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Overview
- Description
- An injectable medication intended to treat an inflammatory bowel disease called ulcerative colitis.
- Description
- An injectable medication intended to treat an inflammatory bowel disease called ulcerative colitis.
- DrugBank ID
- DB14910
- Type
- Biotech
- Clinical Trials
- Phase 0
- 0
- Phase 1
- 25
- Phase 2
- 5
- Phase 3
- 20
- Phase 4
- 1
- Mechanism of Action
- Interleukin-23 subunit alphaBinderAntibody
- Interleukin-23 subunit alpha
Identification
- Summary
Mirikizumab is an anti-IL-23 monoclonal antibody used as a second-line therapy for moderate-to-severe active ulcerative colitis.
- Generic Name
- Mirikizumab
- DrugBank Accession Number
- DB14910
- Background
Mirikizumab is a monoclonal antibody developed by Eli Lilly intended to treat ulcerative colitis. It inhibits the actions of interleukin-23 (IL-23), a pro-inflammatory cytokine that activates pathways contributing to the development of inflammatory diseases.1,4
Mirikizumab is approved in Japan3 and received a positive opinion from the EMA's Committee for Medicinal Products for Human Use in March 2023.1 In April 2023, the US FDA declined to approve mirikizumab for the treatment of ulcerative colitis on the basis of manufacturing concerns.3 It was officially approved in the EU in May 20237 and Canada in July 20238, and was eventually approved in the US in October 20236 for the treatment of adult patients with moderate-to-severely active ulcerative colitis.
- Type
- Biotech
- Groups
- Approved, Investigational
- Biologic Classification
- Protein Based Therapies
Monoclonal antibody (mAb) - Protein Chemical Formula
- Not Available
- Protein Average Weight
- 147000.0 Da
- Sequences
>SUBUNIT_1 QVQLVQSGAEVKKPGSSVKVSCKASGYKFTRYVMHWVRQAPGQGLEWMGYINPYNDGTNY NEKFKGRVTITADKSTSTAYMELSSLRSEDTAVYYCARNWDTGLWGQGTTVTVSSASTKG PSVFPLAPCSRSTSESTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSL SSVVTVPSSSLGTKTYTCNVDHKPSNTKVDKRVESKYGPPCPPCPAPEAAGGPSVFLFPP KPKDTLMISRTPEVTCVVVDVSQEDPEVQFNWYVDGVEVHNAKTKPREEQFNSTYRVVSV LTVLHQDWLNGKEYKCKVSNKGLPSSIEKTISKAKGQPREPQVYTLPPSQEEMTKNQVSL TCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSRLTVDKSRWQEGNVFSC SVMHEALHNHYTQKSLSLSLG
>SUBUNIT_2 QVQLVQSGAEVKKPGSSVKVSCKASGYKFTRYVMHWVRQAPGQGLEWMGYINPYNDGTNY NEKFKGRVTITADKSTSTAYMELSSLRSEDTAVYYCARNWDTGLWGQGTTVTVSSASTKG PSVFPLAPCSRSTSESTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSL SSVVTVPSSSLGTKTYTCNVDHKPSNTKVDKRVESKYGPPCPPCPAPEAAGGPSVFLFPP KPKDTLMISRTPEVTCVVVDVSQEDPEVQFNWYVDGVEVHNAKTKPREEQFNSTYRVVSV LTVLHQDWLNGKEYKCKVSNKGLPSSIEKTISKAKGQPREPQVYTLPPSQEEMTKNQVSL TCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSRLTVDKSRWQEGNVFSC SVMHEALHNHYTQKSLSLSLG
>SUBUNIT_3 DIQMTQSPSSLSASVGDRVTITCKASDHILKFLTWYQQKPGKAPKLLIYGATSLETGVPS RFSGSGSGTDFTLTISSLQPEDFATYYCQMYWSTPFTFGGGTKVEIKRTVAAPSVFIFPP SDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLT LSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC
>SUBUNIT_4 DIQMTQSPSSLSASVGDRVTITCKASDHILKFLTWYQQKPGKAPKLLIYGATSLETGVPS RFSGSGSGTDFTLTISSLQPEDFATYYCQMYWSTPFTFGGGTKVEIKRTVAAPSVFIFPP SDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLT LSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC
Download FASTA FormatReferences:
- NIH Inxight: Mirikizumab [Link]
- Synonyms
- Mirikizumab
- External IDs
- LY-3074828
- LY3074828
Pharmacology
- Indication
Mirikizumab is indicated for the treatment of adult patients with moderate-to-severely active ulcerative colitis.5,7,8
Reduce drug development failure ratesBuild, train, & validate machine-learning modelswith evidence-based and structured datasets.Build, train, & validate predictive machine-learning models with structured datasets.- Associated Conditions
Indication Type Indication Combined Product Details Approval Level Age Group Patient Characteristics Dose Form Treatment of Moderately to severely active ulcerative colitis •••••••••••• ••••• ••••••••• Treatment of Moderately to severely active ulcerative colitis •••••••••••• ••••• ••••••••• Treatment of Moderately to severely active ulcerative colitis •••••••••••• ••••• ••••••••• - Contraindications & Blackbox Warnings
Prevent Adverse Drug Events TodayTap into our Clinical API for life-saving information on contraindications & blackbox warnings, population restrictions, harmful risks, & more.Avoid life-threatening adverse drug events with our Clinical API- Pharmacodynamics
Mirikizumab exerts its therapeutic effect by inhibiting the activity of an inflammatory cytokine, interleukin-23 (IL-23), which is involved in mucosal inflammation.5 In clinical studies of patients with ulcerative colitis involving both induction- and maintenance-phase treatment, a positive relationship was observed between mirikizumab average concentration and rates of clinical remission and clinical response.5
- Mechanism of action
Mirikizumab is a monoclonal antibody directed against the p19 subunit of human interleukin-23 (IL-23). The binding of mirikizumab to its target inhibits the interaction between IL-23 and the IL-23 receptor, thereby normalizing the overproduction of effector cytokines driving the pathogenesis of inflammatory diseases, including ulcerative colitis.1
Target Actions Organism AInterleukin-23 subunit alpha binderantibodyHumans - Absorption
Following subcutaneous administration, the geometric mean absolute bioavailability was 44% and the median Tmax was 5 days.5 The site of subcutaneous injection did not significantly influence mirikizumab bioavailability. The estimated steady-state Cmax, AUCtau, and Ctrough of mirikizumab following subcutaneous administration in patients with ulcerative colitis were 10.1 μg/mL, 160 μgday/mL, and 1.70 μg/mL, respectively.5 The estimated steady-state Cmax, AUCtau, and Ctrough of mirikizumab following intravenous infusion in patients with ulcerative colitis were 99.7 μg/mL, 538 μgday/mL, and 2.75 μg/mL, respectively.5
- Volume of distribution
The geometric mean total volume of distribution in patients with ulcerative colitis was approximately 4.83 L.5
- Protein binding
Not Available
- Metabolism
As with other therapeutic proteins, mirikizumab is likely degraded into smaller peptides and amino acids via catabolic pathways.5
- Route of elimination
Not Available
- Half-life
The geometric mean elimination half-life in patients with ulcerative colitis was approximately 9.3 days.5
- Clearance
The geometric mean clearance of mirikizumab was found to be approximately 0.0229 L/h and is independent of dose.5
- Adverse Effects
Improve decision support & research outcomesWith structured adverse effects data, including: blackbox warnings, adverse reactions, warning & precautions, & incidence rates. View sample adverse effects data in our new Data Library!Improve decision support & research outcomes with our structured adverse effects data.- Toxicity
Not Available
- Pathways
- Not Available
- Pharmacogenomic Effects/ADRs
- Not Available
Interactions
- Drug Interactions
- This information should not be interpreted without the help of a healthcare provider. If you believe you are experiencing an interaction, contact a healthcare provider immediately. The absence of an interaction does not necessarily mean no interactions exist.
Drug Interaction Integrate drug-drug
interactions in your softwareAbatacept The risk or severity of adverse effects can be increased when Abatacept is combined with Mirikizumab. Adalimumab The risk or severity of adverse effects can be increased when Adalimumab is combined with Mirikizumab. Adenovirus type 7 vaccine live The risk or severity of adverse effects can be increased when Mirikizumab is combined with Adenovirus type 7 vaccine live. Aldesleukin The risk or severity of adverse effects can be increased when Aldesleukin is combined with Mirikizumab. Alefacept The risk or severity of adverse effects can be increased when Alefacept is combined with Mirikizumab. - Food Interactions
- No interactions found.
Products
Drug product information from 10+ global regionsOur datasets provide approved product information including:dosage, form, labeller, route of administration, and marketing period.Access drug product information from over 10 global regions.- Brand Name Prescription Products
Name Dosage Strength Route Labeller Marketing Start Marketing End Region Image Omvoh Injection, solution 100 mg Subcutaneous Eli Lilly Nederland B.V. 2023-06-20 Not applicable EU 
Omvoh Injection, solution 100 mg/1mL Subcutaneous Eli Lilly Nederland B.V. 2023-10-26 Not applicable US 
Omvoh Injection, solution, concentrate 300 mg Intravenous Eli Lilly Nederland B.V. 2023-06-20 Not applicable EU Omvoh Solution 100 mg / mL Subcutaneous Eli Lilly & Co. Ltd. 2023-12-05 Not applicable Canada 
Omvoh Injection, solution 100 mg Subcutaneous Eli Lilly Nederland B.V. 2023-06-20 Not applicable EU
Categories
- ATC Codes
- L04AC24 — Mirikizumab
- Drug Categories
- Amino Acids, Peptides, and Proteins
- Analgesics
- Anti-Inflammatory Agents
- Anti-Ulcer Agents
- Antibodies
- Antibodies, Monoclonal
- Antibodies, Monoclonal, Humanized
- Antineoplastic and Immunomodulating Agents
- Antirheumatic Agents
- Blood Proteins
- Gastrointestinal Agents
- Globulins
- Immunoglobulins
- Immunoproteins
- Immunosuppressive Agents
- Interleukin Inhibitors
- Interleukin-23 Antagonist
- Proteins
- Serum Globulins
- Chemical TaxonomyProvided by Classyfire
- Description
- Not Available
- Kingdom
- Organic Compounds
- Super Class
- Organic Acids
- Class
- Carboxylic Acids and Derivatives
- Sub Class
- Amino Acids, Peptides, and Analogues
- Direct Parent
- Peptides
- Alternative Parents
- Not Available
- Substituents
- Not Available
- Molecular Framework
- Not Available
- External Descriptors
- Not Available
- Affected organisms
- Humans
Chemical Identifiers
- UNII
- Z7HVY03PHP
- CAS number
- 1884201-71-1
References
- General References
- CHMP Summary of Positive Opinion: Omvoh (mirikizumab) [Link]
- FiercePharma: FDA rejects Eli Lilly's ulcerative colitis prospect mirikizumab, citing manufacturing shortfalls [Link]
- Eli Lilly and Company: Lilly’s mirikizumab met primary endpoint and key secondary endpoints in Phase 2 study, including reductions of gastrointestinal lesions [Link]
- UniProt: Interleukin-23 subunit alpha (Q9NPF7) [Link]
- FDA Approved Drug Products: Omvoh (mirikizumab-mrkz) injection for intravenous or subcutaneous administration [Link]
- Eli Lilly and Company: FDA Approves Lilly's Omvoh™ (mirikizumab-mrkz), A First-in-Class Treatment for Adults with Moderately to Severely Active Ulcerative Colitis [Link]
- EMA Summary of Product Characteristics: Omvoh (mirikizumab) concentrate for solution for infusion [Link]
- Health Canada Product Monograph: Omvoh (mirikizumab) solution for subcutaneous or intravenous administration [Link]
- External Links
- 2668384
- Wikipedia
- Mirikizumab
Clinical Trials
- Clinical Trials
Clinical Trial & Rare Diseases Add-on Data Package
Explore 4,000+ rare diseases, orphan drugs & condition pairs, clinical trial why stopped data, & more. Preview package Phase Status Purpose Conditions Count Start Date Why Stopped 100+ additional columns Unlock 175K+ rows when you subscribe.View sample data4 Recruiting Treatment Ulcerative Colitis 1 somestatus stop reason just information to hide 3 Active Not Recruiting Treatment Ulcerative Colitis 1 somestatus stop reason just information to hide 3 Active Not Recruiting Treatment Ulcerative Colitis / Ulcerative Colitis Chronic 1 somestatus stop reason just information to hide 3 Completed Treatment Crohn's Disease (CD) 1 somestatus stop reason just information to hide 3 Completed Treatment Psoriasis 2 somestatus stop reason just information to hide
Pharmacoeconomics
- Manufacturers
- Not Available
- Packagers
- Not Available
- Dosage Forms
Form Route Strength Injection, solution Intravenous 20 mg/1mL Injection, solution Subcutaneous 100 mg Injection, solution Subcutaneous 100 mg/1mL Injection, solution, concentrate Intravenous 300 mg Solution Intravenous 20 mg / mL Solution Subcutaneous 100 mg / mL - Prices
- Not Available
- Patents
- Not Available
Properties
- State
- Liquid
- Experimental Properties
- Not Available
Targets
- Kind
- Protein
- Organism
- Humans
- Pharmacological action
- Yes
- Actions
- BinderAntibody
- General Function
- Associates with IL12B to form the pro-inflammatory cytokine IL-23 that plays different roles in innate and adaptive immunity (PubMed:11114383). Released by antigen-presenting cells such as dendritic cells or macrophages, binds to a heterodimeric receptor complex composed of IL12RB1 and IL23R to activate JAK2 and TYK2 which then phosphorylate the receptor to form a docking site leading to the phosphorylation of STAT3 and STAT4 (PubMed:29287995, PubMed:32474165, PubMed:33606986). This process leads to activation of several pathways including p38 MAPK or NF-kappa-B and promotes the production of pro-inflammatory cytokines such as interleukin-17A/IL17A (PubMed:12023369). In turn, participates in the early and effective intracellular bacterial clearance (PubMed:32474165). Promotes the expansion and survival of T-helper 17 cells, a CD4-positive helper T-cell subset that produces IL-17, as well as other IL-17-producing cells (PubMed:17676044)
- Specific Function
- cytokine activity
- Gene Name
- IL23A
- Uniprot ID
- Q9NPF7
- Uniprot Name
- Interleukin-23 subunit alpha
- Molecular Weight
- 20729.56 Da
References
Drug created at May 20, 2019 14:34 / Updated at November 12, 2023 09:09