Overview
Mirikizumab is a monoclonal antibody developed by Eli Lilly intended to treat ulcerative colitis. It inhibits the actions of interleukin-23 (IL-23), a pro-inflammatory cytokine that activates pathways contributing to the development of inflammatory diseases. Mirikizumab is approved in Japan and received a positive opinion from the EMA's Committee for Medicinal Products for Human Use in March 2023. In April 2023, the US FDA declined to approve mirikizumab for the treatment of ulcerative colitis on the basis of manufacturing concerns. It was officially approved in the EU in May 2023 and Canada in July 2023, and was eventually approved in the US in October 2023 for the treatment of adult patients with moderate-to-severely active ulcerative colitis.
Indication
Mirikizumab is indicated for the treatment of adult patients with moderate-to-severely active ulcerative colitis.
Associated Conditions
- Moderately to Severely Active Ulcerative Colitis
Research Report
A Comprehensive Monograph on Mirikizumab (Omvoh) for the Treatment of Inflammatory Bowel Disease
Executive Summary & Drug Profile
Executive Summary
Mirikizumab, marketed under the brand name Omvoh, represents a significant advancement in the therapeutic landscape for inflammatory bowel disease (IBD). It is a first-in-class, humanized immunoglobulin G4 (IgG4) monoclonal antibody that exhibits high specificity for the p19 subunit of the pro-inflammatory cytokine interleukin-23 (IL-23).[1] This targeted mechanism of action allows for selective inhibition of the IL-23 signaling pathway, a critical driver of mucosal inflammation in IBD.[3] Mirikizumab is approved for the treatment of adults with moderately to severely active ulcerative colitis (UC) and Crohn's disease (CD), offering a new therapeutic option for patients who have had an inadequate response to, lost response to, or were intolerant of conventional or other biologic therapies.[1]
The approvals were based on robust data from two pivotal Phase 3 clinical trial programs: LUCENT for ulcerative colitis and VIVID for Crohn's disease.[7] In UC, the LUCENT program demonstrated that Mirikizumab was superior to placebo for both inducing and maintaining clinical remission and endoscopic improvement.[6] Notably, the program was the first to formally establish efficacy in improving bowel urgency, a highly burdensome patient-reported symptom.[9] In CD, the VIVID-1 trial showed Mirikizumab was superior to placebo in achieving co-primary endpoints of clinical remission and endoscopic response at one year.[8] Long-term extension studies for both indications have confirmed the durability of these responses over multiple years, supported by a consistent and manageable safety profile.[11]
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/07/10 | Not Applicable | Not yet recruiting | Rubix LS | ||
2025/05/31 | Phase 4 | Not yet recruiting | |||
2025/04/22 | Phase 3 | Recruiting | |||
2025/04/22 | Phase 3 | Recruiting | |||
2024/10/03 | Phase 4 | Recruiting | |||
2024/09/19 | Phase 2 | Recruiting | |||
2024/06/26 | Phase 1 | Completed | |||
2023/03/24 | Phase 3 | Recruiting | |||
2023/03/14 | Phase 3 | Active, not recruiting | |||
2022/12/09 | Phase 1 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Eli Lilly and Company | 0002-8011 | SUBCUTANEOUS | 100 mg in 1 mL | 10/26/2023 | |
| Eli Lilly and Company | 0002-7575 | INTRAVENOUS | 20 mg in 1 mL | 10/26/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 5/26/2023 | ||
Authorised | 5/26/2023 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| OMVOH mirikizumab 100 mg/mL solution for injection pre-filled syringe | 391348 | Medicine | A | 9/27/2023 | |
| OMVOH mirikizumab 300 mg/15 mL (20 mg/mL) concentrated injection vial for IV infusion | 391349 | Medicine | A | 9/27/2023 | |
| OMVOH mirikizumab 100 mg/mL + 200 mg/2 mL solution for injection autoinjector (pre-filled pen) composite pack (citrate-free formulation) | 461105 | Medicine | A | 7/4/2025 | |
| OMVOH mirikizumab 100 mg/mL solution for injection pre-filled syringe (citrate-free formulation) | 461088 | Medicine | A | 7/4/2025 | |
| OMVOH mirikizumab 100 mg/mL solution for injection autoinjector (pre-filled pen) (citrate-free formulation) | 461045 | Medicine | A | 7/4/2025 | |
| OMVOH mirikizumab 100 mg/mL + 200 mg/2 mL solution for injection pre-filled syringe (composite pack) (citrate free formulation) | 461265 | Medicine | A | 7/4/2025 | |
| OMVOH mirikizumab 100 mg/mL solution for injection autoinjector (pre-filled pen) | 391347 | Medicine | A | 9/27/2023 |
Health Canada Drug Approvals
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| OMVOH 100 MG SOLUCION INYECTABLE EN PLUMA PRECARGADA | 1231736004 | SOLUCIÓN INYECTABLE EN PLUMA PRECARGADA | Diagnóstico Hospitalario | Commercialized | |
| OMVOH 100 MG SOLUCION INYECTABLE EN PLUMA PRECARGADA + OMVOH 200 MG SOLUCION INYECTABLE EN PLUMA PRECARGADA | 1231736009 | SOLUCIÓN INYECTABLE EN PLUMA PRECARGADA | Diagnóstico Hospitalario | Not Commercialized | |
| OMVOH 300 MG CONCENTRADO PARA SOLUCION PARA PERFUSION | 1231736001 | CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN | Uso Hospitalario | Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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