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ZANUBRUTINIB
CAS NO.: 1691249-45-2
Chemical Formula: C27H29N5O3
Molecular Weight: 471.5000
DMF&GMP status: Please contact us for more details.
Description:
Zanubrutinib is an inhibitor of Bruton's tyrosine kinase (BTK) with potential antineoplastic activity. Upon administration, zanubrutinib inhibits the activity of BTK and prevents the activation of the B-cell antigen receptor (BCR) signaling pathway. This prevents both B-cell activation and BTK-mediated activation of downstream survival pathways, which leads to the inhibition of the growth of malignant B-cells that overexpress BTK. BTK, a member of the Src-related BTK/Tec family of cytoplasmic tyrosine kinases, is overexpressed in B-cell malignancies; it plays an important role in B-lymphocyte development, activation, signaling, proliferation and survival.

Zanubrutinib is an oral inhibitor of Bruton’s tyrosine kinase that is used in the therapy of refractory mantle cell lymphoma. Zanubrutinib has been associated with a low rate of serum enzyme elevations during therapy, but has not been linked to cases of clinically apparent acute liver injury although it may pose a risk for reactivation of hepatitis B in susceptible patients.

Zanubrutinib is a novel Bruton's tyrosine kinase (BTK) inhibitor used for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. Mantle cell lymphoma is an aggressive mature B-cell non-Hodgkin lymphoma that is associated with early relapse, poor clinical outcomes, and long-term survival. BTK is an enzyme that plays a role in oncogenic signalling pathways, where it promotes the survival and proliferation of malignant B cells. Compared to the first-generation BTK inhibitor [ibrutinib], zanubrutinib displays higher potency and selectivity for BTK with fewer off-target effects. Due to this enhanced selectivity towards BTK, zanubrutinib belongs to the second-generation BTK inhibitor drug group that also includes [acalabrutinib], which was approved by the FDA in 2017. Zanubrutinib was granted accelerated approval by the FDA in November 2019 based on clinical trial results that demonstrated an 84% overall response rate from zanubrutinib therapy in patients with MCL, which measures the proportion of patients in a trial whose tumour is entirely or partially destroyed by a drug. It is currently marketed under the trade name BRUKINSA™ and is available as oral capsules.

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Approvals
Active Ingredient Dosage Form; Route Strength Proprietary Name Applicant
ZANUBRUTINIBCAPSULE;ORAL80MGBRUKINSABEIGENE USA INC
Patent Data
Patent No. Patent Expiration Drug Substance Claim Drug Product Claim Patent Use Code
944710604/22/2034DSDPU-2145
Exclusive Data
Exclusivity Code Exclusivity Expiration
NCE 11/14/2024
ODE-276 11/14/2026