Thursday, July 23, 2026

Drug profile · INN

exemestane

exemestane (APO-EXEMESTANE) is a cytochrome p450 19a1 inhibitor. Associated with Pfizer Australia Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

FDA: approved TGA: approved NMPA: clinical trials
US status approved
Patents linked 0
Pipeline programs 25
News articles 0
Drug details — exemestane
US status
approved
Class
Route
ORAL
Patents
0
Programs
25
Data quality
0.89

Quick answer

exemestane (APO-EXEMESTANE) is a cytochrome p450 19a1 inhibitor. Associated with Pfizer Australia Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

Reviewed by James Park Regulatory Affairs Editor Last reviewed Jun 8, 2026

Key facts

INN exemestane
Brand APO-EXEMESTANE
Mechanism Cytochrome P450 19A1 inhibitor
Target Aromatase
Route ORAL
Formulation TABLET

Mechanism of action

Cytochrome P450 19A1 inhibitor

Primary target: Aromatase

Approval history

Regional status spokes: FDA status · APAC status

Authority Status Date
FDA approved
TGA approved
NMPA clinical trials

Pipeline programs

  1. C4391022 Phase 3 · First Biotech (Australia) · Hormone receptor-positive, her2-negative advanced/metastatic
  2. C4551002 Phase 3 · First Biotech (Australia) · Hormone Receptor-Positive, HER2-Negative Advanced/Metastatic
  3. CLEE011O12001 Phase 3 · Novartis India · HR-positive HER-2- negative Breast Cancer
  4. D8535C00001 Phase 3 · AstraZeneca · ER+/HER2- Early Breast Cancer
  5. D9722C00001 Phase 3 · AstraZeneca · Advanced Breast Cancer
  6. GEICAM/2011-03_S1007 Phase 3 · Ningbo Cancer Hospital · patients with node positive breast cancer who do not have hi
  7. I3Y-MC-JPCF Phase 3 · Eli Lilly and · Breast Cancer
  8. J2J-OX-JZLC Phase 3 · Eli Lilly and · Breast Cancer

Related & competitor drugs

  1. anastrozole Cytochrome P450 19A1 inhibitor
  2. letrozole Cytochrome P450 19A1 inhibitor
  3. testolactone Cytochrome P450 19A1 inhibitor

Frequently asked questions

What is exemestane?

exemestane (APO-EXEMESTANE) is a cytochrome p450 19a1 inhibitor. Associated with Pfizer Australia Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for exemestane?

APO-EXEMESTANE is a marketed brand name for exemestane. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of exemestane?

exemestane has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.