Ozmosi | Sacituzumab govitecan Drug Profile

Product Description

Sacituzumab govitecan-hziy is a type of targeted therapy drug called an antibody-drug conjugate. It consists of a monoclonal antibody linked to a toxic drug called SN-38 that binds to a protein on the surface of some cancer cells. The linked drug enters these cancer cells and blocks an enzyme called topoisomerase I. This damages the DNA of the cancer cells and kills them. (Sourced from: https://www.cancer.gov/about-cancer/treatment/drugs/sacituzumabgovitecan-hziy)

Mechanisms of Action: TROP2 Inhibitor

Novel Mechanism: No

Modality: Antibody Drug Conjugate

Route of Administration: Intravenous

FDA Designation: Accelerated Approval - Breast Cancer|Oncology Solid Tumor Unspecified|Triple Negative Breast Cancer
Accelerated Approval - Oncology Solid Tumor Unspecified|Transitional Cell Carcinoma
Breakthrough Therapy - Small Cell Lung Cancer
Fast Track - Oncology Solid Tumor Unspecified|Transitional Cell Carcinoma
Orphan Drug - Breast Cancer|Oncology Solid Tumor Unspecified|Triple Negative Breast Cancer
Orphan Drug - Glioblastoma *

Approval Status: Approved

Approved Indications: None

Known Adverse Events: None

Company: Gilead Sciences
Company Location: Western America
Company CEO: Daniel P. O’Day
Additional Commercial Interests: Everest Medicines

Clinical Description

Map of Global Clinical Trials for Sacituzumab govitecan

Countries in Clinic: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Croatia, Czech Republic, France, Georgia, Germany, Greece, Hong Kong, Hungary, Ireland, Israel, Italy, Japan, Korea, Malaysia, Mexico, Netherlands, Poland, Portugal, Puerto Rico, Romania, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, United States, Unknown Location

Active Clinical Trial Count: 97

Recent & Upcoming Milestones

Clinical Outcomes Reported - Gilead Sciences presented P3 Breast Cancer results on 2025-11-07 for Sacituzumab govitecan
Clinical Outcomes Reported - Gilead Sciences presented P3 Triple Negative Breast Cancer results on 2025-10-19 for Sacituzumab govitecan
Clinical Outcomes Reported - Gilead Sciences presented P3 Triple Negative Breast Cancer results on 2025-05-23 for Sacituzumab govitecan

Highest Development Phases

Phase 1: Liver Failure

Trial ID	Trial	Phase	Trial Status	Disease	Primary Completion Date	Probability of Success	Latest Trial Update Date	Data Updated
NCT04617522	IMMU-132-15	P1	Recruiting	Liver Failure	2026-12-01	50%	2024-07-27	Primary Completion Date\|Primary Endpoints\|Study Completion Date\|Treatments
NCT05833867	RAD-SG	P1	Recruiting	Bladder Cancer\|Transitional Cell Carcinoma	2025-12-01	50%	2025-01-03	Primary Completion Date\|Primary Endpoints\|Start Date\|Treatments
NCT06923826	TROP2	P2	Recruiting	Salivary Gland Cancer\|Salivary Gland Diseases\|Thyroid Cancer	2030-04-01	12%	2025-07-26	Primary Endpoints\|Start Date\|Treatments\|Trial Status
NCT06477419	NCT06477419	P2	Recruiting	Mesothelioma	2029-06-21	12%	2024-06-28	Primary Endpoints\|Treatments
NCT05884320	NCI-2023-04260	P2	Recruiting	Salivary Gland Cancer	2028-07-31	12%	2026-01-10	Primary Completion Date\|Primary Endpoints\|Study Completion Date\|Treatments
NCT07063212	NCT07063212	P2	Recruiting	Mouth Cancer\|Laryngeal Cancer\|Oropharyngeal Cancer\|Squamous Cell Carcinoma\|Head and Neck Cancer	2028-01-02	12%	2025-07-15	Primary Endpoints\|Treatments
NCT06235216	SETHY	P2	Recruiting	Anaplastic Thyroid Carcinoma\|Thyroid Cancer	2027-12-01	64%	2024-09-26	Primary Endpoints\|Start Date\|Treatments\|Trial Status
NCT04724018	NCT04724018	P2	Recruiting	Renal Cell Carcinoma\|Transitional Cell Carcinoma\|Bladder Cancer	2027-02-01	12%	2025-11-05	Primary Completion Date\|Primary Endpoints\|Study Completion Date\|Treatments\|Trial Status
NCT06682728	UCI 23-59	P2	Recruiting	Bladder Cancer\|Muscle Cancer\|Transitional Cell Carcinoma	2026-12-01	12%	2024-11-22	Primary Endpoints\|Treatments\|Trial Status
NCT06100874	SATEEN	P2	Recruiting	Male Breast Cancer	2026-11-30	12%	2024-03-16	Primary Endpoints\|Start Date\|Treatments
NCT06401824	CO-NL-979-6888	P2	Recruiting	Brain Cancer\|Small Cell Lung Cancer\|Non-Small-Cell Lung Cancer	2026-11-01	12%	2025-05-07	Primary Endpoints\|Start Date\|Treatments\|Trial Status
NCT06329869	SG-ESCC	P2	Recruiting	Squamous Cell Carcinoma\|Esophageal Cancer	2026-11-01	12%	2024-12-03	Primary Endpoints\|Start Date\|Trial Status
NCT06028932	NCT06028932	P2	Active, not recruiting	Ovarian Cancer	2026-11-01	2%	2025-09-16
NCT05119907	EVER-132-003	P2	Active, not recruiting	Oncology Solid Tumor Unspecified	2026-10-01	12%	2025-11-18	Primary Completion Date\|Primary Endpoints\|Study Completion Date\|Treatments
NCT06248515	STUDY00007501	P2	Recruiting	Thymoma	2026-04-01	12%	2024-05-30	Primary Completion Date\|Primary Endpoints\|Start Date
NCT04986579	NCT04986579	P2	Recruiting	Breast Cancer\|Alopecia	2026-06-01	75%	2024-06-28	Primary Completion Date\|Primary Endpoints\|Study Completion Date\|Treatments
NCT05838521	NCT05838521	P2	Recruiting	Cervical Cancer\|Uterine Cancer	2026-06-01	12%	2024-01-12	Primary Endpoints\|Start Date
NCT04468061	Saci-IO TNBC	P2	Recruiting	Triple Negative Breast Cancer	2026-04-01	12%	2024-04-17	Primary Completion Date\|Primary Endpoints\|Study Completion Date\|Treatments
NCT05186974	EVOKE-02	P2	Active, not recruiting	Non-Small-Cell Lung Cancer	2026-02-01	2%	2024-08-24	Primary Completion Date\|Primary Endpoints\|Treatments
NCT06123468	SAGA	P2	Completed	Gastrointestinal Cancer\|Adenocarcinoma\|Esophageal Cancer	2026-01-07	66%	2026-01-09	Patient Enrollment\|Primary Completion Date\|Primary Endpoints\|Study Completion Date\|Treatments\|Trial Status
NCT04039230	NCT04039230	P2	Recruiting	Breast Cancer	2025-12-01	12%	2024-04-02	Primary Completion Date\|Primary Endpoints\|Study Completion Date\|Treatments
NCT04251416	NCT04251416	P2	Active, not recruiting	Endometrial Cancer	2025-12-01	12%	2025-08-14	Primary Endpoints\|Treatments\|Trial Status
NCT03725761	UW18043	P2	Active, not recruiting	Prostate Cancer	2024-04-18	12%	2025-04-26
2024-512279-10-00	GS-US-595-6184	P3	Recruiting	Triple Negative Breast Cancer	2033-05-20		2025-05-02	Treatments
NCT07178730	ADAPT-TN-IV	P3	Not yet recruiting	Triple Negative Breast Cancer	2033-03-31	65%	2025-09-18	Primary Endpoints

Recent News Events

Date	Type	Title
01/12/2026	News Article	Royalty Pharma to Highlight Accomplishments and Provide Business Update at 44th Annual J.P. Morgan Healthcare Conference
01/09/2026	News Article	Royalty Pharma Announces Dividend Increase
12/29/2025	News Article	Royalty Pharma Acquires Remaining Royalty Interest in Roche's Evrysdi for $240 Million and Potential Milestones
12/23/2025	News Article	SN BioScience received US FDA Orphan Drug Designation for its Nano Anti-Cancer Drug 'SNB-101' on Gastric Cancer.

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Sacituzumab govitecan

Alternative Names: sacituzumab govitecan, immu-132, trodelvy, sacituzumab govitecan-hziy Clinical Status: Active Latest Update: 2026-01-09 Latest Update Note: Clinical Trial Update