Positive final Phase I results
The final results from the Phase I clinical for our neuropathic pain drug candidate PN6047, demonstrates safety and tolerability and a lack of the adverse effects commonly associated with conventional opioids. The findings from the Phase I trial show that PN6047 is safe and well-tolerated at the doses tested, with no serious adverse events reported.
PN6047 was also completely devoid of adverse events typically associated with conventional opioids like oxycodone and morphine, such as respiratory depression, constipation, itching, or untoward effects following withdrawal symptoms. This validates the unique preclinical profile of PN6047, which shows that it acts very selectively on the delta opioid receptor, distinguishing it fundamentally from conventional opioids that target the mu opioid receptor.
With the Phase I trial's final report at hand and after fruitful discussions with clinical Key Opinion Leaders on designing the Phase IIa Proof of Concept study, PharmNovo is well-prepared to move PN6047 into the next stages of clinical testing.
Positive final Phase I results
The final results from the Phase I clinical for our neuropathic pain drug candidate PN6047, demonstrates safety and tolerability and a lack of the adverse effects commonly associated with conventional opioids. The findings from the Phase I trial show that PN6047 is safe and well-tolerated at the doses tested, with no serious adverse events reported.
PN6047 was also completely devoid of adverse events typically associated with conventional opioids like oxycodone and morphine, such as respiratory depression, constipation, itching, or untoward effects following withdrawal symptoms. This validates the unique preclinical profile of PN6047, which shows that it acts very selectively on the delta opioid receptor, distinguishing it fundamentally from conventional opioids that target the mu opioid receptor.
With the Phase I trial's final report at hand and after fruitful discussions with clinical Key Opinion Leaders on designing the Phase IIa Proof of Concept study, PharmNovo is well-prepared to move PN6047 into the next stages of clinical testing.
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Breaking new ground in pain management
Breaking new ground in pain management In the latest episode of BioBizBuzz, PharmNovo CEO Per von Mentzer sits down with host Mike Ward to discuss how we’re tackling one of modern medicine’s most urgent challenges: finding effective, non-addictive treatments for chronic and neuropathic pain. The conversation highlights the development of our lead candidate PN6047, a selective delta-opioid receptor agonist designed to deliver strong pain relief without the addiction risks or sedation associated with traditional opioids. Per shares insights into the scientific rationale, clinical potential, and why neuropathic pain—often caused by nerve damage from conditions like diabetes or chemotherapy—demands new thinking. For anyone interested in neuroscience, biotech innovation, or the future of pain management, this episode offers a glimpse into what could become a paradigm shift in treatment. Listen to the full episode here:
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CTA submission for PN6047
PharmNovo AB is pleased to announce that the 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 submitted in Spain. The full title of the application 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.” Based on a strategic company decision, PharmNovo has submitted the CTA, in the first instance, to the Spanish Health Authorities only. Submission to the Czech Republic and Poland, the two other countries in which the trial will be conducted, is planned to take place following approval in Spain, which is expected by October 2025. Subject to additional investment, patient enrolment is expected to start by Quarter 1 2026.
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PharmNovo at the LSX World Congress in London
Take the opportunity to listen to Per von Mentzer, CEO, presenting PN6047 at the LSX World Congress in April 2025 in London. PharmNovo is redefining pain management with PN6047, a first-in-class Delta Opioid Receptor Agonist (DORA), safer, non-addictive solution for neuropathic pain. Unlike traditional opioids, PN6047 eliminates concerns of side effects, abuse potential, and tolerance. With a proven safety profile from Phase I trials and a market projected to exceed EUR 13 billion by 2033, PN6047 is set to be a game-changer.
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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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