Decitabine/cedazuridine

Phase 2Small molecule

Decitabine/cedazuridine is one of 55 small molecule programs targeting Mutant IDH1 Inhibitor Olutasidenib. It is currently in Phase 2.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

Mutant IDH1 Inhibitor OlutasidenibRecruiting

Maintenance TherapyActive, not recruiting

MDSRecruiting

MesotheliomaRecruiting

Mutant IDH1 Inhibitor OlutasidenibPreclinical

Recruiting

Maintenance TherapyPhase 1

Active, not recruiting

MDSPhase 1

Recruiting

MesotheliomaPhase 2

Recruiting

Competition

Competitive Landscape

26 competitors in Mesothelioma

#DrugCompanyPhaseTrials

Afinitor

Lynparza

Zometa

Nexavar

Iressa

Yondelis

Tazverik

Mitosol

Photofrin

PPinnacle Biologics Inc.

Approved

—10

Beleodaq

AAcrotech Biopharma Inc.

Approved

—

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

Q3 2029

Phase 2Recruiting

Mesothelioma

NCT05960773

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

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

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

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

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

1 more indication

Mesothelioma1 trial

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

Recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT05960773·15 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 2[1]
Company: Otsuka

Decitabine/cedazuridine

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q1 2027

Q4 2027

Q2 2029

Q3 2029

Trials by Indication[1]

Maintenance Therapy1 trial

Myelodysplastic Syndromes1 trial

MDS1 trial

Chronic Myelomonocytic Leukemia1 trial

Mutant IDH1 Inhibitor Olutasidenib1 trial

Mesothelioma1 trial

References

Drug Info

Quick Facts

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