Eli Lilly and Company announced on October 27, 2025, that the U.S. Food and Drug Administration (FDA) approved a simplified, single-injection, once-monthly maintenance regimen of Omvoh (mirikizumab-mrzk) for adults with moderately to severely active ulcerative colitis (UC). The approved subcutaneous dose is 200 mg/2 mL.

This approval offers patients a simpler maintenance experience, replacing the previously required two-injection regimen. The single-injection maintenance dose is expected to be available in the U.S. in early 2026. This new dosing option is a citrate-free formulation and will be offered in either a prefilled pen or a prefilled syringe.

The single-injection maintenance approval is based on data from a Phase 1 study confirming that a single 200 mg/2 mL subcutaneous injection is bioequivalent to the previously approved two-injection regimen.

This decision follows European Union authorization of Omvoh for single-injection maintenance dosing in UC. It marks the third FDA approval for Omvoh in 2025, following earlier approvals for Crohn’s disease and a citrate-free formulation.

Omvoh is indicated for the treatment of moderately to severely active ulcerative colitis and moderately to severely active Crohn’s disease in adults. The medicine functions as an interleukin-23p19 (IL-23p19) antagonist, selectively inhibiting the IL-23 pathway implicated in inflammatory bowel disease (IBD) pathogenesis.

Treatment with Omvoh begins with an induction phase consisting of 300 mg intravenous (IV) infusions administered every four weeks for a total of three infusions. After this initial phase, patients transition to subcutaneous self-injections every four weeks for maintenance treatment.

Omvoh can cause serious side effects, including infections, liver problems, and severe allergic reactions, which may require hospitalization. Healthcare providers should assess patients for tuberculosis (TB) before starting treatment and monitor liver enzyme and bilirubin levels before, during, and after therapy.

For adults treated for ulcerative colitis, the most common side effects of Omvoh include upper respiratory infections, injection-site reactions, joint pain, rash, headache, and herpes viral infections.