frexalimab

Phase 3Monoclonal antibody

Sanofi

frexalimab is one of 211 small molecule programs targeting Insulin Secretion. It is currently in Phase 3.

Indications

Total Trials

Active Trials

210

Competitors

Pipeline

Status by Indication[3][1]

Indication

Insulin SecretionActive, not recruiting

Kidney TransplantActive, not recruiting

Multiple SclerosisActive, not recruiting

Focal Segmental GlomerulosclerosisActive, not recruiting

Kidney Transplant RejectionRecruiting

Secondary Progressive Multiple SclerosisActive, not recruiting

Type 1 Diabetes MellitusActive, not recruiting

Insulin SecretionPhase 2

Active, not recruiting

Kidney TransplantPhase 2/Phase 3

Active, not recruiting

Multiple SclerosisPhase 3

Active, not recruiting

Focal Segmental GlomerulosclerosisPhase 2

Active, not recruiting

Kidney Transplant RejectionPreclinical

Recruiting

Secondary Progressive Multiple SclerosisPhase 3

Active, not recruiting

Type 1 Diabetes MellitusPhase 2

Active, not recruiting

Competition

Competitive Landscape

560 competitors in Multiple Sclerosis

#DrugCompanyPhaseTrials

frexalimab

Sanofi

Phase 3

2 2

Betaseron

Bayer

Preclinical

16 3

Kesimpta

Novartis

Preclinical

15 4

Tysabri

Biogen

Preclinical

14 5

Avonex

EMD Serono

Preclinical

22 6

Campath

GGenzyme, a Sanofi Company

Preclinical

12 7

Zinbryta

Roche

Preclinical

2 8

Flomax

Sanofi

Preclinical

1 9

Myfortic

Novantrone

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

Timeline

Expected Milestones

Q2 2027

Phase 3Recruiting

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

Efficacy and Safety Studies of Frexalimab (SAR441344) in Adults With Relapsing Forms of Multiple Sclerosis

Recruiting· Sanofi logo

Sanofi·Phase 3·NCT06141473·1,600 enrolled

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

Focal Segmental Glomerulosclerosis1 trial

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

Recruiting· Sanofi logo

Sanofi·Phase 2·NCT06500702·84 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

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

Focal Segmental Glomerulosclerosis1 trial

Secondary Progressive Multiple Sclerosis1 trial

Type 1 Diabetes Mellitus1 trial

Kidney Transplant Rejection1 trial

References

Drug Info

Quick Facts

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