HelpAcademyLoginJoin us as a Member

UGN-103

Not yet reviewed: Listed from FDA or ClinicalTrials.gov records; an editor has not checked it yetListed from FDA or ClinicalTrials.gov records; an editor has not checked it yet.

UroGen Pharma Ltd. URGN · Bladder Cancer; Urothelial Carcinoma; Urothelial Carcinoma Bladder

Sign in to save UGN-103 to a watchlist Sign in to set an alert for UGN-103

Key figures

  • Next catalyst

    None scheduled

    Only dates with a source are listed

  • Phase

    Phase 3

    Not recorded

  • Linked trials

    1

    From ClinicalTrials.gov

  • Latest FDA action

    None on record

    From Drugs@FDA

Recalls, shortages, patents and EU status at a glance

Key information

Sponsor
UroGen Pharma Ltd. URGN Source: Company record for UroGen Pharma Ltd. (opens in a new tab)
Indications
Bladder Cancer; Urothelial Carcinoma; Urothelial Carcinoma Bladder Source: Conditions from ClinicalTrials.gov (opens in a new tab)
Designations
None recorded
Next catalyst
None scheduled

Development timeline

  1. Preclinical Completed
  2. Phase 1 Completed
  3. Phase 2 Completed
  4. Phase 3 Current stageFirst trial start 29 Aug 20241 linked trial
  5. Filed Not yet
  6. Approved Not yet

Overview

Mechanism
Not recorded
Route
Not recorded
Modality
Not recorded
Specialties
Not recorded

Overview text is written by HealthTrade editors.

Key dates

No catalysts yet. Editors add each date together with its source.

FDA designations

No FDA designations are on record for UGN-103. Editors add each one with its source.

Filed application

No filed application is on record for UGN-103. Approvals are listed under FDA actions.

FDA advisory committees

No FDA advisory committee meetings are on record for UGN-103.

Clinical trials

Trials linked to UGN-103
TrialTitlePhaseStatusEnrollmentPrimary completionResults posted
NCT06331299ClinicalTrials.gov record for NCT06331299 (opens in a new tab)UTOPIAA Phase 3 Study of UGN-103 for Treatment of Patients With Low-grade Intermediate-risk Non-muscle Invasive Bladder CancerPhase 3Completed99 (actual)11 Sep 2025 (actual) Yes First posted Results on ClinicalTrials.gov for NCT06331299 (opens in a new tab)

Posted results on ClinicalTrials.gov for UTOPIA

Serious adverse events (Up to 15 months. Study conduct is ongoing and data are summarized through a cutoff date of 18 Mar 2026. As of the data cutoff date, ongoing patients were followed through at least Study Month 9, with the earliest enrolled patients followed through Study Month 15.): UGN-103 2 of 99

Source: ClinicalTrials.gov results for NCT06331299 (opens in a new tab)· imported

Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately.

Source: ClinicalTrials.gov, U.S. National Library of Medicine. Posted results are shown as ClinicalTrials.gov prints them; results from company and journal sources are entered by editors and listed separately. Full result tables are on ClinicalTrials.gov.

Trial quality

About CT-VCA

Loading trial quality…

FDA actions

No FDA approvals on record for this drug.

FDA recalls load here.

FDA drug shortages load here.

Orange Book patents load here.

FAERS adverse event counts load here.

Papers and preprints load here.

Community discussion loads here.

EU status (EMA)

EMA's medicines data lists no human medicine with the same active substance as UGN-103.

Source: European Medicines Agency (EMA), medicines data download.

Related news

No recent headlines mention this drug.

Sources

Record updated .

Dates come from company and FDA disclosures and can change. Nothing on this page is investment advice.