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.
- Source
- openFDA — Drugs@FDA applications and drug labels (SPL)
- Dataset
- Drugs@FDA via openFDA
- Version
- drugsfda-2026-09-04
- Retrieved
- Sep 8, 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-20260908-000001
| Jurisdiction · authority | Cancer | Indication | Status | Approval date | Source |
|---|---|---|---|---|---|
| US FDA | — | Efficacy supplement 1997-12-12 (see label) | approved | Dec 12, 1997 | openfda |
| US FDA | Prostate Carcinoma | 1. INDICATIONS AND USAGE Bicalutamide tablets 50 mg daily is indicated for use in combination therapy with a luteinizing hormone-releasing hormone (LHRH) analog for the treatment of Stage D 2 metastatic carcinoma of the prostate. Bicalutamide tablets 150 mg daily is not approved for use alone or with other treatments [see Clinical Studies (14.2) ]. Bicalutamide tablets 50 mg is an androgen receptor inhibitor indicated for use in combination therapy with a luteinizing hormone-releasing hormone (LHRH) analog for the treatment of Stage D 2 metastatic carcinoma of the prostate. (1) Bicalutamide tablets 150 mg daily is not approved for use alone or with other treatments. (1) | approved | Oct 4, 1995 | openfda |
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 19 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.
- 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 (138)
Most recently updated first, 50 per page.
- Source
- ClinicalTrials.gov
- Dataset
- ClinicalTrials.gov API v2 studies
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
| 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 |