remibrutinib
remibrutinib: developed by 1 company · 16 clinical trials tracked · 1 FDA decision.
remibrutinib evidence translation
What we can confirm
1 FDA record · 16 tracked trials
What it means
What to watch
Prepared research question
How could remibrutinib → NVS affect its developer, and what evidence supports the link?
Traceable citations · Unknowns marked
See linked entities and source evidence8 indications · 0 study sponsors
Related indications
Study sponsors
No additional listed-company sponsor is linked.
Development Pipeline (3)
| Company | Phase |
|---|---|
| Novartis AG (NVS) Chronic Spontaneous Urticaria; Papulopustular Rosacea; Aller… | Phase 3 |
| Novartis AG (NVS) | Phase 3 |
| Novartis AG (NVS) Indication of the Parent Protocol; Chronic Spontaneous Urtic… | Phase 3 |
Clinical Trials (16)showing 10 most recent
An Open-label, Single-center Study of Remibrutinib Using Ultra High-field (7T) MR Imaging in Relapsing or Progressive MS (RemiSeven)
Primary endpoint: Quantitative MRI volumetric measurements
A 52-week Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess Efficacy and Safety of Remibrutinib (LOU064) in Adult and Adolescent Participants With IgE-mediated Food Allergy
Primary endpoint: Sub-study 1: Number of participants achieving response status (tolerated at least 600 mg of peanut protein)
REMIBRUTINIB: EVALUATION OF FLUID AND INFLAMMATORY NEUROIMAGING ENDPOINTS IN MULTIPLE SCLEROSIS (REDEFINE-MS)
Primary endpoint: Change in Microglial Activity Measured by [11C]-DPA-713 PET
A 52-week Multi-center, Randomized, Double-blind, Placebo Controlled Phase 3 Study to Evaluate the Efficacy, Safety and Tolerability of Remibrutinib in Adult Participants With Severe Chronic Pruritus of Unknown Origin (CPUO)
Primary endpoint: Proportion of participants achieving ≥4 point reduction from baseline in Worst itch Numerical Rating Scale (WI NRS)
A Double-blind, Double-dummy, Parallel Group, Multicenter Phase 3 Extension Study Evaluating the Long-term Safety and Efficacy of 2 Doses of Remibrutinib in Adult Participants With Moderate to Severe Hidradenitis Suppurativa
Primary endpoint: Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
An Open-label, Multi-center Protocol for Patients Who Have Completed a Previous Novartis Sponsored Remibrutinib Study and Are Judged by the Investigator to Benefit From Continued Treatment With Remibrutinib.
Primary endpoint: Number of participants with the occurrence of AEs or SAEs
A Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of Remibrutinib in Patients With Secondary Progressive Multiple Sclerosis
Primary endpoint: Time to 6-month confirmed disability progression (6mCDP) on Expanded Disability Status Scale (EDSS)
A Phase 1, Open-label Study to Investigate the Pharmacokinetics and Safety of Remibrutinib (LOU064) in Participants With Severe Renal Impairment Compared to Matched Healthy Participants With Normal Renal Function
Primary endpoint: Cmax, ss of remibrutinib in blood
A US Phase 3b, Multi-center, Randomized, Double-blind, Double-Dummy 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
Primary endpoint: Absolute change from baseline in Weekly Urticaria Activity Score (UAS7) at Week 4
A 12-week Randomized, Participant and Investigator-blinded, Placebo-controlled, Exploratory Study in Adult Participants With Chronic Urticaria to Assess the Efficacy and Safety and Explore the Mechanism of Action of Remibrutinib (LOU064)
Primary endpoint: Absolute change from baseline in the weekly most bothersome symptom Numeric Rating Scale (NRS) score on the Urticaria Symptom Daily Diary (USDD)
Frequently asked questions
Who is developing remibrutinib?
remibrutinib is being developed by Novartis AG.
How many clinical trials involve remibrutinib?
BioSniper tracks 16 clinical trials involving remibrutinib.
What is remibrutinib's latest FDA decision?
The most recent tracked FDA decision for remibrutinib is Approval, dated September 30, 2025.