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Clinical trials
catalyst calendar across sponsors →Studies where URGN is the lead sponsor, as filed with ClinicalTrials.gov. Completion dates are the sponsor's own projected windows and are revised as a study runs. Active studies first, then completed and stopped — newest readout first within each.
17 interventional · 1 observational · 1 expanded access · 5 with posted results
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| Study | Phase | Status | Interventions | Conditions | Enrollment | Primary completion | Readout in | Updated |
|---|---|---|---|---|---|---|---|---|
| A Phase 3 Single-arm Study of UGN-104 for the Treatment of Low-grade Upper Tract Urothelial CancerNCT06774131Complete response rate (CRR)Open-label · Treatment | Phase 3 | Recruiting | Drug: UGN-104 | Upper Urinary Tract Urothelial Carcinoma, Urothelial Carcinoma | 70 | Mar 2027 | ≤ 224 d | 2026-06-16 |
| uTRACT Jelmyto Registry: A Registry of Patients With Upper Tract Urothelial Cancer (UTUC) Treated With JelmytoNCT05874921observationalRate of CR or no evidence of disease (NED) at first evaluation post-treatment | — | Recruiting | Drug: Jelmyto (mitomycin) for pyelocalyceal solution | Urothelial Carcinoma, Urothelial Carcinoma Recurrent, Urothelial Carcinoma Ureter, Urothelial Carcinoma Ureter Recurrent, Urothelial Cancer of Renal Pelvis, Urothelial Carcinoma of the Renal Pelvis and Ureter, Carcinoma, Transitional Cell, Transitional Cell Carcinoma of Renal Pelvis | 400 | Apr 2026 | — | 2025-02-28 |
| A Phase 3 Study of UGN-103 for Treatment of Patients With Low-grade Intermediate-risk Non-muscle Invasive Bladder CancerNCT06331299Complete response rate (CRR)Open-label · Treatment | Phase 3 | Active, not recruiting | Drug: UGN-103 | Bladder Cancer, Urothelial Carcinoma, Urothelial Carcinoma Bladder | 99 | 2025-09-11actual | — | 2026-01-15 |
| A Phase 3 Single-Arm Study of UGN-102 for Treatment of Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder CancerNCT05243550results2024-11-04Complete Response Rate (CRR)Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Active, not recruiting | Drug: UGN-102 | Bladder Cancer, Urothelial Carcinoma, Urothelial Carcinoma Bladder | 240 | 2023-04-26actual | — | 2026-05-11 |
| A Phase 1 Dose-escalation Study of UGN-301 in Patients With Recurrent Non-muscle Invasive Bladder Cancer (NMIBC)NCT05375903Incidence of dose-limiting toxicities (DLTs) and treatment-emergent adverse events (TEAEs)Non-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: UGN-301, UGN-201, Gemcitabine | Non-muscle Invasive Bladder Cancer, NMIBC, Carcinoma in Situ of Bladder, Bladder Cancer, Urothelial Carcinoma Bladder, Urothelial Carcinoma Recurrent | 51 | 2026-01-09actual | — | 2026-01-14 |
| A Phase 3 Study of UGN-102 for Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder CancerNCT04688931results2024-06-06Disease-free Survival (DFS)Randomized · Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Terminatedsponsor's stated reason: Alternate approach pursued | Drug: UGN-102 · Procedure: TURBT | Bladder Cancer, Urothelial Carcinoma, Urothelial Carcinoma Bladder | 282 | 2023-03-17actual | — | 2024-06-06 |
| Feasibility of Home Instillation of UGN-102 for Treatment of Low-Grade (LG) Non-Muscle Invasive Bladder Cancer (NMIBC)NCT05136898results2024-09-19Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Discontinuation, and TEAEs of Special Interest.Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: UGN-102 | Bladder Cancer, Urothelial Carcinoma, Urothelial Carcinoma Bladder | 8 | 2023-02-02actual | — | 2024-09-19 |
| Efficacy and Safety of UGN-101 in Recurrent PatientsNCT04006691Complete response (CR) rateOpen-label · Treatment | Phase 3 | Withdrawnsponsor's stated reason: Due to projected low enrollment, it has decided not to move forward with the study. | Drug: UGN-101 instillations | Carcinoma, Transitional Cell Carcinoma, Transitional Cell Cancer of the Renal Pelvis and Ureter | 0 | 2020-03-31 | — | 2020-05-07 |
| A Phase 2b Study of UGN-102 for Low Grade Intermediate Risk Non-Muscle-Invasive Bladder CancerNCT03558503results2022-07-25Complete Response (CR) Rate for UGN-102 TreatmentOpen-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: UGN-102 | Bladder Cancer, Urothelial Carcinoma, Urothelial Carcinoma Bladder | 63 | 2020-01-03actual | — | 2022-09-16 |
| The OLYMPUS Study - Optimized DeLivery of Mitomycin for Primary UTUC StudyNCT02793128results2020-11-20The Primary Efficacy Endpoint Was the Number of Patients Attaining Complete Response (CR) at the End of the Treatment Period (PDE Visit).Open-label · TreatmentInformed Consent Form ↗ · Study Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: UGN-101 instillations | Carcinoma, Transitional Cell, Transitional Cell Carcinoma of Renal Pelvis | 71 | 2019-04-05actual | — | 2020-12-22 |
| Safety and Efficacy Study of Intravesical Instillations of BotuGelTM, Slow Release RTGel Based Botox® Formulations, in Idiopathic OAB Patients With Urinary Incontinence ("INTIMO2")NCT02674269Urinary retentionRandomized · Quadruple-masked · Treatment | Phase 1/2 | Withdrawnsponsor's stated reason: UroGen's RTGelTM delivery system technology for use with neurotoxins licensed to Allergan plc before the activation of this trial. | Drug: 300 IU of BotuGelTM (60ml), 400 IU of BotuGelTM (60ml) · Device: TC-3 Gel | Overactive Bladder | 0 | Oct 2016 | — | 2017-06-16 |
| Pre-TURBT TC-3 Gel Intravesical Instillation in NMIBCNCT01803295ablative effect of pre-TURBT intravesical instillations of the treatments on The bladder lesion(s) of NMIBC patientsRandomized · Open-label · Treatment | Not applicable | Completed | Device: 40 mg MMC gel, 80 mg MMC gel · Other: Standard of care MMC mixed with water | Carcinoma of Urinary Bladder, Superficial | 80 | Jul 2016actual | — | 2017-06-16 |
| Safety of Pre-TURBT Intravesical Instillation of Escalating Doses of TC-3 Gel and MMC in NMIBC PatientsNCT02307487Rate of Adverse Events (AE) findings considered to be dose limiting according to the CTCAE V 4.0Non-randomized · Open-label · Treatment | Phase 2 | Completed | Drug: 120 mg MMC in 90ml gel, 140 mg MMC in 90ml gel, 160 mg MMC in 90ml gel, 120 mg MMC in 60ml gel, 140 mg MMC in 60ml gel, 160 mg MMC in 60ml gel | Bladder Cancer, Neoplasms, Urinary Bladder Diseases, Urologic Diseases | 14 | Apr 2016actual | — | 2017-06-16 |
| Safety and Efficacy of Intravesical Botulinum Toxin in TC-3 Gel in OAB PatientsNCT02179099SafetyOpen-label · Treatment | Phase 1/2 | Terminatedsponsor's stated reason: Decision to open a randomized controlled trial with two groups receiving different Botulinum Toxin in comparison to placebo group. | Device: BTX mixed with TC-3 Gel | Overactive Bladder | 3 | Nov 2015actual | — | 2016-03-01 |
| Efficacy and Safety of Intravesical Instillations of Botulinum Toxin in TC-3 Gel in IC PatientsNCT01997983VAS scoreOpen-label · Treatment | Phase 1/2 | Completed | Device: TC-3 Gel mixed with Botox (BTX) | Interstitial Cystitis, IC | 15 | Apr 2014actual | — | 2016-04-12 |
| Pilot Study to Evaluate the Clinical Response to Mitomycin-C in Hydrogel (TC-3) Administered Intravesically in NMIBC PatientsNCT02891460Subject's degree of response at 2-4 weeks post-treatmentNon-randomized · Open-label · Treatment | Not applicable | Completed | Device: 40 mg MMC in 40 mL TC-3., 80 mg MMC in 40 mL TC-3. | Urinary Bladder Neoplasms, Urologic Neoplasms, Neoplasms, Urinary Bladder Diseases, Urologic Diseases | 18 | Feb 2014actual | — | 2016-09-08 |
| Safety and Tolerability Study Which Evaluate Intravesical Instillation With Mitomycin C Mixed With TC-3 Drug Retaining Hydrogel Device In Patients With Muscle Invasive Bladder CancerNCT01648010Assessment of systemic and urine pharmacokinetics of MMC following intravesical instillation of TC-3 mixed with MMC for safety evaluation.Non-randomized · Open-label | Not applicable | Completed | Device: TC-3 gel, TC-3 gel mixed with Mitomycin C (MMC) | Carcinoma of Urinary Bladder, Invasive | 7 | May 2013actual | — | 2013-05-07 |
| A Prospective Open Label Comparative Dose Ranging Study Evaluating the Effect of Pre-TURBT Intravesical Instillation of Mitomycin C (MMC) Mixed With TC-3 Gel in Patients With Non Muscle Invasive Bladder Cancer (NMIBC)NCT01799499Ablative effect of pre-TURBT intravesical instillations with 20,40,80 mg of MMC mixed with 60cc TC-3 Hydrogel on bladder lesion(s) of NMIBC patientsRandomized · Open-label · Treatment | Not applicable | Withdrawnsponsor's stated reason: Change in the company clinical trials priority | Device: TC-3 hydrogel, TC-3 hydrogel, TC-3 hydrogel | Non Muscle Invasive Bladder Cancer | 0 | Mar 2013actual | — | 2015-09-01 |
| Named Patient Program for Mitomycin for Pyelocalyceal SolutionNCT05494411expanded access | — | Available | Drug: Mitomycin for pyelocalyceal solution | Urothelial Cancer of Renal Pelvis, Urothelial Carcinoma of the Renal Pelvis and Ureter, Urothelial Carcinoma Ureter, Urothelial Carcinoma Ureter Recurrent, Urothelial Carcinoma, Urothelial Carcinoma Recurrent | — | — | — | 2025-02-28 |
Primary completion is the date the sponsor filed with the registry — their own projection, revised whenever they revise it, unless the row is marked actual.
Source: ClinicalTrials.gov, retrieved 2026-08-19