Drugs / Frexalimab
Frexalimab
Trials 10
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT05845996 | Nov 2018 → Apr 2020 | — | Sanofi | Completed | No outcome recorded |
| Phase 25 trials · 1 met primary · 1 missed | ||||||
| Phase 2 | NCT06500702 | Dec 2024 → Dec 2026 expected | focal segmental glomerulosclerosis, minimal change disease | Sanofi | Recruiting | No outcome recorded |
| Phase 2 | NCT06111586 | Dec 2023 → Apr 2027 expected | type 1 diabetes mellitus | Sanofi | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05039840 | Nov 2021 → Sep 2026 overdue | systemic lupus erythematosus | Sanofi | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04879628 | Jun 2021 → Sep 2022 overdue | multiple sclerosis | Sanofi | Active not recruiting | Met primary |
| Phase 2 | NCT04572841 | Nov 2020 → Nov 2023 | Sjogren syndrome | Sanofi | Completed | Missed primary |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT07412470 | Mar 2026 → Aug 2029 expected | transplant rejection | Sanofi | Recruiting | No outcome recorded |
| Phase 33 trials | ||||||
| Phase 3 | NCT07325292 | Jan 2026 → Jul 2027 expected | multiple sclerosis | Sanofi | Recruiting | No outcome recorded |
| Phase 3 | NCT06141486 | Dec 2023 → Mar 2028 expected | multiple sclerosis | Sanofi | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06141473 | Dec 2023 → May 2027 expected | multiple sclerosis | Sanofi | Active not recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2024-06-28 | Sanofi | Results Media Update: Frexalimab new phase 2 data showed reduction of key biomarker of nerve cell damage in relapsing MS sanofi.com ↗
New phase 2 results showed significant reduction in plasma levels of neurofilament light chain (NfL) after one year of treatment, a biomarker of nerve cell damage that is typically elevated in people living with MS. |
| 2024-04-17 | Sanofi | Results Press Release: New 48-week frexalimab phase 2 data support potential for high sustained efficacy in multiple sclerosis sanofi.com ↗
Sanofi’s CD40L antibody, frexalimab, demonstrated sustained reduction of disease activity and favorable tolerability after nearly one year in participants with relapsing multiple sclerosis. |
| 2024-02-15 | Sanofi | Results Press Release: Phase 2 data published in NEJM show potential of frexalimab as high-efficacy therapy in relapsing MS sanofi.com ↗
Findings also showed both doses of frexalimab provided significant reduction in new or enlarging T2 lesions, a secondary endpoint of the study. |
| 2023-05-31 | Sanofi | Results Press Release: Positive Phase 2 data of novel investigational anti-CD40L antibody frexalimab show significantly reduced disease activity in relapsing multiple sclerosis sanofi.com ↗
Following 12 weeks of therapy, the number of new gadolinium-enhancing (GdE) T1-lesions was reduced by 89% and 79% in the higher- and lower-dose treatment arms, respectively, compared with placebo, meeting the study’s primary endpoint. |
All press releases naming this drug 4 releases
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 12 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Frexalimab | “Frexalimab intravenous (IV) loading dose followed by subcutaneous (SC) doses, 24 weeks” NCT05039840 ↗ |
| Known as | INX 021 | ChEMBL registry synonym — accepted as the source's own label CHEMBL5095122 ↗ |
| Known as | INX 021-56 | ChEMBL registry synonym — accepted as the source's own label CHEMBL5095122 ↗ |
| Known as | SAR441344 | “Efficacy and Safety Study of Frexalimab (SAR441344) in Adults With Nonrelapsing Secondary Progressive Multiple Sclerosis” NCT06141486 ↗4“Efficacy and Safety of Frexalimab (SAR441344) in the Treatment of Systemic Lupus Erythematosus” NCT05039840 ↗ |
| Known as | XC 01129 | ChEMBL registry synonym — accepted as the source's own label CHEMBL5095122 ↗ |
| Action | Inhibit | “frexalimab, a CD40L-antagonist Monoclonal Antibody” NCT06111586 ↗ |
| Modality | Monoclonal antibody | “Frexalimab is a humanised monoclonal antibody specific for CD40L undergoing evaluation for treatment of various immune-mediated conditions.” PMID 42203212 ↗ May 2026 |
| Route | Intravenous | “single intravenous (IV) loading dose” NCT04572841 ↗ |