Fenebrutinib

Phase 3Small molecule

Fenebrutinib is one of 47 small molecule programs targeting Primary Progressive Multiple Sclerosis. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

Primary Progressive Multiple SclerosisActive, not recruiting

Multiple SclerosisActive, not recruiting

Relapsing Multiple SclerosisActive, not recruiting

Multiple Sclerosis, Primary ProgressiveActive, not recruiting

Primary Progressive Multiple SclerosisPhase 3

Active, not recruiting

Multiple SclerosisPhase 2

Active, not recruiting

Relapsing Multiple SclerosisPhase 3

Active, not recruiting

Multiple Sclerosis, Primary ProgressivePhase 3

Active, not recruiting

Competition

Competitive Landscape

560 competitors in Multiple Sclerosis

#DrugCompanyPhaseTrials

Fenebrutinib

Roche

Phase 3

2 2

Betaseron

Bayer

Preclinical

16 3

Kesimpta

Novartis

Preclinical

15 4

Tysabri

Biogen

Preclinical

14 5

Avonex

EMD Serono

Preclinical

22 6

Campath

GGenzyme, a Sanofi Company

Preclinical

12 7

Flomax

Sanofi

Preclinical

1 8

Pred Forte

Novantrone

Circadin

NNeurim Pharmaceuticals Ltd.

Preclinical

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

Timeline

Expected Milestones

Q4 2026

Phase 2Active, not recruiting

Multiple Sclerosis

NCT05119569

Q3 2027

Phase 3Active, not recruiting

Relapsing Multiple Sclerosis

NCT04586023

Phase 3Active, not recruiting

Multiple Sclerosis, Primary Progressive

NCT04544449

Q4 2027

Phase 3Active, not recruiting

Multiple Sclerosis

NCT04586010

Q1 2029

Phase 2Recruiting

Relapsing Multiple Sclerosis

NCT07161258

Clinical

Trials by Indication[1]

Multiple Sclerosis2 trials

A Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Teriflunomide in Relapsing Multiple Sclerosis (RMS)

Active, not recruiting· Roche logo

Roche·Phase 3·NCT04586010·746 enrolled

A Study to Investigate the Efficacy of Fenebrutinib in Relapsing Multiple Sclerosis (RMS)

Active, not recruiting· Roche logo

Roche·Phase 2·NCT05119569·109 enrolled

Relapsing Multiple Sclerosis2 trials

An Open-label, Single-arm Study to Evaluate Pharmacokinetics, Pharmacodynamic Effects, Safety and Tolerability of Fenebrutinib in Children and Adolescents With Relapsing Multiple Sclerosis

Recruiting· Roche logo

Roche·Phase 2·NCT07161258·12 enrolled

A Phase III Multicenter Randomized, Double-blind, Double-dummy, Parallel-group Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Teriflunomide in Adult Patients With Relapsing Multiple Sclerosis

Active, not recruiting· Roche logo

Roche·Phase 3·NCT04586023·751 enrolled

Oral1 trial

Study Investigating a Single Oral Dose of Fenebrutinib in Healthy Volunteers

Completed· Roche logo

Roche·Phase 1·NCT03596632·8 enrolled

Multiple Sclerosis, Primary Progressive1 trial

A Phase III Multicenter, Randomized, Double-Blind, Double-Dummy, Parallel-Group Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Ocrelizumab in Adult Patients With Primary Progressive Multiple Sclerosis.

Active, not recruiting· Roche logo

Roche·Phase 3·NCT04544449·985 enrolled

Sources

References

[1]
ClinicalTrials.gov — 6 trial records for Fenebrutinib. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Fenebrutinib compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Fenebrutinib. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Roche company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: Roche

Fenebrutinib

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q3 2027

Q4 2027

Q1 2029

Trials by Indication[1]

Multiple Sclerosis2 trials

Relapsing Multiple Sclerosis2 trials

Oral1 trial

Multiple Sclerosis, Primary Progressive1 trial

References

Drug Info

Quick Facts

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