UGN-103: medac CDMO Enables Clinical Progress in Phase 3 UTOPIA Trial for recurrent LG-IR-NMIBC

Wedel, July 21, 2025 – The recent completion of patient enrollment in UroGen Pharma’s Phase 3 UTOPIA trial marks a major step forward in the development of UGN-103 (mitomycin) for intravesical solution under investigation for the treatment of recurrent low-grade, intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). medac CDMO is proud to contribute significantly to this achievement as the development and manufacturing partner for UGN-103.

UGN-103, UroGen’s RTGel^® technology combined with medac’s licensed mitomycin, is a next-generation formulation that is planned to follow UroGen’s currently approved medicine in the United States for the treatment of adult patients with recurrent LG-IR-NMIBC.(formerly UGN-102). The mitomycin component included in UGN-103 was developed by medac CDMO to offer important enhancements, including shorter production timelines and a simplified reconstitution process.

The UTOPIA trial is a single-arm, global study assessing efficacy and safety in patients receiving once-weekly UGN-103 instillations over six weeks. The primary endpoint is complete response at three months, with extended follow-up to assess durability of response.

As part of a strategic licensing and supply agreement with UroGen, medac CDMO led the pharmaceutical development of the mitomycin component included in UGN-103, based on medac’s intellectual property. Our development expertise and specialized infrastructure enabled the successful transfer into a robust and scalable GMP manufacturing process, while ensuring compliance with the highest regulatory and quality standards.

This project exemplifies medac CDMO’s mission to support complex pharmaceutical innovations through tailored solutions, reliable execution, and deep technical insight. Our cross-functional teams across Germany and the Czech Republic continue to provide flexible and high-performance CDMO services to partners worldwide.

With UGN-103, we are not just supporting a new therapeutic option—we are once again delivering  A SOLUTION AHEAD.

RTGel® is a registered trademark of UroGen Pharma, Ltd.