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Vepugratinib

Phase 3

Carcinoma, Transitional Cell | Small molecule | Oncology |Eli Lilly and Company|Last Updated: Jul 13, 2026

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment450

FDA Designations

No designations recorded

Clinical trial landscape

Vepugratinib · 1 trial · 3 indications

Phase 3 1
NCT07218380A Study of Vepugratinib (LY3866288) in Participants With Cancer in the Urinary TractCarcinoma, Transitional Cell
RECRUITING450 Analytics
PHASE3RECRUITING
A Study of Vepugratinib (LY3866288) in Participants With Cancer in the Urinary Tract
Carcinoma, Transitional CellUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of participants with treatment-related adverse events related to vepugratinib in combination with EV and pembrolizumab
From baseline up to 90 months
Safety Lead-in: Overall Response Rate (ORR)
From baseline up to 90 months

ORR by Investigator Assessment.

Progression-free Survival (PFS)
Baseline to Study Completion (estimated as 6 years)

PFS by blinded independent committee review (BICR).

Secondary Endpoints

Safety Lead-in: Disease Control Rate (DCR)
From baseline up to the end of Cycle 2 (each Cycle is 21 days)
Safety Lead-in: Time to Response (TTR)
From baseline up to 90 months
Overall Survival (OS)
Baseline to Study Completion (estimated as 6 years)
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Vepugratinib + EV + Pembrolizumab (Safety Lead In)EXPERIMENTALVepugratinib administered orally with EV + pembrolizumab administered IV
Vepugratinib + Enfortumab Vedotin (EV) + PembrolizumabEXPERIMENTALVepugratinib administered orally, and EV + pembrolizumab administered by intravenous (IV) infusion.
Placebo + EV + PembrolizumabPLACEBO_COMPARATORPlacebo administered orally, and EV + pembrolizumab administered by IV infusion.

Interventions

NameTypeDescription
VepugratinibDRUGAdministered orally
PlaceboOTHERAdministered orally
EVDRUGAdministered by IV infusion
PembrolizumabDRUGAdministered by IV infusion
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites286

Inclusion Criteria: * Have histologically confirmed, unresectable locally advanced or metastatic urothelial cancer (mUC). Individuals with mixed histology other than small cell or neuroendocrine carcinoma are eligible if a urothelial component is present. * Have a qualifying fibroblast growth facto...

Countries:United StatesAustraliaBrazilCanadaChinaCzechiaDenmarkFranceGermanyHungaryItalyJapanNetherlandsPolandSouth KoreaSpainTaiwanTurkey (Türkiye)United Kingdom
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Recent Changes (Last 90 Days)

LOWJul 13, 2026NCT07218380lastUpdatePostDate: changed
LOWJul 13, 2026NCT07218380lastUpdatePostDate: changed
LOWJul 7, 2026NCT07218380lastUpdatePostDate: changed
LOWJul 7, 2026NCT07218380lastUpdatePostDate: changed
LOWJun 23, 2026NCT07218380lastUpdatePostDate: changed
LOWJun 23, 2026NCT07218380lastUpdatePostDate: changed
LOWJun 3, 2026NCT07218380lastUpdatePostDate: changed
LOWJun 3, 2026NCT07218380lastUpdatePostDate: changed
LOWMay 26, 2026NCT07218380primaryCompletionDate: changed
LOWMay 24, 2026NCT07218380studyFirstPostDate: changed

Frequently asked questions about Vepugratinib

What is Vepugratinib used for?

Vepugratinib is an investigational small molecule being studied for the treatment of transitional cell carcinoma, a type of cancer that occurs in the urinary tract, including the urinary bladder. It is also being evaluated in patients with neoplasm metastasis, meaning cancer that has spread to other parts of the body.

What does Vepugratinib target?

Vepugratinib is a kinase inhibitor, as indicated by its '-tinib' suffix. Kinase inhibitors work by blocking specific enzymes called kinases, which are involved in cell signaling and growth. By inhibiting these kinases, Vepugratinib aims to interfere with the growth and spread of cancer cells.

Who makes Vepugratinib?

Vepugratinib is being developed by Eli Lilly and Company, a pharmaceutical company traded on the stock exchange under the ticker symbol LLY. The company is conducting clinical trials to evaluate the drug's safety and effectiveness in patients with transitional cell carcinoma.

What phase is Vepugratinib in?

Vepugratinib is currently in Phase 3 clinical development. This means it is being studied in a large, late-stage trial to confirm its efficacy and monitor side effects in a larger patient population. It is still investigational and has not been approved by regulatory authorities.

What clinical trials is Vepugratinib in?

Vepugratinib is being studied in a Phase 3 clinical trial with the identifier NCT07218380. This trial is recruiting participants with transitional cell carcinoma, urinary bladder neoplasms, and neoplasm metastasis. The study is randomized, double-blind, and placebo-controlled, with an estimated enrollment of 450 participants.

Is Vepugratinib the same as LY3866288?

Yes, Vepugratinib is also known as LY3866288. In clinical trial NCT07218380, the drug is referred to by this alternative name. Both names refer to the same investigational drug being developed by Eli Lilly and Company for the treatment of urinary tract cancers.