Drug · Small Molecule
Mitoxantrone
CI-DRUG-00000674Explore in graph →CHEMBL58 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 MITOXANTRONE INJECTION (DIN 02286300) under ATC L01DB07 MITOXANTRONE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Dec 3, 2007 | health-canada-dpd |
| CA Health Canada | — | Marketed in Canada as MITOXANTRONE INJECTION (DIN 02267535) under ATC L01DB07 MITOXANTRONE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | withdrawnsource: Cancelled Post Marketsince Jul 9, 2018 | Mar 28, 2006 | health-canada-dpd |
| CA Health Canada | — | Marketed in Canada as MITOXANTRONE INJECTION USP (DIN 02244614) under ATC L01DB07 MITOXANTRONE. 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 16 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 | 18 | 8 | 51 | 216 | 6 | CA, US | Apr 11, 2006 | 1991-02 |
| Leukemia | Phase4 | Phase 4 | 15 | 7 | 28 | 137 | 0 | — | — | 1993-01 |
| Malignant Thyroid Gland Neoplasm | Phase4 | Phase 4 | 1 | 0 | 0 | 1 | 0 | — | — | Feb 1, 2026 |
| Malignant Breast Neoplasm | Phase3 | Phase 3 | 0 | 0 | 3 | 7 | 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 (217)
Most recently updated first, 50 per page.
- Source
- ClinicalTrials.gov
- Dataset
- ClinicalTrials.gov API v2 studies
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
| NCT | Title | Status | Phase | Enrollment (n) | Sponsor | Countries | Last update | Source |
|---|---|---|---|---|---|---|---|---|
| NCT00006114 | Combination Chemotherapy in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy | unknown | Phase 2 | — | GERCOR - Multidisciplinary Oncology Cooperative GroupOTHER | 1 | Mar 1, 2011 | clinicaltrials |
| NCT00499018 | Dose Dense Chemotherapy + Rituximab +/-Intensified High Dose Chemoimmunotherapy With Support of Peripheral Autologous Stem Cell in Diffuse Large B-Cell Lymphoma |