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glycopyrrolate

Generic: GLYCOPYRROLATE·Brand: CUVPOSA, DARTISLA ODT, GLYCOPYRROLATE, GLYRX-PF, LONHALA MAGNAIR KIT, ROBINUL, ROBINUL FORTE, SEEBRI NEOHALER

glycopyrrolate: developed by 1 company · 3 clinical trials tracked · 1 FDA decision.

glycopyrrolate evidence translation

What we can confirm

1 FDA record · 3 tracked trials

What it means

Source-backed records connect glycopyrrolate to NVS; that link alone does not prove the drug works.

What to watch

Watch active trials and any change in FDA or trial status.
BioSniper AIPage evidence connected

Prepared research question

How could glycopyrrolate → NVS affect its developer, and what evidence supports the link?

Run cited research

Traceable citations · Unknowns marked

See linked entities and source evidence1 indications · 0 study sponsors

Study sponsors

No additional listed-company sponsor is linked.

Development Pipeline (2)
CompanyPhase
Novartis AG (NVS)Approved
Novartis AG (NVS)Approved
Clinical Trials (3)

A Phase II, Randomized, Double-Blind, Cross-Over 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

NCT07132983·Phase 2
Completed

Primary endpoint: Ensifentrine single dose area under the curve from time 0 to time t (AUC0-t)

InterventionalRandomizedtriple33 enrolledStarted 2025-10Completion 2025-114 sites · United StatesVerona Pharma, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA

A Phase IIb, Randomized, Double-blind, Placebo- Controlled, Parallel Group Study to Assess the Efficacy and Safety of Ensifentrine-glycopyrrolate Fixed-dose Combination at Two Dose Levels Compared to Glycopyrrolate or Ensifentrine Monotherapy in Subjects With COPD

NCT07016412·Phase 2
Completed

Primary endpoint: Change from baseline in average forced expiry volume in 1 second (FEV1) area under the curve versus time, from time 0 to 4 hours (AUC0-4h)

InterventionalRandomizedquadruple497 enrolledStarted 2025-07Completion 2026-0850 sites · United StatesVerona Pharma, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA

A Phase IIb, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy, Safety, and Pharmacokinetics of Glycopyrrolate Inhalation Solution Over 1 Week in Subjects With COPD

NCT06545500·Phase 2
Completed

Primary endpoint: Change From Average Baseline in Morning Trough Forced Expiratory Volume in 1 Second (FEV1)

InterventionalRandomizedtriple46 enrolledStarted 2024-08Completion 2025-017 sites · United StatesVerona Pharma, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA
FDA Decisions1 records
Approval(NVS)FDA ↗
NDA207923Type 3 - New Dosage FormStandardInhalationPowder

Frequently asked questions

Who is developing glycopyrrolate?

glycopyrrolate is being developed by Novartis AG.

How many clinical trials involve glycopyrrolate?

BioSniper tracks 3 clinical trials involving glycopyrrolate.

What is glycopyrrolate's latest FDA decision?

The most recent tracked FDA decision for glycopyrrolate is Approval, dated October 29, 2015.