TRODELVY

(Sacituzumab Govitecan)

Phase 3Antibody–drug conjugate

Gilead

TRODELVY is one of 230 biologic programs targeting Esophageal Squamous Cell Carcinoma. It is currently in Phase 3.

Indications

Total Trials

Active Trials

229

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Esophageal Squamous Cell CarcinomaRecruiting

Triple-Negative Breast CancerRecruiting

Breast CancerNot yet recruiting

Cervical CancerRecruiting

Solid TumorRecruiting

Small Cell Lung Cancer ( SCLC )Recruiting

Metastatic Triple-Negative Breast CancerRecruiting

Metastatic Breast CancerRecruiting

Metastatic HER2-Negative Breast CarcinomaRecruiting

Localized Muscle Invasive Bladder Urothelial CarcinomaRecruiting

Esophageal Squamous Cell CarcinomaPhase 2

Recruiting

Triple-Negative Breast CancerPhase 3

Recruiting

Breast CancerPhase 3

Not yet recruiting

Cervical CancerPhase 2

Recruiting

Solid TumorPhase 1

Recruiting

Small Cell Lung Cancer ( SCLC )Phase 2

Recruiting

Metastatic Triple-Negative Breast CancerPreclinical

Recruiting

Metastatic Breast CancerPreclinical

Recruiting

Metastatic HER2-Negative Breast CarcinomaPhase 2

Recruiting

Localized Muscle Invasive Bladder Urothelial CarcinomaPhase 1

Recruiting

Showing 10 of 15 indications

Competition

Competitive Landscape

706 competitors in Breast Cancer

#DrugCompanyPhaseTrials

TRODELVY

Gilead

Phase 3

3 2

Lexiscan

Astellas

Preclinical

1 3

Methylthioninium Chloride

PProvepharm SAS

Preclinical

3 4

Sporanox

SSebela Pharmaceuticals Development LLC

Preclinical

1 5

Neoadjuvant Treatment

SShanghai Zhongshan Hospital

Preclinical

1 6

Recombinant Human Endostatin

PPeking University Third Hospital

Preclinical

1 7

Tianeptine

Pfizer

Preclinical

1 8

Diuretic

RReprieve Cardiovascular, Inc

Preclinical

1 9

Bisphosphonate

Amgen

Preclinical

2 10

Tc99m Sestamibi

MM.D. Anderson Cancer Center

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 2Recruiting

Anatomic Stage IV Breast Cancer AJCC V8

NCT03606967

Q1 2027

Phase 2Active, not recruiting

Locally Advanced or Metastatic Urothelial Carcinoma

NCT05327530

Q4 2027

Phase 1Recruiting

Localized Muscle Invasive Bladder Urothelial Carcinoma

NCT05833867

Phase 3Active, not recruiting

Metastatic Bladder Urothelial Carcinoma

NCT04579224

Phase 2Recruiting

Esophageal Squamous Cell Carcinoma

NCT06329869

Phase 2Recruiting

Differentiated Thyroid Cancer

NCT06235216

Clinical

Trials by Indication[1]

Breast Cancer3 trials

SERIES: SEquencing Sacituzumab Govitecan AfteR T-DXd In ER+/HER2 LOW/ULTRA LOW MetaStatic Breast Cancer

Recruiting·RReshma L. Mahtani, D.O.·Phase 2·NCT06263543·75 enrolled

NeoAdjuvant Dynamic Marker - Adjusted Personalized Therapy Comparing Sacituzumab Govitecan+Pembrolizumab vs. SoC Chemotherapy in Clinical Stage II-III, Triple-negative Early Breast Cancer

Not yet recruiting·WWest German Study Group·Phase 3·NCT07178730·765 enrolled

Phase 1b/2 Study to Evaluate Antibody-Drug Conjugate Sacituzumab Govitecan in Combination With PARP Inhibitor Talazoparib in Patients With Metastatic Breast Cancer

Active, not recruiting·MMassachusetts General Hospital·Preclinical·NCT04039230·75 enrolled

Triple Negative Breast Neoplasms2 trials

Multi-center, Open-label, Single-arm Phase II Clinical Trial of Sacituzumab-Govitecan Plus Q901 in Advanced TNBC

Not yet recruiting·YYonsei University·Phase 2·NCT07788222·48 enrolled

A Phase 2, Multicenter, Randomized, Open-label Trial Assessing Sacituzumab-govitecan and Trastuzumab-deruxtecan Combinations in an Alternating Regimen for Patients With Metastatic or Locally Advanced HER2-low Triple-negative Breast Cancer

Not yet recruiting·UUNICANCER·Phase 2·NCT07151586·260 enrolled

Triple-Negative Breast Cancer2 trials

NeoAdjuvant Dynamic Marker - Adjusted Personalized Therapy Comparing Sacituzumab Govitecan Versus Sacituzumab Govitecan+Pembrolizumab in Low-risk, Triple-negative Early Breast Cancer (ADAPT-TN-III)

Recruiting·WWest German Study Group·Phase 3·NCT06081244·348 enrolled

ISIdE: Open Label, Multicentric, Single-arm Phase IIIB Trial to Evaluate the Safety and Efficacy of Sacituzumab Govitecan in Triple Negative Metastatic Breast Cancer Patients With a Biomarker Analysis

Active, not recruiting·UUNICANCER·Phase 3·NCT05552001·96 enrolled

Locally Advanced Urothelial Carcinoma1 trial

A Phase III Randomized Trial of Pembrolizumab in Combination With Sacituzumab Govitecan-hziy vs Standard of Care in Anti-PD(L)1-Resistant Advanced Urothelial Cancer

Recruiting·NNational Cancer Institute (NCI)·Phase 3·NCT06524544·320 enrolled

Recurrent Platinum-Sensitive Fallopian Tube Endometrioid Adenocarcinoma1 trial

A Randomized Phase II Trial of Sacituzumab Govitecan-HZIY (SG) and Bevacizumab Versus Standard of Care Carboplatin, Pegylated Liposomal Doxorubicin (PLD) and Bevacizumab in Patients With Platinum-Sensitive Ovarian Cancer That Has Progressed on Prior Maintenance PARP Inhibitor Therapy

Recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT07504588·87 enrolled

23 more indications

Anatomic Stage IV Breast Cancer AJCC v81 trial

Randomized Phase 2 Clinical Trial of Nab-Paclitaxel + Durvalumab (MEDI4736) + Tremelimumab + Neoantigen Vaccine vs. Nab-Paclitaxel + Durvalumab (MEDI4736) + Tremelimumab in Patients With Metastatic Triple Negative Breast Cancer

Recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT03606967·86 enrolled

Gland1 trial

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

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT05884320·63 enrolled

Metastatic Bladder Urothelial Carcinoma1 trial

A Phase III Randomized Trial of Eribulin (NSC #707389) With Gemcitabine Versus Standard of Care (Physician's Choice) for Treatment of Metastatic Urothelial Carcinoma Refractory to, or Ineligible for, Anti PD1/PDL1 Therapy

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 3·NCT04579224·131 enrolled

Extensive Stage Small Cell Lung Cancer (ES-SCLC)1 trial

A Global, Multicenter, Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Standard of Care (SOC) in Participants With Previously Treated Extensive Stage Small Cell Lung Cancer (ES-SCLC)

Recruiting· Gilead logo

Gilead·Phase 3·NCT06801834·695 enrolled

Advanced Malignant Solid Neoplasm1 trial

Optimizing Antibody-Drug Conjugate Therapy Through Molecular Analysis for Therapy Choice (ADC MATCH)

Recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT06311214·500 enrolled

Small Cell Carcinoma1 trial

A Phase II Study of Sacituzumab Govitecan With or Without Atezolizumab Immunotherapy in Rare Genitourinary Tumors (SMART) Such as High Grade Neuroendocrine Carcinomas, Adenocarcinoma, and Squamous Cell Bladder/Urinary Tract Cancer, Renal Medullary Carcinoma and Penile Cancer

Recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT06161532·60 enrolled

Recurrent Lung Non-Small Cell Carcinoma1 trial

A Randomized Phase II Study of Sacituzumab Govitecan Alone, Ivonescimab Alone, or Sacituzumab Govitecan and Ivonescimab in Participants With Previously-Treated Actionable Genomic Alteration Positive Stage IV or Recurrent Non-Small Cell Lung Cancer (Lung-MAP Sub-Study)

Recruiting·SSWOG Cancer Research Network·Phase 2·NCT07393555·117 enrolled

Metastatic Breast Cancer1 trial

A Phase Ib/II, Open-label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic Breast Cancer (Morpheus-panBC)

Recruiting· Roche logo

Roche·Preclinical·NCT03424005·1,132 enrolled

Urinary Bladder Cancer1 trial

An Open Label, Single-arm, Phase 2 Study of Perioperative Sacituzumab Govitecan in Combination With Zimberelimab and Domvanalimab for Patients With Muscle Invasive Bladder Cancer Ineligible for Cisplatin-based Chemotherapy

Active, not recruiting·FFundación para el Progreso de la Oncología en Cantabria·Phase 2·NCT06133517·70 enrolled

Advanced Triple Negative Breast Cancer1 trial

A Phase II Study of First-Line Sacituzumab Govitecan in Advanced Untreated Triple-Negative Breast Cancer Patients.

Recruiting·NNathalie Levasseur·Phase 2·NCT07299409·24 enrolled

Locally Advanced or Metastatic Urothelial Carcinoma1 trial

A Phase II, Multicenter, Randomized, Open Label, Parallel-Arm, Umbrella Study of Avelumab (MSB0010718C) in Combination With Other AntiTumor Agents as a Maintenance Treatment in Participants With Locally Advanced or Metastatic Urothelial Carcinoma Whose Disease Did Not Progress With First Line Platinum-Containing Chemotherapy (JAVELIN Bladder Medley)

Active, not recruiting· EMD Serono Research & Development Institute, Inc. logo

EMD Serono Research & Development Institute, Inc.·Phase 2·NCT05327530·256 enrolled

Esophageal Squamous Cell Carcinoma1 trial

A Phase II Study of Sacituzumab Govitecan for Advanced Esophageal Squamous Cell Carcinoma Patients

Recruiting·NNational Taiwan University Hospital·Phase 2·NCT06329869·35 enrolled

Metastatic Pancreatic Adenocarcinoma1 trial

An Umbrella Clinical Trial of Antibody/Peptide-Drug Conjugates Matched by Mass Spectrometry-Based Absolute Quantitation of Proteins in Locally Advanced or Metastatic Pancreatic or Breast Cancer

Not yet recruiting·FFudan University·Phase 2·NCT07825753·225 enrolled

Differentiated Thyroid Cancer1 trial

A Multicenter, Open Label, Two Cohort, Single Arm, Phase II Study to Evaluate the Efficacy and Safety of the Anti-TROP2 Antibody-drug Conjugate Sacituzumab Govitecan in Patients With Advanced Differentiated and Anaplastic Thyroid Neoplasms.

Recruiting·GGrupo Espanol de Tumores Neuroendocrinos·Phase 2·NCT06235216·42 enrolled

Solid Tumor1 trial

A Phase 1 Study to Evaluate the Safety and Tolerability of GS-0201 as Monotherapy and in Combination in Adults With Advanced Solid Tumors

Recruiting· Gilead logo

Gilead·Phase 1·NCT06167317·278 enrolled

Urothelial Carcinoma1 trial

A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatments and Combinations in Patients With Urothelial Carcinoma (MORPHEUS-UC)

Terminated· Roche logo

Roche·Preclinical·NCT03869190·272 enrolled

Small Cell Lung Cancer ( SCLC )1 trial

Phase II Study of Sacituzumab Govitecan With Atezolizumab/Durvalumab as Maintenance Therapy for Extensive-Stage Small Cell Lung Cancer

Recruiting·BBindu R Potugari·Phase 2·NCT07339059·35 enrolled

Cervical Cancer1 trial

A Phase II Evaluation of Sacituzumab Govitecan (IMMU-132), an Anti-Trop-2-SN-38 Antibody-drug Conjugate in Patients With Recurrent or Persistent Cervical Cancer

Recruiting·YYale University·Phase 2·NCT05838521·20 enrolled

HRD Cancer1 trial

A Phase I/II Study of Sacituzumab Govitecan Plus Berzosertib in Small Cell Lung Cancer, Extra-Pulmonary Small Cell Neuroendocrine Cancer and Homologous Recombination-Deficient Cancers Resistant to PARP Inhibitors

Completed·NNational Cancer Institute (NCI)·Preclinical·NCT04826341·35 enrolled

Localized Muscle Invasive Bladder Urothelial Carcinoma1 trial

Adaptive RADiation Therapy With Concurrent Sacituzumab Govitecan (SG) for Bladder Preservation in Patients With MIBC (RAD-SG).

Recruiting·SShilpa Gupta, MD·Phase 1·NCT05833867·20 enrolled

Invasive Breast Cancer1 trial

A Phase 2 Study of Response-guided Neoadjuvant Sacituzumab Govitecan (IMMU-132) in Patients With Localized Triple-Negative Breast Cancer (NeoSTAR)

Recruiting·MMassachusetts General Hospital·Phase 2·NCT04230109·239 enrolled

Metastatic Triple-negative Breast Cancer1 trial

Phase I/II Study of Naxitamab and Sacituzumab Govitecan in Patients With Metastatic Triple-negative Breast Cancer (TNBC)

Recruiting·MM.D. Anderson Cancer Center·Preclinical·NCT07011654·31 enrolled

Metastatic HER2-Negative Breast Carcinoma1 trial

A Randomized Clinical Trial Comparing ctDNA-Directed Therapy Change With Standard of Care in Patients With Metastatic Triple Negative Breast Cancer

Recruiting·VVanderbilt-Ingram Cancer Center·Phase 2·NCT05770531·160 enrolled

Regulatory

FDA Approval Timeline[4]

Apr 22, 2020

TRODELVY

BLA BLA761115

Sources

References

[1]
ClinicalTrials.gov — 32 trial records for Sacituzumab Govitecan. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Sacituzumab Govitecan compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Sacituzumab Govitecan. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (BLA BLA761115). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Gilead company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Antibody–drug conjugate[2]
Highest Phase: Phase 3[1]
Company: Gilead

TRODELVY

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Q4 2027

Trials by Indication[1]

Breast Cancer3 trials

Triple Negative Breast Neoplasms2 trials

Triple-Negative Breast Cancer2 trials

Locally Advanced Urothelial Carcinoma1 trial

Recurrent Platinum-Sensitive Fallopian Tube Endometrioid Adenocarcinoma1 trial

Anatomic Stage IV Breast Cancer AJCC v81 trial

Gland1 trial

Metastatic Bladder Urothelial Carcinoma1 trial

Extensive Stage Small Cell Lung Cancer (ES-SCLC)1 trial

Advanced Malignant Solid Neoplasm1 trial

Small Cell Carcinoma1 trial

Recurrent Lung Non-Small Cell Carcinoma1 trial

Metastatic Breast Cancer1 trial

Urinary Bladder Cancer1 trial

Advanced Triple Negative Breast Cancer1 trial

Locally Advanced or Metastatic Urothelial Carcinoma1 trial

Esophageal Squamous Cell Carcinoma1 trial

Metastatic Pancreatic Adenocarcinoma1 trial

Differentiated Thyroid Cancer1 trial

Solid Tumor1 trial

Urothelial Carcinoma1 trial

Small Cell Lung Cancer ( SCLC )1 trial

Cervical Cancer1 trial

HRD Cancer1 trial

Localized Muscle Invasive Bladder Urothelial Carcinoma1 trial

Invasive Breast Cancer1 trial

Metastatic Triple-negative Breast Cancer1 trial

Metastatic HER2-Negative Breast Carcinoma1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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