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Drug

Sacituzumab govitecan

Approved · FDA
ClassDNA topoisomerase I inhibitorEmerging researchLate-stage developmentCooling momentum
10
Research papers
72
Active clinical trials
2
Protein targets
12
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Phase II Trial of Sacituzumab Govitecan in Recurrent and/or Metastatic Secretory Gland Cancers

Clinical trial2026-07-16Results expected Q3 2028 · ClinicalTrials.gov

Efficacy and Safety of Sacituzumab Govitecan in Patients With Advanced Solid Tumors (TROPiCS-03): Analysis in Patients With Advanced Endometrial Cancer.

Research2024-07-31Journal of clinical oncology : official journal of the American Society of Clinical Oncology

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Sacituzumab govitecan
RxNorm CUI
2360232
ChEMBL ID
CHEMBL3545262
ATC codes
L01FX17
UNII
M9BYU8XDQ6
Primary mechanism
DNA topoisomerase I inhibitor
Regulatory jurisdictions
fda

Pharmacology & targets

2 targets

Known molecular targets and mechanisms supported by curated pharmacology databases.

DNA topoisomerase 1
TOP1 · P11387
INHIBITORDNA topoisomerase I inhibitor
BINDING AGENTTumor-associated calcium signal transducer 2 binding agent

Regulatory timeline

12 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2020-04-22
Latest approval
2026-06-24
Authorities
FDA
Total events
12
fdaU.S. Food and Drug Administration· 12 events
2026-06-24Indication expansion
Indication expansion: SACITUZUMAB GOVITECAN (BLA761115)
Evidence ↗
2026-06-24Indication expansion
Indication expansion: SACITUZUMAB GOVITECAN (BLA761115)
Evidence ↗
2025-03-26Label change
Label change: SACITUZUMAB GOVITECAN (BLA761115)
Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

Clinical trials

86 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
86
registered trials across all phases
LATEST COMPLETION 2026
72
Active studies
52
Recruiting
13
Late-stage (III+)
6
Completed
8
Discontinued
PHASE DISTRIBUTIONn = 86
Early Phase 11Phase 15Phase 1 / 216Phase 251Phase 2 / 31Phase 311Phase N / A1

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Recent completions

Trials that read out recently, adding to the completed evidence base.

Research activity

10 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time
20212026
Most influential
Recent papers
Major research themes8
Antibodies, Monoclonal, Humanized8Immunoconjugates6Camptothecin5Triple Negative Breast Neoplasms3Carcinoma, Transitional Cell2Antibodies, Monoclonal1Antineoplastic Combined Chemotherapy Protocols1Breast Neoplasms1
Journals, researchers & institutions
Top journals
  • Journal of clinical oncology : official journal of the American Society of Clinical Oncology3
  • The New England journal of medicine2
  • Annals of oncology : official journal of the European Society for Medical Oncology1
  • Cancer discovery1
  • Clinical pharmacokinetics1
  • JCO oncology practice1
Leading researchers
  • Bardia A2
  • Im SA2
  • Kalinsky K2
  • Mekan S2
  • Schmid P2
  • Tolaney SM2
  • Wang X2
  • Abdou Y1
Leading institutions
free-text, unnormalised
  • Massachusetts General Hospital2
  • Seoul National University Hospital2
  • Yale School of Medicine2
  • AdventHealth Cancer Institute1
  • Araujo Jorge Cancer Hospital1
  • Asan Medical Center1

Related diseases

3 conditions

Regulator-approved indications and conditions co-mentioned with this drug across the research literature. Number shows shared papers.

Related drugs

6 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

Studied across 10 of the same disease areas as Sacituzumab govitecan in the shared literature.

10 shared papers10 shared diseases

Studied across 10 of the same disease areas as Sacituzumab govitecan in the shared literature.

10 shared diseases2 shared papers

Studied across 7 of the same disease areas as Sacituzumab govitecan in the shared literature.

7 shared diseases1 shared paper

Studied across 5 of the same disease areas as Sacituzumab govitecan in the shared literature.

5 shared diseases1 shared paper

Studied across 5 of the same disease areas as Sacituzumab govitecan in the shared literature.

5 shared diseases1 shared paper

Studied across 3 of the same disease areas as Sacituzumab govitecan in the shared literature.

3 shared diseases1 shared paper
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.