# ASCERTAIN-V

Source: https://onco.cc/trials/ascertain-v/  
OnCo record `ascertain-v` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

ASCERTAIN-V is the study behind the first all-oral AML regimen, approved in May 2026.

## Summary

ASCERTAIN-V, trial NCT04657081 sponsored by Taiho Oncology and reported in 2026, is the study behind the first all-oral acute myeloid leukaemia regimen, approved in May 2026. OnCo links it to acute myeloid leukaemia, the oral decitabine and cedazuridine record, venetoclax and the pairing of venetoclax with a hypomethylating agent. The remission rate is in line with the venetoclax-azacitidine arm of VIALE-A, supporting equivalence of the oral backbone, but there is no randomised comparison, which is the open question.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-07
- Registry id: NCT04657081
- Phase: 1/2
- Setting: Newly diagnosed AML unfit for intensive induction: oral decitabine-cedazuridine + venetoclax
- Sponsor: Taiho Oncology
- Enrolled: 101
- Result: CR 41.6%; median time to CR 2 months.
- Outcomes: Complete remission: Decitabine-cedazuridine + venetoclax 41.6%
- Replication: CR rate is in line with the VIALE-A venetoclax-azacitidine arm (36.7%), supporting equivalence of the oral backbone; no randomised comparison.

## Sources

- ClinicalTrials.gov NCT04657081: https://clinicaltrials.gov/study/NCT04657081

## Connected records

- cancers: [Acute myeloid leukaemia](https://onco.cc/cancers/aml/)
- technologies: [Epigenetic drugs (HDAC, DNMT, EZH2, IDH, menin, BET)](https://onco.cc/technologies/epigenetic-drugs/)
- drugs: [Decitabine + cedazuridine (oral)](https://onco.cc/drugs/decitabine-cedazuridine/), [Venetoclax](https://onco.cc/drugs/venetoclax/)
- companies: [Taiho Pharmaceutical (Otsuka)](https://onco.cc/companies/taiho/)
- pairings: [Venetoclax + hypomethylating agent](https://onco.cc/pairings/venetoclax-plus-hma/)

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