drug
Onureg
Marketedupdated 5mo 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
- phase3A Multi-phase Study of ASTX030 (Azacitidine and Cedazuridine) in Myeloid Neoplasm Alone or in Combination With Venetoclax in AML (AZTOUND Study)
- phase2AZA + Venetoclax as Maintenance Therapy in Patients With AML in Remission
- 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 BMS-986497 (ORM-6151) as a Monotherapy, in Double and Triple Combination With Azacitidine and Venetoclax in Participants With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome
- phase1A Study of Bleximenib in Combination With Acute Myeloid Leukemia (AML) Directed Therapies
- phase2Roll-over Study for Patients Who Have Completed a Prior Novartis-sponsored Sabatolimab (MBG453) Study and Are Judged by the Investigator to Benefit From Continued Treatment With Sabatolimab.
- phase2Study of the Safety and Efficacy of APR-246 in Combination With Azacitidine
- phase1A Study to Assess Safety and Preliminary Efficacy of LP-108 Combined With Azacitidine In Subjects With AML, MDS, CMML
Patent cliff
source: FDA Orange Bookfirst barrier falls
Sep 1, 2027
328 days
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 88466283.7y
- Jun 3, 2030formulationUS 88466283.7y
- May 14, 2029formulationUS 115714362.6y
- May 14, 2029formulationUS 115714362.6y
- May 14, 2029method-of-use (U-2950)US 120534822.6y
- May 14, 2029method-of-use (U-2950)US 120534822.6y
FDA exclusivities (3)
- May 20, 2029ODE-399Orphan Drug (7y)2.6y
- Sep 1, 2027ODE-320Orphan Drug (7y)328d
- Sep 1, 2027ODE-320Orphan Drug (7y)328d
News(2)
- BMS dumps $100M Orum degrader-antibody conjugate after glimpsing phase 1 dataBristol Myers Squibb has axed the degrader-antibody conjugate it bought from Orum Therapeutics for $100 million, walking away from the asset after seeing phase 1 data.fiercebiotech · 19d ago
- 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 · 4mo ago
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