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Isatuximab IV
Isatuximab IV is a CD38-targeting monoclonal antibody Small molecule drug developed by Sanofi. It is currently in Phase 3 development for Multiple myeloma (in combination with pomalidomide and dexamethasone), Multiple myeloma (in combination with carfilzomib and dexamethasone). Also known as: SAR650984, SARCLISA®.
Isatuximab is a monoclonal antibody that binds to CD38 on the surface of multiple myeloma cells, triggering their destruction through multiple immune mechanisms.
Isatuximab IV is used to treat multiple myeloma, including relapse, refractory, and newly diagnosed cases with severe renal impairment. It is administered intravenously as part of a combination therapy, such as with CM336, a BCMA/CD3 bispecific antibody.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Oncology Phase 3 boost
+3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway. -
Big-pharma sponsor
+3.0pp
Sanofi is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Isatuximab IV |
|---|---|
| Also known as | SAR650984, SARCLISA® |
| Sponsor | Sanofi |
| Drug class | CD38-targeting monoclonal antibody |
| Target | CD38 |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Isatuximab targets CD38, a surface antigen highly expressed on multiple myeloma cells. By binding to CD38, it activates antibody-dependent cellular cytotoxicity (ADCC), antibody-dependent cellular phagocytosis (ADCP), and complement-dependent cytotoxicity (CDC), leading to direct tumor cell death. It also modulates the immunosuppressive tumor microenvironment by reducing CD38+ regulatory T cells and myeloid-derived suppressor cells.
Approved indications
- Multiple myeloma (in combination with pomalidomide and dexamethasone)
- Multiple myeloma (in combination with carfilzomib and dexamethasone)
Common side effects
- Infusion-related reactions
- Neutropenia
- Anemia
- Thrombocytopenia
- Fatigue
- Pneumonia
- Upper respiratory tract infection
Key clinical trials
- Isatuximab, Pomalidomide, Elotuzumab and Dexamethasone in Relapsed and/or Refractory Multiple Myeloma (PHASE2)
- Study of Selinexor With Carfilzomib, Isatuximab and Dexamethasone for Patients With Relapsed and/or Refractory Multiple Myeloma (PHASE1, PHASE2)
- Elimination of Minimal Residual Disease After Transplant (PHASE2)
- Isatuximab, Carfilzomib, Pomalidomide, and Dexamethasone for the Treatment of Relapsed or Refractory Multiple Myeloma (PHASE2)
- Donor Immune Cells (TGFbi NK Cells) and Isatuximab for the Treatment of Relapsed or Refractory Multiple Myeloma (PHASE1)
- A Study to Investigate Subcutaneous Isatuximab in Combination With Weekly Carfilzomib and Dexamethasone in Adult Participants With Relapsed and/or Refractory Multiple Myeloma (PHASE2)
- Post-Autologous Transplant Maintenance With Isatuximab and Lenalidomide in Minimal Residual Disease Positive Multiple Myeloma (PHASE2)
- Lenalidomide, Bortezomib and Dexamethasone Induction Therapy With Either Intravenous or Subcutaneous Isatuximab in Patients With Newly Diagnosed Multiple Myeloma (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Isatuximab IV CI brief — competitive landscape report
- Isatuximab IV updates RSS · CI watch RSS
- Sanofi portfolio CI
Frequently asked questions about Isatuximab IV
What is Isatuximab IV?
How does Isatuximab IV work?
What is Isatuximab IV used for?
Who makes Isatuximab IV?
Is Isatuximab IV also known as anything else?
What drug class is Isatuximab IV in?
What development phase is Isatuximab IV in?
What are the side effects of Isatuximab IV?
What does Isatuximab IV target?
Related
- Drug class: All CD38-targeting monoclonal antibody drugs
- Target: All drugs targeting CD38
- Manufacturer: Sanofi — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Multiple myeloma (in combination with pomalidomide and dexamethasone)
- Indication: Drugs for Multiple myeloma (in combination with carfilzomib and dexamethasone)
- Also known as: SAR650984, SARCLISA®
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing