FDA · United States
exemestane — FDA regulatory status
exemestane (APO-EXEMESTANE) regulatory status in the United States is tracked from public FDA records and cross-linked clinical and patent datasets on NovaPharmaNews. Current status: FDA approved.
Status snapshot
- Status
- FDA approved
- Brand
- APO-EXEMESTANE
- Originator
- Pfizer Australia Pty Ltd
- Mechanism
- Cytochrome P450 19A1 inhibitor
- Target
- Aromatase
- Structured fields
- 7
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 — FDA: approved.
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
| Regulator | Region | Status | Date | Source |
|---|---|---|---|---|
| FDA | United States | approved | — | Evidence |
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 FDA approval status of exemestane?
exemestane currently shows FDA approved in our United States regulatory index. Confirm on the official FDA 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.