Novartis remibrutinib first therapy to achieve Phase III primary endpoint in chronic inducible urticaria (CIndU)

Positive results from a late-stage clinical trial offer new hope for the approximately 29 million adults worldwide living with chronic inducible urticaria (CIndU). Novartis announced topline results from the RemIND trial on February 18, 2026, demonstrating that the oral medication remibrutinib significantly improved symptoms in patients with three common types of CIndU.

A New Approach to Chronic Hives

CIndU is a chronic skin condition characterized by hives and/or swelling triggered by specific external factors, such as pressure, cold, or heat. This differs from chronic spontaneous urticaria (CSU), which has no identifiable triggers. Currently, many patients manage their CIndU symptoms with antihistamines, often without complete relief. Remibrutinib, a highly selective oral BTK inhibitor, represents a potential first-in-class targeted therapy for this condition.

RemIND Trial Results

The Phase III RemIND trial involved adults with CIndU whose symptoms were not adequately controlled by antihistamines. The trial focused on three prevalent subtypes: symptomatic dermographism, cold urticaria and cholinergic urticaria. Participants receiving remibrutinib experienced significantly higher rates of complete symptom resolution at Week 12 compared to those receiving a placebo.

Did You Know? Remibrutinib is already approved in the US and China, under the brand name Rhapsido^®, for the treatment of chronic spontaneous urticaria (CSU) in adults who haven’t responded to antihistamines.

Remibrutinib works by blocking the BTK pathway, which plays a key role in the release of histamine – a substance that drives the hives and swelling associated with CIndU. The trial also indicated that remibrutinib was well-tolerated, with a favorable safety profile and no evidence of liver safety concerns.

What’s Next for Remibrutinib?

Novartis has already submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) seeking approval for remibrutinib to treat symptomatic dermographism. The company plans to submit the full data set from the RemIND trial to health authorities globally in the coming months. These findings are also expected to be presented at upcoming medical conferences.

Expert Insight: The success of the RemIND trial across multiple CIndU subtypes suggests remibrutinib could address a significant unmet need for patients who haven’t found adequate relief with existing treatments. A targeted therapy option could substantially improve the quality of life for those living with this challenging condition.

Beyond CIndU, remibrutinib is also being investigated for other immune-mediated conditions, including hidradenitis suppurativa and food allergy, as well as potential applications in neuroscience.

Frequently Asked Questions

What is chronic inducible urticaria (CIndU)?

CIndU is a chronic skin condition affecting an estimated 0.5 percent of the population, or 29 million people worldwide, characterized by hives and/or swelling with identifiable external triggers like pressure, sunlight, friction, heat, cold or water.

How does remibrutinib work?

Remibrutinib is a highly selective, oral BTK inhibitor that blocks the BTK pathway involved in the release of histamine, a key driver of hives and swelling.

What were the primary endpoints of the RemIND trial?

The primary endpoint of the RemIND trial was the proportion of complete responders at Week 12 assessed through provocation tests specific to three CIndU subtypes: symptomatic dermographism, cold urticaria and cholinergic urticaria.

Could a targeted therapy like remibrutinib change the way chronic inducible urticaria is managed for millions of people?