Beyond CSU, Remibrutinib Shows Promise in Treatment of Adults With Peanut Allergy

When treating adults with peanut allergy, remibrutinib (Rhapsido; Novartis) demonstrated superior efficacy and a favorable safety profile compared with placebo, according to data published in the Journal of Allergy and Clinical Immunology and presented at the 2026 American Academy of Allergy, Asthma & Immunology Annual Meeting.¹

What Is Remibrutinib?

The FDA approved remibrutinib in September 2025, making it the first oral Bruton tyrosine kinase (BTK) inhibitor approved for chronic spontaneous urticaria (CSU). The drug is intended to inhibit the release of histamine and other proinflammatory mediators by targeting BTK, offering a unique approach to CSU management. It is a pill taken twice per day and does not require injections or lab monitoring, making it a more accessible, manageable option for patients.^2,3 There is also evidence that remibrutinib may also have positive impacts on food allergies, according to experts.¹

Remibrutinib has previously demonstrated its pharmacodynamics and efficacy in food allergies in a randomized phase 1 trial (NCT03918980),⁴ where 1 dose of the agent was rapidly absorbed in healthy adult participants with or without asymptomatic atopic diathesis, a hereditary predisposition to reactions that manifest as atopic dermatitis, allergic rhinitis, asthma, and allergic reactions. Additionally, it was well tolerated at all doses, without dose‐limiting toxicity, and demonstrated encouraging pharmacodynamic effects in blood and skin, with a favorable safety profile.^4,5

What Did the Study Find?

In the current randomized, double-blind, placebo-controlled phase 2 clinical trial (NCT05432388),⁶ the efficacy, safety, and tolerability of 3 doses of remibrutinib were evaluated in patients with a confirmed peanut allergy. After completing a 4-week screening duration in which they received a reaction-eliciting dose of 30 mg or less of remibrutinib, 76 adults aged 18 to 55 years were enrolled and randomly assigned to receive 10, 25, or 100 mg twice daily for 4 weeks; placebo for 3 weeks followed by 1 week of 25 mg of remibrutinib twice daily; or placebo alone. Fifty-nine participants were included in the final efficacy analysis.^1,6,7

The primary end point was defined as having tolerated a single dose of at least 600 mg of peanut protein without dose-limiting symptoms during the food challenge at week 4.^1,6

The findings indicated that all remibrutinib doses had higher response rates than placebo for the primary end point. The 10-, 25-, and 100-mg twice-daily doses had estimated response rates (ERRs) of 0.41, 0.52, and 0.84 at week 4, respectively. For the placebo run-in and 1-week remibrutinib 25-mg twice-daily dose, the ERR was 0.88.¹

“These food allergy data further strengthen the evidence supporting remibrutinib as a novel, well-tolerated, oral option for patients with allergic and immune-mediated diseases, complementing the recent FDA approval in CSU and underscoring its broader therapeutic potential,” Angelika Jahreis, MD, PhD, global head of immunology development at Novartis, said in a news release. “Our priority is advancing therapies for patients who have few alternatives and expanding the reach of innovative medicines to transform care across multiple, high-need disease areas.”⁸

The authors noted that remibrutinib was well tolerated, with no serious adverse events (AEs). There were no worrisome signals in infections, infestations, nasopharyngitis, upper respiratory tract infection, or potential systemic AEs (eg, blood cell count dynamics, new enzyme abnormalities, petechiae). These data support further assessment of remibrutinib as a therapeutic option for IgE-mediated food allergy.^1,7

“Because of these results and other evidence coming in from other disease models, a phase 3 study in adults and adolescents with IgE-mediated food allergy, probably expanding beyond peanuts, is planned to start later in 2026," Wayne G. Shreffler, MD, PhD, director of the Food Allergy Center at Massachusetts General Hospital in Boston, said in a news release. “ My bias, looking at the options we have, is that this is an exciting possibility as we look out in this sort of 3- to 5-year time frame of what we might be able to offer a patient.”⁷

REFERENCES

1. Wood R, Tan R, Shah R, et al. Efficacy and safety of remibrutinib, a Bruton's tyrosine kinase inhibitor, for individuals with IgE-mediated peanut allergy. J Allergy Clin Immunol. 2026;157(suppl 2):AB190. doi:10.1016/j.jaci.2025.12.569

2. McGovern G. Remibrutinib promotes early symptom control in patients with chronic spontaneous urticaria. Pharmacy Times. February 27, 2026. Updated March 2, 2026. Accessed March 2, 2026. https://www.pharmacytimes.com/view/remibrutinib-promotes-early-symptom-control-in-patients-with-chronic-spontaneous-urticaria

3. Mosnaim G, Ferruggia K. AAAAI: Remibrutinib emerges as first oral advanced therapy for chronic spontaneous urticaria. Pharmacy Times. March 1, 2026. Accessed March 2, 2026. https://www.pharmacytimes.com/view/aaaai-remibrutinib-emerges-as-first-oral-advanced-therapy-for-chronic-spontaneous-urticaria

4. Single dose and multiple dose study to assess safety and tolerability of LOU064. ClinicalTrials.gov. Updated October 12, 2021. Accessed March 2, 2026. https://clinicaltrials.gov/study/NCT03918980

5. Kaul M, End P, Cabanski M, et al. Remibrutinib (LOU064): a selective potent oral BTK inhibitor with promising clinical safety and pharmacodynamics in a randomized phase I trial. Clin Transl Sci. 2021;14(5):1756-1768. doi:10.1111/cts.13005

6. Study of efficacy, safety and tolerability of remibrutinib in adult participants with an allergy to peanuts. ClinicalTrials.gov. Updated May 20, 2025. Accessed March 2, 2026. https://clinicaltrials.gov/study/NCT05432388

7. Phend C. Oral biologic shows promise for food allergy treatment. MedPage Today. March 1, 2026. Updated March 2, 2026. Accessed March 2, 2026. https://www.medpagetoday.com/meetingcoverage/aaaai/120100

8. Novartis presents Rhapsido (remibrutinib) data at AAAAI, showing potential beyond chronic spontaneous urticaria (CSU). News release. Novartis. February 23, 2026. Accessed March 2, 2026. https://www.novartis.com/news/media-releases/novartis-presents-rhapsido-remibrutinib-data-aaaai-showing-potential-beyond-chronic-spontaneous-urticaria-csu