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Sacituzumab Govitecan (SG)
Sacituzumab Govitecan (SG) is a Antibody-drug conjugate (ADC) Small molecule drug developed by University of California, Irvine. It is currently in Phase 3 development for Metastatic triple-negative breast cancer, Metastatic urothelial carcinoma, Non-small cell lung cancer. Also known as: Trodelvy®, GS-0132, IMMU 132, Trodelvy.
Sacituzumab govitecan is an antibody-drug conjugate that targets Trop-2 on cancer cells and delivers the topoisomerase I inhibitor SN-38 directly to tumor tissue.
Sacituzumab Govitecan (SG) is an antibody drug conjugate that targets the tumor-associated calcium signal transducer 2. It is being studied for the treatment of various cancers, including triple-negative breast neoplasms, neoplasm metastasis, HER 2 low-expressing breast cancer, salivary gland cancer, and thyroid cancer.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Oncology Phase 3 boost
+3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Sacituzumab Govitecan (SG) |
|---|---|
| Also known as | Trodelvy®, GS-0132, IMMU 132, Trodelvy, IMMU-132 |
| Sponsor | University of California, Irvine |
| Drug class | Antibody-drug conjugate (ADC) |
| Target | Trop-2 (TACSTD2) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
The drug consists of a humanized monoclonal antibody against Trop-2 (a tumor-associated antigen) conjugated to govitecan, which is metabolized to SN-38, a potent topoisomerase I inhibitor. Upon binding to Trop-2 on cancer cell surfaces, the antibody-drug conjugate is internalized, releasing SN-38 intracellularly to induce DNA damage and apoptosis. This targeted delivery approach aims to maximize efficacy while reducing systemic toxicity compared to unconjugated chemotherapy.
Approved indications
- Metastatic triple-negative breast cancer
- Metastatic urothelial carcinoma
- Non-small cell lung cancer
Common side effects
- Neutropenia
- Diarrhea
- Nausea
- Fatigue
- Anemia
Key clinical trials
- Bispecific T-Cell Engager Tarlatamab and TROP2 Targeted Antibody Drug Conjugate Sacituzumab Govitecan in Previously Treated Extensive-Stage Small Cell Lung Cancer and Extrapulmonary Neuroendocrine Cancer (PHASE1, PHASE2)
- Study of Sacituzumab Tirumotecan Combined With Toripalimab for Resectable Stage II-IIIB NSCLC (PHASE2)
- Study of Sacituzumab Govitecan Versus Standard of Care in Participants With Previously Treated Extensive Stage Small Cell Lung Cancer (PHASE3)
- Study of Novel Treatment Combinations in Patients With Lung Cancer (PHASE2)
- Study of Sacituzumab Govitecan in Participants With Urothelial Cancer That Cannot Be Removed or Has Spread (PHASE2)
- Adaptive RADiation Therapy With Concurrent Sacituzumab Govitecan (SG) for Muscle Invasive Bladder Cancer (PHASE1)
- A Study of Sacituzumab Govitecan in Combination With Cetuximab in People With Head and Neck Squamous Cell Cancer (HNSCC) (PHASE2)
- Saci Nivo Rela for TNBC (PHASE1, PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Sacituzumab Govitecan (SG) CI brief — competitive landscape report
- Sacituzumab Govitecan (SG) updates RSS · CI watch RSS
- University of California, Irvine portfolio CI
Frequently asked questions about Sacituzumab Govitecan (SG)
What is Sacituzumab Govitecan (SG)?
How does Sacituzumab Govitecan (SG) work?
What is Sacituzumab Govitecan (SG) used for?
Who makes Sacituzumab Govitecan (SG)?
Is Sacituzumab Govitecan (SG) also known as anything else?
What drug class is Sacituzumab Govitecan (SG) in?
What development phase is Sacituzumab Govitecan (SG) in?
What are the side effects of Sacituzumab Govitecan (SG)?
What does Sacituzumab Govitecan (SG) target?
Related
- Drug class: All Antibody-drug conjugate (ADC) drugs
- Target: All drugs targeting Trop-2 (TACSTD2)
- Manufacturer: University of California, Irvine — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Metastatic triple-negative breast cancer
- Indication: Drugs for Metastatic urothelial carcinoma
- Indication: Drugs for Non-small cell lung cancer
- Also known as: Trodelvy®, GS-0132, IMMU 132, Trodelvy, IMMU-132
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing