Grünenthal, a Germany-based pharmaceutical company, announced on Monday that the company has successfully concluded a Phase I trial evaluating the safety and tolerability of its proprietary NOP agonist.

The company says that in the trial, which involved 113 healthy participants, the compound was demonstrated to be safe and well tolerated, with no dose-dependent adverse event pattern observed. Grünenthal is now planning to progress its NOP agonist into a Phase II trial that aims to enrol 400 US-based patients undergoing bunionectomy, a model for evaluating the efficacy and safety of a compound as a treatment for acute pain. The trial will commence later this year with results expected in the second half of 2027.

Grünenthal says that through its specific selectivity for the nociceptin receptor, its NOP agonist features a unique mechanism of action for the treatment of acute and chronic pain and may present a first-in-class therapy option. It further claims that the compound has the potential to deliver robust pain relief in a broad range of conditions without the side effects commonly associated with opioids. During the Phase I trial, no such adverse events, including somnolence, constipation or respiratory depression, or events suggesting any abuse liability potential were observed.