FDA Approves Single-Dose Formulation of Mirikizumab-mrkz for Ulcerative Colitis

The US Food and Drug Administration (FDA) has approved mirikizumab-mrkz (Omvoh) as a single-injection once-monthly maintenance regimen for adult patients with ulcerative colitis.1

Announced on October 27, 2025, by parent company Eli Lilly, this approval is based on results from a phase 1 study comparing 1 200 mg/2 mL subcutaneous injection to 2 100 mg/1 mL injections. The study confirmed the bioequivalence of the new 1-dose treatment to the previously approved 2-dose regimen.1

“In clinical practice, we see that simplifying maintenance treatment can make a difference in the overall patient experience,” Miguel Regueiro, MD, a gastroenterologist specializing in inflammatory bowel disease, said in a statement. “A single monthly injection of Omvoh gives patients a regimen that’s easier to manage alongside the unpredictability of living with ulcerative colitis.”1

The phase 1 study on which this approval is based is 1 of 3 unnamed phase 1 studies conducted to assess the pharmacokinetics and safety of the original and single-dose formulations of mirikizumab-mrkz. Investigators included overtly healthy patients aged 18-65 years with a body mass index from 18-34 kg/m2, inclusive. Patients were excluded if they had significant allergies to mirikizumab or humanized monoclonal antibodies, had an abnormal blood pressure, pulse rate, or temperature, or intended to use over-the-counter or prescription medication within 7 days prior to dosing.2

A total of 396 patients were included and randomly assigned to either the original or 1-dose mirikizumab-mrkz. Ultimately, 199 patients received the original dose and 197 received the 1-dose formulation. The primary endpoint of bioequivalence between the 2 doses was met, as the ratios of geometric LSM were within the prespecified equivalence limits of 0.8 and 1.25. Additionally, mean serum concentration profiles were similar, showing no significant differences between the 2 formulations.2

Mirikizumab-mrkz was first approved in October 2023 as an infusion (300 mg/15 mL) or injection (100 mg/mL) for ulcerative colitis. This approval was based on results from the LUCENT program, which included 2 randomized, double-blind, placebo-controlled phase 3 trials. Since then, mirikizumab-mrkz has been approved in 45 countries.1,3

“People living with 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 statement. “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

According to the press release, Eli Lilly intends to make the mirikizumab-mrkz injection available in the US in early 2026, in the form of a prefilled pen or syringe.1

References

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

2. Otani Y, Feagan BG, D'Haens GR, et al. Pharmacokinetic Comparability and Safety Between Original and Citrate-Free Mirikizumab Formulations for Subcutaneous Injections: Results from Three Clinical Trials. Adv Ther. 2025;42(5):2369-2384. doi:10.1007/s12325-025-03158-y

3. Eli Lilly. FDA Approves Lilly’s Omvoh (mirikizumab-mrkz), A First-in-Class Treatment for Adults with Moderately to Severely Active Ulcerative Colitis. October 26, 2023. Accessed October 27, 2025. https://investor.lilly.com/news-releases/news-release-details/fda-approves-lillys-omvohtm-mirikizumab-mrkz-first-class