Pulmonary Disease)","enrollment":297},{"nctId":"NCT06744374","phase":"","title":"A Comparative Effectiveness Study of Mortality Outcomes and Related Cardiopulmonary Events Among a Cohort of Chronic Obstructive Pulmonary Disease (COPD) Patients Who Initiate Breztri and Multiple Inhaler Triple Therapy (MITT) in the United States (US)","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2024-02-29","conditions":"Pulmonary Disease, Chronic Obstructive","enrollment":22369},{"nctId":"NCT06228092","phase":"PHASE4","title":"Neostigmine/Glyco-pyrrolate 50 Mikrogram/kg or Sugammadex 2 mg/kg for Reversal of Neuromuscular Blockade in Elderly Patients","status":"COMPLETED","sponsor":"Matias Vested","startDate":"2023-12-04","conditions":"Neuromuscular Blockade, Residual","enrollment":40},{"nctId":"NCT06282861","phase":"PHASE4","title":"ANTES B+ Clinical Trial","status":"TERMINATED","sponsor":"Fundacio Privada Mon Clinic Barcelona","startDate":"2024-02-29","conditions":"Chronic Obstructive Pulmonary Disease","enrollment":48},{"nctId":"NCT06841640","phase":"PHASE1, PHASE2","title":"Phase 1/Phase 2a Study of AERO-007 Inhalation Solution, a Nebulized LABA/LAMA Combination for Maintenance Treatment of COPD","status":"COMPLETED","sponsor":"AeroRx Therapeutics Inc.","startDate":"2025-01-15","conditions":"COPD","enrollment":24},{"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},{"nctId":"NCT03111121","phase":"PHASE4","title":"Use of Sugammadex for Reversal of Paralysis in Microlaryngoscopy","status":"COMPLETED","sponsor":"West Virginia University","startDate":"2017-05-04","conditions":"Microlaryngoscopy, Rigid Bronchoscopy","enrollment":79},{"nctId":"NCT06962007","phase":"NA","title":"Sugammadex-Induced Clenching During Neuromuscular Blockade Reversal","status":"COMPLETED","sponsor":"Wonkwang University Hospital","startDate":"2025-05-01","conditions":"Neuromuscular Blockade Reversal Agent, Perioperative Complications, Anesthesia, General","enrollment":240},{"nctId":"NCT03116997","phase":"PHASE3","title":"Study of Recovery of Strength After Surgery Comparing Two Different Medications for Reversal of Muscle Relaxant","status":"COMPLETED","sponsor":"Memorial Sloan Kettering Cancer Center","startDate":"2017-04-07","conditions":"Surgery","enrollment":201},{"nctId":"NCT04937543","phase":"PHASE2","title":"Efficacy of Inhaled Therapies in the Treatment of Acute Symptoms Associated With COVID-19","status":"COMPLETED","sponsor":"UPECLIN HC FM Botucatu Unesp","startDate":"2021-06-28","conditions":"Covid19","enrollment":50},{"nctId":"NCT03679611","phase":"PHASE4","title":"Impact of Sugammadex vs. Neostigmine Reversal on Post-Operative Recovery and Complications","status":"COMPLETED","sponsor":"University Health Network, Toronto","startDate":"2019-01-14","conditions":"Obstructive Sleep Apnea","enrollment":120},{"nctId":"NCT05664633","phase":"PHASE1, PHASE2","title":"The Role of Sugammadex in Posotoperative Urinary Retention in Patients Undergoing Pelvic Floor Reconstructive Procedures","status":"WITHDRAWN","sponsor":"West Virginia University","startDate":"2023-08","conditions":"Postoperative Urinary Retention","enrollment":""},{"nctId":"NCT06844175","phase":"","title":"Early Screening of Young COPD and Pre-COPD","status":"NOT_YET_RECRUITING","sponsor":"yanmengkang","startDate":"2025-03-01","conditions":"Pulmonary Disease, Chronic Obstructive","enrollment":100},{"nctId":"NCT06234345","phase":"PHASE3","title":"Study of Fluticasone/Formoterol/Glycopyrronium for the Treatment Chronic Obstructive Pulmonary Disease (TRIPLAR)","status":"NOT_YET_RECRUITING","sponsor":"Eurofarma Laboratorios S.A.","startDate":"2026-09","conditions":"Chronic Obstructive Pulmonary Disease","enrollment":1252},{"nctId":"NCT05545280","phase":"PHASE4","title":"Postoperative Urinary Retention in Patients After Noncardiac Surgery and Reversal of Neuromuscular Block","status":"COMPLETED","sponsor":"The Cleveland Clinic","startDate":"2023-12-01","conditions":"Neuromuscular Blockade","enrollment":50},{"nctId":"NCT04159610","phase":"PHASE2","title":"Assessment of Safety, Tolerability and Efficacy of 1% GPB Cream Versus Qbrexza® (Glycopyrronium) Cloth 2.4% Under Maximum-Use Conditions in Subjects with Primary Axillary Hyperhidrosis","status":"WITHDRAWN","sponsor":"Dr. August Wolff GmbH & Co. KG Arzneimittel","startDate":"2019-12","conditions":"Primary Axillary Hyperhidrosis","enrollment":""},{"nctId":"NCT06745492","phase":"","title":"Low-dose Neostigmine at TOF Ratio of 0.7 Improves Neuromuscular Recovery","status":"COMPLETED","sponsor":"Seoul National University Hospital","startDate":"2022-10-01","conditions":"Recovery Time","enrollment":59},{"nctId":"NCT06735443","phase":"PHASE2, PHASE3","title":"Comparative Efficacy & Safety of Dexmedetomidine vs Tramadol in Paeds Hernioraphy. A Caudal Anaesthesia Approach","status":"COMPLETED","sponsor":"Sahiwal medical college sahiwal","startDate":"2021-03-06","conditions":"Hemodynamic Stability, Post Operative Pain, Inguinal Hernia Repair","enrollment":60},{"nctId":"NCT06514144","phase":"","title":"Exacerbations Among Patients Receiving Breztri (EROS Study)","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2022-10-01","conditions":"Pulmonary Disease, Chronic Obstructive, Retrospective Studies","enrollment":2409},{"nctId":"NCT06678191","phase":"","title":"Investigation of Fixed Triple Inhaled Combination in Asthmatic Patients, in a Real-life Setting","status":"RECRUITING","sponsor":"Chiesi Hungary Ltd.","startDate":"2024-10-24","conditions":"Asthma, Chronic Obstructive Pulmonary Disease (COPD), Asthma Bronchiale","enrollment":800},{"nctId":"NCT06053541","phase":"","title":"Morbid Rates After Spiriva Chronic Obstructive Pulmonary Disease (COPD) Protocol Change","status":"COMPLETED","sponsor":"Boehringer Ingelheim","startDate":"2021-04-01","conditions":"Pulmonary Disease, Chronic Obstructive","enrollment":3015000},{"nctId":"NCT06045364","phase":"PHASE1, PHASE2","title":"Effect of Glycopyrrolate on Nausea and Vomiting After ERCP Operation","status":"COMPLETED","sponsor":"Jie Chen","startDate":"2023-10-01","conditions":"Nausea and Vomiting","enrollment":130},{"nctId":"NCT05830071","phase":"PHASE1","title":"A Thorough QT (TQT) Study of CHF5993 pMDI in Healthy Volunteers (HV)","status":"COMPLETED","sponsor":"Chiesi Farmaceutici S.p.A.","startDate":"2023-03-29","conditions":"Asthma, Chronic Obstructive Pulmonary Disease (COPD)","enrollment":95},{"nctId":"NCT05331651","phase":"PHASE4","title":"Effect of Glycopyrronium in Combination With Tropisetron in Anti-postoperative Nausea and Vomiting","status":"COMPLETED","sponsor":"The Second Affiliated Hospital of Chongqing Medical University","startDate":"2022-04-21","conditions":"Postoperative Nausea and Vomiting","enrollment":480},{"nctId":"NCT04536402","phase":"","title":"Evaluate the Safety Profile of BGF MDI in Chinese Patients With COPD in Routine Clinical Practice","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2021-03-16","conditions":"Chronic Obstructive Pulmonary Disease","enrollment":3520},{"nctId":"NCT04546672","phase":"PHASE4","title":"Sugammadex To IMprove Bowel Function","status":"COMPLETED","sponsor":"Oregon Health and Science University","startDate":"2021-03-16","conditions":"Bowel Dysfunction, Postoperative Complications, Neuromuscular Blockade","enrollment":120},{"nctId":"NCT05993390","phase":"NA","title":"Pharmacological Reversal of Neuromuscular Blockade in Critically Ill Patients","status":"RECRUITING","sponsor":"Seoul National University Hospital","startDate":"2024-01-11","conditions":"Neuromuscular Blockade, Critical Illness, Neurologic Findings","enrollment":30},{"nctId":"NCT06376942","phase":"PHASE2, PHASE3","title":"A RCT to Compare the Effectiveness of Nebulized Anticholinergics for Cough Suppression During Flexible Bronchoscopy","status":"NOT_YET_RECRUITING","sponsor":"Post Graduate Institute of Medical Education and Research, Chandigarh","startDate":"2024-04-24","conditions":"Subjects Undergoing Flexible Bronchoscopy","enrollment":1050},{"nctId":"NCT06351995","phase":"PHASE3","title":"Neostigmine and Glycopyrrolate by Iontophoresis","status":"ACTIVE_NOT_RECRUITING","sponsor":"James J. Peters Veterans Affairs Medical Center","startDate":"2020-11-06","conditions":"Spinal Cord Injuries, Constipation, Fecal Incontinence","enrollment":6},{"nctId":"NCT05863104","phase":"PHASE2","title":"Assessment of Safety, Tolerability, Systemic Exposure and Efficacy of GPB Cream in Adolescents With Severe Primary Hyperhidrosis","status":"COMPLETED","sponsor":"Dr. August Wolff GmbH & Co. KG Arzneimittel","startDate":"2023-03-07","conditions":"Primary Axillary Hyperhidrosis","enrollment":44},{"nctId":"NCT06317428","phase":"","title":"NT-proBNP Levels During Triple Therapy With Formoterol/Glycopyrrolate/Budesonide in Patients With COPD.","status":"RECRUITING","sponsor":"Istituto Nazionale di Ricovero e Cura per Anziani","startDate":"2022-06-28","conditions":"COPD","enrollment":29},{"nctId":"NCT04606901","phase":"PHASE4","title":"Comparison of Time to Extubation Using Sugammadex or Neostigmine","status":"COMPLETED","sponsor":"Temple University","startDate":"2021-04-08","conditions":"Neuromuscular Blockade, Chronic Obstructive Pulmonary Disease","enrollment":58},{"nctId":"NCT05948891","phase":"","title":"Impact of Fixed TRIple Therapy With Beclometasone/Formoterol/Glycopyrronium DPI (Trimbow® in NEXThaler Device) in Chronic Obstructive PulmoNary Disease in rEal-world Settings: Health-related Quality of Life Patient' eXpectations and characterisTics: the TriNEXT Study","status":"RECRUITING","sponsor":"Chiesi SAS","startDate":"2023-08-01","conditions":"COPD","enrollment":500},{"nctId":"NCT05718934","phase":"PHASE4","title":"Low Dose of Sugammadex vs Neostigmine and Glycopyrrolate for the Reversal of Rocuronium","status":"COMPLETED","sponsor":"Ciusss de L'Est de l'Île de Montréal","startDate":"2022-11-08","conditions":"Neuromuscular Blockade","enrollment":144},{"nctId":"NCT06237478","phase":"NA","title":"Effects of Glycopyrrolate on Heart Rate and Heart Rate Variability in Patients With Different Basic Heart Rate","status":"COMPLETED","sponsor":"Zhuan Zhang","startDate":"2023-03-01","conditions":"Glycopyrrolate","enrollment":54},{"nctId":"NCT05970263","phase":"PHASE4","title":"IKANOS: Breztri Maintenance Versus Any Non-Triple Inhaled Therapy After Hospitalization for a COPD Exacerbation in the US","status":"WITHDRAWN","sponsor":"AstraZeneca","startDate":"2024-01-19","conditions":"COPD","enrollment":""},{"nctId":"NCT05693246","phase":"NA","title":"Effect of Perioperative Use of Glycopyrrolate on Lung Function in Patients Under General Anesthesia","status":"UNKNOWN","sponsor":"Zhuan Zhang","startDate":"2022-10-01","conditions":"Glycopyrrolate","enrollment":90},{"nctId":"NCT02100280","phase":"PHASE4","title":"The Effect of Deep Block Versus Moderate Block on the Stress Response After Laparoscopic Gastrectomy","status":"COMPLETED","sponsor":"Seoul National University Bundang Hospital","startDate":"2014-06-29","conditions":"Neuromuscular Blockade","enrollment":96},{"nctId":"NCT03939923","phase":"PHASE4","title":"Role of Sugammadex as Reversal Agent in Patients Extubated Immediately After Isolated Coronary Artery Bypass Grafting Surgery","status":"COMPLETED","sponsor":"West Virginia University","startDate":"2019-05-01","conditions":"Surgery, Coronary Artery Disease","enrollment":84},{"nctId":"NCT06041984","phase":"PHASE1, PHASE2","title":"Antiperistaltic Effect and Safety of Glycopyrronium for Colonoscopic Polypectomy","status":"UNKNOWN","sponsor":"Jie Chen","startDate":"2023-10-08","conditions":"Glycopyrrolate, Colonoscopy","enrollment":150},{"nctId":"NCT04022733","phase":"NA","title":"Remifentanil in Deep vs Moderate Neuromuscular Blocks During Surgical Pleth Index-guided Anesthesia for Laparoscopic Herniorrhaphy","status":"COMPLETED","sponsor":"Ajou University School of Medicine","startDate":"2019-10-30","conditions":"Hernia Abdominal Wall","enrollment":134},{"nctId":"NCT03904550","phase":"PHASE2","title":"Neuromuscular Blockade in Patients With Severe Renal Impairment","status":"COMPLETED","sponsor":"University of Texas Southwestern Medical Center","startDate":"2019-12-10","conditions":"Neuromuscular Blockade, Renal Impairment","enrollment":49},{"nctId":"NCT03742141","phase":"NA","title":"Intraoperative Video Laryngoscopy as Adjunct for Nerve Monitoring","status":"COMPLETED","sponsor":"Icahn School of Medicine at Mount Sinai","startDate":"2018-10-17","conditions":"Vocal Cord Function in Neck Procedures","enrollment":125},{"nctId":"NCT03513406","phase":"PHASE3","title":"Comparison of Reversal of Neuromuscular Blockade With Sugammadex Versus Neostigmine Plus Glycopyrolate in Patients Undergoing Burn Surgery","status":"COMPLETED","sponsor":"University of Kansas Medical Center","startDate":"2018-03-15","conditions":"Burns","enrollment":7},{"nctId":"NCT05997004","phase":"NA","title":"Glycopyrrolate Prophylaxis for Prevention of Bradyarrhythmia During Laparoscopic Cholecystectomy","status":"COMPLETED","sponsor":"National Academy of Medical Sciences, Nepal","startDate":"2018-05-01","conditions":"Bradyarrhythmia, Cardiac Arrest, Tachycardia","enrollment":62},{"nctId":"NCT03915821","phase":"NA","title":"Memory Changes in Patients With Major Depression Disorder Treated With ECT","status":"COMPLETED","sponsor":"Assiut University","startDate":"2020-12-15","conditions":"Depressive Disorder","enrollment":60},{"nctId":"NCT03735563","phase":"PHASE4","title":"Premedication for Less Invasive Surfactant Administration","status":"RECRUITING","sponsor":"University of Oulu","startDate":"2019-02-11","conditions":"Surfactant Deficiency Syndrome Neonatal","enrollment":40},{"nctId":"NCT05099055","phase":"PHASE3","title":"Dexmedetomine as Adjuvant for Spinal Anesthesia in Elective Cesarian Sections : a Pilot Study","status":"COMPLETED","sponsor":"St. Justine's Hospital","startDate":"2022-03-15","conditions":"Analgesia, Analgesics, Opioid, Anesthesia, Obstetrical","enrollment":42},{"nctId":"NCT02867761","phase":"PHASE3","title":"RETHINC: REdefining THerapy In Early COPD for the Pulmonary Trials Cooperative","status":"COMPLETED","sponsor":"University of Michigan","startDate":"2017-08-29","conditions":"COPD (Chronic Obstructive Pulmonary Disease)","enrollment":780},{"nctId":"NCT02825576","phase":"PHASE4","title":"Prevention of Postoperative Events Following Reversal With Sugammadex or Neostigmine","status":"TERMINATED","sponsor":"Northern Sydney Anaesthesia Research Institute","startDate":"2018-12-03","conditions":"Pulmonary Complications","enrollment":30},{"nctId":"NCT05265507","phase":"PHASE4","title":"Comparison of Postoperative Anti-nausea and Vomiting Effect Between Glycopyrronium and Ondansetron","status":"UNKNOWN","sponsor":"The Second Affiliated Hospital of Chongqing Medical University","startDate":"2022-03-21","conditions":"Postoperative Nausea and Vomiting","enrollment":480},{"nctId":"NCT03290287","phase":"","title":"Aclidinium Bromide Post-Authorisation Safety Study to Evaluate the Risk of Cardiovascular Endpoints","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2017-03-01","conditions":"Pulmonary Disease, Chronic Obstructive","enrollment":26839},{"nctId":"NCT05694234","phase":"","title":"Influences of Sugammadex on Postoperative Progress in Patients With Myasthenia Gravis Undergoing Video-assisted Thoracoscopic Thymectomy: Retrospective Study","status":"COMPLETED","sponsor":"Yonsei University","startDate":"2021-09-01","conditions":"Myasthenia Gravis","enrollment":265},{"nctId":"NCT01845441","phase":"PHASE2","title":"Use of Dexmedetomidine in Acute Stroke and Cerebral Vasospasm Interventions","status":"TERMINATED","sponsor":"University Hospitals Cleveland Medical Center","startDate":"2012-04","conditions":"Stroke, Brain Ischemia, Vasospasm, Intracranial","enrollment":7},{"nctId":"NCT05253404","phase":"NA","title":"Laryngeal Mask Airway Facilitates a Safe and Smooth Emergence From Anesthesia in Patients Undergoing Craniotomy","status":"COMPLETED","sponsor":"Chang Gung Memorial Hospital","startDate":"2022-02-15","conditions":"Complications, Pulmonary","enrollment":62},{"nctId":"NCT05288075","phase":"PHASE1","title":"Study to Compare Relative Bioavailability of 3 Indacaterol/Glycopyrronium Test Products and Reference Product","status":"COMPLETED","sponsor":"Orion Corporation, Orion Pharma","startDate":"2022-02-28","conditions":"Healthy Volunteers","enrollment":24},{"nctId":"NCT03112993","phase":"PHASE4","title":"Speed of Recovery of Reversal of Neuromuscular Blockade in Geriatric Patients Undergoing Spine Surgery","status":"COMPLETED","sponsor":"University of Missouri-Columbia","startDate":"2017-05-30","conditions":"Spine Surgery","enrollment":40},{"nctId":"NCT01937247","phase":"PHASE2, PHASE3","title":"Redesigned Process in the Operating Room","status":"COMPLETED","sponsor":"American University of Beirut Medical Center","startDate":"2018-05-18","conditions":"Non-operative Time, General Surgery, Above 18 Years of Age","enrollment":120},{"nctId":"NCT04873531","phase":"NA","title":"Feasibility of Neostigmine for Intraoperative Neuromonitoring in Thyroid Surgery","status":"COMPLETED","sponsor":"Seoul National University Hospital","startDate":"2021-05-10","conditions":"Thyroid Diseases, Surgical Injury, Nerve Monitoring","enrollment":44},{"nctId":"NCT03574337","phase":"PHASE4","title":"Residual Neuromuscular Blockade in Cardiac Surgery Patients","status":"WITHDRAWN","sponsor":"Henry Ford Health System","startDate":"2018-08-01","conditions":"Residual Neuromuscular Blockade","enrollment":""},{"nctId":"NCT04671355","phase":"PHASE4","title":"TRIMBOW® and RELVAR® on Lung Stiffness Reduction Assessed Through Forced Oscillation Technique in Patients With COPD","status":"WITHDRAWN","sponsor":"Chiesi Farmaceutici S.p.A.","startDate":"2021-10-04","conditions":"COPD","enrollment":""},{"nctId":"NCT04671030","phase":"PHASE1","title":"Use of a Prokinetic Agent as an Adjunct to Thrice Weekly Bowel Care After SCI","status":"COMPLETED","sponsor":"James J. Peters Veterans Affairs Medical Center","startDate":"2018-01-15","conditions":"Spinal Cord Injuries, Constipation, Neurogenic Bowel","enrollment":6},{"nctId":"NCT03627858","phase":"","title":"Fixed Dose Triple Therapy in Severe Chronic Obstructive Pulmonary Disease in a Real World Setting","status":"COMPLETED","sponsor":"Chiesi SA/NV","startDate":"2018-08-01","conditions":"Chronic Obstructive Pulmonary Disease","enrollment":149},{"nctId":"NCT03322657","phase":"PHASE4","title":"Sugammadex Versus Neostigmine for Reversal of Rocuronium Neuromuscular","status":"COMPLETED","sponsor":"The Cleveland Clinic","startDate":"2017-11-14","conditions":"Neuromuscular Blockade, Anesthesia","enrollment":69},{"nctId":"NCT02119234","phase":"PHASE1","title":"Pharmacokinetics of CHF 5993 pMDI With and Without Spacer in COPD Patients","status":"COMPLETED","sponsor":"Chiesi Farmaceutici S.p.A.","startDate":"2014-03","conditions":"COPD","enrollment":36},{"nctId":"NCT01176903","phase":"PHASE1, PHASE2","title":"Safety and Efficacy Study of Glyco pMDI After Single and Repeated Administration","status":"COMPLETED","sponsor":"Chiesi Farmaceutici S.p.A.","startDate":"2010-08","conditions":"Chronic Obstructive Pulmonary Disease (COPD)","enrollment":65},{"nctId":"NCT01176851","phase":"PHASE1","title":"Biopharmaceutical Study of Glyco pMDI With or Without Charcoal Block vs IV Bolus in Healthy Volunteers","status":"COMPLETED","sponsor":"Chiesi Farmaceutici S.p.A.","startDate":"2010-07","conditions":"Healthy","enrollment":20},{"nctId":"NCT01917331","phase":"PHASE3","title":"Efficacy of Fixed Combination of Beclometasone + Formoterol + Glycopyrrolate Versus Foster® in COPD","status":"COMPLETED","sponsor":"Chiesi Farmaceutici S.p.A.","startDate":"2014-03","conditions":"Chronic Obstructive Pulmonary Disease","enrollment":1368},{"nctId":"NCT02189577","phase":"PHASE2","title":"Efficacy and Safety of Glycopyrrolate Bromide of COPD Patients","status":"COMPLETED","sponsor":"Chiesi Farmaceutici S.p.A.","startDate":"2014-06","conditions":"Chronic Obstructive Pulmonary Disease","enrollment":100},{"nctId":"NCT01911364","phase":"PHASE3","title":"Efficacy of Fixed Combination of Beclometasone + Formoterol + Glycopyrrolate in Chronic Obstructive Pulmonary Disease","status":"COMPLETED","sponsor":"Chiesi Farmaceutici S.p.A.","startDate":"2014-01","conditions":"Chronic Obstructive Pulmonary Disease","enrollment":3686},{"nctId":"NCT02040597","phase":"PHASE1","title":"A Study to Investigate the Pharmacokinetics, Safety and Tolerability of CHF 5993 pMDI in Subjects With Renal Impairment.","status":"COMPLETED","sponsor":"Chiesi Farmaceutici S.p.A.","startDate":"2014-01","conditions":"Chronic Obstructive Pulmonary Disease (COPD)","enrollment":42},{"nctId":"NCT01398111","phase":"PHASE1","title":"Pharmacokinetic Interaction Study of Glycopyrrolate and Formoterol in Healthy Volunteers","status":"COMPLETED","sponsor":"Chiesi Farmaceutici S.p.A.","startDate":"2011-05","conditions":"COPD","enrollment":44}],"_emaApprovals":[],"_faersSignals":[{"count":1505,"reaction":"DYSPNOEA"},{"count":955,"reaction":"ASTHMA"},{"count":901,"reaction":"COUGH"},{"count":779,"reaction":"PNEUMONIA"},{"count":772,"reaction":"WHEEZING"},{"count":554,"reaction":"MALAISE"},{"count":553,"reaction":"DRUG INEFFECTIVE"},{"count":530,"reaction":"DEATH"},{"count":524,"reaction":"FATIGUE"},{"count":522,"reaction":"CHRONIC OBSTRUCTIVE PULMONARY DISEASE"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{"route":"Intramuscular"},"crossReferences":{"chemblId":"CHEMBL1201335"},"formularyStatus":[],"_approvalHistory":[{"date":"20080321","type":"ORIG","sponsor":"CHARTWELL RX","applicationNumber":"ANDA040847"},{"date":"20260119","type":"SUPPL","sponsor":"CHARTWELL RX","applicationNumber":"ANDA040847"},{"date":"20121206","type":"SUPPL","sponsor":"CHARTWELL RX","applicationNumber":"ANDA040847"},{"date":"20181025","type":"ORIG","sponsor":"PIRAMAL CRITICAL","applicationNumber":"ANDA210842"},{"date":"20211013","type":"ORIG","sponsor":"UMEDICA","applicationNumber":"ANDA212591"},{"date":"20241007","type":"ORIG","sponsor":"SCIEGEN PHARMS","applicationNumber":"ANDA216297"},{"date":"20250613","type":"SUPPL","sponsor":"SCIEGEN PHARMS","applicationNumber":"ANDA216297"},{"date":"20170623","type":"ORIG","sponsor":"SOMERSET THERAPS LLC","applicationNumber":"ANDA207639"}],"developmentCodes":[],"ownershipHistory":[],"publicationCount":1326,"therapeuticAreas":["Metabolic"],"biosimilarFilings":[],"companionDiagnostics":[],"genericManufacturerList":[],"phase":"marketed","status":"active","brandName":"Glycopyrrolate","genericName":"Glycopyrrolate","companyName":"Yonsei University","companyId":"yonsei-university","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Glycopyrrolate is a small molecule medication that belongs to the muscarinic anticholinergic group. It can be administered via various routes, including inhalation, and is used to treat conditions such as COPD, as indicated by clinical trials.","enrichmentLevel":3,"visitCount":0,"regulatoryByCountry":[{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"1961-08-11T00:00:00.000Z","mah":"CASPER PHARMA LLC","brand_name_local":"ROBINUL","application_number":"NDA012827"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"1975-02-06T00:00:00.000Z","mah":"HIKMA","brand_name_local":"ROBINUL","application_number":"NDA017558"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"1975-12-17T00:00:00.000Z","mah":"ROBINS AH","brand_name_local":"ROBINUL","application_number":"NDA014764"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"1983-09-09T00:00:00.000Z","mah":"WATSON LABS","brand_name_local":"GLYCOPYRROLATE","application_number":"ANDA085563"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"1986-07-23T00:00:00.000Z","mah":"AM REGENT","brand_name_local":"GLYCOPYRROLATE","application_number":"ANDA089335"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"1988-06-15T00:00:00.000Z","mah":"HOSPIRA","brand_name_local":"GLYCOPYRROLATE","application_number":"ANDA089393"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"1991-09-10T00:00:00.000Z","mah":"TEVA PARENTERAL","brand_name_local":"GLYCOPYRROLATE","application_number":"ANDA081169"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2004-12-22T00:00:00.000Z","mah":"CHARTWELL RX","brand_name_local":"GLYCOPYRROLATE","application_number":"ANDA040568"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2006-08-31T00:00:00.000Z","mah":"PH HEALTH","brand_name_local":"GLYCOPYRROLATE","application_number":"ANDA040653"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2008-03-21T00:00:00.000Z","mah":"CHARTWELL RX","brand_name_local":"GLYCOPYRROLATE","application_number":"ANDA040847"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2008-12-29T00:00:00.000Z","mah":"RISING","brand_name_local":"GLYCOPYRROLATE","application_number":"ANDA040821"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2009-03-05T00:00:00.000Z","mah":"HIKMA INTL PHARMS","brand_name_local":"GLYCOPYRROLATE","application_number":"ANDA040836"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2009-08-18T00:00:00.000Z","mah":"SUN PHARM INDS LTD","brand_name_local":"GLYCOPYRROLATE","application_number":"ANDA040844"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2012-03-12T00:00:00.000Z","mah":"LGM PHARMA","brand_name_local":"GLYCOPYRROLATE","application_number":"ANDA091522"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2012-09-21T00:00:00.000Z","mah":"VELZEN PHARMA PVT","brand_name_local":"GLYCOPYRROLATE","application_number":"ANDA090195"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2014-02-03T00:00:00.000Z","mah":"REGCON HOLDINGS","brand_name_local":"GLYCOPYRROLATE","application_number":"ANDA091182"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2015-10-29T00:00:00.000Z","mah":"NOVARTIS","brand_name_local":"SEEBRI NEOHALER","application_number":"NDA207923"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2015-10-29T00:00:00.000Z","mah":"NOVARTIS","brand_name_local":"UTIBRON NEOHALER","application_number":"NDA207930"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2016-06-20T00:00:00.000Z","mah":"NATCO","brand_name_local":"GLYCOPYRROLATE","application_number":"ANDA091413"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2017-01-03T00:00:00.000Z","mah":"APPCO","brand_name_local":"GLYCOPYRROLATE","application_number":"ANDA207201"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2017-06-15T00:00:00.000Z","mah":"AMNEAL","brand_name_local":"GLYCOPYRROLATE","application_number":"ANDA208973"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2017-06-23T00:00:00.000Z","mah":"SOMERSET THERAPS LLC","brand_name_local":null,"application_number":"ANDA207639"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2017-10-27T00:00:00.000Z","mah":"FRESENIUS KABI USA","brand_name_local":"GLYCOPYRROLATE","application_number":"ANDA209328"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2018-07-11T00:00:00.000Z","mah":"EXELA PHARMA","brand_name_local":"GLYRX-PF","application_number":"NDA210997"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2018-10-25T00:00:00.000Z","mah":"PIRAMAL CRITICAL","brand_name_local":null,"application_number":"ANDA210842"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2018-10-31T00:00:00.000Z","mah":"FRESENIUS KABI USA","brand_name_local":"GLYCOPYRROLATE","application_number":"ANDA209024"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2018-11-30T00:00:00.000Z","mah":"ALEMBIC","brand_name_local":"GLYCOPYRROLATE","application_number":"ANDA203657"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2019-03-20T00:00:00.000Z","mah":"CAPLIN","brand_name_local":"GLYCOPYRROLATE","application_number":"ANDA211705"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2019-05-14T00:00:00.000Z","mah":"SANDOZ","brand_name_local":"GLYCOPYRROLATE","application_number":"ANDA211334"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2020-02-21T00:00:00.000Z","mah":"SAGENT","brand_name_local":"GLYCOPYRROLATE","application_number":"ANDA210083"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2020-07-08T00:00:00.000Z","mah":"ACCORD HLTHCARE","brand_name_local":"GLYCOPYRROLATE","application_number":"ANDA213238"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2021-03-04T00:00:00.000Z","mah":"XIROMED","brand_name_local":null,"application_number":"ANDA212227"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2021-07-06T00:00:00.000Z","mah":"MEITHEAL","brand_name_local":"GLYCOPYRROLATE","application_number":"ANDA212802"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2021-08-09T00:00:00.000Z","mah":"PH HEALTH","brand_name_local":"GLYCOPYRROLATE","application_number":"ANDA204438"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2021-10-13T00:00:00.000Z","mah":"UMEDICA","brand_name_local":null,"application_number":"ANDA212591"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2022-04-21T00:00:00.000Z","mah":"FRESENIUS KABI USA","brand_name_local":"GLYCOPYRROLATE","application_number":"NDA214919"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2022-07-05T00:00:00.000Z","mah":"ANNORA PHARMA","brand_name_local":null,"application_number":"ANDA213698"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2022-07-05T00:00:00.000Z","mah":"SUVEN PHARMS","brand_name_local":"GLYCOPYRROLATE","application_number":"ANDA212467"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2022-10-21T00:00:00.000Z","mah":"AMNEAL","brand_name_local":"GLYCOPYRROLATE","application_number":"ANDA215333"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2022-11-28T00:00:00.000Z","mah":"OMNIVIUM PHARMS","brand_name_local":"GLYCOPYRROLATE","application_number":"ANDA212871"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2023-02-07T00:00:00.000Z","mah":"LUPIN","brand_name_local":"GLYCOPYRROLATE","application_number":"ANDA213655"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2023-02-23T00:00:00.000Z","mah":"AZURITY","brand_name_local":"PREVDUO","application_number":"NDA216903"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2023-02-27T00:00:00.000Z","mah":"MANKIND PHARMA","brand_name_local":"GLYCOPYRROLATE","application_number":"ANDA217354"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2023-04-18T00:00:00.000Z","mah":"AUROBINDO PHARMA","brand_name_local":null,"application_number":"ANDA202675"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2024-07-10T00:00:00.000Z","mah":"QUAGEN","brand_name_local":"GLYCOPYRROLATE","application_number":"ANDA212696"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2024-08-19T00:00:00.000Z","mah":"GRANULES","brand_name_local":"GLYCOPYRROLATE","application_number":"ANDA214735"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2024-10-07T00:00:00.000Z","mah":"SCIEGEN PHARMS","brand_name_local":null,"application_number":"ANDA216297"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2024-12-31T00:00:00.000Z","mah":"AUROBINDO PHARMA LTD","brand_name_local":"GLYCOPYRROLATE","application_number":"ANDA214847"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2025-04-08T00:00:00.000Z","mah":"MSN","brand_name_local":"GLYCOPYRROLATE","application_number":"ANDA216084"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2025-12-23T00:00:00.000Z","mah":"BIONPHARMA","brand_name_local":"GLYCOPYRROLATE","application_number":"ANDA220062"},{"country_code":"AU","regulator":"TGA","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":"US","regulator":"FDA","status":"approved","approval_date":null,"mah":"WATSON LABS","brand_name_local":"GLYCOPYRROLATE","application_number":"ANDA085562"},{"country_code":"AU","regulator":"TGA","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":"KR","regulator":"MFDS","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":"KR","regulator":"MFDS","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":"AE","regulator":"MOH","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":"AE","regulator":"MOH","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":"AE","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":"SG","regulator":"HSA","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":"SG","regulator":"HSA","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":"IL","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"IL","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"IL","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"IL","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"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":"QUAD PHARMS","brand_name_local":"GLYCOPYRROLATE","application_number":"ANDA089397"},{"country_code":"IL","regulator":"MOH","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},{"country_code":"GB","regulator":"MHRA","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},{"country_code":"GB","regulator":"MHRA","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},{"country_code":"AU","regulator":"TGA","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}],"patentsNormalised":[{"patent_number":"11278683","territory":"US","patent_type":"Formulation","expiry_date":"2026-08-16T00:00:00.000Z","status":"active","paragraph_iv_filed":false},{"patent_number":"8479730","territory":"US","patent_type":"Formulation","expiry_date":"2028-10-11T00:00:00.000Z","status":"active","paragraph_iv_filed":false},{"patent_number":"8182838","territory":"US","patent_type":"Formulation","expiry_date":"2028-10-20T00:00:00.000Z","status":"active","paragraph_iv_filed":false},{"patent_number":"9265900","territory":"US","patent_type":"Formulation","expiry_date":"2028-12-07T00:00:00.000Z","status":"active","paragraph_iv_filed":false},{"patent_number":"10940110","territory":"US","patent_type":"Formulation","expiry_date":"2029-02-26T00:00:00.000Z","status":"active","paragraph_iv_filed":false},{"patent_number":"9789270","territory":"US","patent_type":"Formulation","expiry_date":"2030-10-30T00:00:00.000Z","status":"active","paragraph_iv_filed":false},{"patent_number":"9168556","territory":"US","patent_type":"Formulation","expiry_date":"2032-09-01T00:00:00.000Z","status":"active","paragraph_iv_filed":false},{"patent_number":"9604018","territory":"US","patent_type":"Formulation","expiry_date":"2033-05-16T00:00:00.000Z","status":"active","paragraph_iv_filed":false},{"patent_number":"10376661","territory":"US","patent_type":"Formulation","expiry_date":"2035-09-14T00:00:00.000Z","status":"active","paragraph_iv_filed":false},{"patent_number":"10688518","territory":"US","patent_type":"Formulation","expiry_date":"2036-11-12T00:00:00.000Z","status":"active","paragraph_iv_filed":false},{"patent_number":"10744277","territory":"US","patent_type":"Formulation","expiry_date":"2036-12-07T00:00:00.000Z","status":"active","paragraph_iv_filed":false}],"regulatorySummaries":{"US_FDA_approval_44844":{"country_code":"US","agency":"FDA","entity_type":"approval","entity_id":"44844","summary_short":"The FDA granted marketing authorisation to SCIEGEN PHARMS for Glycopyrrolate on 13 June 2025, under standard expedited pathway.","summary_long":"The FDA approved Glycopyrrolate for marketing in the United States on 13 June 2025. The approval was granted to SCIEGEN PHARMS under standard expedited pathway, with application number ANDA216297. The approved indication for Glycopyrrolate is listed in its labelling.","key_points":["Glycopyrrolate was approved by the FDA on 13 June 2025.","SCIEGEN PHARMS is the marketing authorisation holder.","The approval was granted under standard expedited pathway."],"citations":[{"source":"https://api.fda.gov/drug/drugsfda.json?search=application_number:ANDA216297"}],"generated_at":"2026-05-18T08:06:27.451Z"}},"trialStats":{"total":20,"withResults":11},"validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T01:31:38.931881+00:00","fieldsConflicting":0,"overallConfidence":0.95},"verificationStatus":"verified","dataCompleteness":{"mechanism":false,"indications":true,"safety":true,"trials":true,"score":3}}