Dicot Pharma submits CTA for phase 2b study in EU
Dicot Pharma submits CTA for phase 2b study in EU
Uppsala, Sweden, August 17, 2026. Dicot Pharma AB announces that the company has submitted a Clinical Trial Application (CTA) in EU for the phase 2b study of the drug candidate LIB-01, to be conducted in the United States and Europe. The study aims to evaluate the efficacy of LIB-01 with repeated dosing and provide a basis for dose selection ahead of phase 3.
Dicot Pharma is developing the drug candidate LIB-01, which has the potential to become a completely new treatment concept for erectile dysfunction. As previously announced, in June 2026 the company received clearance from the FDA to initiate the first part of the phase 2b study in the United States, with study initiation planned for the second half of 2026. As the study is planned to be conducted in both the United States and Europe, the corresponding application to initiate the study has now been submitted in the EU. A decision is expected in the fourth quarter of 2026.
The phase 2b study is designed to evaluate the efficacy of LIB-01 with repeated dosing and generate data to support dose selection for phase 3. The company plans to use an adaptive study design enrolling at least 200 participants, including patients with all degrees of erectile dysfunction severity.
“We are making solid progress with the preparations for the phase 2b study and remain on track with our plans. Submitting the application in the EU marks an important milestone, and we look forward to advancing the study in both the United States and Europe,” says Elin Trampe, CEO of Dicot Pharma.