NDAORALTABLETPriority Review
Approved
Sep 2020
Lifecycle
Peak
Competitive Pressure
8/100
Clinical Trials
20
Data completeness
5/8 — Partial
Priority Review
ONUREG (azacitidine) by Bristol Myers Squibb is nucleic acid synthesis inhibitors [moa]. First approved in 2020.
Drug data last refreshed 4h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ONUREG (azacitidine) is an oral nucleoside metabolic inhibitor that works by inhibiting nucleic acid synthesis to suppress abnormal cell proliferation. It is indicated for maintenance treatment of acute myeloid leukemia (AML) patients in complete remission or complete remission with incomplete hematologic recovery after intensive chemotherapy. The drug represents a significant shift from IV azacitidine to an oral formulation, improving patient convenience and compliance.
$0.069BPart D
Peak3.9 years to LOEONUREG is in peak commercial phase with $69M Part D spending and competitive pressure of 8/10, indicating a mature franchise requiring experienced brand and market access teams.
Mechanism of Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Class:
Nucleoside Metabolic Inhibitor
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
The Efficacy and Safety of Selinisole Combined With Azacitidine and Venetoclax in the Treatment of Newly Diagnosed High-risk Myeloid Tumors With TP53 Mutations
Started Nov 2026
30 enrolled
Myeloid Tumors
A Study to Assess How Well the Study Medicine IPN60340 Works in Combination With Azacitidine and Venetoclax, Compared to Placebo in Combination With Azacitidine and Venetoclax, in Participants With Newly Diagnosed Acute Myeloid Leukemia Who Cannot Receive Intensive Chemotherapy
Started Nov 2026
450 enrolled
Acute Myeloid Leukaemia (AML)Acute Myeloid Leukaemia
Study Evaluating the Efficacy and Safety of the Addition of Ivosidenib to Oral Azacitidine (Onureg®) in Patients Over 55 With Acute Myeloid Leukemia (AML) and IDH1 Mutation, in Complete Remission After Intensive Chemotherapy.
Started Sep 2026
60 enrolled
Acute Myeloid Leukemia
A 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)
Started Jul 2026
660 enrolled
Acute Myeloid Leukemia
Assessing PI3K Gamma Inhibition With Azacitidine, Venetoclax and Eganelisib in Patients With Acute Myeloid Leukemia
Started Jul 2026
48 enrolled
Leukemia, MyeloidLeukemiaAcute Myeloid Leukemia+1 more
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.