Danish clinical-stage pharmaceutical company Initiator Pharma A/S (FN STO:INIT) announced on Wednesday that it has secured two new European patents for its lead drug candidate pudafensine, strengthening protection for the compound in pain treatment and its immediate-release oral formulation.

The European Patent Office granted EP 4 608 400, covering pudafensine and its pharmaceutically acceptable salts for treating, preventing or alleviating pain, including neuropathic pain and vulvodynia, with protection running to 2043.

The second patent, EP 4 731 189, covers an immediate-release, pellet-based oral formulation designed to provide rapid and complete release of pudafensine, with protection running to 2044.

Initiator Pharma said that the pain patent directly covers its ongoing Phase 2a proof-of-concept study in vulvodynia, with topline data expected by the end of 2026.

These new patents build on the European patent granted in February 2026 for pudafensine's use in female sexual dysfunction and the company's underlying composition-of-matter protection.

Following validation, the patents can provide protection across much of Europe through the Unitary Patent system, with additional protection in selected non-unitary patent countries including the United Kingdom, Switzerland, Spain, Poland, Ireland and Norway.

Initiator Pharma said the grants, together with rights in the United States, Asia and other major markets, extend pudafensine's patent protection into the 2040s and support its international partnering and licensing strategy.