Frexalimab Clinical Trials (2026): 6 Studies for Multiple Sclerosis & Focal Segmental Glomerulosclerosis
Hipa.ai Research · Source: ClinicalTrials.gov / AACT
Synced daily from ClinicalTrials.gov via AACT. Last sync: .
6 Frexalimab clinical trials are catalogued on Hipa.ai from the AACT mirror of ClinicalTrials.gov, spanning 4 indications (including Multiple Sclerosis & Focal Segmental Glomerulosclerosis) and 3,560 total planned enrollment. 3 Phase 3 Frexalimab trials and 2 Phase 2 are listed. 4 Frexalimab clinical trials are actively recruiting at 41 U.S. sites across 17 states. Most recent activity: NCT07412470 (Aug 2033).
Where to Participate: All Frexalimab Trial Sites in the U.S. (41 sites across 17 states)
Every actively recruiting Frexalimabtrial site, sorted by state then city. Each row links to the trial detail page (eligibility, contacts, full study record). Sites no longer enrolling at the location level are excluded. ClinicalTrials.gov / AACT does not provide street-level addresses; the map link uses the facility's geocoded coordinates where available.
| State | Facility | City | Trial | Map |
|---|---|---|---|---|
| AL | Investigational Site Number : 8400007 | Birmingham35233 | NCT06500702 | Map |
| AL | North Central Neurology Associates- Site Number : 8401100 | Cullman35058 | NCT07325292 | Map |
| AL | Alabama Neurology Associates- Site Number : 8400115 | Homewood35209 | NCT07325292 | Map |
| AZ | Center for Neurology and Spine - Phoenix - East Bell Road- Site Number : 8400195 | Phoenix85032 | NCT07325292 | Map |
| AZ | Perseverance Research Center- Site Number : 8400138 | Scottsdale85253 | NCT07325292 | Map |
| CA | Investigational Site Number : 8400015 | Orange92868 | NCT06500702 | Map |
| CA | Investigational Site Number : 8400012 | San Francisco94143 | NCT06500702 | Map |
| CA | University of California San Francisco - Mission Bay- Site Number : 8400012 | San Francisco94158 | NCT06111586 | Map |
| CA | Private Practice - Dr. Regina Berkovich- Site Number : 8400005 | West Hollywood90048 | NCT07325292 | Map |
| CO | Advanced Neurology of Colorado- Site Number : 8400148 | Fort Collins80528 | NCT07325292 | Map |
| FL | Neurology of Central Florida- Site Number : 8400147 | Altamonte Springs32714 | NCT07325292 | Map |
| FL | University of Miami Hospital- Site Number : 8400013 | Miami33136 | NCT06111586 | Map |
| FL | Aqualane Clinical Research- Site Number : 8400026 | Naples34105 | NCT07325292 | Map |
| FL | AdventHealth Orlando- Site Number : 8400002 | Orlando32803 | NCT06111586 | Map |
| FL | Neurology Associates of Ormond Beach- Site Number : 8400086 | Ormond Beach32174 | NCT07325292 | Map |
| FL | Investigational Site Number : 8400025 | Tampa33612 | NCT06500702 | Map |
| FL | Palm Beach Neurology- Site Number : 8400105 | West Palm Beach33407 | NCT07325292 | Map |
| GA | Emory Children's Center- Site Number : 8400020 | Atlanta30322 | NCT06500702 | Map |
| GA | Joi Life Wellness Group LLC- Site Number : 8400192 | Smyrna30080 | NCT07325292 | Map |
| IL | Investigational Site Number : 8400014 | Chicago60611 | NCT06500702 | Map |
| IL | Investigational Site Number : 8400017 | Hinsdale60521 | NCT06500702 | Map |
| IL | Consultants in Neurology- Site Number : 8400020 | Northbrook60062 | NCT07325292 | Map |
| MI | Investigational Site Number : 8400010 | Ann Arbor48109 | NCT06500702 | Map |
| MI | Michigan Institute for Neurological Disorders- Site Number : 8400004 | Farmington Hills48334 | NCT07325292 | Map |
| MN | Investigational Site Number : 8400019 | Edina55435 | NCT06500702 | Map |
| NV | Investigational Site Number : 8400018 | Las Vegas89107 | NCT06500702 | Map |
| NJ | Holy Name Medical Center- Site Number : 8400101 | Teaneck07666 | NCT07325292 | Map |
| NM | Investigational Site Number: 8400028 | Albuquerque87109 | NCT06500702 | Map |
| NY | Investigational Site Number : 8400001 | New York10032 | NCT06500702 | Map |
| NY | Montefiore Medical Center - Moses Campus- Site Number : 8400006 | The Bronx10467 | NCT07412470 | Map |
| NC | Investigational Site Number : 8400021 | Chapel Hill27599 | NCT06500702 | Map |
| NC | Piedmont HealthCare - Lake Norman Neurology- Site Number : 8400002 | Charlotte28210 | NCT07325292 | Map |
| NC | Raleigh Neurology Associates- Site Number : 8400014 | Raleigh27607 | NCT07325292 | Map |
| OH | The Ohio State University- Site Number : 8400009 | Columbus43210 | NCT07325292 | Map |
| TN | Hope Neurology- Site Number : 8400019 | Knoxville37922 | NCT07325292 | Map |
| TX | Investigational Site Number : 8400024 | Dallas75204 | NCT06500702 | Map |
| TX | ANESC Research- Site Number : 8400187 | El Paso79912 | NCT07325292 | Map |
| TX | Investigational Site Number : 8400005 | El Paso79902 | NCT06500702 | Map |
| TX | Investigational Site Number: 8400016 | Houston77054 | NCT06500702 | Map |
| TX | North Texas Institute of Neurology & Headache - Plano- Site Number : 8400082 | Plano75024 | NCT07325292 | Map |
| TX | North Texas Institute of Neurology & Headache - Plano- Site Number : 8400083 | Plano75024 | NCT07325292 | Map |
Frexalimab clinical trials at a glance: phase × recruitment status
| Phase | recruiting | active not recruiting | Total |
|---|---|---|---|
| P2 | 2 | 2 | |
| P2/P3 | 1 | 1 | |
| P3 | 1 | 2 | 3 |
Recruiting Frexalimab clinical trials (4)
Studies currently enrolling participants. Click any NCT ID to view the trial detail page (eligibility, sites, contacts).
| NCT ID | Title | Phase | Indication | Enrollment | Started |
|---|---|---|---|---|---|
| NCT07412470 | FREXERAA Study to Investigate the Efficacy and Safety of Frexalimab Versus Tacrolimus in Adults Undergoing Kidney Transplantation | P2/P3 | Kidney Transplant Rejection | 526 | Mar 2026 |
| NCT06111586 | FABULINUSFrexalimAB in Preservation of Endogenous insULIN Secretion Compared to Placebo in adUlts and Adolescents on Top of inSulin Therapy (FABULINUS) | P2 | Type 1 Diabetes Mellitus | 192 | Dec 2023 |
| NCT07325292 | FrexciteNon-inferiority Study of Frexalimab Subcutaneous Administration Compared to Intravenous Administration in Adult Participants With Multiple Sclerosis | P3 | Multiple Sclerosis | 160 | Jan 2026 |
| NCT06500702 | RESULTA 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 | P2 | Focal Segmental Glomerulosclerosis | 84 | Dec 2024 |
Frexalimab clinical trials by indication
Multiple Sclerosis (3)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT07325292 | Frexcite | P3 | recruiting | Non-inferiority Study of Frexalimab Subcutaneous Administration Compared to Intravenous Administration in Adult Participants With Multiple Sclerosis |
| NCT06141486 | FREVIVA | P3 | active not recruiting | Efficacy and Safety Study of Frexalimab (SAR441344) in Adults With Nonrelapsing Secondary Progressive Multiple Sclerosis |
| NCT06141473 | FREXALT | P3 | active not recruiting | Efficacy and Safety Studies of Frexalimab (SAR441344) in Adults With Relapsing Forms of Multiple Sclerosis |
Kidney Transplant Rejection (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT07412470 | FREXERA | P2/P3 | recruiting | A Study to Investigate the Efficacy and Safety of Frexalimab Versus Tacrolimus in Adults Undergoing Kidney Transplantation |
Focal Segmental Glomerulosclerosis (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06500702 | RESULT | P2 | recruiting | 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 |
Type 1 Diabetes Mellitus (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06111586 | FABULINUS | P2 | recruiting | FrexalimAB in Preservation of Endogenous insULIN Secretion Compared to Placebo in adUlts and Adolescents on Top of inSulin Therapy (FABULINUS) |
Frexalimab pivotal trial highlights (Phase 2/3/4)
Phase-2/3/4 studies with named acronyms — the registration-grade trials most cited in label discussions and Wikipedia.
| Acronym | NCT | Phase | Status | Indication | Enrollment | PubMed |
|---|---|---|---|---|---|---|
| Frexcite | NCT07325292 | P3 | recruiting | Multiple Sclerosis | 160 | — |
| FREVIVA | NCT06141486 | P3 | active not recruiting | Multiple Sclerosis | 943 | — |
| FREXALT | NCT06141473 | P3 | active not recruiting | Multiple Sclerosis | 1,655 | — |
| FABULINUS | NCT06111586 | P2 | recruiting | Type 1 Diabetes Mellitus | 192 | — |
| RESULT | NCT06500702 | P2 | recruiting | Focal Segmental Glomerulosclerosis | 84 | — |
All Frexalimab trials (6)
Sorted by most recent activity (completion → start → posted date). Each row links to the trial detail page on Hipa.ai.
| NCT ID | Acronym | Title | Phase | Status | Enrollment | Sponsor | Started |
|---|---|---|---|---|---|---|---|
| NCT07412470 | FREXERA | A Study to Investigate the Efficacy and Safety of Frexalimab Versus Tacrolimus in Adults Undergoing Kidney Transplantation | P2/P3 | recruiting | 526 | Sanofi | Mar 2026 |
| NCT06111586 | FABULINUS | FrexalimAB in Preservation of Endogenous insULIN Secretion Compared to Placebo in adUlts and Adolescents on Top of inSulin Therapy (FABULINUS) | P2 | recruiting | 192 | Sanofi | Dec 2023 |
| NCT07325292 | Frexcite | Non-inferiority Study of Frexalimab Subcutaneous Administration Compared to Intravenous Administration in Adult Participants With Multiple Sclerosis | P3 | recruiting | 160 | Sanofi | Jan 2026 |
| NCT06141486 | FREVIVA | Efficacy and Safety Study of Frexalimab (SAR441344) in Adults With Nonrelapsing Secondary Progressive Multiple Sclerosis | P3 | active not recruiting | 943 | Sanofi | Dec 2023 |
| NCT06500702 | RESULT | 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 | P2 | recruiting | 84 | Sanofi | Dec 2024 |
| NCT06141473 | FREXALT | Efficacy and Safety Studies of Frexalimab (SAR441344) in Adults With Relapsing Forms of Multiple Sclerosis | P3 | active not recruiting | 1,655 | Sanofi | Dec 2023 |
Frexalimab clinical trials: frequently asked questions
- How many Frexalimab clinical trials are there?
- 6 Frexalimab clinical trials are catalogued on Hipa.ai, sourced from the AACT mirror of ClinicalTrials.gov. 4 are actively recruiting participants.
- Are Frexalimab clinical trials recruiting in 2026?
- Yes — 4 Frexalimab trials are actively recruiting in 2026, with 41 U.S. sites across 17 states. See the recruiting trials and the per-state site list further down this page.
- What conditions is Frexalimab being studied for?
- Frexalimab is being studied for Multiple Sclerosis, Focal Segmental Glomerulosclerosis, Glomerulonephritis Minimal Lesion, Kidney Transplant Rejection, Type 1 Diabetes Mellitus. The trials are grouped by indication on this page.
- What phase is Frexalimab in?
- Frexalimab clinical trials span 3 Phase 3, 2 Phase 2. The phase × status matrix at the top of this page breaks down counts by phase and recruitment status.
- Who sponsors Frexalimab clinical trials?
- The lead sponsor across the most Frexalimab trials is Sanofi. Each trial row links to the full study detail page including sponsor information.
Sources and methodology
Trial inventory derived from the AACT mirror of ClinicalTrials.gov. Trials are filtered to those naming Frexalimabas an intervention. Phase, status, enrollment, sponsor, and dates are taken from the source `studies` table; primary indication is the first listed condition. Acronyms are extracted from each trial's brief title where present. PubMed links are populated for trials whose published primary outcomes have been indexed in our evidence cache.
Last refreshed .
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