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
- 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 NUBEQA (DIN 02496348) under ATC L02BB06 DAROLUTAMIDE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Mar 24, 2020 | health-canada-dpd |
| EU EMA | Nonmetastatic Castration-Resistant Prostate Carcinoma | NUBEQA is indicated for the treatment of adult men with non‑metastatic castration resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease (see section 5.1). metastatic hormone‑sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (see section 5.1). metastatic hormone‑sensitive prostate cancer (mHSPC) in combination with docetaxel and androgen deprivation therapy (see section 5.1). | approved | Mar 27, 2020 | ema |
| US FDA | — | Efficacy supplement 2025-06-03 (see label) | approved | Jun 3, 2025 | 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 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 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
| NCT | Title | Status | Phase | Enrollment (n) | Sponsor | Countries | Last update | Source |
|---|---|---|---|---|---|---|---|---|
| NCT03568656 | Study to Evaluate CCS1477 in Advanced Tumours | completed | Phase 1 / Phase 2 | 219 | CellCentric Ltd.INDUSTRY | 6 | Sep 25, 2026 | clinicaltrials |
| NCT05818683 | A Study of Pasritamig (JNJ-78278343) in Combination With Other Agents for Metastatic Prostate Cancer | recruiting | Phase 1 | 300 |