dostarlimab

Trade name: Jemperli

mAbapprovedBreakthrough Therapy FDA

Approved

Apr 22, 2021

Dostarlimab, sold under the brand name Jemperli, is a monoclonal antibody used as an anti-cancer medication for the treatment of endometrial cancer. Dostarlimab is a programmed death receptor-1 (PD-1)–blocking monoclonal antibody. — Wikipedia

Clinical trial activity

80 trials · 62 clinical orgs · 1 marketing orgs

Phase 1
21
Phase 2
66
Phase 3
11
Phase 4
1

Earliest trial started Jan 1, 2012 (NCT02248298)

Timeline

2010s

  1. Jan 1, 2012

    Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2018

    Earliest Phase 2 Sponsor(trial)

  3. Jan 1, 2018

    Earliest Phase 3 Sponsor(trial)

2020s

  1. Apr 22, 2021

    GlaxoSmithKline — Earliest FDA Approval

  2. Apr 22, 2021

    GlaxoSmithKline — Marketing Organization

  3. Apr 22, 2021

    GlaxoSmithKline — NDA Secondary Org

  4. Apr 22, 2021

    GlaxoSmithKline — NDA Organization

Indications

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewAcceleratedBreakthroughApr 22, 2021

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

  • garnet
  • garnet
  • tsr-042

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07108270Phase 2Nov 30, 2025GlaxoSmithKline
NCT07013851Phase 2Oct 1, 2025GlaxoSmithKline, Grupo Español de Investigación en Cáncer de Ovario
NCT07115927Phase 2Sep 30, 2025GlaxoSmithKline, University of London
NCT06897527Phase 4Jul 15, 2025GlaxoSmithKline
NCT06879717Phase 1/Phase 2 (Phase 2)Apr 30, 2025iOnctura
NCT06830239Phase 2Mar 31, 2025Katholieke Universiteit Leuven
NCT06796907Phase 1/Phase 2 (Phase 2)Mar 4, 2025GlaxoSmithKline
NCT06762405Phase 3Feb 6, 2025University of Burgundy
NCT06757244Phase 2Jan 15, 2025GlaxoSmithKline, Hôpital FOCH, University of Versailles
NCT06567782Phase 2Dec 5, 2024GlaxoSmithKline
NCT06365970Phase 2Oct 31, 2024GlaxoSmithKline, University of Pittsburgh
NCT06640049Phase 2Oct 17, 2024GlaxoSmithKline
NCT06521567Phase 1/Phase 2 (Phase 2)Sep 13, 2024GlaxoSmithKline
NCT06405230Phase 1/Phase 2 (Phase 2)Aug 15, 2024GlaxoSmithKline
NCT06333314Phase 2Jul 23, 2024GlaxoSmithKline, National Cancer Institute, France, UNICANCER
NCT06472076Phase 3Jun 10, 2024GlaxoSmithKline, iTeos Therapeutics
NCT06278857Phase 2Jun 1, 2024GlaxoSmithKline, University of Queensland
NCT06385548Phase 1/Phase 2 (Phase 2)May 31, 2024Universidad Autonoma de Barcelona
NCT06317311Phase 2May 7, 2024GlaxoSmithKline
NCT06256588Phase 3Mar 21, 2024GlaxoSmithKline
Showing 20 of 80 trials
Page 1 / 4

Organizations

Research & Development (62)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
GlaxoSmithKlineFor profit432142018
TesaroFor profit17832016
Harvard UniversityAcademic/Hospital4412020
University of Texas at HoustonAcademic/Hospital4422021
iTeos TherapeuticsFor profit3022022
ARCAGY-GINECOFor profit2212019
European Network for Gynaecological Oncological TrialAcademic/Hospital2012018
Grupo Español de Investigación en Cáncer de OvarioAcademic/Hospital2212019
Gynecologic Oncology GroupAcademic/Hospital2022019
Memorial Sloan-Kettering Cancer CenterAcademic/Hospital2212019
Universidad Autonoma de BarcelonaAcademic/Hospital2112019
University of IowaAcademic/Hospital2212021
University of PittsburghAcademic/Hospital2212019
23andMe, Inc.For profit1012020
AGO GermanyAcademic/Hospital1112022
Apices Soluciones S.L.For profit1012019
Centre Leon BerardAcademic/Hospital1112023
Dong-A UniversityAcademic/Hospital1112012
Duke UniversityAcademic/Hospital1012021
Emory UniversityAcademic/Hospital1012021
62 organizations
Page 1 / 4

Marketing (4)

OrganizationOrg typeRelationshipDate
GlaxoSmithKlineFor profitMKTGApr 22, 2021
GlaxoSmithKlineFor profitSYNAug 17, 2021
GlaxoSmithKlineFor profitNDA2Apr 22, 2021
GlaxoSmithKlineFor profitNDAApr 22, 2021