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LoDAC
LoDAC is a Nucleoside analog / Antimetabolite Small molecule drug developed by Sunshine Lake Pharma Co., Ltd.. It is currently in Phase 3 development for Acute myeloid leukemia (AML) in elderly or unfit patients, Myelodysplastic syndrome (MDS). Also known as: Low Dose Cytarabine.
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).
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Oncology Phase 3 boost
+3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
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
Frequently asked questions about LoDAC
What is LoDAC?
How does LoDAC work?
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Who makes LoDAC?
Is LoDAC also known as anything else?
What drug class is LoDAC in?
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What does LoDAC target?
Related
- Drug class: All Nucleoside analog / Antimetabolite drugs
- Target: All drugs targeting DNA synthesis (cytidine deaminase inhibition pathway)
- Manufacturer: Sunshine Lake Pharma Co., Ltd. — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Acute myeloid leukemia (AML) in elderly or unfit patients
- Indication: Drugs for Myelodysplastic syndrome (MDS)
- Also known as: Low Dose Cytarabine
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing