Drug · Small Molecule
Bendamustine
CI-DRUG-00000717Explore in graph →CHEMBL487253 Approved
Regulatory
Approvals (31)
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 BENDAMUSTINE HYDROCHLORIDE FOR INJECTION (DIN 02541998) under ATC L01AA09 BENDAMUSTINE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Sep 8, 2025 | health-canada-dpd |
| CA Health Canada | — | Marketed in Canada as BENDAMUSTINE HYDROCHLORIDE FOR INJECTION (DIN 02542005) under ATC L01AA09 BENDAMUSTINE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Oct 8, 2024 | health-canada-dpd |
| CA Health Canada | — | Marketed in Canada as BENVYON (DIN 02524309) under ATC L01AA09 BENDAMUSTINE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Jan 30, 2023 |
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 18 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 | 71 | 29 | 65 | 279 | 31 | CA, US | Mar 20, 2008 | 2001-09 |
| Non-Hodgkin Lymphoma | Approved | Phase 4 | 46 | 19 | 41 | 162 | 7 | US | Mar 20, 2008 | 2004-01 |
| Leukemia | Approved | Phase 4 | 16 | 4 | 22 | 80 | 6 | US | Mar 20, 2008 | 2001-09 |
| Hodgkin Lymphoma | Phase4 | Phase 4 | 6 | 1 | 2 | 29 | 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 (282)
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 |
|---|---|---|---|---|---|---|---|---|
| NCT06846671 | A Study of Tacabrutideg (BGB-16673) Compared to Investigator's Choice in Participants With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Previously Exposed to Both Bruton Tyrosine Kinase (BTK) and B-cell Leukemia/Lymphoma 2 Protein (BCL2) Inhibitors(CaDAnCe-302) | recruiting | Phase 3 | 250 | BeOne MedicinesINDUSTRY | 14 | Sep 28, 2026 | clinicaltrials |
| NCT05023980 | A Study of Pirtobrutinib (LOXO-305) Versus Bendamustine Plus Rituximab (BR) in Untreated Patients With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) |