Initiator Pharma A/S announced that the drug candidates, pudafensine and IP2018, have shown significant efficacy in preclinical models for Female Sexual Dysfunction (FSD). Based on the findings, the company is reviewing the potential to extend the clinical indications for the drug candidates to include FSD. During the last two years, Initiator Pharma has internally investigated its phase II drug candidates, pudafenedine and IP2018, currently developed in two types of male Erectile Dysfunction, in preclinical models for Female sexual dysfunction (FSD).

Significant efficacy has been shown for both pudafensine andIP2018 in the animal models tested for FSD. The tested models are highly relevant and offer a way to predict efficacy in the clinical setting. Based on these promising findings, the board and leadership team are reviewing the potential for extending the previous efforts in male erectile dysfunction (ED) also to include FSD.

In ED significant clinical efficacy has been shown in phase II trials, and Initiator Pharma is developing a strategy to tackle sexual health disorders covering both female and male sexual dysfunctions. The strategic review will include the data generated to establish the best development plan, positioning and commercialization strategy for these two assets going forward. The review will be executed in Fourth Quarter, 2023, from both a commercial and clinical perspective, to best capture and optimize the large potential value offered by these two assets.