Drug · Small Molecule
Cladribine
CI-DRUG-00000686Explore in graph →CHEMBL1619 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 CLADRIBINE INJECTION (DIN 02494574) under ATC L01BB04 CLADRIBINE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Aug 19, 2020 | health-canada-dpd |
| CA Health Canada | — | Marketed in Canada as CLADRIBINE INJECTION (DIN 02319918) under ATC L01BB04 CLADRIBINE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Jun 30, 2009 | health-canada-dpd |
| CA Health Canada | — | Marketed in Canada as LEUSTATIN 1MG/ML (DIN 02022117) under ATC L01BB04 CLADRIBINE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | withdrawnsource: Cancelled Post Marketsince Dec 19, 2011 |
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 4 | 23 | 17 | 10 | 77 | 5 | CA, EU, US | Apr 14, 2004 | 1994-10 |
| Leukemia | Approved | Phase 4 | 19 | 15 | 6 | 59 | 1 | EU | Apr 14, 2004 | 1994-10 |
| Non-Hodgkin Lymphoma | Approved | Phase 4 | 5 | 4 | 1 | 14 | 1 | EU | Apr 14, 2004 | 2004-02 |
| Hodgkin Lymphoma | Phase2 | Phase 2 | 0 | 0 | 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 (78)
Most recently updated first, 50 per page.
- Source
- ClinicalTrials.gov
- Dataset
- ClinicalTrials.gov API v2 studies
- Retrieved
- Sep 18, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
| NCT | Title | Status | Phase | Enrollment (n) | Sponsor | Countries | Last update | Source |
|---|---|---|---|---|---|---|---|---|
| NCT04375631 | CLAG-M or FLAG-Ida Chemotherapy and Reduced-Intensity Conditioning Donor Stem Cell Transplant for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia, Myelodysplastic Syndrome, or Chronic Myelomonocytic Leukemia | recruiting | Phase 1 | 120 | Fred Hutchinson Cancer CenterOTHER | 1 | Sep 17, 2026 | clinicaltrials |
| NCT06463587 | Efficacy and Safety of a New Formulation of Oral Cladribine Compared With Placebo in Participants With Generalized Myasthenia Gravis (MyClad) |