All FDA-approved EMA-approved PMDA-approved
Target Card Uniprot Example: P23975

remibrutinib 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Stem definition	Drug id	CAS RN
agammaglobulinaemia tyrosine kinase (Bruton tyrosine kinase) inhibitors	5798	1787294-07-8

Description:

Molecule

Description

Molfile Inchi Smiles Synonyms: remibrutinib rhapsido LOU064

Remibrutinib is a selective Bruton's tyrosine kinase (BTK) inhibitor that forms a covalent bond with a cysteine residue in the BTK active site, leading to durable inactivation of BTK. The therapeutic effect of remibrutinib in CSU is achieved through inhibition of 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. Molecular weight: 507.54 Formula: C27H27F2N5O3 CLOGP: 4.47 LIPINSKI: 1 HAC: 8 HDO: 2 TPSA: 110.44 ALOGS: ROTB: 9 Status: ONP Legend: OFP - off patent OFM - off market ONP - on patent

Drug dosage:

None

ADMET properties:

None

Predicted pharmacokinetic/toxicological properties (PK-AZ):

None

Approvals:

Date	Agency	Company	Orphan
Sept. 30, 2025	FDA	Novartis
April 23, 2026	EMA	Novartis Europharm Limited

FDA Adverse Event Reporting System (Female)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Petechiae	371.92	75.77	60	229	15681	90612477
Contusion	96.23	75.77	34	255	251182	90376976
Heavy menstrual bleeding	83.73	75.77	18	271	20512	90607646

FDA Adverse Event Reporting System (Male)

None

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Petechiae	126.77	69.27	22	110	23295	110565872

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	L04AA60	ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS IMMUNOSUPPRESSANTS IMMUNOSUPPRESSANTS Selective immunosuppressants
MeSH PA	D000092004	Tyrosine Kinase Inhibitors
MeSH PA	D004791	Enzyme Inhibitors
MeSH PA	D047428	Protein Kinase Inhibitors
FDA EPC	N0000175605	Kinase Inhibitor
FDA MoA	N0000185503	P-Glycoprotein Inhibitors
FDA MoA	N0000193934	Brutons Tyrosine Kinase Inhibitors
CHEBI has role	CHEBI:35705	immunosuppressive agent
CHEBI has role	CHEBI:38637	tyrosine kinase inhibitor

Related Drugs by ATC class:

L04AA Selective immunosuppressants 10 drugs

abataceptalefaceptapremilastbelataceptbelumosudilcladribinegusperimusimlifidasemycophenolic acidnerandomilast

Drug Use | Suggest Off label Use Form| |View source of the data|

Disease	Relation	SNOMED_ID	DOID
Chronic spontaneous urticaria (CSU)	indication	302162004

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
25MG	RHAPSIDO	NOVARTIS	N218436	Sept. 30, 2025	RX	TABLET	ORAL	10457647	Nov. 13, 2034	TREATMENT OF CHRONIC AUTOIMMUNE URTICARIA
25MG	RHAPSIDO	NOVARTIS	N218436	Sept. 30, 2025	RX	TABLET	ORAL	12419889	Jan. 19, 2043	TREATMENT OF CHRONIC SPONTANEOUS URTICARIA

Orange Book exclusivity data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
25MG	RHAPSIDO	NOVARTIS	N218436	Sept. 30, 2025	RX	TABLET	ORAL	Sept. 30, 2030	NEW CHEMICAL ENTITY

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Tyrosine-protein kinase BTK	Kinase	Q06187	BTK_HUMAN	INHIBITOR	IC50	8.39		DRUG LABEL	DRUG LABEL
Potassium voltage-gated channel subfamily H member 2	Ion channel	Q12809	KCNH2_HUMAN		IC50	5.85		CHEMBL
Bile salt export pump	Transporter	O95342	ABCBB_HUMAN		IC50	5.18		CHEMBL
Epidermal growth factor receptor	Kinase	P00533	EGFR_HUMAN		Kd	4.52		CHEMBL
Receptor tyrosine-protein kinase erbB-2	Kinase	P04626	ERBB2_HUMAN		Kd	4.52		CHEMBL
Receptor tyrosine-protein kinase erbB-4	Kinase	Q15303	ERBB4_HUMAN		Kd	4.52		CHEMBL
Tyrosine-protein kinase JAK3	Kinase	P52333	JAK3_HUMAN		Kd	4.72		CHEMBL
Tyrosine-protein kinase ITK/TSK	Kinase	Q08881	ITK_HUMAN		Kd	4.52		CHEMBL
Tyrosine-protein kinase Tec	Kinase	P42680	TEC_HUMAN		Kd	7.11		CHEMBL
Tyrosine-protein kinase TXK	Kinase	P42681	TXK_HUMAN		Kd	4.77		CHEMBL
Tyrosine-protein kinase Blk	Kinase	P51451	BLK_HUMAN		Kd	4.52		CHEMBL
Phosphatidylinositol 4-kinase beta	Kinase	Q9UBF8	PI4KB_HUMAN		IC50	5.51		CHEMBL
Cytoplasmic tyrosine-protein kinase BMX	Kinase	P51813	BMX_HUMAN		Kd	6.27		CHEMBL

External reference:

ID	Source
CHEMBL4483575	ChEMBL_ID
C000722911	MESH_SUPPLEMENTAL_RECORD_UI
DB16852	DRUGBANK_ID
4044286	VANDF
C5446791	UMLSCUI
CHEBI:746867	CHEBI
11062	INN_ID
118107483	PUBCHEM_CID
398451	MMSL
44469	MMSL
d10331	MMSL
020264	NDDF
10457	IUPHAR_LIGAND_ID
I7MVZ8HDNU	UNII
2724365	RXNORM
D12285	KEGG_DRUG

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
RHAPSIDO	HUMAN PRESCRIPTION DRUG LABEL	1	0078-1483	TABLET	25 mg	ORAL	NDA	28 sections