Urothelial Cancer

Oncology
9
Pipeline Programs
7
Companies
8
Clinical Trials
2 recruiting
1
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
0
4
1
1
2
1
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

ADC
360%
Small Molecule
240%
+ 3 programs with unclassified modality

On Market (1)

Approved therapies currently available

Astellas
PADCEVApproved
enfortumab vedotin
Astellas
injection2019

Competitive Landscape

6 companies ranked by most advanced pipeline stage

Astellas
AstellasChina - Shenyang
1 program
1
1
Enfortumab vedotinPhase 3ADC
AstraZeneca
AstraZenecaCAMBRIDGE, United Kingdom
1 program
1
MEDI4736Phase 31 trial
Active Trials
NCT02516241Active Not Recruiting1,126Est. Dec 2026
DS
Daiichi SankyoChina - Shanghai
1 program
1
Dato-DXdPhase 2/33 trials
Active Trials
NCT07129993Recruiting630Est. Jan 2030
NCT05374512Active Not Recruiting644Est. Nov 2028
NCT05104866Active Not Recruiting732Est. Jul 2026
Pfizer
PfizerNEW YORK, NY
2 programs
1
1
Gemcitabine, Cisplatin, SunitinibPhase 2Small Molecule1 trial
PF-08634404Phase 1/21 trial
Active Trials
NCT07421700Not Yet Recruiting132Est. Sep 2028
NCT00821327Completed36Est. Aug 2012
GS
Gilead SciencesFOSTER CITY, CA
2 programs
2
Sacituzumab GovitecanPhase 1/2ADC
Sacituzumab GovitecanPhase 1/2ADC1 trial
Active Trials
NCT04724018Recruiting106Est. May 2028
Ipsen
IpsenChina - Tianjin
1 program
1
Niraparib plus CabozantinibPhase 1/2Small Molecule1 trial
Active Trials
NCT03425201Completed67Est. Jul 2024

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
2028
2029
2030
Daiichi SankyoDato-DXd
Daiichi SankyoDato-DXd
AstraZenecaMEDI4736
Daiichi SankyoDato-DXd
PfizerGemcitabine, Cisplatin, Sunitinib
PfizerPF-08634404
Gilead SciencesSacituzumab Govitecan
IpsenNiraparib plus Cabozantinib

Clinical Trials (8)

Total enrollment: 3,473 patients across 8 trials

NCT05374512Daiichi SankyoDato-DXd

A Study of Dato-DXd Versus Investigator's Choice Chemotherapy in Patients With Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer, Who Are Not Candidates for PD-1/PD-L1 Inhibitor Therapy (TROPION-Breast02)

Start: May 2022Est. completion: Nov 2028644 patients
Phase 3Active Not Recruiting
NCT05104866Daiichi SankyoDato-DXd

A Phase-3, Open-Label, Randomized Study of Dato-DXd Versus Investigator's Choice of Chemotherapy (ICC) in Participants With Inoperable or Metastatic HR-Positive, HER2-Negative Breast Cancer Who Have Been Treated With One or Two Prior Lines of Systemic Chemotherapy (TROPION-Breast01)

Start: Oct 2021Est. completion: Jul 2026732 patients
Phase 3Active Not Recruiting
NCT02516241AstraZenecaMEDI4736

Study of MEDI4736 (Durvalumab) With or Without Tremelimumab Versus Standard of Care Chemotherapy in Urothelial Cancer

Start: Nov 2015Est. completion: Dec 20261,126 patients
Phase 3Active Not Recruiting
NCT07129993Daiichi SankyoDato-DXd

Study of Datopotamab Deruxtecan Plus Carboplatin or Cisplatin Versus Gemcitabine Plus Carboplatin or Cisplatin in Participants With Locally Advanced or Metastatic Urothelial Carcinoma

Start: Sep 2025Est. completion: Jan 2030630 patients
Phase 2/3Recruiting
NCT00821327PfizerGemcitabine, Cisplatin, Sunitinib

Gemzar, Cisp, Sunitinib Urothelial Ca

Start: Aug 2008Est. completion: Aug 201236 patients
Phase 2Completed
NCT07421700PfizerPF-08634404

A Study to Learn About PF-08634404 Alone or In Combination With Enfortumab Vedotin in Urothelial Cancer

Start: Feb 2026Est. completion: Sep 2028132 patients
Phase 1/2Not Yet Recruiting
NCT04724018Gilead SciencesSacituzumab Govitecan

Sacituzumab Govitecan Plus EV in Metastatic UC

Start: May 2021Est. completion: May 2028106 patients
Phase 1/2Recruiting
NCT03425201IpsenNiraparib plus Cabozantinib

Niraparib in Combination with Cabozantinib (XL184) in Patients with Advanced Urothelial Cancer (NICARAGUA)

Start: Oct 2019Est. completion: Jul 202467 patients
Phase 1/2Completed

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Phase Legend

Preclinical— Lab & animal studies
Phase 1— Safety & dosing
Phase 2— Efficacy testing
Phase 3— Large-scale trials
On Market— Approved & available

Key Insights

2 late-stage (Phase 3) programs — potential near-term approvals
2 actively recruiting trials targeting 3,473 patients
7 companies competing in this space

Related Indications

Breast Cancer(530)Non-small Cell Lung Cancer(373)Prostate Cancer(371)Multiple Myeloma(244)Advanced Solid Tumors(221)Acute Myeloid Leukemia(204)Cancer(187)Neoplasms(173)Colorectal Cancer(166)Advanced Solid Tumor(165)