FDA Approves Single-Injection, Once-Monthly Maintenance Regimen for Lilly’s Omvoh in Ulcerative Colitis

The FDA has approved a single-injection, once-monthly maintenance regimen for Eli Lilly’s Omvoh (mirikizumab-mrkz) for adults with moderately to severely active ulcerative colitis (UC).

New Omvoh regimen offers greater convenience for ulcerative colitis patients

The regulatory action provides a more convenient dosing option to improve adherence and quality of life for patients managing the unpredictable symptoms of UC.¹

"People living with the constant discomfort and disruption caused by the symptoms of ulcerative colitis need treatments that offer the potential to achieve lasting remission and a convenient dosing option that fits easily into their lives," George Salem, MD, director of Crohn's and Colitis Center at OU HEALTH, said in a press release. "With this approval, patients who respond to induction therapy with Omvoh can continue maintenance therapy with the convenience of just one injection each month—delivering the same proven results with fewer injections."¹

About Omvoh and its mechanism of action

• Omvoh is an interleukin (IL)-23p19 antagonist that selectively attaches to the p19 subunit of IL-23 to interfere with its interaction with the IL-23 receptor. 
• Omvoh was approved in October 2023 as the first and only IL23p19 antagonist indicated to treat adults with moderately to severely active UC.²
• The newly approved, updated formulation of Omvoh delivers similar efficacy as the previously approved two-injection regimen, which simplifies maintenance therapy for those continuing treatment after induction.

Clinical data support simplified dosing with equivalent efficacy

• The latest approval is based on findings from a Phase I trial that compared a single 200 mg/2 mL subcutaneous (SC) injection to two 100 mg/1 mL injections.
• The study showed that the single Omvoh injection is bioequivalent to the two-injection regimen that was previously approved by the FDA.¹
• The Omvoh treatment regimen begins with 300-mg IV infusions every four weeks, totaling three infusions.
• At week 12, the regimen shifts to SC self-injection every four weeks for maintenance treatment.

Long-term data confirm durable remission and consistent safety profile

• Data from a multiyear Phase III trial released in October 2024 show that Omvoh produces stable, long-term remission and improved symptoms in patients with UC with a consistent safety profile.³
• The long-term, open-label, Phase III LUCENT-3 (NCT03519945) trial was an extension of the LUCENT-1 and LUCENT-2 trials, which evaluated the efficacy and safety of Omvoh in patients with UC for up to three years.⁴
• Results demonstrated that among patients who achieved clinical remission with Omvoh after one year in the LUCENT-2 trial, 81% maintained long-term clinical remission; 82% achieved long-term endoscopic remission; 72% experienced mucosal healing; 79% achieved corticosteroid-free clinical remission; and patients achieved sustained, clinically meaningful improvements in symptom score decrease for bowel urgency (-4.72).
• In terms of safety, 7.4% of patients experienced serious adverse events, with 5.3% discontinuing treatment as a result. The long-term safety profile in the trial was consistent with the previously established profile of Omvoh with no new safety signals reported.
• Overall results from the LUCENT trial program demonstrated a sustained benefit with Omvoh across symptomatic, clinical, endoscopic, and histologic endpoints for up to three years, regardless of prior treatment failure with TNF inhibitors, tofacitinib, or other biologic therapies.

Next steps and availability

The single 200 mg/2 mL dose administered via prefilled pen or syringe will become available in early 2026, following similar authorization in the European Union.

"Building on the introduction of a citrate-free formulation of Omvoh earlier this year, this approval further delivers on our commitment by providing patients the same outcomes in a single-injection maintenance regimen that fits more seamlessly into their lives,” Ashley Diaz-Granados, senior vice president of U.S. Immunology at Lilly, said in a press release.¹

References

1. Lilly's Omvoh (mirikizumab-mrkz) approved by U.S. FDA as a single-injection maintenance regimen in adults with ulcerative colitis. News release. Eli Lilly. October 27, 2025. Accessed October 28, 2025. https://investor.lilly.com/news-releases/news-release-details/lillys-omvoh-mirikizumab-mrkz-approved-us-fda-single-injection

2. FDA Approves Lilly's Omvoh™ (mirikizumab-mrkz), A First-in-Class Treatment for Adults with Moderately to Severely Active Ulcerative Colitis. News release. Eli Lilly. October 26, 2023. Accessed October 28, 2025. https://investor.lilly.com/news-releases/news-release-details/fda-approves-lillys-omvohtm-mirikizumab-mrkz-first-class

3. Lilly's mirikizumab is first and only IL23p19 antagonist to report long-term, multi-year, sustained efficacy and safety data for both ulcerative colitis and Crohn's disease. News release. Eli Lilly. October 28, 2024. Accessed October 28, 2025. https://investor.lilly.com/news-releases/news-release-details/lillys-mirikizumab-first-and-only-il23p19-antagonist-report-long

4. A Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT 3). ClinicalTrials.gov. Updated October 16, 2025. Accessed October 28, 2025. https://clinicaltrials.gov/study/NCT03519945