frexalimab

Phase 3Monoclonal antibody

Sanofi

frexalimab is one of 112 small molecule programs targeting Multiple Sclerosis. It is currently in Phase 3.

Indications

Total Trials

Active Trials

111

Competitors

Pipeline

Status by Indication[3][1]

Indication

Multiple SclerosisActive, not recruiting

Kidney Transplant RejectionRecruiting

Type 1 Diabetes MellitusActive, not recruiting

Focal Segmental GlomerulosclerosisRecruiting

Secondary Progressive Multiple SclerosisRecruiting

Multiple SclerosisPhase 3

Active, not recruiting

Kidney Transplant RejectionPreclinical

Recruiting

Type 1 Diabetes MellitusPhase 2

Active, not recruiting

Focal Segmental GlomerulosclerosisPhase 2

Recruiting

Secondary Progressive Multiple SclerosisPhase 3

Recruiting

Competition

Competitive Landscape

145 competitors in Multiple Sclerosis

#DrugCompanyPhaseTrials

Clemastine Fumarate

Novartis

Phase 3

2 2

Activated Charcoal

Sanofi

Phase 3

1 3

Mayzent

Novartis

Phase 3

1 4

frexalimab

Sanofi

Phase 3

2 5

Antihistamine

Arrowhead Pharmaceuticals

Phase 3

2 6

Recombinant Zoster Vaccine

MMAXVAX Biotechnology Limited Liability Company

Phase 3

1 7

MRI Contrast-Enhancing Agents

Sanofi

Phase 3

3 8

Tolebrutinib

Sanofi

Phase 3

4 9

PBR06

UUniversity Hospital, Bordeaux

Phase 3

3 10

IMU-838

IImmunic AG

Phase 3

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q2 2027

Phase 3Active, not recruiting

Multiple Sclerosis

NCT06141473

Q1 2028

Phase 2Recruiting

Focal Segmental Glomerulosclerosis

NCT06500702

Phase 3Recruiting

Secondary Progressive Multiple Sclerosis

NCT06141486

Q4 2028

Phase 3Recruiting

Multiple Sclerosis

NCT07325292

Q4 2030

Phase 2Active, not recruiting

Type 1 Diabetes Mellitus

NCT06111586

Clinical

Trials by Indication[1]

Multiple Sclerosis2 trials

A Randomized, Phase 3, Open-label Study to Investigate Pharmacokinetics, Safety, and Efficacy of Subcutaneous Compared to Intravenous Frexalimab in Adult Participants With Multiple Sclerosis

Recruiting· Sanofi logo

Sanofi·Phase 3·NCT07325292·160 enrolled

Master Protocol of Two Independent, Randomized, Double-blind, Phase 3 Studies Comparing Efficacy and Safety of Frexalimab (SAR441344) to Teriflunomide in Adult Participants With Relapsing Forms of Multiple Sclerosis

Active, not recruiting· Sanofi logo

Sanofi·Phase 3·NCT06141473·1,655 enrolled

Secondary Progressive Multiple Sclerosis1 trial

Efficacy and Safety Study of Frexalimab (SAR441344) in Adults With Nonrelapsing Secondary Progressive Multiple Sclerosis

Recruiting· Sanofi logo

Sanofi·Phase 3·NCT06141486·900 enrolled

Focal Segmental Glomerulosclerosis1 trial

A Parallel-group Treatment, Phase 2a, Multicenter, Randomized, Double-blind, Placebo-controlled Umbrella Study to Evaluate the Efficacy and Safety of Frexalimab, Brivekimig, and Rilzabrutinib in Participants Aged 16 to 75 Years With Primary Focal Segmental Glomerulosclerosis (FSGS) or Minimal Change Disease (MCD)

Recruiting· Sanofi logo

Sanofi·Phase 2·NCT06500702·84 enrolled

Type 1 Diabetes Mellitus1 trial

A Randomized, Double-blind, Placebo-controlled, Multi-center Phase 2b Study With a Blinded Extension and an Optional Open-label Extension-Assessing the Safety and Efficacy of Frexalimab, a CD40L-antagonist Monoclonal Antibody, for the Preservation of Pancreatic β-cell Function in Adults, Adolescents and Children With Newly Diagnosed Type 1 Diabetes on Insulin Therapy

Active, not recruiting· Sanofi logo

Sanofi·Phase 2·NCT06111586·197 enrolled

Kidney Transplant Rejection1 trial

A Seamless Phase 2/3 Randomized, Open-label Study to Investigate Efficacy and Safety of Frexalimab Versus Tacrolimus in Adult Kidney Transplant Recipients

Recruiting· Sanofi logo

Sanofi·Preclinical·NCT07412470·526 enrolled

Sources

References

[1]
ClinicalTrials.gov — 6 trial records for frexalimab. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — frexalimab compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for frexalimab. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Sanofi company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Monoclonal antibody[2]
Highest Phase: Phase 3[1]
Company: Sanofi

frexalimab

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q2 2027

Q1 2028

Q4 2028

Q4 2030

Trials by Indication[1]

Multiple Sclerosis2 trials

Secondary Progressive Multiple Sclerosis1 trial

Focal Segmental Glomerulosclerosis1 trial

Type 1 Diabetes Mellitus1 trial

Kidney Transplant Rejection1 trial

References

Drug Info

Quick Facts

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