Eli Lilly’s Omvoh Delivers Sustained Four-Year Remission In Ulcerative Colitis

Eli Lilly and Company has reported new long-term data showing that Omvoh® (mirikizumab-mrkz) is the first and only interleukin-23p19 (IL-23p19) inhibitor proven to deliver sustained, four-year outcomes in patients with moderately to severely active ulcerative colitis (UC). Results from the Phase 3 LUCENT-3 open-label extension study, presented at United European Gastroenterology (UEG) Week 2025 in Berlin, demonstrated durable efficacy across clinical, endoscopic, histologic, and quality-of-life endpoints—even among patients who had previously failed biologic or advanced therapies.

"Helping people with ulcerative colitis achieve long-term comprehensive disease control is a major goal for gastroenterologists, as it has remained out of reach for many patients," said Bruce Sands, M.D., M.S., Dr. Burrill B. Crohn Professor of Medicine and Chief of the Dr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai. "These long-term findings reinforce mirikizumab as a highly effective biologic for UC management, showing sustained clinical, endoscopic and steroid-free remission over four years, and improvement in bowel urgency, which can present a significant burden on patients' lives."

After four years of treatment in LUCENT-3, 78% of patients maintained corticosteroid-free and sustained clinical remission, 81% achieved endoscopic remission, and 90% reached remission on the Inflammatory Bowel Disease Questionnaire (IBDQ). Additionally, 66% showed histological-endoscopic mucosal improvement, while 93% reported a ≥3-point reduction on the Urgency Numeric Rating Scale (UNRS)—a key patient-reported measure of bowel urgency severity. These findings were assessed using a modified non-responder imputation (mNRI) approach.

"With these results, Omvoh continues to set a high standard as the first and only IL-23p19 with evidence of sustained efficacy and consistent safety in ulcerative colitis over four years," said Mark Genovese, M.D., senior vice president of Lilly Immunology development. "Lilly is shaping the future of IBD care to make life better for patients by redefining what's possible in terms of steroid-free, long-lasting, comprehensive disease control, including durable clinical and endo-histologic remission and relief of disruptive symptoms like bowel urgency."

The long-term safety profile of Omvoh remained consistent with prior studies, with no new safety signals observed. Among patients continuing from the LUCENT-2 trial, 12% experienced serious adverse events, and 7% discontinued due to adverse events. Beyond UC, Lilly continues to expand the mirikizumab program with combination studies—including eltrekibart and LY4268989 (MORF-057)—and has initiated the COMMIT-UC and COMMIT-CD trials exploring mirikizumab with incretin-based therapies. Omvoh is now approved in 44 countries for the treatment of moderately to severely active UC and Crohn’s disease.