LOU064

Pipeline

Status by Indication[3][1]

Competition

Competitive Landscape

AsthmaAtopic DermatitisHidradenitis SuppurativaChronic Spontaneous Urticaria

1050 competitors in Asthma

#DrugCompanyPhaseTrials

1

LOU064

Novartis

Phase 3

12

Veramyst

GSK

Preclinical

463

Xolair

Roche

Preclinical

254

Cinqair

Teva

Preclinical

135

Celexa

AbbVie

Preclinical

16

Spiriva

Boehringer Ingelheim

Preclinical

87

Qvar

Chiesi Farmaceutici S.p.A.

Preclinical

88

Atrovent

Boehringer Ingelheim

Preclinical

59

Formoterol Fumarate

AstraZeneca

Preclinical

810

Symbicort

AstraZeneca

Preclinical

6Show 18 more competitors

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Clinical

Trials by Indication[1]

Efficacy and Safety3 trials

This Was a Dose-finding Study to Evaluate Efficacy and Safety of LOU064 in Patients With CSU Inadequately Controlled by H1-antihistamines

Completed·Novartis·Phase 2·NCT03926611·311 enrolled

A Phase 3 Study of Efficacy and Safety of Remibrutinib in the Treatment of CSU in Adults Inadequately Controlled by H1 Antihistamines

Completed·Novartis·Phase 3·NCT05030311·470 enrolled

A Phase 3 Study of Efficacy and Safety of Remibrutinib in the Treatment of CSU in Adults Inadequately Controlled by H1-antihistamines

Completed·Novartis·Phase 3·NCT05032157·455 enrolled

Chronic Spontaneous Urticaria2 trials

An Extension Study of Long-term Efficacy, Safety and Tolerability of Remibrutinib in Chronic Spontaneous Urticaria Patients Who Completed Preceding Studies With Remibrutinib

Active, not recruiting·Novartis·Phase 3·NCT05513001·696 enrolled

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.

Completed·Novartis·Phase 3·NCT05795153·144 enrolled

Safety and Efficacy1 trial

A Safety and Efficacy Study of Remibrutinib in the Treatment of CSU in Japanese Adults Inadequately Controlled by H1-antihistamines

Completed·Novartis·Phase 3·NCT05048342·71 enrolled

Single Dose1 trial

Single Dose and Multiple Dose Study to Assess Safety and Tolerability of LOU064

Completed·Novartis·Phase 1·NCT03918980·185 enrolled

Asthma1 trial

Study of Efficacy and Safety of LOU064 in Inadequately Controlled Asthma Patients

Terminated·Novartis·Phase 2·NCT03944707·76 enrolled

4 more indications

Hidradenitis Suppurativa1 trial

Study of Efficacy and Safety of Investigational Treatments in Patients With Moderate to Severe Hidradenitis Suppurativa

Active, not recruiting·Novartis·Phase 2·NCT03827798·248 enrolled

Double-blind1 trial

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

Recruiting·Novartis·Phase 3·NCT05677451·100 enrolled

Papulopustular Rosacea1 trial

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 2 Study to Investigate the Efficacy, Safety and Tolerability of Remibrutinib (LOU064) in Adult Patients With Papulopustular Rosacea (PPR)

Recruiting·Novartis·Phase 2·NCT07681271·80 enrolled

Unspecified1 trial

An Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of LOU064 in Subjects With CSU

Completed·Novartis·Phase 2·NCT04109313·229 enrolled

Details

Drug Info

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