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The FDA is expected to decide on Fenebrutinib for Relapsing and primary progressive multiple sclerosis in an undisclosed window, under an NDA from Genentech (Roche).
What the FDA is deciding on Fenebrutinib for Multiple Sclerosis
The FDA is reviewing Genentech (Roche)'s application to approve Fenebrutinib for relapsing and primary progressive multiple sclerosis.
An oral BTK inhibitor, a pill that blocks an enzyme in B cells and the brain's immune cells, under Priority Review for both relapsing MS and primary progressive MS. In the Phase 3 FENhance 1 and 2 trials it cut the yearly relapse rate by 51.1% and 58.5% compared with teriflunomide over 96 weeks.
In the Phase 3 FENtrepid trial in primary progressive MS it met its main goal of not being worse than Ocrevus at slowing disability progression. Roche reported liver enzyme rises more often with fenebrutinib than with Ocrevus in FENtrepid. Roche announced the acceptance on September 30, 2026 but has not disclosed a target action date.
Who the Fenebrutinib decision matters to
Multiple sclerosis is a chronic autoimmune disease where the immune system attacks the protective myelin sheath surrounding nerve fibers in the brain and spinal cord. This disrupts communication between the brain and body, causing a wide range of neurological symptoms.
MS follows several distinct clinical courses, including relapsing-remitting, secondary progressive, and primary progressive forms. While not curable, more than 20 FDA-approved disease-modifying therapies can significantly slow progression, and an active research pipeline is pursuing remyelination, neuroprotection, and novel approaches targeting the underlying causes of the disease.
Prevalence: Approximately 1 million people in the U.S.; about 1 in 300. Worldwide, an estimated 2.8 million people live with MS. See our full Multiple Sclerosis page for current treatments, recruiting trials, and community resources.
How Fenebrutinib works
Fenebrutinib: reversible, non-covalent BTK inhibitor with CNS penetration and high selectivity (130-fold over other kinases), targeting B cells and microglia. Our full Fenebrutinib profile covers how it works, side effects in plain language, and its trial history.
What an approval or a rejection of Fenebrutinib would mean
An approval starts a second race rather than ending the first one: specialty pharmacy setup, insurance review, and patient assistance typically take weeks even when everything goes right. Our guide to the 90 days after a rare disease approval explains the timeline and the moves families can make on day 1.
A complete response letter would mean the FDA declined to approve in the application's current form. The letter describes what the FDA wants addressed, and the company then decides whether to resubmit, run more studies or stop. Either way, this page updates with the outcome and what it means.
Where Multiple Sclerosis treatment stands today
Read our full Multiple Sclerosis treatment summary
Multiple sclerosis research remains among the most active areas in neurology, with trials spanning every disease subtype and stage. BTK inhibitors are the most closely watched drug class in the current pipeline.
Genentech/Roche's fenebrutinib reported positive Phase 3 results between November 2025 and March 2026, becoming the first BTK inhibitor to show benefit in both relapsing MS and primary progressive MS.
In the relapsing MS trials FENhance 1 and 2, fenebrutinib reduced the annualized relapse rate by 51% and 59% compared with teriflunomide over at least 96 weeks. In FENtrepid, fenebrutinib was non-inferior to ocrelizumab on confirmed disability progression in PPMS over at least 120 weeks.
The PPMS result is the first major pipeline advance for that subtype since ocrelizumab's 2017 approval.
On September 30, 2026 the FDA accepted Roche's application under priority review for both relapsing and primary progressive MS; Roche has not announced a decision date. More deaths occurred on fenebrutinib than on the comparison drugs, 7 versus 1 in the relapsing trials, and Roche says they happened at different times and had varied causes.
Novartis's remibrutinib met its main goal in both Phase 3 trials (REMODEL-1 and REMODEL-2), reducing relapses compared with teriflunomide, Novartis announced on September 1, 2026. Novartis plans to present the full results at the joint ECTRIMS-ACTRIMS meeting in Toronto in October 2026.
Sanofi's tolebrutinib received a Complete Response Letter from the FDA dated December 23, 2025 for non-relapsing secondary progressive MS.
The FDA cited the risk of severe drug-induced liver injury (6 Hy's Law cases across the 2,700-patient Phase 3 program, including one patient who needed a liver transplant and later died) and said a favorable benefit-risk profile could not be established.
The European Commission approved the same drug as Cenrifki on June 23, 2026 for secondary progressive MS without relapses in the last 2 years, so it is available in Europe but not in the United States. Sanofi's separate PERSEUS Phase 3 study of tolebrutinib in primary progressive MS did not meet its primary endpoint in December 2025, and a PPMS regulatory submission is no longer expected.
Remyelination therapies represent another major frontier.
The CCMR-Two Phase 2a trial, presented at ECTRIMS 2025, showed that a combination of metformin and clemastine produced a statistically significant reduction in visual evoked potential latency, a biomarker of remyelination, in 70 relapsing-remitting MS patients already on a stable disease-modifying therapy.
The difference was 1.2 milliseconds, which the investigators called smaller than expected, and the 6-month treatment window showed no improvement in disability or visual function. Longer studies are planned.
Neuroprotective agents like PIPE-307 and PIPE-791 targeting CNS receptor pathways are also in clinical testing. EBV-targeted therapies are an emerging and potentially transformative approach, supported by the 2022 Bjornevik et al.
Science study showing EBV infection increases MS risk roughly 32-fold in a 10-million-person U.S. military cohort. Trials are now exploring antivirals and vaccines aimed at the virus now considered a necessary trigger for MS. Autologous hematopoietic stem cell transplantation (AHSCT) continues to show durable results in aggressive relapsing MS.
Whether you have relapsing-remitting, secondary progressive, primary progressive, or treatment-resistant MS, there are active trials addressing your specific disease pattern. The National MS Society maintains a research portal and can help connect patients with appropriate studies.
The Multiple Sclerosis page has every treatment and trial →Meanwhile, 533 Multiple Sclerosis studies are open or about to open
Whatever the FDA decides here, research on Multiple Sclerosis does not stop. The most recently updated:
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Frequently asked questions
When will the FDA decide on Fenebrutinib?
Genentech (Roche) has not disclosed a decision date.
Who disclosed it: Genentech (Roche). The FDA does not publish these dates.
Can it move: the FDA can act early, and a major amendment to the application can push the date back 3 months.
What is Fenebrutinib being reviewed for?
Genentech (Roche) submitted an NDA for Fenebrutinib in Relapsing and primary progressive multiple sclerosis.
What to know: An oral BTK inhibitor, a pill that blocks an enzyme in B cells and the brain's immune cells, under Priority Review for both relapsing MS and primary progressive MS. In the Phase 3 FENhance 1 and 2 trials it cut the yearly relapse rate by 51.1% and 58.5% compared with teriflunomide over 96 weeks. In the Phase 3 FENtrepid trial in primary progressive MS it met its main goal of not being worse than Ocrevus at slowing disability progression. Roche reported liver enzyme rises more often with fenebrutinib than with Ocrevus in FENtrepid. Roche announced the acceptance on September 30, 2026 but has not disclosed a target action date.
How it works: Reversible, non-covalent BTK inhibitor with CNS penetration and high selectivity (130-fold over other kinases), targeting B cells and microglia.
More: the Fenebrutinib drug page explains it in plain language.
Is there already an FDA-approved treatment for Multiple Sclerosis?
Yes. Trial Friend's drug list includes 10 FDA-approved drugs for Multiple Sclerosis.
Approved: Copaxone (glatiramer acetate), Tysabri (natalizumab), Gilenya (fingolimod), Aubagio (teriflunomide), Tecfidera (dimethyl fumarate), Ocrevus (ocrelizumab), Mayzent (siponimod), Zeposia (ozanimod), Kesimpta (ofatumumab), Briumvi (ublituximab).
Also coming: Tolebrutinib, Frexalimab.
Check: the Multiple Sclerosis page also searches FDA drug labels for approved treatments.
What did the Fenebrutinib trials show?
In the Phase 3 FENhance 1 and 2 trials, fenebrutinib reduced the yearly relapse rate by 51.1% and 58.5% versus teriflunomide over at least 96 weeks. In the Phase 3 FENtrepid trial in primary progressive MS, fenebrutinib was non-inferior to ocrelizumab on confirmed disability progression over at least 120 weeks; the 12% lower risk it showed over the whole trial was not statistically significant.
More: the Fenebrutinib drug page has the full trial history and sources.
What are the side effects of Fenebrutinib?
In FENtrepid, the most common side effects were infections (67.0% vs 70.9% on ocrelizumab), nausea (12.0% vs 7.1%) and bleeding. In Phase 3 trials, liver enzyme elevations were more frequent than with ocrelizumab in FENtrepid (13.3% vs 2.9%) but similar to teriflunomide in FENhance 1 and 2, bleeding events were slightly more common (10.2% vs 8.1% in FENtrepid), and more deaths occurred on fenebrutinib, from varied causes (1.4% vs 0.2% in FENtrepid, and 7 vs 1 in FENhance 1 and 2 during the reporting period, with 1 more fenebrutinib death after it).
More: the Fenebrutinib drug page lists the warnings in full.
Can I get Fenebrutinib before the FDA decides?
Usually only through a clinical trial or an expanded access program, and the company decides whether to offer one.
Trials: 533 Multiple Sclerosis studies are open or about to open. See them.
Check your fit: Match Me compares your details with every open trial.
Expanded access: your doctor can ask Genentech (Roche) directly. Registered programs are listed on ClinicalTrials.gov.
How much will Fenebrutinib cost?
Genentech (Roche) has not announced a price. Drugmakers usually set it around approval.
Help paying: drugmaker programs and charity funds usually open at launch.
Find help: the patient assistance finder lists programs by insurance type.
What happens after the Fenebrutinib decision?
This page updates with the outcome the day it is announced.
If approved: getting the drug still takes time. Specialty pharmacy setup, insurance review and patient assistance often take weeks. Our guide covers what families can do on day 1.
If not approved: a complete response letter means the FDA declined the application in its current form. Many are about manufacturing or how data were presented, and companies often resubmit.
Where this date comes from
The FDA does not publish PDUFA dates; companies disclose them. This one comes from Roche press release, September 30, 2026. Dates can move, and the FDA can act early or late. This page rechecks against our calendar, which is re-verified daily.