Drug · Monoclonal Antibody
Isatuximab
CI-DRUG-00000738Explore in graph →CHEMBL3545131 Approved
Regulatory
Approvals (10)
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
- openFDA — Drugs@FDA applications and drug labels (SPL)
- Dataset
- Drugs@FDA via openFDA
- Version
- drugsfda-2026-09-11
- Retrieved
- Sep 14, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Evidence
- regulatory
- License
- CC0 1.0 Universal (public domain; https://open.fda.gov/license/)
- Run
- ING-OPENFDA-20260914-000001
| Jurisdiction · authority | Cancer | Indication | Status | Approval date | Source |
|---|---|---|---|---|---|
| US FDA | — | Efficacy supplement 2024-10-25 (see label) | approved | Oct 25, 2024 | openfda |
| US FDA | — | Efficacy supplement 2024-10-25 (see label) | approved | Oct 25, 2024 | openfda |
| US FDA | — | Efficacy supplement 2024-09-20 (see label) | approved | Sep 20, 2024 | openfda |
| US FDA | — | Efficacy supplement 2023-11-01 (see label) | approved | Nov 1, 2023 | openfda |
| US |
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 10 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 3 | 49 | 21 | 13 | 67 | 10 | CA, EU, US | Mar 2, 2020 | Jan 21, 2015 |
| Non-Hodgkin Lymphoma | Approved | Phase 3 | 43 | 17 | 12 | 57 | 2 | EU, US | Mar 2, 2020 | Jan 21, 2015 |
| Multiple Myeloma | Approved | Phase 3 | 42 | 17 | 12 | 54 | 2 | EU, US | Mar 2, 2020 | Jan 21, 2015 |
| Leukemia | Phase2 | Phase 2 | 3 | 3 | 0 | 5 | 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 (68)
Most recently updated first, 50 per page.
- Source
- ClinicalTrials.gov
- Dataset
- ClinicalTrials.gov API v2 studies
- Retrieved
- Sep 19, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
| NCT | Title | Status | Phase | Enrollment (n) | Sponsor | Countries | Last update | Source |
|---|---|---|---|---|---|---|---|---|
| NCT07652905 | CM336 Plus Isa-VR in Newly Diagnosed Primary Plasma Cell Leukemia(CAREMM-011) | recruiting | Phase 2 | 24 | Institute of Hematology & Blood Diseases Hospital, ChinaOTHER | 1 | Sep 18, 2026 | clinicaltrials |
| NCT04883242 | Isatuximab, Carfilzomib, Pomalidomide, and Dexamethasone for the Treatment of Relapsed or Refractory Multiple Myeloma |