Fenebrutinibe
Roche
BTK inhibitor
Cut relapses by 51% and 58% vs teriflunomide and matched ocrelizumab in primary progressive MS. FDA priority review.
Accepted: Sep 2026
Autoimmune · brain and spinal cord
Multiple Sclerosis
There are many drugs to reduce relapses, but little for progressive MS. The big bet now is BTK inhibitors, pills that act inside the nervous system.
- Cure
- None yet
- Current treatment
- Over 20 drugs that reduce relapses
- Who has it
- About 2.8 million people worldwide
- Updated
6candidates on the board
Filed for approvalfurthest phase
2updates in 2026
What changed
The latest developments, newest first.
ProgressNasal foralumab reduces microglial activation in progressive MS
Phase 2a study with 19 patients with non-active secondary progressive MS. At the 50 mcg dose, nasal foralumab reduced microglial activation on PET versus placebo. Preliminary result, reported by the company.
ProgressFDA accepts fenebrutinib filing
First BTK inhibitor filed for both relapsing and primary progressive MS, under priority review.
StoppedFDA declines tolebrutinib
Sanofi is still talking to the agency and awaits other regulators.
Treatments in development
Each column is a step on the road to the pharmacy. Colors show the type of treatment.
- Antibody or biologic (2)
- Oral drug (3)
- Cell, gene or RNA therapy (1)
Filed for approvalagency review · 2
Tolebrutinibe
Sanofi
BTK inhibitor
Delayed progression by 31% in secondary progressive MS, but the FDA declined it in Dec 2025. Awaiting Europe.
Declined in the US
Phase 3confirmation · 2
Remibrutinibe
Novartis
BTK inhibitor
In phase 3 for relapsing MS vs teriflunomide.
In phase 3
Frexalimabe
Sanofi
Anti-CD40L antibody
Phase 3 trials in relapsing and progressive MS.
In phase 3
Phase 2efficacy and dose · 1
Foralumabe nasal (Tiziana)
✓ Phase 2 complete
Tiziana Life Sciences
Nasal anti-CD3 antibody targeting microglia
Phase 2a, 19 patients. 50 mcg dose reduced microglial activation on PET vs placebo. Preliminary data, released by the company.
Next steps with FDA
Phase 1safety · 1
CAR-T anti-CD19
Kyverna e outros
Engineered T cells
Tested in treatment-resistant progressive MS. Small studies.
Early studies
Left behind
Candidates that looked promising and were stopped. Most treatments tested never reach the market.
Evobrutinibe
2023 · Merck KGaA's BTK inhibitor; phase 3 trials did not beat teriflunomide.
Frequently asked questions
Is there a cure for Multiple Sclerosis?
None yet. Current treatment: Over 20 drugs that reduce relapses.
Which Multiple Sclerosis treatments are being tested?
Fasevia tracks 6 candidates: Fenebrutinibe (Filed for approval); Tolebrutinibe (Filed for approval); Remibrutinibe (Phase 3); Frexalimabe (Phase 3); Foralumabe nasal (Tiziana) (Phase 2 complete); CAR-T anti-CD19 (Phase 1).
What is the most advanced Multiple Sclerosis treatment in development?
The furthest along today is Fenebrutinibe (Roche), in filed for approval. Cut relapses by 51% and 58% vs teriflunomide and matched ocrelizumab in primary progressive MS. FDA priority review.
When could a new Multiple Sclerosis treatment arrive?
A drug has to complete phase 3 and be reviewed by health agencies such as the FDA or EMA, which usually takes several years. The leading candidate today is in filed for approval.