NDAINTRAVENOUSINJECTABLEPriority Review
Approved
Oct 2005
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
6
Data completeness
4/8 — Partial
Priority Review
ARRANON (nelarabine) by Novartis is nucleic acid synthesis inhibitors [moa]. First approved in 2005.
Drug data last refreshed 8h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ARRANON (nelarabine) is an intravenous nucleoside metabolic inhibitor approved in 2005 for hematologic malignancies, specifically T-cell acute lymphoblastic leukemia and T-cell lymphoma. It works by inhibiting nucleic acid synthesis, disrupting DNA replication in rapidly dividing cancer cells. The drug represents a specialized oncology option for difficult-to-treat lymphoid malignancies.
LOE Approaching
As LOE approaches, the commercial team is likely consolidating and focusing on managed care defense rather than growth initiatives.
Mechanism of Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Class:
Nucleoside Metabolic Inhibitor
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (6)
The Efficacy and Safety of Nelarabine Injection in Patients With T-lymphoblastic Leukemia and T-lymphoblastic Lymphoma
Started May 2024
83 enrolled
T-lymphoblastic LeukemiaT-lymphoblastic Lymphoma
Pharmacokinetic (PK) and Pharmacodynamic (PD) Study of Nelarabine in Patients With Relapsed/Refractory Lymphoid Malignancies
Started Jun 2010
29 enrolled
Leukemia
Trial of Nelarabine, Etoposide and Cyclophosphamide in Relapsed T-cell ALL and T-cell LL
Started Jun 2010
23 enrolled
Relapsed T-Cell Acute Lymphoblastic LeukemiaRelapsed T-Cell Lymphoblastic Lymphoma
Observational Study of Nelarabine in Children and Young Adults
Started Feb 2009
28 enrolled
Leukaemia, Lymphoblastic, Acute
Drug Use Investigation for ARRANON G (Nelarabine) Injection 250mg
Started Jan 2008
343 enrolled
Cancer
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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.