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.

health-canada-dpdRegulatory11 approval records · authority, jurisdiction and indication text as published.

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 3 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

Computedclinicaltrials

Curated evidence

Clinical evidence (1)

CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.

civicCuratedShowing 1–1 of 1 evidence items · levels, directions and significance as curated at the source; each row links to its CIViC record.

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.

clinicaltrialsPublishedShowing 51–52 of 52 studies · status and phase as posted by the registrant; each row links to the study record.

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

Molecule

Record

Kind: Small Molecule
Mechanism: Androgen Receptor antagonist
Targets: 1 gene
UNII: 76W6J0943E
Aliases: 2-Methyl-N-[4-nitro-3-(trifluoromethyl)phenyl]propanamide, 4'-Nitro-3'-trifluoromethylisobutyranilide, Alpha,alpha,alpha-trifluoro-2-methy-4'-nitro-m-propionotoluidide, Apimid, Cebatrol, Chimax, Cytomid, DOM-FLUTAMIDE, Drogenil, Euflex, EUFLEX, Eulexin, EULEXIN, Eulexine, Flucinom, Flucinome, Flugerel, Fluken, Flulem, FLUT, Flutabene, Flutacan, Fluta-Gry, Flutamex, Flutamida, Flutamide, FLUTAMIDE-250, Flutamin, Flutan, Flutaplex … (+19)

Data updated 17 hours agoSource updated unknown

Identifiers

Codes (23)

Upstream identifiers kept as first-class codes; each links to its registry where a stable public URL exists.

System	Code	Label
ATC (WHO)	L02BB01	FLUTAMIDE
DIN (Health Canada)	00637726