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 17h ago · AI intelligence enriched 1mo 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 myelodysplastic clone expansion. It is indicated for maintenance therapy in adult patients with myelodysplastic syndrome (MDS) who have responded to prior intensive chemotherapy. The drug represents a significant shift from IV azacitidine by offering convenient oral dosing for a chronic maintenance setting.
$0.069BPart D
Peak3.6 years to LOEProduct is at peak commercial maturity with $69M Part D spending but relatively small claim volume (2,847 in 2023), suggesting a niche market with high per-unit value and specialized sales infrastructure.
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)
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
540 enrolled
Acute Myeloid Leukaemia (AML)Acute Myeloid Leukaemia
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 Phase 1b/2 Study of Ropeginterferon Alfa-2b Added to Azacitidine in MDS/AML With TP53 Mutations
Started Oct 2026
30 enrolled
RopeginterferonAlfa-2bAzacitidine+1 more
A Phase 1b Study of CLN-049 in Combination With Azacitidine and Venetoclax in AML Patients
Started Oct 2026
90 enrolled
AML (Acute Myeloid Leukemia)
Sonrotoclax Plus Azacitidine in Patients With MDS-IB2
Started Oct 2026
60 enrolled
Myelodysplastic Syndromes, High Risk
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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.