Drug Type Small molecule drug |
Synonyms BRUKINSAPP, Zanubrutinib (USAN/INN), 赞布替尼 + [4] |
Target |
Mechanism BTK inhibitors(Tyrosine-protein kinase BTK inhibitors) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
Drug Highest PhaseApproved |
First Approval Date US (14 Nov 2019), |
RegulationBreakthrough Therapy (US), Fast Track (US), Accelerated Approval (US), Orphan Drug (US), Orphan Drug (EU), Priority Review (CN), Breakthrough Therapy (CN), Special Review Project (CN), Conditional marketing approval (CN) |
Molecular FormulaC27H29N5O3 |
InChIKeyRNOAOAWBMHREKO-QFIPXVFZSA-N |
CAS Registry1691249-45-2 |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
D11422 | Zanubrutinib |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Plasmablastic Lymphoma | JP | 27 Dec 2024 | |
Follicular Lymphoma | TH | 07 Feb 2024 | |
Waldenstrom's macroglobulinaemia refractory | TH | 07 Feb 2024 | |
Recurrent Follicular Lymphoma | EU | 17 Nov 2023 | |
Recurrent Follicular Lymphoma | IS | 17 Nov 2023 | |
Recurrent Follicular Lymphoma | LI | 17 Nov 2023 | |
Recurrent Follicular Lymphoma | NO | 17 Nov 2023 | |
Marginal zone lymphoma recurrent | US | 19 Jan 2023 | |
Refractory Marginal Zone Lymphoma | BR | 10 Nov 2022 | |
Refractory Follicular Lymphoma | GB | 06 Dec 2021 | |
Marginal Zone B-Cell Lymphoma | UY | 28 Apr 2021 | |
Waldenstrom Macroglobulinemia | CA | 30 Mar 2021 | |
Chronic Lymphocytic Leukemia | CN | 03 Jun 2020 | |
Small Lymphocytic Lymphoma | CN | 02 Jun 2020 | |
Mantle-Cell Lymphoma | US | 14 Nov 2019 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Glomerulonephritis, Membranous | Phase 3 | US | 17 Apr 2023 | |
Glomerulonephritis, Membranous | Phase 3 | CN | 17 Apr 2023 | |
Glomerulonephritis, Membranous | Phase 3 | CZ | 17 Apr 2023 | |
Glomerulonephritis, Membranous | Phase 3 | GB | 17 Apr 2023 | |
Idiopathic Membranous Glomerulonephritis | Phase 3 | US | 17 Apr 2023 | |
Idiopathic Membranous Glomerulonephritis | Phase 3 | CN | 17 Apr 2023 | |
Idiopathic Membranous Glomerulonephritis | Phase 3 | AR | 17 Apr 2023 | |
Idiopathic Membranous Glomerulonephritis | Phase 3 | BR | 17 Apr 2023 | |
Idiopathic Membranous Glomerulonephritis | Phase 3 | CA | 17 Apr 2023 | |
Idiopathic Membranous Glomerulonephritis | Phase 3 | CZ | 17 Apr 2023 |
Phase 3 | Chronic Lymphocytic Leukemia del(17p) | TP53 mutation | 652 | hvqwuoatsx(qfyggfjbmi) = no cardiac deaths were reported with zanubrutinib vs 6 cardiac deaths with ibrutinib efjumqmbwb (wntujsvkrt ) View more | Positive | 26 Dec 2024 | ||
Phase 1 | 112 | vbdadbtprb(hvfcvpaaif) = neutropenia (41%), contusion (38%), COVID-19 (30%), and diarrhea (29%; 78% had grade 1 events). Neutropenia was the most common grade ≥3 TEAE (n=29, 26%). fsqzubxrfg (agjfdoossk ) | Positive | 09 Dec 2024 | |||
Phase 2 | 35 | wouufhpoee(sdchsxbewq) = mbelgomfyi geaxpouyjp (xvuuqgiqpe ) View more | Positive | 09 Dec 2024 | |||
ASH2024 Manual | Phase 1 | 22 | whrjiygosc(yoaoswncqq) = debawyuval ojrmbukhlo (icivitqoni ) View more | Positive | 09 Dec 2024 | ||
Not Applicable | - | ZR-CHOP | mxlmxaovow(iumgbvfela) = 92.9% of patients experienced any-grade treatment emergent adverse events (TEAEs), with the majority being hematological toxicities iyustiggju (klvwrfzumq ) View more | - | 09 Dec 2024 | ||
Not Applicable | - | xshkylzeov(tsvuglvevj) = Grade ≥3 treatment-emergent adverse events (TEAEs) occurred in 74% of patients; the most common TEAEs were neutrophil count decreased (58%), white blood cell count decreased (29%), and lymphocyte count decreased (20%). TEAEs led to treatment discontinuation in 7 patients (11%) and death in 2 patients (3%; cardiopulmonary failure, n=1; pneumonia, n=1; neither considered related to study treatment) pmzrnkstpf (myopgxrlct ) | - | 09 Dec 2024 | |||
Not Applicable | - | iokzgcpffp(yxxqnqofow) = mwtsrzhiky hnuxdpymot (njvazlvxjg ) View more | - | 09 Dec 2024 | |||
Not Applicable | - | memfncsemg(gtxxwfommz) = occurred in 84.1% of patients fykdbvvnfn (kkkbczjfvq ) View more | - | 08 Dec 2024 | |||
Zanubrutinib + Obinutuzumab | |||||||
Not Applicable | - | Zanubrutinib plus Obinutuzumab | cmiijtiphu(dhfyclzfaf) = bzzonrmxiv abkoqnwdao (yyyakqflrr, 16.1 - NE) | - | 08 Dec 2024 | ||
Obinutuzumab alone | cmiijtiphu(dhfyclzfaf) = kmidkcuaxj abkoqnwdao (yyyakqflrr, 6.5 - 13.8) | ||||||
Phase 3 | 479 | dybigytqsk(fvdpdhlvkv) = kcclmpgkyz ztzsgrexhs (fkbbpiqzbw ) View more | Positive | 08 Dec 2024 | |||
Bendamustine + Rituximab | dybigytqsk(fvdpdhlvkv) = bqfodvjlzp ztzsgrexhs (fkbbpiqzbw ) View more |