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Low dose ARA-C (LDAC) (low-dose-ara-c-ldac)
Low dose ARA-C (LDAC) (generic name: low-dose-ara-c-ldac) is a drug developed by Pfizer Inc.. It is currently in Phase 1 development.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Big-pharma sponsor
+3.0pp
Pfizer Inc. is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +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 | low-dose-ara-c-ldac |
|---|---|
| Sponsor | Pfizer Inc. |
| Phase | Phase 1 |
Approved indications
Common side effects
- NAUSEA
- DIARRHOEA
- THROMBOCYTOPENIA
- HYPOKALAEMIA
- DECREASED APPETITE
- ANAEMIA
- Nausea
- FATIGUE
- Neutropenia
- Thrombocytopenia
- Diarrhoea
- CONSTIPATION
Key clinical trials
- Cladribine Plus Low Dose Cytarabine (LDAC) Alternating With Decitabine in Patients With Acute Myeloid Leukemia (AML) or High-Risk Myelodysplastic Syndrome (MDS) (PHASE2)
- Safety and Tolerability of Ziftomenib Combinations in Patients With Relapsed/Refractory Acute Myeloid Leukemia (PHASE1)
- Uproleselan, Cladribine, and Low Dose Cytarabine for the Treatment of Patients With Treated Secondary Acute Myeloid Leukemia (PHASE1, PHASE2)
- Venetoclax, Cladribine, Low Dose Cytarabine, and Azacitidine in Treating Patients With Previously Untreated Acute Myeloid Leukemia (PHASE2)
- Prospective Non-interventional Study of Adult Patients With Acute Myeloid Leukemia (AML)
- A Study of Venetoclax in Combination With Low Dose Cytarabine Versus Low Dose Cytarabine Alone in Treatment Naive Patients With Acute Myeloid Leukemia Who Are Ineligible for Intensive Chemotherapy (PHASE3)
- FHD-286 as Monotherapy or Combination Therapy in Subjects With Advanced Hematologic Malignancies (PHASE1)
- An Efficacy and Safety Study of AG-221 (CC-90007) Versus Conventional Care Regimens in Older Subjects With Late Stage Acute Myeloid Leukemia Harboring an Isocitrate Dehydrogenase 2 Mutation (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:
- Low dose ARA-C (LDAC) CI brief — competitive landscape report
- Low dose ARA-C (LDAC) updates RSS · CI watch RSS
- Pfizer Inc. portfolio CI
Frequently asked questions about Low dose ARA-C (LDAC)
What is Low dose ARA-C (LDAC)?
Who makes Low dose ARA-C (LDAC)?
What is the generic name of Low dose ARA-C (LDAC)?
What development phase is Low dose ARA-C (LDAC) in?
What are the side effects of Low dose ARA-C (LDAC)?
Related
- Manufacturer: Pfizer Inc. — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing