Drug · Small Molecule
Idarubicin
CI-DRUG-00000293Explore in graph →NCIt C562 CHEMBL1117 CIViC Approved
Regulatory
Approvals (13)
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 IDARUBICIN (DIN 02410028) under ATC L01DB06 IDARUBICIN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Nov 4, 2014 | health-canada-dpd |
| CA Health Canada | — | Marketed in Canada as IDARUBICIN HYDROCHLORIDE INJECTION (DIN 02337584) under ATC L01DB06 IDARUBICIN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | withdrawnsource: Cancelled Post Marketsince Oct 7, 2021 | Apr 13, 2010 | health-canada-dpd |
| CA Health Canada | — | Marketed in Canada as IDAMYCIN PFS (DIN 02282496) under ATC L01DB06 IDARUBICIN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | withdrawnsource: Cancelled Post Market |
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 2 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 | 32 | 18 | 50 | 192 | 13 | CA, US | Feb 17, 1997 | 1993-01 |
| Leukemia | Approved | Phase 4 | 32 | 18 | 42 | 174 | 1 | US | Feb 17, 1997 | 1993-01 |
| Malignant Liver Neoplasm | Phase3 | Phase 3 | 0 | 0 | 1 | 4 | 0 | — | — | 2009-12 |
| Non-Hodgkin Lymphoma | Phase3 | Phase 3 | 0 | 0 | 3 | 4 | 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
- 22081665
- Run
- ING-CIVIC-20260908-000001
| Therapy | Cancer | Type | Level | Direction · significance | Rating (1–5) | Status | Evidence | Source |
|---|---|---|---|---|---|---|---|---|
| DNMT3A R8821 | ||||||||
| Idarubicin | Acute Myeloid Leukemia | |||||||
Clinical trials
Trials with this intervention (193)
Most recently updated first, 50 per page.
- Source
- ClinicalTrials.gov
- Dataset
- ClinicalTrials.gov API v2 studies
- Retrieved
- Sep 19, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
| NCT | Title | Status | Phase | Enrollment (n) | Sponsor | Countries | Last update | Source |
|---|---|---|---|---|---|---|---|---|
| NCT00801489 | Fludarabine Phosphate, Cytarabine, Filgrastim-sndz, Gemtuzumab Ozogamicin, and Idarubicin Hydrochloride in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome | recruiting | Phase 2 | 270 | M.D. Anderson Cancer CenterOTHER | 1 | Sep 18, 2026 | clinicaltrials |
| NCT03214562 | Venetoclax With Combination Chemotherapy in Treating Patients With Newly Diagnosed or Relapsed or Refractory Acute Myeloid Leukemia |