> Trialight public data. Index of pages: https://trialight.com/llms.txt
> Web page: https://trialight.com/data/asset/mirikizumab-125dbf98-9c8f-4161-a506-f2b426cbee0c
> Record changed: 2026-10-13

# Mirikizumab

Highest phase reached

Approved

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3990014)

Drug type

Antibody

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3990014)

First approval year

2023

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3990014)

## Development status

**First approval year**

2023

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3990014)

**Listing at source**

Listed

**Highest phase reached**

Approved

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3990014)

## Names and chemistry

**Drug type**

Antibody

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3990014)

**Drug name**

Mirikizumab

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3990014)

### Brand names (2)

- omvoh
- Omvoh

### Other names (24)

- 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

## Identifiers

**CAS registry numbers**

- 1884201-71-1

**ChEMBL ID**

CHEMBL3990014

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3990014)

**FDA ingredient codes (UNII)**

- Z7HVY03PHP

### ATC classification codes (2)

- L04AC
- L04AC24

Sources for recorded values

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3990014)

### RxNorm IDs (RxCUI) (2)

- 2668384
- 2668385

## Regulatory information

### United States

**Applicant**

ELI LILLY AND CO

**Approval date**

26 Oct 2023

**Application number**

BLA761279

### European Union

**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

Source: [www.ema.europa.eu](https://www.ema.europa.eu/en/medicines/human/EPAR/omvoh)

### Other regulatory facts

**First in class**

No

**Orphan designation**

No

**Availability**

Prescription only

## Pharmacology

### Drug classification

**Pharmacology name**

mirikizumab

**Type**

Antibody

**Drug name stem**

\-mab; -mab

**Approval recorded by Guide to Pharmacology**

Yes

#### Administration routes

- Parenteral

### Mechanisms of action (3)

- **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

### Investigated indications (5)

- **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

### Open Targets indications (12)

- **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

### Trial references (19)

- NCT01947933  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01947933)
- NCT02899988  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02899988)
- NCT03482011  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03482011)
- NCT03535194  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03535194)
- NCT03556202  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03556202)
- NCT03718884  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03718884)
- NCT02589665  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02589665)
- NCT03518086  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03518086)
- NCT03519945  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03519945)
- NCT03524092  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03524092)
- NCT04004611  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04004611)
- NCT04469062  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04469062)
- NCT04844606  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04844606)
- NCT05767021  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05767021)
- NCT05784246  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05784246)
- NCT02891226  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02891226)
- NCT03926130  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03926130)
- NCT04232553  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04232553)
- NCT05509777  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05509777)

## Dosing

**Dose**

300 mg

**Route**

Intravenous

**How often**

Every 4 weeks

### Conditions of use

- Infuse over at least 30 minutes

## Chemical properties

**Prodrug**

No

**Chirality**

Single enantiomer

**Inorganic**

No

**Natural product**

No

### Sequences (3)

- **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''

## National Drug Codes

- 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](https://trialight.com/data/trial/a-bioequivalence-study-of-mirikizumab-ly3074828-in-healthy-66c85922-0858-4fa5-a0f5-958e525f0e08.md)
- [A Bioequivalence Study of Mirikizumab (LY3074828) Solution in Healthy Participants](https://trialight.com/data/trial/a-bioequivalence-study-of-mirikizumab-ly3074828-solution-in-f9d1d4b3-5de5-44e2-b8cc-5b4322e4c740.md)
- 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)

- [Crohn disease](https://trialight.com/data/condition/crohn-disease-f7aa2cd8-9680-56b5-858c-2b75f88fb0d0.md)
- [Immune system disorder](https://trialight.com/data/condition/immune-system-disorder-24846188-b462-515c-bb34-142255a648c8.md)
- [Ulcerative colitis](https://trialight.com/data/condition/ulcerative-colitis-afbc4579-f001-5a8a-b904-28f09f344ab5.md)

### In development for (2)

- [Inflammatory bowel disease](https://trialight.com/data/condition/inflammatory-bowel-disease-619080ac-2d43-5ad3-b078-9699e1241655.md) Phase 3
- [Psoriasis](https://trialight.com/data/condition/psoriasis-4340caf0-883c-54c7-886d-31e59b80dead.md) Phase 3

### Targets (2)

- [IL12B](https://trialight.com/data/target/il12b-92e53178-7b56-555c-ac6b-a1235d8fe7e5.md) Interleukin-23 inhibitor
- [IL23A](https://trialight.com/data/target/il23a-e11f3992-27b4-5bef-9242-07ab6ac420e9.md) Interleukin-23 inhibitor

---

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