Remibrutinib

Generic Name: Remibrutinib

Drug Type: Small Molecule

Chemical Formula: C_₂₇H_₂₇F_₂N_₅O_₃

CAS Number: 1787294-07-8

Unique Ingredient Identifier: I7MVZ8HDNU

Clinical Trials

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

Phase 3

Not yet recruiting

Conditions: Chronic Spontaneous Urticaria (CSU)

Interventions: Drug: Remibrutinib
Drug: Remibrutinib matching placebo
Drug: Placebo solution for injection
Drug: Dupilumab

First Posted Date: 2025-03-10

Last Posted Date: 2025-03-10

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 400

Registration Number: NCT06868212

Study of Remibrutinib (LOU064) Efficacy and Safety and Exploration of Its Mechanism of Action in Participants With Chronic Urticaria

Phase 2

Not yet recruiting

Conditions: Chronic Urticaria (CU): Chronic Inducible Urticaria (CINDU) and Chronic Spontaneous Urticaria (CSU)

Interventions: Drug: Remibrutinib
Drug: Placebo

First Posted Date: 2025-03-10

Last Posted Date: 2025-05-18

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 44

Registration Number: NCT06865651

A Study to Investigate the Efficacy, Safety and Tolerability of Remibrutinib Versus Placebo in Adult Patients With Generalized Myasthenia Gravis

Phase 3

Recruiting

Conditions: Generalized Myasthenia Gravis

Interventions: Drug: Remibrutinib (Blinded)
Other: Placebo
Drug: Remibrutinib (Open Label)

First Posted Date: 2024-12-20

Last Posted Date: 2025-04-24

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 180

Registration Number: NCT06744920

Locations: 🇺🇸
Dent Neurological Institute, Buffalo, New York, United States

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.

Phase 3

Recruiting

Conditions: Chronic Spontaneous Urticaria

Interventions: Drug: Omalizumab
Drug: Placebo to omalizumab
Drug: Remibrutinib
Drug: Placebo to remibrutinib

First Posted Date: 2023-09-18

Last Posted Date: 2025-05-06

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 468

Registration Number: NCT06042478

Locations: 🇻🇳
Novartis Investigative Site, Ho Chi Minh, Vietnam

A Study to Investigate Efficacy, Safety, and Tolerability of Remibrutinib Compared With Placebo in Adults With CINDU Inadequately Controlled by H1-antihistamines

Phase 3

Recruiting

Conditions: Chronic Inducible Urticaria

Interventions: Drug: Remibrutinib
Other: Placebo

First Posted Date: 2023-08-04

Last Posted Date: 2025-05-06

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 348

Registration Number: NCT05976243

Locations: 🇺🇸
Allervie Clinical Research, Birmingham, Alabama, United States
🇺🇸
Acuro Research Inc, Little Rock, Arkansas, United States
🇺🇸
Kern Research, Bakersfield, California, United States

and more 27 locations

A Multicenter, Open-label Phase 3 Study: Ambulatory Blood Pressure Monitoring in Adult Patients With Chronic Spontaneous Urticaria Inadequately Controlled by H1-antihistamines Treated With Remibrutinib up to 12 Weeks.

Phase 3

Completed

Conditions: Chronic Spontaneous Urticaria

Interventions: Drug: LOU064

First Posted Date: 2023-04-03

Last Posted Date: 2025-04-30

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 144

Registration Number: NCT05795153

Locations: 🇺🇸
Acuro Research Inc, Little Rock, Arkansas, United States
🇺🇸
Florida Ctr Allergy Asthma Research, Aventura, Florida, United States
🇺🇸
Finlay Medical Research, Greenacres City, Florida, United States

and more 8 locations

Study of Efficacy, Safety and Tolerability of Remibrutinib in Adult Participants With an Allergy to Peanuts

Phase 2

Completed

Conditions: Allergy, Peanut

Interventions: Drug: remibrutinib
Drug: placebo

First Posted Date: 2022-06-27

Last Posted Date: 2025-05-20

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 76

Registration Number: NCT05432388

Locations: 🇺🇸
Western Sky Medical Research, El Paso, Texas, United States
🇺🇸
Allergy Associates of Utah, Sandy, Utah, United States
🇺🇸
Seattle Allergy and Asthma Rsch, Seattle, Washington, United States

and more 20 locations

Global Managed Access Program Cohort for Remibrutinib in Adult Patients With Chronic Spontaneous Urticaria

Conditions: Chronic Spontaneous Urticaria

First Posted Date: 2021-12-28

Last Posted Date: 2024-10-28

Lead Sponsor: Novartis Pharmaceuticals

Registration Number: NCT05170724

Efficacy and Safety of Remibrutinib Compared to Teriflunomide in Participants With Relapsing Multiple Sclerosis (RMS)

Phase 3

Recruiting

Conditions: Relapsing Multiple Sclerosis

Interventions: Drug: Remibrutinib
Drug: Teriflunomide

First Posted Date: 2021-12-14

Last Posted Date: 2025-04-30

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 800

Registration Number: NCT05156281

Locations: 🇺🇸
Neurocare Plus, Houston, Texas, United States
🇺🇸
Ctr for Neurology and Spine, Phoenix, Arizona, United States
🇺🇸
Vladimir Royter MD APMC, Hanford, California, United States

and more 57 locations

Efficacy and Safety of Remibrutinib Compared to Teriflunomide in Participants With Relapsing Multiple Sclerosis (RMS)

Phase 3

Recruiting

Conditions: Relapsing Multiple Sclerosis

Interventions: Drug: Remibrutinib
Drug: Teriflunomide

First Posted Date: 2021-12-07

Last Posted Date: 2025-03-03

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 800

Registration Number: NCT05147220

Locations: 🇺🇸
US Associates in Research, Miami, Florida, United States
🇺🇸
AZ Integrated Neuro and Spine, Phoenix, Arizona, United States
🇺🇸
Honor Health Research Institute, Scottsdale, Arizona, United States

and more 69 locations

Drug Development Updates

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