Johnson & Johnson Launches Phase 3 Trials of Oral IL-23R Cyclopeptide Icotrokinra for Ulcerative Colitis and Crohn’s Disease

▎Armstrong

On September 29, 2025, Johnson & Johnson registered two Phase III clinical trials on Clinicaltrials.gov for Icotrokinra, an oral cyclic peptide inhibitor of IL-23R, to treat Crohn's disease and ulcerative colitis. The trials plan to enroll 1,092 and 882 patients respectively, with preliminary completion expected by 2028.

JNJ-2113 (Icotrokinra) is Protagonist's core pipeline, clinically developed in collaboration with Johnson & Johnson, while exploring multiple indications.

In March this year, Johnson & Johnson disclosed the Phase 2b clinical data of Icotrokinra for the treatment of ulcerative colitis. Compared with other therapeutic drugs, JNJ-2113 showed a higher clinical response rate after 12 weeks of treatment, and its advantage was more significant compared with IL-23 antibody.

The trend in clinical remission rate data is consistent with this.

Summary

Icotrokinra Demonstrates Excellent Efficacy in Phase II Clinical Trials for Ulcerative ColitisSets another benchmark for the direction of oral cyclic peptide iterative antibody drugs in the chronic disease field. Meanwhile, Protagonist has applied its technology platform to more important targets, including oral IL-17 inhibitors, oral GLP-1/GIP/GCG triple-target agonists, and more.