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Brukinsa · pharmadog

pharmadog
drugs
Brukinsa

drug · small molecule

patient view →

zanubrutinib

Marketedupdated 2mo ago

by $ONC BeOne Medicines Ltd.🔗 ChEMBL

Approved

community read0 votes

Small molecule drug with a maximum clinical stage of Approval (across all indications), with 5 approved and 19 investigational indications.

targets

Tyrosine-protein kinase BTK

all catalysts(1)

phase 3 initiation · 1

News(0)

no news has mentioned this drug yet

brand

Brukinsa

trade names

Brukinsa

generic

zanubrutinib

MOA

Tyrosine-protein kinase BTK inhibitor

indication

Membranous Glomerulonephritis

phase

marketed

phase 3 initiation

Stanford University — zanubrutinib (Phase III Trial Initiation)

Data sources

ClinicalTrials.gov · OpenTargets

last refreshed 1h ago

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Patent cliff

source: FDA Orange Book

first barrier falls

Nov 14, 2026

130 days

Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.

patents (25)

Jan 19, 2043method-of-use (U-3720)US 11786531
Jan 19, 2043method-of-use (U-3716)US 11786531
Jan 19, 2043method-of-use (U-3716)US 11896596
Jan 19, 2043method-of-use (U-3875)US 11896596
Jan 19, 2043method-of-use (U-3875)US 11911386
Jan 19, 2043method-of-use (U-3875)US 11911386
Jun 10, 2040formulationUS 12233069
Jun 24, 2039method-of-use (U-3860)US 11701357
Jun 24, 2039method-of-use (U-3860)US 11701357
Aug 15, 2037compositionUS 10927117
Aug 15, 2037compositionUS 10927117
Aug 15, 2037method-of-use (U-3728)US 11591340
Aug 15, 2037method-of-use (U-3729)US 11591340
Aug 15, 2037compositionUS 11851437
Aug 15, 2037compositionUS 11851437
Aug 15, 2037method-of-use (U-3860)US 11884674
Aug 15, 2037method-of-use (U-2145)US 11884674
Aug 15, 2037method-of-use (U-2145)US 11970500
Aug 15, 2037method-of-use (U-2145)US 11970500
Apr 22, 2034method-of-use (U-2145)US 10570139
Apr 22, 2034method-of-use (U-2145)US 10570139
Apr 22, 2034formulationUS 11142528
Apr 22, 2034formulationUS 11142528
Apr 22, 2034compositionUS 9447106
Apr 22, 2034compositionUS 9447106

FDA exclusivities (14)

Mar 7, 2031ODE*ODE*4.7y
Mar 7, 2031ODE-467Orphan Drug (7y)4.7y
Jan 19, 2030ODE*ODE*3.5y
Jan 19, 2030ODE-274Orphan Drug (7y)3.5y
Sep 14, 2028ODE-370Orphan Drug (7y)2.2y
Sep 14, 2028ODE*ODE*2.2y

Aug 31, 2028

ODE*

ODE*

2.2y

Aug 31, 2028ODE-371Orphan Drug (7y)2.2y

Mar 7, 2027I-936Indication (3y)243d

Mar 7, 2027I-936Indication (3y)243d

Nov 14, 2026ODE*ODE*130d

Nov 14, 2026ODE-276Orphan Drug (7y)130d

Jan 19, 2026I-817Indication (3y)

Jan 19, 2026I-817Indication (3y)

🐶 often sniffed alongside

top 3

drugImmunology1 co-mentions · 1 sources
companyStanford University1 co-mentions · 1 sources
tagImmunology1 co-mentions · 1 sources

Trials studying zanubrutinib

phase2A Phase 2 Trial Of The Combination Of Zanubrutinib, Sonrotoclax, And Obinutuzumab For Patients With Treatment-Naïve Chronic Lymphocytic Leukemianot yet recruitingn=40
phase2A Study of Emavusertib + An Approved Bruton Tyrosine Kinase Inhibitor (BTKi) in Participants With Chronic Lymphocytic Leukemia (CLL) and Other B-cell Malignanciesrecruitingn=108
phase3A Study of Zanubrutinib Plus Anti-CD20 Versus Lenalidomide Plus Rituximab in Participants With Relapsed/Refractory Follicular or Marginal Zone Lymphomarecruitingn=780
phase2Zanubrutinib, Bendamustine, Rituximab Prev. Untreated WMrecruitingn=56
phase2A Study to Investigate Safety and Effectiveness of BGB-16673 in Combination With Other Agents in Participants With Relapsed or Refractory B-Cell Malignanciesrecruitingn=80
phase3Study of Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Obinutuzumab in Participants With Chronic Lymphocytic Leukemia (CLL)active not recruitingn=652
phase3A Study to Investigate the Efficacy and Safety of Sonrotoclax Plus Zanubrutinib Compared With Placebo Plus Zanubrutinib in Adults With Relapsed/Refractory Mantle Cell Lymphoma (CELESTIAL-RRMCL)recruitingn=300
phase1A Study to Investigate the Relative Bioavailability and Food Effect of a Fixed-Dose Combination Tablet Containing Zanubrutinib and Sonrotoclax (BG-71332) in Healthy Adultscompletedn=24

more trials →