Last reviewed 2026-05-19 · How we verify

ASTX727 Dose Confirmation

Astex Pharmaceuticals, Inc. · Phase 1 active Small molecule ✓ Verified May 2026 Quality 45/100

ASTX727 Dose Confirmation is a Hypomethylating agent combination Small molecule drug developed by Astex Pharmaceuticals, Inc.. It is currently in Phase 1 development. Also known as: ASTX727 oral (combination of oral E7727 and oral decitabine), IV decitabine.

Combines decitabine (DNA hypomethylating agent) with cedazuridine (cytidine deaminase inhibitor) to enable oral administration and improve bioavailability.

ASTX727, a small molecule, is being studied in combination with Cytarabine Hydrochloride for the treatment of Acute Myeloid Leukemia, Recurrent Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia, Higher Risk Myelodysplastic Syndrome, and Chronic Myelomonocytic Leukemia. ASTX727, also known as Bisantrene Dihydrochloride, is administered in high and low doses as part of the study.

Likelihood of approval

9.6% vs 9.6% industry baseline

If approved by FDA: likely 2033–2036

Steps remaining: Phase 2 → Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

Baseline phase 1 → approval rate +9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2033–2036	—
EMA	EU	2034–2037	+0.7 yr
MHRA	GB	2034–2037	+0.7 yr
Health Canada	CA	2034–2038	+0.9 yr
TGA	AU	2034–2038	+1.2 yr
PMDA	JP	2034–2038	+1.5 yr
NMPA	CN	2035–2039	+2.3 yr
MFDS	KR	2034–2038	+1.4 yr
CDSCO	IN	2034–2039	+1.8 yr
ANVISA	BR	2035–2039	+2.3 yr

Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).

Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.

At a glance

Generic name	ASTX727 Dose Confirmation
Also known as	ASTX727 oral (combination of oral E7727 and oral decitabine), IV decitabine
Sponsor	Astex Pharmaceuticals, Inc.
Drug class	Hypomethylating agent combination
Modality	Small molecule
Phase	Phase 1

Mechanism of action

Decitabine inhibits DNA methyltransferases, leading to hypomethylation and reactivation of tumor suppressor genes. Cedazuridine inhibits cytidine deaminase in the gastrointestinal tract and liver, preventing decitabine degradation and allowing effective oral dosing instead of intravenous administration.

Approved indications

Common side effects

No common side effects on file.

Key clinical trials

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

ASTX727 Dose Confirmation CI brief — competitive landscape report
ASTX727 Dose Confirmation updates RSS · CI watch RSS
Astex Pharmaceuticals, Inc. portfolio CI

Frequently asked questions about ASTX727 Dose Confirmation

What is ASTX727 Dose Confirmation?

ASTX727 Dose Confirmation is a Hypomethylating agent combination drug developed by Astex Pharmaceuticals, Inc..

How does ASTX727 Dose Confirmation work?

Combines decitabine (DNA hypomethylating agent) with cedazuridine (cytidine deaminase inhibitor) to enable oral administration and improve bioavailability.

Who makes ASTX727 Dose Confirmation?

ASTX727 Dose Confirmation is developed by Astex Pharmaceuticals, Inc. (see full Astex Pharmaceuticals, Inc. pipeline at /company/astex-pharmaceuticals-inc).

Is ASTX727 Dose Confirmation also known as anything else?

ASTX727 Dose Confirmation is also known as ASTX727 oral (combination of oral E7727 and oral decitabine), IV decitabine.

What drug class is ASTX727 Dose Confirmation in?

ASTX727 Dose Confirmation belongs to the Hypomethylating agent combination class. See all Hypomethylating agent combination drugs at /class/hypomethylating-agent-combination.

What development phase is ASTX727 Dose Confirmation in?

ASTX727 Dose Confirmation is in Phase 1.

Drug class: All Hypomethylating agent combination drugs
Manufacturer: Astex Pharmaceuticals, Inc. — full pipeline
Also known as: ASTX727 oral (combination of oral E7727 and oral decitabine), IV decitabine

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing