> Trialight public data. Index of pages: https://trialight.com/llms.txt
> Web page: https://trialight.com/data/asset/frexalimab-1bb81466-d62a-41c9-8b80-76bdac85ccb3
> Record changed: 2026-10-13

# Frexalimab

Highest phase reached

Phase 3

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL5095122)

Drug type

Antibody

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL5095122)

## Development status

**Listing at source**

Listed

**Highest phase reached**

Phase 3

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL5095122)

## Names and chemistry

**Drug type**

Antibody

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL5095122)

**Drug name**

Frexalimab

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL5095122)

### Other names (28)

- frexalimab
- Frexalimab
- frexalimab \[INN\]
- FREXALIMAB \[USAN\]
- Frexalimab \[WHO-DD\]
- frexalimab inn
- frexalimab usan
- frexalimab who dd
- Immunoglobulin G1 (272-arginine,325-alanine), anti-(human CD40 ligand) (human-mus musculus monoclonal SAR441344 gamma1-chain), disulfide with human-mus musculus monoclonal SAR441344 kappa-chain, dimer
- immunoglobulin g1 272 arginine 325 alanine anti human cd40 ligand human mus musculus monoclonal sar441344 gamma1 chain disulfide with human mus musculus monoclonal sar441344 kappa chain dimer
- inx 021
- INX 021
- inx 021 56
- INX 021-56
- inx021
- INX021
- inx021 56
- INX021-56
- sar 441344
- SAR-441344
- sar441344
- Sar441344
- SAR441344
- SAR441344 IV
- xc 01129

And 3 more, listed on the interactive page.

## Identifiers

**CAS registry numbers**

- 2515463-86-0

**ChEMBL ID**

CHEMBL5095122

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL5095122)

**FDA ingredient codes (UNII)**

- WO7SFK0ENJ

## Regulatory information

### Other regulatory facts

**First in class**

No

**Orphan designation**

No

## Pharmacology

### Drug classification

**Drug name stem**

\-mab

### Investigated indications (5)

- **Condition**  
Nervous System Diseases

**Highest recorded phase**  
1

**Condition identifier**  
EFO:0000618

**Subject identifier**  
D009422
- **Condition**  
Sjogren's Syndrome

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0000699

**Subject identifier**  
D012859
- **Condition**  
Autoimmune Diseases

**Highest recorded phase**  
1

**Condition identifier**  
EFO:0005809

**Subject identifier**  
D001327
- **Condition**  
Diabetes Mellitus, Type 1

**Highest recorded phase**  
2

**Condition identifier**  
MONDO:0005147

**Subject identifier**  
D003922
- **Condition**  
Multiple Sclerosis

**Highest recorded phase**  
3

**Condition identifier**  
MONDO:0005301

**Subject identifier**  
D009103

### Open Targets indications (12)

- **Condition identifier**  
EFO\_0000618
- **Condition identifier**  
EFO\_0000699

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_0005809
- **Condition identifier**  
MONDO\_0000450

**Highest recorded phase**  
3
- **Condition identifier**  
MONDO\_0005071
- **Condition identifier**  
MONDO\_0005147

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0005301

**Highest recorded phase**  
3
- **Condition identifier**  
MONDO\_0006835

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0007179
- **Condition identifier**  
MONDO\_0007915

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0010030

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0100313

**Highest recorded phase**  
2

### Trial references (5)

- NCT04572841  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04572841)
- NCT04879628  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04879628)
- NCT06141473  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06141473)
- NCT06141486  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06141486)
- NCT06111586  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06111586)

## Chemical properties

**Prodrug**

No

**Chirality**

Single enantiomer

**Inorganic**

No

**Natural product**

No

### Sequences (5)

- **Component**  
Heavy chain

**Type**  
Protein

**Sequence**  
EVQLQESGPGLVKPSETLSLTCTVSGDSITNGFWIWIRKPPGNKLEYMGYISYSGSTYYNPSLKSRISISRDTSKNQFSLKLSSVTAADTGVYYCAYRSYGRTPYYFDYWGQGTTLTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKAEPKSCDKTHTCPPCPAPELLGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSHRDPEVKFNWYVDGVEVHNAKTKPREEQYNSTYRVVSVLTVLHQDWLNGKEYKCAVSNKALPAPIEKTISKAKGQPREPQVYTLPPSRDELTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPGK
- **Component**  
Light chain

**Type**  
Protein

**Sequence**  
DIVMTQSPSFLSASVGDRVTITCKASSNLGHAVAWYQQKPGKSPKLLIYSASNRYTGVPDRFSGSGSGTDFTLTISSLQPEDFADYFCQQYDDYPYTFGGGTKLEIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC
- **Component**  
Glycosylation sites (N)

**Sequence**  
300 $ 300'
- **Component**  
Disulfide bridges

**Sequence**  
22-95 $ 22''-95'' $ 23'-88' $ 23'''-88''' $ 134'-194' $ 134'''-194''' $ 147-203 $ 147''-203'' $ 223-214' $ 223''-214''' $ 229-229'' $ 232-232'' $ 264-324 $ 264''-324'' $ 370-428 $ 370''-428''
- **Component**  
Glycosylation sites (N)

**Sequence**  
300 $ 300''

## Related records

### Trials (10)

- A Study to Evaluate the Efficacy and Safety of Frexalimab, Brivekimig, or Rilzabrutinib in Participants Aged 16 to 75 Years With Primary Focal Segmental Glomerulosclerosis or Minimal Change Disease
- A Study to Investigate the Efficacy and Safety of Frexalimab Versus Tacrolimus in Adults Undergoing Kidney Transplantation
- Efficacy and Safety of Frexalimab (SAR441344) in the Treatment of Systemic Lupus Erythematosus
- [Efficacy and Safety Studies of Frexalimab (SAR441344) in Adults With Relapsing Forms of Multiple Sclerosis](https://trialight.com/data/trial/efficacy-and-safety-studies-of-frexalimab-sar441344-in-9348ac4f-5759-4557-9e91-20570fc44ceb.md)
- Efficacy and Safety Study of Frexalimab (SAR441344) in Adults With Nonrelapsing Secondary Progressive Multiple Sclerosis
- Frexalimab in Preservation of Endogenous Insulin Secretion Compared to Placebo in Adults, Adolescents and Children on Top of Insulin Therapy (FABULINUS)
- Non-inferiority Study of Frexalimab Subcutaneous Administration Compared to Intravenous Administration in Adult Participants With Multiple Sclerosis
- Proof-of-concept Study for SAR441344 (Frexalimab) in Relapsing Multiple Sclerosis
- Safety, Tolerability, Pharmacokinetics, and Therapeutic Efficacy of SAR441344 in Primary Sjögren's Syndrome (pSjS)
- Study of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenous and Subcutaneous Single and Repeated Doses of SAR441344 in Healthy Adult Subjects

### In development for (6)

- [Autoimmune disease](https://trialight.com/data/condition/autoimmune-disease-8a8fd8aa-2d04-5f24-b839-ba96a70c11e9.md) Phase 1
- [Multiple sclerosis](https://trialight.com/data/condition/multiple-sclerosis-62806c95-fe1b-529e-bd16-95cb92d15375.md) Phase 3
- Nervous system disorder Phase 1
- [Sjogren syndrome](https://trialight.com/data/condition/sjogren-syndrome-a76424ca-3898-5b4e-82c0-867f8103dce0.md) Phase 2
- [Systemic lupus erythematosus](https://trialight.com/data/condition/systemic-lupus-erythematosus-6c9d074f-cc5f-588b-bf0c-6338d30c6eac.md) Phase 2
- Type 1 diabetes mellitus Phase 2

---

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