Rhapsido (remibrutinib): Novartis expands its chronic urticaria portfolio with new CIndU data

Responsible: ad hoc news Lifestyle & Consumer Desk. Reviewed prior to publication on June 12, 2026 at 10:15:52 PM ET. Details in the imprint.

With fresh Phase III data from the RemIND trial, Novartis is putting a bright spotlight on Rhapsido (remibrutinib), its oral treatment for chronic hives. The company reported that Rhapsido met primary endpoints across the three most common forms of chronic inducible urticaria (CIndU), reinforcing its role as a targeted option beyond standard antihistamines. For US patients, Rhapsido is already approved as a prescription medicine for chronic spontaneous urticaria (CSU) that remains uncontrolled on antihistamines, and the new data may broaden how the drug is perceived in the chronic urticaria space.

What Rhapsido does for chronic urticaria patients

Rhapsido is an oral Bruton tyrosine kinase (BTK) inhibitor designed to modulate key immune pathways that drive chronic urticaria symptoms such as hives and itching. According to Novartis, it is taken once daily and is intended for adults with chronic spontaneous urticaria whose symptoms are not adequately controlled with antihistamines. In this CSU setting, the drug is positioned as a targeted alternative for patients who continue to experience frequent flares despite standard therapy.

In the RemIND Phase III trial, Novartis evaluated remibrutinib in chronic inducible urticaria, which includes subtypes where hives are triggered by specific stimuli, such as cold, delayed pressure or symptomatic dermographism. The company reported that Rhapsido achieved statistically significant and clinically meaningful symptom control in approximately twice as many patients compared with placebo, with responses observed as early as week 2 in two of the CIndU subtypes. Higher rates of complete response were reported at week 12, and Novartis highlighted a favorable safety profile without observed liver safety concerns in the study. These findings suggest that the mechanism that benefits CSU patients may also translate to broader chronic urticaria populations, though regulatory decisions for CIndU will require further review.

Rhapsido is not intended for every type of hives. The approved US indication focuses on chronic spontaneous urticaria, and Novartis notes that the medicine should not be used for other forms of hives outside its labeled use. As with other targeted immune therapies, treatment requires a prescription and medical supervision, and patients are advised to discuss potential benefits and risks, including infections or other adverse events, with their healthcare provider based on the prescribing information available on the official Novartis announcement.

Positioning in the Novartis allergy and immunology portfolio

Chronic urticaria can significantly affect quality of life, impacting sleep, work and daily routines, and many patients cycle through multiple therapies before achieving adequate control. Novartis has long had a presence in immunology and dermatology, and Rhapsido fits into this broader strategy by addressing an area of persistent unmet need. The company presents remibrutinib as a next generation, highly selective BTK inhibitor and is also studying it in other immune-mediated conditions, underscoring its platform ambitions.

From a practical standpoint, an oral daily tablet may appeal to patients seeking a convenient alternative to injectable biologics in the chronic urticaria treatment landscape. The current US prescribing information focuses on adults with CSU not controlled by antihistamines, and payers will ultimately shape how widely Rhapsido is used based on coverage decisions, step therapy requirements and comparative cost versus biologic options. For patients and physicians navigating treatment decisions, efficacy, safety profile and route of administration are likely to be key points of comparison across available therapies.

Novartis frames the RemIND CIndU data as an important milestone, since this is described as the first global Phase III trial to demonstrate efficacy in multiple chronic inducible urticaria subtypes. If regulators eventually consider label expansions based on this evidence, Rhapsido could play a larger role across the chronic urticaria spectrum. For now, it remains a targeted prescription option for CSU in the US, with additional clinical evidence emerging in related conditions.

Rhapsido therefore sits at the intersection of Novartis allergy, dermatology and immunology efforts and may support the companys long term focus on specialty medicines. Shares of Novartis (CH0012005267, ticker NVS) traded at $101.30 on the NYSE on June 12, 2026.

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