drug
Onureg
Marketedupdated 3mo agoby Bristol-Myers Squibb Co
Approvedcommunity read0 votes
🐶 often sniffed alongside
top 8- drugazacitidine21 co-mentions · 9 sources
- tagApproval12 co-mentions · 3 sources
- tagSmall Molecule8 co-mentions · 4 sources
- tagAML7 co-mentions · 2 sources
- tagOncology3 co-mentions · 2 sources
- tagDrug Shortage3 co-mentions · 3 sources
- tagPulmonology2 co-mentions · 1 sources
- drugivosidenib2 co-mentions · 1 sources
Small molecule drug with a maximum clinical stage of Approval (across all indications), with 5 approved and 49 investigational indications.
all catalysts(2)
Trials studying Onureg
- phase2Pacritinib in CMML
- phase2Oral Azacitidine Combined With Venetoclax in Previously Untreated Higher-risk Myelodysplastic Syndromes
- phase2Venetoclax and Azacitidine for Non-Elderly Adult Patients With Acute Myeloid Leukemia
- phase3A Study to Assess Adverse Events and Change in Disease Activity When Intravenous (IV) Pivekimab Sunirine is Given in Combination With Oral Venetoclax and IV or Subcutaneous Azacitidine in Adult Participants With Acute Myeloid Leukemia (AML)
- phase1Study of Revumenib, Azacitidine, and Venetoclax in Pediatric and Young Adult Patients With Refractory or Relapsed Acute Myeloid Leukemia
- phase1Nivolumab or Nivolumab and Azacitidine in Patients With Recurrent, Resectable Osteosarcoma
- phase1A Phase Ib Study of Rezatapopt in Combination With Azacitidine in Patients With TP53Y220C Mutant Myeloid Malignancies (Acute Myeloid Leukemia or Myelodysplastic Syndrome)
- phase2Study of SLS009 (Formerly GFH009) a Potent Highly Selective CDK9 Inhibitor in Patients With Hematologic Malignancies and High-Risk Newly Diagnosed AML
Patent cliff
source: FDA Orange Bookfirst barrier falls
Sep 1, 2027
~1.1 years out
Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.
patents (6)
- Jun 3, 2030formulationUS 88466283.8y
- Jun 3, 2030formulationUS 88466283.8y
- May 14, 2029formulationUS 115714362.8y
- May 14, 2029formulationUS 115714362.8y
- May 14, 2029method-of-use (U-2950)US 120534822.8y
- May 14, 2029method-of-use (U-2950)US 120534822.8y
FDA exclusivities (3)
- May 20, 2029ODE-399Orphan Drug (7y)2.8y
- Sep 1, 2027ODE-320Orphan Drug (7y)1.1y
- Sep 1, 2027ODE-320Orphan Drug (7y)1.1y
News(1)
- Dr Dinardo on the FDA Approval of Decitabine/Cedazuridine Plus Venetoclax in AMLCourtney D. DiNardo, MD, MSCE, discusses the FDA approval of decitabine/cedazuridine plus venetoclax in acute myeloid leukemia.onclive · 3mo ago
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