Last update 04 Oct 2025

Sacituzumab govitecan-hziy

Overview

Basic Info

Drug Type
Antibody drug conjugate (ADC)
Synonyms
hRS7-SN38 antibody drug conjugate, Isactuzumab govitecan, Sacituzumab Govitecan
+ [11]
Action
inhibitors
Mechanism
TOP1 inhibitors(DNA topoisomerase I inhibitors), Trop-2 inhibitors(Tumor-associated calcium signal transducer 2 inhibitors)
Originator Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
United States (22 Apr 2020),
RegulationPriority Review (United States), Breakthrough Therapy (United States), Fast Track (United States), Accelerated Approval (United States), Orphan Drug (United States), Priority Review (China), Orphan Drug (South Korea), Orphan Drug (Australia), Priority Review (Australia), Fast Track (South Korea), Priority Review (Taiwan Province), Conditional marketing approval (China)
Login to view timeline

Structure/Sequence

Boost your research with our ADC technology data.
Boost your research with our ADC technology data.

External Link

R&D Status

Approved
10 top approved records.
Login
to view more data
IndicationCountry/LocationOrganizationDate
Metastatic Triple-Negative Breast Carcinoma
European Union
22 Nov 2021
Metastatic Triple-Negative Breast Carcinoma
Iceland
22 Nov 2021
Metastatic Triple-Negative Breast Carcinoma
Liechtenstein
22 Nov 2021
Metastatic Triple-Negative Breast Carcinoma
Norway
22 Nov 2021
Breast Cancer
Switzerland
09 Sep 2021
Hormone receptor positive HER2 negative breast cancer
Australia
06 Sep 2021
Transitional Cell Carcinoma
United States
13 Apr 2021
Triple Negative Breast Cancer
United States
22 Apr 2020
Developing
10 top R&D records.
Login
to view more data
IndicationHighest PhaseCountry/LocationOrganizationDate
Metastatic breast cancerNDA/BLA
China
17 May 2021
Extensive stage Small Cell Lung CancerPhase 3
United States
04 Apr 2025
Extensive stage Small Cell Lung CancerPhase 3
Japan
04 Apr 2025
Extensive stage Small Cell Lung CancerPhase 3
Argentina
04 Apr 2025
Extensive stage Small Cell Lung CancerPhase 3
Australia
04 Apr 2025
Extensive stage Small Cell Lung CancerPhase 3
Belgium
04 Apr 2025
Extensive stage Small Cell Lung CancerPhase 3
Brazil
04 Apr 2025
Extensive stage Small Cell Lung CancerPhase 3
Canada
04 Apr 2025
Extensive stage Small Cell Lung CancerPhase 3
France
04 Apr 2025
Extensive stage Small Cell Lung CancerPhase 3
Germany
04 Apr 2025
Login to view more data

Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 4
25
(Sacituzumab Govitecan-hziy (Parent Study: IMMU-132-01))
horrbygxrh = ofugntactx kckulygren (vqgweejzuq, gdrasfqlre - vvedzamxde)
-
30 Sep 2025
(Sacituzumab Govitecan-hziy (Parent Study: IMMU-132-05))
horrbygxrh = kajadsnyio kckulygren (vqgweejzuq, lmvesmioiv - nzacucejez)
Phase 3
Metastatic breast cancer
HR Positive | HER2 Negative
232
ygmwslxapd(tkibwjbtpl) = qdyavlmbgu xjwclewmsr (ezmryenrev, 4.2 - 6.7)
Positive
01 Aug 2025
Treatment of physician’s choice (TPC)
ygmwslxapd(tkibwjbtpl) = mwpfhhussw xjwclewmsr (ezmryenrev, 2.8 - 4.2)
Phase 2
31
Neoadjuvant Sacituzumab Govitecan (SG) + Pembrolizumab (Pembro)
plzjozjgpa(ccqnthvsws) = qsjzewoxgx abyzotyaiy (oktzrxteqw, 21.8 - 57.8)
Positive
30 May 2025
Phase 2
Triple Negative Breast Cancer
Neoadjuvant
PR Negative | HER2 Negative | ER Negative
50
ojshgrhhqm(slzbotrwpg) = ubikrwcmga wugcouuurb (tfgdxsojfg, 19.5 - 46.7)
Positive
30 May 2025
Sacituzumab govitecan + Pembrolizumab + additional neoadjuvant chemotherapy
ojshgrhhqm(slzbotrwpg) = llhvhpbbpi wugcouuurb (tfgdxsojfg, 35.5 - 64.5)
Phase 3
443
cpppqpcpxw(pyzqwfynpn) = ipkbewdeyy xcqdyqulvh (srucvztrag, 9.3 - 16.7)
Positive
30 May 2025
chemotherapy + pembrolizumab
cpppqpcpxw(pyzqwfynpn) = wohlpgylck xcqdyqulvh (srucvztrag, 7.3 - 9.3)
Phase 2
Advanced Urothelial Carcinoma
First line | Maintenance
-
nkaahrqmsa(vudfnibyhp) = xjqkzwofqb crsjlbrvvy (rynegagzja, 7.43 - NE)
Positive
30 May 2025
nkaahrqmsa(vudfnibyhp) = dcjowzxrtf crsjlbrvvy (rynegagzja, 3.32 - 6.77)
Phase 2
Muscle Invasive Bladder Urothelial Carcinoma
Neoadjuvant
Trop-2 | ctDNA assessment
37
phstfrcfrr(ratoxgnwmg) = zeqarbxzec cetsnmxrwf (ifjcprrgxz, 66 - 94)
Positive
30 May 2025
Placebo
cvgkrttlde(dnbvjxxjid) = ovnurpoyef avgevutczy (hdvidkqbyj )
Phase 2
95
Sacituzumab govitecan (SG) alone
tcmhsvcmna(amalgimhmx) = tnajnlovzb bfouiuqqev (zzlnqgagxb )
Positive
30 May 2025
Sacituzumab govitecan (SG) combined with pembrolizumab (SG-pembro)
tcmhsvcmna(amalgimhmx) = cwineggltp bfouiuqqev (zzlnqgagxb )
Not Applicable
83
nivmnthgdl(tnsbahozfy) = The most common grade ≥2 AE was neutropenia (63.9%), with no BMI or weight change association htjqpqkzvb (yaqtdeuyyd )
Negative
30 May 2025
(Normal weight)
Not Applicable
Metastatic HER2-Negative Breast Carcinoma
HER2-negative | TP53 | PIK3CA ...
91
Sacituzumab govitecan (SG)
tbrwbqxagv(mygrbtydit) = smmuzbntdn lcrufqqapu (cgcwbjmfce )
-
30 May 2025
Login to view more data

Translational Medicine

Boost your research with our translational medicine data.
Boost your research with our translational medicine data.

Deal

Boost your decision using our deal data.
Boost your decision using our deal data.

Core Patent

Boost your research with our Core Patent data.
Boost your research with our Core Patent data.

Clinical Trial

Identify the latest clinical trials across global registries.
Identify the latest clinical trials across global registries.

Approval

Accelerate your research with the latest regulatory approval information.
Accelerate your research with the latest regulatory approval information.

Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.
Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

Understand key drug designations in just a few clicks with Synapse.
Understand key drug designations in just a few clicks with Synapse.
AI Agents Built for Biopharma Breakthroughs
Accelerate discovery. Empower decisions. Transform outcomes.
Get started for free today!
Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Start your data trial now!
Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.
Bio
Bio Sequences Search & Analysis
Sign up for free
Chemical
Chemical Structures Search & Analysis
Sign up for free