TGA / PMDA / NMPA · Asia-Pacific
glycopyrronium — TGA / PMDA / NMPA regulatory status
glycopyrronium (AXHIDROX) regulatory status in the Asia-Pacific is tracked from public TGA / PMDA / NMPA records and cross-linked clinical and patent datasets on NovaPharmaNews. Current status: TGA approved · NMPA clinical trials.
Status snapshot
- Status
- TGA approved · NMPA clinical trials
- Brand
- AXHIDROX
- Originator
- Novartis Pharmaceuticals
- Mechanism
- Muscarinic acetylcholine receptor inhibitor
- Structured fields
- 9
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 — TGA: approved; NMPA: clinical trials.
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
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 TGA / PMDA / NMPA approval status of glycopyrronium?
glycopyrronium currently shows TGA approved · NMPA clinical trials in our Asia-Pacific regulatory index. Confirm on the official TGA / PMDA / NMPA 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.