Drug · Small Molecule
Nilutamide
CI-DRUG-00000405Explore in graph →NCIt C1173 CHEMBL1274 CIViC Approved
Regulatory
Approvals (7)
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 ANANDRON (DIN 02221861) under ATC L02BB02 NILUTAMIDE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | withdrawnsource: Dormantsince Aug 3, 2024 | Aug 20, 1997 | health-canada-dpd |
| CA Health Canada | — | Marketed in Canada as ANANDRON - TAB 100MG (DIN 02221888) under ATC L02BB02 NILUTAMIDE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | withdrawnsource: Cancelled Post Marketsince Jul 22, 2003 | Aug 20, 1997 | health-canada-dpd |
| CA Health Canada | — | Marketed in Canada as ANANDRON TAB 50MG (DIN 01989642) under ATC L02BB02 NILUTAMIDE. 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 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 3 | 3 | 1 | 5 | 10 | 7 | CA, US | Jul 15, 2016 | Feb 8, 1995 |
| Malignant Prostate Neoplasm | Approved | Phase 3 | 3 | 1 | 5 | 10 | 1 | US | Jul 15, 2016 | Feb 8, 1995 |
- Source
- clinicaltrials
- Layer
- derived (computed by CancerIndex)
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 (10)
Most recently updated first, 50 per page.
- Source
- ClinicalTrials.gov
- Dataset
- ClinicalTrials.gov API v2 studies
- Retrieved
- Sep 15, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
| NCT | Title | Status | Phase | Enrollment (n) | Sponsor | Countries | Last update | Source |
|---|---|---|---|---|---|---|---|---|
| NCT03070886 | Antiandrogen Therapy and Radiation Therapy With or Without Docetaxel in Treating Patients With Prostate Cancer That Has Been Removed by Surgery | active not recruiting | Phase 2 / Phase 3 | 612 | NRG OncologyOTHER | 3 | Sep 14, 2026 | clinicaltrials |
| NCT01786265 | Finite Androgen Ablation With or Without Abiraterone Acetate and Prednisone in Treating Patients With Recurrent Prostate Cancer | active not recruiting |