The CTA is Submitted
PharmNovo is pleased to announce that a Clinical Trial Application (CTA) has been submitted to the Swedish Medical Products Agency (MPA) as well as to the ethics committee for a phase I First in Human (FIH) clinical trial with our lead candidate PN6047.
The FIH trial will be conducted at the Swedish CRO Clinical Trial Consultants AB (CTC) at their FIH facility in Uppsala. It is planned to enrol approximately 100 healthy subjects into the trial.
The CTA submission is the culmination of several years of dedicated CMC- and preclinical work creating documentation that the compound is safe for human testing, and the submission of the CTA for the FIH clinical trial represent a major milestone in the development of PN6047.
The CTA is Submitted
PharmNovo is pleased to announce that a Clinical Trial Application (CTA) has been submitted to the Swedish Medical Products Agency (MPA) as well as to the ethics committee for a phase I First in Human (FIH) clinical trial with our lead candidate PN6047.
The FIH trial will be conducted at the Swedish CRO Clinical Trial Consultants AB (CTC) at their FIH facility in Uppsala. It is planned to enrol approximately 100 healthy subjects into the trial.
The CTA submission is the culmination of several years of dedicated CMC- and preclinical work creating documentation that the compound is safe for human testing, and the submission of the CTA for the FIH clinical trial represent a major milestone in the development of PN6047.
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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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Endowed Chair awarded
We are delighted to share that Professor Amynah Pradhan has been awarded a prestigious Endowed Chair at Washington University, where she now serves as the Russell D. and Mary B. Shelden Professor of Anesthesiology.
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CTA approval 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 approved in Spain. 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.”
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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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