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A Multi-phase, Pharmacokinetics, Safety, and Efficacy Study of ASTX030 (Azacitidine and Cedazuridine) as Monotherapy in Subjects With Myeloid Neoplasm or in Combination With Venetoclax in Subjects With AML (AZTOUND Study)

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Trial Profile

A Multi-phase, Pharmacokinetics, Safety, and Efficacy Study of ASTX030 (Azacitidine and Cedazuridine) as Monotherapy in Subjects With Myeloid Neoplasm or in Combination With Venetoclax in Subjects With AML (AZTOUND Study)

Status: Recruiting
Phase of Trial: Phase II/III

Latest Information Update: 08 Oct 2026

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At a glance

  • Drugs Azacitidine/cedazuridine (Primary) ; Azacitidine; Azacitidine; Cedazuridine
  • Indications Acute myeloid leukaemia; Chronic myelomonocytic leukaemia; Myelodysplastic syndromes; Myeloproliferative disorders
  • Focus Pharmacokinetics; Registrational
  • Acronyms AZTOUND
  • Sponsors Astex Pharmaceuticals; Taiho Oncology

Most Recent Events

  • 30 Sep 2026 Primary endpoint has been met (Phase 3 : total cycle area under the curve (AUC) from 0 to 24 hours (AUC0-24) exposures) , according to a Tahio oncology media release
  • 30 Sep 2026 According to Tahio oncology media release, results from AZTOUND will be submitted for presentation at an international medical conference
  • 30 Sep 2026 According to Tahio oncology media release, based on the results, Taiho Oncology intends to submit a New Drug Application to the U.S. Food and Drug Administration (FDA) seeking approval of azacitidine and cedazuridine as an oral treatment regimen for adults with MDS or CMML.

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