Dicot Pharma AB (Nasdaq First North:DICOT) announced on Monday that it has submitted an Investigational New Drug application to the US Food and Drug Administration (FDA) in preparation for a phase 2b study of LIB-01, its drug candidate for erectile dysfunction.

The planned study aims to evaluate LIB-01's efficacy with repeated dosing and support dose selection ahead of phase 3 development. It follows the company's phase 2a trial, which Dicot Pharma said demonstrated clinically relevant, long-acting treatment effects for LIB-01.

The adaptive phase 2b study is expected to enrol at least 200 participants, with flexibility to adjust patient numbers during the trial, and will evaluate three dose levels across all severity levels of erectile dysfunction.

Dicot Pharma plans to begin the phase 2b trial in the second half of 2026 across multiple centres in the United States and Europe.

The FDA has up to 30 days to review the submission and raise questions related to the study design. The company is also preparing a corresponding regulatory filing in Europe.