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mirikizumab

Generic: mirikizumab·Brand: Omvoh

mirikizumab: sourced relationships with 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

Source-backed records connect mirikizumab to LLY; that link alone does not prove the drug works.

What to watch

Watch active trials and any change in FDA or trial status.
BioSniper AIPage evidence connected

Prepared research question

How could mirikizumab → LLY affect its developer, and what evidence supports the link?

Run cited research

Traceable citations · Unknowns marked

See linked entities and source evidence5 indications · 0 study sponsors

Related indications

For the treatment of moderately to severely active ulcerative colitis in adults and for the treatment of moderately to severely active Crohn's disease in adults.Crohn's DiseaseHealthyInflammatory Bowel DiseasesUlcerative Colitis

Study sponsors

No additional listed-company sponsor is linked.

Dated Pipeline Records (1)
CompanyDated record stage
ELI LILLY & Co (LLY)
Reported 2023-10-26 · Current development: unknownSource
For the treatment of moderately to severely active ulcerativ…
Approved
Clinical Trial Registry Records (16)showing 10 most recent

MIRICURE: Mirikizumab With Curettage and Repair (Closure) for Perianal Fistulizing Crohn's Disease

NCT07782021Registry updated 2026-08-24·Phase 4
Not yet recruiting

Primary endpoint: Proportion of participants achieving combined clinical remission and radiologic response

Interventionalopen50 targetStarted 2026-12Completion 2029-072 sites · United StatesIcahn School of Medicine at Mount Sinai

INSIGHT-IBD Pragmatic Study: Investigation of Mirikizumab in Real World Settings for Mirikizumab

NCT07686757Registry updated 2026-10-02·Phase 4
Enrolling by invitation

Primary endpoint: Proportion of Patients Requiring an Increase in IBD Disease Management

InterventionalRandomizedopen400 targetStarted 2026-08Completion 2028-0611 sites · United StatesSpecialty Networks Research.

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

NCT07612267Registry updated 2026-09-08·Phase 4
Recruiting

Primary endpoint: Concentration of Mirikizumab in Breast Milk

Interventionalopen14 targetStarted 2026-08Completion 2028-0920 sites · Canada, Denmark, Germany, Israel…Eli Lilly and Company

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

NCT07483099Registry updated 2026-10-08·Phase 2
Recruiting

Primary endpoint: Percentage of Participants with Crohn's Disease who Achieve Endoscopic Response

InterventionalRandomizedopen60 targetStarted 2026-05Completion 2028-0370 sites · Belgium, Brazil, Canada, China…Eli Lilly and Company

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

NCT07483073Registry updated 2026-10-08·Phase 2
Recruiting

Primary endpoint: Number of Participants Allocated to Each of the Intervention-Specific Appendices (ISA)

InterventionalRandomizedopen60 targetStarted 2026-05Completion 2028-0370 sites · Belgium, Brazil, Canada, China…Eli Lilly and Company

An Adaptive Two-Stage Bioequivalence Study of Subcutaneous Injections of Mirikizumab Solution in Healthy Participants

NCT07446101Registry updated 2026-05-14·Phase 1
Recruiting

Primary endpoint: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3074828

InterventionalRandomizedopen450 targetStarted 2026-03Completion 2027-025 sites · United StatesEli Lilly and Company

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

NCT07186101Registry updated 2026-10-08·Phase 2
Recruiting

Primary endpoint: Percentage of Participants Who Achieve Clinical Remission with Modified Mayo Score (mMS)

InterventionalRandomizeddouble252 targetStarted 2025-11Completion 2029-03147 sites · Austria, Brazil, Canada, China…Eli Lilly and Company

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

NCT06937099Registry updated 2026-10-07·Phase 3
Recruiting

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

InterventionalRandomizeddouble290 targetStarted 2025-06Completion 2028-05183 sites · Austria, Belgium, Brazil, Bulgaria…Eli Lilly and Company

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

NCT06937086Registry updated 2026-10-07·Phase 3
Recruiting

Primary endpoint: Percentage of Participants Who Simultaneously Achieve Clinical Remission and at Least 10% Weight Reduction

InterventionalRandomizeddouble350 targetStarted 2025-06Completion 2028-04187 sites · Austria, Belgium, Brazil, Bulgaria…Eli Lilly and Company

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

NCT06598943Registry updated 2026-10-07·Phase 2
Active, not recruiting

Primary endpoint: Percentage of Participants Achieving Clinical Remission

InterventionalRandomizeddouble143 targetStarted 2024-10Completion 2027-07207 sites · Argentina, Belgium, Canada, Colombia…Eli Lilly and Company
FDA Decisions1 records
Approval(LLY)FDA ↗
BLA761279Type 1 - New Molecular EntityOrphan DrugStandardOtherVial

Frequently asked questions

Which companies have sourced relationships with mirikizumab?

mirikizumab has dated SEC/FDA relationship records for 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.