drug · small molecule
zanubrutinib
Marketedupdated 3mo agoby $ONC BeOne Medicines Ltd.🔗 ChEMBL
Approvedcommunity read0 votes
🐶 often sniffed alongside
top 3Small 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)
Trials studying zanubrutinib
- phase2Study of Zanubrutinib in Older Patients With Previously Untreated Chronic Lymphocytic Leukemia (CLL)
- phase3A Study to Examine the Efficacy and Safety of Zanubrutinib Given to Adults With Primary Membranous Nephropathy
- phase3A Study of Zanubrutinib Plus Anti-CD20 Versus Lenalidomide Plus Rituximab in Participants With Relapsed/Refractory Follicular or Marginal Zone Lymphoma
- phase2Zanubrutinib, Obinutuzumab, Sonrotoclax (BOSon) or BGB-16673, Obinutuzumab, Sonrotoclax (DOSon) in TN CLL/SLL
- 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)
- phase2A Phase 2 Trial Of The Combination Of Zanubrutinib, Sonrotoclax, And Obinutuzumab For Patients With Treatment-Naïve Chronic Lymphocytic Leukemia
- phase2A Study of Emavusertib + An Approved Bruton Tyrosine Kinase Inhibitor (BTKi) in Participants With Chronic Lymphocytic Leukemia (CLL) and Other B-cell Malignancies
- phase2Zanubrutinib, Bendamustine, Rituximab Prev. Untreated WM
Patent cliff
source: FDA Orange Bookfirst barrier falls
Nov 14, 2026
91 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*4.6y
- Mar 7, 2031ODE-467Orphan Drug (7y)4.6y
- Jan 19, 2030ODE*ODE*3.4y
- Jan 19, 2030ODE-274Orphan Drug (7y)3.4y
- Sep 14, 2028ODE-370Orphan Drug (7y)2.1y
- Sep 14, 2028ODE*ODE*2.1y
- Aug 31, 2028ODE*ODE*2.0y
- Aug 31, 2028ODE-371Orphan Drug (7y)2.0y
- Mar 7, 2027I-936Indication (3y)204d
- Mar 7, 2027I-936Indication (3y)204d
- Nov 14, 2026ODE*ODE*91d
- Nov 14, 2026ODE-276Orphan Drug (7y)91d
- Jan 19, 2026I-817Indication (3y)
- Jan 19, 2026I-817Indication (3y)
News(5)
- BeOne commits $300M to US manufacturing expansion, creating 120 new jobsThe 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 · 22d ago
- Ipsen’s $450M blood cancer drug; FDA selects first cohort for “pre-check” pilot programThe 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 · 1mo ago
- BeOne’s Brukinsa succeeds in frontline mantle cell lymphoma studyBeOne 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 · 1mo ago
- Biotech leaders campaign for Pazdur; Takeda to lay off 4,500 workersHundreds 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 · 3mo ago
- Retrospective Data Show Potential Real-World TTNT and OS Improvements With Next-Generation BTK Inhibitors in R/R MCLRetrospective data showed zanubrutinib was associated with improved real-world overall survival vs ibrutinib in second- or third-line mantle cell lymphoma.onclive · 3mo ago
Data sources
last refreshed 18m ago
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