Eli Lilly's Omvoh meets primary endpoint in Phase 3 pediatric ulcerative colitis trial
LLY•Eli Lilly said Omvoh met the primary clinical remission endpoint in the Phase 3 SHINE-2 trial in children with ulcerative colitis. The company plans global regulatory submissions to extend the drug’s adult indication to patients ages 6 to 17.
1. Trial results
Omvoh met the primary clinical remission endpoint in the Phase 3 SHINE-2 trial in children with ulcerative colitis. One-year results showed sustained symptom relief, including corticosteroid-free remission without surgery among patients who responded to initial treatment.
2. Regulatory plans and safety
Eli Lilly plans global regulatory submissions to expand Omvoh’s existing adult indication to pediatric patients ages 6 to 17. The findings were presented at United European Gastroenterology Week 2026; safety findings were consistent with Omvoh’s established adult profile, with no new safety signals identified.
