CDEK
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Isatuximab

Trade name: Sarclisa

mAbapprovedOrphan Drug FDA

Approved

Mar 2, 2020

Isatuximab, sold under the brand name Sarclisa, is a monoclonal antibody (mAb) medication for the treatment of multiple myeloma. — Wikipedia

Clinical trial activity

81 trials · 72 clinical orgs · 1 marketing orgs

Phase 1
24
Phase 2
68
Phase 3
13
Phase 4
0

Earliest trial started May 1, 2010 (NCT01084252)

Timeline

2010s

  1. Jan 1, 2010

    Earliest Phase 1 Sponsor(trial)

  2. May 22, 2014

    Orphan Drug Designation

  3. Jan 1, 2016

    Earliest Phase 3 Sponsor(trial)

  4. Jan 1, 2017

    Earliest Phase 2 Sponsor(trial)

2020s

  1. Mar 2, 2020

    Sanofi-Aventis — Earliest FDA Approval

  2. Mar 2, 2020

    Sanofi-Aventis — Marketing Organization

  3. Mar 2, 2020

    Sanofi-Aventis — NDA Secondary Org

  4. Mar 2, 2020

    Sanofi-Aventis — NDA Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedMar 2, 2020

Chemistry & pharmacology

Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Parenteral
Availability
Prescription Only
Multi-specific
No

Oral

No

Parenteral

Yes

Topical

No

Sources

Also known as

  • isatuximab
  • isatuximab
  • sar650984
  • sar-650984

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06832865Phase 2Aug 1, 2026Harvard University, Pfizer, Sanofi
NCT07053436Phase 2Oct 1, 2025Multiple Myeloma Research Consortium, Multiple Myeloma Research Foundation
NCT07045909Phase 2Jun 30, 2025Clinica Universidad de Navarra, PETHEMA Foundation, University of Salamanca
NCT06762769Phase 2Jun 2, 2025Sanofi, University of London
NCT06517017Phase 2Nov 30, 2024Sanofi, University of Utah
NCT06356571Phase 2Nov 17, 2024Sanofi
NCT06648889Phase 2Oct 31, 2024J. W. Goethe University, Sanofi
NCT06216158Phase 3Apr 5, 2024Bristol-Myers Squibb, Julius-Maximilians University, Koordinierungszentren für Klinische Studien bzw. Zentren für klinische Studien, Sanofi, University of Heidelberg
NCT06203912Phase 1Mar 5, 2024Ohio State University, Sanofi
NCT05862766Early Phase 1 (Phase 1)Jan 1, 2024New York University
NCT05911321Phase 2Dec 30, 2023Genzyme, University of North Carolina at Chapel Hill
NCT05922501Phase 2Nov 30, 2023GlaxoSmithKline, Harvard University, Sanofi
NCT05776979Phase 2Sep 30, 2023Sanofi, University of Texas at Houston
NCT05873205Phase 2Jul 21, 2023Memorial Sloan-Kettering Cancer Center, Sanofi
NCT05690984Phase 2Jun 26, 2023Medical College of Wisconsin
NCT05804032Phase 3Apr 14, 2023Deutsche Studiengruppe Multiples Myelom, Koordinierungszentren für Klinische Studien bzw. Zentren für klinische Studien, Sanofi, University of Heidelberg
NCT05704049Phase 2Apr 5, 2023Sanofi
NCT05669989Phase 2Apr 5, 2023Sanofi
NCT05665140Phase 2/Phase 3 (Phase 3)Jan 31, 2023Universitaetsklinikum Schleswig-Holstein
NCT05344833Phase 2Dec 31, 2022University of Illinois at Chicago
Showing 20 of 81 trials
Page 1 / 5

Organizations

Research & Development (72)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
SanofiFor profit532432010
Harvard UniversityAcademic/Hospital5412020
GenzymeFor profit4012020
AmgenFor profit3022020
Bristol-Myers SquibbFor profit3012021
Intergroupe Francophone du MyelomeAcademic/Hospital3222021
Medical College of WisconsinAcademic/Hospital3312020
University of HeidelbergAcademic/Hospital3312018
Assistance Publique - Hôpitaux de ParisAcademic/Hospital2212021
Columbia UniversityAcademic/Hospital2212020
European Myeloma NetworkAcademic/Hospital2222020
GlaxoSmithKlineFor profit2112021
Hellenic Society of HematologyAcademic/Hospital2212021
Koordinierungszentren für Klinische Studien bzw. Zentren für klinische StudienAcademic/Hospital2012023
National Cancer Institute (NCI)Government2022018
National Kapodistrian University of AthensAcademic/Hospital2012021
PETHEMA FoundationAcademic/Hospital2222022
RocheFor profit2212018
University of California, San FranciscoAcademic/Hospital2222014
University of NavarraAcademic/Hospital2022021
72 organizations
Page 1 / 4

Marketing (3)

OrganizationOrg typeRelationshipDate
Sanofi-AventisFor profitMKTGMar 2, 2020
Sanofi-AventisFor profitNDA2Mar 2, 2020
Sanofi-AventisFor profitNDAMar 2, 2020