Drug · Small Molecule

Bicalutamide

CI-DRUG-00000109Explore in graph →NCIt C1599 CHEMBL409 CIViC Approved

Regulatory

Approvals (28)

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-dpdRegulatory28 approval records from 2 sources (hover a row badge for its dataset) · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
CA Health Canada	—	Marketed in Canada as BICALUTAMIDE (DIN 02519178) under ATC L02BB03 BICALUTAMIDE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Apr 28, 2022	health-canada-dpd
CA Health Canada	—	Marketed in Canada as VAN-BICALUTAMIDE (DIN 02428709) under ATC L02BB03 BICALUTAMIDE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Post Marketsince Aug 7, 2019	Jun 22, 2015	health-canada-dpd
CA Health Canada	—	Marketed in Canada as RAN-BICALUTAMIDE (DIN 02371324) under ATC L02BB03 BICALUTAMIDE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Post Market

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 18 hours 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	27	11	42	134	28	CA, US	Oct 4, 1995	1994-12
Malignant Prostate Neoplasm	Approved	Phase 4	17	6	36	104	1	US	Oct 4, 1995	1994-12
Malignant Breast Neoplasm	Phase3	Phase 3	6	2	1	12	0	—	—	Mar 23, 2007
Malignant Salivary Gland Neoplasm	Phase2	Phase 2	1	1	0	1

Curated evidence

Clinical evidence (4)

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

civicCuratedShowing 1–4 of 4 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 (138)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 1–50 of 138 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
NCT02531516	An Efficacy and Safety Study of JNJ-56021927 (Apalutamide) in High-risk Prostate Cancer Subjects Receiving Primary Radiation Therapy: ATLAS	active not recruiting	Phase 3	1,503	Aragon Pharmaceuticals, Inc.INDUSTRY	23	Sep 25, 2026	clinicaltrials
NCT03070886	Antiandrogen Therapy and Radiation Therapy With or Without Docetaxel in Treating Patients With Prostate Cancer That Has Been Removed by Surgery

Molecule

Record

Kind: Small Molecule
Mechanism: Androgen Receptor antagonist
Targets: 1 gene
UNII: A0Z3NAU9DP
Aliases: 4-Cyano-3-trifluoromethyl-N-(3-p-fluorophenylsulfonyl-2-hydroxy-2-methylpropionyl)aniline, 4'-Cyano-alpha,alpha,alpha-trifuloro-3-[(p-fluorophenyl)sulfonyl]-2-methyl-m-lactotoluidide, ACCEL-BICALUTAMIDE, ACH-BICALUTAMIDE, ACT BICALUTAMIDE, AG-BICALUTAMIDE, APO-BICALUTAMIDE, AVA-BICALUTAMIDE, Bicalutamida, Bicalutamide, Calutide, Casodex, CASODEX, Cassotide, Cosudex, DOM-BICALUTAMIDE, ICI 176,334, ICI 176334, ICI-176334, ICI176,334-1, JAMP BICALUTAMIDE, Kalumid, MED-BICALUTAMIDE, MYLAN-BICALUTAMIDE, N-[4-Cyano-3-(trifluoromethyl)phenyl]3-3[(4-fluorophenyl)sulfonyl]-2-hydroxy-2-methyl-propanamide, (+/-)-N-[4-Cyano-3-(trifluoromethyl)phenyl]-3-[(4-fluorophenyl)sulfonyl]-2-hydroxy-2-methylpropanamide, NRA-BICALUTAMIDE, NSC-759816, NTP-BICALUTAMIDE, NU-BICALUTAMIDE … (+9)

Data updated 21 hours agoSource updated unknown

Identifiers

Codes (53)

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

System	Code	Label
ATC (WHO)	L02BB03	BICALUTAMIDE