Drug · Small Molecule
Flutamide
CI-DRUG-00000251Explore in graph →NCIt C509 CHEMBL806 CIViC Approved
Regulatory
Approvals (12)
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
- Health Canada — Drug Product Database (DPD)
- Dataset
- Health Canada DPD
- Version
- dpd-2026-09-11
- Retrieved
- Sep 11, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Evidence
- regulatory
- License
- Open Government Licence – Canada (https://open.canada.ca/en/open-government-licence-canada)
- Run
- ING-HEALTHCANADADPD-20260911-000001
| Jurisdiction · authority | Cancer | Indication | Status | Approval date | Source |
|---|---|---|---|---|---|
| CA Health Canada | — | Marketed in Canada as FLUTAMIDE-250 (DIN 02239388) under ATC L02BB01 FLUTAMIDE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | withdrawnsource: Cancelled Post Marketsince Jul 23, 2009 | Feb 22, 1999 | health-canada-dpd |
| CA Health Canada | — | Marketed in Canada as FLUTAMIDE (DIN 02239045) under ATC L02BB01 FLUTAMIDE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | withdrawnsource: Cancelled Post Marketsince Oct 25, 2016 | Dec 1, 1998 | health-canada-dpd |
| CA Health Canada | — | Marketed in Canada as FLUTAMIDE (DIN 02238560) under ATC L02BB01 FLUTAMIDE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed |
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 | 5 | 1 | 25 | 52 | 12 | CA, US | Oct 8, 1998 | 1994-10 |
| Malignant Prostate Neoplasm | Approved | Phase 4 | 5 | 1 | 24 | 42 | 1 | US | Sep 18, 2001 | 1994-10 |
| Malignant Ovarian Neoplasm | Phase2 | Phase 2 | 0 | 0 | 0 | 1 | 0 | — | — | 2005-01 |
Curated evidence
Clinical evidence (1)
CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.
- Source
- CIViC — Clinical Interpretation of Variants in Cancer
- Dataset
- CIViC evidence items
- Version
- civic-2026-09-08
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Evidence
- expert curation
- License
- CC0 1.0
- PMID
- 26000489
- Run
- ING-CIVIC-20260908-000001
| Therapy | Cancer | Type | Level | Direction · significance | Rating (1–5) | Status | Evidence | Source |
|---|---|---|---|---|---|---|---|---|
| AR Mutation1 | ||||||||
| Bicalutamide + Cyproterone Acetate | ||||||||
Clinical trials
Trials with this intervention (52)
Most recently updated first, 50 per page.
- Source
- ClinicalTrials.gov
- Dataset
- ClinicalTrials.gov API v2 studies
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
| NCT | Title | Status | Phase | Enrollment (n) | Sponsor | Countries | Last update | Source |
|---|---|---|---|---|---|---|---|---|
| NCT00003026 | Hormone Therapy in Treating Patients With Advanced Prostate Cancer | completed | Phase 3 | 966 | European Organisation for Research and Treatment of Cancer - EORTCNETWORK | 7 | Jul 2, 2012 | clinicaltrials |
| NCT00002881 | Flutamide, Suramin, and Hydrocortisone in Treating Patients With Prostate Cancer | completed |