Molecule
Mirikizumab is an interleukin-23 antagonist indicated for the treatment of moderately to severely active ulcerative colitis in adults. It is available as injection and kits for subcutaneous and intravenous use. MedsAcross supplies Mirikizumab for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
OMVOH is indicated for the treatment of: moderately to severely active ulcerative colitis in adults. moderately to severely active Crohn's disease in adults. OMVOH TM is an interleukin-23 antagonist indicated for the treatment of: moderately to severely active ulcerative colitis in adults moderately to severely active Crohn's disease in adults
Source: US FDA prescribing information
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. Research in animal models has shown that pharmacologic inhibition of IL-23p19 can ameliorate intestinal inflammation. Mirikizumab-mrkz inhibits the release of pro-inflammatory cytokines and chemokines.
Source: US FDA prescribing information
Prior to Treatment Initiation Evaluate patients for tuberculosis (TB) infection. Obtain liver enzymes and bilirubin levels. Complete all age-appropriate vaccinations according to current immunization guidelines. Recommended Dosage for Ulcerative Colitis Induction Dosage: Week 0, Week 4, and Week 8: Infuse 300 mg intravenously over at least 30 minutes. 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). Recommended Dosage for Crohn's Disease Induction Dosage: Week 0, Week 4, and Week 8: Infuse 900 mg intravenously over at least 90 minutes. 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).
Source: US FDA prescribing information
OMVOH is contraindicated in patients with a history of serious hypersensitivity reaction to mirikizumab-mrkz or any of the excipients. History of serious hypersensitivity reaction to mirikizumab-mrkz or any of the excipients.
Source: US FDA prescribing information
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. 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. 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. Hepatotoxicity: Drug-induced liver injury has been reported.
Source: US FDA prescribing information
The following topics are also discussed in detail in the Warnings and Precautions section: Hypersensitivity Reactions Infections Tuberculosis Hepatotoxicity Most common adverse reactions are: Ulcerative colitis (≥2%): Induction: upper respiratory tract infections and arthralgia. Maintenance: upper respiratory tract infections, injection site reactions, arthralgia, rash, headache, and herpes viral infection. Crohn's disease (≥5%): upper respiratory tract infections, injection site reactions, headache, arthralgia, and elevated liver tests
Source: US FDA prescribing information
CYP450 Substrates Increased concentrations of cytokines (e.g., IL-1, IL-6, IL-10, TNFα, IFN) during chronic inflammation associated with certain diseases including Crohn's disease may suppress the formation of CYP450 enzymes. Therapeutic proteins, including mirikizumab-mrkz, that decrease the concentrations of these pro-inflammatory cytokines may increase the formation of CYP450 enzymes resulting in decreased CYP450 substrate exposure. Upon initiation or discontinuation of OMVOH in patients treated with concomitant CYP450 substrates, monitor drug concentrations or other therapeutic parameters, and adjust the dosage of the CYP450 substrate as needed. See the prescribing information of specific CYP450 substrates.
Source: US FDA prescribing information
Store refrigerated at 2°C to 8°C (36°F to 46°F). Do not freeze. If needed, the prefilled pen or prefilled syringe may be stored at room temperature up to 30°C (86°F) for up to 2 weeks in the original carton to protect from light. Once OMVOH has been stored at room temperature, do not return to the refrigerator. Do not shake. Keep OMVOH in the original carton to protect from light until the time of use.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
4 presentations of Mirikizumab, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Omvoh kitSubcutaneous Cold chain | Eli Lilly | US FDA | Available on request |
| Omvoh 100 mg/1 mL injectionSubcutaneous Cold chain | Eli Lilly | US FDA | Available on request |
| Omvoh 200 mg/2 mL injectionSubcutaneous Cold chain | Eli Lilly | US FDA | Available on request |
| Omvoh 300 mg/15 mL injectionIntravenous Cold chain | Eli Lilly | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Yes, on request. MedsAcross lists 4 presentations of Mirikizumab and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Mirikizumab, including Omvoh.
Yes. The US FDA first approved Mirikizumab on 26 October 2023, according to Drugs@FDA.
Yes. Mirikizumab has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
At least one listed presentation of Mirikizumab must be kept cold, so it is shipped in temperature-controlled packaging. Check the storage line on each presentation.
Mirikizumab is classified under ATC code L04AC (Immunosuppressive drug, subgroup L04AC).
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.