Mirikizumab

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
References:
  1. NIH Inxight: Mirikizumab [Link]
Download FASTA Format
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

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Associated Conditions
Indication TypeIndicationCombined Product DetailsApproval LevelAge GroupPatient CharacteristicsDose Form
Treatment ofModerately to severely active ulcerative colitis••••••••••••••••••••••••••
Treatment ofModerately to severely active ulcerative colitis••••••••••••••••••••••••••
Treatment ofModerately to severely active ulcerative colitis••••••••••••••••••••••••••
Contraindications & Blackbox Warnings
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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

TargetActionsOrganism
AInterleukin-23 subunit alpha
binder
antibody
Humans
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
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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.
DrugInteraction
Adenovirus type 7 vaccine liveThe risk or severity of adverse effects can be increased when Mirikizumab is combined with Adenovirus type 7 vaccine live.
Anthrax vaccineThe risk or severity of adverse effects can be increased when Mirikizumab is combined with Anthrax vaccine.
Bacillus calmette-guerin substrain connaught live antigenThe risk or severity of adverse effects can be increased when Mirikizumab is combined with Bacillus calmette-guerin substrain connaught live antigen.
Bacillus calmette-guerin substrain russian BCG-I live antigenThe risk or severity of adverse effects can be increased when Mirikizumab is combined with Bacillus calmette-guerin substrain russian BCG-I live antigen.
Bacillus calmette-guerin substrain tice live antigenThe risk or severity of adverse effects can be increased when Mirikizumab is combined with Bacillus calmette-guerin substrain tice live antigen.
Food Interactions
No interactions found.

Products

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Brand Name Prescription Products
NameDosageStrengthRouteLabellerMarketing StartMarketing EndRegionImage
OmvohInjection, solution100 mgSubcutaneousEli Lilly Nederland B.V.2023-06-20Not applicableEU flag
OmvohInjection, solution100 mgSubcutaneousEli Lilly Nederland B.V.2023-06-20Not applicableEU flag
OmvohInjection, solution20 mg/1mLIntravenousEli Lilly and Company2023-10-26Not applicableUS flag
OmvohSolution100 mg / mLSubcutaneousEli Lilly & Co. Ltd.2023-12-05Not applicableCanada flag
OmvohInjection, solution100 mgSubcutaneousEli Lilly Nederland B.V.2023-06-20Not applicableEU flag

Categories

Drug Categories
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
  1. CHMP Summary of Positive Opinion: Omvoh (mirikizumab) [Link]
  2. FiercePharma: FDA rejects Eli Lilly's ulcerative colitis prospect mirikizumab, citing manufacturing shortfalls [Link]
  3. Eli Lilly and Company: Lilly’s mirikizumab met primary endpoint and key secondary endpoints in Phase 2 study, including reductions of gastrointestinal lesions [Link]
  4. UniProt: Interleukin-23 subunit alpha (Q9NPF7) [Link]
  5. FDA Approved Drug Products: Omvoh (mirikizumab-mrkz) injection for intravenous or subcutaneous administration [Link]
  6. 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]
  7. EMA Summary of Product Characteristics: Omvoh (mirikizumab) concentrate for solution for infusion [Link]
  8. Health Canada Product Monograph: Omvoh (mirikizumab) solution for subcutaneous or intravenous administration [Link]
RxNav
2668384
Wikipedia
Mirikizumab

Clinical Trials

Clinical Trials
PhaseStatusPurposeConditionsCount
3Active Not RecruitingTreatmentUlcerative Colitis2
3CompletedTreatmentCrohn's Disease (CD)1
3CompletedTreatmentPsoriasis2
3RecruitingTreatmentCrohn's Disease (CD)2
3RecruitingTreatmentCrohn's Disease (CD) / Inflammatory Bowel Diseases (IBD) / Ulcerative Colitis / Ulcerative Colitis Chronic1

Pharmacoeconomics

Manufacturers
Not Available
Packagers
Not Available
Dosage Forms
FormRouteStrength
Injection, solutionIntravenous20 mg/1mL
Injection, solutionSubcutaneous100 mg
Injection, solutionSubcutaneous100 mg/1mL
Injection, solution, concentrateIntravenous300 mg
SolutionIntravenous20 mg / mL
SolutionSubcutaneous100 mg / mL
Prices
Not Available
Patents
Not Available

Properties

State
Liquid
Experimental Properties
Not Available

Targets

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Kind
Protein
Organism
Humans
Pharmacological action
Yes
Actions
Binder
Antibody
General Function
Not Available
Specific Function
Associates with IL12B to form the IL-23 interleukin, a heterodimeric cytokine which functions in innate and adaptive immunity. IL-23 may constitute with IL-17 an acute response to infection in peri...
Gene Name
IL23A
Uniprot ID
Q9NPF7
Uniprot Name
Interleukin-23 subunit alpha
Molecular Weight
20729.56 Da
References
  1. Eli Lilly and Company: Lilly’s mirikizumab met primary endpoint and key secondary endpoints in Phase 2 study, including reductions of gastrointestinal lesions [Link]
  2. FDA Approved Drug Products: Omvoh (mirikizumab-mrkz) injection for intravenous or subcutaneous administration [Link]

Drug created at May 20, 2019 14:34 / Updated at November 12, 2023 09:09