UGN-102
UroGen Pharma Ltd. URGN · Bladder Cancer; Urothelial Carcinoma; Urothelial Carcinoma Bladder
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
- Preclinical Completed
- Phase 1 Completed
- Phase 2 Completed
- Phase 3 Current stageFirst trial start 1 Mar 20221 linked trial
- Filed Not yet
- 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-102. Editors add each one with its source.
Filed application
No filed application is on record for UGN-102. Approvals are listed under FDA actions.
FDA advisory committees
No FDA advisory committee meetings are on record for UGN-102.
Clinical trials
| Trial | Title | Phase | Status | Enrollment | Primary completion | Results posted |
|---|---|---|---|---|---|---|
| NCT05243550ClinicalTrials.gov record for NCT05243550 (opens in a new tab)ENVISION | A Phase 3 Single-Arm Study of UGN-102 for Treatment of Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer | Phase 3 | Active, not recruiting | 240 (actual) | 26 Apr 2023 (actual) | Yes First posted Results on ClinicalTrials.gov for NCT05243550 (opens in a new tab) |
Posted results on ClinicalTrials.gov for ENVISION Serious adverse events (Up to 21 months. Study conduct is ongoing and data are summarized through a cutoff date of 04 Apr 2024. As of the data cutoff date, ongoing patients were followed through at least Study Month 15, with the earliest enrolled patients followed through Study Month 21.): UGN-102 29 of 240 Source: ClinicalTrials.gov results for NCT05243550 (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. Publications listing ENVISION (3), newest first
Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies. | ||||||
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-VCALoading 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-102.
Source: European Medicines Agency (EMA), medicines data download.
Related news
No recent headlines mention this drug.
Sources
- ClinicalTrials.gov NCT05243550 (opens in a new tab) Licence: public-domain. Official registry record this listing came from
Record updated .
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