Mirikizumab

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

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Evaluating the Efficacy and Safety of Mirikizumab in Adults Over 60 With Moderate to Severe Crohn's Disease and Ulcerative Colitis	2025/07/10	NCT07059130	Not Applicable	Not yet recruiting	Rubix LS
Open-label Single-arm Study to Assess the Efficacy of Mirikizumab in Patients With Inflammatory Strictures Due to CD	2025/05/31	NCT06997965	Phase 4	Not yet recruiting	Alimentiv Inc.
Mirikizumab and Tirzepatide Administered in Adult Participants With Moderately to Severely Active Crohn's Disease and Obesity or Overweight	2025/04/22	NCT06937099	Phase 3	Recruiting	Eli Lilly and Company
Mirikizumab Administered at the Same Time as Tirzepatide in Adult Participants With Moderately to Severely Active Ulcerative Colitis and Obesity or Overweight: Phase 3b Study	2025/04/22	NCT06937086	Phase 3	Recruiting	Eli Lilly and Company
Association Between Effectiveness of Mirikizumab and UC Patients with High Neutrophilic Infiltration in Epithelium of the Colonic Mucosa	2024/10/03	NCT06626165	Phase 4	Recruiting	Showa Inan General Hospital
A Study of Eltrekibart and Mirikizumab in Adult Patients With Moderately to Severely Active Ulcerative Colitis	2024/09/19	NCT06598943	Phase 2	Recruiting	Eli Lilly and Company
A Bioequivalence Study of Citrate Free Mirikizumab (LY3074828) in Healthy Participants	2024/06/26	NCT06475729	Phase 1	Completed	Eli Lilly and Company
A Study of Mirikizumab (LY3074828) in Pediatric Participants With Moderately to Severely or Active Ulcerative Colitis	2023/03/24	NCT05784246	Phase 3	Recruiting	Eli Lilly and Company
A Study of Mirikizumab (LY3074828) in Participants With Moderately to Severely Active Ulcerative Colitis	2023/03/14	NCT05767021	Phase 3	Active, not recruiting	Eli Lilly and Company
A Bioequivalence Study of Mirikizumab (LY3074828) Solution in Healthy Participants	2022/12/09	NCT05644353	Phase 1	Completed	Eli Lilly and Company

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Omvoh	Eli Lilly and Company	0002-8011	SUBCUTANEOUS	100 mg in 1 mL	10/26/2023
Omvoh	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
Omvoh	Eli Lilly Nederland B.V.,Papendorpseweg 83,3528 BJ Utrecht,The Netherlands	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	Eli Lilly Australia Pty Ltd	Medicine	A	9/27/2023
OMVOH mirikizumab 300 mg/15 mL (20 mg/mL) concentrated injection vial for IV infusion	391349	Eli Lilly Australia Pty Ltd	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	Eli Lilly Australia Pty Ltd	Medicine	A	7/4/2025
OMVOH mirikizumab 100 mg/mL solution for injection pre-filled syringe (citrate-free formulation)	461088	Eli Lilly Australia Pty Ltd	Medicine	A	7/4/2025
OMVOH mirikizumab 100 mg/mL solution for injection autoinjector (pre-filled pen) (citrate-free formulation)	461045	Eli Lilly Australia Pty Ltd	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	Eli Lilly Australia Pty Ltd	Medicine	A	7/4/2025
OMVOH mirikizumab 100 mg/mL solution for injection autoinjector (pre-filled pen)	391347	Eli Lilly Australia Pty Ltd	Medicine	A	9/27/2023

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
OMVOH	eli lilly canada inc	02539853	Solution - Subcutaneous	100 MG / ML	12/5/2023
OMVOH	eli lilly canada inc	02539845	Solution - Subcutaneous	100 MG / ML	12/5/2023
OMVOH	eli lilly canada inc	02539861	Solution - Intravenous	20 MG / ML	10/3/2023

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
OMVOH 100 MG SOLUCION INYECTABLE EN PLUMA PRECARGADA	Eli Lilly Nederland B.V.	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	Eli Lilly Nederland B.V.	1231736009	SOLUCIÓN INYECTABLE EN PLUMA PRECARGADA	Diagnóstico Hospitalario	Not Commercialized
OMVOH 300 MG CONCENTRADO PARA SOLUCION PARA PERFUSION	Eli Lilly Nederland B.V.	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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