NDAORALTABLETPriority Review
Approved
Sep 2020
Lifecycle
Peak
Competitive Pressure
8/100
Clinical Trials
20
Data completeness
7/8 — Comprehensive
Priority Review
ONUREG (azacitidine) by Bristol Myers Squibb is nucleic acid synthesis inhibitors [moa]. Approved for acute myeloid leukemia, myelodysplastic syndromes. First approved in 2020.
Drug data last refreshed 19h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ONUREG (azacitidine) is an oral nucleoside metabolic inhibitor approved by the FDA in September 2020 for treating myelodysplastic syndromes (MDS), including refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia. It works by inhibiting nucleic acid synthesis to suppress abnormal cell proliferation. This oral formulation represents a significant advancement over intravenous azacitidine, improving patient convenience and adherence in a difficult-to-treat hematologic malignancy space.
$0.1BPart D
4.1 years to LOEMechanism of Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Class:
Nucleoside Metabolic Inhibitor
Indications (2)
Worked on ONUREG at Bristol Myers Squibb? Share your interview experience or compensation data (+7 days Pro)
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.