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

Phaseactive not recruitingcompletedunknownTotal
P144
P2112
P3145

Tolebrutinib clinical trials by indication

Relapsing Multiple Sclerosis (4)

NCTAcronymPhaseStatusTitle
NCT06372145P3active not recruitingA Study to Investigate Long-term Safety and Tolerability of Tolebrutinib in Participants With Multiple Sclerosis.
NCT03996291SAR442168P2completedLong Term Safety and Efficacy Study of Tolebrutinib (SAR442168) in Participants With Relapsing Multiple Sclerosis
NCT04410991GEMINI 2P3completedRelapsing Forms of Multiple Sclerosis (RMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (GEMINI 2)
NCT04410978GEMINI 1P3completedRelapsing Forms of Multiple Sclerosis (RMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (GEMINI 1)

Multiple Sclerosis (3)

NCTAcronymPhaseStatusTitle
NCT04742400P2unknownTolebrutinib, a Brain-penetrant Bruton's Tyrosine Kinase Inhibitor, for the Modulation of Chronically Inflamed White Matter Lesions in Multiple Sclerosis
NCT06106074P1completedStudy of the Tolerability and Pharmacokinetics of Oral Doses of SAR442168 With a Food Effect Investigation in Healthy Adult Participants
NCT06064539P1completedStudy of Drug-drug Interaction of the Effects of Gemfibrozil and Rifampicin on SAR442168 in Healthy Adult Subjects

Hepatic Function Abnormal (1)

NCTAcronymPhaseStatusTitle
NCT05283915P1completedStudy 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)

NCTAcronymPhaseStatusTitle
NCT05282030P1completedStudy 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)

NCTAcronymPhaseStatusTitle
NCT04411641HERCULESP3completedNonrelapsing Secondary Progressive Multiple Sclerosis (NRSPMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (HERCULES)

Primary Progressive Multiple Sclerosis (1)

NCTAcronymPhaseStatusTitle
NCT04458051PERSEUSP3completedPrimary 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.

AcronymNCTPhaseStatusIndicationEnrollmentPubMed
PERSEUSNCT04458051P3completedPrimary Progressive Multiple Sclerosis767
HERCULESNCT04411641P3completedNon-relapsing Secondary Progressive Multiple Sclerosis1,131
GEMINI 2NCT04410991P3completedRelapsing Multiple Sclerosis899
GEMINI 1NCT04410978P3completedRelapsing Multiple Sclerosis974
SAR442168NCT03996291P2completedRelapsing Multiple Sclerosis125

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 IDAcronymTitlePhaseStatusEnrollmentSponsorStarted
NCT06372145A Study to Investigate Long-term Safety and Tolerability of Tolebrutinib in Participants With Multiple Sclerosis.P3active not recruiting2,500SanofiApr 2024
NCT04742400Tolebrutinib, a Brain-penetrant Bruton's Tyrosine Kinase Inhibitor, for the Modulation of Chronically Inflamed White Matter Lesions in Multiple SclerosisP2unknown12National Institute of Neurological Disorders and Stroke (NINDS)Apr 2021
NCT04458051PERSEUSPrimary Progressive Multiple Sclerosis (PPMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (PERSEUS)P3completed767SanofiAug 2020
NCT03996291SAR442168Long Term Safety and Efficacy Study of Tolebrutinib (SAR442168) in Participants With Relapsing Multiple SclerosisP2completed125SanofiSep 2019
NCT04411641HERCULESNonrelapsing Secondary Progressive Multiple Sclerosis (NRSPMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (HERCULES)P3completed1,131SanofiSep 2020
NCT04410991GEMINI 2Relapsing Forms of Multiple Sclerosis (RMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (GEMINI 2)P3completed899SanofiJun 2020
NCT04410978GEMINI 1Relapsing Forms of Multiple Sclerosis (RMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (GEMINI 1)P3completed974SanofiJun 2020
NCT05282030Study to Assess the Plasma Concentration of Tolebrutinib Given as a Tablet to Adult Participants With Renal Impairment Compared to Healthy Participants.P1completed22SanofiMar 2022
NCT05283915Study to Assess the Plasma Concentration of Tolebrutinib Given as a Tablet to Adult Participants With Mild Hepatic Impairment Compared to Participants With Normal Hepatic FunctionP1completed10SanofiMar 2022
NCT06106074Study of the Tolerability and Pharmacokinetics of Oral Doses of SAR442168 With a Food Effect Investigation in Healthy Adult ParticipantsP1completed71SanofiAug 2020
NCT06064539Study of Drug-drug Interaction of the Effects of Gemfibrozil and Rifampicin on SAR442168 in Healthy Adult SubjectsP1completed30SanofiMay 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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