MedPath

Isatuximab

Generic Name
Isatuximab
Brand Names
Sarclisa
Drug Type
Biotech
CAS Number
1461640-62-9
Unique Ingredient Identifier
R30772KCU0

Overview

Isatuximab (formerly SAR650984) is a humanized, IgG1-derived monoclonal antibody (mAb) produced from a Chinese hamster ovary (CHO) cell line. Structurally, isatuximab is comprised of two identical immunoglobulin kappa light chains and two identical immunoglobulin gamma heavy chains. It is a cytolytic antibody targeted against CD38, a glycoprotein found on the surface of some immune cells that is highly expressed by malignant plasma cells in multiple myeloma. Along with daratumumab, another anti-CD38 mAb, isatuximab constitutes a novel treatment modality for patients with difficult-to-treat multiple myeloma. Following three consecutive years on the yearly "Antibodies to watch" list published in "mAb", a peer-reviewed scientific journal dedicated to antibody research, isatuximab was granted Orphan Drug designation and approved on March 2nd, 2020, for the treatment of multiple myeloma. It is manufactured by Sanofi-Aventis U.S. under the brand name Sarclisa.

Indication

Isatuximab is indicated in combination with pomalidomide and dexamethasone for the treatment of multiple myeloma in adults who have received at least two prior therapies including lenalidomide and a proteasome inhibitor. It is also indicated in combination carfilzomib and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received 1 to 3 prior lines of therapy.

Associated Conditions

  • Multiple Myeloma (MM)
  • Refractory Multiple Myeloma
  • Relapsed Multiple Myeloma

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2025/07/01
Not Applicable
Recruiting
PETHEMA Foundation
2025/02/18
Phase 2
Not yet recruiting
2025/01/08
Phase 2
Recruiting
2024/10/18
Phase 2
Recruiting
Goethe University
2024/07/24
Phase 2
Not yet recruiting
2024/04/10
Phase 2
Recruiting
2024/01/22
Phase 3
Recruiting
University of Heidelberg Medical Center
2024/01/12
Phase 1
Recruiting
Elvira Umyarova
2023/11/07
Phase 1
Recruiting
2023/06/28
Phase 2
Not yet recruiting

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Sanofi-Aventis U.S. LLC
0024-0654
INTRAVENOUS
100 mg in 5 mL
6/16/2025
Sanofi-Aventis U.S. LLC
0024-0656
INTRAVENOUS
500 mg in 25 mL
6/16/2025

EMA Drug Approvals

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
SARCLISA CONCENTRATE FOR SOLUTION FOR INFUSION 20MG/ML
SIN16630P
INFUSION, SOLUTION CONCENTRATE
20mg/mL
10/17/2022

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
SARCLISA
sanofi-aventis canada inc
02498243
Solution - Intravenous
500 MG / 25 ML
7/3/2020
SARCLISA
sanofi-aventis canada inc
02498235
Solution - Intravenous
100 MG / 5 ML
7/3/2020

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
SARCLISA 20 MG/ML CONCENTRADO PARA SOLUCION PARA PERFUSION
1201435001IP1
CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN
Uso Hospitalario
Commercialized
SARCLISA 20 MG/ML CONCENTRADO PARA SOLUCION PARA PERFUSION
1201435001IP
CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN
Uso Hospitalario
Commercialized

Philippines FDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product
Company
Registration Number
Dosage Form
Strength
Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

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