Oral Icotrokinra Demonstrates Efficacy in Ulcerative Colitis Regardless of Prior Advanced Therapy Exposure
Icotrokinra, a selective interleukin-23 (IL-23) receptor antagonist, showed consistent efficacy in patients with moderately to severely active ulcerative colitis (UC), including those with prior inadequate response to advanced therapies, according to results from the phase 2b ANTHEM-UC trial.
ANTHEM-UC was a 28-week, randomized, double-blind, placebo-controlled study evaluating once-daily oral icotrokinra across multiple dose levels. The trial enrolled 252 adults with a modified Mayo score of 5 to 9 and endoscopic evidence of active disease. Patients were stratified by prior exposure to advanced therapies, including biologics, and randomized to receive icotrokinra 100 mg, 200 mg, 400 mg, or placebo.
At week 12, all icotrokinra dose groups met the primary endpoint of clinical response compared with placebo. Clinically meaningful improvements were also observed across secondary endpoints, including symptomatic remission, clinical remission, endoscopic improvement, and histologic-endoscopic mucosal improvement. These benefits were maintained or further improved through week 28.
Importantly, efficacy was observed regardless of prior treatment history. The authors reported that “participants with moderately to severely active ulcerative colitis experienced clinically meaningful efficacy with once-daily oral icotrokinra irrespective of advanced therapy medication history.”
These findings highlight the potential of icotrokinra as an oral alternative targeting the IL-23 pathway, a key driver of inflammation in UC. The once-daily dosing and oral administration may offer advantages for patients seeking non-injectable therapies.
Reference
Edward V. Loftus, Vipul Jairath, Maria T. Abreu. Efficacy of icotrokinra, the first targeted oral peptide that selectively blocks the interleukin-23 receptor, in ulcerative colitis patients with or without prior intolerance or inadequate response to advanced therapies: results from the ANTHEM-UC study. Presented at: Digestive Disease Week; May 2–5, 2026; Chicago, Illinois.
