Mirikizumab
Highest phase reached
Approved
Drug type
Antibody
First approval year
2023
- First approval year
- 2023
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Antibody
- Drug name
- Mirikizumab
- omvoh
- Omvoh
- ly 3074828
- LY-3074828
- ly3074828
- LY3074828
- mirikizumab
- Mirikizumab
- Mirikizumab - IV
- Mirikizumab (MIR)
- mirikizumab [INN]
- MIRIKIZUMAB [JAN]
- Mirikizumab [MI]
- MIRIKIZUMAB [USAN]
- Mirikizumab [WHO-DD]
- mirikizumab inn
- Mirikizumab IV
- mirikizumab jan
- mirikizumab mi
- mirikizumab mrkz
- Mirikizumab mrkz [WHO-DD]
- mirikizumab mrkz who dd
- mirikizumab usan
- mirikizumab who dd
- Mirikizumab- IV
- Mirikizumab-mrkz
- CAS registry numbers
- 1884201-71-1
- ChEMBL ID
- CHEMBL3990014
- FDA ingredient codes (UNII)
- Z7HVY03PHP
- L04AC
- L04AC24
Sources for recorded values
- 2668384
- 2668385
- Applicant
- ELI LILLY AND CO
- Approval date
- 26 Oct 2023
- Application number
- BLA761279
- Status
- Authorised
- Status date
- 26 May 2023
- Authorisation date
- 26 May 2023
- Approved indications
- Omvoh is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic treatment.
- Product number
- EMEA/H/C/005122
- Authorisation holder
- Eli Lilly Nederland B.V.
- Priority medicines scheme
- No
- Generic
- No
- Biosimilar
- No
- Generic medicines
- 0
- Biosimilar medicines
- 0
- Advanced therapy
- No
- Conditional approval
- No
- Additional monitoring
- Yes
- Accelerated assessment
- No
- Exceptional circumstances
- No
Therapeutic areas
- Colitis, Ulcerative
European medicines record
- First in class
- No
- Orphan designation
- No
- Availability
- Prescription only
- Pharmacology name
- mirikizumab
- Type
- Antibody
- Drug name stem
- -mab; -mab
- Approval recorded by Guide to Pharmacology
- Yes
Administration routes
- Parenteral
- Action
- Binding
- Action type
- Binding
- Target
- IL-23A
- Gene symbol
- IL-23A
- Median affinity
- 10.68
- Affinity units
- pKd
- Primary target
- Yes
- Mechanism
- Interleukin-23 inhibitor
- Action type
- Inhibitor
- Target
- Interleukin-23
- Protein identifier
- P29460
- Mechanism
- Interleukin-23 inhibitor
- Action type
- Inhibitor
- Target
- Interleukin-23
- Protein identifier
- Q9NPF7
Open Targets mechanisms
- Mechanism
- Interleukin-23 inhibitor
- Action type
- Inhibitor
- Target
- Interleukin-23
- Condition
- Crohn Disease
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000384
- Subject identifier
- D003424
- Condition
- Immune System Diseases
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000540
- Subject identifier
- D007154
- Condition
- Psoriasis
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000676
- Subject identifier
- D011565
- Condition
- Colitis, Ulcerative
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000729
- Subject identifier
- D003093
- Condition
- Inflammatory Bowel Diseases
- Highest recorded phase
- 3
- Condition identifier
- EFO:0003767
- Subject identifier
- D015212
- Condition identifier
- EFO_0000384
- Condition identifier
- EFO_0000540
- Condition identifier
- EFO_0000676
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000729
- Condition identifier
- EFO_0003767
- Highest recorded phase
- 3
- Condition identifier
- EFO_1001494
- Highest recorded phase
- 3
- Condition identifier
- HP_0001513
- Highest recorded phase
- 3
- Condition identifier
- HP_0025502
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0005011
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0005046
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0005083
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0005101
- Highest recorded phase
- 4
- NCT01947933
- NCT02899988
- NCT03482011
- NCT03535194
- NCT03556202
- NCT03718884
- NCT02589665
- NCT03518086
- NCT03519945
- NCT03524092
- NCT04004611
- NCT04469062
- NCT04844606
- NCT05767021
- NCT05784246
- NCT02891226
- NCT03926130
- NCT04232553
- NCT05509777
- Dose
- 300 mg
- Route
- Intravenous
- How often
- Every 4 weeks
Conditions of use
- Infuse over at least 30 minutes
- Prodrug
- No
- Chirality
- Single enantiomer
- Inorganic
- No
- Natural product
- No
- Component
- Heavy chain
- Type
- Protein
- Sequence
- QVQLVQSGAEVKKPGSSVKVSCKASGYKFTRYVMHWVRQAPGQGLEWMGYINPYNDGTNYNEKFKGRVTITADKSTSTAYMELSSLRSEDTAVYYCARNWDTGLWGQGTTVTVSSASTKGPSVFPLAPCSRSTSESTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTKTYTCNVDHKPSNTKVDKRVESKYGPPCPPCPAPEAAGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSQEDPEVQFNWYVDGVEVHNAKTKPREEQFNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKGLPSSIEKTISKAKGQPREPQVYTLPPSQEEMTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSRLTVDKSRWQEGNVFSCSVMHEALHNHYTQKSLSLSLG
- Component
- Light chain
- Type
- Protein
- Sequence
- DIQMTQSPSSLSASVGDRVTITCKASDHILKFLTWYQQKPGKAPKLLIYGATSLETGVPSRFSGSGSGTDFTLTISSLQPEDFATYYCQMYWSTPFTFGGGTKVEIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC
- Component
- Disulfide bridges location
- Sequence
- 22-96$22''-96''$23'-88'$23'''-88'''$142-198$142''-198''$221-221''$224-224''
- 0002-1442
- 0002-3116
- 0002-7575
- 0002-7717
- 0002-7722
- 0002-8011
- 0002-8870
Related records
Trials (49)
- A Bioequivalence Study of Mirikizumab (LY3074828) in Healthy Participants
- A Bioequivalence Study of Mirikizumab (LY3074828) Solution in Healthy Participants
- A Long-term Extension Study of Mirikizumab (LY3074828) in Participants With Crohn's Disease
- A Long-term Study to Evaluate Safety and Maintenance of Treatment Effect of LY3074828 in Participants With Moderate-to-Severe Plaque Psoriasis (OASIS-3)
- A Maintenance Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis
- A Master Protocol (AMAZ): A Study of Mirikizumab (LY3074828) in Pediatric Participants With Ulcerative Colitis or Crohn's Disease (SHINE-ON)
- A Safety Study of Mirikizumab (LY3074828)
- A Study of Eltrekibart and Mirikizumab in Adult Patients With Moderately to Severely Active Ulcerative Colitis
- A Study of Injections of LY3074828 in Healthy Participants
- A Study of LY3074828 in Healthy Participants
- A Study of Mirikizumab (LY3074828) in Children and Teenagers With Ulcerative Colitis (UC)
- A Study of Mirikizumab (LY3074828) in Healthy Participants
- A Study of Mirikizumab (LY3074828) in Participants With Active Crohn's Disease
- A Study of Mirikizumab (LY3074828) in Participants With Crohn's Disease
- A Study of Mirikizumab (LY3074828) in Participants With Moderate to Severe Plaque Psoriasis
- A Study of Mirikizumab (LY3074828) in Participants With Moderate to Severe Ulcerative Colitis
- A Study of Mirikizumab (LY3074828) in Participants With Moderately to Severely Active Ulcerative Colitis
- A Study of Mirikizumab (LY3074828) in Participants With Ulcerative Colitis
- A Study of Mirikizumab (LY3074828) in Pediatric Participants With Crohn's Disease
- A Study of Mirikizumab (LY3074828) in Pediatric Participants With Moderately to Severely or Active Ulcerative Colitis
Approved for (3)
In development for (2)
- Inflammatory bowel disease Phase 3
- Psoriasis Phase 3