Despite two recent FDA approvals, two-thirds of physicians report high unmet need in CSU, highlighting potential for clinical advancement, according to Spherix Global Insights.
EXTON, PA, October 24, 2025 – Chronic spontaneous urticaria (CSU), marked by unpredictable and often debilitating flare patterns, continues to impose a significant burden on patients and healthcare providers in the United States. Individuals living with CSU experience greater physical discomfort, emotional distress, and economic strain than those managing other chronic inflammatory skin diseases, such as atopic dermatitis or psoriasis. Despite the high disease burden, treatment options have historically been limited, leaving many patients inadequately controlled on standard antihistamines or existing biologic therapies. Recent findings from Spherix Global Insights’ Market Dynamix™: CSU US, 2025 reveal that unmet need remains exceptionally high across the patient population, particularly among those with severe or refractory disease, as well as individuals on a second-line biologic, after a primary advanced systemic failure.
Most allergists continue to manage CSU patients independently, while dermatologists frequently co-manage or refer more complex cases. However, the recent introduction of Sanofi/Regeneron’s Dupixent® (dupilumab) for CSU has begun to reshape these referral dynamics. Dermatologists, drawing on their extensive familiarity with Dupixent in other dermatologic conditions, are increasingly managing CSU patients within their own practices, leading to a measurable reduction in referrals to allergists. Despite evolving referral patterns, allergists report significantly higher use of biologics for the treatment of CSU than their dermatology counterparts.
According to Spherix’s Launch Dynamix™: Dupixent in CSU service, early post-approval data reveal that Dupixent adoption rates among allergists are nearly double those among dermatologists. While Genentech/Novartis’ Xolair® (omalizumab) continues to hold the dominant position in the biologic segment, brand share is nearly twice as high among allergists as among dermatologists. However, allergists and dermatologists differ notably in their perceptions and use of Dupixent and Xolair for CSU, creating opportunities for differentiation, particularly among various patient types. These evolving prescribing patterns underscore both the complexity of CSU management and clinicians’ readiness to integrate novel mechanisms of action.
The recent FDA approval of Novartis’ Rhapsido™ (remibrutinib), the first oral BTK inhibitor indicated for CSU, marks yet another pivotal milestone in expanding treatment options for patients who remain symptomatic despite existing therapies. Findings from Market Dynamix™: CSU, US 2025 highlight that current products fail to fully meet key treatment attributes, positioning BTK inhibition as a promising advance for disease control and patient quality of life. Physicians across both specialties are highly likely to prescribe Rhapsido for refractory patients and anticipate that over half of their refractory patients will be appropriate candidates for it.
Beginning in November, Spherix Global Insights will track the U.S. launch of Rhapsido through its Launch Dynamix™ service, providing continuous, real-time intelligence on prescriber adoption, patient outcomes, and market evolution. As CSU care enters a new era defined by targeted biologics and small-molecule innovation, Spherix remains committed to delivering data-driven insights that empower stakeholders to anticipate change, optimize strategy, and improve outcomes for those living with this burdensome condition.
Market Dynamix™ is an independent service providing analysis of markets anticipated to experience a paradigm shift within the next three to five years. Insights highlight market size, current treatment approaches, unmet needs, and expert opinions on the likely disruption introduced by pipeline agents.
Launch Dynamix™ is an independent service providing monthly benchmarking of newly launched products for the first eighteen months of commercial availability, augmented by a quarterly deep dive into promotional activity, barriers to uptake, and patient types gravitating to the launch brand.
About Spherix Global Insights
Spherix is a leading independent market intelligence and advisory firm that delivers commercial value to the global life sciences industry, across the brand lifecycle.
The seasoned team of Spherix experts provides an unbiased and holistic view of the landscape within rapidly evolving specialty markets, including dermatology, gastroenterology, rheumatology, nephrology, neurology, ophthalmology, and hematology. Spherix clients stay ahead of the curve by leveraging the insights of the extensive Spherix Physician Community.
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Spherix Global Insights Contacts
Andy Stankus, Dermatology Franchise Head
Andy.stankus@spherixglobalinsights.com
Colleen Carpinella, Dermatology Director
