Grünenthal has enrolled the first patient in a Phase 2 trial of its experimental nociceptin receptor agonist for moderate-to-severe pain following bunion surgery, with results expected in early 2028.
The U.S. study, designated KF7040-21, will evaluate the compound’s efficacy, safety and tolerability in adults after bunionectomy. Up to 400 participants could be enrolled across two stages.
The randomized, double-blind trial includes placebo and active-treatment controls. An initial proof-of-concept stage will enroll 96 participants. An interim analysis will determine whether the study proceeds to a dose-ranging stage involving up to 304 additional participants.
That second stage would compare three doses of the investigational drug with placebo and an active comparator.
The compound selectively activates the nociceptin receptor, known as NOP, which is involved in pain signaling. Grünenthal said Phase 1 findings reported earlier this year supported further clinical testing.
Bunionectomy removes an enlargement of bone and soft tissue, usually near the base of the big toe. The procedure provides a postoperative bone-pain model used to assess investigational pain medicines.
Grünenthal Chief Scientific Officer Uli Brödl said the trial would assess whether selective NOP activation offers another approach to pain relief.
The company cited preclinical findings suggesting NOP agonists may provide analgesia without abuse potential. Those findings do not establish the compound’s benefits or risks in humans.
Subscribe to our e-Newsletters
Stay up to date with the latest news, articles, and events. Plus, get special offers
from American Pharmaceutical Review – all delivered right to your inbox!
Sign up now!