Company profile
UROGEN PHARMA LTD.
NASDAQ:URGNBiotechnology: Pharmaceutical Preparations
Drug pipeline (3)
| Asset | Stage | Revenue | Trials | Status |
|---|---|---|---|---|
| ZUSDURI | approved | $50.4MQ2 2026 | 4 | approved |
| JELMYTO | approved | $22.0MQ2 2026 | 4 | approved |
| ZALIFRELIMAB | phase2 | — | 6 | completed, terminated, withdrawn |
Revenue is the latest quarter the company reported for that product, from SEC filings; a fourth quarter is the year less nine months when no filing states one. Trial counts are of the product's ingredients, deduplicated by trial, so products sharing an ingredient share trials.
Clinical trials (12)
| NCT ID | Phase | Status | Start | Completion | Sponsor name | Title |
|---|---|---|---|---|---|---|
| NCT05375903 | phase1 | completed | 2022-06-01 | 2026-01-09 | UroGen Pharma Ltd. | A Phase 1 Dose-escalation Study of UGN-301 in Patients With Recurrent Non-muscle Invasive Bladder Cancer (NMIBC) |
| NCT07725796 | phase1 | not_yet_recruiting | 2026-09-30 | 2029-08-02 | UroGen Pharma, Inc., a subsidiary of UroGen Pharma Ltd. | A Phase 1 Dose-escalation Study of UGN-501 Administered Intravesically in Adult Participants With Recurrent NMIBC |
| NCT03558503 | phase2 | completed | 2018-10-15 | 2020-01-03 | UroGen Pharma Ltd. | A Phase 2b Study of UGN-102 for Low Grade Intermediate Risk Non-Muscle-Invasive Bladder Cancer |
| NCT05243550 | phase3 | active_not_recruiting | 2022-03-01 | 2023-04-26 | UroGen Pharma Ltd. | A Phase 3 Single-Arm Study of UGN-102 for Treatment of Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer |
| NCT06774131 | phase3 | recruiting | 2025-08-06 | 2027-03-01 | UroGen Pharma Ltd. | A Phase 3 Single-arm Study of UGN-104 for the Treatment of Low-grade Upper Tract Urothelial Cancer |
FDA applications (2)
| Application | Approved | Type | Applicant | Products | ||||
|---|---|---|---|---|---|---|---|---|
| NDA 215793 | 2025-06-12 | NDA | UROGEN PHARMA LTD | |||||
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| NDA 211728 | 2020-04-15 | NDA | UROGEN PHARMA LTD | |||||
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