FLUDARA
LOE ApproachingNDAINJECTIONINJECTABLEPriority Review
Approved
Apr 1991
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
2/8 — Basic
Priority Review
Drug data last refreshed 3h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
FLUDARA (fludarabine phosphate) is an injectable small-molecule nucleoside analog approved in 1991 for hematologic malignancies. It works by inhibiting DNA synthesis through suppression of DNA polymerase alpha, ribonucleotide reductase, and DNA primase, making it active against rapidly dividing cancer cells. The drug is administered intravenously and has been a foundational therapy in oncology for over three decades.
LOE Approaching
Product is in late-stage lifecycle with approaching loss of exclusivity, likely requiring defensive commercial strategies and lean operational teams.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Induction and Consolidation With Fludarabine, Cytarabine, Idarubicin, and Venetoclax for the Treatment of Acute Myeloid Leukemia
Started Dec 2025
102 enrolled
Acute Myeloid LeukemiaMyelodysplastic Syndrome
A Study to Find the Highest Dose of Imetelstat in Combination With Fludarabine and Cytarabine for Patients With AML, MDS or JMML That Has Come Back or Does Not Respond to Therapy
Started Feb 2025
36 enrolled
Recurrent Childhood Acute Myeloid LeukemiaRecurrent Childhood Myelodysplastic SyndromeRecurrent Juvenile Myelomonocytic Leukemia+3 more
A Proof of Concept Pilot Study of the Addition of Venetoclax to Standard Remission Induction Chemotherapy Fludarabine or Cladrabine, Cytarabine, and Granulocyte Colony Stimulating Factor (G-CSF) (FLAG or CLAG) for Frontline Therapy of Secondary Acute Myeloid Leukemia
Started Jun 2024
10 enrolled
Secondary Acute Myeloid Leukemia
Lifileucel With Reduced Dose Fludarabine/Cyclophosphamide Lymphodepletion and Interleukin-2 for the Treatment of Patients With Unresectable or Metastatic Melanoma
Started Dec 2023
11 enrolled
Clinical Stage IV Cutaneous Melanoma AJCC v8Metastatic MelanomaPathologic Stage IIIC Cutaneous Melanoma AJCC v8+1 more
90Y-DOTA-anti-CD25 Basiliximab, Fludarabine, Melphalan, and Total Marrow and Lymphoid Irradiation for the Treatment of High-Risk Acute Leukemia or Myelodysplastic Syndrome
Started Jul 2022
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.