NDAINTRAMUSCULAR, INTRAVENOUSSOLUTION
Approved
Apr 2022
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
13
Data completeness
5/8 — Partial
GLYCOPYRROLATE (glycopyrrolate) by Fresenius Kabi is 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. Approved for neuromuscular blockade reversal. First approved in 2022.
Drug data last refreshed 1w ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Glycopyrrolate is an intravenous/intramuscular anticholinergic (antimuscarinic) agent approved in April 2022 by Fresenius Kabi for neuromuscular blockade reversal. It works by inhibiting acetylcholine action on postganglionic cholinergic nerves and smooth muscle, effectively controlling excessive secretions and reversing neuromuscular blockade in perioperative settings. The drug is currently in peak commercial lifecycle with moderate competitive pressure (30%).
Peak
Product is at peak commercial maturity with modest ASP of $1.34; brand team size likely stable with focus on market penetration and clinical adoption in operating rooms.
Mechanism of Action
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…
Indications (1)
Clinical Trials (13)
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
Started Oct 2025
33 enrolled
Chronic Obstructive Pulmonary Disease
A Phase IIb Ensifentrine-glycopyrrolate Fixed-dose Combination Dose Ranging Study in Subjects With COPD
Started Jul 2025
480 enrolled
Chronic Obstructive Pulmonary Disease
A Phase IIb Study of Glycopyrrolate Inhalation Solution Over 1 Week in Subjects With COPD
Started Aug 2024
46 enrolled
Chronic Obstructive Pulmonary Disease
Sugammadex vs Neostigmine/Glycopyrrolate on Urinary Retention After Spine Surgery
Started Aug 2023
118 enrolled
Spine SurgeryReversal of Neuromuscular BlockadeUrinary Retention Postoperative
Efficacy and Safety of Glycopyrrolate Bromide of COPD Patients
Started Jun 2014
100 enrolled
Chronic Obstructive Pulmonary Disease
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.