Eli Lilly’s Omvoh (mirikizumab-mrkz) has shown a 50% clinical remission rate in paediatric patients with ulcerative colitis (UC).
In the Phase III SHINE-2 study (NCT05784246), 81% of patients treated with the IL-23p19 inhibitor achieved clinical response at week 12; among those responders who were aged six to 17, 73.1% achieved clinical response after 52 weeks.
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At the same one-year time point, 50% achieved clinical remission, meeting the trial’s primary endpoint, and 50% of patients were corticosteroid-free in clinical remission without surgery.
There was a 71.2% symptomatic remission rate, a 53.8% endoscopic improvement, and a 44.2% endoscopic remission rate.
The safety profile of Omvoh in children and adolescents was consistent with its established safety profile in adults, with no new safety signals identified.
Lilly said that the paediatric week 52 clinical remission rate was similar to that observed among adult week 12 responders in the LUCENT-2 trial (NCT03524092), which was 50.7%.
Omvoh gained US Food and Drug Administration (FDA) approval for adults with moderately to severely active UC in October 2023 and gained a label expansion for its use in Crohn’s disease in January 2025. The single-injection maintenance regimen gained FDA approval for UC in October 2025.
Based on the SHINE-2 findings, Lilly plans to submit these data to global regulators to support a potential label expansion. If approved, Omvoh would be the first IL-23p19 inhibitor indicated for paediatric UC.
Paediatric-onset UC is relatively uncommon and is often more extensive and severe than disease that begins in adulthood, with up to half of children treated with corticosteroids becoming dependent on them, and up to one-third requiring surgery within a year.
Half the patients in SHINE-2 entered the study with severe disease activity as measured by the Pediatric Ulcerative Colitis Activity Index (PUCAI), and 54% had previous biologic failure.
Dr Marla Dubinsky, professor of paediatrics and medicine at the Icahn School of Medicine at Mount Sinai, and paid consultant for Lilly, said: “For children with ulcerative colitis, every year spent relying on corticosteroids or facing the possibility of surgery can have important implications for growth, development and quality of life. Considering these challenges, the finding that half of the paediatric patients who responded to Omvoh achieved corticosteroid-free clinical remission without surgery at one year is particularly meaningful, especially in a population where many patients had previously experienced treatment failure with advanced therapies.”
Lilly is also investigating Omvoh in other forms of paediatric inflammatory bowel disease, including a long-term extension study in UC and Crohn’s disease (NCT04844606) and an ongoing Phase III study in paediatric Crohn’s disease (NCT05509777). The company has defined Omvoh as a key product in its portfolio, alongside its flagship obesity and type 2 diabetes drugs Zepbound and Mounjaro (tirzepatide). Buoyed the label expansions, Omvoh’s sales grew 36% in Q2 2026 compared to the same quarter last year.
