Adalvo announces continued progress in the development of its Mirabegron/Solifenacin fixed-dose combination product, targeting unmet clinical needs in the treatment of overactive bladder (OAB) syndrome.
The formulation integrates Mirabegron and Solifenacin in a single tablet, offering a differentiated therapeutic strategy for adult patients with urgency, increased micturition frequency, and/or urgency incontinence.
This program involves high formulation complexity, requiring tailored pharmaceutical development and multi-region regulatory planning. The BE program is progressing well, with results expected by mid-July 2025.
Mirabegron/Solifenacin is intended for launch following the expiry of relevant patents in key markets, including the EU.
Adalvo has also obtained several marketing approvals for Mirabegron monotherapy, highlighting its leading position in the urology space and its ability to navigate both regulatory and IP frameworks in high-barrier markets.
With combined global MAT sales for Mirabegron and Solifenacin estimated at $3.7 billion in 2024 and a 3% CAGR over the past three years (IQVIA), the combination product represents a strong commercial opportunity in a mature yet growth-oriented segment.
Adalvo continues to expand its urology pipeline with differentiated assets, designed for regulatory clarity, commercial viability, and therapeutic relevance.
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