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    DRUG CLASS:

    Cytidine deaminase inhibitor

    Related drugs:
    3d
    Eltanexor (KPT-8602) With Inqovi (Decitabine-Cedazuridine) in High-Risk Myelodysplastic Syndromes (clinicaltrials.gov)
    P1/2, N=3, Terminated, National Cancer Institute (NCI) | Completed --> Terminated; Drug company withdrew support.
    Trial termination
    |
    Inqovi (decitabine/cedazuridine) • eltanexor (KPT-8602)
    10d
    Pre-emptive Therapy With DEC-C to Improve Outcomes in MDS Patients With Measurable Residual Disease Post Allogeneic Hematopoietic Cell Transplant (clinicaltrials.gov)
    P1/2, N=209, Recruiting, Washington University School of Medicine | N=126 --> 209
    Enrollment change
    |
    Inqovi (decitabine/cedazuridine)
    11d
    LANTana: Lutathera and ASTX727 in Neuroendocrine Tumours (clinicaltrials.gov)
    P1, N=27, Recruiting, Imperial College London | Trial completion date: Dec 2025 --> Feb 2029 | Trial primary completion date: Dec 2025 --> Jun 2026
    Trial completion date • Trial primary completion date
    |
    Inqovi (decitabine/cedazuridine) • Lutathera (lutetium Lu 177 dotatate)
    25d
    NCI-2021-02246: Testing Oral Decitabine and Cedazuridine (ASTX727) in Combination With Venetoclax for Higher-Risk Acute Myeloid Leukemia Patients (clinicaltrials.gov)
    P1/2, N=5, Active, not recruiting, National Cancer Institute (NCI) | N=55 --> 5 | Trial completion date: Oct 2025 --> Nov 2026 | Trial primary completion date: Oct 2025 --> Jun 2025
    Enrollment change • Trial completion date • Trial primary completion date • Tumor mutational burden
    |
    BCL2 (B-cell CLL/lymphoma 2)
    |
    Venclexta (venetoclax) • cytarabine • daunorubicin • Inqovi (decitabine/cedazuridine) • Starasid (cytarabine ocfosfate)
    1m
    Decitabine-cedazuridine in patients with MDS and TP53 mutations. (PubMed, Blood Adv)
    Median survival was 13.1 months (95% CI: 8.4 - 21.3) for DEC-C vs 8.0 months (95% CI: 5.2 - 13.0) for single agent parenteral HMA (log-rank, p=0.047). In patients with MDS harboring TP53mut, DEC-C may improve overall survival compared to parenteral HMA.
    Journal
    |
    TP53 (Tumor protein P53)
    |
    TP53 mutation • TP53 wild-type
    |
    Inqovi (decitabine/cedazuridine)
    2ms
    Entrectinib in Combination With ASTX727 for the Treatment of Relapsed/Refractory TP53 Mutated Acute Myeloid Leukemia (clinicaltrials.gov)
    P1, N=13, Active, not recruiting, OHSU Knight Cancer Institute | Suspended --> Active, not recruiting
    Enrollment closed
    |
    TP53 (Tumor protein P53)
    |
    TP53 mutation
    |
    Rozlytrek (entrectinib) • Inqovi (decitabine/cedazuridine)
    2ms
    ASCENT1: Research Study Investigating How Well NDec Works in People With Sickle Cell Disease (clinicaltrials.gov)
    P2, N=96, Completed, Novo Nordisk A/S | Active, not recruiting --> Completed | Trial primary completion date: Aug 2025 --> Dec 2024
    Trial completion • Trial primary completion date
    |
    hydroxyurea • decitabine/ tetrahydrouridine (EPI01)
    2ms
    Oral Decitabine/Cedazuridine (DEC-C) in Combination With Nivolumab for Patients With Mucosal Melanoma (clinicaltrials.gov)
    P1/2, N=8, Active, not recruiting, University of Colorado, Denver | Trial completion date: Jul 2026 --> Oct 2026 | Trial primary completion date: Jul 2025 --> Oct 2025
    Trial completion date • Trial primary completion date • Checkpoint inhibition • IO biomarker
    |
    CD4 (CD4 Molecule)
    |
    Opdivo (nivolumab) • Inqovi (decitabine/cedazuridine)
    3ms
    A Phase 1 Trial of ASTX030 in Patients With Myelodysplastic Syndrome (clinicaltrials.gov)
    P1, N=40, Recruiting, Otsuka Pharmaceutical Co., Ltd. | Trial completion date: May 2025 --> Jan 2026 | Trial primary completion date: Apr 2025 --> Dec 2025
    Trial completion date • Trial primary completion date
    |
    cedazuridine/azacitidine (ASTX030)
    3ms
    Oral Decitabine (ASTX727) and Durvalumab in Recurrent and/or Metastatic Head and Neck Cancer Patients (clinicaltrials.gov)
    P1, N=13, Completed, Massachusetts General Hospital | Active, not recruiting --> Completed | Phase classification: P1/2 --> P1 | Trial completion date: Jan 2025 --> Sep 2024 | Trial primary completion date: Jan 2025 --> Sep 2024
    Trial completion • Phase classification • Trial completion date • Trial primary completion date • IO biomarker
    |
    Imfinzi (durvalumab) • azacitidine • Imjudo (tremelimumab-actl) • Inqovi (decitabine/cedazuridine)
    3ms
    ASTX727-03: Phase 1-2 Study of Low Dose ASTX727 (ASTX727 LD) in Lower Risk MDS (clinicaltrials.gov)
    P1/2, N=160, Active, not recruiting, Taiho Oncology, Inc. | Trial primary completion date: Oct 2024 --> Oct 2025
    Trial primary completion date
    |
    Inqovi (decitabine/cedazuridine)
    4ms
    Decitabine/Cedazuridine (INQOVI), an Oral DNA Demethylating Agent, in Subjects With BAP1 Cancer Predisposition Syndrome and Subclinical, Early-Stage Mesothelioma (clinicaltrials.gov)
    P2, N=9, Suspended, National Cancer Institute (NCI) | N=15 --> 9 | Recruiting --> Suspended
    Enrollment change • Trial suspension
    |
    BAP1 (BRCA1 Associated Protein 1)
    |
    Inqovi (decitabine/cedazuridine)