mirikizumab
mirikizumab: developed by 1 company · 16 clinical trials tracked · 1 FDA decision.
mirikizumab evidence translation
What we can confirm
1 FDA record · 16 tracked trials
What it means
What to watch
Prepared research question
How could mirikizumab → LLY affect its developer, and what evidence supports the link?
Traceable citations · Unknowns marked
See linked entities and source evidence4 indications · 1 study sponsors
Related indications
Study sponsors
Development Pipeline (1)
| Company | Phase |
|---|---|
| ELI LILLY & Co (LLY) For the treatment of moderately to severely active ulcerativ… | Approved |
Clinical Trials (16)showing 10 most recent
MIRICURE: Mirikizumab With Curettage and Repair (Closure) for Perianal Fistulizing Crohn's Disease
Primary endpoint: Proportion of participants achieving combined clinical remission and radiologic response
INSIGHT-IBD Pragmatic Study: Investigation of Mirikizumab in Real World Settings for Mirikizumab
Primary endpoint: Proportion of Patients Requiring an Increase in IBD Disease Management
A Study to Evaluate Mirikizumab Concentrations in Breast Milk Following Administration of Mirikizumab by Subcutaneous Injection in Lactating Participants Receiving Mirikizumab Therapeutically for an Approved Indication
Primary endpoint: Concentration of Mirikizumab in Breast Milk
A Phase 2, Multicenter, Randomized, Open-Label, Active-Controlled Study to Investigate LY4395089/Mirikizumab Co-administration Compared With Mirikizumab in Adults With Moderately to Severely Active Crohn's Disease
Primary endpoint: Percentage of Participants with Crohn's Disease who Achieve Endoscopic Response
A Master Protocol for Phase 2, Randomized, Controlled Studies of Multiple Interventions for the Treatment of Adults With Moderately to Severely Active Ulcerative Colitis or Crohn's Disease
Primary endpoint: Number of Participants Allocated to Each of the Intervention-Specific Appendices (ISA)
An Adaptive Two-Stage Bioequivalence Study of Subcutaneous Injections of Mirikizumab Solution in Healthy Participants
Primary endpoint: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3074828
A Phase 2, Multicenter, Randomized, Double-Blind, Active-Controlled Study of LY4268989 (MORF-057) Co-Administered With Mirikizumab in Adults With Moderately to Severely Active Ulcerative Colitis
Primary endpoint: Percentage of Participants Who Achieve Clinical Remission with Modified Mayo Score (mMS)
A Phase 3b, Randomized, Multicenter, Controlled Study of Mirikizumab and Placebo or Mirikizumab Concomitantly Administered With Tirzepatide in Adult Participants With Moderately to Severely Active Crohn's Disease and Obesity or Overweight
Primary endpoint: Percentage of Participants Who Simultaneously Achieve Clinical Remission by Crohn's Disease Activity Index (CDAI), Endoscopic Remission, and at least 10% Weight Reduction
A Phase 3b, Randomized, Multicenter, Controlled Study of Mirikizumab and Placebo or Mirikizumab Concomitantly Administered With Tirzepatide in Adult Participants With Moderately to Severely Active Ulcerative Colitis and Obesity or Overweight
Primary endpoint: Percentage of Participants Who Simultaneously Achieve Clinical Remission and at Least 10% Weight Reduction
An Adaptive, Dose-Ranging, Phase 2 Study of Eltrekibart Given Alone or in Combination With Mirikizumab for the Treatment of Adult Patients With Moderately to Severely Active Ulcerative Colitis
Primary endpoint: Percentage of Participants Achieving Clinical Remission
FDA Decisions1 records
Frequently asked questions
Who is developing mirikizumab?
mirikizumab is being developed by ELI LILLY & Co.
How many clinical trials involve mirikizumab?
BioSniper tracks 16 clinical trials involving mirikizumab.
What is mirikizumab's latest FDA decision?
The most recent tracked FDA decision for mirikizumab is Approval, dated October 26, 2023.