EMA · European Union
glycopyrronium — EMA regulatory status
glycopyrronium (AXHIDROX) regulatory status in the European Union is tracked from public EMA records and cross-linked clinical and patent datasets on NovaPharmaNews. Current status: EMA approved.
Status snapshot
- Status
- EMA approved
- Brand
- AXHIDROX
- Originator
- Novartis Pharmaceuticals
- Mechanism
- Muscarinic acetylcholine receptor inhibitor
- Structured fields
- 7
Sponsor / originator context: Novartis Pharmaceuticals. Pipeline programs and exclusivity signals below are joined from ClinicalTrials.gov-linked projects and USPTO/EPO patent rows associated with this INN.
Pharmacology context used for competitive intelligence: Muscarinic acetylcholine receptor inhibitor. This page is a status aggregation for professional reference — not prescribing advice.
Regional decision snapshot — EMA: approved.
Linked evidence on this spoke: 6 published clinical programs and 1 related patent record. Use the tables below for NCT identifiers, phases, and exclusivity dates; verify against primary sources before BD or medical decisions.
Regulatory timeline
| Regulator | Region | Status | Date | Source |
|---|---|---|---|---|
| EMA | European Union | approved | — | Evidence |
Linked clinical programs
| Program | Phase | Sponsor | NCT |
|---|---|---|---|
| Glycopyrronium bromide | Phase 3 | Novartis India | NCT00929110 |
| 01INDA2024 | Phase 1 | Anaxis Pharma | 2024-514725-38-00 |
| D5985C00008 | Phase 1 | AstraZeneca | 2023-504089-43-00 |
| D5985C00009 | Phase 1 | AstraZeneca | 2023-509914-12-00 |
| Glycopyrronium | Approved | Chinese Academy of | NCT05265507 |
| Glycopyrronium in Combination With Tropisetron | Approved | First People's Hospital | NCT05331651 |
Related patents
| Number | Title | Jurisdiction |
|---|---|---|
| 10906871 | Processes for making, and methods of using, glycopyrronium compounds | US |
Related hubs
FAQ
What is the EMA approval status of glycopyrronium?
glycopyrronium currently shows EMA approved in our European Union regulatory index. Confirm on the official EMA label or EPAR before clinical or commercial use.
Where does NovaPharmaNews get glycopyrronium regulatory data?
Status fields are joined from public sources (openFDA / EMA / regional agencies), ClinicalTrials.gov-linked programs, and patent registries. See /about/data-sources for attribution.
How many clinical programs are linked to glycopyrronium?
This spoke lists 6 published programs associated with glycopyrronium in our pipeline index.