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
A Study to Compare Two Formulations of Mirikizumab (LY3074828) in Healthy Participants
- Conditions
- Healthy
- Interventions
- First Posted Date
- 2021-10-06
- Last Posted Date
- 2025-03-04
- Lead Sponsor
- Eli Lilly and Company
- Target Recruit Count
- 237
- Registration Number
- NCT05069896
- Locations
- 🇺🇸
Covance Dallas, Dallas, Texas, United States
🇺🇸LabCorp CRU, Inc., Daytona Beach, Florida, United States
🇺🇸QPS, Springfield, Missouri, United States
A Master Protocol (AMAZ): A Study of Mirikizumab (LY3074828) in Pediatric Participants With Ulcerative Colitis or Crohn's Disease (SHINE-ON)
- Conditions
- Ulcerative ColitisUlcerative Colitis ChronicCrohn's DiseaseInflammatory Bowel Diseases
- Interventions
- First Posted Date
- 2021-04-14
- Last Posted Date
- 2025-05-21
- Lead Sponsor
- Eli Lilly and Company
- Target Recruit Count
- 150
- Registration Number
- NCT04844606
- Locations
- 🇺🇸
UCSF Medical Center at Mission Bay, San Francisco, California, United States
🇺🇸Connecticut Children's Medical Center, Hartford, Connecticut, United States
🇺🇸Emory University School of Medicine, Atlanta, Georgia, United States
A Study of Mirikizumab in Healthy Participants
- Conditions
- Healthy
- Interventions
- First Posted Date
- 2020-10-29
- Last Posted Date
- 2024-02-20
- Lead Sponsor
- Eli Lilly and Company
- Target Recruit Count
- 240
- Registration Number
- NCT04607733
- Locations
- 🇺🇸
QPS, Springfield, Missouri, United States
🇺🇸Covance Dallas, Dallas, Texas, United States
🇺🇸Covance Clinical Research Inc, Madison, Wisconsin, United States
A Study to Compare Two Different Formulations of Mirikizumab in Healthy Participants
- First Posted Date
- 2020-09-14
- Last Posted Date
- 2024-01-25
- Lead Sponsor
- Eli Lilly and Company
- Target Recruit Count
- 60
- Registration Number
- NCT04548219
- Locations
- 🇺🇸
QPS, Springfield, Missouri, United States
A Study of Mirikizumab (LY3074828) in Participants With Ulcerative Colitis
- Conditions
- Ulcerative Colitis
- Interventions
- First Posted Date
- 2020-07-13
- Last Posted Date
- 2021-05-06
- Lead Sponsor
- Eli Lilly and Company
- Registration Number
- NCT04469062
A Long-term Extension Study of Mirikizumab (LY3074828) in Participants With Crohn's Disease
- First Posted Date
- 2020-01-18
- Last Posted Date
- 2025-04-18
- Lead Sponsor
- Eli Lilly and Company
- Target Recruit Count
- 778
- Registration Number
- NCT04232553
- Locations
- 🇨🇳
Zhongshan Hospital Affiliated to Xiamen University, Xiamen, Fujian, China
🇨🇳The First People's Hospital of Foshan, Foshan, Guangdong, China
🇨🇳Tongji Hospital Tongji Medical,Science & Technology, Wuhan, Hubei, China
A Study of Mirikizumab in Healthy Chinese Participants
- Conditions
- Healthy
- Interventions
- First Posted Date
- 2019-10-24
- Last Posted Date
- 2024-01-26
- Lead Sponsor
- Eli Lilly and Company
- Target Recruit Count
- 60
- Registration Number
- NCT04137380
- Locations
- 🇨🇳
Shanghai Xuhui Central Hospital, Xuhui District, Shanghai, China
🇨🇳Peking University First Hospital, Beijing, China
A Study of Mirikizumab (LY3074828) in Children and Teenagers With Ulcerative Colitis (UC)
- First Posted Date
- 2019-07-02
- Last Posted Date
- 2024-03-26
- Lead Sponsor
- Eli Lilly and Company
- Target Recruit Count
- 26
- Registration Number
- NCT04004611
- Locations
- 🇺🇸
Childrens Hospital of Orange County, Orange, California, United States
🇺🇸Connecticut Children's Medical Center, Hartford, Connecticut, United States
🇺🇸Riley Hospital for Children, Carmel, Indiana, United States
A Study of Mirikizumab (LY3074828) in Participants With Crohn's Disease
- Conditions
- Crohn's Disease
- Interventions
- First Posted Date
- 2019-04-24
- Last Posted Date
- 2024-12-27
- Lead Sponsor
- Eli Lilly and Company
- Target Recruit Count
- 1158
- Registration Number
- NCT03926130
- Locations
- 🇺🇸
University Hospitals Cleveland Medical Center, Cleveland, Ohio, United States
🇺🇸Digestive Health Specialists, Tupelo, Mississippi, United States
🇺🇸GastroIntestinal Biosciences Clinical Trials, Los Angeles, California, United States
A Study of Injections of LY3074828 in Healthy Participants
- Conditions
- Healthy
- Interventions
- First Posted Date
- 2019-03-22
- Last Posted Date
- 2024-02-20
- Lead Sponsor
- Eli Lilly and Company
- Target Recruit Count
- 66
- Registration Number
- NCT03886948
- Locations
- 🇺🇸
Covance Clinical Research Inc, Daytona Beach, Florida, United States
Drug Development Updates
Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.