FDA Approves Once-Monthly Mirikizumab-mrkz Regimen for Ulcerative Colitis: Daily Dose

Patient Care brings primary care clinicians a lot of medical news every day—it’s easy to miss an important study. The Daily Dose provides a concise summary of one of the website's leading stories you may not have seen.

On November 5, 2025, we reported on the FDA approval of a single-injection, once-monthly maintenance regimen of mirikizumab-mrkz (Omvoh, Eli Lilly) for adults with moderately to severely active ulcerative colitis.

The approval

The approval marks the third FDA approval for mirikizumab in 2025, following approvals for Crohn disease and a citrate-free formulation. The single-injection maintenance dose will be available in the US via prefilled pen or prefilled syringe in early 2026.

The simplified dosing comes as new data demonstrate the effectiveness of mirikizumab in addressing bowel urgency, one of the most challenging symptoms for patients with ulcerative colitis. Results from the phase 3b LUCENT-URGE study, presented at the American College of Gastroenterology Annual Scientific Meeting in October 2025, showed that patients experienced a 55% reduction in daily episodes of bowel urgency from baseline by week 12. By week 28, bowel urgency severity was reduced by 52%, and nearly one-third of patients were able to delay using the restroom for at least 15 minutes after feeling urgency, up from 4% at baseline. LUCENT-URGE was the first study in inflammatory bowel disease to assess bowel urgency across three measures—severity, frequency and stool deferral time—reflecting the spectrum of its burden on patients.

Click here for more details.