Drug · Small Molecule
Darolutamide
CI-DRUG-00000737Explore in graph →CHEMBL4297185 Approved
Regulatory
Approvals (6)
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-2026-09-11
- Retrieved
- Sep 14, 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-20260914-000001
| Jurisdiction · authority | Cancer | Indication | Status | Approval date | Source |
|---|---|---|---|---|---|
| US FDA | — | Efficacy supplement 2025-06-03 (see label) | approved | Jun 3, 2025 | openfda |
| US FDA | — | Efficacy supplement 2022-08-05 (see label) | approved | Aug 5, 2022 | openfda |
| US FDA | — | Efficacy supplement 2021-01-07 (see label) | approved | Jan 7, 2021 | openfda |
| US FDA | Nonmetastatic Castration-Resistant Prostate Carcinoma | NUBEQA is an androgen receptor inhibitor indicated for the treatment of adult patients with: non-metastatic castration-resistant prostate cancer (nmCRPC). ( 1 ) metastatic castration-sensitive prostate cancer (mCSPC). ( 1 ) metastatic castration-sensitive prostate cancer (mCSPC) in combination with docetaxel. ( 1 ) NUBEQA is indicated for the treatment of adult patients with: non-metastatic castration resistant prostate cancer (nmCRPC) metastatic castration-sensitive prostate cancer (mCSPC) metastatic castration-sensitive prostate cancer (mCSPC) in combination with docetaxel. |
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 14 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 | 54 | 30 | 20 | 82 | 6 | CA, EU, US | Jul 30, 2019 | 2011-03 |
| Malignant Prostate Neoplasm | Approved | Phase 4 | 36 | 20 | 11 | 51 | 2 | EU, US | Jul 30, 2019 | 2011-03 |
| Malignant Breast Neoplasm | Phase2 | Phase 2 | 1 | 1 | 0 | 3 | 0 | — | — | Jul 23, 2018 |
| Malignant Salivary Gland Neoplasm | Phase2 | Phase 2 | 1 | 0 | 0 | 2 |
Curated evidence
Clinical evidence (0)
CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.
Data not yet available
Clinical trials
Trials with this intervention (96)
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 |
|---|---|---|---|---|---|---|---|---|
| NCT06282588 | Treatment of High-Risk Prostate Cancer Guided by Novel Diagnostic Radio- and Molecular Tracers(THUNDER) | recruiting | Phase 2 / Phase 3 | 493 | Cancer Research AntwerpOTHER | 1 | Mar 19, 2026 | clinicaltrials |
| NCT07428642 | PSMA PET/CT-Based Multimodal Model for Predicting Response to First-Line Therapy in mHSPC. | completed |