Remibrutinib Shows Promise for Peanut Allergy Treatment in Phase 2 Study

Philadelphia – A new study offers promising evidence that remibrutinib, a medication already approved for chronic spontaneous urticaria (hives), may significantly improve tolerance to peanuts in adults with IgE-mediated peanut allergy. Presented at the American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting on March 6, 2026, the phase 2 trial suggests that remibrutinib could potentially offer a new therapeutic avenue for managing this potentially life-threatening allergy. IgE-mediated peanut allergy occurs when the body’s immune system overreacts to proteins found in peanuts, triggering allergic reactions that can range from mild symptoms like hives and itching to severe, life-threatening anaphylaxis.

Remibrutinib’s Mechanism and Prior Approval

Remibrutinib works by selectively inhibiting Bruton’s tyrosine kinase (BTK), an enzyme involved in immune cell signaling. By blocking BTK, the drug aims to dampen the allergic response. The Food and Drug Administration (FDA) approved remibrutinib in late September 2025 for the treatment of chronic spontaneous urticaria, paving the way for its investigation in other allergic conditions.

Study Design and Key Findings

The multicenter, randomized, double-blind, placebo-controlled phase 2 study, led by Robert A. Wood, MD, FAAAAI, of Johns Hopkins University School of Medicine, involved 76 adults with IgE-mediated peanut allergy. Participants had a baseline eliciting dose of 100 mg or less of peanut protein – meaning that’s the smallest amount of peanut protein that would trigger a reaction. Participants were divided into five groups, receiving either remibrutinib at doses of 10 mg, 25 mg, or 100 mg twice daily for four weeks, or a placebo. A final group received placebo for three weeks followed by 25 mg of remibrutinib twice daily for one week.

The primary outcome was the proportion of participants who could tolerate a single dose of at least 600 mg of peanut protein without experiencing dose-limiting symptoms after four weeks of treatment. The results showed a clear dose-dependent effect: a significantly higher proportion of participants in the remibrutinib groups were able to tolerate the 600 mg dose compared to the placebo group (10 mg, 40%. 25 mg, 50%; 100 mg, 86.7% vs. 0%). Even higher doses – 1,000 mg and 3,000 mg – showed increased tolerance rates in the remibrutinib groups. Notably, 100% of participants who received placebo followed by 25 mg remibrutinib achieved tolerance to at least 600 mg of peanut protein.

“Remibrutinib showed superior efficacy vs. Placebo with dose-dependent effects,” Dr. Wood stated during his presentation. The study also evaluated tolerance to 1,000 mg and 3,000 mg doses of peanut protein, with the higher remibrutinib doses demonstrating progressively better tolerance rates.

What the Study Doesn’t Tell Us

Whereas these findings are encouraging, it’s crucial to acknowledge the study’s limitations. The sample size was relatively little, and the study duration was limited to four weeks. Which means we don’t yet know the long-term effects of remibrutinib on peanut allergy tolerance. The study only assessed tolerance to a single challenge dose; it didn’t evaluate whether remibrutinib could prevent reactions to accidental peanut exposure in real-world settings. The study population was also relatively homogenous, and further research is needed to determine whether these findings apply to individuals with different characteristics, such as varying degrees of allergy severity or co-existing allergic conditions.

Safety Profile and Adverse Events

The safety profile of remibrutinib in this study appeared to be comparable to placebo. A larger proportion of participants in the placebo group experienced adverse events (80%) compared to those receiving remibrutinib (ranging from 33.3% to 52.6% depending on the dose). No serious adverse events were reported, and only one participant discontinued treatment due to an adverse event. The most commonly reported adverse events were mild and included infections and infestations, which occurred in a small proportion of participants in all groups.

Implications for Peanut Allergy Management

Peanut allergy affects millions of people worldwide, and currently, the primary management strategies involve strict avoidance of peanuts and carrying epinephrine auto-injectors for emergency treatment of anaphylaxis. Oral immunotherapy (OIT), which involves gradually increasing exposure to peanut protein, is another option, but it carries risks and requires careful monitoring. Remibrutinib represents a potentially new approach to peanut allergy management, offering the possibility of increasing tolerance without the require for continuous allergen exposure.

Next Steps: A Phase 3 Trial on the Horizon

Based on the promising results of this phase 2 study, researchers are planning a larger, phase 3 trial to further evaluate the efficacy and safety of remibrutinib in adults and adolescents with IgE-mediated food allergy, potentially expanding beyond peanut allergy. Dr. Wood indicated that this trial is expected to begin later in 2026. This larger trial will be critical to confirm these initial findings and determine whether remibrutinib can ultimately develop into a valuable treatment option for individuals living with the challenges of food allergy. The study’s findings, originally presented at the AAAAI Annual Meeting, were also published in the Journal of Allergy and Clinical Immunology.

For individuals with peanut allergy, it remains essential to follow current guidelines for allergy management, including strict avoidance of peanuts and carrying epinephrine auto-injectors. Staying informed about the latest research developments and discussing treatment options with a qualified allergist is also crucial. You can find more information about peanut allergy and management strategies from organizations like Food Allergy Research & Education (FARE).