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SARCLISA (ISATUXIMAB-IRFC)
SARCLISA (generic name: ISATUXIMAB-IRFC) is a CD38-directed Cytolytic Antibody [EPC] drug developed by SANOFI AVENTIS US. It is currently FDA-approved for Multiple myeloma.
SARCLISA is a treatment that combines isatuximab, lenalidomide, and bortezomib to target multiple myeloma, a type of blood cancer. Isatuximab works by inhibiting the lymphocyte differentiation antigen CD38, a protein involved in cell signaling.
At a glance
| Generic name | ISATUXIMAB-IRFC |
|---|---|
| Sponsor | SANOFI AVENTIS US |
| Drug class | CD38-directed Cytolytic Antibody [EPC] |
| Target | Lymphocyte differentiation antigen CD38 |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
Approved indications
- Multiple myeloma
Common side effects
- upper respiratory tract infection
- infusion-related reaction
- pneumonia
Drug interactions
- SARCLISA
- SARCLISA
Key clinical trials
- A Phase I/2 Dose Escalation Safety, Pharmacokinetic and Efficacy Study of Multiple Intravenous Administrations of a Humanized Monoclonal Antibody (SAR650984) Against CD38 in Patients With Selected CD3 (Phase 1)
- Randomized, Open Label, Multicenter Study Assessing The Clinical Benefit Of Isatuximab Combined With Carfilzomib (Kyprolis®) And Dexamethasone Versus Carfilzomib With Dexamethasone In Patients With Re (Phase 3)
- A Prospective, Non-interventional, Multinational, Observational Study With Isatuximab in Patients With Relapsed and/or Refractory Multiple Myeloma (RRMM) (N/A)
- A Phase 2 Multi-Center, Open Label Study of Isatuximab Added to Standard CyBorD Induction and Lenalidomide Maintenance Treatments in Newly Diagnosed, Transplant Eligible Multiple Myeloma (Phase 2)
- A Phase 3 Randomized, Open-label, Multicenter Study Comparing Isatuximab (SAR650984) in Combination With Pomalidomide and Low-Dose Dexamethasone Versus Pomalidomide and Low-Dose Dexamethasone in Patie (Phase 3)
- An Open, Randomised, Controlled, Phase II Trial of CellProtect in Combination With Isatuximab Antibody Versus Isatuximab Antibody Alone as Maintenance Treatment in Patients With Multiple Myeloma Under (Phase 2)
- A Pilot Trial Using Isatuximab to Overcome Platelet Transfusion Refractoriness in Human Leukocyte Antigen Allo-Immunized Patients (EARLY/Phase 1)
- Randomized Phase 2 Trial of Isatuximab During Autologous Stem Cell Collection and Transplantation Period in Patients With Multiple Myeloma, Relapsed Hodgkin's and Non-Hodgkin's Lymphoma (Phase 2)
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:
- SARCLISA CI brief — competitive landscape report
- SARCLISA updates RSS · CI watch RSS
- SANOFI AVENTIS US portfolio CI
Frequently asked questions about SARCLISA
What is SARCLISA?
What is SARCLISA used for?
Who makes SARCLISA?
What is the generic name of SARCLISA?
What drug class is SARCLISA in?
What development phase is SARCLISA in?
What are the side effects of SARCLISA?
What does SARCLISA target?
Related
- Drug class: All CD38-directed Cytolytic Antibody [EPC] drugs
- Target: All drugs targeting Lymphocyte differentiation antigen CD38
- Manufacturer: SANOFI AVENTIS US — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Multiple myeloma
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing