# UGN-103

Source: https://onco.cc/drugs/ugn-103/  
OnCo record `ugn-103` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

UGN-103 is an experimental chemotherapy (mitomycin) delivered via hydrogel from UroGen Pharma in phase 3 trials for bladder & urothelial cancer, with its target not yet stated publicly.

## Summary

UGN-103 is a chemotherapy (mitomycin) delivered via hydrogel developed by UroGen Pharma. Its molecular target is not stated in the ClinicalTrials.gov intervention record, and OnCo has not confirmed one from the sponsor's pipeline page. The sponsor states: Combines UroGen's RTGel technology with medac's proprietary formulation of mitomycin (75 mg dosage strength) for recurrent low-grade intermediate-risk non-muscle invasive bladder cancer. ClinicalTrials.gov describes the intervention as: UGN-103 consists of mitomycin and sterile hydrogel (a proprietary thermally responsive gel) that is used to reconstitute mitomycin before instillation. The reverse thermal properties of UGN-103 allow for local administration of mitomycin as. It is the investigational product in 1 recruiting or active industry-led phase 2 and phase 3 interventional cancer trial, including the phase 3 study NCT06331299 (A Phase 3 Study of UGN-103 for Treatment of Patients With Low-grade Intermediate-risk Non-muscle Invasive Bladder Cancer), in bladder & urothelial cancer. The largest, NCT06331299, plans to enrol 99 participants (actual) with primary completion was scheduled for 2025-09-11 on the registry. Status reflects the highest phase registered on ClinicalTrials.gov; no efficacy results are recorded here.

## Fields

- Kind: Treatment
- Status: phase-3
- Last checked: 2026-09-11
- Also known as: UGN-103 (mitomycin) for intravesical solution
- Tags: pipeline; ctgov-ingest
- Modality: chemotherapy (mitomycin) delivered via hydrogel
- Mechanism: Combines UroGen's RTGel technology with medac's proprietary formulation of mitomycin (75 mg dosage strength) for recurrent low-grade intermediate-risk non-muscle invasive bladder cancer.

## Sources

- ClinicalTrials.gov: trials of UGN-103: https://clinicaltrials.gov/search?intr=UGN-103
- Sponsor page: https://www.urogen.com/pipeline

## Connected records

- cancers: [Bladder & urothelial cancer](https://onco.cc/cancers/urothelial/)
- companies: [UroGen Pharma](https://onco.cc/companies/urogen-pharma/)
- trials: [A Phase 3 Study of UGN-103 for Treatment of Patients With Low-grade Intermediate-risk Non-muscle Invasive Bladder Cancer](https://onco.cc/trials/nct06331299/)

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