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Mirikizumab

Mirikizumab is a humanized IgG4 kappa monoclonal antibody that selectively binds to the p19 subunit of the cytokine interleukin-23 (IL-23), inhibiting its activity and thereby reducing inflammation in immune-mediated diseases.^[1] Marketed under the brand name Omvoh by Eli Lilly and Company, it is approved for the treatment of adults with moderately to severely active ulcerative colitis (UC) when conventional or biologic therapies have had an inadequate response, lost response, or were not tolerated, and for adults with moderately to severely active Crohn's disease (CD) under similar conditions.^[2]^[3] For UC, the medication is administered as an intravenous infusion for induction (300 mg at weeks 0, 4, and 8) followed by subcutaneous injections for maintenance (200 mg every four weeks). For CD, induction is 900 mg IV at weeks 0, 4, and 8, followed by 300 mg subcutaneous every four weeks.^[2]^[4] The mechanism of action of mirikizumab involves blocking the IL-23p19 subunit, which prevents downstream signaling that promotes pro-inflammatory cytokine production and T-cell activation in the gut mucosa, addressing the underlying pathophysiology of UC and CD.^[5] This targeted approach positions it as an IL-23p19 antagonist for these inflammatory bowel diseases (IBD), demonstrating clinical efficacy in achieving clinical remission, endoscopic improvement, and histologic-endoscopic mucosal improvement in phase 3 trials such as LUCENT-1, LUCENT-2, and VIVID-1.^[6] Common adverse reactions include upper respiratory infections, arthralgia, and injection site reactions, with a safety profile consistent across indications and no new signals observed in long-term use.^[3] Mirikizumab received its initial regulatory approvals for UC in the European Union on May 26, 2023, by the European Medicines Agency (EMA), and in the United States on October 26, 2023, by the U.S. Food and Drug Administration (FDA).^[1]^[7] The FDA expanded approval to include CD on January 15, 2025, with the EMA's Committee for Medicinal Products for Human Use (CHMP) issuing a positive opinion in December 2024, followed by European Commission approval in early 2025, reflecting its broadening role in IBD management.^[8]^[1] Developed by Eli Lilly, mirikizumab was initially investigated for moderate-to-severe plaque psoriasis, showing promising phase 3 results, but the company shifted focus to IBD indications in 2021 to prioritize unmet needs in gastrointestinal disorders.^[9] As of 2025, it is available in over 44 countries and represents a key advancement in biologic therapies for IBD, with ongoing research exploring its long-term outcomes and potential in other IL-23-driven conditions.^[10]

Medical uses

Indications

Mirikizumab is approved for the treatment of moderately to severely active ulcerative colitis (UC) in adults who have had an inadequate response, loss of response, or intolerance to conventional therapies such as corticosteroids, azathioprine, or 6-mercaptopurine, or to advanced therapies including biologics (e.g., TNF blockers or vedolizumab) or Janus kinase inhibitors (e.g., tofacitinib).^[4] It is also indicated for moderately to severely active Crohn's disease (CD) in adults who have shown inadequate response, loss of response, or intolerance to corticosteroids, immunomodulators (e.g., azathioprine, 6-mercaptopurine, or methotrexate), or biologics such as TNF blockers or integrin receptor antagonists.^[4] As an interleukin-23p19 inhibitor, mirikizumab plays a key role in managing inflammatory bowel diseases by inducing and maintaining clinical remission, endoscopic improvement, and histologic-endoscopic mucosal improvement in patients with UC and CD.^[4] In pivotal clinical trials for UC, it demonstrated higher rates of clinical remission during induction therapy compared to placebo, with 24.2% of patients achieving remission at week 12 versus 13.3% in the placebo group.^[11] Similar efficacy was observed in CD trials, where mirikizumab supported sustained remission and mucosal healing over maintenance periods.^[4] Although initially developed for plaque psoriasis, where phase 2 studies showed promising results in reducing symptoms, mirikizumab is not approved for this indication, with development efforts redirected toward inflammatory bowel diseases.^[12]

Dosage and administration

Mirikizumab is administered via intravenous (IV) infusion for induction therapy in adults with moderately to severely active ulcerative colitis (UC) or Crohn's disease (CD), followed by subcutaneous (SC) injections for maintenance.^[4] For UC, the recommended induction regimen consists of 300 mg administered as an IV infusion over at least 30 minutes at weeks 0, 4, and 8.^[4] The maintenance regimen begins at week 12 with 200 mg SC every 4 weeks, which may be given as a single 200 mg/2 mL injection using a prefilled pen or syringe, or as two consecutive 100 mg/1 mL injections.^[4]^[13] In October 2025, the U.S. FDA approved a citrate-free formulation of the 200 mg/2 mL single-injection option for UC maintenance to improve patient convenience, available in prefilled pens or syringes starting in early 2026.^[13] For CD, induction therapy involves 900 mg IV infusion over at least 90 minutes at weeks 0, 4, and 8.^[4] Maintenance treatment starts at week 12 with 300 mg SC every 4 weeks, administered as two consecutive injections: one 100 mg/1 mL and one 200 mg/2 mL, in any order.^[4] IV infusions must be performed by a healthcare professional using a dedicated line, with dilution in 0.9% sodium chloride or 5% dextrose injection; no premedication is required.^[3] For SC administration, patients should receive proper training on self-injection technique, targeting sites such as the abdomen, thigh, or upper arm, with rotations to different locations at least 2 inches apart to avoid irritation.^[3] Allow the prefilled syringe or pen to reach room temperature for about 45 minutes before injection, and do not use if the solution is discolored or contains particles.^[3] No dosage adjustments are necessary for patients with mild to moderate renal or hepatic impairment.^[4] Safety and efficacy have not been established in pediatric patients, and data in elderly patients (≥65 years) are limited, with no specific adjustments recommended based on age.^[4] Mirikizumab should be stored refrigerated at 2°C to 8°C (36°F to 46°F) in its original carton to protect from light; it may be kept at room temperature up to 30°C (86°F) for no more than 2 weeks before use.^[4] Do not freeze, shake, or expose to direct sunlight or heat sources.^[4]

Adverse effects

Common adverse effects

The common adverse effects of mirikizumab are typically mild to moderate in severity and do not usually lead to treatment discontinuation. These effects occur at rates similar to or slightly higher than placebo in clinical trials and are consistent across indications for ulcerative colitis and Crohn's disease.^[4] In the LUCENT trials for ulcerative colitis, upper respiratory tract infections were the most frequent, affecting 8% of patients during induction and 14% during maintenance therapy. Injection site reactions, primarily erythema and swelling, occurred in 9% of patients receiving subcutaneous doses during maintenance. Arthralgia was reported in 2% during induction and 7% during maintenance, while headache and rash each affected approximately 4% of patients in the maintenance phase.^[4]^[14] In the ADVANCE induction trial and SERENITY maintenance extension (combined as CD-1) for Crohn's disease, upper respiratory tract infections were reported in 28% of patients through week 52. Injection site reactions occurred in 10%, headache in 6%, and arthralgia in 6%. Elevated liver tests were noted in 5%.^[4]^[15] The overall safety profile of mirikizumab in patients with inflammatory bowel disease remains favorable, with these common effects generally manageable through supportive care.^[4]

Serious adverse effects

Mirikizumab, an interleukin-23 inhibitor, is associated with an increased risk of serious infections, including reactivation of latent tuberculosis, with serious infections occurring in less than 1% of patients during ulcerative colitis induction therapy and including cases such as intestinal sepsis, listeria sepsis, and pneumonia.^[3] Prior to initiating treatment, patients should be screened for tuberculosis infection, and live vaccines should be avoided during therapy to mitigate infectious risks.^[3] In clinical trials for psoriasis, serious adverse events, which may encompass infections, were reported at a rate of approximately 1.2% during the induction period.^[16] Serious hypersensitivity reactions, including anaphylaxis and infusion-related reactions, have been reported with mirikizumab administration, occurring rarely at less than 1% incidence; discontinuation is recommended if severe reactions occur.^[3] In the European Medicines Agency product information, infusion-related hypersensitivity reactions were uncommon (0.4%), all non-serious in trials, though severe cases warrant immediate medical intervention.^[1] Long-term clinical data have observed malignancies, such as gastrointestinal and skin cancers, in mirikizumab-treated patients, occurring at low rates with no established causality due to small event numbers and confounding factors in immunocompromised populations.^[17] Hepatotoxicity, including drug-induced liver injury with elevated liver enzymes, has been reported, with ALT elevations ≥3× upper limit of normal in 2.3% of patients and ≥5× in 0.7%; one case met Hy's Law criteria.^[1] Monitoring of liver enzymes and bilirubin is required at baseline and periodically for at least 24 weeks after initiation, with treatment interruption if significant elevations occur.^[3] In long-term extension trials such as LUCENT-3 (up to 152 weeks as of 2025), serious adverse events occurred in 7.4% of patients, with 5.3% discontinuing due to adverse reactions and no new safety signals identified.^[18]

Pharmacology

Mechanism of action

Mirikizumab is a humanized immunoglobulin G4 (IgG4) monoclonal antibody that selectively binds to the p19 subunit of interleukin-23 (IL-23), a pro-inflammatory cytokine.^[1] This binding prevents IL-23 from interacting with its receptor, which is expressed on T cells and natural killer (NK) cells, thereby inhibiting downstream signaling pathways that promote inflammation.^[19] By blocking this interaction, mirikizumab reduces the release of effector cytokines such as IL-17A, IL-17F, and IL-22, which are produced by Th17 cells and other immune effectors and contribute to the differentiation and maintenance of these pro-inflammatory T helper cells.^[20] The selectivity of mirikizumab for the p19 subunit of IL-23 distinguishes it from broader interleukin inhibitors, as IL-12 shares only the p40 subunit with IL-23 and is therefore spared, potentially minimizing off-target immunosuppression.^[1] In the context of inflammatory bowel diseases (IBD), IL-23 plays a central role in driving chronic mucosal inflammation in both ulcerative colitis (UC) and Crohn's disease (CD) by dysregulating innate and adaptive immune responses, including the expansion of Th17 cells and activation of innate lymphoid cells.^[21] This targeted blockade normalizes IL-23-mediated cytokine production, addressing key pathogenic mechanisms without broadly disrupting IL-12-dependent pathways.^[20]

Pharmacokinetics

Mirikizumab exhibits linear pharmacokinetics, with exposure increasing in a dose-proportional manner across intravenous (IV) doses of 60 to 2400 mg and subcutaneous (SC) doses of 120 to 400 mg, as observed in patients with ulcerative colitis (UC) and Crohn's disease (CD).^[3] Following SC administration, the absolute bioavailability is approximately 44% (coefficient of variation [CV] 34%) in UC and 36.3% (CV 31%) in CD, with median time to maximum concentration (Tmax) of 5 days in both populations.^[3] Steady-state concentrations are achieved after approximately 16 weeks of maintenance dosing every 4 weeks, consistent with the drug's elimination half-life.^[3] No clinically significant accumulation occurs with repeated SC dosing at 4-week intervals.^[3] The volume of distribution at steady state is approximately 4.83 L (CV 21%) in UC and 4.4 L (CV 14%) in CD, indicating limited distribution primarily to plasma and extracellular fluid.^[3] Clearance is dose-independent and estimated at 0.0229 L/hour (CV 34%, equivalent to approximately 0.55 L/day) in UC and 0.0202 L/hour (CV 38%, equivalent to approximately 0.48 L/day) in CD.^[3] The elimination half-life is approximately 9.3 days (CV 40% in UC and CV 26% in CD).^[3] As a monoclonal antibody, mirikizumab is primarily eliminated through catabolic pathways similar to endogenous immunoglobulin G, with no involvement of hepatic metabolism or renal excretion.^[3] Population pharmacokinetic analyses indicate that clearance slightly increases with higher body weight, leading to modestly lower exposure (e.g., 20-38% lower average concentrations in patients ≥90 kg compared to <90 kg), though this does not impact clinical efficacy.^[3] No clinically meaningful differences in pharmacokinetics are observed based on age (18-79 years), sex, race, or mild-to-moderate renal impairment (creatinine clearance 30-89 mL/min).^[3] Hepatic impairment data are limited, but bilirubin levels do not affect clearance.^[3] Exposure-response relationships demonstrate that higher trough concentrations of mirikizumab are associated with improved clinical remission rates in both UC and CD.^[22] For example, in CD, near-maximal endoscopic response at week 12 was achieved with exposures corresponding to 900 mg IV induction dosing, and sustained remission at week 52 correlated with maintenance trough levels from 300 mg SC dosing.^[22] Similar positive correlations between exposure and remission endpoints, including clinical and endoscopic outcomes, were observed in UC patients.^[23]

Development and history

Clinical trials

The clinical development of mirikizumab included pivotal phase 3 trials for ulcerative colitis (UC) and Crohn's disease (CD), focusing on adults with moderately to severely active inflammatory bowel disease (IBD). Endpoints in UC trials utilized the modified Mayo score for clinical remission (stool frequency subscore ≤1, rectal bleeding subscore =0, and endoscopic subscore ≤1), while CD trials employed the Crohn's Disease Activity Index (CDAI) for clinical remission and the Simple Endoscopic Score for Crohn's Disease (SES-CD) for endoscopic response.^[14]^[24] The LUCENT-1 and LUCENT-2 trials evaluated mirikizumab for UC in a combined cohort of 1281 adults aged 18-80 years with moderately to severely active disease (modified Mayo score 4-9, despite conventional therapy or biologic failure). LUCENT-1 was a 12-week randomized, double-blind, placebo-controlled induction study in which patients received intravenous mirikizumab 300 mg at weeks 0, 4, and 8; 24.2% achieved clinical remission at week 12 compared to 13.3% on placebo (P<0.001). Responders from LUCENT-1 entered LUCENT-2, a 40-week randomized, double-blind, placebo-controlled maintenance study with subcutaneous mirikizumab 200 mg every 4 weeks; 49.9% achieved clinical remission at week 40 versus 25.1% on placebo (P<0.001). Both trials also demonstrated significant improvements in endoscopic remission and bowel urgency.^[14] For CD, the VIVID-1 trial assessed mirikizumab in adults with moderately to severely active disease (CDAI 220-450, SES-CD ≥7 or ≥4 for isolated ileitis, with prior inadequate response to conventional or biologic therapy). VIVID-1 was a 52-week randomized, double-blind, placebo-controlled and active-controlled treat-through induction and maintenance study (n=1065; mirikizumab n=579, placebo n=199) in which patients received intravenous mirikizumab 900 mg at weeks 0, 4, and 8 followed by subcutaneous 300 mg every 4 weeks; 32% achieved endoscopic response (≥50% reduction in SES-CD) at week 12 versus 11% on placebo (p<0.001). At week 52, clinical remission (CDAI <150) was achieved by 53% versus 36% on placebo (p<0.001), and endoscopic response by 46% versus 23% (p<0.001). The VIVID-2 open-label extension study provided long-term data for CD patients from VIVID-1, with sustained clinical remission and endoscopic response observed through week 104.^[24]^[4] The LUCENT-3 open-label extension study provided long-term data for UC patients from LUCENT-1 and LUCENT-2 (n=593 mirikizumab-treated through week 256). Among week 52 responders, 56.1% maintained clinical remission at week 152 (3 years), with 78% achieving corticosteroid-free clinical remission through 4 years as of 2025; no new safety signals emerged. Similar sustained benefits were reported in CD extensions, with 92.9% of year-1 remitters maintaining clinical remission at year 2.^[18]^[25]^[26] Earlier phase 2 and 3 trials for moderate-to-severe plaque psoriasis, including AMAGINE-1 (n=807, induction with intravenous mirikizumab) and OASIS-1/2 (n=1,300 combined, subcutaneous maintenance), demonstrated superior efficacy over placebo, with 75-91% achieving PASI 90 at week 16 and sustained responses through 52 weeks. However, Eli Lilly discontinued the psoriasis program in 2021 to prioritize IBD development, despite positive results and no new safety concerns.^[16]^[9]

Regulatory approvals

Mirikizumab received its first regulatory approval in Japan in March 2023 from the Ministry of Health, Labour and Welfare for induction and maintenance treatment of moderate to severe ulcerative colitis (UC) in adults.^[27] In the United States, the Food and Drug Administration (FDA) approved mirikizumab on October 26, 2023, for treatment of moderately to severely active UC in adults, based on results from the phase 3 LUCENT trials.^[7] This approval was expanded on January 15, 2025, to include moderately to severely active Crohn's disease (CD) in adults, supported by data from the phase 3 VIVID-1 and VIVID-2 trials.^[8] The European Medicines Agency (EMA) granted marketing authorization for mirikizumab on May 26, 2023, for moderately to severely active UC in adults who have had an inadequate response, loss of response, or intolerance to conventional or biologic therapy.^[28] This was extended in early 2025 to include moderately to severely active CD in adults, following a positive opinion from the Committee for Medicinal Products for Human Use in December 2024.^[29] Approvals in other regions followed closely: Health Canada authorized mirikizumab in October 2023 for moderately to severely active UC in adults.^[30] The Therapeutic Goods Administration in Australia approved it in May 2024 for UC, with expansion to CD occurring in 2025.^[31] Post-approval updates include an FDA supplemental biologics application approved on October 27, 2025, allowing a single-injection 200 mg subcutaneous maintenance regimen every 4 weeks for UC, replacing the prior two-injection option and utilizing a citrate-free formulation; this will be available in prefilled pens or syringes starting early 2026.^[13] Mirikizumab has received orphan drug designations in the US and EU for pediatric UC and CD, incentivizing development for these rare pediatric indications.^[32]^[33]

Society and culture

Legal status

Mirikizumab is classified as a prescription-only medicine in all countries where it has received regulatory approval, including the United States, European Union member states, the United Kingdom, Australia, and Switzerland.^[4]^[28]^[34]^[35] As a biologic agent, it is approved in the United States under the Food and Drug Administration's Biologics License Application pathway as a humanized immunoglobulin G4 (IgG4) monoclonal antibody.^[4] Mirikizumab is not designated as a controlled substance and carries no scheduling under the U.S. Drug Enforcement Administration.^[36] Access to mirikizumab is limited to adults aged 18 years and older with moderately to severely active ulcerative colitis or Crohn's disease who have had an inadequate response to conventional therapy or other biologics. Initiation of treatment generally requires supervision by a gastroenterologist experienced in managing inflammatory bowel disease, and in the United States, prior authorization is typically required from insurance providers or formularies such as those of the Department of Veterans Affairs or commercial payers.^[4]^[37]^[38] Globally, access varies by national health systems; in the United Kingdom, it is available through the National Health Service following recommendations from the National Institute for Health and Care Excellence for ulcerative colitis (2023) and Crohn's disease (2025). Eli Lilly and Company provides patient assistance programs in the United States to support access for uninsured or underinsured eligible patients.^[39]^[40]^[41] As of 2025, the prescribing information for mirikizumab includes no black box warnings, but it emphasizes risks of serious hypersensitivity reactions, including anaphylaxis, and increased infection susceptibility, with recommendations to avoid live vaccines during treatment and immediately prior to or after treatment.^[4]

Names

Mirikizumab is the international nonproprietary name (INN) assigned by the World Health Organization for this monoclonal antibody.^[42] In the United States, it is designated as mirikizumab-mrkz, incorporating the suffix "-mrkz" to denote the originator biologic product as per United States Adopted Names (USAN) conventions.^[4] The primary brand name for mirikizumab is Omvoh, marketed globally by Eli Lilly and Company and pronounced "ahm-VOH."^[43] During its development, the drug was known by the code name LY3074828.^[44] The INN mirikizumab is used consistently worldwide, with no variations reported across major regions.^[28] The brand name Omvoh is uniform in approved markets, including the United States, European Union, Canada, Japan, Australia.^[45] Omvoh is available in two main formulations: an intravenous solution of 300 mg/15 mL (20 mg/mL concentration) in a single-dose vial for induction therapy, and subcutaneous injection options including 100 mg/1 mL (100 mg/mL) and 200 mg/2 mL (100 mg/mL) in single-dose prefilled pens or syringes for maintenance therapy.^[4]^[1]

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