Tolebrutinib Clinical Trials (2026): 11 Studies for Relapsing Multiple Sclerosis & Multiple Sclerosis
Hipa.ai Research · Source: ClinicalTrials.gov / AACT
Synced daily from ClinicalTrials.gov via AACT. Last sync: .
11 Tolebrutinib clinical trials are catalogued on Hipa.ai from the AACT mirror of ClinicalTrials.gov, spanning 6 indications (including Relapsing Multiple Sclerosis & Multiple Sclerosis) and 6,541 total planned enrollment. 5 Phase 3 Tolebrutinib trials and 2 Phase 2 are listed. Most recent activity: NCT06372145 (Apr 2029).
Tolebrutinib clinical trials at a glance: phase × recruitment status
| Phase | active not recruiting | completed | unknown | Total |
|---|---|---|---|---|
| P1 | 4 | 4 | ||
| P2 | 1 | 1 | 2 | |
| P3 | 1 | 4 | 5 |
Tolebrutinib clinical trials by indication
Relapsing Multiple Sclerosis (4)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06372145 | — | P3 | active not recruiting | A Study to Investigate Long-term Safety and Tolerability of Tolebrutinib in Participants With Multiple Sclerosis. |
| NCT03996291 | SAR442168 | P2 | completed | Long Term Safety and Efficacy Study of Tolebrutinib (SAR442168) in Participants With Relapsing Multiple Sclerosis |
| NCT04410991 | GEMINI 2 | P3 | completed | Relapsing Forms of Multiple Sclerosis (RMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (GEMINI 2) |
| NCT04410978 | GEMINI 1 | P3 | completed | Relapsing Forms of Multiple Sclerosis (RMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (GEMINI 1) |
Multiple Sclerosis (3)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT04742400 | — | P2 | unknown | Tolebrutinib, a Brain-penetrant Bruton's Tyrosine Kinase Inhibitor, for the Modulation of Chronically Inflamed White Matter Lesions in Multiple Sclerosis |
| NCT06106074 | — | P1 | completed | Study of the Tolerability and Pharmacokinetics of Oral Doses of SAR442168 With a Food Effect Investigation in Healthy Adult Participants |
| NCT06064539 | — | P1 | completed | Study of Drug-drug Interaction of the Effects of Gemfibrozil and Rifampicin on SAR442168 in Healthy Adult Subjects |
Hepatic Function Abnormal (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05283915 | — | P1 | completed | Study to Assess the Plasma Concentration of Tolebrutinib Given as a Tablet to Adult Participants With Mild Hepatic Impairment Compared to Participants With Normal Hepatic Function |
Renal Impairment (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05282030 | — | P1 | completed | Study to Assess the Plasma Concentration of Tolebrutinib Given as a Tablet to Adult Participants With Renal Impairment Compared to Healthy Participants. |
Non-relapsing Secondary Progressive Multiple Sclerosis (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT04411641 | HERCULES | P3 | completed | Nonrelapsing Secondary Progressive Multiple Sclerosis (NRSPMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (HERCULES) |
Primary Progressive Multiple Sclerosis (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT04458051 | PERSEUS | P3 | completed | Primary Progressive Multiple Sclerosis (PPMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (PERSEUS) |
Tolebrutinib 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 |
|---|---|---|---|---|---|---|
| PERSEUS | NCT04458051 | P3 | completed | Primary Progressive Multiple Sclerosis | 767 | — |
| HERCULES | NCT04411641 | P3 | completed | Non-relapsing Secondary Progressive Multiple Sclerosis | 1,131 | — |
| GEMINI 2 | NCT04410991 | P3 | completed | Relapsing Multiple Sclerosis | 899 | — |
| GEMINI 1 | NCT04410978 | P3 | completed | Relapsing Multiple Sclerosis | 974 | — |
| SAR442168 | NCT03996291 | P2 | completed | Relapsing Multiple Sclerosis | 125 | — |
All Tolebrutinib trials (11)
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 |
|---|---|---|---|---|---|---|---|
| NCT06372145 | A Study to Investigate Long-term Safety and Tolerability of Tolebrutinib in Participants With Multiple Sclerosis. | P3 | active not recruiting | 2,500 | Sanofi | Apr 2024 | |
| NCT04742400 | Tolebrutinib, a Brain-penetrant Bruton's Tyrosine Kinase Inhibitor, for the Modulation of Chronically Inflamed White Matter Lesions in Multiple Sclerosis | P2 | unknown | 12 | National Institute of Neurological Disorders and Stroke (NINDS) | Apr 2021 | |
| NCT04458051 | PERSEUS | Primary Progressive Multiple Sclerosis (PPMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (PERSEUS) | P3 | completed | 767 | Sanofi | Aug 2020 |
| NCT03996291 | SAR442168 | Long Term Safety and Efficacy Study of Tolebrutinib (SAR442168) in Participants With Relapsing Multiple Sclerosis | P2 | completed | 125 | Sanofi | Sep 2019 |
| NCT04411641 | HERCULES | Nonrelapsing Secondary Progressive Multiple Sclerosis (NRSPMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (HERCULES) | P3 | completed | 1,131 | Sanofi | Sep 2020 |
| NCT04410991 | GEMINI 2 | Relapsing Forms of Multiple Sclerosis (RMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (GEMINI 2) | P3 | completed | 899 | Sanofi | Jun 2020 |
| NCT04410978 | GEMINI 1 | Relapsing Forms of Multiple Sclerosis (RMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (GEMINI 1) | P3 | completed | 974 | Sanofi | Jun 2020 |
| NCT05282030 | Study to Assess the Plasma Concentration of Tolebrutinib Given as a Tablet to Adult Participants With Renal Impairment Compared to Healthy Participants. | P1 | completed | 22 | Sanofi | Mar 2022 | |
| NCT05283915 | Study to Assess the Plasma Concentration of Tolebrutinib Given as a Tablet to Adult Participants With Mild Hepatic Impairment Compared to Participants With Normal Hepatic Function | P1 | completed | 10 | Sanofi | Mar 2022 | |
| NCT06106074 | Study of the Tolerability and Pharmacokinetics of Oral Doses of SAR442168 With a Food Effect Investigation in Healthy Adult Participants | P1 | completed | 71 | Sanofi | Aug 2020 | |
| NCT06064539 | Study of Drug-drug Interaction of the Effects of Gemfibrozil and Rifampicin on SAR442168 in Healthy Adult Subjects | P1 | completed | 30 | Sanofi | May 2020 |
Tolebrutinib clinical trials: frequently asked questions
- How many Tolebrutinib clinical trials are there?
- 11 Tolebrutinib clinical trials are catalogued on Hipa.ai, sourced from the AACT mirror of ClinicalTrials.gov. 9 are marked completed.
- Are Tolebrutinib clinical trials recruiting in 2026?
- No active Tolebrutinib trials are recruiting on ClinicalTrials.gov as of the current AACT refresh. Trials may resume; this page is updated daily.
- What conditions is Tolebrutinib being studied for?
- Tolebrutinib is being studied for Relapsing Multiple Sclerosis, Multiple Sclerosis, Primary Progressive Multiple Sclerosis, Progressive Relapsing Multiple Sclerosis, Renal Impairment and 3 more. The trials are grouped by indication on this page.
- What phase is Tolebrutinib in?
- Tolebrutinib clinical trials span 5 Phase 3, 2 Phase 2, 4 Phase 1. The phase × status matrix at the top of this page breaks down counts by phase and recruitment status.
- Who sponsors Tolebrutinib clinical trials?
- The lead sponsor across the most Tolebrutinib trials is Sanofi, with 1 additional lead sponsor listed in the data. 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 Tolebrutinibas 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.
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