Phase I study completed for PN6047
In August 2022, PharmNovo initiated the First-In-Human, (FIH), clinical study for the company’s drug candidate PN6047, aimed at evaluating its safety and tolerability. By August 2023, the study was completed, involving 104 subjects across 13 cohorts, which included both Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) cohorts. Each cohort consisted of 8 subjects, with 6 receiving active treatment and 2 receiving placebo.
The headline results of the Phase I study show that PN6047 is well tolerated when taken with food at all tested doses. The pharmacokinetics were found to be robust and predictable, making it suitable for three-times-daily administration. This dosing regimen is expected to provide an effective drug exposure level.
PN6047 exhibited no signs of adverse events typically associated with conventional opioids, such as respiratory depression, seizures, abuse potentials such as euphoria or withdrawal symptoms, cardio-vascular concern, pruritus or constipation.
The completed Phase I study with PN6047, demonstrating both safety and tolerability at doses expected to be efficacious. Furthermore, the study indicates that PN6047 offers a different safety profile compared to conventional opioids in terms of side effects and pharmacology. A major milestone has been achieved!
Phase I study completed for PN6047
In August 2022, PharmNovo initiated the First-In-Human, (FIH), clinical study for the company’s drug candidate PN6047, aimed at evaluating its safety and tolerability. By August 2023, the study was completed, involving 104 subjects across 13 cohorts, which included both Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) cohorts. Each cohort consisted of 8 subjects, with 6 receiving active treatment and 2 receiving placebo.
The headline results of the Phase I study show that PN6047 is well tolerated when taken with food at all tested doses. The pharmacokinetics were found to be robust and predictable, making it suitable for three-times-daily administration. This dosing regimen is expected to provide an effective drug exposure level.
PN6047 exhibited no signs of adverse events typically associated with conventional opioids, such as respiratory depression, seizures, abuse potentials such as euphoria or withdrawal symptoms, cardio-vascular concern, pruritus or constipation.
The completed Phase I study with PN6047, demonstrating both safety and tolerability at doses expected to be efficacious. Furthermore, the study indicates that PN6047 offers a different safety profile compared to conventional opioids in terms of side effects and pharmacology. A major milestone has been achieved!
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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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