Novartis reports Phase III success for remibrutinib in chronic inducible urticaria

Edited by Robert McTiernan··2 min read

Novartis announced positive results from its Phase III program evaluating remibrutinib in patients with chronic inducible urticaria (CIndU), with the oral Bruton’s tyrosine kinase (BTK) inhibitor meeting its primary endpoint of symptom improvement versus placebo. The data mark the first time a therapy has achieved a Phase III primary endpoint in this heterogeneous form of chronic urticaria, a condition with limited approved treatment options. The results further extend Novartis’ late-stage immunology pipeline as the company seeks to build beyond its established biologic franchise in allergic and dermatologic disease.

Remibrutinib is a highly selective, oral, covalent BTK inhibitor designed to block signaling pathways involved in mast cell and B-cell activation, both central to the pathophysiology of urticaria. By targeting intracellular signaling rather than circulating immunoglobulin E (IgE), the drug represents a mechanistically distinct approach compared with current biologic standards of care. The molecule gained approval from the US FDA in September 2025 under the brand name Rhapsido, indicated for adults with chronic spontaneous urticaria (CSU) who remain symptomatic despite H1-antihistamine treatment. The molecule’s development in chronic inducible urticaria (CIndU) would constitute a potential label expansion.

Trial specifics

The Phase III program in CIndU evaluated remibrutinib in adult patients with symptomatic disease inadequately controlled by second-generation H1-antihistamines. The randomized, placebo-controlled trials assessed the efficacy and safety of oral remibrutinib administered twice daily during a double-blind treatment period.

The primary endpoint measured change from baseline in urticaria activity, using a validated symptom score specific to CIndU subtypes. Novartis reported that remibrutinib demonstrated statistically significant improvement versus placebo on this primary endpoint. Detailed numerical data were not disclosed in the topline announcement. Safety findings were described as consistent with the drug’s previously reported profile in chronic spontaneous urticaria (CSU), with no new safety signals identified.

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Novartis said it plans to present detailed data at upcoming medical meetings and to engage with regulatory authorities, including the US FDA, regarding potential submission to expand the Rhapsido label into CIndU.

Research context

Chronic inducible urticaria comprises a group of disorders in which hives and angioedema are triggered by specific physical stimuli such as cold, heat, pressure, or sunlight. CIndU lacks therapies specifically approved by the US FDA. Patients are typically treated with high-dose antihistamines and, in refractory cases, off-label biologics.

BTK plays a role in signaling downstream of the high-affinity IgE receptor on mast cells, which release histamine and other inflammatory mediators during urticarial reactions. By inhibiting BTK, remibrutinib aims to suppress mast cell activation more directly than anti-IgE approaches.

Key competitors and related assets in chronic urticaria include:

  • Novartis’ own anti-IgE monoclonal antibody omalizumab (Xolair), developed with Genentech, which is approved by the US FDA for CSU but not specifically for CIndU.
  • Sanofi and Regeneron’s IL-4Rα antibody dupilumab (Dupixent), which has reported Phase III data in CSU and is being positioned as an alternative biologic option in antihistamine-refractory disease.
  • Celldex Therapeutics’ anti-KIT monoclonal antibody barzolvolimab, currently in Phase II/III development in CSU, targeting mast cell survival through KIT inhibition.