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Compound · clinical trials

Frexalimab clinical trials

Also listed in trial records as SAR441344
Source: ClinicalTrials.gov, U.S. National Library of Medicine — the 8 trials in our USA, UK, China and India registers that name Frexalimab as an intervention. Synced 25 Sep 2026
8Current trials
3Recruiting now
1Lead sponsor
4Country registers
Maintained by Sreepriya Prasannan
MSc Digital Transformation of Life Sciences (Innopharma Education / Griffith College); MSc & BSc Botany HSE Spark Ignite 2026 โ€” Top 14 finalist
Compiled from ClinicalTrials.gov registry records ยท Last verified ยท Editorial standards
At a glance

Frexalimab is named as an intervention in 8 current clinical trials in our USA, UK, China and India registers. 3 are recruiting patients now. The most common phase is Phase 2. The lead sponsor is Sanofi. The most-studied condition is Multiple Sclerosis.

Trials by status

  • Recruiting338%
  • Active, closed563%

Trials by phase

  • Phase 2450%
  • Phase 3338%
  • Phase 2/3113%
01

Clinical trials of Frexalimab

8 trials
StudyPhaseStatusLead sponsorRegisters
Non-inferiority Study of Frexalimab Subcutaneous Administration Compared to Intravenous Administration in Adult Participants With Multiple Sclerosis
NCT07325292 · Multiple Sclerosis
Phase 3 Recruiting Sanofi USA, China
A Study to Investigate the Efficacy and Safety of Frexalimab Versus Tacrolimus in Adults Undergoing Kidney Transplantation
NCT07412470 · Kidney Transplant Rejection
Phase 2/3 Recruiting Sanofi UK, USA, China
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
NCT06500702 · ClinicalTrials.gov ↗ · Focal Segmental Glomerulosclerosis, Glomerulonephritis Minimal Lesion
Phase 2 Recruiting Sanofi UK, USA, China
Efficacy and Safety Studies of Frexalimab (SAR441344) in Adults With Relapsing Forms of Multiple Sclerosis
NCT06141473 · ClinicalTrials.gov ↗ · Multiple Sclerosis
Phase 3 Active, closed Sanofi UK, USA, India, China
Efficacy and Safety Study of Frexalimab (SAR441344) in Adults With Nonrelapsing Secondary Progressive Multiple Sclerosis
NCT06141486 · ClinicalTrials.gov ↗ · Multiple Sclerosis
Phase 3 Active, closed Sanofi UK, USA, India, China
Proof-of-concept Study for SAR441344 (Frexalimab) in Relapsing Multiple Sclerosis
NCT04879628 · Multiple Sclerosis
Phase 2 Active, closed Sanofi USA
Efficacy and Safety of Frexalimab (SAR441344) in the Treatment of Systemic Lupus Erythematosus
NCT05039840 · Systemic Lupus Erythematosus
Phase 2 Active, closed Sanofi USA
Frexalimab in Preservation of Endogenous Insulin Secretion Compared to Placebo in Adults, Adolescents and Children on Top of Insulin Therapy (FABULINUS)
NCT06111586 · ClinicalTrials.gov ↗ · Type 1 Diabetes Mellitus
Phase 2 Active, closed Sanofi UK, USA

Registers list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.

02

Conditions studied with Frexalimab

6 conditions
Multiple Sclerosis4Type 1 Diabetes Mellitus1Focal Segmental Glomerulosclerosis1Glomerulonephritis Minimal Lesion1Kidney Transplant Rejection1Systemic Lupus Erythematosus1
03

Sponsors

lead sponsor per trial
Lead sponsorTrials
Sanofi8
04

By country register

RegisterTrialsRecruiting
Clinical trials in USA83
Clinical trials in UK52
Clinical trials in China53
Clinical trials in India20

A trial with sites in more than one country appears in each of those registers.

05

Related compounds

06

Questions about Frexalimab trials

How many clinical trials are testing Frexalimab?

8 current trials in our USA, UK, China and India registers name Frexalimab (also registered as SAR441344) as a drug or biological intervention, as of the registry sync on 25 September 2026. Completed and withdrawn studies are not counted.

Are Frexalimab trials recruiting patients?

Yes. 3 of the 8 trials are recruiting: 3 with sites in USA, 2 with sites in UK and 3 with sites in China. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.

Who sponsors Frexalimab clinical trials?

The lead sponsor is Sanofi. The number in brackets is how many trials each organisation leads.

Where does this information come from?

Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Frexalimab works or whether it is effective, and it is not medical advice.

How this page is built

Everything on this page is copied from public ClinicalTrials.gov registry records โ€” it is not written from memory, and nothing here describes how Frexalimab works or whether it is effective. Each trial links to its own record so you can check it yourself.

This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Frexalimab (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 25 Sep 2026.

Please verify before you rely on this. This page is general information for life-science and pharmaceutical professionals. It is not medical advice, and it has not been reviewed by a clinician โ€” our editorial team holds life-science qualifications, not clinical ones. It is not exhaustive and may not reflect the most recent label change. Always check the official prescribing information (US Prescribing Information or EU SmPC) and speak to your doctor or pharmacist before acting on anything here. Drugs in the same class are not automatically interchangeable, and approvals, brand names and indications differ between the US, the EU/Ireland (EMA/HPRA) and other regions. Spotted an error? Tell us โ€” we correct promptly and log it.