Novartis’ Remibrutinib Shows Promise as First Targeted Therapy for Chronic Inducible Urticaria

Basel, Switzerland – February 24, 2026 – Novartis announced positive results from its Phase III RemIND trial evaluating remibrutinib, an oral BTK inhibitor, for the treatment of chronic inducible urticaria (CIndU). The trial met its primary endpoints across three prevalent types of CIndU – symptomatic dermographism, cold urticaria and cholinergic urticaria – demonstrating significantly higher complete response rates versus placebo at Week 12. This marks a potential breakthrough in treating CIndU, a condition affecting an estimated 29 million adults worldwide.

Understanding Chronic Inducible Urticaria

CIndU is a chronic skin condition characterized by hives and/or swelling triggered by external factors such as pressure, sunlight, friction, heat, cold, or water. It differs from chronic spontaneous urticaria (CSU), which has no identifiable triggers. The condition can significantly impact daily life, with many patients experiencing inadequate relief from antihistamines.

Remibrutinib: A Targeted Approach

Remibrutinib is a highly selective, oral Bruton’s tyrosine kinase (BTK) inhibitor. It works by blocking the BTK pathway, which plays a crucial role in the release of histamine – a key driver of hives, and swelling. By reducing histamine release, remibrutinib aims to alleviate the symptoms of CIndU.

RemIND Trial Results: A Detailed Look

The Phase III RemIND trial (NCT05976243) was a global, multicenter, randomized, double-blind, placebo-controlled study. The study focused on adults with CIndU whose symptoms were not adequately controlled by H1-antihistamines. The primary endpoint – the proportion of complete responders at Week 12, assessed through provocation tests specific to each CIndU subtype – was met across all three prevalent types:

• Symptomatic Dermographism: Characterized by itchy hives caused by skin friction or scratching.
• Cold Urticaria: Triggered by skin exposure to cold, leading to wheals or swelling.
• Cholinergic Urticaria: Manifests with small hives triggered by body heating, such as during exercise or hot baths.

Remibrutinib demonstrated statistically significant and clinically meaningful results in all three subtypes, achieving higher complete response rates compared to placebo.

Regulatory Status and Future Outlook

Novartis has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) seeking approval of remibrutinib for the treatment of symptomatic dermographism. The company plans to submit the full data set to health authorities globally in the coming months, with findings expected to be presented at upcoming medical congresses.

Remibrutinib is already approved in the US and China for the treatment of chronic spontaneous urticaria (CSU) under the brand name Rhapsido®. Novartis is too investigating remibrutinib for other immune-mediated conditions, including hidradenitis suppurativa and food allergy, as well as in neuroscience applications.

Key Takeaways

• Remibrutinib has shown promising results in Phase III trials as a targeted therapy for CIndU.
• The RemIND trial met its primary endpoints across three common CIndU subtypes.
• Remibrutinib works by inhibiting the BTK pathway, reducing histamine release and alleviating symptoms.
• Novartis has submitted an sNDA to the FDA for approval in symptomatic dermographism.