ONCASPAR
LOE Approachingpegaspargase
BLAINTRAMUSCULARVIAL
Approved
Feb 1994
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
8
Data completeness
3/8 — Basic
ONCASPAR (pegaspargase) is l-asparaginase is an enzyme that catalyzes the conversion of the amino acid l-asparagine into aspartic acid and ammonia. First approved in 1994.
Drug data last refreshed 7h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ONCASPAR (pegaspargase) is a PEGylated L-asparaginase enzyme that depletes plasma asparagine to kill leukemic cells dependent on exogenous asparagine supply. It is used in acute lymphoblastic leukemia (ALL) and some T-cell lymphomas. The drug works by exploiting the metabolic vulnerability of leukemic cells with low asparagine synthetase expression.
LOE Approaching
As an aging biologic approaching LOE with moderate competitive pressure (30), team focus is shifting toward lifecycle extension, real-world evidence, and preparation for biosimilar entry rather than growth initiatives.
Mechanism of Action
L-asparaginase is an enzyme that catalyzes the conversion of the amino acid L-asparagine into aspartic acid and ammonia. The pharmacological effect of ONCASPAR is thought to be based on the killing of leukemic cells due to depletion of plasma asparagine. Leukemic cells with low expression of…
Pharmacologic Class:
Asparagine-specific Enzyme
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (8)
Sintilimab, Pegaspargase Plus GemOx for Untreated Extranodal NK/T-Cell Lymphoma
Started May 2024
49 enrolled
Extranodal NK/T-cell Lymphoma
A Roll-over Study to Provide Continued Treatment With Lyophilized Pegaspargase (S95014) in Pediatric Patients With Acute Lymphoblastic Leukemia (ALL)
Started Jun 2021
75 enrolled
Acute Lymphoblastic Leukemia
A Study Comparing the Blood Levels of Both Pegaspargase (S95014) Formulations (Liquid vs Lyophilized) in the Treatment of Paediatric Patients With Acute Lymphoblastic Leukemia (ALL)
Started May 2021
89 enrolled
Acute Lymphoblastic Leukemia
A Clinical Study of SHP674 (Pegaspargase) in Participants With Newly Diagnosed, Untreated Acute Lymphoblastic Leukemia
Started Oct 2019
28 enrolled
Acute Lymphoblastic Leukemia
A Dose Confirmation and Pharmacokinetic Study of Pegcrisantaspase Administered as Intravenous (IV) Infusion in Children and Young Adults With Acute Lymphoblastic Leukemia (ALL) /Lymphoblastic Lymphoma (LBL). Following Hypersensitivity to Pegaspargase (Oncaspar)
Started Sep 2014
4 enrolled
Acute Lymphoblastic LeukemiaLymphoblastic Lymphoma
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.