Post by Dicot Pharma AB

New milestone achieved: We've received FDA clearance to initiate the first part of our phase 2b study with LIB-01, our drug candidate for erectile dysfunction. This activates the IND and marks an important milestone in the US. Part I will establish the highest dose for the study, while we bring forward a preclinical study to meet the FDA's request for additional toxicology data ahead of Part II. In parallel, we're preparing our application to start the study in Europe. Building on strong phase 2a results, the study will explore repeated dosing and three dose levels across all severity grades of erectile dysfunction. We remain on track to start in the second half of 2026 – a significant step forward for LIB-01. https://lnkd.in/eFZck3_6 #erectiledysfunction #drugdevelopment #biotech #innovation