Novartis' Oral BTK Drug Moves the Needle in CINDU
•February 18, 2026
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Companies Mentioned
Why It Matters
Rhapsido’s potential approval fills a major therapeutic gap in CINDU, offering a disease‑modifying option beyond antihistamines. It also diversifies Novartis’s dermatology portfolio and could generate a new high‑margin revenue stream.
Key Takeaways
- •Rhapsido shows higher complete response rates vs placebo
- •First targeted therapy potential for chronic inducible urticaria
- •Novartis filed worldwide approvals for symptomatic dermographism
- •CINDU affects 0.5% global population, 29 million cases
- •Rhapsido could avoid competition with Dupixent in CSU
Pulse Analysis
Chronic inducible urticaria (CINDU) remains an underserved segment of the dermatology market, affecting roughly half a percent of people worldwide and manifesting as hives triggered by physical stimuli. Patients typically rely on avoidance strategies and second‑generation antihistamines, with off‑label biologics like Xolair offering limited relief. The phase 3 RemIND trial, enrolling 364 antihistamine‑refractory participants, demonstrated that remibrutinib markedly improves complete response rates across symptomatic dermographism, cold urticaria, and cholinergic urticaria, signaling a breakthrough in disease‑specific therapy.
Novartis’s rapid filing for symptomatic dermographism and upcoming submissions for the other CINDU subtypes underscore a strategic push to capture a niche yet sizable market. By securing a first‑in‑class indication, Rhapsido can sidestep direct competition with Sanofi‑Regeneron’s Dupixent, which dominates the chronic spontaneous urticaria (CSU) arena. This differentiation not only broadens Novartis’s dermatology pipeline but also promises higher pricing power, given the lack of existing targeted options for CINDU patients.
The success of Rhapsido may catalyze broader interest in oral BTK inhibitors for allergic and inflammatory skin disorders. As Novartis leverages early uptake data from its CSU launch, the company anticipates scaling sales to rival its historic dermatology hits. Meanwhile, competitors are advancing alternative modalities—such as Sanofi’s KIT inhibitor SAR449028—highlighting a burgeoning race to dominate the urticaria space. For investors and clinicians alike, Rhapsido’s progress signals both a therapeutic advance for patients and a potential new growth engine for Novartis.
Novartis' oral BTK drug moves the needle in CINDU
Novartis is on course to expand the label for its recently approved oral BTK inhibitor Rhapsido, after chalking up a win in chronic skin disorder chronic inducible urticaria (CINDU).
According to the Swiss pharma group, Rhapsido (remibrutinib) achieves significantly higher complete response rates in the three most common forms of CINDU—symptomatic dermographism, cold urticaria, and cholinergic urticaria—compared to placebo in the phase 3 RemIND trial.
CINDU is a group of conditions, affecting around 0.5 % of the global population with 29 million cases worldwide, that is characterised by hives or swelling in response to physical stimuli. In the case of dermographism, that can be friction or light scratching of the skin, while low temperatures—particularly cold water or wind—are the trigger in cold urticaria. Cholinergic urticaria, meanwhile, can result from exercise, strong emotions, or bathing in hot water.
Rhapsido is already cleared to treat chronic spontaneous urticaria (CSU), in which patients suffer hives and swelling with no known cause and is roughly twice as common as CINDU, with an incidence of around 1 % of the global population, according to Novartis.
The company added that it has already filed for approval of the drug for symptomatic dermographism, which is the most common form of CINDU, and will follow up with additional filings around the world—for all three forms—in the coming months.
If approved, Rhapsido could become the first targeted therapy approved for CINDU, which is typically managed by avoiding triggers and the use of second‑generation antihistamines, as well as off‑label treatment with other drugs, including Roche's anti‑IgE antibody Xolair (omalizumab). RemIND enrolled 364 patients whose CINDU symptoms were not controlled using antihistamines.
"Today's findings reinforce that remibrutinib could be the first targeted therapy to improve spontaneous and inducible forms of chronic urticaria, helping address a major gap in care for people living with these conditions," commented Angelika Jahreis, Novartis' head of immunology development.
The new indication could also give Novartis a niche indication where it will not have to compete with Sanofi and Regeneron's huge‑selling anti‑IL‑4 and IL‑13 antibody Dupixent (dupilumab), which was cleared for CSU last year, adding to a long list of approved indications.
Dupixent has also been tested in previous clinical trials for CINDU, with initial results reported in cold urticaria. However, Sanofi's latest pipeline listing suggests it is now focusing on another candidate, KIT inhibitor SAR449028, which is in phase 2 testing. It also has an oral BTK drug (rilzabrutinib) in mid‑stage testing for CSU.
Rhapsido was approved in the US last September and started rolling out onto the market towards the end of the year. So far, the company hasn't reported any sales figures but Novartis CEO Vas Narasimhan pointed to "encouraging" take‑up in CSU patients refractory to antihistamines as well as after the failure of biologics, in the company's fourth‑quarter 2025 results update.
"Rhapsido is one of these brands that we hope over time could become one of the largest…in Novartis' history," he continued, saying the early take‑up is "right in line with some of the most successful dermatology launches."
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