{"id":"glycopyrronium","_fda":{"id":"78796126-f6ed-42e3-b40d-ea5723b89516","set_id":"5b372650-e56e-47a5-93e2-c0c292017059","openfda":{"unii":["1PVF6JLU7B"],"route":["TOPICAL"],"rxcui":["2054118","2054120"],"spl_id":["78796126-f6ed-42e3-b40d-ea5723b89516"],"brand_name":["Qbrexza"],"spl_set_id":["5b372650-e56e-47a5-93e2-c0c292017059"],"package_ndc":["69489-411-01","69489-411-30","69489-411-51","69489-411-05"],"product_ndc":["69489-411"],"generic_name":["GLYCOPYRRONIUM"],"product_type":["HUMAN PRESCRIPTION DRUG"],"substance_name":["GLYCOPYRRONIUM TOSYLATE"],"manufacturer_name":["Journey Medical Corporation"],"application_number":["NDA210361"],"is_original_packager":[true]},"version":"4","pregnancy":["8.1 Pregnancy Risk Summary There are no available data on Qbrexza use in pregnant women to inform a drug-associated risk for adverse developmental outcomes. In pregnant rats, daily oral administration of glycopyrrolate (glycopyrronium bromide) during organogenesis did not result in an increased incidence of gross external or visceral defects [see Data ] . When glycopyrrolate was administered intravenously to pregnant rabbits during organogenesis, no adverse effects on embryo-fetal development were seen. The available data do not support relevant comparisons of systemic glycopyrronium exposures achieved in the animal studies to exposures observed in humans after topical use of Qbrexza. The estimated background risks of major birth defects and miscarriage for the indicated population are unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Data Animal Data Glycopyrrolate was orally administered to pregnant rats at dosages of 50, 200, and 400 mg/kg/day during the period of organogenesis. Glycopyrrolate had no effect on maternal survival, but significantly reduced mean maternal body weight gain over the period of dosing at all dosages evaluated. Mean fetal weight was significantly reduced in the 200 and 400 mg/kg/day dose groups. There were two litters with all resorbed fetuses in the 400 mg/kg/day dose group. There were no effects of treatment on the incidence of gross external or visceral defects. Minor treatment-related skeletal effects included reduced ossification of various bones in the 200 and 400 mg/kg/day dose groups; these skeletal effects were likely secondary to maternal toxicity. Glycopyrrolate was intravenously administered to pregnant rabbits at dosages of 0.1, 0.5, and 1.0 mg/kg/day during the period of organogenesis. Glycopyrrolate did not affect maternal survival under the conditions of this study. Mean maternal body weight gain and mean food consumption over the period of dosing were lower than the corresponding control value in the 0.5 and 1.0 mg/kg/day treatment groups. There were no effects of treatment on fetal parameters, including fetal survival, mean fetal weight, and the incidence of external, visceral, or skeletal defects. Female rats that were pregnant or nursing were orally dosed with glycopyrrolate daily at dosages of 0, 50, 200, or 400 mg/kg/day, beginning on day 7 of gestation, and continuing until day 20 of lactation. Mean body weight of pups in all treatment groups was reduced compared to the control group during the period of nursing, but eventually recovered to be comparable to the control group, post-weaning. No other notable delivery or litter parameters were affected by treatment in any group, including no effects on mean duration of gestation or mean numbers of live pups per litter. No treatment-related effects on survival or adverse clinical signs were observed in pups. There were no effects of maternal treatment on behavior, learning, memory, or reproductive function of pups."],"overdosage":["10 OVERDOSAGE Because glycopyrronium is a quaternary amine which does not easily cross the blood-brain barrier, symptoms of glycopyrronium overdosage are generally more peripheral in nature rather than central compared to other anticholinergic agents. Associated signs and symptoms related to excessive anticholinergic activity may include flushing, hyperthermia, tachycardia, ileus, urinary retention, loss of ocular accommodation and light sensitivity due to mydriasis. In the case of overdose when symptoms are severe or life threatening, therapy may include: Managing per standard of care any acute conditions such as hyperthermia, coma, and/or seizures, as applicable, and managing any myoclonic or choreoathetoid movements which may lead to rhabdomyolysis in some cases of anticholinergic overdosage Managing severe urinary retention with catheterization if not spontaneously reversed within several hours Providing cardiovascular support and/or controlling arrhythmias Maintaining an open airway, providing ventilation as necessary Administering a quaternary ammonium anticholinesterase such as neostigmine to help alleviate severe and/or life threatening peripheral anticholinergic effects. Topical overdosing of Qbrexza could result in an increased incidence or severity of local skin reactions. Administration of Qbrexza under occlusive conditions may result in an increase in anticholinergic effects, including dry mouth and urinary hesitation."],"description":["11 DESCRIPTION Qbrexza (glycopyrronium) cloth, 2.4% is an anticholinergic drug available as a clear, colorless to pale yellow solution on a single-use pre-moistened cloth (an absorbent polypropylene pad) packaged in a pouch for topical administration. Each pouch contains 105 mg glycopyrronium tosylate, equivalent to 66 mg of glycopyrronium. The inactive ingredients are citric acid, dehydrated alcohol, purified water, and sodium citrate. Glycopyrronium tosylate is chemically described as pyrrolidinium, 3-[(2-cyclopentyl-2-hydroxy-2-phenylacetyl)oxy]-1,1-dimethyl-, 4-methylbenzensulfonate, hydrate (1:1:1) with an empirical formula of C 26 H 37 NO 7 S and a molecular weight of 507.6. The structural formula is represented below: Chemical Structure"],"how_supplied":["16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied Qbrexza is supplied as: A single-use cloth pre-moistened with a 2.4% glycopyrronium solution in a pouch Carton of 30 pouches NDC 69489-411-30 16.2 Storage and Handling Store at room temperature 20° - 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F) [See USP Controlled Room Temperature]. Qbrexza is flammable; keep away from heat or flame.","16.1 How Supplied Qbrexza is supplied as: A single-use cloth pre-moistened with a 2.4% glycopyrronium solution in a pouch Carton of 30 pouches NDC 69489-411-30"],"geriatric_use":["8.5 Geriatric Use Clinical trials of Qbrexza did not include sufficient numbers of subjects age 65 years and older to determine whether they respond differently from younger subjects."],"pediatric_use":["8.4 Pediatric Use The safety, effectiveness and pharmacokinetics of Qbrexza have been established in pediatric patients age 9 years and older for topical treatment of primary axillary hyperhidrosis [see Clinical Pharmacology ( 12.3 )] . Use of Qbrexza in this age group is supported by evidence from two multicenter, randomized, double-blind, parallel-group, vehicle-controlled 4-week trials which included 34 pediatric subjects 9 years and older [see Adverse Reactions ( 6.1 ) and Clinical Studies ( 14 )] . The safety and effectiveness of Qbrexza have not been established in pediatric patients under 9 years of age."],"effective_time":"20231219","clinical_studies":["14 CLINICAL STUDIES 14.1 Efficacy and Safety Trials Two randomized, vehicle-controlled multicenter trials, Trial 1 (NCT02530281) and Trial 2 (NCT02530294), were conducted in subjects with primary axillary hyperhidrosis and enrolled a total of 697 subjects 9 years of age or older. Inclusion criteria required that prior to the start of treatment, all subjects produce at least 50 mg of sweat in each axilla over a 5-minute period and rate the severity of their sweating daily over a week with a mean score of 4 or higher on the ASDD item #2, a patient reported outcome instrument scored from 0 (no sweating) to 10 (worst possible sweating). The median sweat production over 5 minutes at baseline was 122 mg in the Qbrexza arm and 113 mg in the vehicle arm in Trial 1, and 127 mg in the Qbrexza arm and 117 mg in the vehicle arm in Trial 2. The average weekly mean score on the ASDD item #2 at baseline was approximately 7.2 across both trials. Subjects were randomized to receive either Qbrexza or vehicle applied once daily to each axilla. The co-primary endpoints were the proportion of subjects having at least a 4-point improvement from baseline in the weekly mean ASDD item #2 score at Week 4 and the mean absolute change from baseline in gravimetrically measured sweat production at Week 4. Clinical Response The results of Trial 1 and Trial 2 are presented in Table 5 below. Table 5: Primary Efficacy Outcomes in Subjects with Primary Axillary Hyperhidrosis Trial 1 Trial 2 Qbrexza, 2.4% N = 229 Vehicle N = 115 Qbrexza 2.4% N = 234 Vehicle N = 119 ASDD Item #2 Response at Week 4: Proportion of subjects with at least a 4-point improvement from baseline in the weekly mean ASDD item #2 at Week 4 53% 28% 66% 27% Change from Baseline in Sweat Production at Week 4 (mg/5 minutes): Median -81 -66 -79 -58 25 th percentile, 75 th percentile -149, -40 -106, -28 -144, -45 -122, -21"],"pharmacodynamics":["12.2 Pharmacodynamics The pharmacodynamics of Qbrexza are not known."],"pharmacokinetics":["12.3 Pharmacokinetics Absorption The pharmacokinetics of glycopyrronium were evaluated in adult and pediatric patients with primary axillary hyperhidrosis following Qbrexza once daily applied to the axillae for 5 days. The mean ± SD exposures of glycopyrronium are presented in Tables 3 and 4. There was no evidence of accumulation. Table 3: Mean ± SD Plasma Exposures of Glycopyrronium in Adults Following Qbrexza Once Daily for 5 days Abbreviations: Maximum concentration (C max ), Area under the time concentration curve (AUC) between 0 and 6 hours following administration of Qbrexza (AU 0-6h ), AUC between 0 and 24 hours following administration of Qbrexza (AUC 0-24h ) Parameter Adult Patients C max (ng/mL) 0.08 ± 0.04 AUC 0-6h (h ∗ ng/mL) 0.2 ± 0.14 AUC 0-24h (h ∗ ng/mL) 0.88 ± 0.57 Median T max (Range) (h) 1 (0, 10) Distribution After IV administration, glycopyrronium has a mean volume of distribution in children aged 1 to 14 years of approximately 1.3 to 1.8 L/kg, with a range from 0.7 to 3.9 L/kg. In adults aged 60-75 years, the volume of distribution was lower (0.42 L/kg ± 0.22). Elimination Metabolism A small proportion of glycopyrronium is metabolized following IV administration. The metabolic pathway for glycopyrronium is not characterized. Excretion Following administration of a single radiolabeled IV glycopyrronium dose to adult subjects who underwent surgery for cholelithiasis, approximately 85% of total radioactivity was excreted in urine and < 5% was present in bile drainage. Greater than 80% of the radioactivity in both urine and bile was unchanged drug. Specific Populations The pharmacokinetics of glycopyrronium were not evaluated in pregnant women or patients with hepatic impairment. Pediatric Subjects The mean ± SD exposures of glycopyrronium in pediatric subjects following Qbrexza once daily for 5 days are presented in Table 4. There was no evidence of accumulation. Table 4: Mean ± SD Plasma Exposures of Glycopyrronium in Pediatric Subjects Aged 10 to 17 years Following Qbrexza Once Daily for 5 days Parameter Pediatric Patients C max (ng/mL) 0.07 ± 0.06 AUC 0-6h (h ∗ ng/mL) 0.18 ± 0.13 AUC 0-24h (h ∗ ng/mL) Not calculated Median T max (Range) (h) 1.5 (0, 6) Patients with Renal Impairment Following a 4 mcg/kg IV dose of a glycopyrronium formulation for IV use, mean glycopyrronium AUC (10.6 mcg·h/L), CL (0.43 L/h/kg) and 3-hour urinary excretion (0.7%) were significantly different in uremic subjects undergoing renal transplantation surgery than those of healthy subjects (3.73 mcg·h/L, 1.14 L/h/kg, and 50%, respectively). Pharmacokinetics of Qbrexza in subjects with renal impairment has not been studied. In Vitro Studies In vitro studies indicated that under the conditions of clinical use, Qbrexza is not expected to induce cytochrome P450 (CYP) enzymes 1A2, 2B6 and 3A4; or inhibit 1A2, 2B6, 2C8, 2C9, 2C19, 2D6 and 3A4."],"adverse_reactions":["6 ADVERSE REACTIONS The following adverse reactions are described in greater detail in other sections • New or Worsening Urinary Retention [see Warnings and Precautions ( 5.1 )] Most common adverse reactions (incidence ≥2%) are dry mouth, mydriasis, oropharyngeal pain, headache, urinary hesitation, vision blurred, nasal dryness, dry throat, dry eye, dry skin, constipation. Local skin reactions, including erythema, burning/stinging and pruritus were also common (>5%) ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Journey Medical Corp. at 1-855-531-1859 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In two double-blind, vehicle-controlled clinical trials (Trial 1 [NCT02530281] and Trial 2 [NCT02530294]) of 459 subjects treated with Qbrexza once daily and 232 treated with vehicle, subjects were 9 to 76 years of age, 47% male, and the percentages of White, Black (including African Americans), and Asian subjects were 82%, 12%, and 1%, respectively. Table 1 summarizes the most frequent adverse reactions (≥2%) in subjects with primary axillary hyperhidrosis treated with Qbrexza. Table 1: Adverse Reactions Occurring in ≥2% of Subjects Adverse Reactions Qbrexza (N=459) n (%) Vehicle (N=232) n (%) Dry mouth 111 (24.2%) 13 (5.6%) Mydriasis 31 (6.8%) 0 Oropharyngeal pain 26 (5.7%) 3 (1.3%) Headache 23 (5.0%) 5 (2.2%) Urinary hesitation 16 (3.5%) 0 Vision blurred 16 (3.5%) 0 Nasal dryness 12 (2.6%) 1 (0.4%) Dry throat 12 (2.6%) 0 Dry eye 11 (2.4%) 1 (0.4%) Dry skin 10 (2.2%) 0 Constipation 9 (2.0%) 0 Table 2 shows the most frequently reported local skin reactions, which were relatively common in both the Qbrexza and vehicle groups. Table 2: Local Skin Reactions a Patients with a post-baseline local skin reaction assessment Local Skin Reactions Qbrexza (N=454) a n (%) Vehicle (N=231) a n (%) Erythema 77 (17.0%) 39 (16.9%) Burning/stinging 64 (14.1%) 39 (16.9%) Pruritus 37 (8.1%) 14 (6.1%) In an open-label safety trial (NCT02553798), 564 subjects were treated for up to an additional 44 weeks after completing Trial 1 or Trial 2. Adverse reactions occurring at a frequency ≥2.0% were: dry mouth (16.9%), vision blurred (6.7%), nasopharyngitis (5.8%), mydriasis (5.3%), urinary hesitation (4.2%), nasal dryness (3.6%), dry eye (2.9%), pharyngitis (2.2%), and application site reactions (pain [6.4%], dermatitis [3.8%], pruritus [3.8%], rash [3.8%], erythema [2.4%]). 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of Qbrexza. Because the reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to Qbrexza exposure. • Genitourinary system disorders : new onset urinary retention [ see Warnings and Precautions ( 5.1 ) ]"],"contraindications":["4 CONTRAINDICATIONS Qbrexza is contraindicated in patients with medical conditions that can be exacerbated by the anticholinergic effect of Qbrexza (e.g., glaucoma, paralytic ileus, unstable cardiovascular status in acute hemorrhage, severe ulcerative colitis, toxic megacolon complicating ulcerative colitis, myasthenia gravis, Sjogren’s syndrome). Qbrexza is contraindicated in patients with medical conditions that can be exacerbated by the anticholinergic effect of Qbrexza (e.g., glaucoma, paralytic ileus, unstable cardiovascular status in acute hemorrhage, severe ulcerative colitis, toxic megacolon complicating ulcerative colitis, myasthenia gravis, Sjogren’s syndrome) ( 4 )"],"drug_interactions":["7 DRUG INTERACTIONS Coadministration of Qbrexza with anticholinergic medications may result in additive interaction leading to an increase in anticholinergic adverse effects. Avoid coadministration of Qbrexza with other anticholinergic-containing drugs ( 7 ) 7.1 Anticholinergics Coadministration of Qbrexza with anticholinergic medications may result in additive interaction leading to an increase in anticholinergic adverse effects [see Warnings and Precautions ( 5 ) and Adverse Reactions ( 6 )] . Avoid coadministration of Qbrexza with other anticholinergic-containing drugs."],"mechanism_of_action":["12.1 Mechanism of Action Glycopyrronium is a competitive inhibitor of acetylcholine receptors that are located on certain peripheral tissues, including sweat glands. In hyperhidrosis, glycopyrronium inhibits the action of acetylcholine on sweat glands, reducing sweating."],"storage_and_handling":["16.2 Storage and Handling Store at room temperature 20° - 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F) [See USP Controlled Room Temperature]. Qbrexza is flammable; keep away from heat or flame."],"clinical_pharmacology":["12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Glycopyrronium is a competitive inhibitor of acetylcholine receptors that are located on certain peripheral tissues, including sweat glands. In hyperhidrosis, glycopyrronium inhibits the action of acetylcholine on sweat glands, reducing sweating. 12.2 Pharmacodynamics The pharmacodynamics of Qbrexza are not known. 12.3 Pharmacokinetics Absorption The pharmacokinetics of glycopyrronium were evaluated in adult and pediatric patients with primary axillary hyperhidrosis following Qbrexza once daily applied to the axillae for 5 days. The mean ± SD exposures of glycopyrronium are presented in Tables 3 and 4. There was no evidence of accumulation. Table 3: Mean ± SD Plasma Exposures of Glycopyrronium in Adults Following Qbrexza Once Daily for 5 days Abbreviations: Maximum concentration (C max ), Area under the time concentration curve (AUC) between 0 and 6 hours following administration of Qbrexza (AU 0-6h ), AUC between 0 and 24 hours following administration of Qbrexza (AUC 0-24h ) Parameter Adult Patients C max (ng/mL) 0.08 ± 0.04 AUC 0-6h (h ∗ ng/mL) 0.2 ± 0.14 AUC 0-24h (h ∗ ng/mL) 0.88 ± 0.57 Median T max (Range) (h) 1 (0, 10) Distribution After IV administration, glycopyrronium has a mean volume of distribution in children aged 1 to 14 years of approximately 1.3 to 1.8 L/kg, with a range from 0.7 to 3.9 L/kg. In adults aged 60-75 years, the volume of distribution was lower (0.42 L/kg ± 0.22). Elimination Metabolism A small proportion of glycopyrronium is metabolized following IV administration. The metabolic pathway for glycopyrronium is not characterized. Excretion Following administration of a single radiolabeled IV glycopyrronium dose to adult subjects who underwent surgery for cholelithiasis, approximately 85% of total radioactivity was excreted in urine and < 5% was present in bile drainage. Greater than 80% of the radioactivity in both urine and bile was unchanged drug. Specific Populations The pharmacokinetics of glycopyrronium were not evaluated in pregnant women or patients with hepatic impairment. Pediatric Subjects The mean ± SD exposures of glycopyrronium in pediatric subjects following Qbrexza once daily for 5 days are presented in Table 4. There was no evidence of accumulation. Table 4: Mean ± SD Plasma Exposures of Glycopyrronium in Pediatric Subjects Aged 10 to 17 years Following Qbrexza Once Daily for 5 days Parameter Pediatric Patients C max (ng/mL) 0.07 ± 0.06 AUC 0-6h (h ∗ ng/mL) 0.18 ± 0.13 AUC 0-24h (h ∗ ng/mL) Not calculated Median T max (Range) (h) 1.5 (0, 6) Patients with Renal Impairment Following a 4 mcg/kg IV dose of a glycopyrronium formulation for IV use, mean glycopyrronium AUC (10.6 mcg·h/L), CL (0.43 L/h/kg) and 3-hour urinary excretion (0.7%) were significantly different in uremic subjects undergoing renal transplantation surgery than those of healthy subjects (3.73 mcg·h/L, 1.14 L/h/kg, and 50%, respectively). Pharmacokinetics of Qbrexza in subjects with renal impairment has not been studied. In Vitro Studies In vitro studies indicated that under the conditions of clinical use, Qbrexza is not expected to induce cytochrome P450 (CYP) enzymes 1A2, 2B6 and 3A4; or inhibit 1A2, 2B6, 2C8, 2C9, 2C19, 2D6 and 3A4."],"indications_and_usage":["1 INDICATIONS AND USAGE Qbrexza is indicated for topical treatment of primary axillary hyperhidrosis in adult and pediatric patients 9 years of age and older. Qbrexza is an anticholinergic indicated for topical treatment of primary axillary hyperhidrosis in adults and pediatric patients 9 years of age and older ( 1 )."],"warnings_and_cautions":["5 WARNINGS AND PRECAUTIONS New or worsening urinary retention: Use with caution in patients with a history of documented urinary retention ( 5.1 ). Control of body temperature: In the presence of high ambient temperature, heat illness may occur; avoid use if patients develop generalized lack of sweating when exposed to hot or very warm environmental temperatures ( 5.2 ). Operating machinery or an automobile: Transient blurred vision may occur with use of Qbrexza. If blurred vision occurs, discontinue use of Qbrexza until symptoms resolve; avoid operating a motor vehicle or other machinery until symptoms resolve ( 5.3 ). 5.1 New or Worsening Urinary Retention New or worsening signs and symptoms of urinary retention (e.g., difficulty passing urine, distended bladder) have occurred in patients taking Qbrexza with or without a history of documented urinary retention. Instruct patients to discontinue use immediately and consult a physician should any of these signs or symptoms develop. Qbrexza should be used with caution in patients with prostatic hypertrophy or bladder-neck obstruction. 5.2 Control of Body Temperature In the presence of high ambient temperature, heat illness (hyperpyrexia and heat stroke due to decreased sweating) can occur with the use of anticholinergic drugs such as Qbrexza. Advise patients using Qbrexza to watch for generalized lack of sweating when in hot or very warm environmental temperatures and to avoid use if not sweating under these conditions. 5.3 Operating Machinery or an Automobile Transient blurred vision may occur with use of Qbrexza. If blurred vision occurs, the patient should discontinue use until symptoms resolve. Patients should be warned not to engage in activities that require clear vision such as operating a motor vehicle or other machinery, or performing hazardous work until the symptoms have resolved. 5.4 Risk of Accidental Exposure Cases of accidental exposure resulting in mydriasis, anisocoria, and blurred vision have been reported in postmarketing surveillance of Qbrexza. The exposures occurred when children accessed Qbrexza wipes discarded in trash or when patients touched the periocular area after using Qbrexza. In most cases, the mydriasis, anisocoria, and blurred vision were temporary and resolved within one week following exposure. The risk of accidental exposure was increased in these cases by not adhering to recommendations for the appropriate use of Qbrexza. Strict adherence to the recommended hand washing after use and disposal instructions is of the utmost importance to prevent accidental exposure. [see Dosage and Administration (2) ]."],"clinical_studies_table":["
Table 5: Primary Efficacy Outcomes in Subjects with Primary Axillary Hyperhidrosis
Trial 1Trial 2
Qbrexza, 2.4% N = 229Vehicle N = 115 Qbrexza 2.4% N = 234Vehicle N = 119
ASDD Item #2 Response at Week 4:
Proportion of subjects with at least a 4-point improvement from baseline in the weekly mean ASDD item #2 at Week 453%28%66%27%
Change from Baseline in Sweat Production at Week 4 (mg/5 minutes):
Median-81 -66-79-58
25th percentile, 75th percentile-149, -40-106, -28-144, -45-122, -21
"],"nonclinical_toxicology":["13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Glycopyrronium tosylate was not carcinogenic when topically applied to rats daily for up to 24 months in solution at concentrations of 1%, 2%, and 4% w/w. When glycopyrrolate was administered via oral gavage to mice for up to 24 months at dosages of 2.5, 7, and 20 mg/kg/day in both genders, no significant changes in tumor incidence were observed when compared to control. When glycopyrrolate was administered via oral gavage to rats for up to 24 months at dosages of 5, 15, and 40 mg/kg/day in both genders, no significant changes in tumor incidence were observed when compared to control. Glycopyrrolate was negative in a battery of genetic toxicology studies that included a bacterial reverse mutation (Ames) assay, a mouse lymphoma assay conducted with L5178Y/TK +/- cells, and an in vivo micronucleus assay with mice. Glycopyrronium tosylate was negative in an Ames assay. Glycopyrrolate was assessed for effects on fertility or general reproductive function in rats. Rats of both genders received glycopyrrolate at dosages up to 100 mg/kg/day via oral gavage. No treatment-related effects on fertility or reproductive parameters were observed in either gender."],"pharmacokinetics_table":["
Table 3: Mean ± SD Plasma Exposures of Glycopyrronium in Adults Following Qbrexza Once Daily for 5 days
Abbreviations: Maximum concentration (Cmax), Area under the time concentration curve (AUC) between 0 and 6 hours following administration of Qbrexza (AU0-6h), AUC between 0 and 24 hours following administration of Qbrexza (AUC0-24h)
ParameterAdult Patients
Cmax (ng/mL) 0.08 ± 0.04
AUC0-6h (h∗ng/mL) 0.2 ± 0.14
AUC0-24h (h∗ng/mL)0.88 ± 0.57
Median Tmax (Range) (h)1 (0, 10)
","
Table 4: Mean ± SD Plasma Exposures of Glycopyrronium in Pediatric Subjects Aged 10 to 17 years Following Qbrexza Once Daily for 5 days
ParameterPediatric Patients
Cmax (ng/mL) 0.07 ± 0.06
AUC0-6h (h∗ng/mL) 0.18 ± 0.13
AUC0-24h (h∗ng/mL)Not calculated
Median Tmax (Range) (h)1.5 (0, 6)
"],"adverse_reactions_table":["
Table 1: Adverse Reactions Occurring in ≥2% of Subjects
Adverse ReactionsQbrexza (N=459) n (%) Vehicle (N=232) n (%)
Dry mouth111 (24.2%)13 (5.6%)
Mydriasis31 (6.8%)0
Oropharyngeal pain26 (5.7%)3 (1.3%)
Headache23 (5.0%)5 (2.2%)
Urinary hesitation16 (3.5%)0
Vision blurred16 (3.5%)0
Nasal dryness12 (2.6%)1 (0.4%)
Dry throat12 (2.6%)0
Dry eye11 (2.4%)1 (0.4%)
Dry skin10 (2.2%)0
Constipation9 (2.0%)0
","
Table 2: Local Skin Reactions
a Patients with a post-baseline local skin reaction assessment
Local Skin ReactionsQbrexza (N=454)a n (%) Vehicle (N=231)a n (%)
Erythema77 (17.0%)39 (16.9%)
Burning/stinging64 (14.1%)39 (16.9%)
Pruritus37 (8.1%)14 (6.1%)
"],"information_for_patients":["17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling ( Patient Information ). New or Worsening Urinary Retention Instruct patients to be alert for signs and symptoms of urinary retention (e.g., difficulty passing urine, distended bladder). Instruct patients to discontinue use and consult a physician immediately should any of these signs or symptoms develop. Control of Body Temperature (Risk of Overheating or Heat Illness) In the presence of high ambient temperature, heat illness due to decreased sweating can occur with the use of anticholinergic drugs such as Qbrexza. Advise patients using Qbrexza to watch for generalized lack of sweating when in hot or very warm environmental temperatures and to avoid use if not sweating under these conditions. Operating Machinery or an Automobile Transient blurred vision may occur with Qbrexza. If this occurs, instruct patients to contact their healthcare provider, discontinue use of Qbrexza and avoid operating a motor vehicle or other machinery, or performing hazardous work until symptoms resolve. Instructions for Administering Qbrexza It is important for patients to understand how to correctly apply Qbrexza (see Patient Information ). Instruct patients to use one cloth to apply Qbrexza to both axillae by wiping the cloth across one underarm, ONE TIME. Using the same cloth, apply the medication to the other underarm, ONE TIME. After applying Qbrexza, discard the cloth in the household trash out of reach of children and others. Wash your hands with soap and water right away after you apply Qbrexza and have thrown away the cloth. Inform patients to avoid touching the periocular area. The Qbrexza that is still on your hands can cause you to have temporary pupil dilation and blurred vision if you touch your eyes. Remind patients not to apply Qbrexza to other body areas or to broken skin. Instruct patients to avoid using Qbrexza with occlusive dressings. Qbrexza is flammable; avoid use near heat or flame. Manufactured for: Journey Medical Corporation Scottsdale, AZ 85258 Version 2, October 2022"],"dosage_and_administration":["2 DOSAGE AND ADMINISTRATION For topical use only. Qbrexza is for topical use in the underarm area only and not for use in other body areas. Qbrexza is administered by a single-use pre-moistened cloth packaged in individual pouches. Qbrexza should be applied to clean dry skin on the underarm areas only. Qbrexza should not be used more frequently than once every 24 hours. Tear open the pouch and pull out the cloth, unfold the cloth, and wipe it across one entire underarm once. Using the same cloth, wipe the other underarm once. A single cloth should be used to apply Qbrexza to both underarms. After applying Qbrexza, discard the cloth in the household trash out of reach of children and others. Wash hands immediately with soap and water after applying and discarding the Qbrexza cloth. Qbrexza may cause temporary dilation of the pupils and blurred vision if it comes in contact with the eyes. Avoid transfer of Qbrexza to the periocular area [see Warnings and Precautions ( 5.3 )] . Do not apply Qbrexza to broken skin. Avoid using Qbrexza with occlusive dressings. For topical use only. Apply Qbrexza once daily to both axillae using a single cloth ( 2 )."],"spl_product_data_elements":["Qbrexza glycopyrronium GLYCOPYRRONIUM TOSYLATE GLYCOPYRRONIUM ANHYDROUS CITRIC ACID TRISODIUM CITRATE DIHYDRATE WATER ALCOHOL"],"dosage_forms_and_strengths":["3 DOSAGE FORMS AND STRENGTHS Cloth: A single-use cloth pre-moistened with 2.4% glycopyrronium solution Cloth: A single-use cloth pre-moistened with 2.4% glycopyrronium solution ( 3 )."],"spl_patient_package_insert":["This Patient Information has been approved by the U.S. Food and Drug Administration. Revised: 10/2022 PATIENT INFORMATION Qbrexza™ (kew brex’ zah) (glycopyrronium) cloth, 2.4% Important Information: Qbrexza is for use on the skin in the underarm area only. What is Qbrexza? Qbrexza is a prescription anticholinergic medicine used on the skin (topical) to treat excessive underarm sweating (primary axillary hyperhidrosis) in adults and children 9 years of age and older. It is not known if Qbrexza is safe and effective in children under 9 years of age. Who should not use Qbrexza? Do not use Qbrexza if you have certain medical conditions that can be made worse by taking an anticholinergic medicine such as glaucoma, severe ulcerative colitis or certain other serious bowel problems associated with severe ulcerative colitis, myasthenia gravis, and Sjogren’s syndrome. Talk to your healthcare provider if you are not sure if you have a medical condition that can be made worse by taking an anticholinergic medicine. Before using Qbrexza, tell your healthcare provider about all of your medical conditions, including if you: have prostate or bladder problems, or problems passing urine have kidney problems are pregnant or plan to become pregnant. It is not known if Qbrexza will harm your unborn baby. are breastfeeding or plan to breastfeed. It is not known if Qbrexza passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with Qbrexza. Tell your healthcare provider about all the medicines you take, including prescription medicines, over-the-counter medicines, vitamins, and herbal supplements. Qbrexza may affect the way other medicines work causing side effects. Especially tell your healthcare provider if you take anticholinergic medicines. Know the medicines you take. Keep a list of your medicines with you and show it to your healthcare provider and pharmacist when you get a new medicine. How should I use Qbrexza? Use Qbrexza exactly as your healthcare provider tells you to use it. Qbrexza comes as a single-use pre-moistened cloth in individual pouches. Qbrexza should be applied to the clean, dry, intact skin, of your underarm areas only. Do not apply Qbrexza to broken skin. Do not cover the treated area with a plastic (occlusive) dressing. Apply Qbrexza to both underarm areas using 1 cloth 1 time every 24 hours. Applying Qbrexza: Carefully tear open the pouch to avoid tearing the Qbrexza cloth. Unfold the Qbrexza cloth and apply Qbrexza by wiping across 1 entire underarm 1 time. Using the same Qbrexza cloth, wipe across the other underarm 1 time. Throw away (discard) the used Qbrexza cloth in the trash out of the reach of children and others. Wash your hands right away after you apply Qbrexza and have thrown away the cloth. It is important that you wash your hands because the Qbrexza that is still on your hands can cause you to have blurred vision if you touch your eyes. Do not reuse the Qbrexza cloth. What should I avoid while using Qbrexza? • Avoid touching eyes. Qbrexza may cause you to have blurred vision that is temporary. If you develop blurred vision, call your healthcare provider, stop using Qbrexza and do not drive, operate machinery, or do hazardous work until your vision is clear. Qbrexza is flammable. Avoid heat and flame while applying Qbrexza to your skin What are the possible side effects of Qbrexza? Qbrexza can cause serious side effects, including: New or worsened urinary retention. People who use Qbrexza may develop new or worse urinary retention. Urinary retention can be caused by a blockage in your bladder. Urinary retention can also happen in men who have a larger than normal prostate. Symptoms of urinary retention may include: difficulty urinating urinating frequently urination in a weak stream or drips full bladder or difficulty emptying your bladder (distended bladder) If you have these symptoms, stop using Qbrexza and call your healthcare provider right away. Problems with control of your body temperature. Qbrexza can cause you to have decreased sweating in areas other than the underarm area which could cause you to become overheated and to develop heat illness. When in hot or very warm temperatures, watch for lack of sweating on your body (generalized) and stop using Qbrexza if you develop lack of sweating on your body. Stop using Qbrexza and call your healthcare provider right away if you develop any of these symptoms of heat illness: hot, red skin decreased alertness or passing out (unconsciousness) fast, weak pulse fast, shallow breathing increased body temperature (fever) Blurred vision. If you develop blurred vision during treatment with Qbrexza, call your healthcare provider, stop using Qbrexza and do not drive, or operate machinery, or do hazardous work until your vision is clear. The most common side effects of Qbrexza include: dry mouth dilation of the pupils of your eyes (mydriasis) sore throat skin redness, burning/stinging or itching in underarm area headache problems with urination blurred vision nasal dryness throat, eye, and skin dryness constipation These are not all of the possible side effects of Qbrexza. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. How should I store Qbrexza? Store Qbrexza at room temperature between 68°F and 77°F (20°C and 25°C). Qbrexza is flammable. Keep Qbrexza away from heat and flame. Keep Qbrexza and all medicines out of the reach of children. General information about the safe and effective use of Qbrexza. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Qbrexza for a condition for which it was not prescribed. Do not give Qbrexza to other people, even if they have the same symptoms you have. It may harm them. You can ask your pharmacist or healthcare provider for information about Qbrexza that is written for health professionals. What are the ingredients in Qbrexza? Active Ingredient: glycopyrronium tosylate Inactive Ingredients: citric acid, dehydrated alcohol, purified water, and sodium citrate Manufactured for: Journey Medical Corporation, Scottsdale, AZ 85258 For more information, go to www.Qbrexza.com or call 1-855-531-1859."],"clinical_pharmacology_table":["
Table 3: Mean ± SD Plasma Exposures of Glycopyrronium in Adults Following Qbrexza Once Daily for 5 days
Abbreviations: Maximum concentration (Cmax), Area under the time concentration curve (AUC) between 0 and 6 hours following administration of Qbrexza (AU0-6h), AUC between 0 and 24 hours following administration of Qbrexza (AUC0-24h)
ParameterAdult Patients
Cmax (ng/mL) 0.08 ± 0.04
AUC0-6h (h∗ng/mL) 0.2 ± 0.14
AUC0-24h (h∗ng/mL)0.88 ± 0.57
Median Tmax (Range) (h)1 (0, 10)
","
Table 4: Mean ± SD Plasma Exposures of Glycopyrronium in Pediatric Subjects Aged 10 to 17 years Following Qbrexza Once Daily for 5 days
ParameterPediatric Patients
Cmax (ng/mL) 0.07 ± 0.06
AUC0-6h (h∗ng/mL) 0.18 ± 0.13
AUC0-24h (h∗ng/mL)Not calculated
Median Tmax (Range) (h)1.5 (0, 6)
"],"use_in_specific_populations":["8 USE IN SPECIFIC POPULATIONS Pediatric use: Safety and efficacy are not established in patients under 9 years of age ( 8.4 ). 8.1 Pregnancy Risk Summary There are no available data on Qbrexza use in pregnant women to inform a drug-associated risk for adverse developmental outcomes. In pregnant rats, daily oral administration of glycopyrrolate (glycopyrronium bromide) during organogenesis did not result in an increased incidence of gross external or visceral defects [see Data ] . When glycopyrrolate was administered intravenously to pregnant rabbits during organogenesis, no adverse effects on embryo-fetal development were seen. The available data do not support relevant comparisons of systemic glycopyrronium exposures achieved in the animal studies to exposures observed in humans after topical use of Qbrexza. The estimated background risks of major birth defects and miscarriage for the indicated population are unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Data Animal Data Glycopyrrolate was orally administered to pregnant rats at dosages of 50, 200, and 400 mg/kg/day during the period of organogenesis. Glycopyrrolate had no effect on maternal survival, but significantly reduced mean maternal body weight gain over the period of dosing at all dosages evaluated. Mean fetal weight was significantly reduced in the 200 and 400 mg/kg/day dose groups. There were two litters with all resorbed fetuses in the 400 mg/kg/day dose group. There were no effects of treatment on the incidence of gross external or visceral defects. Minor treatment-related skeletal effects included reduced ossification of various bones in the 200 and 400 mg/kg/day dose groups; these skeletal effects were likely secondary to maternal toxicity. Glycopyrrolate was intravenously administered to pregnant rabbits at dosages of 0.1, 0.5, and 1.0 mg/kg/day during the period of organogenesis. Glycopyrrolate did not affect maternal survival under the conditions of this study. Mean maternal body weight gain and mean food consumption over the period of dosing were lower than the corresponding control value in the 0.5 and 1.0 mg/kg/day treatment groups. There were no effects of treatment on fetal parameters, including fetal survival, mean fetal weight, and the incidence of external, visceral, or skeletal defects. Female rats that were pregnant or nursing were orally dosed with glycopyrrolate daily at dosages of 0, 50, 200, or 400 mg/kg/day, beginning on day 7 of gestation, and continuing until day 20 of lactation. Mean body weight of pups in all treatment groups was reduced compared to the control group during the period of nursing, but eventually recovered to be comparable to the control group, post-weaning. No other notable delivery or litter parameters were affected by treatment in any group, including no effects on mean duration of gestation or mean numbers of live pups per litter. No treatment-related effects on survival or adverse clinical signs were observed in pups. There were no effects of maternal treatment on behavior, learning, memory, or reproductive function of pups. 8.2 Lactation Risk Summary There are no data on the presence of glycopyrrolate or its metabolites in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Qbrexza and any potential adverse effects on the breastfed infant from Qbrexza or from the underlying maternal condition. 8.4 Pediatric Use The safety, effectiveness and pharmacokinetics of Qbrexza have been established in pediatric patients age 9 years and older for topical treatment of primary axillary hyperhidrosis [see Clinical Pharmacology ( 12.3 )] . Use of Qbrexza in this age group is supported by evidence from two multicenter, randomized, double-blind, parallel-group, vehicle-controlled 4-week trials which included 34 pediatric subjects 9 years and older [see Adverse Reactions ( 6.1 ) and Clinical Studies ( 14 )] . The safety and effectiveness of Qbrexza have not been established in pediatric patients under 9 years of age. 8.5 Geriatric Use Clinical trials of Qbrexza did not include sufficient numbers of subjects age 65 years and older to determine whether they respond differently from younger subjects. 8.6 Renal Impairment The elimination of glycopyrronium is severely impaired in patients with renal failure [see Clinical Pharmacology ( 12.3 )] ."],"spl_patient_package_insert_table":["
This Patient Information has been approved by the U.S. Food and Drug Administration.Revised: 10/2022
PATIENT INFORMATIONQbrexza™ (kew brex’ zah) (glycopyrronium) cloth, 2.4%
Important Information: Qbrexza is for use on the skin in the underarm area only.
What is Qbrexza?Qbrexza is a prescription anticholinergic medicine used on the skin (topical) to treat excessive underarm sweating (primary axillary hyperhidrosis) in adults and children 9 years of age and older.It is not known if Qbrexza is safe and effective in children under 9 years of age.
Who should not use Qbrexza?Do not use Qbrexza if you have certain medical conditions that can be made worse by taking an anticholinergic medicine such as glaucoma, severe ulcerative colitis or certain other serious bowel problems associated with severe ulcerative colitis, myasthenia gravis, and Sjogren’s syndrome.Talk to your healthcare provider if you are not sure if you have a medical condition that can be made worse by taking an anticholinergic medicine.
Before using Qbrexza, tell your healthcare provider about all of your medical conditions, including if you:have prostate or bladder problems, or problems passing urinehave kidney problemsare pregnant or plan to become pregnant. It is not known if Qbrexza will harm your unborn baby.are breastfeeding or plan to breastfeed. It is not known if Qbrexza passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with Qbrexza.Tell your healthcare provider about all the medicines you take, including prescription medicines, over-the-counter medicines, vitamins, and herbal supplements.Qbrexza may affect the way other medicines work causing side effects. Especially tell your healthcare provider if you take anticholinergic medicines.Know the medicines you take. Keep a list of your medicines with you and show it to your healthcare provider and pharmacist when you get a new medicine.
How should I use Qbrexza?Use Qbrexza exactly as your healthcare provider tells you to use it.Qbrexza comes as a single-use pre-moistened cloth in individual pouches.Qbrexza should be applied to the clean, dry, intact skin, of your underarm areas only. Do not apply Qbrexza to broken skin. Do not cover the treated area with a plastic (occlusive) dressing.Apply Qbrexza to both underarm areas using 1 cloth 1 time every 24 hours.Applying Qbrexza:Carefully tear open the pouch to avoid tearing the Qbrexza cloth.Unfold the Qbrexza cloth and apply Qbrexza by wiping across 1 entire underarm 1 time. Using the same Qbrexza cloth, wipe across the other underarm 1 time.Throw away (discard) the used Qbrexza cloth in the trash out of the reach of children and others.Wash your hands right away after you apply Qbrexza and have thrown away the cloth. It is important that you wash your hands because the Qbrexza that is still on your hands can cause you to have blurred vision if you touch your eyes.Do not reuse the Qbrexza cloth.
What should I avoid while using Qbrexza?• Avoid touching eyes. Qbrexza may cause you to have blurred vision that is temporary. If you develop blurred vision, call your healthcare provider, stop using Qbrexza and do not drive, operate machinery, or do hazardous work until your vision is clear.Qbrexza is flammable. Avoid heat and flame while applying Qbrexza to your skin
What are the possible side effects of Qbrexza?Qbrexza can cause serious side effects, including:New or worsened urinary retention.People who use Qbrexza may develop new or worse urinary retention. Urinary retention can be caused by a blockage in your bladder. Urinary retention can also happen in men who have a larger than normal prostate. Symptoms of urinary retention may include:difficulty urinatingurinating frequentlyurination in a weak stream or dripsfull bladder or difficulty emptying your bladder (distended bladder) If you have these symptoms, stop using Qbrexza and call your healthcare provider right away.Problems with control of your body temperature. Qbrexza can cause you to have decreased sweating in areas other than the underarm area which could cause you to become overheated and to develop heat illness. When in hot or very warm temperatures, watch for lack of sweating on your body (generalized) and stop using Qbrexza if you develop lack of sweating on your body.Stop using Qbrexza and call your healthcare provider right away if you develop any of these symptoms of heat illness:hot, red skindecreased alertness or passing out (unconsciousness)fast, weak pulsefast, shallow breathingincreased body temperature (fever)Blurred vision. If you develop blurred vision during treatment with Qbrexza, call your healthcare provider, stop using Qbrexza and do not drive, or operate machinery, or do hazardous work until your vision is clear.The most common side effects of Qbrexza include:dry mouthdilation of the pupils of your eyes (mydriasis)sore throatskin redness, burning/stinging or itching in underarm areaheadacheproblems with urinationblurred visionnasal drynessthroat, eye, and skin drynessconstipationThese are not all of the possible side effects of Qbrexza.Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store Qbrexza?Store Qbrexza at room temperature between 68°F and 77°F (20°C and 25°C).Qbrexza is flammable. Keep Qbrexza away from heat and flame.Keep Qbrexza and all medicines out of the reach of children.
General information about the safe and effective use of Qbrexza.Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Qbrexza for a condition for which it was not prescribed. Do not give Qbrexza to other people, even if they have the same symptoms you have. It may harm them. You can ask your pharmacist or healthcare provider for information about Qbrexza that is written for health professionals.
What are the ingredients in Qbrexza?Active Ingredient: glycopyrronium tosylateInactive Ingredients: citric acid, dehydrated alcohol, purified water, and sodium citrate Manufactured for: Journey Medical Corporation, Scottsdale, AZ 85258For more information, go to www.Qbrexza.com or call 1-855-531-1859.
"],"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - NDC: 69489-411-01 - 1-Count Pouch Label NDC 69489-411-01 Rx Only 1 Single-use Cloth Qbrexza ® (glycopyrronium) cloth ​ 2.4% For Topical Use Only Each pouch contains 1 cloth with 2.8 grams of solution Avoid touching eyes. Wash hands with soap and water immediately after discarding the used cloth . 1-Count Pouch Label","PRINCIPAL DISPLAY PANEL - NDC: 69489-411-30 - 30-Count Carton Label NDC 69489-411-30 Rx Only Qbrexza ® (glycopyrronium) cloth 2.4% For Topical Use Only 30 Single-use Cloths www.Qbrexza.com Avoid touching eyes. Wash hands with soap and water immediately after discarding the used cloth. 30-Count Carton Label"],"carcinogenesis_and_mutagenesis_and_impairment_of_fertility":["13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Glycopyrronium tosylate was not carcinogenic when topically applied to rats daily for up to 24 months in solution at concentrations of 1%, 2%, and 4% w/w. When glycopyrrolate was administered via oral gavage to mice for up to 24 months at dosages of 2.5, 7, and 20 mg/kg/day in both genders, no significant changes in tumor incidence were observed when compared to control. When glycopyrrolate was administered via oral gavage to rats for up to 24 months at dosages of 5, 15, and 40 mg/kg/day in both genders, no significant changes in tumor incidence were observed when compared to control. Glycopyrrolate was negative in a battery of genetic toxicology studies that included a bacterial reverse mutation (Ames) assay, a mouse lymphoma assay conducted with L5178Y/TK +/- cells, and an in vivo micronucleus assay with mice. Glycopyrronium tosylate was negative in an Ames assay. Glycopyrrolate was assessed for effects on fertility or general reproductive function in rats. Rats of both genders received glycopyrrolate at dosages up to 100 mg/kg/day via oral gavage. No treatment-related effects on fertility or reproductive parameters were observed in either gender."]},"safety":{"boxedWarnings":[],"commonSideEffects":[{"effect":"dry mouth","drugRate":"24.2%","_validated":true,"placeboRate":"5.6%"},{"effect":"mydriasis","drugRate":"6.8%","_validated":true,"placeboRate":""},{"effect":"oropharyngeal pain","drugRate":"5.7%","_validated":true,"placeboRate":"1.3%"},{"effect":"headache","drugRate":"5.0%","_validated":true,"placeboRate":"2.2%"},{"effect":"urinary hesitation","drugRate":"3.5%","_validated":true,"placeboRate":""},{"effect":"vision blurred","drugRate":"3.5%","_validated":true,"placeboRate":""},{"effect":"nasal dryness","drugRate":"2.6%","_validated":true,"placeboRate":"0.4%"},{"effect":"dry throat","drugRate":"2.6%","_validated":true,"placeboRate":""},{"effect":"dry eye","drugRate":"2.4%","_validated":true,"placeboRate":"0.4%"},{"effect":"dry skin","drugRate":"2.2%","_validated":true,"placeboRate":""},{"effect":"constipation","drugRate":"2.0%","_validated":true,"placeboRate":""}]},"_chembl":null,"patents":[{"applNo":"N210361","source":"FDA Orange Book","status":"Active","expires":"Oct 17, 2028","territory":"US","drugProduct":true,"patentNumber":"10052267","drugSubstance":false},{"applNo":"N210361","source":"FDA Orange Book","status":"Active","expires":"Feb 28, 2033","territory":"US","drugProduct":true,"patentNumber":"8859610","drugSubstance":false},{"applNo":"N210361","source":"FDA Orange Book","status":"Active","expires":"Feb 28, 2033","territory":"US","drugProduct":false,"patentNumber":"9259414","drugSubstance":false},{"applNo":"N210361","source":"FDA Orange Book","status":"Active","expires":"Jul 18, 2030","territory":"US","drugProduct":true,"patentNumber":"9744105","drugSubstance":false},{"applNo":"N210361","source":"FDA Orange Book","status":"Active","expires":"Feb 28, 2033","territory":"US","drugProduct":true,"patentNumber":"10004717","drugSubstance":false},{"applNo":"N210361","source":"FDA Orange Book","status":"Active","expires":"Dec 10, 2029","territory":"US","drugProduct":true,"patentNumber":"8618160","drugSubstance":false},{"applNo":"N210361","source":"FDA Orange Book","status":"Active","expires":"Feb 28, 2033","territory":"US","drugProduct":true,"patentNumber":"10548875","drugSubstance":true},{"applNo":"N210361","source":"FDA Orange Book","status":"Active","expires":"Feb 28, 2033","territory":"US","drugProduct":true,"patentNumber":"10543192","drugSubstance":false}],"_fixedAt":"2026-03-30T14:13:43.919112","_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=GLYCOPYRRONIUM","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T05:46:36.132132+00:00"},"patents":{"url":"","method":"deterministic","source":"FDA Orange Book","rawText":"","confidence":1,"sourceType":"fda_orange_book","retrievedAt":"2026-04-20T05:46:36.132042+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T05:46:42.414894+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=GLYCOPYRRONIUM","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T05:46:42.908814+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T05:46:34.436174+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T05:46:34.436196+00:00"},"mechanism.oneSentence":{"url":"","method":"ai_extraction","source":"FDA Label + AI","aiModel":"featherless","rawText":"12.1 Mechanism of Action Glycopyrronium is a competitive inhibitor of acetylcholine receptors that are located on certain peripheral tissues, including sweat glands. In hyperhidrosis, glycopyrronium inhibits the action of acetylcholine on sweat glands, reducing sweating.","confidence":0.95,"sourceType":"fda_label","retrievedAt":"2026-04-20T05:46:54.448962+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Muscarinic acetylcholine receptor M1 antagonist","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T05:46:44.022752+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL1201027/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T05:46:43.669989+00:00"},"safety.commonSideEffects":{"url":"","method":"ai_extraction","source":"FDA Label + AI","aiModel":"featherless","rawText":"6 ADVERSE REACTIONS The following adverse reactions are described in greater detail in other sections • New or Worsening Urinary Retention [see Warnings and Precautions ( 5.1 )] Most common adverse reactions (incidence ≥2%) are dry mouth, mydriasis, oropharyngeal pain, headache, urinary hesitation, vision blurred, nasal dryness, dry throat, dry eye, dry skin, constipation. Local skin reactions, including erythema, burning/stinging and pruritus were also common (>5%) ( 6.1 ). To report SUSPECTED ","confidence":0.95,"sourceType":"fda_label","retrievedAt":"2026-04-20T05:47:11.495027+00:00"},"regulatory.fda_application":{"url":"","method":"deterministic","source":"FDA Label","rawText":"NDA210361","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T05:46:34.436200+00:00"}},"_dailymed":{"setId":"5b372650-e56e-47a5-93e2-c0c292017059","title":"QBREXZA (GLYCOPYRRONIUM) CLOTH [JOURNEY MEDICAL CORPORATION]"},"mechanism":{"target":"acetylcholine receptors","modality":"Small Molecule","explanation":"Glycopyrronium works by blocking the action of acetylcholine on sweat glands. This inhibition reduces the amount of sweat produced, which is particularly useful in conditions like hyperhidrosis.","oneSentence":"Glycopyrronium blocks acetylcholine receptors on sweat glands, reducing sweating.","technicalDetail":"Glycopyrronium is a competitive inhibitor of acetylcholine receptors located on certain peripheral tissues, including sweat glands. By binding to these receptors, it prevents acetylcholine from activating them, thereby reducing the stimulation of sweat production."},"_scrapedAt":"2026-03-28T00:32:58.929Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"_validation":{"fieldsValidated":2,"lastValidatedAt":"2026-04-20T05:47:13.392456+00:00","fieldsConflicting":0,"overallConfidence":0.95},"_fixedFields":["sideEffects","patents(8)","modality→Small Molecule"],"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":"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":"NCT07073950","phase":"PHASE4","title":"A Study to Investigate the Effect of Budesonide/Glycopyrronium/Formoterol Fumarate Metered Dose Inhaler (BGF MDI) Compared With Placebo MDI on Heart and Lung Function in Participants With Chronic Obstructive Pulmonary Disease (COPD) and Hyperinflation","status":"RECRUITING","sponsor":"AstraZeneca","startDate":"2025-11-24","conditions":"Chronic Obstructive Pulmonary Disease, Hyperinflation","enrollment":56},{"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":"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":"NCT06283966","phase":"PHASE3","title":"A Study Evaluating the Efficacy of Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dosed Inhaler on Cardiopulmonary Outcomes in Chronic Obstructive Pulmonary Disease","status":"RECRUITING","sponsor":"AstraZeneca","startDate":"2024-02-21","conditions":"COPD (Chronic Obstructive Pulmonary Disease)","enrollment":5000},{"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":"NCT04087590","phase":"PHASE2","title":"Impact of Inhaled PT003 on Complexity and Variability of Tidal Breathing and Oscillatory Mechanics in Stable COPD Patient","status":"TERMINATED","sponsor":"University Hospital, Lille","startDate":"2020-01-14","conditions":"Copd","enrollment":4},{"nctId":"NCT03963167","phase":"","title":"Triple Therapy in Real-life: Impact on Adherence and Health Status (TRITRIAL)","status":"COMPLETED","sponsor":"Chiesi Italia","startDate":"2019-08-21","conditions":"COPD","enrollment":661},{"nctId":"NCT07414134","phase":"","title":"Exacerbations and Real-World Outcomes Among Patients With Chronic Obstructive Pulmonary Disease Following Severe Exacerbation","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2025-10-31","conditions":"Chronic Obstructive Pulmonary Disease","enrollment":3598},{"nctId":"NCT07406048","phase":"","title":"Real-World Effectiveness of a Triple Combination BDP/FF/GB Extrafine in a Single Pressurised Metered Dose Inhaler in Brazilian COPD Patients","status":"NOT_YET_RECRUITING","sponsor":"Chiesi Farmaceutica Ltda.","startDate":"2026-01-30","conditions":"COPD (Chronic Obstructive Pulmonary Disease)","enrollment":396},{"nctId":"NCT06511193","phase":"","title":"Chronicling the COPD Patient Journey and Change in COPD Symptoms, Quality of Life and Exacerbations Following Initiation of Budenoside/Glycopyrronium/Formoterol [BGF]","status":"ACTIVE_NOT_RECRUITING","sponsor":"AstraZeneca","startDate":"2024-09-17","conditions":"Chronic Obstructive Pulmonary Disease (COPD)","enrollment":152},{"nctId":"NCT05776927","phase":"PHASE3","title":"A Study to Evaluate the Efficacy and Safety of QVM149 (Indacaterol Acetate / Glycopyrronium Bromide / Mometasone Furoate) Versus Salmeterol Xinafoate/Fluticasone Propionate in Children From 12 Years to Less Than 18 Years of Age With Asthma.","status":"NOT_YET_RECRUITING","sponsor":"Novartis Pharmaceuticals","startDate":"2026-05-29","conditions":"Asthma","enrollment":304},{"nctId":"NCT06905483","phase":"PHASE4","title":"Comparative Effects of Triple Inhaled Therapy With Budesonide/Glycopyrronium/Formoterol Versus Fluticasone Furoate/Umeclidinium/Vilanterol on Small Airway Disease in COPD Patients: A Randomized Crossover Study","status":"COMPLETED","sponsor":"Thammasat University","startDate":"2025-04-01","conditions":"COPD, Chronic Obstructive Pulmonary Disease (COPD), Small Airway Disease","enrollment":22},{"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":"NCT04924036","phase":"PHASE2","title":"Qbrexza Cloths for Hyperhidrosis of Amputation Sites","status":"COMPLETED","sponsor":"University of Utah","startDate":"2021-09-27","conditions":"Amputation, Hyperhidrosis","enrollment":13},{"nctId":"NCT07301736","phase":"PHASE2","title":"Therapeutic Equivalence of CHF5993 pMDI 100/6/12.5 µg HFA-152a in Subjects With Mild to Moderate Asthma","status":"RECRUITING","sponsor":"Chiesi Farmaceutici S.p.A.","startDate":"2025-12-17","conditions":"Asthma","enrollment":780},{"nctId":"NCT07329946","phase":"NA","title":"Immuno-inflammatory Response of Erdosteine in COPD","status":"NOT_YET_RECRUITING","sponsor":"Pierachille Santus, MD, PhD","startDate":"2026-02-28","conditions":"COPD","enrollment":30},{"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":"NCT06035393","phase":"PHASE2","title":"A Study to Assess the Efficacy and Safety of HRG2005 Inhalation in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease","status":"TERMINATED","sponsor":"Jiangsu HengRui Medicine Co., Ltd.","startDate":"2024-01-15","conditions":"Chronic Obstructive Pulmonary Disease","enrollment":82},{"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":"NCT06480890","phase":"","title":"Real-World Effectiveness of a Triple Combination BDP/FF/GB in a Single Pressurised Metered Dose Inhaler in COPD Patients (TRIPHY)","status":"COMPLETED","sponsor":"Chiesi Farmaceutici S.p.A.","startDate":"2024-07-02","conditions":"Chronic Obstructive Pulmonary Disease","enrollment":362},{"nctId":"NCT06321731","phase":"","title":"Real-World Outcomes in COPD Patients Starting Trixeo (Budesonide/Glycopyrronium/Formoterol) in Spain.","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2024-07-02","conditions":"Chronic Obstructive Pulmonary Disease (COPD)","enrollment":718},{"nctId":"NCT06422676","phase":"","title":"MultIceNtre Non-intERVentional Study for Efficacy,Safety Evaluation of BREZTRI in Pts With COPD in RussiA","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2023-12-29","conditions":"Chronic Obstructive Pulmonary Disease","enrollment":4},{"nctId":"NCT05573464","phase":"PHASE3","title":"A Study to Assess the Safety of Budesonide/Glycopyrronium/Formoterol Fumarate With a Next-Generation Propellant in Participants With Moderate to Very Severe Chronic Obstructive Pulmonary Disease","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2022-09-27","conditions":"Chronic Obstructive Pulmonary Disease (COPD)","enrollment":559},{"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":"NCT04902573","phase":"","title":"A Trial Monitoring Therapy Pathways of Asthma Patients Treated With an Extrafine ICS/LABA/LAMA Single-inhaler Triple Therapy in a Real-world Setting and Characterizing the Effects on Health-related Out-comes","status":"COMPLETED","sponsor":"Chiesi UK","startDate":"2021-06-17","conditions":"Asthma","enrollment":147},{"nctId":"NCT05477108","phase":"PHASE1","title":"Study to Assess the Lung Exposure Bioequivalence of Budesonide, Glycopyrronium, and Formoterol Delivered by BGF MDI With Next-Generation Propellant Compared With BGF MDI With HFA Propellant","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2022-07-29","conditions":"Chronic Obstructive Pulmonary Disease","enrollment":108},{"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":"NCT05569421","phase":"PHASE1","title":"A Study to Assess the Total Systemic Exposure Bioequivalence of of Budesonide, Glycopyrronium, and Formoterol Delivered by BGF MDI With Next-Generation Propellant Compared With BGF MDI With HFA Propellant","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2022-10-11","conditions":"Chronic Obstructive Pulmonary Disease","enrollment":108},{"nctId":"NCT06340581","phase":"PHASE1","title":"A Study to Assess the Lung Exposure Bioequivalence of Budesonide, Glycopyrronium, & Formoterol (BGF) Metered Dose Inhaler (MDI) With a Next-generation Propellant (NGP) With a Spacer, BGF MDI Hydrofluoroalkane (HFA) With a Spacer, as Well as BGF MDI NGP Without a Spacer","status":"WITHDRAWN","sponsor":"AstraZeneca","startDate":"2024-10-17","conditions":"Healthy","enrollment":""},{"nctId":"NCT07103642","phase":"","title":"EXACERBATIONS AND REAL-WORLD OUTOMES AMONG PATIENTS WITH COPD INITIATING BREZTRI (EROS+CP Japan Study)","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2024-08-15","conditions":"Pulmonary Disease, Chronic Obstructive","enrollment":3402},{"nctId":"NCT06297668","phase":"PHASE1","title":"A Study to Assess the Pharmacokinetics and Safety of Budesonide, Glycopyrronium, & Formoterol (BGF) Metered Dose Inhaler (MDI) With a Next-Generation Propellant (NGP) With a Spacer, BGF MDI Hydrofluoroalkane (HFA) With a Spacer, as Well as BGF MDI NGP Without a Spacer","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2024-04-29","conditions":"Chronic Obstructive Pulmonary Disease","enrollment":42},{"nctId":"NCT06742736","phase":"","title":"EXACERBATIONS AND REAL-WORLD OUTOMES INCLUDING CARDIOPULMONARY EVENTS AMONG PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (MITOS: EROS+CP US Study)","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2024-05-31","conditions":"Pulmonary Disease, Chronic Obstructive","enrollment":13000},{"nctId":"NCT05457868","phase":"","title":"Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines (DREAM) - Salbutamol vs Long-acting Muscarinic Antagonists","status":"COMPLETED","sponsor":"Brigham and Women's Hospital","startDate":"2021-02-01","conditions":"Chronic Obstructive Pulmonary Disease","enrollment":124117},{"nctId":"NCT05213611","phase":"","title":"REported Outcomes in COPD With Trixeo in Real worlD","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2022-08-11","conditions":"Chronic Obstructive Pulmonary Disease","enrollment":150},{"nctId":"NCT07058259","phase":"NA","title":"Acupuncture for Persistent Dyspnea Despite Medical Treatment in COPD","status":"ACTIVE_NOT_RECRUITING","sponsor":"Istanbul Medeniyet University","startDate":"2024-11-15","conditions":"COPD (Chronic Obstructive Pulmonary Disease), Acupuncture","enrollment":60},{"nctId":"NCT05311306","phase":"","title":"REported Outcomes in COPD With Trixeo in Real worlD in Germany","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2022-03-15","conditions":"Chronic Obstructive Pulmonary Disease","enrollment":475},{"nctId":"NCT06100042","phase":"","title":"Observational Study on Therapy Pathways of Asthamics Treated With ICS/LABA/LAMA Therapy in a Real-world Setting","status":"ACTIVE_NOT_RECRUITING","sponsor":"Chiesi Italia","startDate":"2024-04-24","conditions":"Asthma","enrollment":200},{"nctId":"NCT06723756","phase":"PHASE1","title":"A Study to Investigate the Exposure of Budesonide, Glycopyrronium, and Formoterol (BGF) Delivered by Hydrofluoroolefin (HFO) Propellant Metered Dose Inhaler (MDI) Compared to a Hydrofluoroalkane (HFA) Propellant MDI in Healthy Adults","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2025-01-23","conditions":"Healthy Participants","enrollment":105},{"nctId":"NCT04609878","phase":"PHASE3","title":"Study to Assess PT010 in Adult and Adolescent Participants With Inadequately Controlled Asthma (KALOS)","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2020-12-15","conditions":"Asthma","enrollment":2274},{"nctId":"NCT04609904","phase":"PHASE3","title":"Study to Assess PT010 in Adult and Adolescent Participants With Inadequately Controlled Asthma (LOGOS)","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2021-03-01","conditions":"Asthma","enrollment":2187},{"nctId":"NCT05915182","phase":"","title":"Real-world, 52-week Prospective Study to Capture the Reasons for Switch to Triple Combination Therapy, Assess the Clinical and Patient Reported Outcomes in Adults With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) Treated With Trixeo Aerosphere™ in Routine Care Settings in Greece","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2023-07-21","conditions":"Pulmonary Disease, Chronic Obstructive (COPD)","enrollment":218},{"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":"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":"NCT05274425","phase":"","title":"A 24-week rPMS Study in Real-world Setting for Enerzair","status":"RECRUITING","sponsor":"Novartis Pharmaceuticals","startDate":"2022-05-09","conditions":"Asthma","enrollment":600},{"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":"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":"NCT05018598","phase":"PHASE4","title":"Step-up to Medium Strength Triple Therapy vs High Strength ICS/LABA in Adult Asthmatics Uncontrolled on Medium Strength ICS/LABA","status":"TERMINATED","sponsor":"Chiesi Farmaceutici S.p.A.","startDate":"2022-02-25","conditions":"Asthma","enrollment":320},{"nctId":"NCT05898984","phase":"PHASE1","title":"Clinical Study to Evaluate the Safety, Tolerability and the Concentration of the BDP (Beclomethasone Dipropionate), Active Metabolite of BDP, FF( Formoterol Fumarate) and GB (Glycopyrronium Bromide), After Inhalation of CHF 5993 at Two Different Doses and QVAR®","status":"COMPLETED","sponsor":"Chiesi Farmaceutici S.p.A.","startDate":"2023-04-24","conditions":"Asthma","enrollment":69},{"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":"NCT06619210","phase":"PHASE2","title":"A Trial to Evaluate the Safety and Efficacy of HL231 Solution for Inhalation in Patients with COPD","status":"COMPLETED","sponsor":"Haisco Pharmaceutical Group Co., Ltd.","startDate":"2022-01-12","conditions":"Chronic Obstructive Pulmonary Disease (COPD)","enrollment":102},{"nctId":"NCT06643078","phase":"PHASE3","title":"A Study to Evaluate the Safety and Efficacy of HL231 Solution for Inhalation in Patients with COPD","status":"RECRUITING","sponsor":"Haisco Pharmaceutical Group Co., Ltd.","startDate":"2023-12-11","conditions":"Chronic Obstructive Pulmonary Disease (COPD)","enrollment":474},{"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":"NCT06567977","phase":"","title":"TriMaximize: A Multicentre, Prospective, Non-interventional Trial in Asthma Patients","status":"RECRUITING","sponsor":"Chiesi Poland Sp. z o.o.","startDate":"2024-08","conditions":"Asthma","enrollment":60},{"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":"NCT05219630","phase":"","title":"Change in Symptom and Quality of Life in COPD by Budesonide/Glycopyrronium/Formoterol Fumarate Pressurized Metered Dose Inhaler (BGF pMDI)","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2022-05-16","conditions":"Pulmonary Disease, Chronic Obstructive","enrollment":106},{"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":"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":"NCT04656223","phase":"","title":"Digital Adherence Monitoring of Inhalative Therapy in Real- Life Conditions","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2020-12-17","conditions":"Asthma","enrollment":434},{"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":"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":"NCT05728749","phase":"","title":"A Multicentre, Prospective, Non-interventional Trial Monitoring Therapy Pathways of Asthma Patients Treated With an Extra-fine ICS/LABA/LAMA Single-inhaler Triple Therapy in a Real-world Setting and Characterizing the Effects on Health-related Outcomes","status":"UNKNOWN","sponsor":"Chiesi SAS","startDate":"2023-03-03","conditions":"ASTHMA","enrollment":300},{"nctId":"NCT03658616","phase":"PHASE3","title":"Assessment of Efficacy and Safety of Topical Administration of 1% Glycopyrronium Bromide (GPB) in Patients With Primary Axillary Hyperhidrosis and the Assessment of Long-term Efficacy and Safety of Topical Administration of 1% GPB Cream in Patients With Primary Axillary Hyperhidrosis.","status":"COMPLETED","sponsor":"Dr. August Wolff GmbH & Co. KG Arzneimittel","startDate":"2018-09-18","conditions":"Primary Axillary Hyperhidrosis","enrollment":518},{"nctId":"NCT05097014","phase":"PHASE4","title":"CHF5993 and CHF1535 pMDI on Lung Hyperinflation and Exercise Endurance Time in Subjects With COPD","status":"COMPLETED","sponsor":"Chiesi Farmaceutici S.p.A.","startDate":"2021-10-28","conditions":"Chronic Obstructive Pulmonary Disease","enrollment":106},{"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":"NCT04600505","phase":"PHASE1","title":"A Study to Assess Drug Absorption of Fixed Dose Combinations of Budesonide, Glycopyrronium, and Formoterol","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2020-10-19","conditions":"Chronic Obstructive Pulmonary Disease (COPD)","enrollment":47},{"nctId":"NCT04259164","phase":"PHASE3","title":"Anti-inflammatory Effects Glycopyrronium","status":"COMPLETED","sponsor":"University Medical Center Groningen","startDate":"2020-09-10","conditions":"Asthma, Allergic Asthma","enrollment":28},{"nctId":"NCT03662711","phase":"PHASE4","title":"Inhaled Long-acting Bronchodilators With or Without Inhaled Glucocorticosteroids for Preventing Hospitalizations and Death in Elderly Patients With Chronic Obstructive Pulmonary Disease","status":"TERMINATED","sponsor":"Università degli Studi di Ferrara","startDate":"2018-11-11","conditions":"Pulmonary Disease, Chronic Obstructive","enrollment":843},{"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":"NCT04873115","phase":"PHASE4","title":"Double-blind, Placebo-controlled, Randomized Clinical Trial Comparing the Efficacy and Safety of Sialanar Plus orAl rehabiLitation Against Placebo Plus Oral Rehabilitation for chIldren and Adolescents With seVere Sialorrhoea and Neurodisabilties,","status":"UNKNOWN","sponsor":"Proveca Pharma Limited","startDate":"2021-05-10","conditions":"Sialorrhea, Neurodevelopmental Disorders","enrollment":80},{"nctId":"NCT04011475","phase":"","title":"A Study in Taiwan Based on Medical Records That Looks at the Occurrence of Flare-ups in Patients With Chronic Obstructive Pulmonary Disease (COPD) Who Started LABA/LAMA or LAMA Treatment","status":"COMPLETED","sponsor":"Boehringer Ingelheim","startDate":"2019-12-29","conditions":"Pulmonary Disease, Chronic Obstructive","enrollment":1617},{"nctId":"NCT03795350","phase":"PHASE1","title":"Lung Deposition of TRIMBOW® pMDI in Healthy Volunteers, Asthmatic and COPD Patients","status":"TERMINATED","sponsor":"Chiesi Farmaceutici S.p.A.","startDate":"2019-01-14","conditions":"Chronic Obstructive Pulmonary Disease, Asthma","enrollment":19},{"nctId":"NCT05120986","phase":"","title":"An Observational Prospective Study to Characterize Patients Initiating Enerzair® Breezhaler®, With or Without Sensor, as a Maintenance Treatment for Asthma","status":"WITHDRAWN","sponsor":"Novartis Pharmaceuticals","startDate":"2022-02-15","conditions":"Asthma","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":"NCT04876677","phase":"PHASE3","title":"Functional Respiratory Imaging Study","status":"COMPLETED","sponsor":"Chiesi Farmaceutici S.p.A.","startDate":"2021-05-25","conditions":"Chronic Obstructive Pulmonary Disease","enrollment":25},{"nctId":"NCT04206761","phase":"PHASE3","title":"Investigating the Effects of QVM149 on MRI Ventilation Defects","status":"WITHDRAWN","sponsor":"Dr. Grace Parraga","startDate":"2021-12-01","conditions":"Asthma","enrollment":""},{"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":"NCT05114434","phase":"","title":"Effect of BDP/Formoterol/G on Cough Efficacy in Moderate to Severe COPD Patients (EFFICACE)","status":"UNKNOWN","sponsor":"University of Parma","startDate":"2021-11","conditions":"COPD, Chronic Obstructive Pulmonary Disease","enrollment":40},{"nctId":"NCT02467452","phase":"PHASE3","title":"Non Inferiority of Fixed Combination of Beclomethasone Dipropionate (BDP) + Formoterol Fumarate (FF) + Glycopyrronium Bromide (GB) Versus Combination of Fluticasone Furoate (FlF)/Vilanterol (VI) + Tiotropium Bromide in Chronic Obstructive Pulmonary Disease (COPD)","status":"COMPLETED","sponsor":"Chiesi Farmaceutici S.p.A.","startDate":"2015-05","conditions":"Chronic Obstructive Pulmonary Disease","enrollment":1479},{"nctId":"NCT02579850","phase":"PHASE3","title":"2-arm Parallel Group Study of Fixed Combination of CHF 5993 vs Ultibro® in COPD Patients","status":"COMPLETED","sponsor":"Chiesi Farmaceutici S.p.A.","startDate":"2015-05-29","conditions":"Chronic Obstructive Pulmonary Disease (COPD)","enrollment":1532},{"nctId":"NCT03158311","phase":"PHASE3","title":"Study to Compare QVM149 and Free Triple Combination of Salmeterol/Fluticasone + Tiotropium","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2018-02-05","conditions":"Asthma","enrollment":1426},{"nctId":"NCT04856098","phase":"PHASE1","title":"Absorption of Indacaterol and Glycopyrronium From Ultibro Breezhaler","status":"COMPLETED","sponsor":"Orion Corporation, Orion Pharma","startDate":"2021-05-07","conditions":"Healthy Volunteers","enrollment":34},{"nctId":"NCT02553798","phase":"PHASE3","title":"Long-term Safety Study of Glycopyrronium in Subjects With Primary Axillary Hyperhidrosis","status":"COMPLETED","sponsor":"Journey Medical Corporation","startDate":"2015-08","conditions":"Hyperhidrosis","enrollment":564},{"nctId":"NCT03880266","phase":"PHASE2","title":"A Study of Glycopyrronium Cloth, 2.4% in Patients With Palmar Hyperhidrosis","status":"COMPLETED","sponsor":"Journey Medical Corporation","startDate":"2019-02-22","conditions":"Palmar Hyperhidrosis","enrollment":72},{"nctId":"NCT02530294","phase":"PHASE3","title":"Study of Glycopyrronium in Subjects With Axillary Hyperhidrosis","status":"COMPLETED","sponsor":"Journey Medical Corporation","startDate":"2015-08","conditions":"Hyperhidrosis","enrollment":353},{"nctId":"NCT02530281","phase":"PHASE3","title":"Study of Glycopyrronium in Axillary Hyperhydrosis","status":"COMPLETED","sponsor":"Journey Medical Corporation","startDate":"2015-07","conditions":"Hyperhidrosis","enrollment":344},{"nctId":"NCT02872090","phase":"PHASE4","title":"Effects of Long Acting Bronchodilators on CARDiac Autonomic Control in Chronic Obstructive Pulmonary Disease (COPD)","status":"COMPLETED","sponsor":"Centre Hospitalier Universitaire de Besancon","startDate":"2016-03","conditions":"Chronic Obstructive Pulmonary Disease","enrollment":42},{"nctId":"NCT03084796","phase":"PHASE2","title":"A 6-week Dose Ranging Study of CHF 5259 pMDI in Subjects With Chronic Obstructive Pulmonary Disease","status":"COMPLETED","sponsor":"Chiesi Farmaceutici S.p.A.","startDate":"2017-07-28","conditions":"COPD, Chronic Obstructive Pulmonary Disease","enrollment":733},{"nctId":"NCT04906655","phase":"PHASE2","title":"An Open Label Study for Palmar Hyperhydrosis","status":"COMPLETED","sponsor":"Pariser, Robert J., M.D.","startDate":"2020-10-01","conditions":"Palmar Hyperhidrosis, Hyperhidrosis, Sweat Gland Diseases","enrollment":120},{"nctId":"NCT03590379","phase":"PHASE2","title":"Efficacy of Fixed Combination of Beclomethasone Dipropionate (BDP) + Formoterol Fumarate (FF) + Glycopyrronium Bromide (GB) (CHF 5993)Administered Via Dry Powder Inhaler (DPI) in Chronic Obstructive Pulmonary Disease (COPD)","status":"COMPLETED","sponsor":"Chiesi Farmaceutici S.p.A.","startDate":"2018-06-15","conditions":"Chronic Obstructive Pulmonary Disease","enrollment":366},{"nctId":"NCT02676076","phase":"PHASE3","title":"TRIple in asthMA With uncontRolled pAtient on Medium streNgth of ICS + LABA","status":"COMPLETED","sponsor":"Chiesi Farmaceutici S.p.A.","startDate":"2016-02-17","conditions":"Asthma","enrollment":1153},{"nctId":"NCT02676089","phase":"PHASE3","title":"TRIple in Asthma hiGh strenGth vErsus Ics/Laba hs and tiotRopium (TRIGGER)","status":"COMPLETED","sponsor":"Chiesi Farmaceutici S.p.A.","startDate":"2016-04-06","conditions":"Asthma","enrollment":1433},{"nctId":"NCT03197818","phase":"PHASE3","title":"Active Controlled Trial of CHF5993 Pressurized Metered-dose Inhaler ( pMDI) vs Symbicort®Turbuhaler® in Patients With Chronic Obstructive Pulmonary Disease ( COPD)","status":"COMPLETED","sponsor":"Chiesi Farmaceutici S.p.A.","startDate":"2016-12-14","conditions":"COPD (Chronic Obstructive Pulmonary Disease)","enrollment":990},{"nctId":"NCT02536508","phase":"PHASE3","title":"Study to Assess the Safety and Tolerability of PT010, PT009 and PT003 in Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease","status":"COMPLETED","sponsor":"Pearl Therapeutics, Inc.","startDate":"2015-08-10","conditions":"COPD","enrollment":627},{"nctId":"NCT04401345","phase":"PHASE4","title":"Effect of Glycopyrrolate on Vasopressors Requirement for Non-elective Caesarean Section Under Spinal Anaesthesia","status":"COMPLETED","sponsor":"Rajesh Deshar","startDate":"2020-06-01","conditions":"Glycopyrrolate, Post-spinal Hypotension, Effect of Drug","enrollment":258}],"_emaApprovals":[],"_faersSignals":[{"count":1699,"reaction":"DEATH"},{"count":1346,"reaction":"DYSPNOEA"},{"count":562,"reaction":"ASTHMA"},{"count":540,"reaction":"CHRONIC OBSTRUCTIVE PULMONARY DISEASE"},{"count":480,"reaction":"DEVICE DELIVERY SYSTEM ISSUE"},{"count":452,"reaction":"PNEUMONIA"},{"count":452,"reaction":"WHEEZING"},{"count":444,"reaction":"COUGH"},{"count":438,"reaction":"DEVICE USE ISSUE"},{"count":435,"reaction":"WRONG TECHNIQUE IN DEVICE USAGE PROCESS"}],"administration":{"route":"Topical"},"_patentsChecked":true,"crossReferences":{"chemblId":"CHEMBL1201027"},"_approvalHistory":[],"publicationCount":695,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"marketed","status":"approved","brandName":"GLYCOPYRRONIUM","genericName":"GLYCOPYRRONIUM","companyName":"","companyId":"","modality":"Small molecule","firstApprovalDate":"1961","aiSummary":"","enrichmentLevel":3,"visitCount":0,"regulatoryByCountry":[{"country_code":"CA","regulator":"Health Canada","status":"approved","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"trialStats":{"total":0,"withResults":0},"validation":{"fieldsValidated":2,"lastValidatedAt":"2026-04-20T05:47:13.392456+00:00","fieldsConflicting":0,"overallConfidence":0.95},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":false,"safety":true,"trials":true,"score":3}}