NCT06331299 (UTOPIA) is a Phase 3 clinical trial of UGN-103 in Bladder Cancer, sponsored by UroGen Pharma Ltd..

Who is sponsoring NCT06331299?

NCT06331299 is sponsored by UroGen Pharma Ltd..

What drugs are being tested in NCT06331299?

Interventions in NCT06331299: UGN-103.

What condition does NCT06331299 study?

NCT06331299 studies Bladder Cancer, Urothelial Carcinoma, Urothelial Carcinoma Bladder.

Is NCT06331299 still recruiting?

NCT06331299 is currently active, enrolled. Last updated 13 January 2026.

Last reviewed 2026-01-13 · How we verify

NCT06331299: UTOPIA

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Phase 3, Single-arm, Multicenter Study to Evaluate the Efficacy and Safety of UGN-103, a Novel Formulation of UGN-102, for the Treatment of Patients With Low-grade (LG) Non-muscle Invasive Bladder Cancer (NMIBC) at Intermediate-risk (IR) of Recurrence

Active, enrolled Phase 3 Last updated 13 January 2026

What this trial tests

Phase 3 trial testing UGN-103 in Bladder Cancer in 99 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

29 August 2024

Primary endpoint
11 September 2025

1 September 2026

Quick facts

Lead sponsor	UroGen Pharma Ltd.
Phase	Phase 3
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	99
Start date	29 August 2024
Primary completion	11 September 2025
Estimated completion	1 September 2026
Sites	48 locations across United States, Bulgaria, Estonia, Georgia, Latvia, Romania, Spain

Drugs / interventions tested

UGN-103 — full drug profile →

Conditions studied

Bladder Cancer — all drugs for Bladder Cancer →
Urothelial Carcinoma — all drugs for Urothelial Carcinoma →
Urothelial Carcinoma Bladder — all drugs for Urothelial Carcinoma Bladder →

Sponsor

UroGen Pharma Ltd. — full company profile →

Who can join

18 and older, any sex, with Bladder Cancer or Urothelial Carcinoma. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Complete response rate (CRR)
Time frame: 3 months
CRR is defined as the proportion of patients who achieved CR at the 3-month Visit.

Sponsor's own description

This Phase 3, single-arm, multicenter study will evaluate the efficacy and safety of UGN-103, a novel formulation of UGN-102, instilled in the urinary bladder of patients with low-grade non-muscle invasive bladder cancer (LG-NMIBC).

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Clinical translation and landscape of stimuli-responsive nanomedicines and microscale therapeutics.
Kobzev D, Kulyk O, Barmin RA, Tatarets A, et al · · 2026 · PMID 42210822 · DOI 10.1039/d6cs00165c
Hydrogels for Cancer Immunotherapy: Strategies From Construction to Application.
Chen X, Wu S, Zhang Y, Feng L, et al · · 2026 · PMID 41640456 · DOI 10.1002/mco2.70615

Verify or expand the search:

Other recruiting trials for Bladder Cancer

Currently open trials in the same condition.

NCT07419295 — A Clinical Trial of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) to Treat Urothelial Cancer (MK-2870-031) · Phase 3 · recruiting
NCT07322263 — Intravesical GEM/DOCE for HR BCG-Unresponsive NMIBC · Phase 2 · recruiting
NCT07420517 — Dutasteride in Patients With Low Grade Non-muscle Invasive Bladder Cancer · Phase 2 · recruiting
NCT07475403 — Urinary Tumor DNA-Guided Systemic Immunotherapy for Unresectable Very-High-Risk Non-Muscle-Invasive Bladder Cancer · Phase 2 · recruiting
NCT07277413 — A Study of IDE892 as Monotherapy and Combination in MTAP-deleted Advanced Solid Tumors · Phase 1 · recruiting

Other UroGen Pharma Ltd. trials

Trials by the same sponsor.

NCT05375903 — A Phase 1 Dose-escalation Study of UGN-301 in Patients With Recurrent Non-muscle Invasive Bladder Cancer (NMIBC) · Phase 1 · completed
NCT05136898 — Feasibility of Home Instillation of UGN-102 for Treatment of Low-Grade (LG) Non-Muscle Invasive Bladder Cancer (NMIBC) · Phase 3 · completed
NCT04688931 — A Phase 3 Study of UGN-102 for Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer · Phase 3 · terminated
NCT04006691 — Efficacy and Safety of UGN-101 in Recurrent Patients · Phase 3 · withdrawn
NCT03558503 — A Phase 2b Study of UGN-102 for Low Grade Intermediate Risk Non-Muscle-Invasive Bladder Cancer · Phase 2 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT06331299 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by UroGen Pharma Ltd.
Last refreshed: 13 January 2026

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06331299.

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