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ONUREG® is indicated for continued treatment of adult patients with acute myeloid leukemia who achieved first complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following intensive induction chemotherapy and are not able to complete intensive curative therapy.


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Mechanism of Action


ONUREG® is an oral HMA that induced cell apoptosis, decreased tumor burden, and increased survival in leukemic models1

ONUREG® is incorporated into both DNA and RNA where it exerts multiple antileukemic effects1

Diagram showing ONUREG® incorporated into both DNA and RNA Diagram showing ONUREG® incorporated into both DNA and RNA
  • Incorporation of ONUREG® into DNA allowed for inhibition of DNA methyltransferases, reduction of DNA methylation, and alteration of gene expression, including re-expression of genes regulating tumor suppression and cell differentiation
  • Incorporation of ONUREG® into RNA inhibited RNA methyltransferases, reduced RNA methylation, decreased RNA stability, and decreased protein synthesis

HMA, hypomethylating agent.

Pharmacodynamic profile for ONUREG®1

  • Greater reduction in global DNA methylation was observed with higher azacitidine plasma exposure in patients with AML administered ONUREG® for 14 days of a 28-day treatment cycle

Recommended dosing1

Oral 14-day dosing of ONUREG® allows for extended drug exposure during each treatment cycle to prolong therapeutic activity
  • The recommended dosage of ONUREG® is one 300 mg tablet orally, once daily for 14 days of a 28-day treatment cycle

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