NDAORALSOLUTION
Approved
Jul 2010
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
13
Data completeness
6/8 — Strong
CUVPOSA (glycopyrrolate) by Merz Therapeutics is tissues, including salivary glands. Approved for chronic severe drooling in patients aged 3-16 years with neurologic conditions associated with problem drooling (e. First approved in 2010.
Drug data last refreshed 2d ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
CUVPOSA is an oral solution of glycopyrrolate, an anticholinergic agent approved for chronic severe drooling in pediatric patients aged 3–16 years with neurologic conditions. It works by blocking muscarinic receptors on salivary glands, indirectly reducing salivation rate. This is the only FDA-approved treatment specifically indicated for problem drooling in children with neurologic disorders.
$0.267MPart D
LOE ApproachingStable
Niche pediatric product with modest Part D volume (553 claims in 2023) and LOE approaching—expect defensive strategy and smaller team focus.
Mechanism of Action
tissues, including salivary glands. Glycopyrrolate indirectly reduces the rate of salivation by preventing the stimulation of these receptors.
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.