Initiator Pharma A/S, a clinical-stage biotech company, today announced the initiation of patient enrollment in its Phase IIa clinical proof-of-concept study evaluating pudafensine in women suffering from vulvodynia.
The patient recruitment has been initiated, with several women currently undergoing screening to assess eligibility for randomisation into the trial. Dosing of the first patients is expected to begin in January 2026, and completion of the study is projected by the end of 2026.
“We have reached a milestone by enrolling the first patients into 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 IIa 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.