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  1. pharmadog
  2. ›drugs
  3. ›Brukinsa
drug · small molecule
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zanubrutinib

Marketedupdated 5mo ago
by $ONC BeOne Medicines Ltd.🔗 ChEMBL
Approved
community read0 votes

🐶 often sniffed alongside

top 3
  • drugImmunology1 co-mentions · 1 sources
  • companyStanford University1 co-mentions · 1 sources
  • tagImmunology1 co-mentions · 1 sources

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
Apr 26, 2026
phase 3 initiation
6mo ago
Stanford University — zanubrutinib (Phase III Trial Initiation)
zanubrutinib
→

Trials studying zanubrutinib

  • phase2A Study to Investigate the Safety of Novel Dose Ramp-up Schedule(s) When Initiating Sonrotoclax in Participants Treated for Blood Cancers.recruitingn=258
  • phase2Rituximab and Zanubrutinib in Patients With Indolent B-cell Lymphomasrecruitingn=43
  • phase3A Study of Zanubrutinib Plus Anti-CD20 Versus Lenalidomide Plus Rituximab in Participants With Relapsed/Refractory Follicular or Marginal Zone Lymphomaactive not recruitingn=799
  • phase3Study of BTK Inhibitor LOXO-305 Versus Approved BTK Inhibitor Drugs in Patients With Mantle Cell Lymphoma (MCL)active not recruitingn=500
  • phase2Study of Zanubrutinib in Older Patients With Previously Untreated Chronic Lymphocytic Leukemia (CLL)not yet recruitingn=95
  • phase3A Study to Investigate Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Acalabrutinib in Adults With Previously Untreated Chronic Lymphocytic Leukemiarecruitingn=500
  • —Zanubrutinib in Patients With Waldenström's Macroglobulinemia, Chronic Lymphocytic Leukemia, Marginal Zone Lymphoma and Follicular Lymphomarecruitingn=845
  • phase2Venetoclax Plus Zanubrutinib for the Treatment of Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphomarecruitingn=155

Patent cliff

source: FDA Orange Book
first barrier falls
Nov 14, 2026
35 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*4.4y
  • Mar 7, 2031ODE-467Orphan Drug (7y)4.4y
  • Jan 19, 2030ODE*ODE*3.3y
  • Jan 19, 2030ODE-274Orphan Drug (7y)3.3y
  • Sep 14, 2028ODE-370Orphan Drug (7y)1.9y
  • Sep 14, 2028ODE*ODE*1.9y
  • Aug 31, 2028ODE*ODE*1.9y
  • Aug 31, 2028ODE-371Orphan Drug (7y)1.9y
  • Mar 7, 2027I-936Indication (3y)148d
  • Mar 7, 2027I-936Indication (3y)148d
  • Nov 14, 2026ODE*ODE*35d
  • Nov 14, 2026ODE-276Orphan Drug (7y)35d
  • Jan 19, 2026I-817Indication (3y)
  • Jan 19, 2026I-817Indication (3y)

News(6)

  • Mid-cap biotechs join Trump’s latest round of drug pricing deals
    Focused on Medicaid, the new pacts now involve more than just large pharmaceutical companies, but still aren’t expected to meaningfully impact drugmaker profits.
    biopharma_dive · 1mo ago
  • BeOne commits $300M to US manufacturing expansion, creating 120 new jobs
    The addition of small molecule capacity at BeOne Medicines’ Hopewell site will support the company’s hematology efforts and bring total investment in the campus to more than $1 billion.
    biospace · 2mo ago
  • Ipsen’s $450M blood cancer drug; FDA selects first cohort for “pre-check” pilot program
    The planned acquisition of Kartos Therapeutics would hand Ipsen a late-stage asset for myelofibrosis. Elsewhere, Sobi hit a regulatory setback and BeOne unveiled more positive Brukinsa data.
    biopharma_dive · 3mo ago
  • BeOne’s Brukinsa succeeds in frontline mantle cell lymphoma study
    BeOne Medicines said its BTK inhibitor Brukinsa cut the risk of disease progression or death by 43% compared to chemoimmunotherapy when used as a first option for mantle cell lymphoma patients. The…
    endpoints · 3mo ago
  • Biotech leaders campaign for Pazdur; Takeda to lay off 4,500 workers
    Hundreds of executives and investors are pushing for Rick Pazdur to be the next FDA commissioner. Elsewhere, Takeda detailed its latest restructuring and Alumis is discarding a once-highly touted i…
    biopharma_dive · 4mo ago
  • Retrospective Data Show Potential Real-World TTNT and OS Improvements With Next-Generation BTK Inhibitors in R/R MCL
    Retrospective data showed zanubrutinib was associated with improved real-world overall survival vs ibrutinib in second- or third-line mantle cell lymphoma.
    onclive · 5mo ago
brand
Brukinsa
trade names
Brukinsa
generic
zanubrutinib
MOA
Tyrosine-protein kinase BTK inhibitor
indication
Membranous Glomerulonephritis
phase
marketed
Data sources
ClinicalTrials.gov · OpenTargets
last refreshed 1h ago
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