Rhapsido

(Remibrutinib)

Phase 3Small molecule

Novartis

Rhapsido is one of 84 small molecule programs targeting Relapsing Multiple Sclerosis. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Relapsing Multiple SclerosisActive, not recruiting

Indication of the Parent ProtocolRecruiting

Chronic Spontaneous Urticaria (CSU)Recruiting

Generalized Myasthenia GravisRecruiting

Chronic Spontaneous UrticariaActive, not recruiting

Multiple Sclerosis (MS) - Relapsing-RemittingNot yet recruiting

Chronic Inducible UrticariaActive, not recruiting

Hidradenitis SuppurativaRecruiting

Secondary Progressive Multiple SclerosisRecruiting

Relapsing Multiple SclerosisPhase 3

Active, not recruiting

Indication of the Parent ProtocolPhase 3

Recruiting

Chronic Spontaneous Urticaria (CSU)Phase 3

Recruiting

Generalized Myasthenia GravisPhase 3

Recruiting

Chronic Spontaneous UrticariaPhase 3

Active, not recruiting

Multiple Sclerosis (MS) - Relapsing-RemittingPhase 2

Not yet recruiting

Chronic Inducible UrticariaPhase 3

Active, not recruiting

Hidradenitis SuppurativaPhase 3

Recruiting

Secondary Progressive Multiple SclerosisPhase 3

Recruiting

Competition

Competitive Landscape

36 competitors in Hidradenitis Suppurativa

#DrugCompanyPhaseTrials

Otezla

Amgen

Approved

2 2

Aldactone

Pfizer

Approved

1 3

Soriatane

GSK

Approved

1 4

Daliresp

AstraZeneca

Approved

—5

Botox

RRevance Therapeutics, Inc.

Approved

1 6

Bimzelx

UCB

Phase 3

5 7

Jakafi

Incyte

Phase 3

4 8

Glucophage

Rinvoq

2 10

Rhapsido

Novartis

Phase 3

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

Timeline

Expected Milestones

Q2 2027

Phase 3Recruiting

Chronic Spontaneous Urticaria (CSU)

NCT06868212

Q3 2027

Phase 3Active, not recruiting

Chronic Spontaneous Urticaria

NCT06042478

Phase 2Recruiting

Chronic Spontaneous Urticaria (CSU)

NCT06865651

Q4 2027

Phase 3Active, not recruiting

Hidradenitis Suppurativa

NCT06799000

Phase 3Active, not recruiting

Hidradenitis Suppurativa

NCT06840392

Q3 2028

Phase 3Not yet recruiting

Chronic Spontaneous Urticaria

NCT07816328

Clinical

Trials by Indication[1]

Chronic Spontaneous Urticaria3 trials

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

Available· Novartis logo

Novartis··NCT05170724

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

Not yet recruiting· Novartis logo

Novartis·Phase 3·NCT07816328·382 enrolled

A Global, Multicenter, Randomized, Double-blind, Double-dummy, Parallel-group, Phase 3b Study to Assess the Efficacy, Safety, and Tolerability of Remibrutinib 25 mg b.i.d. in Comparison to Placebo With Omalizumab 300 mg Every 4 Weeks as Active Control Over 52 Weeks in Adult Patients With Chronic Spontaneous Urticaria Inadequately Controlled by Second Generation H1-antihistamines and an Open-label 52-week Optional Extension to Assess Long-term Efficacy, Safety and Tolerability of Remibrutinib 25 mg b.i.d.

Active, not recruiting· Novartis logo

Novartis·Phase 3·NCT06042478·470 enrolled

Hidradenitis Suppurativa3 trials

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

Recruiting· Novartis logo

Novartis·Phase 3·NCT07665437·710 enrolled

A Randomized, Double-blind, Double-dummy, Placebo-controlled, Multicenter, Phase 3 Study Assessing the Efficacy, Safety, and Tolerability of 2 Doses of Remibrutinib Over a 68-week Treatment Period in Adult and Adolescent Patients With Moderate to Severe Hidradenitis Suppurativa (RECHARGE-2)

Active, not recruiting· Novartis logo

Novartis·Phase 3·NCT06840392·565 enrolled

Active, not recruiting· Novartis logo

Novartis·Phase 3·NCT06799000·588 enrolled

Relapsing Multiple Sclerosis3 trials

A Randomized, Open-label, Parallel-group, Non-inferiority Study Comparing Efficacy, Safety, and Tolerability of Remibrutinib After Switching From Ocrelizumab in Participants Living With Relapsing Multiple Sclerosis, Followed by Open-label Treatment With Remibrutinib

Recruiting· Novartis logo

Novartis·Phase 3·NCT06846281·400 enrolled

A Randomized, Double-blind, Double-dummy, Parallel-group Study, Comparing the Efficacy and Safety of Remibrutinib Versus Teriflunomide in Participants With Relapsing Multiple Sclerosis, Followed by Extended Treatment With Open-label Remibrutinib

Active, not recruiting· Novartis logo

Novartis·Phase 3·NCT05147220·1,000 enrolled

Active, not recruiting· Novartis logo

Novartis·Phase 3·NCT05156281·1,007 enrolled

Chronic Pruritus2 trials

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)

Recruiting· Novartis logo

Novartis·Phase 3·NCT07811869·180 enrolled

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)

Recruiting· Novartis logo

Novartis·Phase 3·NCT07700056·180 enrolled

Chronic Spontaneous Urticaria (CSU)2 trials

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)

Recruiting· Novartis logo

Novartis·Phase 2·NCT06865651·44 enrolled

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

Recruiting· Novartis logo

Novartis·Phase 3·NCT06868212·400 enrolled

9 more indications

Multiple Sclerosis (MS) - Relapsing-remitting2 trials

An Open-label, Single-center Study of Remibrutinib Using Ultra High-field (7T) MR Imaging in Relapsing or Progressive MS (RemiSeven)

Not yet recruiting·MMoein Amin·Phase 2·NCT07222956·20 enrolled

REMIBRUTINIB: EVALUATION OF FLUID AND INFLAMMATORY NEUROIMAGING ENDPOINTS IN MULTIPLE SCLEROSIS (REDEFINE-MS)

Recruiting·WWashington University School of Medicine··NCT07758270·15 enrolled

Allergy1 trial

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

Completed· Novartis logo

Novartis·Phase 2·NCT05432388·76 enrolled

Safety and Efficacy1 trial

A Phase 2 Study to Evaluate the Safety and Efficacy of LOU064 in Patients With Moderate to Severe Sjögren's Syndrome

Terminated· Novartis logo

Novartis·Phase 2·NCT04035668·73 enrolled

Autoimmune and Chronic Inflammatory Diseases1 trial

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

Completed· Novartis logo

Novartis·Phase 1·NCT07032272·16 enrolled

Food Allergy1 trial

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

Recruiting· Novartis logo

Novartis·Phase 3·NCT07768371·576 enrolled

Indication of the Parent Protocol1 trial

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.

Recruiting· Novartis logo

Novartis·Phase 3·NCT07456891·648 enrolled

Chronic Inducible Urticaria1 trial

A 52-week Multi-center, Randomized, Double-blind, Placebo Controlled, Basket Study With an Open-label Extension to Investigate the Efficacy, Safety, and Tolerability of Remibrutinib (LOU064) in Chronic Inducible Urticaria (CINDU) in Adults Inadequately Controlled by H1-antihistamines

Active, not recruiting· Novartis logo

Novartis·Phase 3·NCT05976243·362 enrolled

Generalized Myasthenia Gravis1 trial

A Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy, Safety, and Tolerability of Remibrutinib in Patients With Generalized Myasthenia Gravis, Followed by an Open-label Extension Phase

Recruiting· Novartis logo

Novartis·Phase 3·NCT06744920·180 enrolled

Secondary Progressive Multiple Sclerosis1 trial

A Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of Remibrutinib in Patients With Secondary Progressive Multiple Sclerosis

Recruiting· Novartis logo

Novartis·Phase 3·NCT07225504·1,275 enrolled

Regulatory

FDA Approval Timeline[4]

Sep 30, 2025

RHAPSIDO

NDA NDA218436

Sources

References

[1]
ClinicalTrials.gov — 23 trial records for Remibrutinib. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Remibrutinib compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Remibrutinib. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA218436). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Rhapsido. U.S. Food & Drug Administration.
[6]
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

Patent Landscape[5]

Patent Cliff

Nov 13, 2034

Earliest patent expiration — generic entry possible after this date

Patent #Expires

10457647Nov 13, 2034

9512084Nov 13, 2034

12419889Jan 20, 2043

Rhapsido

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q2 2027

Q3 2027

Q4 2027

Q3 2028

Trials by Indication[1]

Chronic Spontaneous Urticaria3 trials

Hidradenitis Suppurativa3 trials

Relapsing Multiple Sclerosis3 trials

Chronic Pruritus2 trials

Chronic Spontaneous Urticaria (CSU)2 trials

Multiple Sclerosis (MS) - Relapsing-remitting2 trials

Allergy1 trial

Safety and Efficacy1 trial

Autoimmune and Chronic Inflammatory Diseases1 trial

Food Allergy1 trial

Indication of the Parent Protocol1 trial

Chronic Inducible Urticaria1 trial

Generalized Myasthenia Gravis1 trial

Secondary Progressive Multiple Sclerosis1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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