Tolebrutinib

Pipeline

Status by Indication[3][1]

Competition

Competitive Landscape

Multiple SclerosisRelapsing Multiple Sclerosis

145 competitors in Multiple Sclerosis

#DrugCompanyPhaseTrials

1

Versed

CConrado Roberto Hoffmann Filho

Phase 3

22

Questran

KKaruna Therapeutics, Inc., a Bristol Myers Squibb company

Phase 3

23

Zyrtec

KKenvue Brands

Phase 3

14

Activated Charcoal

Sanofi

Phase 3

15

Mayzent

Novartis

Phase 3

16

Antihistamine

Arrowhead Pharmaceuticals

Phase 3

27

Recombinant Zoster Vaccine

MMAXVAX Biotechnology Limited Liability Company

Phase 3

18

MRI Contrast-Enhancing Agents

Sanofi

Phase 3

39

Tolebrutinib

Sanofi

Phase 3

410

IMU-838

IImmunic AG

Phase 3

4Show 25 more competitors

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

Timeline

Expected Milestones

Clinical

Trials by Indication[1]

Multiple Sclerosis4 trials

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

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

Show 1 more trial

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

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

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

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

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

3 more indications

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

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

Relapsing Multiple Sclerosis1 trial

An Interventional, Phase 3 Extension Study to Investigate Long-term Safety and Tolerability of Tolebrutinib in Participants With Relapsing Multiple Sclerosis, Primary Progressive Multiple Sclerosis, or Nonrelapsing Secondary Progressive Multiple Sclerosis

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

Details

Drug Info

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