Less than six months after its inaugural approval, Novartis’ oral BTK inhibitor Rhapsido (remibrutinib) is positioning itself to become the first targeted therapy for chronic inducible urticaria (CIndU).
Impressive clinical trial results In a press release on February 18, Novartis revealed that its Phase 3 Remin trial met its primary endpoints. The study enrolled 364 adults with the three most prevalent types of CIndU who were inadequately controlled by H1-antihistamines:
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Symptomatic dermographism: Hives triggered by friction or light scratching.
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Cold urticaria.
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Cholinergic urticaria: Often triggered by heat or sweating.
The data showed that Rhapsido helped patients achieve “significantly higher complete response rates” compared to placebo after 12 weeks of treatment. The drug also demonstrated benefits across secondary measures, including itch improvement and hive severity.
Filling a major treatment gap Unlike chronic spontaneous urticaria (CSU), which has established treatments like Xolair or Dupixent, there are currently no approved targeted therapies for the inducible form (CIndU). This condition affects an estimated 29 million people worldwide, where hives and swelling are triggered by specific factors such as pressure, sunlight, friction, or water.
Novartis has officially submitted a filing with the FDA for an approval decision in symptomatic dermographism—the most common form of CIndU. If successful, Rhapsido would be the first targeted oral therapy (rather than an injectable) to address both spontaneous and inducible forms of chronic urticaria.
Future expansion Beyond urticaria, Novartis is also developing remibrutinib for other conditions, including myasthenia gravis and multiple sclerosis (MS). A Phase 3 readout for relapsing MS is expected in the second half of 2026.