Clinical Pipeline

Phase 1Phase 2Phase 3

ASTX727 (Cedazuridine and Decitabine)

DNA methyltransferase (DNMT) inhibitor (Hematological Malignancies)


Ownership: Astex

Mechanism of Action: DNA methyltransferase (DNMT) inhibition

Indication: Hematological Malignancies

How this therapy can help

ASTX727 is a unique fixed-dose combination of the hypomethylating agent decitabine, the active ingredient in Dacogen®, and the novel cytidine deaminase inhibitor, E7727 (cedazuridine). ASTX727 was designed to deliver decitabine by oral administration. By inhibiting cytidine deaminase, cedazuridine inhibits the major mechanism by which decitabine is degraded in the gut and liver, and the combination therefore permits the efficient delivery of decitabine orally.

Clinical studies

A Phase 3 clinical study (ASCERTAIN) conducted in the US and Canada has demonstrated that ASTX727 Standard Dose (100mg cedazuridine/35mg decitabine) emulates the pharmacokinetic (PK) & pharmacodynamic (PD) characteristics of a 1-hour intravenous infusion of decitabine in intermediate and high-risk Myelodysplastic Syndromes (MDS) and Chronic Myelomonocytic Leukemia (CMML) patient populations. The ASCERTAIN study has now been expanded to include enrollment of Acute Myeloid Leukemia (AML) patients in the European Union (EU).

Astex is also developing a low-dose formulation of ASTX727 for the treatment of chronic conditions where oral delivery of a hypomethylating agent would be preferred. These include low-risk MDS, and in AML maintenance following intensive chemotherapy.

View all clinical studies with ASTX727

View Presentations and Publications