Chronic Spontaneous Urticaria Treatment Landscape: FDA Approves RHAPSIDO, First Oral BTK Inhibitor | DelveInsight's Perspective on Market Impact, Competitive Landscape and Pipeline Therapies

DelveInsight's latest report highlights the transformative impact of the FDA's approval of RHAPSIDO (remibrutinib) by Novartis AG on September 30, 2025. This landmark approval marks the first oral Bruton tyrosine kinase (BTK) inhibitor specifically designed for chronic spontaneous urticaria, offering revolutionary hope for over 1.7 million patients in the United States suffering from this debilitating condition characterized by recurring hives and angioedema without identifiable triggers.
Key Chronic Spontaneous Urticaria Market Highlights

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RHAPSIDO's approval is expected to be a key chronic spontaneous urticaria market driver, given its first-in-class status as an oral BTK inhibitor targeting histamine release mechanisms.

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Chronic spontaneous urticaria affects approximately 3.2 million diagnosed patients in the seven major economies, with more than 50% remaining symptomatic despite H1 antihistamine treatment.

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Chronic Spontaneous Urticaria Companies: Novartis AG, Roche (Xolair), Sanofi-Regeneron (Dupixent), Teva Pharmaceutical Industries, F. Hoffmann-La Roche Ltd., Pfizer Inc., GlaxoSmithKline plc, Bayer AG, Eli Lilly and Company, Merck & Co., Inc., AstraZeneca, Johnson & Johnson, among others.

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The chronic spontaneous urticaria market size was valued at approximately USD 2 billion across the 7MM in 2024 and is projected to grow at a CAGR of over 15% during the forecast period (2025-2034), reaching more than USD 7.5 billion by 2034.

Market Impact and Chronic Spontaneous Urticaria Patient Population

According to DelveInsight's Chronic Spontaneous Urticaria Market Insight, Epidemiology and Market Forecast [https://www.delveinsight.com/sample-request/chronic-spontaneous-urticaria-market?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=xpr] report, there is a significant unmet medical need with approximately 3.2 million diagnosed prevalent cases of chronic spontaneous urticaria in the 7MM in 2024. The United States accounted for approximately 19% of cases, while the EU4 and the UK collectively represented 44%, and Japan constituted 38% of the total Chronic Spontaneous Urticaria cases.

The condition is a chronic dermatological disorder characterized by the sudden appearance of itchy hives, swelling of deep tissues (angioedema), or both, lasting for more than six weeks without identifiable external triggers. Unlike acute urticaria caused by environmental factors, CSU is an immune-related disorder driven by internal mechanisms such as mast cell activity and histamine release. The age-standardized prevalence ranges from 0.120% to 0.277% across different patient populations, with higher prevalence observed in pediatric patients compared to adults.

The report highlights that the chronic spontaneous urticaria treatment market is set for explosive growth with a robust compound annual growth rate anticipated from 2025 to 2034. RHAPSIDO's approval is expected to be a key driver of this growth trajectory, given its first-in-class oral mechanism targeting BTK pathways and differentiated therapeutic approach addressing underlying histamine release mechanisms.

Download the Chronic Spontaneous Urticaria Market report to understand which other factors are driving the therapeutic market @ CSU Market Trends [https://www.delveinsight.com/sample-request/chronic-spontaneous-urticaria-market?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=xpr].

RHAPSIDO Treatment Approach

RHAPSIDO represents a first-in-class oral Bruton tyrosine kinase (BTK) inhibitor designed to target the underlying chronic spontaneous urticaria pathophysiology by blocking histamine release and inflammatory mediator secretion. Unlike current symptomatic treatments that primarily focus on H1 antihistamine blockade, RHAPSIDO addresses the root cause by selectively inhibiting BTK, an enzyme critical for mast cell activation and histamine release cascades that drive CSU symptomatology. The therapy is administered orally twice daily, offering chronic spontaneous urticaria patients a convenient treatment option that targets disease mechanisms rather than merely managing symptoms, with no requirement for laboratory monitoring.

"The RHAPSIDO approval addresses a critical unmet medical need in chronic spontaneous urticaria treatment," emphasized Novartis leadership. "This represents a paradigm shift from symptomatic management to targeted mechanistic therapy, offering patients the first oral treatment specifically designed to target the underlying BTK-mediated inflammatory cascade driving CSU progression and symptom manifestation."

RHAPSIDO Clinical Validation and Efficacy

The RHAPSIDO FDA approval was based on compelling clinical evidence from the pivotal Phase III REMIX-1 and REMIX-2 studies, which demonstrated statistically significant efficacy in reducing urticaria activity scores in adults with CSU who remained symptomatic despite second-generation H1 antihistamine treatment. Key clinical outcomes include significant improvements in weekly urticaria activity scores (UAS7) by week 12, with well-controlled disease observed as early as two weeks of treatment initiation.

The chronic spontaneous urticaria therapy demonstrated sustained efficacy through 24 weeks of follow-up with a favorable safety profile across the study population, representing a significant advancement over current standard-of-care approaches. Patients treated with 25 mg remibrutinib twice daily showed significantly greater symptom improvements compared to placebo, establishing a new treatment paradigm for antihistamine-resistant chronic spontaneous urticaria patients.

Chronic Spontaneous Urticaria Competitive Landscape and Market Positioning

RHAPSIDO enters a treatment landscape that has historically relied on escalating antihistamine doses and injectable biologics, with current chronic spontaneous urticaria management focusing primarily on symptom suppression rather than mechanistic intervention. The chronic spontaneous urticaria competitive landscape includes established treatments such as high-dose H1 antihistamines, Xolair (omalizumab) by Roche, and recently approved Dupixent (dupilumab) by Sanofi-Regeneron.

Roche's Xolair remains a cornerstone injectable therapy for CSU patients unresponsive to antihistamines, while Sanofi-Regeneron's Dupixent received recent approvals expanding treatment options for this patient population. The European Commission's approval of OMLYCLO (CT-P39), a biosimilar to omalizumab, introduces cost-effective alternatives that increase market competition.

The broader competitive ecosystem includes companies developing next-generation antihistamines, novel biologics, and targeted small molecules. RHAPSIDO's first-in-class status as an oral BTK inhibitor provides unprecedented competitive differentiation, offering patients a non-injectable alternative with a wholesale acquisition cost of $4,521 per 30-day supply and convenient twice-daily oral administration without monitoring requirements.

Explore the Chronic Spontaneous Urticaria Drug Battle: RHAPSIDO vs. other emerging therapies. Discover how these breakthrough CSU therapies compare in efficacy, safety, cost, and market impact @ Chronic Spontaneous Urticaria Drugs Market [https://www.delveinsight.com/sample-request/chronic-spontaneous-urticaria-market?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=xpr].

Emerging Chronic Spontaneous Urticaria Pipeline Therapies

Several companies are actively developing next-generation chronic spontaneous urticaria therapies, including Novartis with expanded remibrutinib investigations across chronic inducible urticaria, food allergies, and hidradenitis suppurativa. Additional pipeline developments include TEZSPIRE (tezepelumab) and Rilzabrutinib (SAR444671), representing innovative approaches targeting different inflammatory pathways.

The chronic spontaneous urticaria pipeline also encompasses advanced biologic agents, combination immunotherapies, and precision medicine approaches based on chronic spontaneous urticaria endotype characterization. Despite this evolving landscape, RHAPSIDO's oral BTK inhibition mechanism and proven clinical efficacy position Novartis to capture substantial market share in a therapeutic area with significant unmet medical needs and growing patient populations requiring alternatives to injectable treatments.

Discover more Chronic Spontaneous Urticaria pipeline therapies and the clinical development progress they are making @ Chronic Spontaneous Urticaria Clinical Pipeline [https://www.delveinsight.com/sample-request/chronic-spontaneous-urticaria-market?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=xpr].

Broader RHAPSIDO Therapeutic Pipeline

Beyond chronic spontaneous urticaria, Novartis is investigating remibrutinib's potential in other immune-mediated conditions, including chronic inducible urticaria, food allergies, and hidradenitis suppurativa. Phase IIb studies in hidradenitis suppurativa demonstrated 73% of patients achieving a 50% reduction in abscesses and inflammatory nodules compared to 34.7% with placebo, potentially expanding the addressable patient population and market opportunity significantly across multiple dermatological and allergic conditions.

Industry Expert Perspective

Clinical experts emphasize the significance of targeting underlying BTK-mediated pathophysiology. "The approval of RHAPSIDO represents a fundamental shift from symptom management to mechanistic intervention," commented leading dermatologists and immunologists. "By inhibiting BTK and reducing histamine release cascades, this therapy addresses the core inflammatory mechanisms driving CSU progression, offering patients the potential for improved long-term outcomes with oral convenience."

Learn more about what other Industry experts are saying about RHAPSIDO FDA Approval and how it will impact the Chronic Spontaneous Urticaria treatment market @ Key Opinion Leaders on CSU Market [https://www.delveinsight.com/sample-request/chronic-spontaneous-urticaria-market?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=xpr].

Looking Forward

The RHAPSIDO approval represents a paradigm shift in chronic spontaneous urticaria treatment and demonstrates the potential for targeted oral therapies to address complex immunological skin conditions. DelveInsight's analysts emphasize that the absence of convenient oral alternatives has highlighted a critical gap in CSU treatment, with current approaches primarily requiring injectable administration or causing sedation and anticholinergic effects with high-dose antihistamines.

As the pharmaceutical industry continues to focus on precision medicine and mechanistic therapies, RHAPSIDO's success may pave the way for similar BTK inhibitor innovations in other underserved dermatological and allergic conditions with significant unmet medical needs. The projected market growth from USD 2.17 billion in 2023 to over USD 7.66 billion by 2032 reflects the transformative potential of targeted oral therapeutics in chronic inflammatory skin diseases.

About DelveInsight Business Research

DelveInsight is a leading pharmaceutical market research and consulting company providing comprehensive market intelligence, competitive analysis, and strategic insights across global healthcare markets. The company specializes in dermatological and immunological landscape analysis, pipeline assessments, and market forecasting for biopharmaceutical companies, investors, and healthcare stakeholders worldwide.

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