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Drug

Mirikizumab

Approved · EMA
Late-stage development

Also known as Omvoh.

RxNorm2668384UNIIZ7HVY03PHP
19
Active clinical trials
1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

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

Clinical trial2026-07-17Results expected Q2 2027 · ClinicalTrials.gov

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

Clinical trial2026-07-07Results expected Q2 2027 · ClinicalTrials.gov

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

Clinical trial2026-07-07Results expected Q2 2027 · ClinicalTrials.gov

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

Clinical trial2026-07-07Results expected Q2 2028 · ClinicalTrials.gov

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

Clinical trial2026-07-07Results expected Q2 2028 · ClinicalTrials.gov

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

Clinical trial2026-07-07Results expected Q2 2028 · ClinicalTrials.gov

A Master Protocol for a Phase 3, Multicenter, Open-label, Long-term Extension Study to Evaluate the Long-term Efficacy and Safety of Mirikizumab in Children and Adolescents With Moderate-to-severe Ulcerative Colitis or Crohn's Disease

Clinical trial2026-06-23Results expected Q4 2030 · ClinicalTrials.gov

Efficacy of Top-down Therapy With Mirikizumab Versus Standard of Care With Azathioprine in Patients With Newly Diagnosed, Moderate-to-severe Crohn's Disease: A 52-week, Multicenter, Open-label, Randomized Controlled Trial

Clinical trial2026-06-22Results expected Q1 2029 · ClinicalTrials.gov

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

Clinical trial2026-06-15Results expected Q3 2028 · ClinicalTrials.gov

A Multicenter, Phase 3b, Open-Label, Single-Arm Study to Investigate Bowel Urgency and Its Relationship With Other Outcome Measures in Adults With Moderately to Severely Active Ulcerative Colitis Treated With Mirikizumab

Clinical trial2026-06-10Results posted · ClinicalTrials.gov

An Open-label Single-arm Study to Assess the Efficacy of Mirikizumab in Patients With Inflammatory Strictures Due to Crohn's Disease

Clinical trial2026-06-01Results expected Q3 2027 · ClinicalTrials.gov

Approval: Omvoh (EMA)

Regulatory2023-05-26EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Mirikizumab
Aliases & brands
Omvoh
RxNorm CUI
2668384
UNII
Z7HVY03PHP
Regulatory jurisdictions
ema

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2023-05-26
Latest approval
2023-05-26
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2023-05-26Approval
Approval: Omvoh (EMA)
Indication: Omvoh is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were… Show full indication

Omvoh is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic treatment.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

40 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
40
registered trials across all phases
LATEST COMPLETION 2026
19
Active studies
17
Recruiting
24
Late-stage (III+)
19
Completed
2
Discontinued
PHASE DISTRIBUTIONn = 40
Phase 18Phase 28Phase 315Phase 49

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Efficacy of Top-down Therapy With Mirikizumab Versus Standard of Care With Azathioprine in Patients With Newly Diagnosed, Moderate-to-severe Crohn's Disease: A 52-week, Multicenter, Open-label, Randomized Controlled Trial

Not yet recruitingPH IVUniversity Hospital Schleswig-Holsteinn=3202029

Efficacy of MIrikizumab to Achieve Transmural Healing in patiENTs With Crohn's Disease : EMINENT-CD

RecruitingPH IVGroupe d'Etude Therapeutique des Affections Inflammatoires Digestivesn=752028

Efficacy of Top-down Therapy With Mirikizumab Versus Standard of Care With Azathioprine in Patients With Newly Diagnosed Moderate-to-severe Ulcerative Colitis: A 52-week, Multicenter, Open-label, Randomized Controlled Trial

RecruitingPH IVUniversity Hospital Schleswig-Holsteinn=3002028

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

Not yet recruitingPH IVEli Lilly and Companyn=142028

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

Not yet recruitingPH IVSpecialty Networks Research.n=4002028

Recent completions

Trials that read out recently, adding to the completed evidence base.

A Multicenter, Phase 3, Open-Label Study to Investigate the Efficacy, Pharmacokinetics, and Safety of Mirikizumab in Participants 2 Years to Less Than 18 Years of Age With Moderately to Severely Active Ulcerative Colitis

CompletedPH IIIEli Lilly and Companyn=632026

A Multicenter, Phase 3b, Open-Label, Single-Arm Study to Investigate Bowel Urgency and Its Relationship With Other Outcome Measures in Adults With Moderately to Severely Active Ulcerative Colitis Treated With Mirikizumab

CompletedPH IIIEli Lilly and Companyn=1722026

Mirikizumab Therapy is Effective for Patients With Moderate to Severe Ulcerative Colitis Patients Whose Geboes Score Grade is ≥3.2) on Endoscopic Biopsy

CompletedPH IVShowa Inan General Hospitaln=1002025

A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Arm, Placebo-Controlled Maintenance Study of Mirikizumab in Patients With Moderately to Severely Active Ulcerative Colitis (LUCENT 2)

CompletedPH IIIKey trialEli Lilly and Companyn=1,3282025

A Phase 3, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Induction Study of Mirikizumab in Conventional-Failed and Biologic-Failed Patients With Moderately to Severely Active Ulcerative Colitis (LUCENT 1)

CompletedPH IIIKey trialEli Lilly and Companyn=1,2812024

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active- Controlled, Treat-Through Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients With Moderately to Severely Active Crohn's Disease

CompletedPH IIIKey trialEli Lilly and Companyn=1,1582023
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.