PharmNovo submits CTA for non-addictive neuropathic pain therapeutic
Ella Day | July 1, 2025 | News story | Medical Communications, Research and Development | Clinical Trial Application (CTA), Neurology, Pain, PharmNovo, chronic cough, clinical trials, migraine, neuropathic pain, opioid use disorder, opioid withdrawal syndrome
Swedish biotech PharmNovo has submitted a clinical trial application (CTA) to the Spanish health authorities for its lead candidate PN6047, a new selective delta opioid receptor agonist. The appeal marks a significant milestone in the company’s mission to develop non-addictive alternatives for neuropathic pain.
PN6047 is a small molecule that selectively targets the delta opioid receptor, offering pain relief without activating the mu opioid receptor – the primary driver of addiction and other side effects associated with conventional opioids. The candidate is designed to enable safe and effective dosing in patients with peripheral neuropathic pain and is set to be evaluated in a phase 2 trial.
The initial CTA submission covers Spain, with filings in the Czech Republic and Poland expected upon approval, expected by October this year. Patient enrolment is planned to begin in the first quarter of 2026, subject to further investment. The study is EU-based but aligned with US Food and Drug Administration guidance from a pre-Investigational New Drug (IND) meeting earlier this year, with full IND submission anticipated in late 2025.
“We have reached an important milestone in the company’s development,” said Per von Mentzer, CEO of PharNovo. “PN6047 offers new hope for the future of neuropathic pain management by enabling a fundamental shift toward safer non-addictive treatments that can redefine care standards.”
PharmNovo is also exploring PN6047 in other indications, including opioid withdrawal syndrome, opioid use disorder, migraine and chronic cough.
Ella Day
1/7/25
This article featured in: August 2025 – The Pharmafile Brief
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