Fenebrutinib is an investigational oral CNS-penetrant reversible non-covalent Bruton’s tyrosine kinase inhibitor in late-stage multiple sclerosis development. Phase III results in primary progressive and relapsing MS studies showed positive efficacy signals versus active comparators, with regulatory submissions planned after full Phase III readouts. The therapy remains investigational.
January and March 2026 drug pipeline updates included Phase 3 results, Fast Track designations and Priority Review decisions across multiple disease areas. Mavacamten, teplizumab-mzwv, anifrolumab, AXS-05, gedatolisib and AFTX-201 were among the programs with notable milestones.
Roche Holding AG shares show potential undervaluation despite strong returns, with DCF models suggesting 59% upside. The pharmaceutical giant trades at P/E ratios below fair value estimates while maintaining solid financial performance and dividend growth. Recent pipeline developments and product innovations support long-term growth prospects.
Phase III FENtrepid trial results show investigational BTK inhibitor fenebrutinib met its primary endpoint of non-inferiority to ocrelizumab in primary progressive MS, with a 12% reduction in disability progression risk and strongest effect on upper limb function.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07161258 |
A Pharmacokinetics (PK), Pharmacodynamics (PD), Safety and Tolerability Study of Fenebrutinib in Children and Adolescents With Relapsing Multiple Sclerosis (RMS) |
RECRUITING | PHASE2 |
| NCT05119569 |
A Study to Investigate the Efficacy of Fenebrutinib in Relapsing Multiple Sclerosis (RMS) |
ACTIVE_NOT_RECRUITING | PHASE2 |
| NCT04586023 |
Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Teriflunomide in Relapsing Multiple Sclerosis (RMS) |
ACTIVE_NOT_RECRUITING | PHASE3 |
| NCT04586010 |
A Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Teriflunomide in Relapsing Multiple Sclerosis (RMS) |
ACTIVE_NOT_RECRUITING | PHASE3 |
| NCT04544449 |
A Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Ocrelizumab in Adult Participants With Primary Progressive Multiple Sclerosis |
ACTIVE_NOT_RECRUITING | PHASE3 |
| NCT03596632 |
Study Investigating a Single Oral Dose of Fenebrutinib in Healthy Volunteers |
COMPLETED | PHASE1 |
