PharmNovo secures CTA approval in Spain

The company’s clinical trial application (CTA) for a Phase IIa proof of concept (PoC) study investigating the safety and efficacy of lead candidate PN6047 in patients with neuropathic pain has been approved in Spain.
“We have reached an important milestone with the company’s development. PN6047 offers new hope for the future of neuropathic pain management by enabling a fundamental shift towards safer non-addictive treatments that can redefine standards of care,” says Per von Mentzer, CEO of PharmNovo.
The full title of the study is: “Randomized Double-Blind Placebo-Controlled Cross-Over Trial of the Safety, Tolerability, and Efficacy of PN6047 HCl in Peripheral Neuropathic Pain Characterized by Mechanical Allodynia.”
Czech Republic and Poland
Submission to the Czech Republic and Poland, the two other countries in which the trial will be conducted, is planned to take place. Subject to additional investment, patient enrolment is expected to start by mid-2026, states the company.
A US IND
Although the study will run in the EU, a US IND is also currently being compiled it is fully aligned with the pre-IND (Investigational New Drug) meeting in January 2025 and an IND is currently being compiled.
Published: October 8, 2025