OMVOH (mirikizumab-mrkz) is an interleukin-23 antagonist indicated for the treatment of moderately to severely active ulcerative colitis in adults. It is also approved for the treatment of adult patients with moderately to severely active Crohn's disease. As a humanized monoclonal antibody, it serves as a therapeutic option for managing these chronic inflammatory conditions.
How OMVOH Works
Mirikizumab-mrkz is a humanized IgG4 monoclonal antibody that selectively binds to the p19 subunit of the human IL-23 cytokine. This action inhibits the cytokine's interaction with the IL-23 receptor, which is involved in mucosal inflammation and the activity of pro-inflammatory immune cell subsets. By blocking this pathway, the drug inhibits the release of pro-inflammatory cytokines and chemokines to ameliorate intestinal inflammation.
Details
- Status
- Prescription
- First Approved
- 2023-10-26
- Routes
- SUBCUTANEOUS, SINGLE-USE
- Dosage Forms
- INJECTABLE, VIAL
OMVOH Approval History
What OMVOH Treats
2 indicationsOMVOH is approved for 2 conditions since its original approval in 2023. These indications span multiple therapeutic areas including oncology, immunology, and more.
OMVOH Target & Pathway
ProTarget
A cytokine that promotes Th17 cell development and maintenance. IL-23 is upstream of IL-17 in the inflammatory cascade driving psoriasis and inflammatory bowel disease. Blocking IL-23 provides sustained control of these conditions.
OMVOH Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in OMVOH's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications OMVOH treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to OMVOH
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Eli Lilly's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
OMVOH FDA Label Details
Indications & Usage
FDA Label (PDF)OMVOH is indicated for the treatment of: moderately to severely active ulcerative colitis in adults. moderately to severely active Crohn's disease in adults. OMVOH TM is an interleukin-23 antagonist indicated for the treatment of: moderately to severely active ulcerative colitis in adults moderately to severely active Crohn's disease in adults
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.