BASEL, Switzerland, June 12, 2026
Novartis announced new Phase III data at the European Academy of Allergy and Clinical Immunology (EAACI) Congress 2026, demonstrating that Rhapsido® (remibrutinib) achieved significant symptom control in patients with chronic inducible urticaria (CIndU), a chronic skin disorder affecting an estimated 29 million people worldwide. Results from the global RemIND Phase III trial showed that Rhapsido met its primary endpoints across the three most common CIndU subtypes—symptomatic dermographism, cold urticaria, and cholinergic urticaria—becoming the first therapy to demonstrate efficacy in a global Phase III trial for chronic inducible urticaria. The findings strengthen the potential of Rhapsido to become the first targeted treatment option for patients whose disease remains inadequately controlled despite treatment with H1-antihistamines, addressing a significant unmet need in allergy and immunology care.
Phase III RemIND Trial Demonstrates Strong Clinical Efficacy
The pivotal RemIND study evaluated the efficacy, safety, and tolerability of oral Rhapsido 25 mg twice daily in adults with CIndU inadequately controlled by antihistamines. Clinical results demonstrated significantly higher complete response rates compared with placebo across all three major disease subtypes. In cold urticaria, Rhapsido achieved a complete response rate of 56.3%, compared with 14.6% for placebo. In symptomatic dermographism, complete response rates reached 29.3% versus 14.0%, while in cholinergic urticaria, response rates were 29.3% compared with 15.8% for placebo.
Importantly, clinical improvements were observed as early as Week 2, with higher rates of complete symptom control achieved by Week 12. These results highlight the therapy’s potential to provide rapid, meaningful, and sustained symptom relief for patients suffering from chronic hives triggered by environmental and physical factors.
First Targeted Therapy Candidate for Chronic Inducible Urticaria
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Chronic inducible urticaria is characterized by recurrent hives and swelling triggered by factors such as cold temperatures, pressure, friction, heat, sunlight, exercise, or emotional stress. Despite the substantial disease burden, there are currently no approved targeted therapies available for the condition. Rhapsido is a highly selective oral Bruton’s Tyrosine Kinase (BTK) inhibitor designed to block pathways involved in histamine release, a key driver of urticaria symptoms.
By reducing histamine-mediated inflammation, the therapy offers a novel mechanism of action that differs from conventional antihistamine treatments. The favorable efficacy profile observed in the RemIND study positions Rhapsido as a potentially transformative therapy for patients who continue to experience debilitating symptoms despite standard treatment options.
Regulatory Progress Expands Novartis Immunology Portfolio
In parallel with the positive Phase III data, Novartis confirmed that it has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration seeking approval of Rhapsido for the symptomatic dermographism subtype of chronic inducible urticaria, with additional global regulatory submissions planned throughout 2026. Rhapsido is already approved in the United States, European Union, China, South Korea, and several other markets for chronic spontaneous urticaria (CSU) in adults who have not responded adequately to antihistamines.
The latest data further reinforce Novartis’ expanding leadership in immunology and allergy research while supporting broader development of remibrutinib across multiple immune-mediated conditions. If approved, Rhapsido could establish a new treatment paradigm and become the first targeted therapy specifically developed for chronic inducible urticaria, providing hope to millions of patients worldwide seeking effective long-term disease control.
Source: Novartis press release
