Rhapsido CIndU long-term data from the Phase III RemIND program show that remibrutinib delivered sustained efficacy through Week 52, Novartis announced from Basel on November 12, 2026. The analysis evaluated Rhapsido 25 mg twice daily in patients with the three most prevalent subtypes of chronic inducible urticaria (CIndU): symptomatic dermographism (SD), cold urticaria (ColdU) and cholinergic urticaria (CholU).
Novartis said the results will be presented as a late-breaking abstract at the ACAAI Annual Scientific Meeting 2026, which runs November 12-16 in Phoenix, Arizona. The company also reported that Rhapsido was well tolerated through Week 52, with an overall safety profile consistent with its approved indications. It added that additional regulatory submissions for CIndU are planned based on the data.
Giselle Mosnaim, MD, MS, an allergist and immunologist at Endeavor Health and the lead RemIND investigator, described how everyday triggers such as cold air, heat or light scratching can cause sudden, painful itching and swelling. She called the research an important step toward treatments that deliver lasting relief. Novartis positions RemIND as the largest Phase III clinical program conducted in CIndU.
Angelika Jahreis, Global Head, Immunology Development at Novartis, said the long-term evidence strengthens the clinical profile of the medicine. She added that it supports efforts to bring it to more patients worldwide. For readers tracking the immunology pipeline, the Rhapsido CIndU readout adds a 52-week dataset to what Novartis describes as the most comprehensive Phase III evidence to date in this disease.
Rhapsido CIndU Week 52 Results From the RemIND Program
The RemIND trial (NCT05976243) is a global Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group study of Rhapsido in adults whose CIndU remained inadequately controlled by H1-antihistamines. It enrolled 362 patients whose symptoms persisted despite treatment with second-generation H1 antihistamines. The primary endpoint is the proportion of complete responders at Week 12, assessed through provocation tests specific to each of the three subtypes.
According to Novartis, patients initially randomized to Rhapsido maintained symptom improvements throughout the treatment period. Patients who began on placebo and switched to Rhapsido at Week 24 reached Week 52 response rates similar to those of patients who received Rhapsido from the start. That crossover comparison is the main basis for the sustained-efficacy claim in the Rhapsido CIndU announcement.
The release did not disclose the Week 12 primary endpoint results, adverse event rates, discontinuation figures or statistical significance values. Those items are listed as Not disclosed here and are not estimated. Novartis also stated that data from RemIND supported the FDA approval of Rhapsido for SD, and that the full data set will support additional regulatory submissions.
Rhapsido CIndU Response Rates by Subtype: SD, ColdU and CholU
Early responses were a headline finding. Complete or partial response rates on subtype-specific provocation tests at Week 1 were 41.8% with Rhapsido versus 19.2% with placebo in SD, and 67.4% versus 28.9% in ColdU. In CholU, the Week 2 rates were 65.2% with Rhapsido versus 45.6% with placebo. Novartis summarized the SD and ColdU results as twice as many Rhapsido-treated patients achieving a treatment response by Week 1 compared with placebo.
At Week 52, complete or partial response rates in patients initially randomized to Rhapsido were 46.8% in SD, 83.3% in ColdU and 58.2% in CholU. Among patients who switched from placebo at Week 24, the corresponding rates were 47.7%, 88.9% and 69.8%. These Rhapsido CIndU figures come from the late-breaking ACAAI abstract cited in the Novartis release.
Readers should note that the release reports combined complete or partial response rates rather than complete response alone. Each subtype was assessed through its own provocation test, so the figures describe different measures across SD, ColdU and CholU. Novartis did not provide per-cohort sample sizes in the announcement, so caution is warranted when comparing subtypes directly.
Why Rhapsido CIndU Evidence Matters for Patients With Chronic Inducible Urticaria
CIndU affects an estimated 0.5 percent of the population, or 29 million people worldwide, according to Novartis, which cites United Nations population data. It differs from chronic spontaneous urticaria (CSU), which has no specific triggers. The company says the condition significantly burdens daily life, with many patients trying multiple antihistamines without adequate relief. That unmet need frames why the Rhapsido CIndU program matters.
Symptomatic dermographism, the most prevalent subtype, causes itchy hives after skin friction or light scratching. Hives appear within 5 minutes and usually last 30 minutes. Cold urticaria causes wheals or angioedema within minutes of cold exposure, usually in exposed areas. Cholinergic urticaria causes small, punctate hives after active or passive body heating, including exercise, strong emotions or hot-water bathing.
Rhapsido is a highly selective, oral Bruton’s tyrosine kinase (BTK) inhibitor that blocks the BTK pathway involved in immune-cell signaling and inflammation. Under that brand name, remibrutinib is approved for CSU in the EU, US, China and Japan, among other countries, and for SD in the US. The 52-week safety profile was reported as consistent with previous studies and established CSU experience, which extends the safety evidence for Rhapsido CIndU use. The release also cites the REMIX-1 and REMIX-2 CSU Phase III studies (NCT05030311 and NCT05032157) in its references.
Rhapsido CIndU Regulatory Outlook and Remibrutinib Pipeline
On regulation, Novartis said additional submissions for CIndU are planned based on the RemIND data. Data from RemIND already supported the FDA approval of Rhapsido for SD. The company gave no submission dates or target regions beyond that statement, so timelines are Not disclosed.
Remibrutinib continues to be studied in other immune-mediated conditions, including hidradenitis suppurativa (HS), food allergy, chronic pruritus of unknown origin and papulopustular rosacea, as well as multiple sclerosis (MS). Novartis places the Rhapsido CIndU readout within an immunology portfolio spanning rheumatology, dermatology and allergy.
