Tolebrutinib

Pipeline

Status by Indication[3][1]

Competition

Competitive Landscape

Multiple SclerosisSecondary Progressive Multiple SclerosisPrimary Progressive Multiple Sclerosis

560 competitors in Multiple Sclerosis

#DrugCompanyPhaseTrials

1

Tolebrutinib

Sanofi

Phase 3

52

Kesimpta

Novartis

Preclinical

153

Avonex

EMD Serono

Preclinical

224

Zinbryta

Roche

Preclinical

25

Pred Forte

Novartis

Preclinical

—6

Myfortic

Novartis

Preclinical

—7

Novantrone

Pfizer

Preclinical

—8

Pletal

Otsuka

Preclinical

19

Wellcovorin

GGlaxo Dba Glaxosmithkline

Preclinical

110

XEOMIN

MMerz Pharmaceuticals GmbH

Preclinical

—Show 13 more competitors

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Clinical

Trials by Indication[1]

Multiple Sclerosis5 trials

Long Term Safety and Efficacy Study of Tolebrutinib (SAR442168) in Participants With Relapsing Multiple Sclerosis

Completed·Sanofi·Phase 2·NCT03996291·125 enrolled

Relapsing Forms of Multiple Sclerosis (RMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (GEMINI 1)

Completed·Sanofi·Phase 3·NCT04410978·974 enrolled

Relapsing Forms of Multiple Sclerosis (RMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (GEMINI 2)

Completed·Sanofi·Phase 3·NCT04410991·899 enrolled

Show 2 more trials

A Study to Investigate Long-term Safety and Tolerability of Tolebrutinib in Participants With Multiple Sclerosis.

Active, not recruiting·Sanofi·Phase 3·NCT06372145·2,500 enrolled

Tolebrutinib, a Brain-penetrant Bruton's Tyrosine Kinase Inhibitor, for the Modulation of Chronically Inflamed White Matter Lesions in Multiple Sclerosis

Active, not recruiting·NNational Institute of Neurological Disorders and Stroke (NINDS)·Phase 2·NCT04742400·12 enrolled

Adult1 trial

Study of the Tolerability and Pharmacokinetics of Oral Doses of SAR442168 With a Food Effect Investigation in Healthy Adult Participants

Completed·Sanofi·Phase 1·NCT06106074·71 enrolled

Primary Progressive Multiple Sclerosis1 trial

Primary Progressive Multiple Sclerosis (PPMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (PERSEUS)

Completed·Sanofi·Phase 3·NCT04458051·767 enrolled

Adult Subject1 trial

Study of Drug-drug Interaction of the Effects of Gemfibrozil and Rifampicin on SAR442168 in Healthy Adult Subjects

Completed·Sanofi·Phase 1·NCT06064539·30 enrolled

Renal Impairment1 trial

Study to Assess the Plasma Concentration of Tolebrutinib Given as a Tablet to Adult Participants With Renal Impairment Compared to Healthy Participants.

Completed·Sanofi·Phase 1·NCT05282030·22 enrolled

2 more indications

Secondary Progressive Multiple Sclerosis1 trial

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

Completed·Sanofi·Phase 3·NCT04411641·1,131 enrolled

Hepatic Impairment1 trial

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

Completed·Sanofi·Phase 1·NCT05283915·10 enrolled

Details

Drug Info

Related News