remibrutinib (LOU064) / Novartis - LARVOL DELTA

Remibrutinib improves chronic spontaneous urticaria independent of baseline immunoglobulin E levels in the phase 3 REMIX studies (EAACI 2025) - No abstract available

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) - No abstract available

Clinical • P3 data • Immunology

24 Weeks Double-blind Randomized Placebo-controlled Trial to Evaluate Efficacy, PK, Safety of LOU064 in Adolescents (12 - <18) With CSU and Inadequate Response to H1-antihistamine Followed by Optional 3 Years Open-label Extension and an Optional 3 Years Safety Long-term Treatment-free Follow-up (clinicaltrials.gov) - P3 | N=100 | Recruiting | Sponsor: Novartis Pharmaceuticals | Trial primary completion date: Nov 2025 ➔ Apr 2026

Trial primary completion date • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria

Remibrutinib Shows Promise for Chronic Hives Relief. (PubMed, JAMA) - No abstract available

Journal • Dermatology • Urticaria

Study of Efficacy, Safety and Tolerability of Remibrutinib in Adult Participants With an Allergy to Peanuts (clinicaltrials.gov) - P2 | N=76 | Completed | Sponsor: Novartis Pharmaceuticals | Active, not recruiting ➔ Completed

Trial completion • Allergy • Food Hypersensitivity • Immunology

Update on the Treatment of Chronic Spontaneous Urticaria. (PubMed, Drugs) - "About 70% of patients with antihistamine-refractory CSU do not reach complete control with omalizumab, the second-line treatment...Several emerging treatments can address these unmet needs including Bruton tyrosine kinase inhibitors, e.g., remibrutinib and rilzabrutinib; anti-KIT monoclonal antibodies, e.g., barzolvolimab; and anti-cytokine therapies, e.g., dupilumab...The most common adverse events were injection site reactions for dupilumab (12%), respiratory tract infections (11%), headache (6%), and petechiae (4%) for remibrutinib and changes in hair color (14%), neutropenia / decreased neutrophil count (9%) and skin hypopigmentation (1%) for barzolvolimab. This review provides an update on the current state of development of treatments for CSU."

Journal • Cardiovascular • Chronic Spontaneous Urticaria • Dermatology • Hematological Disorders • Immunology • Infectious Disease • Neutropenia • Pain • Respiratory Diseases • 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 | Not yet recruiting | Sponsor: Novartis Pharmaceuticals

New P2 trial • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria

RECHARGE 2: Study to Assess Efficacy Safety and Tolerability of Remibrutinib in Adult Patients With Moderate to Severe Hidradenitis Suppurativa (clinicaltrials.gov) - P3 | N=555 | Recruiting | Sponsor: Novartis Pharmaceuticals | Not yet recruiting ➔ Recruiting

Enrollment open • Dermatology • Hidradenitis Suppurativa • Immunology

Novartis BTK inhibitor to be included in priority review in China for the treatment of urticaria [Google translation] (vbdata.cn) - "Novartis' application for the marketing of a Class 1 new drug, remibrutinib tablets, is planned to be included in the priority review. It is suitable for adult patients with chronic spontaneous urticaria (CSU) who still have symptoms after treatment with H1 antihistamines. This marketing application was previously accepted by the CDE on February 27 this year....The first indication of this product is the treatment of chronic spontaneous urticaria. The Phase 3 clinical study for this indication has achieved positive results."

Priority review • Chronic Spontaneous Urticaria • Immunology

Remibrutinib in Chronic Spontaneous Urticaria. (PubMed, N Engl J Med) - P3 | "Treatment with oral remibrutinib resulted in a significant improvement in a composite measure of itching and hives at week 12. (Funded by Novartis Pharmaceuticals; REMIX-1 and REMIX-2 ClinicalTrials.gov numbers, NCT05030311 and NCT05032157, respectively.)."

Clinical • Journal • Cardiovascular • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria

Remibrutinib Exposure in Cerebrospinal Fluid: Insights from a Study in Healthy Participants (AAN 2025) - P3 | "The distribution of remibrutinib into the CSF may imply that remibrutinib may exert pharmacotherapeutic effects in the central nervous system, potentially benefiting conditions such as MS."

Clinical • CNS Disorders • Multiple Sclerosis

RELIEVE: A Study to Investigate the Efficacy, Safety and Tolerability of Remibrutinib Versus Placebo in Adult Patients With Generalized Myasthenia Gravis (clinicaltrials.gov) - P3 | N=180 | Recruiting | Sponsor: Novartis Pharmaceuticals | Not yet recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Myasthenia Gravis

Effect of Remibrutinib on Sleep and Daily Activities in Patients With Chronic Spontaneous Urticaria (CSU) up to Week 52 in the REMIX-1/-2 studies (AAD 2025) - "AIS7 results showed similar trends. In REMIX-1/2, greater proportions of patients receiving remibrutinib showed reduced CSU effects on sleep and activity versus placebo as early as Week 1, with effects sustained through Week 52."

Clinical • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria

An Extension Study of Long-term Efficacy, Safety and Tolerability of Remibrutinib in Chronic Spontaneous Urticaria Patients Who Completed Preceding Studies With Remibrutinib (clinicaltrials.gov) - P3 | N=694 | Active, not recruiting | Sponsor: Novartis Pharmaceuticals | Trial completion date: Feb 2027 ➔ Aug 2027

Trial completion date • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria

Improvements in Itch and Hive Symptoms With Remibrutinib as Early as Week 1 in Patients With Chronic Spontaneous Urticaria (CSU) in REMIX-1/-2 (AAD 2025) - "Patients who transitioned to remibrutinib at Week 24 showed similar reductions to those receiving it from initiation. In the REMIX-1/-2 studies, remibrutinib showed fast and significant improvements in HSS7 and ISS7 as early as Week 1, through to Week 52."

Clinical • 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 | Not yet recruiting | Sponsor: Novartis Pharmaceuticals

New P3 trial • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria

Effects of Remibrutinib Treatment on Ambulatory Blood Pressure in Adult Patients With Chronic Spontaneous Urticaria (CSU) (AAD 2025) - "Remibrutinib showed a favorable tolerability profile with no serious adverse events related to treatment. These data demonstrate that remibrutinib treatment does not have a clinically significant effect on blood pressure in patients with CSU."

Clinical • Cardiovascular • Chronic Spontaneous Urticaria • Dermatology • Hypertension • Immunology • Urticaria

Remibrutinib in patients with moderate to severe hidradenitis suppurativa: Patient reported outcomes from a randomized, phase 2, double-blind, placebo-controlled platform study (AAD 2025) - P2 | "In addition to greater HiSCR rates, remibrutinib showed higher improvement versus placebo in skin pain, skin itch, and DLQI in patients with moderate to severe HS. BTK inhibition may emerge as a promising therapeutic intervention in HS."

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

Efficacy and Safety of Remibrutinib After Switching From Ocrelizumab in Participants Living With Relapsing Multiple Sclerosis. (clinicaltrials.gov) - P3 | N=360 | Not yet recruiting | Sponsor: Novartis Pharmaceuticals

Head-to-Head • New P3 trial • CNS Disorders • Multiple Sclerosis

Novartis data presentations at AAAAI and AAD underscore commitment to advancing treatment of hidradenitis suppurativa (HS) and chronic spontaneous urticaria (CSU) (PRNewswire) - "Novartis announced today it will present data from 17 abstracts, including investigator-initiated trials, across its immunology portfolio at the 2025 American Academy of Allergy Asthma and Immunology (AAAAI) and World Allergy Organization (WAO) Joint Congress and the 2025 American Academy of Dermatology (AAD) Annual Meeting. Data presented at the congresses include long-term urticaria control, sleep, and activity analyses from the Phase III REMIX-1 and REMIX-2 studies evaluating investigational remibrutinib for the treatment of chronic spontaneous urticaria (CSU). Additionally, long-term data from the Cosentyx (secukinumab) Phase III SUNSHINE and SUNRISE trials in patients with hidradenitis suppurativa (HS) and patient-reported outcomes from a Phase II trial evaluating remibrutinib in HS will be presented...These CSU data will support regulatory submissions in the first half of 2025."

Filing • P2 data • P3 data • Chronic Spontaneous Urticaria • Hidradenitis Suppurativa

Effect of Remibrutinib Treatment on the Immune Response to Vaccinations in Healthy Participants (ACTRIMS Forum 2025) - "Interrupted remibrutinib dosing does not relevantly impact immune response to T cell-dependent or T cell-independent vaccines. Concomitant remibrutinib dosing was associated with a lower proportion of responders following T cell-independent PPV-23, and to a lesser extent, T cell-dependent KLH vaccination. Participants showed protective titers for the majority of antigens of the T cell-dependent influenza vaccine at proportions comparable to placebo."

Clinical • Infectious Disease • Influenza • Pneumococcal Infections • Respiratory Diseases

How Does Fenebrutinib Work? Exploring Kinetic and Mechanistic Features That Influence BTK Potency, Selectivity and Pharmacology (ACTRIMS Forum 2025) - P2, P3 | "Fenebrutinib (FEN) is being developed because it is a potent and highly selective noncovalent reversible BTKi that has shown efficacy in several diseases, including a Ph 2 RMS study (NCT05119569) and is currently in Ph 3 trials in RMS (NCT04586010, NCT04586023) and PPMS (NCT04544449).Objectives: Define the BTK binding mechanisms and selectivities of FEN and irreversible covalent inhibitors remibrutinib (REMI), tolebrutinib (TOL) and evobrutinib (EVO); compare their projected relative rates of BTK inhibition at clinical-dose concentrations reported in human CSF. Using biochemical kinetic competition binding assays, we defined binding mechanisms to BTK and to an off-target BMX, a related cytoplasmic protein tyrosine kinase. Fenebrutinib’s slowly reversible binding mechanism allows for potent, selective BTK inhibition and illustrates how kinetic and mechanistic features of drug-target interactions impact pharmacology. Fenebrutinib’s properties and observed..."

CNS Disorders • Hematological Disorders • Immunology • Multiple Sclerosis

Novartis (NVS.US) BTK inhibitor “Remibrutinib“ was the first to apply for listing in China [Google translation] (Sina Corp) - "On February 27, the CDE official website showed that Novartis...BTK inhibitor remibrutinib tablets were the first to be listed in China. Based on the progress of clinical trials and financial report information, it is speculated that the indication reported this time is chronic spontaneous urticaria....Long-term data updated in 2024 showed that the significant symptom improvement demonstrated by remibrutinib at week 12 continued to week 24 compared with placebo."

China filing • Chronic Spontaneous Urticaria

RECHARGE 2: Study to Assess Efficacy Safety and Tolerability of Remibrutinib in Adult Patients With Moderate to Severe Hidradenitis Suppurativa (clinicaltrials.gov) - P3 | N=555 | Not yet recruiting | Sponsor: Novartis Pharmaceuticals

New P3 trial • Dermatology • Hidradenitis Suppurativa • Immunology

Add-on Remibrutinib Quickly Improves Urticaria Control in CSU (HCPLive) - P3 | N=470 | REMIX-1 (NCT05030311) | N=455 | REMIX-2 (NCT05032157) | Sponsor: Novartis Pharmaceuticals | "Add-on remibrutinib quickly improved urticaria control and demonstrated superiority over placebo in patients with chronic spontaneous urticaria...These data will be presented at the 2025 American Academy of Allergy, Asthma, and Immunology (AAAAI)/World Allergy Organization (WAO) Joint Congress....The remibrutinib groups demonstrated fast improvements in mean change from baseline in UCT7 versus placebo at week 2 (REMIX-1: 5.74 versus 1.95; REMIX-2: 5.57 versus 2.27) and week 24 (REMIX-1: 7.17 versus 4.60; REMIX-2: 6.93 versus 4.47), which was sustained through week 52. The remibrutinib groups also had a higher proportion of patients with well controlled urticaria (UCT7 ≥12) at week 24 compared with the placebo groups (REMIX-1: 63.1% versus 41.6%; REMIX-2: 64.8% versus 40.2%), with similar proportions observed at week 52."

P3 data • Chronic Spontaneous Urticaria