At a Glance
- Phase III RemIND trial met primary endpoint of complete response at Week 12 in symptomatic dermographism, cold urticaria, and cholinergic urticaria.
- Oral remibrutinib (Rhapsido®), a selective BTK inhibitor, blocks histamine release in CIndU.
- sNDA submitted to FDA for symptomatic dermographism; approved for CSU in US/China.
- CIndU affects ~29 million worldwide with no prior targeted therapies.
Written By: Samiksha Jadhav BPharm
Reviewed By: Pharmacally Editorial Team
Novartis announced positive topline results from the pivotal Phase III RemIND trial (NCT05976243) evaluating oral remibrutinib in adults with chronic inducible urticaria (CIndU), a mast cell-driven skin condition inadequately controlled by H1-antihistamines.
The trial met its primary endpoint, demonstrating significantly higher complete response rates versus placebo at Week 12 for the three most prevalent CIndU subtypes: symptomatic dermographism, cold urticaria, and cholinergic urticaria.
These findings position remibrutinib as a potential breakthrough the first targeted therapy for CIndU affecting an estimated 0.5% of the global population, or about 29 million people.
CIndU triggers hives (wheals) and/or swelling through identifiable external stimuli like pressure, cold, heat, or friction, distinguishing it from chronic spontaneous urticaria (CSU), which lacks specific triggers.
Patients often cycle through antihistamines without relief, facing a heavy daily burden from symptoms that disrupt work, exercise, and emotional well-being. Symptomatic dermographism causes itchy hives from light skin friction within minutes; cold urticaria leads to wheals on cold-exposed areas; and cholinergic urticaria produces small hives from body heating, such as during exercise or hot showers. No approved targeted therapies exist today, leaving a longstanding unmet need.
Remibrutinib, a highly selective oral Bruton’s tyrosine kinase (BTK) inhibitor marketed as Rhapsido® in the US and China, targets the BTK pathway to block histamine release the key driver of hives and swelling. Building on its recent FDA approval for CSU in adults with inadequate antihistamine response, these RemIND results suggest broader potential across chronic urticaria subtypes.
“The positive RemIND trial results across three different types of CIndU underscore the potential of oral remibrutinib to achieve complete symptom relief,” said Angelika Jahreis, Global Head of Immunology Development at Novartis. Full data will be presented at upcoming medical congresses.
Novartis has submitted a supplemental New Drug Application (sNDA) to the FDA for symptomatic dermographism, CIndU’s most common subtype, with plans to submit the complete dataset to global health authorities soon. Remibrutinib is also under investigation for hidradenitis suppurativa, food allergy, and neuroscience indications, expanding its role in immune-mediated diseases.
These results mark an important advance, potentially transforming CIndU management from symptomatic relief to targeted pathway inhibition.
Reference
Novartis remibrutinib first therapy to achieve Phase III primary endpoint in chronic inducible urticaria (CIndU), 18 February 2026, Novartis remibrutinib first therapy to achieve Phase III primary endpoint in chronic inducible urticaria (CIndU) | Novartis
A Study to Investigate Efficacy, Safety, and Tolerability of Remibrutinib Compared with Placebo in Adults with CINDU Inadequately Controlled by H1-antihistamines, ClinicalTrials.gov ID NCT05976243, Novartis remibrutinib first therapy to achieve Phase III primary endpoint in chronic inducible urticaria (CIndU) | Novartis