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Adalvo submits DCP for first Mirabegron/Solifenacin fixed-dose combination for OAB

Business
29 January 2026

We are pleased to announce the successful DCP submission of our Mirabegron/Solifenacin fixed-dose combination (FDC) tablet.  

Indicated for adults with Overactive Bladder (OAB) Syndrome, this first-of-its-kind therapy has demonstrated improved efficacy compared with monotherapy. 

Looking to grow your urology portfolio? To discuss licensing and partnership opportunities, or to see our full urology portfolio, contact us today

Research shows that OAB prevalence has risen steadily over the past 20 years and now affects nearly 24% of adults worldwide. The need for effective, easy-to-manage treatments has never been greater.  

Adalvo is stepping up to meet this demand with a convenient, differentiated therapy designed to enhance patient adherence

IQVIA figures show the combined global MAT sales for Mirabegron and Solifenacin were estimated at $3.7 billion in 2024, with a 3% CAGR, reflecting a mature yet growing market.   

Building on our early-access EU launches of Mirabegron monotherapy, this FDC submission reinforces our leadership in high-barrier products. We are targeting Day-1 launches across the EU and other key regions immediately following patent expiry. 

For licensing or partnership opportunities, or to see our full portfolio of urology products, contact one of our team.