Decitabine and Cedazuridine

Phase 2Small molecule

Decitabine and Cedazuridine is one of 107 small molecule programs targeting Acute Myeloid Leukemia. It is currently in Phase 2.

Indications

Total Trials

Active Trials

106

Competitors

Pipeline

Status by Indication[3][1]

Indication

Acute Myeloid LeukemiaActive, not recruiting

Acute Myeloid Leukemia Post Cytotoxic TherapyRecruiting

Recurrent Acute Biphenotypic LeukemiaActive, not recruiting

Accelerated Phase Myeloproliferative NeoplasmRecruiting

Chronic Myelomonocytic LeukemiaActive, not recruiting

Myelodysplastic SyndromesActive, not recruiting

Acute Myeloid LeukemiaPhase 2

Active, not recruiting

Acute Myeloid Leukemia Post Cytotoxic TherapyPhase 1

Recruiting

Recurrent Acute Biphenotypic LeukemiaPhase 2

Active, not recruiting

Accelerated Phase Myeloproliferative NeoplasmPhase 2

Recruiting

Chronic Myelomonocytic LeukemiaPhase 2

Active, not recruiting

Myelodysplastic SyndromesPhase 2

Active, not recruiting

Competition

Competitive Landscape

255 competitors in Acute Myeloid Leukemia

#DrugCompanyPhaseTrials

Idamycin

Pfizer

Phase 3

59 2

Fludara

Sanofi

Phase 3

17 3

Vanflyta

Daiichi Sankyo

Phase 3

14 4

Neupogen

EEastern Cooperative Oncology Group

Phase 3

31 5

Nexavar

Bayer

Phase 3

12 6

Cellcept

Roche

Phase 3

10 7

Cytoxan

BBaxter Healthcare Corporation

Phase 3

25 8

Trexall

Jazz Pharmaceuticals

Phase 3

9 9

Busulfex

Peony

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 2Active, not recruiting

Chronic Phase Chronic Myelogenous Leukemia

NCT05007873

Phase 2Active, not recruiting

Acute Myeloid Leukemia

NCT04746235

Phase 1/2Active, not recruiting

Acute Myeloid Leukemia

NCT04817241

PreclinicalActive, not recruiting

Acute Myeloid Leukemia

NCT04657081

Phase 1Recruiting

Acute Myeloid Leukemia

NCT05010772

Q1 2027

Phase 2Active, not recruiting

Locally Advanced Unresectable Primary Central Chondrosarcoma

NCT04340843

Clinical

Trials by Indication[1]

Acute Myeloid Leukemia12 trials

Entrectinib in Combination With ASTX727 for the Treatment of Relapsed/Refractory TP53 Mutated Acute Myeloid Leukemia

Active, not recruiting·OOHSU Knight Cancer Institute·Phase 1·NCT05396859·13 enrolled

Decitabine/Cedazuridine and Venetoclax in Combination With Ivosidenib or Enasidenib for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia

Recruiting·MM.D. Anderson Cancer Center·Phase 1/2·NCT04774393·84 enrolled

Testing Oral Decitabine and Cedazuridine (ASTX727) in Combination With Venetoclax for Higher-Risk Acute Myeloid Leukemia Patients

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 1/2·NCT04817241·5 enrolled

Show 9 more trials

A Randomized Phase II Trial of ASTX727 and Venetoclax Compared With ASTX727, Venetoclax, and Enasidenib for Newly Diagnosed Older Adults With IDH2 Mutant Acute Myeloid Leukemia: A MyeloMATCH Substudy

Recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT06672146·93 enrolled

Master Screening and Reassessment Protocol (MSRP) for the NCI MyeloMATCH Clinical Trials

Recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT05564390·2,000 enrolled

A Single-Arm, Open-Label Pharmacokinetic, Safety, and Efficacy Study of ASTX727 in Combination With Venetoclax in Adult Patients With Acute Myeloid Leukemia

Active, not recruiting· Taiho Oncology, Inc. logo

Taiho Oncology, Inc.·Preclinical·NCT04657081·101 enrolled

A Randomized Phase 2 Trial of Olutasidenib-Based Therapies in Patients With Newly Diagnosed IDH1-Mutant Myeloid Malignancies: A MyeloMATCH Substudy

Not yet recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT07153497·132 enrolled

A Phase I/II Study of ASTX727, Venetoclax, and Gilteritinib for Patients With Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome With an Activating FLT3 Mutation

Recruiting·MM.D. Anderson Cancer Center·Preclinical·NCT05010122·42 enrolled

A Phase 2 Study of Venetoclax in Combination With ASTX727 in Patients With Relapsed/Refractory Acute Myeloid Leukemia, and Newly Diagnosed Elderly Patients With AML Who Are Not Candidates for Intensive Chemotherapy

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT04746235·85 enrolled

A Randomized Phase II Trial of ASTX727 With Standard Duration Versus Shorter Duration of Venetoclax in Genomically Heterogenous AML Among Adults Aged 60 or Older and Less Fit for Intensive Therapy: A MyeloMATCH Substudy

Recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT07437950·126 enrolled

A Phase I Study of Lintuzumab-Ac-225 in Combination With Venetoclax and ASTX-727 in Adults With Newly Diagnosed AML

Suspended·NNational Cancer Institute (NCI)·Phase 1·NCT06802523·53 enrolled

Oral Decitabine-Based Maintenance Therapy in Patients With AML in Remission

Recruiting·MM.D. Anderson Cancer Center·Phase 1·NCT05010772·125 enrolled

Myelodysplastic Syndromes2 trials

PK/Efficacy Bridging Study of ASTX727 in Chinese Subjects With Myelodysplastic Syndromes

Active, not recruiting· Otsuka logo

Otsuka·Phase 1/2·NCT06091267·72 enrolled

Testing the Anti-cancer Drug, Cirtuvivint, and Its Combination With ASTX727 to Improve Outcomes in Patients With Acute Myeloid Leukemia and Myelodysplastic Syndromes

Recruiting·NNational Cancer Institute (NCI)·Phase 1·NCT06484062·54 enrolled

Chronic Myelomonocytic Leukemia2 trials

A Phase I/II Study of Venetoclax in Combination With ASTX727 (Cedazuridine/Decitabine) in Treatment-Naïve High-Risk Myelodysplastic Syndrome (MDS) or Chronic Myelomonocytic Leukemia (CMML)

Active, not recruiting·MM.D. Anderson Cancer Center·Preclinical·NCT04655755·52 enrolled

Venetoclax In Combination With ASTX727, an All-ORal TherapY for Chronic Myelomonocytic Leukemia and Other MDS/MPN With Excess Blasts (VICTORY-MDS/MPN): a Randomized, Phase 2 Trial

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT05600894·132 enrolled

Accelerated Phase Myeloproliferative Neoplasm2 trials

A Randomized Phase 2 Trial of ASTX727 +/- Iadademstat in Accelerated/Blast-Phase Philadelphia Chromosome-Negative Myeloproliferative Neoplasms (MPNs)

Recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT06661915·78 enrolled

A Phase 2 Trial Investigating the Addition of Pacritinib to a Hypomethylating Agent as a Bridge to Allogeneic Hematopoietic Stem Cell Transplant in Patients With Accelerated and Blast Phase Myeloproliferative Neoplasms

Recruiting·UUniversity of Washington·Phase 2·NCT07148947·27 enrolled

Prostate Cancer1 trial

Decitabine/Cedazuridine and Enzalutamide for the Treatment of Metastatic Castrate Resistant Prostate Cancer

Terminated·RRoswell Park Cancer Institute·Phase 1·NCT05037500·8 enrolled

8 more indications

Adult Subject1 trial

A Study of Bisantrene Combined With Cytarabine or With Decitabine for Adult Subjects With Extramedullary AML and MDS

Withdrawn·RRace Oncology Ltd·Phase 1·NCT05456269

Myelodysplastic Syndrome1 trial

A Randomized Phase II Trial of Enasidenib-Based Therapies Versus Cedazuridine-Decitabine in Higher-Risk IDH2-Mutated Myelodysplastic Syndrome: A MyeloMATCH Sub-Study

Recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT06577441·54 enrolled

Chronic Phase Chronic Myelogenous Leukemia1 trial

Phase II Study Assessing Safety and Clinical Activity of the Combination of ASTX727 With Dasatinib in Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase (CML-CP)

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT05007873·39 enrolled

Recurrent B-Cell Non-Hodgkin Lymphoma1 trial

A Phase 1 Study of Nivolumab in Combination With ASTX727 in B-cell Lymphoma (NHL or HL) With an Expansion Cohort in Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) and Hodgkin Lymphoma (HL)

Recruiting·NNational Cancer Institute (NCI)·Phase 1·NCT05272384·32 enrolled

Locally Advanced Unresectable Primary Central Chondrosarcoma1 trial

A Phase 2 Study of Belinostat and SGI-110 (Guadecitabine) or ASTX727 for the Treatment of Unresectable and Metastatic Conventional Chondrosarcoma

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT04340843·19 enrolled

Acute Myeloid Leukemia Post Cytotoxic Therapy1 trial

A Phase 1 Study of Oral Cedazuridine and Decitabine Combination (ASTX727, NSC# 820631) and Filgrastim as Maintenance Therapy Post-Hematopoietic Stem Cell Transplant in Children With High-Risk Acute Myeloid Leukemia

Recruiting·NNational Cancer Institute (NCI)·Phase 1·NCT07012044·47 enrolled

Anatomic Stage III Breast Cancer AJCC v81 trial

Phase I Study Targeting DNA Methyltransferases in Metastatic Triple-Negative Breast Cancer

Suspended·NNational Cancer Institute (NCI)·Phase 1·NCT05673200·32 enrolled

Recurrent Acute Biphenotypic Leukemia1 trial

A Phase II Study of Venetoclax in Combination With 10-day Oral Decitabine in Relapsed/Refractory Acute Myeloid Leukemia

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT04975919·20 enrolled

Sources

References

[1]
ClinicalTrials.gov — 27 trial records for Decitabine and Cedazuridine. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Decitabine and Cedazuridine compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Decitabine and Cedazuridine. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Taiho Oncology, Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 2[1]
Company: Taiho Oncology, Inc.

Decitabine and Cedazuridine

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Trials by Indication[1]

Acute Myeloid Leukemia12 trials

Myelodysplastic Syndromes2 trials

Chronic Myelomonocytic Leukemia2 trials

Accelerated Phase Myeloproliferative Neoplasm2 trials

Prostate Cancer1 trial

Adult Subject1 trial

Myelodysplastic Syndrome1 trial

Chronic Phase Chronic Myelogenous Leukemia1 trial

Recurrent B-Cell Non-Hodgkin Lymphoma1 trial

Locally Advanced Unresectable Primary Central Chondrosarcoma1 trial

Acute Myeloid Leukemia Post Cytotoxic Therapy1 trial

Anatomic Stage III Breast Cancer AJCC v81 trial

Recurrent Acute Biphenotypic Leukemia1 trial

References

Drug Info

Quick Facts

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