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LoDAC
LoDAC is a low-dose cytarabine formulation designed to improve tolerability and efficacy in hematologic malignancies.
LoDAC is a low-dose cytarabine formulation designed to improve tolerability and efficacy in hematologic malignancies. Used for Acute myeloid leukemia (AML) in elderly or unfit patients, Myelodysplastic syndrome (MDS).
At a glance
| Generic name | LoDAC |
|---|---|
| Also known as | Low Dose Cytarabine |
| Sponsor | Sunshine Lake Pharma Co., Ltd. |
| Drug class | Nucleoside analog / Antimetabolite |
| Target | DNA synthesis (cytidine deaminase inhibition pathway) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
LoDAC (low-dose cytarabine) is a nucleoside analog that inhibits DNA synthesis by being incorporated into DNA during the S phase of the cell cycle, leading to cell death. The low-dose formulation aims to optimize the therapeutic window by reducing toxicity while maintaining anti-leukemic activity, particularly in elderly or unfit patients who cannot tolerate standard chemotherapy doses.
Approved indications
- Acute myeloid leukemia (AML) in elderly or unfit patients
- Myelodysplastic syndrome (MDS)
Common side effects
- Myelosuppression / neutropenia
- Thrombocytopenia
- Anemia
- Infection
- Nausea / vomiting
Key clinical trials
- Trial of DFP-10917 vs Non-Intensive or Intensive Reinduction for AML Patients in 2nd/3rd/4th Salvage (PHASE3)
- 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)
- A Study to Evaluate HMPL-306 in Patients With IDH1or IDH2-mutated Acute Myeloid Leukemia (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)
- Low Dose Antenatal Corticosteroids for Late Preterm Delivery (NA)
- 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)
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 CI brief — competitive landscape report
- LoDAC updates RSS · CI watch RSS
- Sunshine Lake Pharma Co., Ltd. portfolio CI