Drug · Monoclonal Antibody
Daratumumab
CI-DRUG-00000726Explore in graph →CHEMBL1743007 Approved
Regulatory
Approvals (19)
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 DARZALEX SC (DIN 02502712) under ATC L01FC01 DARATUMUMAB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Aug 12, 2020 | health-canada-dpd |
| CA Health Canada | — | Marketed in Canada as DARZALEX (DIN 02455978) under ATC L01FC01 DARATUMUMAB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Jul 12, 2016 | health-canada-dpd |
| CA Health Canada | — | Marketed in Canada as DARZALEX (DIN 02455951) under ATC L01FC01 DARATUMUMAB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Jul 12, 2016 | health-canada-dpd |
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 | 139 | 61 | 57 | 254 | 19 | CA, EU, US | Nov 16, 2015 | Jan 31, 2012 |
| Non-Hodgkin Lymphoma | Approved | Phase 4 | 121 | 50 | 54 | 218 | 1 | US | Nov 16, 2015 | Jan 31, 2012 |
| Multiple Myeloma | Approved | Phase 4 | 112 | 44 | 53 | 198 | 1 | US | Nov 16, 2015 | Jan 31, 2012 |
| Leukemia | Phase3 | Phase 3 | 8 | 6 | 2 | 18 | 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 (261)
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 |
|---|---|---|---|---|---|---|---|---|
| NCT03221634 | Efficacy and Safety Study of Pembrolizumab (MK-3475) in Combination With Daratumumab in Participants With Relapsed Refractory Multiple Myeloma (MK-3475-668/KEYNOTE-668) | withdrawn | Phase 2 | 0 | Merck Sharp & Dohme LLCINDUSTRY | 6 | Mar 25, 2019 | clinicaltrials |
| NCT02477891 | Early Access Treatment With Daratumumab for (Relapsed or Refractory) Multiple Myeloma | approved for marketing |