Mirikizumab

Mirikizumab-mrkz is a humanized IgG4 monoclonal antibody that selectively binds to the p19 subunit of human IL-23 cytokine and inhibits its interaction with the IL-23 receptor. IL-23 is involved in mucosal inflammation and affects the differentiation, expansion, and survival of T cell subsets, and innate immune cell subsets, which represent sources of pro-inflammatory cytokines.

• OMVOH is indicated for the treatment of: moderately to severely active ulcerative colitis in adults. moderately to severely active Crohn's disease in adults.ICD-10: K50.90, K51.90

• OMVOH is contraindicated in patients with a history of serious hypersensitivity reaction to mirikizumab-mrkz or any of the excipients [see Warnings and Precautions ( 5.1 )] . History of serious hypersensitivity reaction to mirikizumab-mrkz or any of the excipients.contraindicated

Prior to Treatment Initiation Evaluate patients for tuberculosis (TB) infection. ( 2.1 , 5.3 ) Obtain liver enzymes and bilirubin levels. ( 2.1 , 5.4 ) Complete all age-appropriate vaccinations according to current immunization guidelines. ( 2.1 , 5.5 ) Recommended Dosage for Ulcerative Colitis Induction Dosage : Week 0, Week 4, and Week 8: Infuse 300 mg intravenously over at least 30 minutes. ( 2.2 ) Maintenance Dosage : Week 12 and every 4 weeks thereafter: Inject 200 mg subcutaneously (given as either one injection of 200 mg or as two consecutive injections of 100 mg each). ( 2.2 ) Recommended Dosage for Crohn's Disease Induction Dosage : Week 0, Week 4, and Week 8: Infuse 900 mg intravenously over at least 90 minutes. ( 2.3 ) Maintenance Dosage : Week 12 and every 4 weeks thereafter: Inject 300 mg subcutaneously (given as two consecutive injections of 100 mg and 200 mg in any order). ( 2.3 ) Preparation and Administration Instructions See the full prescribing information for preparation, administration and storage information for intravenous infusion and subcutaneous injection. ( 2.2 , 2.3 , 2.4 , 2.5 ) 2.1 Recommended Evaluations and Immunizations Prior to Treatment Initiation Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with OMVOH [see Warnings and Precautions ( 5.3 )] . Obtain liver enzymes and bilirubin levels prior to initiating treatment with OMVOH [see Warnings and Precautions ( 5.4 )] . Complete all age-appropriate vaccinations according to current immunization guidelines [see Warnings and Precautions ( 5.5 )] .

Hypersensitivity Reactions : Serious hypersensitivity reactions, including anaphylaxis and infusion-related reactions, have been reported. If a severe hypersensitivity reaction occurs, discontinue and initiate appropriate treatment. ( 5.1 ) Infections : OMVOH may increase the risk of infection. Do not initiate treatment with OMVOH in patients with a clinically important active infection until the infection resolves or is adequately treated. If a serious infection develops, do not administer OMVOH until the infection resolves. ( 5.2 ) Tuberculosis : Do not administer OMVOH to patients with active TB infection. Monitor patients receiving OMVOH for signs and symptoms of active TB during and after treatment. ( 5.3 ) Hepatotoxicity : Drug-induced liver injury has been reported. Monitor liver enzymes and bilirubin levels at baseline and for at least 24 weeks of treatment and thereafter according to routine patient management. Interrupt treatment if drug-induced liver injury is suspected, until this diagnosis is excluded. ( 5.4 ) Immunizations : Avoid use of live vaccines. ( 5.5 ) 5.1 Hypersensitivity Reactions Serious hypersensitivity reactions, including anaphylaxis during intravenous infusion, have been reported with OMVOH administration. Infusion-related hypersensitivity reactions, including mucocutaneous erythema and pruritus, were reported during induction [see Adverse Reactions ( 6.1 )] . If a severe hypersensitivity reaction occurs, discontinue OMVOH immediately and initiate appropriate treatment.

The following topics are also discussed in detail in the Warnings and Precautions section: Hypersensitivity Reactions [see Warnings and Precautions ( 5.1 )] Infections [see Warnings and Precautions ( 5.2 )] Tuberculosis [see Warnings and Precautions ( 5.3 )] Hepatotoxicity [see Warnings and Precautions ( 5.4 )] Most common adverse reactions are: Ulcerative colitis (≥2%) : Induction : upper respiratory tract infections and arthralgia. ( 6.1 ) Maintenance: upper respiratory tract infections, injection site reactions, arthralgia, rash, headache, and herpes viral infection. ( 6.1 ) Crohn's disease (≥5%) : upper respiratory tract infections, injection site reactions, headache, arthralgia, and elevated liver tests ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Ulcerative Colitis OMVOH was studied up to 12 weeks in subjects with moderately to severely active ulcerative colitis in a randomized, double-blind, placebo-controlled induction study (UC-1).

8.1 Pregnancy Pregnancy Exposure Registry There will be a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to OMVOH during pregnancy. Pregnant women exposed to OMVOH and healthcare providers are encouraged to call Eli Lilly and Company at 1-800-Lilly-Rx (1-800-545-5979). Risk Summary Available data from case reports of mirikizumab-mrkz use in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Although there are no data on mirikizumab-mrkz, monoclonal antibodies can be actively transported across the placenta, and mirikizumab-mrkz may cause immunosuppression in the in utero-exposed infant. An enhanced pre- and post-natal development study conducted in pregnant monkeys at a dose 20 times the maximum recommended human dose (MRHD) revealed no adverse developmental effects to the developing fetus, or harm to infant monkeys from birth through 6 months of age. There are risks of adverse pregnancy outcomes associated with increased disease activity in women with inflammatory bowel disease (see Clinical Considerations) . The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defects, loss, or other adverse outcomes. In the U.S.

Metabolism

Mirikizumab-mrkz exhibited linear pharmacokinetics with dose-proportional increase in exposure over a dose range of 60 to 2400 mg given as an intravenous injection or over a dose range of 200 to 400 mg given as a subcutaneous injection, in healthy volunteers. There was no apparent accumulation of mirikizumab-mrkz concentrations in serum over time when administered as a subcutaneous injection every 4 weeks to subjects with ulcerative colitis or Crohn's disease.

• Oct 26, 2023BLABLA761279Eli Lilly And Co

Reference statistics from the openFDA drug-shortage dataset. For a live view, consult the FDA database directly. Not clinical guidance.

• Omvoh, Injection, 100 mg/1 mL (NDC 0002-8011-27)To be discontinued
  Sponsor: Eli Lilly and Co.
  Updated Dec 22, 2025
• Omvoh, Injection, 100 mg/1 mL (NDC 0002-8870-27)To be discontinued
  Sponsor: Eli Lilly and Co.
  Updated Dec 22, 2025

1. 1Colitis Ulcerative11115%
2. 2Injection Site Pain8111%
3. 3Drug Ineffective598.1%
4. 4Incorrect Dose Administered294.0%
5. 5Diarrhoea263.6%
6. 6Rash263.6%
7. 7Arthralgia253.4%
8. 8Headache243.3%
9. 9Haematochezia233.2%
10. 10Abdominal Pain212.9%
11. 11Maternal Exposure During Pregnancy202.8%
12. 12Frequent Bowel Movements182.5%
13. 13Pyrexia172.3%
14. 14Dizziness162.2%
15. 15Off Label Use162.2%

The 10 most recently updated of 52 ClinicalTrials.gov registrations naming Mirikizumab as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• A Study of Mirikizumab (LY3074828) in Participants With Moderately to Severely Active Ulcerative Colitis
  Completed · Phase 3 · Interventional · 172 enrolled · Eli Lilly and Company
  NCT05767021updated 2026-06-10
• LY4268989 (MORF-057) Co-Administered With Mirikizumab in Adults With Moderately to Severely Active Ulcerative Colitis:
  Recruiting · Phase 2 · Interventional · 252 enrolled · Eli Lilly and Company
  NCT07186101updated 2026-06-04
• A Master Protocol (IIBD): A Study of Multiple Drugs in Adults With Ulcerative Colitis or Crohn's Disease
  Recruiting · Phase 2 · Interventional · 60 enrolled · Eli Lilly and Company
  NCT07483073updated 2026-06-04
• A Study of LY4395089 and Mirikizumab (LY3074828) Given Together and Mirikizumab (Alone) in Adults With Crohn's Disease
  Recruiting · Phase 2 · Interventional · 60 enrolled · Eli Lilly and Company
  NCT07483099updated 2026-06-04
• 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
  Recruiting · Phase 3 · Interventional · 350 enrolled · Eli Lilly and Company
  NCT06937086updated 2026-06-03
• A Master Protocol (AMAZ): A Study of Mirikizumab (LY3074828) in Pediatric Participants With Ulcerative Colitis or Crohn's Disease (SHINE-ON)
  Recruiting · Phase 3 · Interventional · 150 enrolled · Eli Lilly and Company
  NCT04844606updated 2026-06-03
• A Study of Mirikizumab (LY3074828) in Pediatric Participants With Moderately to Severely or Active Ulcerative Colitis
  Completed · Phase 3 · Interventional · 63 enrolled · Eli Lilly and Company
  NCT05784246updated 2026-06-03
• Mirikizumab and Tirzepatide Administered in Adult Participants With Moderately to Severely Active Crohn's Disease and Obesity or Overweight
  Recruiting · Phase 3 · Interventional · 290 enrolled · Eli Lilly and Company
  NCT06937099updated 2026-06-03
• Open-label Single-arm Study to Assess the Efficacy of Mirikizumab in Patients With Inflammatory Strictures Due to CD
  Recruiting · Phase 4 · Interventional · 60 enrolled · Alimentiv Inc.
  NCT06997965updated 2026-06-01
• A Study to Measure Mirikizumab Levels in Breast Milk of Lactating Participants Receiving Mirikizumab Therapeutically for an Approved Indication
  Not yet recruiting · Phase 4 · Interventional · 14 enrolled · Eli Lilly and Company
  NCT07612267updated 2026-05-28

Frequently asked questions

How does Mirikizumab work?

Mirikizumab-mrkz is a humanized IgG4 monoclonal antibody that selectively binds to the p19 subunit of human IL-23 cytokine and inhibits its interaction with the IL-23 receptor. IL-23 is involved in mucosal inflammation and affects the differentiation, expansion, and survival of T cell subsets, and innate immune cell subsets, which represent sources of pro-inflammatory cytokines.

What is Mirikizumab used for?

According to FDA labeling, Mirikizumab carries indications including: OMVOH is indicated for the treatment of: moderately to severely active ulcerative colitis in adults. moderately to severely active Crohn's disease in adults.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Mirikizumab?

Mirikizumab is classified as Interleukin inhibitors, Interleukin-23 Antagonist, Antibody-Receptor Interactions, Interleukin-23 Antagonists, Decreased Cytokine Activity.

What are the brand names for Mirikizumab?

Mirikizumab is marketed under brand names including Omvoh.

What are the contraindications for Mirikizumab?

Mirikizumab labeling lists contraindications including: OMVOH is contraindicated in patients with a history of serious hypersensitivity reaction to mirikizumab-mrkz or any of the excipients [see Warnings and Precautions ( 5.1 )] . History of serious hypersensitivity reaction to mirikizumab-mrkz or any of the excipients.. Always consult the full prescribing information and a clinician.