Pudafensine, Initiator’s most advanced drug program has successfully demonstrated efficacy in a Clinicial Phase 2a Proof-of-Concept study to treat patients who suffer from organic erectile dysfunction (ED) that do not respond to the currently marketed drugs in the PDE5i class (e.g. Viagra®, Cialis®, Levitra®).

Pudafensine strengthens the natural erection response by having a dual-action, both a central effect initiating erection and a peripheral effect potentiating erection through smooth muscle relaxation. Pudafensine is aimed for treatment of organic erectile dysfunction in patients who have erectile dysfunction (ED) due to abnormalities of the penile arteries and/or veins. Most common risk factors for organic ED are diabetes, overweight, lack of exercise, high cholesterol, high blood pressure, and cigarette smoking.  Since Initiator Pharma was founded and pudafensine acquired, all preclinical development of the drug candidate to enable an application for clinical trials (CTA) has been carried out by the company’s auspices. Pudafensine is developed as a tablet that is taken orally. It is the company’s goal to be able to create a new “First-Line” treatment (recommended treatment) for the large group of men who have organic erectile dysfunction, who are sub-optimally treated with PDE5i products or for whom PDE5i treatment is contraindicated. With the help of a competent research team,  Initiator Pharma’s main business concept is to further develop the existing drug candidate pudafensine through successful Phase 2 studies, which will lay the foundation for a potential exit or partnership agreement.

Clinical status

Pudafensine is currently being evaluated in a Phase 2b randomized, double-blind, placebo-controlled, parallel dosing group clinical trial. The objective of the study is to evaluate the efficacy and safety of high and low doses of pudafensine during a 4-week treatment period in patients suffering from severe to moderate erectile dysfunction.

As planned study enrollment of 120 patients was completed in June 2023 and results are scheduled for Q4 2023. The study is conducted by MAC Clinical Research at multiple sites in the UK.