Johnson & Johnson's Icotrokinra Shows Promise in Ulcerative Colitis, FDA NDA Filed for Psoriasis
Johnson & Johnson has announced promising results for its drug candidate icotrokinra. The Phase 2b ANTHEM-UC study in ulcerative colitis showed positive outcomes, with icotrokinra meeting its primary endpoint at all three doses. The company also submitted a New Drug Application (NDA) to the FDA for icotrokinra's approval in treating moderate to severe plaque psoriasis.
Icotrokinra, a first-in-class targeted oral peptide, selectively blocks the IL-23 receptor. In the ANTHEM-UC study, 36.5% of patients treated with the highest dose achieved endoscopic improvement at Week 12. The study also demonstrated clinically meaningful improvements across key secondary endpoints compared to placebo, with similar safety profiles observed across all icotrokinra dose groups and placebo.
Looking ahead, Johnson & Johnson expects to begin patient enrollment for the Phase 3 ICONIC-UC trial in the fourth quarter of 2025. This trial will focus on adults and adolescents with moderately to severely active ulcerative colitis. The company has already initiated the ICONIC-UC Phase 3 protocol and announced these results at the United European Gastroenterology (UEG) Week 2025.
Icotrokinra's positive results in the ANTHEM-UC study and its submission for FDA approval in psoriasis indicate its potential as a new treatment option for patients with ulcerative colitis and psoriasis. As Johnson & Johnson progresses with its ICONIC-UC Phase 3 trial, further insights into icotrokinra's efficacy and safety are expected.
