Drug · Small Molecule
Anastrozole
CI-DRUG-00000696Explore in graph →CHEMBL1399 Approved
Regulatory
Approvals (39)
Each record names the authority, jurisdiction, indication text and status. A drug approved in one jurisdiction for one indication is not 'approved' in general.
- Source
- openFDA — Drugs@FDA applications and drug labels (SPL)
- Dataset
- Drugs@FDA via openFDA
- Version
- drugsfda-2026-09-11
- Retrieved
- Sep 14, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Evidence
- regulatory
- License
- CC0 1.0 Universal (public domain; https://open.fda.gov/license/)
- Run
- ING-OPENFDA-20260914-000001
| Jurisdiction · authority | Cancer | Indication | Status | Approval date | Source |
|---|---|---|---|---|---|
| US FDA | — | Efficacy supplement 2011-04-18 (see label) | approved | Apr 18, 2011 | openfda |
| US FDA | — | Efficacy supplement 2009-04-30 (see label) | approved | Apr 30, 2009 | openfda |
| US FDA | — | Efficacy supplement 2005-09-16 (see label) | approved | Sep 16, 2005 | openfda |
| US FDA | — | Efficacy supplement 2002-09-05 (see label) | approved | Sep 5, 2002 | openfda |
| US |
Health Canada records are DIN-level: one row per marketed product (brand, strength, form). The Drug Product Database does not publish indications, so no cancer is stated for these rows, and a cancelled or dormant DIN is the status of that one product — not a withdrawal of the molecule.
Data updated 2 days agoSource updated unknown
Derived
Development pipeline
Most advanced stage across all cancers, then per top-level cancer reached through trial conditions or approval indications. Approval in any ingested jurisdiction outranks trial phase; counts are interventional studies.
| Scope | Stage | Max phase | Active | Recruiting | Phase 3 | Trials | Approvals | Jurisdictions | First approval | First trial |
|---|---|---|---|---|---|---|---|---|---|---|
| All cancers | Approved | Phase 4 | 48 | 21 | 63 | 186 | 39 | CA, US | Dec 27, 1995 | 1996-01 |
| Malignant Breast Neoplasm | Approved | Phase 4 | 34 | 16 | 50 | 146 | 3 | US | Dec 27, 1995 | 1996-01 |
| Malignant Ovarian Neoplasm | Phase3 | Phase 3 | 2 | 2 | 1 | 4 | 0 | — | — | 2003-10 |
| Malignant Lung Neoplasm | Phase2 | Phase 2 | 1 | 0 | 0 | 2 | 0 |
Curated evidence
Clinical evidence (0)
CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.
Data not yet available
Clinical trials
Trials with this intervention (205)
Most recently updated first, 50 per page.
- Source
- ClinicalTrials.gov
- Dataset
- ClinicalTrials.gov API v2 studies
- Retrieved
- Sep 30, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
| NCT | Title | Status | Phase | Enrollment (n) | Sponsor | Countries | Last update | Source |
|---|---|---|---|---|---|---|---|---|
| NCT04906395 | Ovarian Suppression Evaluating Subcutaneous Leuprolide Acetate in Breast Cancer(OVELIA) | active not recruiting | Phase 3 | 250 | Tolmar Inc.INDUSTRY | 7 | Sep 29, 2026 | clinicaltrials |
| NCT04711252 | A Comparative Study of AZD9833 Plus Palbociclib Versus Anastrozole Plus Palbociclib in Patients With ER-Positive HER2 Negative Breast Cancer Who Have Not Received Any Systemic Treatment for Advanced Disease |