Initiator Pharma has submitted a Clinical Trial Application (CTA) to the UK Medicines and Healthcare Products Regulatory Agency (MHRA) for a Phase IIa study with pudafensine in women with vulvodynia. The study is being conducted together with MAC Clinical Research which is funding up to £2,5 million. The randomised, placebo-controlled study will involve 24 women and use a four-way crossover design. Patient recruitment is planned to start before the end of 2025 with results expected by the end of 2026.
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Published September 4, 2025
Initiator Pharma applies for phase IIa study in vulvodynia
Notes
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