Novartis presented Phase III RemIND trial data at the European Academy of Allergy and Clinical Immunology (EAACI) Congress this week showing that remibrutinib (Rhapsido®), a Bruton's tyrosine kinase (BTK) inhibitor, met primary endpoints across the three most common subtypes of chronic inducible urticaria (CIndU): symptomatic dermographism (SD), cold urticaria, and cholinergic urticaria. The results mark the first time any compound has demonstrated efficacy in a global Phase III CIndU clinical trial, according to the company.
In the RemIND trial, higher rates of complete response were recorded at week 12, with measurable responses emerging as early as week 2 in two of the three subtypes studied. The clinical endpoint data build on remibrutinib's established mechanism — selective BTK inhibition targeting IgE-mediated mast cell activation — which underpins its existing approvals for chronic spontaneous urticaria (CSU) in the U.S., European Union, China, and several additional markets. The trial enrolled patients with disease inadequately controlled following second-generation H1-antihistamine therapy, representing a high-unmet-need population with few evidence-based escalation options.
"Chronic inducible urticaria is a form of chronic hives in which everyday triggers — pressure, heat, cold, or sunlight — can lead to itchy wheals, and there are currently no approved targeted treatment options," said Prof. Dr. Martin Metz, Deputy Director of the Institute of Allergology at Charité–Universitätsmedizin Berlin. The RemIND findings position remibrutinib as a potential first-in-class approved therapy for CIndU, a mechanistic distinction that carries significant formulary and prescribing implications for immunology specialists.
Novartis has submitted a supplemental New Drug Application (sNDA) to the FDA specifically for the SD subtype, with additional regulatory filings planned globally through the remainder of 2026. For nutraceutical and functional-food operators tracking the immune-health and mast-cell biology space — an area of growing interest given rising consumer focus on histamine intolerance, skin-barrier support, and anti-inflammatory botanicals — the RemIND data offer a clinical benchmark for BTK-pathway modulation. Ingredient developers exploring quercetin, luteolin, and other mast-cell-stabilizing phytocompounds increasingly cite this pathway in structure-function claim rationales, though no dietary ingredient has approached the clinical endpoint precision demonstrated in a double-blind, placebo-controlled Phase III setting.
Angelika Jahreis, Global Head of Immunology Development at Novartis, characterized the CIndU data as "consistent with Rhapsido's proven efficacy and favorable safety profile" in CSU, signaling that the benefit-risk profile established in the broader urticaria population is likely to support the supplemental filing. Operators and formulators in the allergy-wellness and skin-health categories should monitor the FDA review timeline closely, as an approved targeted therapy for CIndU would both validate the immune-trigger mechanism commercially and raise the evidentiary bar for adjacent OTC and supplement positioning.
Written by Michael Politz, Author of Guide to Restaurant Success: The Proven Process for Starting Any Restaurant Business From Scratch to Success (ISBN: 978-1-119-66896-1), Founder of Food & Beverage Magazine, the leading online magazine and resource in the industry. Designer of the Bluetooth logo and recognized in Entrepreneur Magazine's "Top 40 Under 40" for founding American Wholesale Floral, Politz is also the Co-founder of the Proof Awards and the CPG Awards and a partner in numerous consumer brands across the food and beverage sector.