In May 2025, Initiator Pharma entered a convertible credit agreement with MAC Clinical Research (MAC), under which MAC will take on the cost, up to GBP 2.5 million, for conducting the Phase 2a study evaluating pudafensine in patients with vulvodynia. With this approval secured, the company is positioned to initiate patient enrolment immediately and aims to have the first patients dosed before the end of 2025, with study completion projected by the end of 2026.

“We are delighted to have received CTA approval to start our first clinical study in vulvodynia. This milestone represents an important step forward in our mission to develop new treatments for patients living with this under-recognized and debilitating pain condition,” said Claus Olesen, CEO of Initiator Pharma. “Pudafensine has already demonstrated strong clinical potential, and with this study, we aim to generate the first proof-of-concept data in the neuropathic pain condition vulvodynia, an area of huge unmet medical need where no approved therapies exist today.”

The randomized, placebo-controlled Phase 2a study will enroll 24 women with vulvodynia. Using a four-way crossover design, each participant will receive single oral doses of pudafensine and a placebo across different treatment periods, separated by washout intervals. The study will focus on the assessment of pain-relieving effects and the safety of pudafensine.

The crossover study design offers several advantages, including reduced variability by having each participant serve as her own control, and the ability to compare pudafensine against placebo in the same patient population directly. This approach allows for meaningful results from a smaller cohort, making it particularly well-suited for proof-of-concept studies in pain and sexual dysfunction.