Novartis has reported positive results from two phase 3 clinical trials evaluating Rhapsido (remibrutinib) in relapsing multiple sclerosis (MS), with the studies meeting their primary endpoint and showing no liver safety signals.
The twin phase 3 trials, Remodel-1 and Remodel-2, compared Rhapsido with Sanofi’s Aubagio (teriflunomide). According to Novartis, the oral BTK inhibitor reduced annualized relapse rates more effectively than Aubagio, achieving the main objective of both studies.
In addition to relapse reduction, Rhapsido improved measures of inflammatory brain lesions. The company also reported reductions in secondary endpoints related to disability progression. A positive trend was observed in three-month confirmed disability progression, while a preplanned combined analysis of the two identical trials reached nominal significance at six months.
Nearly 2,000 patients participated in the studies and were randomly assigned in a 1:1 ratio to receive either Rhapsido or Aubagio.
Safety Findings Address Long-Standing Concerns Around BTK Inhibitors
A key outcome of the trials was the absence of liver safety concerns, an issue that has affected several other BTK inhibitors under development for multiple sclerosis.
Novartis stated that Rhapsido was well tolerated and that the studies identified no liver safety signal. The company reported that there were no cases meeting Hy’s Law criteria, a standard used to identify patients at high risk of severe drug-induced liver injury.
A Novartis spokesperson also confirmed that no treatment-related deaths were reported in either Remodel trial.
The findings are notable because liver toxicity has been a recurring challenge for the BTK inhibitor class. Previous liver-related concerns led to regulatory actions involving competing programs from Sanofi and Roche.
Comparison With Other BTK Inhibitor Programs
The FDA previously rejected Sanofi’s tolebrutinib. In its complete response letter, the agency cited concerns about severe drug-induced liver injury, including six cases that met Hy’s Law criteria during clinical testing.
Roche’s fenebrutinib also faced scrutiny after an FDA partial clinical hold in 2023 following reports of elevated liver enzymes in two patients. More recently, Roche reported one Hy’s Law case involving fenebrutinib and another involving Aubagio in the phase 3 FENhance1 study in relapsing MS.
During an investor call in January, Roche pharmaceutical chief Teresa Graham said, “It’s also really important to note that since we put liver monitoring in place in the clinical trials, we have not seen any more cases.”
In the FENhance1 and FENhance2 trials, investigators reported eight deaths among patients receiving fenebrutinib, including two considered related to the drug. One death occurred among patients receiving Aubagio.
Regulatory Plans and Broader Development Program
Novartis plans to pursue regulatory approvals for Rhapsido in relapsing MS worldwide. Detailed findings from the Remodel studies are scheduled to be presented at MSToronto2026 in October.
The drug received its first FDA approval in September 2025 for chronic spontaneous urticaria, commonly known as chronic hives.
Beyond relapsing MS, Novartis is evaluating Rhapsido in additional forms of multiple sclerosis and several immune-mediated diseases. The company recently reported positive pivotal results in chronic inducible urticaria, initiated a phase 3 study in food allergy after encouraging mid-stage results, and continues a separate phase 3 program in hidradenitis suppurativa.
The phase 3 announcement follows Novartis’ recent decision to pause development of its investigational autoimmune CAR-T therapy, rapcabtagene autoleucel, after three deaths linked to serious immune-related adverse reactions were reported across clinical studies, including a phase 1/2 trial involving patients with relapsing MS.
Novartis has reported positive topline results from two Phase 3 trials evaluating Rhapsido (remibrutinib) in adults with relapsing multiple sclerosis (RMS). The REMODEL-1 and REMODEL-2 studies met their primary endpoints, strengthening Novartis’ plans to pursue regulatory approvals for the medicine in MS.
Novartis Rhapsido Meets Primary Endpoints
Novartis said Rhapsido significantly reduced annualized relapse rates compared with teriflunomide, an established treatment for relapsing MS. The trials also showed superiority on key secondary endpoints, including reductions in inflammatory brain lesions detected through MRI.
For Novartis, the results provide important evidence that remibrutinib could become a significant oral treatment option for people living with relapsing multiple sclerosis.
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