Last reviewed 2026-05-26 · How we verify

Vepugratinib

Eli Lilly and Company · Phase 3 active Small molecule ✓ Verified May 2026

Vepugratinib is a Small molecule drug developed by Eli Lilly and Company. It is currently in Phase 3 development.

Vepugratinib is being studied in a clinical trial for the treatment of urinary tract cancer, specifically carcinoma of the transitional cell and urinary bladder neoplasms. The study is comparing the efficacy of vepugratinib to a placebo and EV (likely a different treatment or control group) in participants with cancer that has metastasized.

Likelihood of approval

61.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

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).
Big-pharma sponsor +3.0pp
Eli Lilly and Company is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.

Predicted approval windows by jurisdiction (conditional on FDA approval)

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	Vepugratinib
Sponsor	Eli Lilly and Company
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 3

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

A Study of Vepugratinib (LY3866288) in Participants With Cancer in the Urinary Tract (PHASE3)

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:

Vepugratinib CI brief — competitive landscape report
Vepugratinib updates RSS · CI watch RSS
Eli Lilly and Company portfolio CI

Frequently asked questions about Vepugratinib

What is Vepugratinib?

Vepugratinib is a Small molecule drug developed by Eli Lilly and Company.

Who makes Vepugratinib?

Vepugratinib is developed by Eli Lilly and Company (see full Eli Lilly and Company pipeline at /company/eli-lilly).

What development phase is Vepugratinib in?

Vepugratinib is in Phase 3.

Manufacturer: Eli Lilly and Company — full pipeline
Therapeutic area: All drugs in Other

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing