Remibrutinib

Kinase Inhibitor — ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS

Key facts

Remibrutinib is an onp drug in the Kinase Inhibitor class catalogued in DrugCentral. It was first approved by the FDA in 2025. Its mechanism of action is classified as Brutons Tyrosine Kinase Inhibitors and P-Glycoprotein Inhibitors. DrugCentral lists 13 molecular targets, including BTK, TEC and BMX. Recorded indications include Chronic spontaneous urticaria (CSU).

• Approval status: onp (first approved 2025 by the FDA).
• Drug class: Kinase Inhibitor.
• Mechanism of action: Brutons Tyrosine Kinase Inhibitors; P-Glycoprotein Inhibitors.
• Molecular targets: BTK, TEC, BMX and KCNH2 (13 listed in DrugCentral).
• Indications: Chronic spontaneous urticaria (CSU).
• ATC code: L04AA60 (Selective immunosuppressants).
• Molecular formula: C27H27F2N5O3; molecular weight 507.54 g/mol.

Indications & contraindications

Drug–disease relationships curated by DrugCentral (OMOP / SNOMED concepts).

Indications (1)

• Chronic spontaneous urticaria (CSU)

Mechanism & targets

• Mechanism of action (MoA): Brutons Tyrosine Kinase Inhibitors; P-Glycoprotein Inhibitors
• Established pharmacologic class: Kinase Inhibitor

Molecular targets (13)

Target	Gene	Action	Activity
Tyrosine-protein kinase BTK	BTK	inhibitor	IC50 8.39
Tyrosine-protein kinase Tec	TEC	unknown	Kd 7.11
Cytoplasmic tyrosine-protein kinase BMX	BMX	unknown	Kd 6.27
Potassium voltage-gated channel subfamily H member 2	KCNH2	unknown	IC50 5.85
Phosphatidylinositol 4-kinase beta	PI4KB	unknown	IC50 5.51
Bile salt export pump	ABCB11	unknown	IC50 5.18
Tyrosine-protein kinase TXK	TXK	unknown	Kd 4.77
Tyrosine-protein kinase JAK3	JAK3	unknown	Kd 4.72
Tyrosine-protein kinase Blk	BLK	unknown	Kd 4.52
Epidermal growth factor receptor	EGFR	unknown	Kd 4.52
Receptor tyrosine-protein kinase erbB-2	ERBB2	unknown	Kd 4.52
Receptor tyrosine-protein kinase erbB-4	ERBB4	unknown	Kd 4.52
Tyrosine-protein kinase ITK/TSK	ITK	unknown	Kd 4.52

Regulatory approvals (2)

Date	Agency	Marketed as	Applicant	Orphan
2026-04-23	EMA	—	Novartis Europharm Limited
2025-09-30	FDA	—	Novartis

ATC classification

ATC code	Therapeutic hierarchy
L04AA60	ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS › IMMUNOSUPPRESSANTS › IMMUNOSUPPRESSANTS › Selective immunosuppressants

Reported adverse-event signals

Strongest FDA FAERS disproportionality signals (log-likelihood ratio). A signal is a statistical association in spontaneous reports, not proof that the drug causes the event.

MedDRA term	LLR
Petechiae	437.6
Contusion	112.8
Heavy menstrual bleeding	86.5

Chemical structure

Full physicochemical, ADMET and 3D-structure analysis of Remibrutinib is on its molecule page.

• Molecular formula: C₂₇H₂₇F₂N₅O₃
• Molecular weight: 507.54 g/mol
• CAS number: —
• InChIKey: CUABMPOJOBCXJI-UHFFFAOYSA-N
• PubChem CID: 118107483

CC1=C(C=C(C=C1NC(=O)C2=C(C=C(C=C2)C3CC3)F)F)C4=C(C(=NC=N4)N)OCCN(C)C(=O)C=C

Frequently asked questions

Answers are generated from the structured data on this page, not written by hand.

What is Remibrutinib used for?

DrugCentral lists the following indications for Remibrutinib: Chronic spontaneous urticaria (CSU).

How does Remibrutinib work?

Remibrutinib is classified as Brutons Tyrosine Kinase Inhibitors and P-Glycoprotein Inhibitors; its molecular targets in DrugCentral include BTK (inhibitor), TEC, BMX and KCNH2.

When was Remibrutinib first approved?

Remibrutinib was first approved by the FDA in 2025.

What drug class does Remibrutinib belong to?

Remibrutinib is in the Kinase Inhibitor class.

What is the chemical formula of Remibrutinib?

Remibrutinib has the molecular formula C27H27F2N5O3 and a molecular weight of 507.54 g/mol.

Sources

• DrugCentral drug card 5798 — structure, indications, targets, approvals, pharmacologic classes (CC BY-SA 4.0)
• ChEMBL CHEMBL4483575 — compound record and bioactivity
• PubChem CID 118107483 — chemical identifiers
• DrugBank DB16852 — drug record
• FDA UNII I7MVZ8HDNU — substance identity
• DailyMed: FDA labels for Remibrutinib — current prescribing information (label search)
• UniProt Q06187 (BTK) — target protein
• UniProt P42680 (TEC) — target protein
• UniProt P51813 (BMX) — target protein
• UniProt Q12809 (KCNH2) — target protein
• UniProt Q9UBF8 (PI4KB) — target protein
• UniProt O95342 (ABCB11) — target protein
• FDA Adverse Event Reporting System (openFDA FAERS) — adverse-event signals, as aggregated by DrugCentral

How this page is built: methodology · editorial policy & corrections.