Positive FDA feedback for PN6047
PharmNovo has received positive and constructive feedback from the FDA for its lead drug candidate, PN6047, a selective delta opioid receptor agonist aimed at treating peripheral neuropathy with allodynia.
Following a successful pre-IND meeting in January 2025, the FDA provided valuable guidance on the Phase IIa study design and had no critical comments on the CMC or non-clinical data. This paves the way for IND submission by the end of 2025 and a Phase IIa clinical trial application in Europe (Spain, Poland, Czech Republic) by Q3 2025.
Positive FDA feedback for PN6047
PharmNovo has received positive and constructive feedback from the FDA for its lead drug candidate, PN6047, a selective delta opioid receptor agonist aimed at treating peripheral neuropathy with allodynia.
Following a successful pre-IND meeting in January 2025, the FDA provided valuable guidance on the Phase IIa study design and had no critical comments on the CMC or non-clinical data. This paves the way for IND submission by the end of 2025 and a Phase IIa clinical trial application in Europe (Spain, Poland, Czech Republic) by Q3 2025.
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Watch PharmNovo at LSX in Lisbon
Take the opportunity to listen to Per von Mentzer, CEO, presenting PN6047 at the LSX World Europe congress in Lisbon, March 2026. Learn how PharmNovo is shaping a new approach to pain relief with the goal to prove that powerful pain treatment doesn’t have to come with the cost of addiction. Discover how the company’s lead candidate PN6047, delivers effective pain relief without activating the mu-opioid receptor and avoiding the addiction risks associated with conventional opioids. The Phase II-ready Delta Opioid Receptor Agonist (DORA) with first-in-class potential, PN6047 represents a safer, non-addictive approach targeting a neuropathic pain market that is expected to double until 2033 and reach 13 bEUR.
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Capsules ready for Phase IIa Study
PharmNovo is pleased to announce that that the company has completed drug product manufacturing for its lead candidate PN6047. This is an important milestone as the company prepares for its upcoming Phase IIa proof-of-concept study in neuropathic pain.
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Welcome on Board
As the company prepares for the next phase of clinical development, the new Board composition strengthens our strategic capabilities ahead of Phase II development of our lead candidate, PN6047.
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