Product Description
A dinucleotide antimetabolite of a decitabine linked via phosphodiester bond to a guanosine, with potential antineoplastic activity. Following metabolic activation by phosphorylation and incorporation into DNA, guadecitabine inhibits DNA methyltransferase, thereby causing genome-wide and non-specific hypomethylation and inducing cell cycle arrest at S-phase. This agent is resistant to cytidine deaminase, hence may result in gradual release of decitabine both extra- and intracellularly, leading to more prolonged exposures to decitabine. (Sourced from: https://www.cancer.gov/publications/dictionaries/cancer-drug/def/guadecitabine)
Mechanisms of Action: DNA Mtase Inhibitor
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Subcutaneous
FDA Designation: *
Approval Status: Not Approved
Approved Countries: None
Approved Indications: None
Known Adverse Events: None
Company: Otsuka
Company Location: NEW YORK NY 10271
Company CEO:
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: Japan, United Kingdom, United States
Active Clinical Trial Count: 5
Recent & Upcoming Milestones
Highest Development Phases
Phase 2: Acute Monocytic Leukemia|Acute Myeloid Leukemia|Acute Myelomonocytic Leukemia|Chronic Myeloid Leukemia|Chronic Myelomonocytic Leukemia|Kidney Cancer|Myelodysplastic Syndrome|Renal Cell Carcinoma|Transitional Cell Carcinoma
Phase 1: Lung Cancer|Non-Small-Cell Lung Cancer
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|
| HyPeR | P1 |
Recruiting |
Non-Small-Cell Lung Cancer |
2026-09-01 |
12% |
2025-08-19 |
|
| DOSE SELECTION | P1 |
Active, not recruiting |
Lung Cancer |
2026-07-01 |
50% |
2025-08-07 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
| BTCRC-GU16-043 | P2 |
Active, not recruiting |
Renal Cell Carcinoma|Kidney Cancer |
2022-12-01 |
39% |
2022-02-19 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
| JapicCTI-184015 | P2 |
Active |
Myelodysplastic Syndrome|Acute Myelomonocytic Leukemia|Acute Monocytic Leukemia|Chronic Myeloid Leukemia|Chronic Myelomonocytic Leukemia|Acute Myeloid Leukemia |
2020-12-01 |
|||
| GU-114 | P2 |
Active, not recruiting |
Transitional Cell Carcinoma |
2020-07-12 |
2020-08-20 |
Patient Enrollment|Primary Completion Date|Primary Endpoints|Treatments|Trial Status |