Drug · Small Molecule
Busulfan
CI-DRUG-00000666Explore in graph →CHEMBL820 Approved
Regulatory
Approvals (11)
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 PMS-BUSULFAN (DIN 02477343) under ATC L01AB01 BUSULFAN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Mar 29, 2019 | health-canada-dpd |
| CA Health Canada | — | Marketed in Canada as BUSULFAN FOR INJECTION (DIN 02463733) under ATC L01AB01 BUSULFAN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Oct 4, 2017 | health-canada-dpd |
| CA Health Canada | — | Marketed in Canada as BUSULFEX (DIN 02240602) under ATC L01AB01 BUSULFAN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | withdrawnsource: Cancelled Post Marketsince Sep 1, 2020 |
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 19 hours 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 | 53 | 22 | 52 | 371 | 11 | CA, EU, US | Jun 26, 1954 | 1987-08 |
| Leukemia | Approved | Phase 4 | 38 | 15 | 31 | 240 | 1 | US | Jun 26, 1954 | 1987-08 |
| Non-Hodgkin Lymphoma | Phase4 | Phase 4 | 10 | 5 | 6 | 71 | 0 | — | — | 1988-03 |
| Multiple Myeloma | Phase4 | Phase 4 | 3 | 1 | 3 | 40 | 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 (373)
Most recently updated first, 50 per page.
- Source
- ClinicalTrials.gov
- Dataset
- ClinicalTrials.gov API v2 studies
- Retrieved
- Sep 29, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
| NCT | Title | Status | Phase | Enrollment (n) | Sponsor | Countries | Last update | Source |
|---|---|---|---|---|---|---|---|---|
| NCT07524530 | Stem Cell Transplantation for Participants With Germline RUNX1 Associated Blood Cancers | not yet recruiting | Phase 2 | 102 | National Cancer Institute (NCI)NIH | 1 | Sep 28, 2026 | clinicaltrials |
| NCT07775313 | Base-Edited Hematopoietic Stem/Progenitor Cell Gene Therapy for Treatment of CXCR4-WHIM | enrolling by invitation | Phase 1 / Phase 2 |