NDAINTRAMUSCULAR, INTRAVENOUSSOLUTION
Approved
Jul 2018
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
13
Data completeness
4/8 — Partial
GLYRX-PF (glycopyrrolate) by Gen Pharmaceuticals 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. First approved in 2018.
Drug data last refreshed 5h ago · AI intelligence enriched 8h ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
GLYRX-PF is a generic intravenous/intramuscular anticholinergic (antimuscarinic) solution containing glycopyrrolate. It inhibits acetylcholine action on postganglionic cholinergic nerves and smooth muscle, reducing gastric secretions and controlling excessive pharyngeal, tracheal, and bronchial secretions. This is a peaking product approved in 2018 by Gen Pharmaceuticals for injection-based perioperative and symptomatic use.
Peak
Peak-stage injectable positioned in a moderately competitive market (30/100 pressure score); team focus is on sustaining market share in anesthesia and hospital settings.
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
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
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
Clinical Study of Ensifentrine-Glycopyrrolate (MK-5884A/RPL554) Fixed-dose Combination Dose Ranging in Participants With COPD (MK-5884A-029/RPL554-CO-212)
Started Jul 2025
497 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.