Is Zanubrutinib registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 1 valid registration of Zanubrutinib, including Brukinsa (80 mg, Capsule, SAR 26739.45).

Is Zanubrutinib approved by the US FDA?

Drugs@FDA lists 3 application product lines for Zanubrutinib, including BRUKINSA (Prescription); BRUKINSA (Prescription); BRUKINSA (Discontinued).

Is Zanubrutinib authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Zanubrutinib: Brukinsa.

Is Zanubrutinib on the WHO Model List of Essential Medicines?

Yes — 8.2.2. Targeted therapies (complementary list): Therapeutic equivalent to ibrutinib for Chronic lymphocytic leukaemia or small lymphocytic lymphoma.

Are there safety signals or safety updates for Zanubrutinib?

US FDA: 1 entry (latest 2024-06-04).

Active substance

Zanubrutinib

SFDA 1
US FDA 3
EMA 1
Health Canada 2
WHO EML 1
Safety 1

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Brukinsa	80 mg	Capsule · Oral use	120 Bottle	SAR 26739.45	NCE · Prescription	BEONE MEDICINES	Valid

Indications — CHI Daman Drug Formulary

CHRONIC LYMPHOCYTIC LEUKEMIA (CLL); FOLLICULAR LYMPHOMA; LYMPHOPLASMACYTIC LYMPHOMA; MANTLE CELL LYMPHOMA; MARGINAL ZONE LYMPHOMA

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
BRUKINSA	160MG	tablet · oral	BEONE MEDICINES USA	Prescription	10 Jun 2025
BRUKINSA	80MG	capsule · oral	BEONE MEDICINES USA	Prescription	10 Jun 2025
BRUKINSA	80MG	capsule · oral	BEONE MEDICINES USA	Discontinued	14 Nov 2019

EMA European Union — centrally authorised medicines

Brukinsa BeOne Medicines Ireland Limited · Authorised · authorised 22 Nov 2021 · ATC L01EL03

Therapeutic indication (EMA)

Brukinsa as monotherapy is indicated for the treatment of adult patients with Waldenström’s macroglobulinaemia (WM) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo-immunotherapy. Brukinsa as monotherapy is indicated for the treatment of adult patients with marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based therapy. Brukinsa as monotherapy is indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL). Brukinsa in combination with obinutuzumab is indicated for the treatment of adult patients with refractory or relapsed follicular lymphoma (FL) who have received at least two prior systemic therapies.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
BRUKINSA	02512963	80 MG	CAPSULE · ORAL	BEONE MEDICINES I GMBH
BRUKINSA	02554267	160 MG	TABLET · ORAL	BEONE MEDICINES I GMBH

WHO WHO Model List of Essential Medicines (2025)

8.2.2. Targeted therapies · complementary
Therapeutic equivalent to ibrutinib for Chronic lymphocytic leukaemia or small lymphocytic lymphoma

Safety signals and safety-related labeling changes

US FDA 4 Jun 2024 BRUKINSA — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for zanubrutinib →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.