Novartis Remibrutinib Shows Positive Results in Chronic Inducible Urticaria Trial
Novartis announced positive topline results from its Phase III RemIND trial of remibrutinib in chronic inducible urticaria, meeting the primary endpoint for the three most prevalent types of the condition with significantly higher complete response rates versus placebo.
Novartis has announced positive topline results from its pivotal Phase III RemIND trial of oral remibrutinib in chronic inducible urticaria (CIndU). The primary endpoint was met for the three most prevalent types of CIndU, those being symptomatic dermographism, cold urticaria and cholinergic urticaria. Significantly higher complete response rates were achieved versus placebo at week 12.
Results from the late-stage trial showed statistically significant and clinically meaningful benefits, reflecting the potential of the drug to achieve complete symptom relief for patients. CIndU is characterized by itchy hives and swelling.
The data represent an important advance in the treatment of CIndU, demonstrating the potential of remibrutinib to be the first targeted therapy for CIndU and address a major unmet need.
The drug is already approved in the U.S. and China for the treatment of adults with chronic spontaneous urticaria, under the brand name Rhapsido. Regulatory reviews for the CSU indication are also underway in several major healthcare markets, including the European Union and Japan.
Remibrutinib works by targeting Bruton's tyrosine kinase (BTK), a protein involved in immune cell activation and the release of histamine and inflammatory mediators that cause allergic reactions. By blocking this pathway, the drug helps reduce the underlying immune activity responsible for urticaria symptoms.
Novartis continues to expand the development program for remibrutinib beyond CSU and CIndU. The drug is currently being studied in other immune-mediated conditions such as hidradenitis suppurativa. The company is also presenting Phase II clinical data exploring remibrutinib as a treatment for IgE-mediated peanut allergy, with plans to launch a Phase III program for food allergies in the second half of 2026.
New analyses from the REMIX-1 and REMIX-2 Phase III clinical trials, which evaluated the effectiveness of remibrutinib in patients suffering from chronic spontaneous urticaria, demonstrate improved disease control and early symptom relief among participants treated with the therapy.
The company will present results at an upcoming medical congress.