Patient recruitment is progressing as planned, with half of the study target patient population already dosed and several patients having successfully completed the trial. Additional eligible participants are currently being screened in accordance with the study’s inclusion and exclusion criteria. Completion of the study and release of topline data are expected by the end of 2026.

“We have, in collaboration with MAC Clinical Research, advanced patient enrollment in our first clinical study in vulvodynia. This 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 this study is designed to deliver the first proof-of-concept data in vulvodynia—a neuropathic pain condition with significant unmet medical need and no approved therapies to date.”

The randomized, placebo-controlled Phase 2a study is planned to enroll 24 women diagnosed 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.