Rhapsido

(Remibrutinib)

Phase 3Small molecule

Novartis

Rhapsido is one of 263 small molecule programs targeting Allergy. It is currently in Phase 3.

Indications

Total Trials

Active Trials

262

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

AllergyActive, not recruiting

UrticariaActive, not recruiting

Myasthenia GravisActive, not recruiting

Multiple SclerosisActive, not recruiting

Hidradenitis SuppurativaActive, not recruiting

Chronic Spontaneous UrticariaActive, not recruiting

Relapsing Multiple SclerosisActive, not recruiting

Indication of the Parent ProtocolRecruiting

Chronic PruritusNot yet recruiting

Chronic Spontaneous Urticaria (CSU)Recruiting

AllergyPhase 2

Active, not recruiting

UrticariaPhase 2

Active, not recruiting

Myasthenia GravisPhase 3

Active, not recruiting

Multiple SclerosisPhase 3

Active, not recruiting

Hidradenitis SuppurativaPhase 3

Active, not recruiting

Chronic Spontaneous UrticariaPreclinical

Active, not recruiting

Relapsing Multiple SclerosisPhase 3

Active, not recruiting

Indication of the Parent ProtocolPhase 3

Recruiting

Chronic PruritusPhase 3

Not yet recruiting

Chronic Spontaneous Urticaria (CSU)Phase 3

Recruiting

Showing 10 of 11 indications

Competition

Competitive Landscape

560 competitors in Multiple Sclerosis

#DrugCompanyPhaseTrials

Rhapsido

Novartis

Phase 3

1 2

Kesimpta

Novartis

Preclinical

15 3

Tysabri

Biogen

Preclinical

14 4

Avonex

EMD Serono

Preclinical

22 5

Campath

GGenzyme, a Sanofi Company

Preclinical

12 6

Zinbryta

Roche

Preclinical

2 7

Flomax

Sanofi

Preclinical

1 8

Novantrone

Pred Forte

Myfortic

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

Omalizumab

NCT06042478

Q4 2027

Phase 2Recruiting

Urticaria

NCT06865651

Q1 2028

Phase 3Recruiting

Hidradenitis Suppurativa

NCT06799000

Phase 3Recruiting

Hidradenitis Suppurativa

NCT06840392

Clinical

Trials by Indication[1]

Hidradenitis Suppurativa3 trials

A Phase 3 Study to Assess Efficacy Safety and Tolerability of Remibrutinib in Adult and Adolescent Patients With Moderate to Severe Hidradenitis Suppurativa

Recruiting· Novartis logo

Novartis·Phase 3·NCT06840392·555 enrolled

A Phase 3 Study to Assess Efficacy Safety and Tolerability of Remibrutinib in Adult and Adolescent Patients With Moderate to Severe Hidradenitis Suppurativa (RECHARGE 1)

Recruiting· Novartis logo

Novartis·Phase 3·NCT06799000·555 enrolled

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

Not yet recruiting· Novartis logo

Novartis·Phase 3·NCT07665437·710 enrolled

Relapsing Multiple Sclerosis2 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·NCT06846281·360 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·NCT05156281·1,007 enrolled

Urticaria1 trial

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

Recruiting· Novartis logo

Novartis·Phase 2·NCT06865651·44 enrolled

Efficacy1 trial

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

Active, not recruiting· Novartis logo

Novartis·Phase 3·NCT05976243·362 enrolled

Chronic Spontaneous Urticaria1 trial

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

Available· Novartis logo

Novartis··NCT05170724

11 more indications

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

Renal Impairment1 trial

A Study to Investigate the Pharmacokinetics and Safety of Remibrutinib in Participants With Severe Renal Impairment Compared to Matched Healthy Participants.

Completed· Novartis logo

Novartis·Phase 1·NCT07032272·16 enrolled

Multiple Sclerosis1 trial

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

Active, not recruiting· Novartis logo

Novartis·Phase 3·NCT05147220·1,001 enrolled

Imaging1 trial

A Study of Remibrutinib Using MR Imaging in Relapsing or Progressive MS

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

Myasthenia Gravis1 trial

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

Recruiting· Novartis logo

Novartis·Phase 3·NCT06744920·180 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

Omalizumab1 trial

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.

Active, not recruiting· Novartis logo

Novartis·Phase 3·NCT06042478·470 enrolled

Chronic Pruritus1 trial

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)

Not yet recruiting· Novartis logo

Novartis·Phase 3·NCT07700056·180 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

Chronic Spontaneous Urticaria (CSU)1 trial

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

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

Regulatory

FDA Approval Timeline[4]

Sep 30, 2025

RHAPSIDO

NDA NDA218436

Sources

References

[1]
ClinicalTrials.gov — 19 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

Q1 2028

Trials by Indication[1]

Hidradenitis Suppurativa3 trials

Relapsing Multiple Sclerosis2 trials

Urticaria1 trial

Efficacy1 trial

Chronic Spontaneous Urticaria1 trial

Allergy1 trial

Renal Impairment1 trial

Multiple Sclerosis1 trial

Imaging1 trial

Myasthenia Gravis1 trial

Safety and Efficacy1 trial

Omalizumab1 trial

Chronic Pruritus1 trial

Secondary Progressive Multiple Sclerosis1 trial

Chronic Spontaneous Urticaria (CSU)1 trial

Indication of the Parent Protocol1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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