Frexalimab History and Updates

19 events · 2023 – present

Synced daily from openFDA and ClinicalTrials.gov. Last sync: .

0
FDA Approvals
0
Label Revisions
19
Trial Milestones
0
Pivotal Publications
Frexalimab — history and updatesFDA approvals, label revisions, recalls, trials, and pivotal publicationsFDA approvalsLabel revisionsRecalls + safetyTrialsPublications2024202520262027202820292030Trial: NCT07412470 2026-03-13 → 2029-08-15 (primary completion)Trial: NCT07325292 2026-01-14 → 2027-07-15 (primary completion)Trial: NCT06500702 2024-12-19 → 2026-12-23 (primary completion)Trial: NCT06141486 2023-12-27 → 2028-03-24 (primary completion)Trial: NCT06141473 2023-12-13 → 2027-05-06 (primary completion)Trial: NCT06111586 2023-12-11 → 2027-04-28 (primary completion)today (2026-06-09)FDA approvalLabel revisionRecall or safetyTrial activityPivotal publication

Source: openFDA, ClinicalTrials.gov via AACT, PubMed · Hipa.ai, 2026-06-09Download chart as PNG

This page tracks every FDA action, clinical trial milestone, and major publication for Frexalimab since 2023, drawn from openFDA, ClinicalTrials.gov, and PubMed.

Upcoming & expected milestones

Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT06141486
Efficacy and Safety Study of Frexalimab (SAR441344) in Adults With Nonrelapsing Secondary Progressive Multiple Sclerosis
Primary completion· ClinicalTrials.gov
Phase 2 primary completion: NCT06500702
A Study to Evaluate the Efficacy and Safety of Frexalimab, Brivekimig, or Rilzabrutinib in Participants Aged 16 to 75 Years With Primary Foc
Primary completion· ClinicalTrials.gov
Phase 2 primary completion: NCT06111586
FrexalimAB in Preservation of Endogenous insULIN Secretion Compared to Placebo in adUlts and Adolescents on Top of inSulin Therapy (FABULINU
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT06141473
Efficacy and Safety Studies of Frexalimab (SAR441344) in Adults With Relapsing Forms of Multiple Sclerosis
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT07325292
Non-inferiority Study of Frexalimab Subcutaneous Administration Compared to Intravenous Administration in Adult Participants With Multiple S
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT06141486
Efficacy and Safety Study of Frexalimab (SAR441344) in Adults With Nonrelapsing Secondary Progressive Multiple Sclerosis

Past events

2026
Trial started· ClinicalTrials.gov
Phase 2/Phase 3 trial started: NCT07412470
A Study to Investigate the Efficacy and Safety of Frexalimab Versus Tacrolimus in Adults Undergoing Kidney Transplantation
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT07325292
Non-inferiority Study of Frexalimab Subcutaneous Administration Compared to Intravenous Administration in Adult Participants With Multiple S
2024
Trial started· ClinicalTrials.gov
Phase 2 trial started: NCT06500702
A Study to Evaluate the Efficacy and Safety of Frexalimab, Brivekimig, or Rilzabrutinib in Participants Aged 16 to 75 Years With Primary Foc
2023
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT06141486
Efficacy and Safety Study of Frexalimab (SAR441344) in Adults With Nonrelapsing Secondary Progressive Multiple Sclerosis
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT06141473
Efficacy and Safety Studies of Frexalimab (SAR441344) in Adults With Relapsing Forms of Multiple Sclerosis
Trial started· ClinicalTrials.gov
Phase 2 trial started: NCT06111586
FrexalimAB in Preservation of Endogenous insULIN Secretion Compared to Placebo in adUlts and Adolescents on Top of inSulin Therapy (FABULINU

Sources

FDA approvals, label revisions, and recalls come from the public openFDA APIs (Drugs@FDA, Drug Label, Drug Enforcement). Drug-safety communications come from the FDA RSS feed. Trial milestones come from ClinicalTrials.gov via the AACT pg dump. Pivotal-publication events come from PubMed, filtered to high-impact journals linked to a Phase 3 trial in our inventory.