Rhapsido (remibrutinib) / Novartis - LARVOL DELTA

RELIEF: A Real-world Study of Remibrutinib in Chronic Spontaneous Urticaria Patients (clinicaltrials.gov) - P=N/A | N=350 | Recruiting | Sponsor: Novartis Pharmaceuticals

New trial • Real-world evidence • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria

REASSERT: Remibrutinib in Real-world Clinical Practice - a US Sub-study (clinicaltrials.gov) - P=N/A | N=505 | Recruiting | Sponsor: Novartis Pharmaceuticals | Not yet recruiting ➔ Recruiting

Enrollment open • Real-world evidence • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria

Remibrutinib: “The committee discussed the issues identified in this application.”; Chronic spontaneous urticaria (European Medicines Agency) - CHMP Final Minutes of the meeting on 21 - 24 Jul 2025: “The committee adopted the CHMP recommendation and scientific discussion together with the list of questions”

CHMP • Chronic Spontaneous Urticaria • Immunology

A CENTRALLY-ACTING BTK INHIBITOR AMELIORATES AGGRESSIVE MSA-C SUPPRESSING PROINFLAMMATORY MICROGLIA AND PHOSPHORYLATED Α-SYNUCLEIN FORMATION (ADPD 2026) - "Tolebrutinib and remibrutinib, respectively centrally and peripherally-acting Bruton's tyrosine kinase inhibitors (BTKi), were orally administered to Tg mice 4 times a week from 18 to 26 weeks of age, and clinicopathologically evaluated. Single-cell RNA sequencing revealed a unique microglia cluster that highly expresses Toll-like receptor 2, transglutaminase 2, arginase-1, and various inflammatory cytokines compared with other clusters. A centrally-acting BTKi could be a novel therapy for MSA-C by suppressing proinflammatory microglia like SAM."

IO biomarker • Ataxia • CNS Disorders • Inflammation • Movement Disorders • Multiple System Atrophy • Solid Tumor • ITGAM • PLP1 • SNCA • TGM2 • TLR2

REASSERT: Remibrutinib in Real-world Clinical Practice (clinicaltrials.gov) - P=N/A | N=3280 | Recruiting | Sponsor: Novartis Pharmaceuticals | Not yet recruiting ➔ Recruiting | Trial completion date: Aug 2030 ➔ Oct 2031 | Trial primary completion date: Aug 2030 ➔ Oct 2031

Enrollment open • Real-world evidence • Trial completion date • Trial primary completion date • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria

Efficacy and Safety of Remibrutinib After Switching From Ocrelizumab in Participants With Relapsing Multiple Sclerosis: RESHAPE Study Design (ACTRIMS Forum 2026) - P3 | "This study will provide scientific evidence comparing the benefit-risk profile of remibrutinib in pwRMS who transition from ocrelizumab versus those who continue treatment with ocrelizumab."

Clinical • CNS Disorders • Inflammation • Multiple Sclerosis

Efficacy and safety of remibrutinib, a Bruton's tyrosine kinase inhibitor, for individuals with IgE-mediated peanut allergy (AAAAI 2026) - "Conclusions Remibrutinib showed superior efficacy versus placebo in adults with peanut allergy, with a favourable safety profile. These data support further assessment of remibrutinib as a therapeutic option for IgE-mediated food allergy."

Clinical • Allergy • Food Hypersensitivity • Immunology

Remibrutinib Decreases Urticaria Disease Activity Leading To Improved Disease Control: An Analysis From The REMIX‑1/‑2 Studies (AAAAI 2026) - "Remibrutinib showed higher reductions in UAS7 vs placebo consistently through weeks 2 (14.7±0.5 vs 24.0±0.6), 12 (9.3±0.5 vs 16.5±0.7), and 24 (8.3±0.5 vs 14.2±0.8) and improvements in UCT7 vs placebo at weeks 2, 12, and 24 (10.5±0.2 vs 7.3±0.2; 11.4±0.2 vs 9.1±0.3, 11.9±0.2 vs 9.9±0.3, respectively). These improvements were sustained Conclusions Remibrutinib showed early and sustained reduction in UAS7 and concurrent improvement in UCT7, with a strong inverse correlation observed between these outcomes."

Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria

Remibrutinib Alleviates Atopic Dermatitis via Downregulation of Keratinocyte-Derived TSLP and Th2 Immune Activation (AAAAI 2026) - "Integrative analysis indicated that Conclusions BTK inhibition alleviates AD by downregulating keratinocyte-derived TSLP and disrupting the TSLP–OX40–OX40L–Th2 axis. These findings highlight BTK as a promising therapeutic target in AD, bridging epithelial signaling and immune regulation."

IO biomarker • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation • TNFSF4 • TSLP

Remibrutinib Provides Fast Symptom Relief Within the First Week of Treatment in Chronic Spontaneous Urticaria, as Measured by Daily Urticaria Activity Score: Pooled REMIX-1/-2 Studies (AAAAI 2026) - "From days 1 to 7, remibrutinib showed greater reduction in disease activity versus placebo; mean±SE UAS within 12 hours was 3.96±0.07 versus 3.99±0.08, reducing to 3.09±0.07 versus 3.92±0.08 on day 2 and 2.25±0.08 versus 3.49±0.10 on day 7. At baseline, 1.3% of remibrutinib-treated patients versus 0.7% on placebo were in the lowest UAS band, increasing to 6.5% vs 2.4% within 12 hours and 37.0% vs 9.7% Conclusions Remibrutinib showed early CSU symptom control compared to placebo, with reduction in disease activity noted within the first 12 hours and sustained through day 7."

Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria

Now Approved: A New Path Forward with RHAPSIDO® (AAAAI 2026) - "Sponsored by Novartis Pharmaceuticals Description: Corporation Get an insightful view of RHAPSIDO®, including: Mechanism of action with RHAPSIDO Demonstrated efficacy and safety data Getting patients started on RHAPSIDO"

A Novel Panel of Autoantibodies May Assist In The Molecular Diagnosis Of CSU (AAAAI 2026) - P3 | "Analysis was performed on serum samples from up to 109 healthy subjects and up to 468 non-Asian CSU patients from the REMIX-1/-2 clinical trials (NCT05030311, NCT05032157) which evaluated the safety and efficacy of remibrutinib, an oral Results Several autoantigen-specific IgE (including TPO, MPO and CCL8) and IgG (including FcεRI, IL13 and CUZD1) Aabs were significantly elevated in CSU patients compared to healthy volunteers...Combination of Aabs into a panel improved discrimination between CSU patients and healthy volunteers compared to single autoantibodies, enabling accurate diagnosis with high sensitivity and Conclusions We identified a combination of CSU-associated autoantibodies that can discriminate between CSU patients and healthy subjects with high sensitivity and specificity. This may help to molecularly define CSU and inform on pathomechanisms involved."

Cardiovascular • Chronic Spontaneous Urticaria • Dermatology • Immunology • Pruritus • Urticaria • CCL8 • IL13

Properties of FDA-approved small molecule protein kinase inhibitors: a 2026 update. (PubMed, Pharmacol Res) - "The following ten drugs received FDA approval in 2025 - avutometinib (inhibiting MEK1/2 in serous ovarian carcinomas), defactinib (blocking FAK in low grade serous ovarian carcinomas), delgocitinib (antagonizing the JAK family in hand eczema), mirdametinib (inhibiting MEK1/2 in type I neurofibromatosis), remibrutinib (blocking BTK in chronic spontaneous urticaria), rilzabrutinib (antagonizing BTK in chronic immune thrombocytopenia), sunvozertinib (blocking mutant exon 21 insertion EGFR NSCLC), taletrectinib (inhibiting mutant ROS1 in NSCLC), vimseltinib (blocking CSF1R in tenosynovial giant cell tumors), and zongertinib (antagonizing mutant HER2 in NSCLC). This article summarizes the physicochemical properties of all 94 FDA-approved small molecule protein kinase inhibitors including the molecular weight, number of hydrogen bond donors/acceptors, ligand efficiency, lipophilic efficiency, polar surface area, and solubility. A total of 45 of the 94 FDA-approved drugs have a..."

FDA event • Journal • Review • Atopic Dermatitis • Chronic Spontaneous Urticaria • Contact Dermatitis • Dermatology • Genetic Disorders • Giant Cell Tumor of Bone • Hematological Disorders • Immune Thrombocytopenic Purpura • Immunology • Lung Cancer • Neurofibromatosis • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Ovarian Serous Adenocarcinoma • Solid Tumor • Tenosynovial Giant Cell Tumor • Thrombocytopenia • Thrombocytopenic Purpura • Urticaria • CSF1R • EGFR • HER-2 • ROS1

Involvement of Btk in Cardiovascular Disease and Its Therapeutic Targeting. (PubMed, Circulation) - "First-generation BTKi such as ibrutinib demonstrate antithrombotic efficacy but are limited by off-target effects, including bleeding and atrial fibrillation. Second- and third-generation inhibitors (eg, acalabrutinib, zanubrutinib, and pirtobrutinib) show enhanced selectivity, reducing cardiovascular toxicity in patients with B-cell malignancies. Highly selective BTKi (fenebrutinib and remibrutinib) do not show bleeding in clinical trials of various autoimmune disorders, and covalent selective BTKi applied at low dosage are expected to selectively inhibit Btk in platelets without bleeding side effects. Preclinical data and early observations from compassionate use in patients with atypical autoimmune thrombosis highlight the potential of BTKi as selective antithrombotic agents beyond traditional therapies. This review conceptualizes and underscores Btk's pivotal role at immune-thrombosis interfaces in atherothrombosis, advocating for precision medicine approaches..."

Journal • Review • Atherosclerosis • Atrial Fibrillation • Cardiovascular • Hematological Disorders • Hematological Malignancies • Immunology • Inflammation • Oncology • Primary Immunodeficiency • Thrombosis • NLRP3

Systemic Treatments for Chronic Spontaneous Urticaria: Anti-IgE and Beyond. (PubMed, J Allergy Clin Immunol Pract) - "Current standard of care includes nonsedating H1-antihistamines and omalizumab, which targets peripheral blood IgE and downregulates mast cell and basophil IgE receptors...Dupilumab received FDA approval for H1-antihistamine-refractory CSU, supporting targeting type 2 cytokines, IL-4 and IL-13. Most recently, a Bruton's tyrosine kinase inhibitor (BTKi), remibrutinib, demonstrated significant reductions in Urticaria Activity Score over 7 days in phase 3 trials, leading to FDA approval. Newer c-Kit (cKit or KIT) inhibitors have also shown efficacy in CSU and CIndU, with barzolvolimab showing sustained efficacy post-treatment...Some drugs have been halted in development because of safety concerns, such as fenebrutinib (BTKi), THB001 (Larvol; c-Kit inhibitor), and EP262 (MRGPRX2 antagonist), whereas others, targeting the alarmin thymic stromal lymphopoietin (tezepelumab), the Th2 cytokine IL-5 (mepolizumab) and its receptor IL-5R (benralizumab), as well as lirentelimab..."

Journal • Review • Cardiovascular • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria • IL13 • IL4 • IL5 • SIGLEC8 • TSLP • TYK2

Rhapsido: Regulatory decision in EU for chronic spontaneous urticaria in H1 2026 (Novartis) - Q4 2025 Results: Regulatory decision in Japan for chronic spontaneous urticaria in H2 2026; Regulatory submission for hidradenitis suppurativa in 2028

EMA approval • Filing • Japan approval • Chronic Spontaneous Urticaria • Hidradenitis Suppurativa • Immunology

PRT15 Now Approved: A new path forward with RHAPSIDO® (remibrutinib) (AAD 2026) - "Sponsored by: Novartis Pharmaceuticals Corporation DESCRIPTION This program will provide an insightful view of RHAPSIDO®, including mechanism of action with RHAPSIDO; demonstrated efficacy and safety data; and getting patients started on RHAPSIDO."

F048 Chronic Urticaria: What's New (AAD 2026) - "DESCRIPTION The purpose of this session is to highlight the recent major advances in this field as CSU and CIndU cases continue to persist despite being treated with antihistamines, and Omalizumab. New targeted treatments Dupilumab and Remibrutinib have been approved for use in CSU the last year...Describe evidence-based strategies for treatment selection considering clinical guidelines and patient-specific factors 3. Review and describe the mechanisms of CSU and emerging biologic therapies and small molecules in the treatment of CSU and CIndU"

Dermatology • Immunology • Urticaria

REMODEL-2: Efficacy and Safety of Remibrutinib Compared to Teriflunomide in Participants With Relapsing Multiple Sclerosis (RMS) (clinicaltrials.gov) - P3 | N=1011 | Active, not recruiting | Sponsor: Novartis Pharmaceuticals | Recruiting ➔ Active, not recruiting

Enrollment closed • CNS Disorders • Multiple Sclerosis

REMODEL-1: Efficacy and Safety of Remibrutinib Compared to Teriflunomide in Participants With Relapsing Multiple Sclerosis (RMS) (clinicaltrials.gov) - P3 | N=1001 | Active, not recruiting | Sponsor: Novartis Pharmaceuticals | Recruiting ➔ Active, not recruiting

Enrollment closed • CNS Disorders • Multiple Sclerosis

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 | Completed | Sponsor: Novartis Pharmaceuticals | Recruiting ➔ Completed

Trial completion • Immunology • Inflammation • Renal Disease

REASSERT: Remibrutinib in Real-world Clinical Practice - a US Sub-study (clinicaltrials.gov) - P=N/A | N=505 | Not yet recruiting | Sponsor: Novartis Pharmaceuticals

New trial • Real-world evidence • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria

Remibrutinib: First Approval. (PubMed, Drugs) - "It has subsequently been approved for use in the same indication in China and is under regulatory review in the EU and Japan. This article summarises the milestones in the development of remibrutinib leading to this first approval for CSU in adult patients who remain symptomatic despite H1-antihistamine treatment."

Journal • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria

A Phase 3 Study to Assess Efficacy Safety and Tolerability of Remibrutinib in Adult and Adolescent Patients With Moderate to Severe Hidradenitis Suppurativa (RECHARGE 1) (clinicaltrials.gov) - P3 | N=555 | Recruiting | Sponsor: Novartis Pharmaceuticals | Trial completion date: Oct 2028 ➔ Feb 2028 | Trial primary completion date: Sep 2028 ➔ Oct 2027

Trial completion date • Trial primary completion date • Dermatology • Hidradenitis Suppurativa • Immunology

REASSERT: Remibrutinib in Real-world Clinical Practice (clinicaltrials.gov) - P=N/A | N=3280 | Not yet recruiting | Sponsor: Novartis Pharmaceuticals

New trial • Real-world evidence • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria