CDEK
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sacituzumab govitecan

Trade name: Trodelvy

mAbapprovedADCFast Track FDABreakthrough Therapy FDA

Approved

Apr 22, 2020

Sacituzumab govitecan, sold under the brand name Trodelvy by Gilead Sciences, is a Trop-2-directed antibody and topoisomerase inhibitor drug conjugate used for the treatment of metastatic triple-negative breast cancer and metastatic urothelial cancer. — Wikipedia

Clinical trial activity

105 trials · 84 clinical orgs · 2 marketing orgs

Phase 1
28
Phase 2
91
Phase 3
17
Phase 4
0

Earliest trial started Feb 1, 2013 (NCT01631552)

Timeline

2010s

  1. Jan 1, 2013

    Immunomedics — Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2016

    Immunomedics — Earliest Phase 2 Sponsor(trial)

  3. Jan 1, 2017

    Immunomedics — Earliest Phase 3 Sponsor(trial)

2020s

  1. Apr 22, 2020

    Gilead Sciences — Earliest FDA Approval

  2. Apr 22, 2020

    Immunomedics — Marketing Organization

  3. Apr 22, 2020

    Gilead Sciences — NDA Secondary Org

  4. Apr 22, 2020

    Gilead Sciences — NDA Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewAcceleratedFast trackBreakthroughApr 22, 2020

Chemistry & pharmacology

Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Parenteral
Availability
Prescription Only
Multi-specific
No
Payload
SN-38

Oral

No

Parenteral

Yes

Topical

No

Black box warningFirst in class

Sources

Also known as

  • immu-132
  • immu-132
  • immu-132
  • immu-132
  • sacituzumab govitecan
  • sacituzumab govitecan
  • sacituzumab govitecan
  • sacituzumab govitecan
  • sacituzumab govitecan

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07178730Phase 3Jan 31, 2026Ev. Hospital Bethesda, Moenchengladbach, Gilead Sciences, Kliniken Essen-Mitte, Germany, Ludwig Maximilians University, Ruhr University Bochum, West German Study Group
NCT07299409Phase 2Dec 31, 2025British Columbia Cancer Agency
NCT07134556Phase 2Dec 8, 2025MedSIR, University of Bristol
NCT06963905Phase 1/Phase 2 (Phase 2)Nov 30, 2025Bristol-Myers Squibb, Yale University
NCT07258108Phase 2Nov 21, 2025Sun Yat-Sen University
NCT07151586Phase 2Oct 31, 2025Institut Paoli-Calmettes, UNICANCER
NCT07163481Phase 1Oct 31, 2025Central South University, Gilead Sciences
NCT07040644Phase 2Sep 30, 2025Sun Yat-Sen University
NCT07011654Phase 1/Phase 2 (Phase 2)Sep 19, 2025University of Texas at Houston, Y-Mabs, Inc
NCT07088211Phase 2Jul 31, 2025Jiao Tong University
NCT07063212Phase 2Jul 2, 2025Gilead Sciences, Memorial Sloan-Kettering Cancer Center
NCT06926920Phase 1/Phase 2 (Phase 2)Apr 30, 2025Gilead Sciences
NCT06923826Phase 2Apr 15, 2025Gilead Sciences, National University of Singapore
NCT06865677Phase 2Apr 1, 2025National Cancer Institute (NCI)
NCT06706219Phase 2Mar 31, 2025Central South University
NCT06827613Phase 1/Phase 2 (Phase 2)Mar 31, 2025Marengo Therapeutics, Inc.
NCT07046455N/AMar 1, 2025Peking University
NCT06524544Phase 3Feb 6, 2025ECOG-ACRIN Cancer Research Group, National Cancer Institute (NCI)
NCT06612203Phase 1/Phase 2 (Phase 2)Jan 31, 2025Debiopharm, Gilead Sciences, MedSIR, University of Bristol
NCT06311214Phase 2Dec 20, 2024National Cancer Institute (NCI), University of Texas at Houston
Showing 20 of 105 trials
Page 1 / 6

Organizations

Research & Development (84)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Gilead SciencesFor profit461232018
ImmunomedicsFor profit161042013
National Cancer Institute (NCI)Government9522018
Harvard UniversityAcademic/Hospital8722019
MerckFor profit7122020
University of Texas at HoustonAcademic/Hospital4312023
Yale UniversityAcademic/Hospital4412020
Everest MedicinesFor profit3322020
MedSIRAcademic/Hospital3312023
Sun Yat-Sen UniversityAcademic/Hospital3312024
University of South FloridaAcademic/Hospital3322021
Bristol-Myers SquibbFor profit2012021
British Columbia Cancer AgencyAcademic/Hospital2212024
Central South UniversityAcademic/Hospital2222025
Guangzhou Medical UniversityAcademic/Hospital2212024
IQVIAFor profit2022020
Ludwig Maximilians UniversityAcademic/Hospital2022023
Medidata SolutionsFor profit2022020
Memorial Sloan-Kettering Cancer CenterAcademic/Hospital2212024
ParexelFor profit2022020
84 organizations
Page 1 / 5

Marketing (3)

OrganizationOrg typeRelationshipDate
Gilead SciencesFor profitNDA2Apr 22, 2020
Gilead SciencesFor profitNDAApr 22, 2020
ImmunomedicsFor profitMKTGApr 22, 2020