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Cuvposa (GLYCOPYRRONIUM BROMIDE)
Cuvposa works by blocking the action of a chemical called acetylcholine, which stimulates the muscarinic receptors in the body.
Cuvposa, marketed by Shionogi, is an anticholinergic drug specifically indicated to reduce chronic severe drooling, a niche but significant unmet need. Its key strength lies in its targeted mechanism of action, effectively blocking acetylcholine to manage symptoms, with a key composition patent expiring in 2028. The primary risk is competition from off-patent alternatives such as propantheline, which has been available since 1953 and is widely accessible as a generic.
At a glance
| Generic name | GLYCOPYRRONIUM BROMIDE |
|---|---|
| Sponsor | Shionogi |
| Drug class | Anticholinergic |
| Target | Muscarinic acetylcholine receptor M1 |
| Modality | Small molecule |
| Therapeutic area | Metabolic |
| Phase | FDA-approved |
| First approval | 1961 |
Mechanism of action
Actions: 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 by lack cholinergic innervation. These peripheral cholinergic receptors are present in the autonomic effector cells of smooth muscle, cardiac muscle, the sino-atrial node, the atrioventricular node, exocrine glands, and, to limited degree, in the autonomic ganglia. Thus. it diminishes the volume and free acidity of gastric secretions and controls excessive pharyngeal, tracheal, and bronchial secretions. Glycopyrrolate antagonizes muscarinic symptoms (e.g.. bronchorrhea, bronchospasm, bradycardia, and intestinal hypermotility) induced by cholinergic drugs such as the anticholinesterases. The highly polar quaternary ammonium group of glycopyrrolate limits its passage across lipid membranes such as the blood-brain barrier, in contrast to atropine sulfate and scopol
Approved indications
- Reduce chronic severe drooling
Common side effects
- hypertension
- hypotension
- seizures
- respiratory arrest
- cardiac arrest
- cardiac arrhythmias
- heart block
- QTc interval prolongation
- malignant hyperthermia
- pruritus
- edema
- erythema
Drug interactions
- Digoxin
- Amantadine
- Atenolol
- Metformin
- Haloperidol
- Levodopa
- Potassium Chloride
Key clinical trials
- Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Glycopyrronium (Bromide) in Children (6 to Less Than 12 Years) With Asthma (PHASE2)
- A Phase IIb Ensifentrine-glycopyrrolate Fixed-dose Combination Dose Ranging Study in Subjects With COPD (PHASE2)
- Pooled Analysis of Single-arm Studies of Budesonide/Glycopyrronium/Formoterol (BGF) in Routine Care Setting
- Fixed Triple Inhaled Combination in Asthmatic Patients in a Real-life Setting (STRENGTH)
- Neostigmine and Glycopyrrolate for the Treatment of Headache After Dural Puncture (PHASE2)
- Fixed Triple Inhaled Combination in Asthmatic Patients in a Real-life Setting
- Post-marketing Phase 4 Safety & Tolerability Study of Breztri aerosphereTM in Indian Patients With Chronic Obstructive Pulmonary Disease (PHASE4)
- Outcomes in Real-life After Initation of Treatment With Trixeo (Budesonide / Glycopyrronium / Formoterol)
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Cuvposa CI brief — competitive landscape report
- Cuvposa updates RSS · CI watch RSS
- Shionogi portfolio CI