drug · small molecule
zanubrutinib
Marketedupdated 5mo 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
- phase2A Study to Investigate the Safety of Novel Dose Ramp-up Schedule(s) When Initiating Sonrotoclax in Participants Treated for Blood Cancers.
- phase2Rituximab and Zanubrutinib in Patients With Indolent B-cell Lymphomas
- phase3A Study of Zanubrutinib Plus Anti-CD20 Versus Lenalidomide Plus Rituximab in Participants With Relapsed/Refractory Follicular or Marginal Zone Lymphoma
- phase3Study of BTK Inhibitor LOXO-305 Versus Approved BTK Inhibitor Drugs in Patients With Mantle Cell Lymphoma (MCL)
- phase2Study of Zanubrutinib in Older Patients With Previously Untreated Chronic Lymphocytic Leukemia (CLL)
- phase3A Study to Investigate Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Acalabrutinib in Adults With Previously Untreated Chronic Lymphocytic Leukemia
- —Zanubrutinib in Patients With Waldenström's Macroglobulinemia, Chronic Lymphocytic Leukemia, Marginal Zone Lymphoma and Follicular Lymphoma
- phase2Venetoclax Plus Zanubrutinib for the Treatment of Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma
Patent cliff
source: FDA Orange Bookfirst 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 dealsFocused 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 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 · 2mo 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 · 3mo 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 · 3mo 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 · 4mo 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 · 5mo ago
Data sources
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