Wednesday, July 8, 2026

Drug profile · INN

letrozole

letrozole (ARX-LETROZOLE) is a cytochrome p450 19a1 inhibitor. Associated with Novartis Pharmaceuticals. Route of administration: oral. Current US regulatory status: approved.

FDA: approved TGA: approved NMPA: clinical trials
US status approved
Patents linked 1
Pipeline programs 47
News articles 0
Drug details — letrozole
US status
approved
Class
Route
ORAL
Patents
1
Programs
47
Data quality
0.89

Quick answer

letrozole (ARX-LETROZOLE) is a cytochrome p450 19a1 inhibitor. Associated with Novartis Pharmaceuticals. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN letrozole
Brand ARX-LETROZOLE
Mechanism Cytochrome P450 19A1 inhibitor
Target Aromatase
Route ORAL
Formulation TABLET

Mechanism of action

Cytochrome P450 19A1 inhibitor

Primary target: Aromatase

Approval history

Authority Status Date
FDA approved
TGA approved
NMPA clinical trials

Pipeline programs

  1. BO41843 Phase 3 · HOFFMANN-LA ROCHE · ESTROGEN RECEPTOR-POSITIVE, HER2-NEGATIVE LOCALLY ADVANCED O
  2. C4391024 Phase 3 · First Biotech (Australia) · Advanced/Metastatic Breast Cancer
  3. CLEE011O12001 Phase 3 · Novartis India · HR-positive HER-2- negative Breast Cancer
  4. CLEE011O12301C Phase 3 · Novartis India · hormone receptor (HR)-positive, HER2-negative, early breast
  5. D8534C00001 Phase 3 · AstraZeneca · Estrogen Receptor-Positive, HER-2 negative Advanced Breast C
  6. D8535C00001 Phase 3 · AstraZeneca · ER+/HER2- Early Breast Cancer
  7. D9722C00001 Phase 3 · AstraZeneca · Advanced Breast Cancer
  8. GEICAM/2011-03_S1007 Phase 3 · Ningbo Cancer Hospital · patients with node positive breast cancer who do not have hi

Related & competitor drugs

  1. anastrozole Cytochrome P450 19A1 inhibitor
  2. exemestane Cytochrome P450 19A1 inhibitor
  3. testolactone Cytochrome P450 19A1 inhibitor
  1. US 10548905

    Amorphous onapristone compositions and methods of making the same

    Expires Mon Jan 30 2040 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

Frequently asked questions

What is letrozole?

letrozole (ARX-LETROZOLE) is a cytochrome p450 19a1 inhibitor. Associated with Novartis Pharmaceuticals. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for letrozole?

ARX-LETROZOLE is a marketed brand name for letrozole. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of letrozole?

letrozole 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.