remibrutinib
remibrutinib: sourced relationships with 1 company · 18 clinical trials tracked · 1 FDA decision.
remibrutinib evidence translation
What we can confirm
1 FDA record · 18 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.
Dated Pipeline Records (3)
| Company | Dated record stage |
|---|---|
| Novartis AG (NVS) Reported 2025-09-30 · Current development: unknownSource Chronic Pruritus of Unknown Origin; Indication of the Parent… | Phase 3 |
| Novartis AG (NVS) Reported 2025-09-30 · Current development: unknownSource Papulopustular Rosacea; Chronic Spontaneous Urticaria; Aller… | Phase 3 |
| Novartis AG (NVS) Reported 2025-09-30 · Current development: unknownSource | Phase 3 |
Clinical Trial Registry Records (18)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 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 Global, Multi-center, Open-label Study, Investigating a Remibrutinib- and Omalizumab-Based Treatment Algorithm in Adult Patients With Chronic Spontaneous Urticaria Inadequately Controlled by H1-Antihistamines, to Achieve Fast and Well-Controlled Disease Within 24 Weeks
Primary endpoint: Proportion of participants achieving Urticaria Activity Score over 7 days (UAS7) ≤6 (yes/no)
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)
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)
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 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
Frequently asked questions
Which companies have sourced relationships with remibrutinib?
remibrutinib has dated SEC/FDA relationship records for Novartis AG.
How many clinical trials involve remibrutinib?
BioSniper tracks 18 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.