Decitabine/cedazuridine

Phase 3Small molecule

Otsuka

Decitabine/cedazuridine is one of 131 small molecule programs targeting Mesothelioma. It is currently in Phase 3.

Indications

Total Trials

Active Trials

130

Competitors

Pipeline

Status by Indication[3][1]

Indication

MesotheliomaActive, not recruiting

Chronic Myelomonocytic LeukemiaActive, not recruiting

Myelodysplastic SyndromesActive, not recruiting

Mutant IDH1 Inhibitor OlutasidenibRecruiting

MesotheliomaPhase 2

Active, not recruiting

Chronic Myelomonocytic LeukemiaPhase 3

Active, not recruiting

Myelodysplastic SyndromesPhase 2

Active, not recruiting

Mutant IDH1 Inhibitor OlutasidenibPreclinical

Recruiting

Competition

Competitive Landscape

207 competitors in Myelodysplastic Syndromes

#DrugCompanyPhaseTrials

Reblozyl

Bristol-Myers Squibb

Phase 3

15 2

Epogen

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Phase 3

8 3

Promacta

GSK

Phase 3

2 4

Thalomid

Bristol-Myers Squibb

Phase 3

2 5

Fludara

Sanofi

Phase 3

2 6

Rydapt

Novartis

Phase 3

1 7

Xospata

Astellas

Phase 3

1 8

Neupogen

EEastern Cooperative Oncology Group

Phase 3

4 9

Zarnestra

KKura Oncology, Inc.

Phase 3

4 10

Cerubidine

EEastern Cooperative Oncology Group

Phase 3

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

Timeline

Expected Milestones

Q1 2027

Phase 1Active, not recruiting

Maintenance Therapy

NCT03613532

Q4 2027

Phase 1Recruiting

MDS

NCT05636514

Q2 2029

PreclinicalRecruiting

Mutant IDH1 Inhibitor Olutasidenib

NCT06445959

Clinical

Trials by Indication[1]

Maintenance Therapy1 trial

Venetoclax Added to Fludarabine + Busulfan Prior to Transplant and to Maintenance Therapy for AML, MDS, and MDS/MPN

Active, not recruiting·JJacqueline Garcia, MD·Phase 1·NCT03613532·102 enrolled

Mesothelioma1 trial

Decitabine/Cedazuridine (INQOVI), an Oral DNA Demethylating Agent, in Subjects With BAP1 Cancer Predisposition Syndrome and Subclinical, Early-Stage Mesothelioma

Suspended·NNational Cancer Institute (NCI)·Phase 2·NCT05960773·9 enrolled

Myelodysplastic Syndromes1 trial

A Study of Oral Decitabine/Cedazuridine in Combination With Magrolimab in Participants With Intermediate- to Very High-Risk Myelodysplastic Syndromes (MDS)

Terminated·AAstex Pharmaceuticals, Inc.·Phase 2·NCT05835011·2 enrolled

Chronic Myelomonocytic Leukemia1 trial

A Study Comparing Treatment Preference Between Oral Decitabine/Cedazuridine and Azacitidine in Myelodysplastic Syndrome, Low-Blast Acute Myeloid Leukemia, or Chronic Myelomonocytic Leukemia

Active, not recruiting· Otsuka logo

Otsuka·Phase 3·NCT05883956·13 enrolled

MDS1 trial

Combined Evaluation of Epigenetic and Sensitising Therapy in AML and MDS

Recruiting·CClinical Hub for Interventional Research (CHOIR)·Phase 1·NCT05636514·12 enrolled

1 more indication

Mutant IDH1 Inhibitor Olutasidenib1 trial

Phase 1b/2 Study of Decitabine and Venetoclax in Combination With the Targeted Mutant IDH1 Inhibitor Olutasidenib

Recruiting·MM.D. Anderson Cancer Center·Preclinical·NCT06445959·78 enrolled

Sources

References

[1]
ClinicalTrials.gov — 6 trial records for Decitabine/cedazuridine. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Decitabine/cedazuridine compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Decitabine/cedazuridine. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Otsuka company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: Otsuka

Decitabine/cedazuridine

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q1 2027

Q4 2027

Q2 2029

Trials by Indication[1]

Maintenance Therapy1 trial

Mesothelioma1 trial

Myelodysplastic Syndromes1 trial

Chronic Myelomonocytic Leukemia1 trial

MDS1 trial

Mutant IDH1 Inhibitor Olutasidenib1 trial

References

Drug Info

Quick Facts

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