Novartis Initiates Pivotal Phase III Trial of BTK Inhibitor Remibrutinib for Hidradenitis Suppurativa

▎Armstrong

On February 21, 2025, Novartis registered a Phase III clinical trial on Clinicaltrials.gov for the BTK inhibitor Remibrutinib in treating adults with moderate to severe hidradenitis suppurativa.

This Phase III clinical trial plans to enroll 555 adult patients with moderate to severe hidradenitis suppurativa, with an expected completion in 2028.

Remibrutinib announced positive Phase III results for urticaria last year and is expected to submit an application for market approval in the first half of this year. In terms of expanding indications, Novartis will initiate a pivotal Phase III clinical trial for generalized myasthenia gravis this year, in addition to hidradenitis suppurativa.

Novartis is expected to submit the marketing application for Remibrutinib in treating CINDU in 2026, the marketing application for multiple sclerosis in 2027, and the marketing application for myasthenia gravis after 2028.

Summary

Besides Novartis, Sanofi is also focusing on expanding the application of BTK inhibitors in autoimmune diseases, simultaneously developing two BTK inhibitors. In China, BeiGene's zanubrutinib is advancing to Phase III clinical trials for membranous nephropathy, while InnoCare Pharma’s orelabrutinib is progressing with clinical trials for multiple sclerosis, ITP, lupus, and NMOSD indications in autoimmune conditions.