Drug · Other
Romidepsin
CI-DRUG-00000719Explore in graph →CHEMBL343448 Approved
Regulatory
Approvals (5)
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 ISTODAX (DIN 02414295) under ATC L01XH02 ROMIDEPSIN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Feb 5, 2014 | 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 15 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 | 5 | 3 | 4 | 83 | 5 | CA, US | Nov 5, 2009 | 1997-08 |
| Non-Hodgkin Lymphoma | Approved | Phase 3 | 3 | 2 | 3 | 42 | 1 | US | Nov 5, 2009 | Mar 8, 2001 |
| Malignant Bladder Neoplasm | Phase2 | Phase 2 | 1 | 1 | 0 | 3 | 0 | — | — | 2004-06 |
| Malignant Breast Neoplasm | Phase2 | Phase 2 | 1 | 0 | 0 | 5 | 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 (85)
Most recently updated first, 50 per page.
- Source
- ClinicalTrials.gov
- Dataset
- ClinicalTrials.gov API v2 studies
- Retrieved
- Sep 17, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
| NCT | Title | Status | Phase | Enrollment (n) | Sponsor | Countries | Last update | Source |
|---|---|---|---|---|---|---|---|---|
| NCT01947140 | Pralatrexate + Romidepsin in Relapsed/Refractory Lymphoid Malignancies(PDX+Romi) | terminated | Phase 1 / Phase 2 | 57 | Jennifer AmengualOTHER | 1 | Sep 16, 2026 | clinicaltrials |
| NCT04447027 | Romidepsin, CC-486 (5-azacitidine), Dexamethasone, and Lenalidomide (RAdR) for Relapsed/Refractory T-cell Malignancies | completed |