#tolebrutinib
Tolebrutinib Research Data (New Multiple Sclerosis Drug)
patienttalk.org/tolebrutinib...
December 3, 2024 at 1:58 PM
Tolebrutinib on a fast track towards final FDA approval to treat #SPMS. #MS themswire.com/tolebrutinib...
Tolebrutinib nears the MS approval finish line - The MS Wire
Tolebrutinib is a disease-modifying therapy on the brink of being approved to fight multiple sclerosis. Fingers crossed that it is.
themswire.com
January 16, 2025 at 6:57 PM
Tolebrutinib in Nonrelapsing Secondary Progressive Multiple Sclerosis | New England Journal of Medicine www.nejm.org/doi/full/10....

‘…risk of disability progression was lower among those who received treatment with tolebrutinib than among those who received placebo’
Tolebrutinib in Nonrelapsing Secondary Progressive Multiple Sclerosis | NEJM
Throughout the course of multiple sclerosis, gradually progressive neurologic impairment can occur, which has been called disability accrual. Current disease-modifying therapies for multiple sclero...
www.nejm.org
May 17, 2025 at 3:40 PM
#MSFriday

“Breaking news: tolebrutinib is licensed by the EU for treating non-relapsing SPMS”
April 24, 2026 at 2:29 PM
#MS_Selfie ACTRIMS 2025 Highlights

Tolebrutinib results offer real hope for people with smouldering MS and possibly how to identify high-risk subjects (PRL+) who are more likely to respond to tolebrutinib. =>
ACTRIMS 2025 Highlights
Tolebrutinib results that offer real hope for people with with smouldering MS and possibly how to identify high-risk subjects (PRL+) who are more likely to respond to tolebrutinib.
buff.ly
March 3, 2025 at 3:29 PM
Tolebrutinib, an experimental BTK inhibitor, gets FDA’s Breakthrough designation to treat non-relapsing Secondary Progressive #MS
www.sanofi.com/en/media-roo...
Press Release: Tolebrutinib designated Breakthrough Therapy by the FDA for non-relapsing secondary progressive multiple sclerosis
Tolebrutinib designated Breakthrough Therapy by the FDA for non-relapsing secondary progressive multiple sclerosis Designation is based on positive results from the HERCULES study in adults with...
www.sanofi.com
December 15, 2024 at 1:11 PM
🧠🛡️ Tolebrutinib, MS tedavisinde umut vadediyormuş.

Faz 3 HERCULES çalışmasının sonuçlarına göre, Tolebrutinib engellilik ilerlemesini geciktirerek multipl sklerozun bu formu (SPMS) için ilk potansiyel tedavi olabilir.

Yüzde 31'lik gecikme.

Onay bekliyor.
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newsroom.clevelandclinic.org
April 9, 2025 at 12:47 PM
"FDA pushes back to December its decision on Sanofi’s tolebrutinib," presumably to wait for the results of the PERSEUS trial-tolebrutinib vs. placebo in primary progressive MS) multiplesclerosisnewstoday.com/news-posts/2...
FDA delays decision until December on Sanofi's tolebrutinib for MS
The U.S. Food and Drug Administration is delaying by three months its decision on whether or not to approve tolebrutinib for treating MS.
multiplesclerosisnewstoday.com
September 22, 2025 at 8:49 PM
In a press release, Sanofi announces that tolebrutinib (an oral bruton's tyrosine kinase inhibitor) was not successful in slowing disability progression in primary progressive MS (PERSEUS trial data). They intend to pursue FDA approval for SPMS www.globenewswire.com/news-release...
Press Release : Sanofi provides update on tolebrutinib regulatory submission in non-relapsing secondary progressive multiple sclerosis
Sanofi provides update on tolebrutinib regulatory submission in non-relapsing secondary progressive multiple sclerosis Ongoing discussions with the FDA...
www.globenewswire.com
December 16, 2025 at 5:55 AM
Tolebrutinib is a BTK inhibitor that is being studied for the treatment of relapsing multiple sclerosis. Research findings from the GEMINI 1 and GEMINI 2 trials comparing tolebrutinib with teriflunomide are summarized in a new Quick Take video. nej.md/3S1hY5N

#MedSky #NeuroSky
Tolebrutinib versus Teriflunomide in Multiple Sclerosis | NEJM
Quick Take Video Summary from The New England Journal of Medicine — Tolebrutinib versus Teriflunomide in Multiple Sclerosis
nej.md
May 20, 2025 at 1:03 PM
New press release from Sanofi - tolebrutinib did NOT meet it's primary endpoint in PP-MS trial
www.sanofi.com/en/media-roo...
Press Release: Sanofi provides update on tolebrutinib in primary progressive multiple sclerosis
Sanofi provides update on tolebrutinib in primary progressive multiple sclerosis PERSEUS phase 3 study in primary progressive multiple sclerosis did not meet its primary endpoint in delaying time to....
www.sanofi.com
December 15, 2025 at 6:28 PM
The United Arab Emirates has approved tolebrutinib (a bruton's tyrosine kinase inhibitor) for multiple sclerosis. it is not yet FDA/EMA approved. timesofindia.indiatimes.com/world/middle...
What is Tolebrutinib? The world’s first oral treatment approved in UAE for progressive multiple sclerosis | World News - Times of India
Middle East News: Tolebrutinib, the first oral treatment approved in UAE for progressive multiple sclerosis, targets chronic inflammation that leads to disability progression, transforming MS manageme...
timesofindia.indiatimes.com
August 26, 2025 at 8:18 PM
#MS_Selfie News: good and bad

The tolebrutinib results have now been published. High-dose ocrelizumab in relapsing MS is a no. =>
News: good and bad
The tolebrutinib results have now been published. High-dose ocrelizumab in relapsing MS is a no.
gavingiovannoni.substack.com
April 9, 2025 at 12:57 AM
🙋Ahoj všem!!!
Za RP děkuji!!! ❤️
#roztrousenenoviny 📰

🌍První lék na "tichou progresi" RS schválen. Spojené arabské emiráty jsou první zemí na světě, která schválila tolebrutinib

Více: ⬇️
www.roztrouseni.cz/prvni-lek-na...
První lék na
Spojené arabské emiráty (SAE) se staly první zemí na světě, která schválila experimentální lék tolebrutinib pro léčbu dospělých s nerelabující sekundárně progresivní roztroušenou sklerózou (SPRS). Per...
www.roztrouseni.cz
August 30, 2025 at 5:36 PM
Phase III trial data for #BTKi tolebrutinib in relapsing #multiplesclerosis and non-relapsing SP-MS out now. FDA decision for #tolebrutinib for SP-MS and disability progression more generally (PIRA) expected in September this year

www.nejm.org/doi/full/10....
www.nejm.org/doi/full/10....
Tolebrutinib in Nonrelapsing Secondary Progressive Multiple Sclerosis | NEJM
Throughout the course of multiple sclerosis, gradually progressive neurologic impairment can occur, which has been called disability accrual. Current disease-modifying therapies for multiple sclero...
www.nejm.org
April 8, 2025 at 5:31 PM
A U.S. regulatory decision on tolebrutinib will again be delayed while a late-stage trial of the drug for a different form of the disease didn’t hit its main goal. on.wsj.com/45b0cUr
Sanofi Multiple Sclerosis Drug Hit by Double Setback
A U.S. regulatory decision on tolebrutinib will again be delayed while a late-stage trial of the drug for a different form of the disease didn’t hit its main goal.
on.wsj.com
December 15, 2025 at 6:56 AM
#MS_Selfie Q&A 161: How to make someone with MS eligible for tolebrutinib

Welcome to the farce we call MS clinical practice => buff.ly/rEoAb3z
Q&A 161: how to make someone with MS eligible for tolebrutinib
Welcome to the farce we call MS clinical practice.
gavingiovannoni.substack.com
April 30, 2026 at 3:57 AM
There are currently no approved treatments for nonrelapsing secondary progressive multiple sclerosis. Research findings from the HERCULES trial examining the efficacy and safety of the BTK inhibitor tolebrutinib are summarized in a new Quick Take video. nej.md/4kj1QIH

#MedSky #NeuroSky
May 28, 2025 at 1:05 PM
I've just heard from my MS consultant that the class of drugs I am taking to treat my Lymphoma may help aspects of MS.

The link to the MS Society's summary is below

www.mssociety.org.uk/research/lat...

#MS #MultipleSclerosis
HERCULES trial shows tolebrutinib slows progression in non-active secondary progressive MS
For the first time, a phase 3 trial has shown a drug can slow down disability progression in people with secondary progressive MS who don’t have relapses. In two other phase 3 trials, tolebrutinib als...
www.mssociety.org.uk
February 19, 2025 at 4:47 PM
Potential mechanisms of action of Bruton's Tyrosine Kinase Inhibitors (i.e. tolebrutinib, fenebrutinib, evobrutinib) in Multiple Sclerosis pubmed.ncbi.nlm.nih.gov/42126690/
May 13, 2026 at 7:41 PM
Hello #MS folks

I’m happy to see so many familiar faces!

I’m an Army vet w/ MS since my 20s (now 60) nonactive SPMS

Participated in ATA188 and Tolebrutinib trials-both a bust for me

My husband died from Alzheimer’s in March and I had COVID in Sep so it’s been a terrible year even w/o politics!
November 18, 2024 at 8:13 PM
The FDA explains its rejection of the multiple sclerosis drug tolebrutinib in a Complete Response Letter (CRL). "A favorable benefit-risk profile could not be established for any patient subpopulation" download.open.fda.gov/crl/CRL_NDA2...
download.open.fda.gov
January 6, 2026 at 9:03 PM
For første gang nogensinde kan personer med ikke-aktiv sekundær progressiv sclerose se frem til behandling med medicin, som har vist sig at have en betydelig effekt på sygdomsudviklingen. Præparatet, der hedder tolebrutinib, kan være på markedet i 2026, vurderer professor Finn Sellebjerg. #sundpol
Hvad er tolebrutinib? | Scleroseforeningen
For første gang nogensinde kan personer med ikke-aktiv sekundær progressiv sclerose se frem til behandling med medicin, som har vist sig at have en betydelig effekt på sygdomsudviklingen. Præparatet, ...
www.scleroseforeningen.dk
April 4, 2025 at 11:03 AM