Trial win lifts hopes for Novartis Rhapsido in chronic hives

Edited by ad hoc news New Releases & Launches Desk. Reviewed before publication on 06/15/2026 at 8:15 PM ET. Details in the imprint.

Novartis is putting fresh clinical momentum behind its late-stage allergy pipeline: new Phase III data show that Rhapsido (remibrutinib), an oral Bruton’s tyrosine kinase inhibitor, met primary endpoints in chronic inducible urticaria, strengthening the case for what could become the first targeted therapy for this difficult chronic hive disorder. In the RemIND trial program presented at the European Academy of Allergy and Clinical Immunology (EAACI) Congress, twice as many patients achieved clinically meaningful symptom control on Rhapsido compared with placebo, with responses emerging as early as week 2 in some subtypes and a safety profile described as favorable and without observed liver safety concerns so far. The company highlighted these data in an official EAACI press release.

What Rhapsido is designed to do for chronic inducible urticaria

Rhapsido, the Novartis brand name for remibrutinib, is being developed as a once-daily oral small molecule that selectively inhibits Bruton’s tyrosine kinase (BTK), a key signaling node in mast cells and other immune cells involved in the release of histamine and inflammatory mediators that drive hives and angioedema. By dampening this pathway upstream of histamine release rather than simply blocking peripheral H1 receptors, the drug aims to offer deeper and more sustained control of wheals and itch for patients whose disease remains inadequately controlled despite standard treatment with second-generation H1 antihistamines. In the RemIND development program, Novartis evaluated remibrutinib across the three most common subtypes of chronic inducible urticaria - symptomatic dermographism, cold urticaria and cholinergic urticaria - and reported statistically significant improvements on disease activity scores and complete response rates versus placebo at 12 weeks, reinforcing the mechanistic rationale for BTK inhibition in this setting. Specialist coverage from Medscape summarized the trial design and efficacy readout.

Chronic inducible urticaria (CIndU) is a subset of chronic urticaria in which physical or environmental triggers such as pressure on the skin, temperature changes or exercise provoke recurrent hives lasting more than six weeks, often with considerable impact on quality of life, sleep and work productivity. Epidemiological estimates cited by Novartis suggest that chronic urticaria overall affects roughly 1 percent of the global population at any given time, with a substantial minority of patients experiencing an inducible form that can prove challenging to manage even with high-dose antihistamine therapy. For many of these patients, current guideline-based options after antihistamines are limited mainly to biologic agents like omalizumab, which require regular injections and can be associated with access and cost constraints in some markets, leaving room for an oral targeted drug that could be prescribed more broadly in specialist allergy and dermatology practices.

Against this backdrop, the new RemIND data are strategically important because they extend the Rhapsido clinical evidence base beyond chronic spontaneous urticaria, where remibrutinib is already being studied, into the inducible forms that currently lack any approved targeted therapies. Novartis has disclosed that the Phase III program used separate randomized, placebo-controlled trials for each major CIndU subtype, with consistent trends favoring remibrutinib on symptom scores and patient-reported outcomes, and with no new safety signals relative to prior studies in urticaria and other immune-mediated conditions. These results, if confirmed by regulators, could allow the company to position Rhapsido across a spectrum of chronic urticaria phenotypes, potentially addressing both spontaneous and inducible disease with a single oral BTK inhibitor.

Regulatory strategy is already moving forward: Novartis has submitted a supplemental New Drug Application (sNDA) to the US Food and Drug Administration seeking approval of Rhapsido for at least one chronic inducible urticaria subtype and plans additional filings with health authorities worldwide through 2026, signaling confidence in both the strength of the data and the unmet need narrative. In parallel, the company is working on health-economic analyses and real-world evidence plans to demonstrate that better symptom control and oral administration could translate into fewer emergency visits, improved productivity and potentially lower long-term healthcare utilization for patients living with persistent, trigger-induced hives. For US patients, market entry will depend on how quickly the FDA reviews the sNDA, how labeling and any required risk management conditions are defined, and how payers assess the cost-benefit equation relative to existing biologic options and off-label therapies.

For clinicians, one key question is how Rhapsido would fit into evolving treatment algorithms if approved: some allergists envision using an oral BTK inhibitor earlier in the course of disease for patients who do not respond to optimized doses of second-generation H1 antihistamines, reserving biologics for those who either fail BTK therapy or have contraindications, while others may prefer to sequence Rhapsido after biologics once more long-term safety and comparative effectiveness data become available. The convenience of oral dosing, lack of observed liver safety concerns to date and relatively rapid onset of action reported in the RemIND trials are likely to be appealing features in a condition where symptom flares can be unpredictable and disruptive, but prescribers will also weigh BTK class effects, potential infection risks and interactions with other immunomodulating drugs when making decisions in individual cases.

From a portfolio perspective, Rhapsido is one of several late-stage immunology assets that Novartis is advancing in dermatology and allergy, sitting alongside programs in chronic spontaneous urticaria, atopic dermatitis and other inflammatory conditions where targeted small molecules could complement or compete with monoclonal antibodies. Management has previously pointed to remibrutinib as a meaningful medium-term growth driver in the immunology franchise, particularly if the drug can secure approvals in multiple urticaria indications and potentially in additional mast cell-driven diseases over time. Industry analysts following specialty pharma note that chronic urticaria remains underdiagnosed and undertreated in many markets, suggesting that education campaigns and broader screening by primary care physicians and dermatologists could expand the addressable patient pool for any new oral therapy with compelling efficacy and safety.

Within Novartis, a successful launch of Rhapsido in chronic inducible urticaria would reinforce the Basel-based group’s strategy of focusing on higher-margin innovative medicines while pruning legacy and off-patent assets. Investors are watching the Rhapsido program as part of a broader pipeline narrative that also includes gene therapies, radioligand treatments and cardiovascular drugs, all aimed at sustaining growth as older blockbusters face competition. Shares of Novartis AG (CH0012005267) last traded on the SIX Swiss Exchange in Zurich at 121.88 Swiss francs on 06/15/2026, according to market data cited by financial portal The Market and summarized by ad-hoc-news. The latest trading snapshot shows a modest intraday move for this SMI heavyweight.

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