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Mirikizumab - Intravenous (IV)
Mirikizumab is a monoclonal antibody that selectively inhibits interleukin-23 (IL-23) signaling to reduce inflammatory immune responses.
Mirikizumab is a monoclonal antibody that selectively inhibits IL-23 signaling by binding to the p19 subunit of IL-23, reducing inflammatory responses in immune-mediated diseases. Used for Ulcerative colitis, Crohn's disease.
At a glance
| Generic name | Mirikizumab - Intravenous (IV) |
|---|---|
| Also known as | Omvoh, LY3074828 |
| Sponsor | University of North Carolina, Chapel Hill |
| Drug class | IL-23 inhibitor monoclonal antibody |
| Target | IL-23 p19 subunit |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | FDA-approved |
Mechanism of action
Mirikizumab binds to the p19 subunit of IL-23, a key cytokine involved in driving Th17 cell differentiation and inflammatory responses. By blocking IL-23, the drug suppresses pathogenic T-cell responses implicated in autoimmune and inflammatory diseases. This mechanism is distinct from IL-12/23 inhibitors and provides selective IL-23 pathway inhibition.
Approved indications
- Ulcerative colitis
- Crohn's disease
Common side effects
- Nasopharyngitis
- Upper respiratory tract infection
- Headache
- Injection site reactions
Key clinical trials
- A Master Protocol (AMAZ): A Study of Mirikizumab (LY3074828) in Pediatric Participants With Ulcerative Colitis or Crohn's Disease (SHINE-ON) (PHASE3)
- A Master Protocol (IIBD): A Study of Multiple Drugs in Adults With Ulcerative Colitis or Crohn's Disease (PHASE2)
- A Study of LY4395089 and Mirikizumab (LY3074828) Given Together and Mirikizumab (Alone) in Adults With Crohn's Disease (PHASE2)
- Mirikizumab in the Treatment of Chronic Inflammatory Conditions of the Pouch (PHASE4)
- A Maintenance Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (PHASE3)
- An Induction Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT 1) (PHASE3)
- A Study of Mirikizumab (LY3074828) in Children and Teenagers With Ulcerative Colitis (UC) (PHASE2)
- A Study of Mirikizumab (LY3074828) Injection in Healthy Participants (PHASE1)
Primary sources
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| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |