TGA / PMDA / NMPA · Asia-Pacific
exemestane — TGA / PMDA / NMPA regulatory status
exemestane (APO-EXEMESTANE) 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
- APO-EXEMESTANE
- Originator
- Pfizer Australia Pty Ltd
- Mechanism
- Cytochrome P450 19A1 inhibitor
- Target
- Aromatase
- Structured fields
- 9
Sponsor / originator context: Pfizer Australia Pty Ltd. 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: Cytochrome P450 19A1 inhibitor. Target: Aromatase. 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: 25 published clinical programs and 0 related patent records. 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 |
|---|---|---|---|
| C4391022 | Phase 3 | First Biotech (Australia) | 2023-506487-13-00 |
| C4551002 | Phase 3 | First Biotech (Australia) | 2025-520566-22-00 |
| CLEE011O12001 | Phase 3 | Novartis India | 2022-503001-38-01 |
| D8535C00001 | Phase 3 | AstraZeneca | 2023-504031-41-00 |
| D9722C00001 | Phase 3 | AstraZeneca | 2023-504180-16-00 |
| GEICAM/2011-03_S1007 | Phase 3 | Ningbo Cancer Hospital | 2024-515368-29-00 |
| I3Y-MC-JPCF | Phase 3 | Eli Lilly and | 2023-509671-17-00 |
| J2J-OX-JZLC | Phase 3 | Eli Lilly and | 2023-506786-63-00 |
| J6M-MC-JSGD | Phase 3 | Eli Lilly and | 2025-522791-92-00 |
| MK-5684-015 | Phase 3 | MSD Merck Sharp | 2024-519563-18-00 |
| NRG-GY019 | Phase 3 | Ningbo Cancer Hospital | 2024-516530-36-00 |
| OP-1250-301 | Phase 3 | Olema Pharmaceuticals | 2023-505871-63-00 |
Related hubs
FAQ
What is the TGA / PMDA / NMPA approval status of exemestane?
exemestane 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 exemestane 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 exemestane?
This spoke lists 25 published programs associated with exemestane in our pipeline index.