LOU064

Phase 3Small molecule

Novartis

LOU064 is one of 9 small molecule programs targeting Chronic Spontaneous Urticaria. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

Chronic Spontaneous UrticariaActive, not recruiting

Chronic Spontaneous UrticariaPhase 3

Active, not recruiting

Competition

Competitive Landscape

12 competitors in Chronic Spontaneous Urticaria

#DrugCompanyPhaseTrials

Claritin

PPerrigo Company

Approved

1 2

ICP-332

BBeijing InnoCare Pharma Tech Co., Ltd.

Phase 3

1 3

Barzolvolimab

CCelldex Therapeutics

Phase 3

4 4

JYB1904

JJemincare

Phase 3

2 5

CM512

KKeymed Biosciences Co.Ltd

Phase 2

1 6

Human Interleukin-2 (IL-2) (proleukin)

NNova Scotia Health Authority

Phase 3

1 7

LOU064

Novartis

Phase 3

3 8

BGB-16673

BBeOne Medicines

Phase 1

1 9

BBT001

BBambusa Therapeutics

Preclinical

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

Timeline

Expected Milestones

Q3 2027

Phase 3Active, not recruiting

Chronic Spontaneous Urticaria

NCT05513001

Q4 2027

Phase 2Recruiting

Papulopustular Rosacea

NCT07681271

Q1 2028

Phase 1Recruiting

Hidradenitis Suppurativa

NCT07855276

Q1 2032

Phase 3Active, not recruiting

Chronic Spontaneous Urticaria

NCT05677451

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 logo

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 logo

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 logo

Novartis·Phase 3·NCT05032157·455 enrolled

Chronic Spontaneous Urticaria3 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 logo

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 logo

Novartis·Phase 3·NCT05795153·144 enrolled

A Double-blind, Randomized, Placebo-controlled Trial to Evaluate the Efficacy, Pharmacokinetics and Safety of Remibrutinib (LOU064) for 24 Weeks in Adolescents From 12 to Less Than 18 Years of Age With Chronic Spontaneous Urticaria Inadequately Controlled by H1-antihistamines Followed by an Optional Open-label Extension for up to Another 3 Years and an Optional Safety Long-term Treatment-free Follow-up Period for up to an Additional 3 Years

Active, not recruiting· Novartis logo

Novartis·Phase 3·NCT05677451·100 enrolled

Hidradenitis Suppurativa2 trials

A Randomized, Subject and Investigator Blinded, Placebo-controlled and Multi-center Platform Study, to Assess Efficacy and Safety of Different Investigational Drugs in Patients With Moderate to Severe Hidradenitis Suppurativa

Completed· Novartis logo

Novartis·Phase 2·NCT03827798·248 enrolled

A Randomized, Double-blind, Placebo-controlled Mechanistic Study in Adult Patients With Moderate to Severe Hidradenitis Suppurativa to Explore the Effects of Remibrutinib on Tissue Level

Recruiting· Novartis logo

Novartis·Phase 1·NCT07855276·30 enrolled

Single Dose1 trial

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

Completed· Novartis logo

Novartis·Phase 1·NCT03918980·185 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 logo

Novartis·Phase 3·NCT05048342·71 enrolled

3 more indications

Asthma1 trial

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

Terminated· Novartis logo

Novartis·Phase 2·NCT03944707·76 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 logo

Novartis·Phase 2·NCT07681271·100 enrolled

Unspecified1 trial

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

Completed· Novartis logo

Novartis·Phase 2·NCT04109313·229 enrolled

Sources

References

[1]
ClinicalTrials.gov — 13 trial records for LOU064. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — LOU064 compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for LOU064. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Novartis company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: Novartis

LOU064

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q3 2027

Q4 2027

Q1 2028

Q1 2032

Trials by Indication[1]

Efficacy and Safety3 trials

Chronic Spontaneous Urticaria3 trials

Hidradenitis Suppurativa2 trials

Single Dose1 trial

Safety and Efficacy1 trial

Asthma1 trial

Papulopustular Rosacea1 trial

Unspecified1 trial

References

Drug Info

Quick Facts

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