remibrutinib (LOU064) / Novartis - LARVOL DELTA

Biologic and small molecule therapies in chronic spontaneous urticaria: an update. (PubMed, Curr Opin Allergy Clin Immunol) - "The rapid increase in clinical trials in the field of CSU has already led to a significant improvement in treatment options beyond anti-IgE therapy with omalizumab in Japan and the USA, and further approvals of biologics and small molecules are expected shortly. It is expected that with a wider range of different approved therapeutic approaches, the treatment of CSU will have to be tailored to the urticaria subtype or patient profile in the future."

Journal • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria

Comparative efficacy and safety of biologics and systemic immunomodulatory treatments for chronic urticaria: Systematic review and network meta-analysis. (PubMed, J Allergy Clin Immunol) - "Among individuals with chronic urticaria refractory to antihistamines, standard-dose omalizumab and remibrutinib are among the most effective drugs across multiple patient-important outcomes with a favorable safety profile across the studied duration. Cyclosporine may be effective but may be among the most harmful. Dupilumab improves itch and wheals, but it is uncertain whether it improves angioedema or quality of life. Lower doses of omalizumab are of intermediate effectiveness and favorable safety. The net benefit of conventional immunosuppressants is uncertain."

Journal • Retrospective data • Cardiovascular • Dermatology • Immunology • Urticaria

Efficacy and safety of remibrutinib in chronic spontaneous urticaria : a systematic review and meta-analysis (EADV 2025) - No abstract available

Retrospective data • Review • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria

REMIX-1/-2: Long-term efficacy of remibrutinib in patients with CSU from the European region (EADV 2025) - No abstract available

Clinical • Cardiovascular • Dermatology • Dermatopathology • Immunology • Urticaria

Remibrutinib in patients with moderate to severe hidradenitis suppurativa: International Hidradenitis Suppurativa Severity Scoring System (IHS4) outcomes from a randomised, phase 2, double-blind, placebo-controlled platform study (EADV 2025) - No abstract available

Clinical • P2 data • Dermatology • Hidradenitis Suppurativa • Immunology

Remibrutinib in patients with moderate to severe hidradenitis suppurativa: Patient-reported outcomes from a randomised, phase 2, double-blind, placebo-controlled platform study (EADV 2025) - No abstract available

Clinical • P2 data • Patient reported outcomes • Dermatology • Hidradenitis Suppurativa • Immunology

Efficacy of Omalizumab, Dupilumab, and Remibrutinib in Chronic Spontaneous Urticaria: Phase Data and Placebo Response. (PubMed, Allergy) - No abstract available

Journal • Allergy • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria

RECLAIM: A Study to Evaluate Efficacy of Remibrutinib Compared to Dupilumab at Early Timepoints in Adults With Chronic Spontaneous Urticaria Inadequately Controlled by Second Generation H1-antihistamines (clinicaltrials.gov) - P3 | N=400 | Recruiting | Sponsor: Novartis Pharmaceuticals | Not yet recruiting ➔ Recruiting

Enrollment open • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria

Phase 3b Study to Assess the Efficacy, Safety, and Tolerability of Remibrutinib in Comparison to Placebo, With Omalizumab as Active Control, in Adult CSU Patients, Followed by an Open-label 52-week Optional Extension. (clinicaltrials.gov) - P3 | N=470 | Active, not recruiting | Sponsor: Novartis Pharmaceuticals | Recruiting ➔ Active, not recruiting

Enrollment closed • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria

A Study to Investigate the Pharmacokinetics and Safety of Remibrutinib in Participants With Severe Renal Impairment Compared to Matched Healthy Participants. (clinicaltrials.gov) - P1 | N=16 | Not yet recruiting | Sponsor: Novartis Pharmaceuticals

New P1 trial • Immunology • Inflammation • Renal Disease

The current and future landscape of Bruton's tyrosine kinase inhibitors in allergy. (PubMed, J Allergy Clin Immunol) - "Several proof-of-concept studies using early-generation compounds such as ibrutinib and acalabrutinib demonstrated the ability of short courses of BTK inhibitors (BTKis) to reduce skin test responses to allergens, suppress basophil activation responses, and even completely prevent reactivity to allergenic food ingestion in humans. In particular, remibrutinib has demonstrated remarkable efficacy and safety with chronic use for chronic spontaneous urticaria and is poised to become the first BTKi approved in the United States for use in the allergy space. This review summarizes work using BTKis to treat allergic disorders, emphasizing safety and practical considerations for clinicians."

Journal • Review • Allergy • Chronic Spontaneous Urticaria • Dermatology • Food Hypersensitivity • Immunology • Urticaria

Bruton's Tyrosine Kinase Inhibitor Attenuates Skin Lesions in an Atopic Dermatitis Mouse Model by Suppressing Th2 Inflammation and Mast Cell Activation (EAACI 2025) - "Method An atopic dermatitis (AD)-like mouse model was established through topical application of MC903 from day 0 (D0) to D14. These findings were corroborated at the protein level using IHC and ELISA, confirming the suppression of key cytokine expression. Conclusion This study highlights the role of remibrutinib in reducing clinical symptoms, suppress mast cell degranulation, and downregulate key Th2 cytokines, supporting its role as a promising therapeutic strategy for AD."

IO biomarker • Late-breaking abstract • Preclinical • Atopic Dermatitis • Dermatitis • Immunology • Inflammation

Bruton's Tyrosine Kinase Inhibitor Attenuates Mast Cell Activation via Both FceRI- and MRGPRX2-Mediated Pathways (EAACI 2025) - "Method Remibrutinib and fenebrutinib were used to inhibit BTK signaling. Conclusion BTK inhibitors attenuate both FceRI- and MRGPRX2-mediated mast cell activation. These findings highlight the protective role of BTK inhibitors in the treatment of CSU, not only by suppressing immunoglobulin synthesis but also by directly inhibiting mast cell activation."

Immunology

Remibrutinib improves chronic spontaneous urticaria independent of baseline immunoglobulin E levels in the phase 3 REMIX studies (EAACI 2025) - "Ertas et al. Allergy 2018; 73(3):705-712"

P3 data • Immunology

Remibrutinib demonstrates sustained control of angioedema in patients with chronic spontaneous urticaria: 52-week treatment results from the phase 3 REMIX studies (EAACI 2025) - "Remibrutinib also showed greater reduction in weekly Urticaria Activity Scores vs placebo, with improvement observed as early as week 1 (−13.1 vs −3.4), and the effect was sustained up to week 52 (at week 52: −24.3 for remibrutinib patients and −24.4 for placebo-remibrutinib transitioned patients). Conclusion In patients with angioedema at BL, remibrutinib showed fast improvements in angioedema activity, achieving higher AAS7=0 response rates vs placebo as early as week 1, with effects sustained up to week 52 in 82% of patients."

Clinical • P3 data • Immunology

Evaluating remibrutinib in the treatment of chronic spontaneous urticaria. (PubMed, Immunotherapy) - "The next step involves administering omalizumab, a monoclonal antibody targeting IgE, however, a subset of patients may not respond to this treatment underscoring the necessity for alternative treatment options. The safety profile was also commendable, with no significant treatment-related adverse events requiring therapy cessation or posing immediate health risks to patients. These results indicate that remibrutinib may become a preferred oral treatment for patients with moderate to severe CSU who do not adequately respond to standard therapies."

Journal • Review • Chronic Spontaneous Urticaria • Dermatology • Immunology • Inflammation • Urticaria

Remibrutinib in Chronic Spontaneous Urticaria. (PubMed, N Engl J Med) - No abstract available

Journal • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria

Remibrutinib in Chronic Spontaneous Urticaria. Reply. (PubMed, N Engl J Med) - No abstract available

Journal • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria

Remibrutinib in Chronic Spontaneous Urticaria. (PubMed, N Engl J Med) - No abstract available

Journal • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria

Remibrutinib in Chronic Spontaneous Urticaria. (PubMed, N Engl J Med) - No abstract available

Journal • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria

Study of Remibrutinib (LOU064) Efficacy and Safety and Exploration of Its Mechanism of Action in Participants With Chronic Urticaria (clinicaltrials.gov) - P2 | N=44 | Recruiting | Sponsor: Novartis Pharmaceuticals | Not yet recruiting ➔ Recruiting

Enrollment open • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria

Novel inhibitors of the scaffolding function of BTK selectively and potently block BTK signaling and are efficacious in preclinical models of chronic spontaneous urticaria (SID 2025) - "Although no BTK inhibitors are yet approved for dermatologic diseases, LOU064 (remibrutinib, Novartis) has demonstrated Phase 3 efficacy in CSU and encouraging Phase 2 data in hidradenitis suppurativa...In a clinically-relevant mouse model of CSU, BTK SH2 inhibitors achieve efficacy equivalent to BTK TKIs. Selective, potent, and durable inhibitors of BTK's scaffolding function have the potential to safely enable broader clinical efficacy in dermatologic disease."

Late-breaking abstract • Preclinical • Chronic Spontaneous Urticaria • CNS Disorders • Dermatology • Hidradenitis Suppurativa • Immunology • Inflammatory Arthritis • Multiple Sclerosis • Rheumatoid Arthritis • Rheumatology • Urticaria • PLCG2

Next generation Bruton's tyrosine kinase inhibitors - characterization of in vitro potency and selectivity. (PubMed, Eur J Pharmacol) - "BTKi ranked in their selectivity as follows (most selective to least): remibrutinib, fenebrutinib, evobrutinib, orelabrutinib, rilzabrutinib and tolebrutinib. These data suggest that next generation BTKi show important differences in their in vitro target binding and selectivity when compared under the same conditions."

Journal • Preclinical • Allergy • Immunology

Biological and target synthetic treatments for chronic spontaneous urticaria: A systematic review and network meta-analysis. (PubMed, Clin Transl Allergy) - "The findings of this study indicate that the biological agent omalizumab 300 mg and the oral small molecule remibrutinib at doses of 35 mg, 25 mg, or 10 mg are recommended for patients with antihistamine-refractory CSU."

Clinical • Journal • Retrospective data • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria

Remibrutinib: FDA decision for chronic spontaneous urticaria in H2 205 (Novartis) - Q1 2025 Results: Regulatory submission for Hidradenitis suppurativa in 2028 or later

FDA approval • Filing • Chronic Spontaneous Urticaria • Hidradenitis Suppurativa • Immunology