Drug · Other
Ropeginterferon Alfa-2b
CI-DRUG-00000776Explore in graph →CHEMBL4297819 Approved
Regulatory
Approvals (4)
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-2026-09-29
- Retrieved
- Sep 29, 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-20260929-000001
| Jurisdiction · authority | Cancer | Indication | Status | Approval date | Source |
|---|---|---|---|---|---|
| CA Health Canada | — | Marketed in Canada as BESREMI (DIN 02569728) under ATC L03AB15 ROPEGINTERFERON ALFA-2B. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Sep 14, 2026 | health-canada-dpd |
| US FDA | — | Efficacy supplement 2026-08-28 (see label) | approved | Aug 28, 2026 | openfda |
| US FDA | Essential Thrombocythemia | The treatment of adults with essential thrombocythemia. | approved | Nov 12, 2021 | openfda |
| US FDA | Polycythemia Vera | The treatment of adults with polycythemia vera. |
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 18 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 | 10 | 4 | 6 | 16 | 4 | CA, US | Nov 12, 2021 | Aug 30, 2013 |
| Leukemia | Phase2 | Phase 2 | 2 | 1 | 0 | 3 | 0 | — | — | Aug 30, 2013 |
| Malignant Liver Neoplasm | Phase2 | Phase 2 | 0 | 0 | 0 | 1 | 0 | — | — | Feb 12, 2019 |
| Non-Hodgkin Lymphoma | Phase1 | Phase 1 | 1 | 1 | 0 | 1 | 0 | — |
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 (17)
Most recently updated first, 50 per page.
- Source
- ClinicalTrials.gov
- Dataset
- ClinicalTrials.gov API v2 studies
- Retrieved
- Sep 29, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
| NCT | Title | Status | Phase | Enrollment (n) | Sponsor | Countries | Last update | Source |
|---|---|---|---|---|---|---|---|---|
| NCT07722611 | A Clinical Trial of Bomedemstat in Participants With Polycythemia Vera (MK-3543-025) | recruiting | Phase 2 / Phase 3 | 380 | Merck Sharp & Dohme LLCINDUSTRY | 1 | Sep 28, 2026 | clinicaltrials |
| NCT07269470 | Phase II Study Assessing the Safety and Efficacy of Dasatinib in Combination With Ropeginterferon in Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase | recruiting |