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  1. pharmadog
  2. ›drugs
  3. ›Rhapsido
drug · small molecule
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remibrutinib

Marketedupdated 3mo ago
by $NVS NOVARTIS AG🔗 ChEMBL
Approved
community read0 votes

🐶 often sniffed alongside

top 3
  • tagApproval4 co-mentions · 1 sources
  • drugRHAPSIDO4 co-mentions · 1 sources
  • tagSmall Molecule2 co-mentions · 1 sources

Small molecule drug with a maximum clinical stage of Approval (across all indications), with an approval for immune system disease and 5 investigational indications.

all catalysts(1)

approval · 1
Sep 30, 2025
approval
$NVS151.97+0.72%
11mo ago
RHAPSIDO (REMIBRUTINIB) — FDA approval
remibrutinib
→

Trials studying remibrutinib

  • phase3A 52-week Study of Remibrutinib in IgE-mediated Food Allergynot yet recruitingn=576
  • phase2Study of Remibrutinib (LOU064) Efficacy and Safety and Exploration of Its Mechanism of Action in Participants With Chronic Urticariarecruitingn=44
  • phase3A Study to Evaluate the Efficacy and Safety of Remibrutinib in Secondary Progressive Multiple Sclerosisrecruitingn=1,275
  • phase3A Phase 3 Study to Assess Efficacy Safety and Tolerability of Remibrutinib in Adult and Adolescent Patients With Moderate to Severe Hidradenitis Suppurativaactive not recruitingn=565
  • phase3A Study to Investigate the Efficacy, Safety and Tolerability of Remibrutinib Versus Placebo in Adult Patients With Generalized Myasthenia Gravisrecruitingn=180
  • phase3Efficacy and Safety of Remibrutinib Compared to Teriflunomide in Participants With Relapsing Multiple Sclerosis (RMS)active not recruitingn=1,000
  • phase3Efficacy and Safety of Remibrutinib Compared to Teriflunomide in Participants With Relapsing Multiple Sclerosis (RMS)active not recruitingn=1,007
  • phase3Efficacy and Safety of Remibrutinib After Switching From Ocrelizumab in Participants Living With Relapsing Multiple Sclerosis.recruitingn=360
more trials →

Patent cliff

source: FDA Orange Book
first barrier falls
Sep 30, 2030
~4.1 years out

Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.

patents (3)

  • Jan 20, 2043method-of-use (U-4281)US 12419889
  • Nov 13, 2034method-of-use (U-4280)US 10457647
  • Nov 13, 2034compositionUS 9512084

FDA exclusivities (1)

  • Sep 30, 2030NCENew Chemical Entity (5y)4.1y

News(2)

  • Processa acquires Vidya for potential BTK inhibitor rival to Novartis’ Rhapsido
    Processa Pharmaceuticals has made a push into the autoimmune space via the acquisition of Vidya Therapeutics, which delivers a potential rival to Novartis’ Rhapsido.
    fiercebiotech · 19d ago
  • Novartis climbs on upbeat drug sales as key readouts loom
    A return to quarterly sales growth boosted shares higher on Tuesday, though a handful of coming study results will have a bigger impact on the company’s long-term outlook.
    biopharma_dive · 27d ago
brand
Rhapsido
generic
remibrutinib
MOA
12.1 Mechanism of Action Remibrutinib is an oral, small molecule kinase inhibitor that inhibits Bruton’s tyrosine kinase (BTK). BTK is an intracellular protein expressed in mast cells, basophils, B cells, macrophages, and thrombocytes. BTK is involved in intracellular signaling via Fc epsilon receptor-1 (FcεR1), Fc gamma receptors (FcγR), and the B cell antigen receptor (BCR). Remibrutinib also inhibits the BTK-related kinases tec protein tyrosine kinase (TEC) and BMX non-receptor tyrosine kinase (BMX). Remibrutinib inhibits mast cell and basophil degranulation, including release of histamine and other proinflammatory mediators, mediated by pathogenic IgE or IgG directed against the FcεR1 or IgE.
indication
Chronic Inducible Urticaria
phase
marketed
Data sources
openFDA · ClinicalTrials.gov · OpenTargets
last refreshed 16m ago
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