tolebrutinib

After months of delay, the U.S. Food and Drug Administration (FDA) has rejected Sanofi‘s application seeking approval of tolebrutinib for the treatment of adults with nonrelapsing secondary progressive multiple sclerosis (MS). While Sanofi announced earlier this month that the decision was likely to be delayed again…

Following negative Phase 3 trial results, Sanofi announced that it will not be pursuing approval of its experimental therapy tolebrutinib for primary progressive multiple sclerosis (PPMS). Meanwhile, a decision from the U.S. Food and Drug Administration (FDA) on tolebrutinib’s use in nonrelapsing secondary progressive MS (SPMS) is likely…

Note: This story was updated Sept. 23, 2025, to correct the generic name of Aubagio from tolebrutinib to teriflunomide. The U.S. Food and Drug Administration (FDA) has delayed by three months its decision on whether or not to approve Sanofi’s tolebrutinib as a treatment for multiple sclerosis (MS),…

The United Arab Emirates became the first country to approve tolebrutinib, clearing it to treat adults with nonrelapsing secondary progressive multiple sclerosis (SPMS). Sanofi’s oral BTK inhibitor is also the first approved therapy that directly addresses the chronic inflammation that contributes to disability progression independent of relapses. “The…

Sanofi‘s oral BTK inhibitor tolebrutinib significantly delayed the onset of six-month confirmed disability progression compared with a placebo, by 31%, in people with nonrelapsing secondary progressive multiple sclerosis (SPMS). That’s according to recently published data from the HERCULES Phase 3 trial (NCT04411641), where the experimental therapy…

Note: This story was updated April 4, 2025, to clarify the specific disability measures and that tolebrutinib is believed to target smoldering neuroinflammation. The U.S. Food and Drug Administration (FDA) has granted priority review to an application from Sanofi seeking the approval of its BTK inhibitor…

Note: This story was updated March 6, 2025, to clarify the specific disability measures and results assessed in each trial. Sanofi’s experimental BTK inhibitor tolebrutinib may be more effective at reducing the risk of disability accumulation in people with multiple sclerosis (MS) who have evidence of paramagnetic…

The U.S. Food and Drug Administration (FDA) has granted breakthrough therapy designation to Sanofi’s BTK inhibitor candidate tolebrutinib for the treatment of adults with nonrelapsing secondary progressive multiple sclerosis (SPMS). According to Sanofi, tolebrutinib is the first investigational BTK inhibitor with the ability to reach the brain…

Sanofi’s tolebrutinib significantly delayed disability progression, by 31%, and increased the rates of disability improvement compared with a placebo in people with nonrelapsing secondary progressive multiple sclerosis (SPMS), according to new data from the HERCULES Phase 3 clinical trial. The investigational BTK inhibitor also was found to significantly…

Treatment with the investigational BTK inhibitor tolebrutinib significantly delayed the onset of confirmed disability progression in people with nonrelapsing secondary progressive multiple sclerosis (SPMS) compared with a placebo, meeting the primary goal of the HERCULES Phase 3 trial. A preliminary analysis of liver safety was consistent with previous…

Nearly one year of treatment with tolebrutinib, an oral small molecule being developed by Sanofi, failed to eliminate iron rim lesions in adults with multiple sclerosis (MS), according to data from a small Phase 2 clinical trial. Researchers are continuing to examine study results to determine…

Treatment with tolebrutinib for up to nearly three years was tied to low relapse rates, stable disability, and few new brain lesions among people with relapsing forms of multiple sclerosis (MS), according to new data from the long-term safety (LTS) extension of a Phase 2b trial. The data…

About 2.5 years of treatment with tolebrutinib was associated with low relapse rates and stable disability levels among people with relapsing forms of multiple sclerosis (MS), according to data in an ongoing, open-label extension of a Phase 2b trial. The oral treatment also continued to show a “favorable”…

The U.S. Food and Drug Administration (FDA) has placed a partial clinical hold on Phase 3 trials testing the investigational therapy tolebrutinib in people with multiple sclerosis (MS) and myasthenia gravis based on reports of medication-induced liver injury. Under the clinical hold, new enrollment at U.S. sites…

PoNS Device for MS-associated Gait Problems Now Available in US One clinical trial showed that MS patients who used the portable neuromodulation stimulator (PoNS) device as part of an exercise program had greater improvements in gait than those using only the exercise program. A second trial showed that those…

Long-term treatment with tolebrutinib significantly reduced signs of disease-related brain damage in people with relapsing multiple sclerosis (MS), according to new data from a Phase 2 clinical trial and its extension study. Specifically, the investigational oral therapy was found to keep the number of inflamed brain lesions…

The National Medical Products Administration (NMPA) of China has agreed to approve a Phase 2 trial testing the safety and efficacy of the investigational therapy SN1011 in people with multiple sclerosis (MS). SN1011 is being developed by SinoMab Bioscience to treat a range of autoimmune and inflammatory…

#ACTRIMS2022 – Cognitive Training Paired With tDCS Aids Patients A treatment to clear “cog fog” would be welcomed by many people with MS. Over 75% of us are troubled by cognitive problems. In this study, adding painless transcranial direct current stimulation to standard cognitive training improved results when compared…

Tolebrutinib, an investigative inhibitor of Bruton’s tyrosine kinase (BTK) being developed by Sanofi to treat all forms of multiple sclerosis (MS), shows the potential to be more potent than other BTK inhibitors also in advanced clinical trials, scientists reported. The findings, based on preclinical data, were shared at the Americas…

Nerve Repair Therapy NVG-291 Safe, Well-tolerated in Healthy People This experimental therapy has a long way to go before it becomes reality. But it’s encouraging that this first step found NVG-291’s side effects to be mild and short-lasting. NVG-291 is designed to promote remyelination by modulating an enzyme called…

Sanofi Genzyme has extended its collaboration with Koneksa to bring digital measures into its Phase 3 trials of tolebrutinib, an investigational therapy for relapsing and progressive forms of multiple sclerosis (MS). Through this joint effort, Koneksa’s digital biomarkers were applied to clinical trials of Parkinson’s…

Ocrevus (ocrelizumab) continues to be the most commonly prescribed therapy for progressive forms of multiple sclerosis (MS), including primary progressive MS (PPMS) and secondary progressive MS (SPMS), according to an analysis from the market intelligence firm Spherix Global Insights. However, other therapies are “gaining traction” among…

Is orelabrutinib one of the next big MS therapies? Biogen is betting at least $125 million that it is. Orelabrutinib is an experimental oral BTK inhibitor (BTKi). BTKi’s are designed to selectively block an enzyme that’s important for the activation of B-cells and microglia. Some of those immune cells…

Sanofi Genzyme has launched a website to help connect people with multiple sclerosis (MS) to one of the company’s four ongoing clinical trials testing its investigational therapy tolebrutinib. Interested men and women may qualify for a clinical trial if they are…

Stem Cell Therapy Shows 2-year Benefit for Progressive MS Patients in Phase 1 Trial Stem cell studies always catch my eye. This very small study involves people treated with their own bone marrow, which was collected and expanded to give it the ability to modulate the MS immune response…

Investigators are looking for people with progressive forms of multiple sclerosis (MS) to participate in two Phase 3 clinical trials assessing the safety and effectiveness of tolebrutinib (SAR442168), an oral BTK inhibitor that is being investigated as a potential treatment, the National Multiple Sclerosis Society announced…

Two global Phase 3 clinical trials, both comparing Sanofi Genzyme’s investigational tolebrutinib with its approved therapy Aubagio, are enrolling a total of 1,800 people with relapsing multiple sclerosis (MS), the company said. All patients in both studies — dubbed GEMINI 1 and GEMINI 2 — will…

Tolebrutinib (SAR442168), an investigational oral BTK inhibitor to treat relapsing forms of multiple sclerosis (MS), was seen to prevent the loss of myelin when given to a mouse model of demyelination in a preclinical study. The investigative therapy achieves this by preventing…