Swedish pharmaceutical company Dicot Pharma AB (Nasdaq First North:DICOT) said on Thursday that it has received clearance from the US Food and Drug Administration (FDA) to initiate Part I of its Phase 2b study for LIB-01, an investigational treatment for erectile dysfunction.

Part I will determine the highest dose to be evaluated in the efficacy-focused Part II. Additional toxicology data are required before US initiation of Part II, prompting an acceleration of a planned preclinical study.

The FDA has reviewed the Investigational New Drug (IND) application and raised no questions regarding the submitted preclinical and clinical safety documentation, thereby activating the IND for the study's first part.

The Phase 2b programme builds on Phase 2a results showing clinically relevant and long-lasting effects. It will evaluate multiple dose levels, including those previously demonstrating proof of concept and a higher dose.

Dicot Pharma also plans to submit an application to initiate the study in Europe in the third quarter of 2026, with the study expected to begin in the second half of 2026.