Frexalimab

Summary

Frexalimab (CHEMBL5095122) is a phase-3 clinical-stage antibody; indicated across 5 conditions including multiple sclerosis and sjogren syndrome.

At a glance

• Status: Max clinical phase 3 (not approved)
• Modality: Antibody
• Indications: 5 conditions
• Clinical trials: 8

Identifiers

Drug identity and classification

Field	Value
ChEMBL ID	CHEMBL5095122
Name	Frexalimab
Type	Antibody
Max phase	3

Also known as: Frexalimab, INX 021, INX021, SAR-441344, Sar441344, SAR441344, XC 01129, XC01129, FREXALIMAB

Targets

Targets

No target linkage available.

Bioactivity

No ChEMBL bioactivity rows at pChembl ≥ 5 (expected for biologics / antibodies).

Target pathways

No target-pathway data for this drug (no mapped target genes).

Indications & clinical

Indications

5 diseases in clinical trials (phase 1–3, investigational — not approved indications). Highest ChEMBL trial phase per disease; a non-cancer approved use is occasionally logged at phase 3 here.

Disease (in trials)	Phase	MONDO	EFO
multiple sclerosis	3	MONDO:0005301	MONDO:0005301
Sjogren syndrome	2	MONDO:0010030	EFO:0000699
type 1 diabetes mellitus	2	MONDO:0005147	MONDO:0005147
nervous system disorder	1	MONDO:0005071	EFO:0000618
autoimmune disease	1	MONDO:0007179	EFO:0005809

Clinical trials

Total trials: 8.

Phase distribution

Phase	Trials
PHASE3	3
PHASE2	3
PHASE2/PHASE3	1
PHASE1	1

Top trials by phase / activity

NCT	Phase	Status	Title
NCT06141473	PHASE3	ACTIVE_NOT_RECRUITING	Efficacy and Safety Studies of Frexalimab (SAR441344) in Adults With Relapsing Forms of Multiple Sclerosis
NCT06141486	PHASE3	ACTIVE_NOT_RECRUITING	Efficacy and Safety Study of Frexalimab (SAR441344) in Adults With Nonrelapsing Secondary Progressive Multiple Sclerosis
NCT07325292	PHASE3	RECRUITING	Non-inferiority Study of Frexalimab Subcutaneous Administration Compared to Intravenous Administration in Adult Participants With Multiple Sclerosis
NCT07412470	PHASE2/PHASE3	RECRUITING	A Study to Investigate the Efficacy and Safety of Frexalimab Versus Tacrolimus in Adults Undergoing Kidney Transplantation
NCT06111586	PHASE2	RECRUITING	FrexalimAB in Preservation of Endogenous insULIN Secretion Compared to Placebo in adUlts and Adolescents on Top of inSulin Therapy (FABULINUS)
NCT06500702	PHASE2	RECRUITING	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
NCT04572841	PHASE2	COMPLETED	Safety, Tolerability, Pharmacokinetics, and Therapeutic Efficacy of SAR441344 in Primary Sjögren’s Syndrome (pSjS)
NCT05845996	PHASE1	COMPLETED	Study of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenous and Subcutaneous Single and Repeated Doses of SAR441344 in Healthy Adult Subjects

Clinical evidence (CIViC)

No CIViC predictive evidence (expected for non-precision-medicine drugs).

Pharmacology

Pharmacogenomics

No PharmGKB pharmacogenomic data curated for this drug.

Related molecules

Related molecules

No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).