ASTX727 — Competitive Intelligence Brief

ASTX727 (ASTX727) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Hypomethylating agent. Area: Oncology.

phase 3 Hypomethylating agent DNA methyltransferase (DNMT) Oncology Small molecule

Target snapshot

ASTX727 (ASTX727) — Taiho Oncology, Inc.. ASTX727 is a fixed-dose combination of decitabine and cedazuridine that inhibits DNA methyltransferase to reactivate silenced tumor suppressor genes in myelodysplastic syndrome.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
ASTX727 TARGET	ASTX727	Taiho Oncology, Inc.	phase 3	Hypomethylating agent	DNA methyltransferase (DNMT)
Decitabine and cedazuridine	Decitabine and cedazuridine	Race Oncology Ltd	marketed	Hypomethylating agent	DNA methyltransferase (DNMT)
Decitabine combined with HAAG Regimen	Decitabine combined with HAAG Regimen	The First Affiliated Hospital of Soochow University	phase 3	Hypomethylating agent combined with chemotherapy regimen	DNA methyltransferase (DNMT); also targets topoisomerase II and DNA synthesis
Decitabine in combination with R-CHOP	Decitabine in combination with R-CHOP	Second Affiliated Hospital of Nanchang University	phase 3	Hypomethylating agent combined with chemotherapy regimen	DNA methyltransferase (decitabine component); CD20, topoisomerase II, microtubule dynamics (R-CHOP components)
Subcutaneous azacitidine	Subcutaneous azacitidine	Otsuka Australia Pharmaceutical Pty Ltd	phase 3	Hypomethylating agent	DNA methyltransferase
Azacitidine combined HHT	Azacitidine combined HHT	Shandong Provincial Hospital	phase 3	Hypomethylating agent combined with protein synthesis inhibitor	DNA methyltransferase (DNMT) and eukaryotic translation elongation factor 2 (eEF-2)
Gilteritinib + Azacitidine + Venetoclax	Gilteritinib + Azacitidine + Venetoclax	Institute of Hematology & Blood Diseases Hospital, China	phase 3	FLT3 inhibitor + hypomethylating agent + BCL-2 inhibitor combination	FLT3, DNA methyltransferase, BCL-2

Recent regulatory actions (last 90 days)

No regulatory actions in the last 90 days for this set.

Upcoming PDUFA dates (next 180 days)

No PDUFA dates in the next 180 days for this set.

Patent timeline (forward window)

No upcoming patent expiries for this set.

Sponsor landscape (Hypomethylating agent class)

1. AbbVie (prior sponsor, Abbott) · 1 drug in this class
2. Assistance Publique - Hôpitaux de Paris · 1 drug in this class
3. Bio-Path Holdings, Inc. · 1 drug in this class
4. Grupo Cooperativo de Estudio y Tratamiento de las Leucemias Agudas y Mielodisplasias · 1 drug in this class
5. Otsuka Australia Pharmaceutical Pty Ltd · 1 drug in this class
6. Race Oncology Ltd · 1 drug in this class
7. Shirley Ryan AbilityLab · 1 drug in this class
8. Taiho Oncology, Inc. · 1 drug in this class