Clinical Trials
Novartis bags Phase III win for Remibrutinib in chronic inducible urticaria
The results mark a potential breakthrough for patients living with CIndU, a condition with limited treatment options
- By IPP Bureau
| February 20, 2026
Pharma powerhouse Novartis has notched a major clinical victory, reporting positive topline results from its pivotal Phase III RemIND trial of oral remibrutinib in chronic inducible urticaria (CIndU).
The study met its primary endpoint across the three most common forms of the disease — symptomatic dermographism, cold urticaria and cholinergic urticaria — delivering significantly higher complete response rates versus placebo at Week 12.
The results mark a potential breakthrough for patients living with CIndU, a condition with limited treatment options. Novartis said the data position remibrutinib to become the first targeted therapy for CIndU, addressing a substantial unmet medical need.
“The positive RemIND trial results across three different types of CIndU underscore the potential of oral remibrutinib to achieve complete symptom relief for people living with CIndU and build on its recent FDA approval in chronic spontaneous urticaria (CSU),” said Angelika Jahreis, Global Head, Immunology Development, Novartis.
“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.”
Building on the momentum, Novartis has filed a supplemental New Drug Application (sNDA) with the U.S. Food and Drug Administration seeking approval of remibrutinib for symptomatic dermographism, the most prevalent form of CIndU.
The company said it plans to submit the full data package to global health authorities in the coming months and will present detailed findings from the RemIND trial at upcoming medical congresses.
If approved, remibrutinib could significantly expand treatment options for patients across both spontaneous and inducible chronic urticaria — and further strengthen Novartis’ position in immunology.
