Mirikizumab

Generic Name: Mirikizumab

Brand Names: Omvoh

Drug Type: Biotech

CAS Number: 1884201-71-1

Unique Ingredient Identifier: Z7HVY03PHP

Background: 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

Mirikizumab and Tirzepatide Administered in Adult Participants With Moderately to Severely Active Crohn's Disease and Obesity or Overweight

Phase 3

Not yet recruiting

Conditions: Crohn's Disease
Obesity or Overweight

Interventions: Drug: Mirikizumab
Drug: Tirzepatide
Drug: Placebo

First Posted Date: 2025-04-22

Last Posted Date: 2025-04-27

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 290

Registration Number: NCT06937099

Locations: 🇺🇸
California Medical Research Associates, Northridge, California, United States
🇺🇸
Precision Clinical Research, Sunrise, Florida, United States
🇺🇸
Rush University Medical Center, Chicago, Illinois, United States

and more 123 locations

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

Phase 3

Not yet recruiting

Conditions: Ulcerative Colitis
Obesity or Overweight

Interventions: Drug: Mirikizumab
Drug: Tirzepatide
Drug: Placebo

First Posted Date: 2025-04-22

Last Posted Date: 2025-04-22

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 350

Registration Number: NCT06937086

Locations: 🇺🇸
California Medical Research Associates, Northridge, California, United States
🇺🇸
Precision Clinical Research, Sunrise, Florida, United States
🇺🇸
Rush University Medical Center, Chicago, Illinois, United States

and more 125 locations

Association Between Effectiveness of Mirikizumab and UC Patients with High Neutrophilic Infiltration in Epithelium of the Colonic Mucosa

Phase 4

Recruiting

Conditions: Ulcerative Colitis

Interventions: Drug: Mirikizumab
Drug: Vedolizumab

First Posted Date: 2024-10-03

Last Posted Date: 2024-10-04

Lead Sponsor: Showa Inan General Hospital

Target Recruit Count: 100

Registration Number: NCT06626165

Locations: 🇯🇵
Showa Inan General Hospital, Komagane, Nagano, Japan

A Study of Eltrekibart and Mirikizumab in Adult Patients With Moderately to Severely Active Ulcerative Colitis

Phase 2

Recruiting

Conditions: Ulcerative Colitis
Ulcerative Colitis Chronic

Interventions: Drug: Eltrekibart
Drug: Placebo
Drug: Mirikizumab

First Posted Date: 2024-09-19

Last Posted Date: 2025-04-18

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 140

Registration Number: NCT06598943

Locations: 🇺🇸
Southern California GI and Liver Centers (SCLC), Coronado, California, United States
🇺🇸
Om Research, LLC, Lancaster, California, United States
🇺🇸
United Medical Doctors, Los Alamitos, California, United States

and more 170 locations

A Bioequivalence Study of Citrate Free Mirikizumab (LY3074828) in Healthy Participants

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Citrate-Free Mirikizumab

First Posted Date: 2024-06-26

Last Posted Date: 2025-01-24

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 484

Registration Number: NCT06475729

Locations: 🇺🇸
CenExel ACT, Anaheim, California, United States
🇺🇸
Fortrea Clinical Research Unit, Madison, Wisconsin, United States
🇺🇸
Clinical Pharmacology of Miami, Miami, Florida, United States

and more 1 locations

A Study of Mirikizumab (LY3074828) in Pediatric Participants With Moderately to Severely or Active Ulcerative Colitis

Phase 3

Recruiting

Conditions: Ulcerative Colitis

Interventions: Drug: Mirikizumab IV
Drug: Mirikizumab SC

First Posted Date: 2023-03-24

Last Posted Date: 2025-04-18

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 60

Registration Number: NCT05784246

Locations: 🇺🇸
Rady Children's Hospital- San Diego, San Diego, California, United States
🇺🇸
University of California-San Francisco-Mission Bay, San Francisco, California, United States
🇺🇸
Connecticut Children's Medical Center, Hartford, Connecticut, United States

and more 53 locations

A Study of Mirikizumab (LY3074828) in Participants With Moderately to Severely Active Ulcerative Colitis

Phase 3

Active, not recruiting

Conditions: Ulcerative Colitis
Ulcerative Colitis Chronic

Interventions: Drug: Mirikizumab

First Posted Date: 2023-03-14

Last Posted Date: 2025-02-28

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 160

Registration Number: NCT05767021

Locations: 🇺🇸
Advanced Research Associates, LLC, Miami, Florida, United States
🇺🇸
Gastroenterology Research of San Antonio, San Antonio, Texas, United States
🇺🇸
Southern Star Research Institute, LLC, San Antonio, Texas, United States

and more 117 locations

A Bioequivalence Study of Mirikizumab (LY3074828) Solution in Healthy Participants

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Mirikizumab

First Posted Date: 2022-12-09

Last Posted Date: 2025-03-28

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 450

Registration Number: NCT05644353

Locations: 🇺🇸
Clinical Pharmacology of Miami, Miami, Florida, United States
🇺🇸
Altasciences Clinical Los Angeles, Inc, Cypress, California, United States
🇺🇸
Qps-Mra, Llc, Miami, Florida, United States

and more 3 locations

A Bioequivalence Study of Mirikizumab (LY3074828) in Healthy Participants

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Mirikizumab

First Posted Date: 2022-08-25

Last Posted Date: 2024-07-05

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 396

Registration Number: NCT05515601

Locations: 🇺🇸
Labcorp Clinical Research LP, Dallas, Texas, United States
🇺🇸
Altasciences Clinical Los Angeles, Inc, Cypress, California, United States
🇺🇸
QPS, Springfield, Missouri, United States

and more 2 locations

A Study of Mirikizumab (LY3074828) in Pediatric Participants With Crohn's Disease

Phase 3

Recruiting

Conditions: Crohn's Disease

Interventions: Drug: Mirikizumab

First Posted Date: 2022-08-22

Last Posted Date: 2025-04-18

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 90

Registration Number: NCT05509777

Locations: 🇺🇸
Cook Children's Medical Center, Fort Worth, Texas, United States
🇺🇸
University of Vermont Medical Center, Burlington, Vermont, United States
🇺🇸
University of California San Diego, La Jolla, California, United States

and more 78 locations

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