A new medication called Rhapsido has demonstrated the ability to control symptoms in twice as many patients with chronic inducible urticaria (CIndU) compared to placebo, offering the first targeted therapy for a condition that affects an estimated 29 million people globally. The drug, which works by blocking a specific immune pathway involved in hive formation, met its primary goals across three common subtypes of the condition in a large clinical trial.

What Is Chronic Inducible Urticaria and Why Does It Matter?

Chronic inducible urticaria is a skin condition where everyday triggers cause itchy hives and swelling. Unlike other forms of chronic hives, CIndU has specific triggers that set it off. The condition affects roughly 0.5 percent of the global population, placing a significant burden on daily life. Many patients cycle through antihistamines without finding adequate relief, leaving them with limited options for managing their symptoms.

The three most common subtypes of CIndU each have distinct triggers. Symptomatic dermographism, the most prevalent form, causes hives from shear force on the skin such as friction or light scratching, with wheals appearing in less than five minutes and typically lasting around 30 minutes. Cold urticaria develops after skin exposure to cold temperatures, leading to hives or swelling within minutes of exposure. Cholinergic urticaria manifests with small hives triggered by body heating from exercise, strong emotions, or hot water exposure.

How Does Rhapsido Work to Relieve Hives?

Rhapsido is a highly selective oral medication that blocks a pathway called BTK, which is involved in the release of histamine from immune cells. Histamine is the key chemical driver behind hive formation and swelling in urticaria. By reducing histamine release, the drug helps relieve the itching and skin reactions that characterize CIndU. The medication is already approved in the United States, European Union, China, and several other countries for treating chronic spontaneous urticaria, a related but different condition where hives occur without specific triggers.

What Did the Clinical Trial Show?

The RemIND trial was a global Phase III study that tested Rhapsido's effectiveness across the three most common CIndU subtypes. At week 12 of treatment, patients taking Rhapsido achieved complete responses at significantly higher rates than those receiving placebo. The drug demonstrated a favorable safety profile with no observed liver safety concerns. Notably, responses were seen as early as week two in two of the three subtypes, suggesting relatively rapid symptom improvement for some patients.

The trial results are particularly significant because they represent the first time any treatment has demonstrated efficacy across multiple CIndU subtypes in a global Phase III clinical trial. This breakthrough comes at a time when greater than 50 percent of CIndU patients experience significant disease burden despite treatment with standard H1-antihistamines, the current first-line therapy.

What Are the Next Steps for Patients?

Novartis has submitted a supplemental application to the U.S. Food and Drug Administration seeking approval of Rhapsido specifically for symptomatic dermographism, the most common CIndU subtype. The company plans to continue additional filings with health authorities globally throughout 2026. This regulatory pathway could bring the medication to patients who currently have no approved targeted treatment options.

• Current Treatment Gap: More than 50 percent of CIndU patients experience significant disease burden despite taking standard H1-antihistamines, indicating that existing medications are insufficient for many people.
• Disease Prevalence: An estimated 29 million people worldwide have chronic inducible urticaria, yet no approved targeted therapies existed before this development.
• Trial Efficacy: Rhapsido demonstrated statistically significant and clinically meaningful symptom control in twice as many patients compared to placebo across the three most common CIndU subtypes.

"Chronic inducible urticaria is a form of chronic hives in which everyday triggers such as pressure, heat, cold, or sunlight can lead to itchy wheals, and there are currently no approved targeted treatment options. The RemIND results across the three most common CIndU subtypes highlight the potential of Rhapsido as an important new treatment option for patients with significant unmet need," said Prof. Dr. med. Martin Metz, Deputy Director of the Institute of Allergology at Charité-Universitätsmedizin Berlin, Germany.

Prof. Dr. med. Martin Metz, Deputy Director, Institute of Allergology, Charité-Universitätsmedizin Berlin, Germany

Why Is This Development Important for Allergy and Immunology?

The approval of Rhapsido for CIndU would represent a major shift in how doctors treat this condition. For decades, patients with CIndU have had few options beyond standard antihistamines, which work by blocking histamine receptors but do not address the underlying immune mechanism driving histamine release. Rhapsido takes a different approach by targeting the BTK pathway itself, potentially offering more effective symptom control for patients who have not responded adequately to conventional therapy.

Beyond CIndU, Rhapsido is also being investigated for other immune-mediated conditions, including hidradenitis suppurativa, a chronic inflammatory skin condition, and food allergy. These ongoing studies suggest that BTK inhibition may have broader applications in treating various allergic and immune-mediated diseases.

For the millions of people living with chronic inducible urticaria, the potential approval of Rhapsido offers hope for better symptom control and improved quality of life. The trial data presented at the European Academy of Allergy and Clinical Immunology Congress demonstrate that targeted immune therapy can address the root cause of CIndU, moving beyond the limitations of antihistamine-only treatment approaches.