Drug · Small Molecule
Belzutifan
CI-DRUG-00000105Explore in graph →NCIt C135627 CHEMBL4585668 CIViC Approved
Regulatory
Approvals (10)
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 WELIREG (DIN 02528908) under ATC L01XX74 BELZUTIFAN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Sep 1, 2022 | health-canada-dpd |
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 12 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 3 | 29 | 12 | 8 | 34 | 10 | CA, EU, US | Aug 13, 2021 | Nov 17, 2016 |
| Malignant Kidney Neoplasm | Approved | Phase 3 | 19 | 7 | 7 | 24 | 2 | US | Aug 13, 2021 | Dec 7, 2016 |
| Malignant Breast Neoplasm | Phase2 | Phase 2 | 1 | 0 | 0 | 1 | 0 | — | — | Nov 27, 2024 |
| Malignant Cervical Neoplasm | Phase2 | Phase 2 | 1 | 1 | 0 | 1 | 0 |
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
- 34818478
- Run
- ING-CIVIC-20260908-000001
| Therapy | Cancer | Type | Level | Direction · significance | Rating (1–5) | Status | Evidence | Source |
|---|---|---|---|---|---|---|---|---|
| VHL Mutation1 | ||||||||
| Belzutifan | Von Hippel-Lindau Disease | |||||||
Clinical trials
Trials with this intervention (34)
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 |
|---|---|---|---|---|---|---|---|---|
| NCT04626479 | Substudy 03A: A Study of Immune and Targeted Combination Therapies in Participants With First Line (1L) Renal Cell Carcinoma (MK-3475-03A) | completed | Phase 1 / Phase 2 | 393 | Merck Sharp & Dohme LLCINDUSTRY | 14 | Sep 25, 2026 | clinicaltrials |
| NCT04626518 | Substudy 03B: A Study of Immune and Targeted Combination Therapies in Participants With Second Line Plus (2L+) Renal Cell Carcinoma (MK-3475-03B/KEYMAKER-U03) |