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LoDAC (Low Dose Cytarabine)
Low-dose cytarabine is a nucleoside analog that inhibits DNA synthesis by incorporating into DNA and blocking cell division, primarily affecting rapidly dividing hematopoietic cells.
Low-dose cytarabine is a nucleoside analog that inhibits DNA synthesis by incorporating into DNA and blocking cell division, primarily affecting rapidly dividing hematopoietic cells. Used for Myelodysplastic syndrome (MDS), Acute myeloid leukemia (AML) in elderly patients unfit for intensive chemotherapy.
At a glance
| Generic name | LoDAC (Low Dose Cytarabine) |
|---|---|
| Sponsor | Astellas Pharma Global Development, Inc. |
| Drug class | Nucleoside analog; antimetabolite |
| Target | DNA polymerase; thymidylate synthase |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Cytarabine is a cytidine analog that is phosphorylated intracellularly and incorporated into DNA, where it inhibits DNA polymerase and prevents DNA elongation. At low doses, it preferentially affects myelodysplastic and leukemic cells while sparing normal hematopoiesis to some degree. The mechanism exploits the differential sensitivity of abnormal cells to DNA synthesis inhibition.
Approved indications
- Myelodysplastic syndrome (MDS)
- Acute myeloid leukemia (AML) in elderly patients unfit for intensive chemotherapy
Common side effects
- Myelosuppression (neutropenia, thrombocytopenia, anemia)
- Infection
- Nausea and vomiting
- Mucositis
- Hepatotoxicity
- Neurotoxicity (at higher doses)
Key clinical trials
- A Study of ASP2215 Versus Salvage Chemotherapy in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With FMS-like Tyrosine Kinase (FLT3) Mutation (PHASE3)
- Trial of Cladribine and Low-Dose Cytarabine (LoDAC) Alternating With Decitabine vs. Hypomethylating Agents (HMA) Plus Venetoclax as Frontline Therapy for AML or High-Grade MDS in Patients Unfit for Intensive Induction (PHASE2)
- HEC73543 Versus Salvage Chemotherapy in R/R FLT3-ITD AML (PHASE3)
- A Study of XY0206 Versus Salvage Chemotherapy In Patients With Relapsed or Refractory AML With FLT3-ITD-Mutation (ALIVE) (PHASE3)
- A Study of SKLB1028 Versus Salvage Chemotherapy in Patients With Relapsed or Refractory (R/R) AML With FLT3-Mutated (PHASE3)
- A Study to Evaluate the Tolerance and Efficacy of Mitoxantrone Hydrochloride Liposome Injection Combined With Cytarabine in Patients With Acute Myeloid Leukemia (AML) (PHASE1, PHASE2)
- (QuANTUM-R): An Open-label Study of Quizartinib Monotherapy vs. Salvage Chemotherapy in Acute Myeloid Leukemia (AML) Subjects Who Are FLT3-ITD Positive (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- LoDAC (Low Dose Cytarabine) CI brief — competitive landscape report
- LoDAC (Low Dose Cytarabine) updates RSS · CI watch RSS
- Astellas Pharma Global Development, Inc. portfolio CI