On September 1, 2026, local time, Novartis announced positive topline results from the Phase III REMODEL-1 and REMODEL-2 trials of remibrutinib in relapsing multiple sclerosis (RMS).
Remibrutinib is a highly selective, potent oral Bruton's tyrosine kinase (BTK) inhibitor. It demonstrated superiority over teriflunomide in reducing annualized relapse rate (ARR) and inflammatory brain lesions, with a favorable safety profile.
The REMODEL results establish remibrutinib as a BTK inhibitor that achieved significant ARR reduction in both Phase III trials in adult patients with RMS.
Key Efficacy Results: Primary and Secondary Endpoints Met
Both REMODEL-1 and REMODEL-2 met their primary endpoints, showing that remibrutinib significantly reduced ARR in RMS patients compared with teriflunomide.
All key secondary endpoints demonstrated superiority, including reduction in MRI lesions (achieved within each trial).
Clinically meaningful delay in disability progression was observed: in the prespecified pooled analysis of REMODEL-1 and REMODEL-2, 3‑month confirmed disability progression (3mCDP) showed a positive trend, and 6‑month confirmed disability progression (6mCDP) reached nominal significance.
Safety Profile: No Liver Injury Signal, Well Tolerated
The safety profile of remibrutinib in REMODEL-1 and REMODEL-2 was consistent with its overall development program, which includes over 4,500 trial participants across multiple indications.
Remibrutinib was well tolerated and continued to show no signal of liver injury, with no cases meeting Hy’s Law criteria.
About Remibrutinib
Remibrutinib is a highly selective oral BTK inhibitor that blocks the BTK pathway, reducing activation of B cells and innate immune cells, thereby modulating the immune regulatory network and associated neuroinflammation.
The drug is by Novartis and is currently being studied in neuroscience indications (including the REMODEL Phase III trial in RMS and the REMASTER trial in SPMS) as well as other immune‑mediated diseases such as hidradenitis suppurativa and food allergy.
Remibrutinib 25 mg received U.S. FDA approval in September 2025 (brand name Rhapsido) and European EMA approval in April 2026 for the treatment of chronic spontaneous urticaria (CSU) in adults.
Novartis Executive Commentary: Addressing Unmet Need for High‑Efficacy Oral Therapy
Shreeram Aradhye, Global Head of Development and Chief Medical Officer at Novartis, stated:
“Despite advances in treatment, there remains an unmet need in oral therapies — one that combines potent relapse prevention, delayed disability progression, and a strong safety profile.
The positive REMODEL results highlight the potential of remibrutinib as a high‑efficacy oral therapy for RMS patients, with a differentiated benefit‑risk profile.
Building on Novartis’ long‑standing legacy of advancing care in MS, these findings further reinforce our commitment to continued innovation and to delivering new options that address the evolving needs of people living with MS.”
About Multiple Sclerosis
Multiple sclerosis (MS) is a chronic inflammatory disease of the central nervous system, characterized by destruction of myelin and axonal damage in the brain, optic nerves, and spinal cord.
Nearly 3 million people worldwide are affected by MS, which is mainly classified into three types: non‑active secondary progressive MS (SPMS), primary progressive MS (PPMS), and relapsing MS (RMS).
RMS is the most common form, encompassing clinically isolated syndrome (CIS), relapsing‑remitting MS (RRMS), and active SPMS. The different types of MS are distinguished by disease presentation and progression, including whether patients experience relapses, disability worsening over time, or both.
