1. Scrip
  2. >>R&D
  3. >>Clinical Trials

Sanofi’s HERCULES Data In MS May Offer Path To Approval For Tolebrutinib

 
• By Joseph Haas

Delaying disease progression in non-relapsing secondary multiple sclerosis may get the BTK inhibitor approved, despite previous pivotal trial failures in relapsing MS.

Man with Multiple Sclerosis standing in his accessible kitchen with a cane
Sanofi's drug may address progressing disability related to MS • Source: Alamy

Sanofi likely bolstered the chances of its multiple sclerosis candidate tolebrutinib finding a treatment niche on 20 September as it reported data from the Phase III HERCULES study showing that the BTK inhibitor can delay disability progression in non-relapsing secondary progressive MS (nrSPMS) while demonstrating what one analyst called a manageable liver safety profile.

Key Takeaways

  • Sanofi’s BTK inhibitor tolebrutinib may offer a delay in confirmed disability in a subset of MS patients, new data from a Phase III study shows.

The data, presented at the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) conference in Copenhagen, came roughly...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Clinical Trials

2025’s Biggest Launches – Half-Year Progress Report

 
• By Andrew McConaghie

Trial setbacks and extra regulatory scrutiny have hit the progress of some new drugs towards expected approvals this year, but early successes have boosted the commercial prospects of others. Fears of disruption from changes at the US FDA are so far unfounded.

Will AstraZeneca Reach Summit And Be A PD-1xVEGF Player?

 
• By Kevin Grogan

Rumor mill suggests a $15bn licensing deal for ivonescimab is in the offing.

Compass Pathways’ Antidepressant Advances In An Increasingly Tough Psychedelic Market

 
• By Manas Mishra

Psychedelics appear to be in vogue after years of being relegated to alternative medicine. But investor pushback after the highly anticipated release of Phase III trial data by Compass Pathways reveals an increasingly high bar for development.

BioMarin’s Roctavian Continues to Shine In Hemophilia A Despite Commercial Woes

 
• By Sushmita Panda

Roctavian shows durable bleed control and safety over five years, but high costs and access hurdles limit its commercial outlook.

More from R&D

BioMarin’s Roctavian Continues to Shine In Hemophilia A Despite Commercial Woes

 
• By Sushmita Panda

Roctavian shows durable bleed control and safety over five years, but high costs and access hurdles limit its commercial outlook.

Dizal’s Zegfrovy Wins US NSCLC Approval, At Lower Dose Than In China

 
• By Dexter Jie Yan

Dizal's EGFR inhibitor Zegfrovy approved in US as new once-daily oral option for second-line NSCLC with EGFR exon 20 insertion mutations, at lower dose than in China.

Novartis’s Cosentyx Suffers Rare Phase III Fail

 
• By Kevin Grogan

Multi-blockbuster falls short in a giant cell arteritis study.