Drug · Small Molecule
Clofarabine
CI-DRUG-00000712Explore in graph →CHEMBL1750 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-2026-09-11
- 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 CLOLAR (DIN 02330407) under ATC L01BB06 CLOFARABINE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Feb 10, 2010 | health-canada-dpd |
| EU EMA | Acute Lymphoblastic Leukemia | Treatment of acute lymphoblastic leukaemia (ALL) in paediatric patients who have relapsed or are refractory after receiving at least two prior regimens and where there is no other treatment option anticipated to result in a durable response. Safety and efficacy have been assessed in studies of patients ? 21 years old at initial diagnosis. | withdrawnsince Oct 18, 2023 | Nov 14, 2019 | ema |
| EU EMA | Acute Lymphoblastic Leukemia | Treatment of acute lymphoblastic leukaemia (ALL) in paediatric patients who have relapsed or are refractory after receiving at least two prior regimens and where there is no other treatment option anticipated to result in a durable response. Safety and efficacy have been assessed in studies of patients ? 21 years old at initial diagnosis. |
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 14 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 | 9 | 7 | 8 | 131 | 4 | CA, EU, US | May 29, 2006 | 1999-02 |
| Leukemia | Approved | Phase 3 | 7 | 5 | 8 | 112 | 2 | EU | May 29, 2006 | 1999-02 |
| Malignant Central Nervous System Neoplasm | Phase3 | Phase 3 | 0 | 0 | 1 | 1 | 0 | — | — | Feb 29, 2012 |
| Malignant Testicular Neoplasm | Phase3 | Phase 3 | 0 | 0 | 1 | 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 (132)
Most recently updated first, 50 per page.
- Source
- ClinicalTrials.gov
- Dataset
- ClinicalTrials.gov API v2 studies
- Retrieved
- Sep 15, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
| NCT | Title | Status | Phase | Enrollment (n) | Sponsor | Countries | Last update | Source |
|---|---|---|---|---|---|---|---|---|
| NCT01188174 | Clofarabine/Ara-C Treatment Combined With Reduced-intensity Conditioning Allogeneic Stem Cell Transplantation for Acute Myeloid Leukemia in Primary Treatment Failure(setric) | completed | Phase 2 | 26 | Nantes University HospitalOTHER | 1 | Sep 14, 2026 | clinicaltrials |
| NCT01885689 | Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia |