Data updated: May 26, 2026
ONCASPAR (pegaspargase)
Trial Activity: Growth 30 active trials
Oncology
Approved 1994-02-01
ONCASPAR (pegaspargase) is an asparagine-specific enzyme indicated for use as a component of a multi-agent chemotherapeutic regimen. It is approved for the treatment of both pediatric and adult patients with acute lymphoblastic leukemia (ALL). The medication is utilized as a first-line therapy or for patients who have developed a hypersensitivity to native forms of L-asparaginase.
How ONCASPAR Works
ONCASPAR is an enzyme that catalyzes the conversion of the amino acid L-asparagine into aspartic acid and ammonia. This action results in the depletion of asparagine levels within the plasma. Leukemic cells with low expression of asparagine synthetase are unable to synthesize their own asparagine and must rely on exogenous sources for survival. By depleting these external sources, the drug facilitates the killing of leukemic cells.
Development Insights
National Cancer Institute (NCI) conducting 12 trials (23%)
84 indications explored (Broad Platform)
→ acute lymphoblastic leukemia (15 trials)
→ b acute lymphoblastic leukemia (8 trials)
→ leukemia (6 trials)
3
Indications
--
Phase 3 Trials
32
Years on Market
Details
- Status
- Prescription
- First Approved
- 1994-02-01
- Patent Cliff
- 2001
- Routes
- N/A
- Dosage Forms
- VIAL
ONCASPAR Approval History
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Original
New Indication
New Form
Label Update
10 FDA actions from 1994 to 2024 · 2 indication expansions
Feb 1994 ORIGINAL
New Form
What ONCASPAR Treats
2 indicationsONCASPAR is approved for 2 conditions since its original approval in 1994. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Acute Lymphoblastic Leukemia
- Hypersensitivity
Source: FDA Label
ONCASPAR Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
1
Same target(s) AND same indication — head-to-head.
Indication competitors
10
Same indication, different mechanism — what else might this patient receive?
Unlock 8 more competitors across all three rings.
Upgrade to Pro Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in ONCASPAR's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications ONCASPAR treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to ONCASPAR
3 of 19FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
RYLAZE
ASPARAGINASE ERWINIA CHRYSANTHEMI (RECOMBINANT)-RYWN
JAZZ PHARMS
Shared indications:
Acute Lymphoblastic LeukemiaHypersensitivity
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Clinical Trial Registry
54 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06124157 | NCI-2023-09214 NCI-2023-09214, AALL2131 | Ph 2 | recruiting | A Study Testing the Combination of Dasatinib or Imatinib to Chemotherapy Treatment With Blinatumomab for Children, Adolescents, and Young Adults With Philadelphia Chromosome Positive (Ph+) or ABL-Class Philadelphia Chromosome-Like (Ph-Like) B-cell Acute Lymphoblastic Leukemia (B-ALL) |
| NCT05602194 | ACCL1931 NCI-2022-08058, ACCL1931 | Ph 3 | active not recruiting | Studying the Effect of Levocarnitine in Protecting the Liver From Chemotherapy for Leukemia or Lymphoma |
| NCT03808610 | 2016-0629 NCI-2018-03360, 2016-0629 | Ph 1, Ph 2 | terminated | Low-Intensity Chemotherapy and Venetoclax in Treating Patients With Relapsed or Refractory B- or T-Cell Acute Lymphoblastic Leukemia |
| NCT07574528 | B2026-235 | Ph 2 | not yet recruiting | A Phase II Study of Sintilimab, Pegaspargase and Selinexor Followed by Radiotherapy in Newly Diagnosed Stage I/II Extranodal NK/T-Cell Lymphoma |
| NCT03959085 | AALL1732 NCI-2019-02845, AALL1732 | Ph 3 | recruiting | Inotuzumab Ozogamicin and Post-Induction Chemotherapy in Treating Patients With High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and B-LLy |
| NCT02112916 results posted | NCI-2014-00712 NCI-2014-00712, s14-01925 | Ph 3 | active not recruiting | Combination Chemotherapy With or Without Bortezomib in Treating Younger Patients With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia or Stage II-IV T-Cell Lymphoblastic Lymphoma |
| NCT02101853 results posted | NCI-2014-00631 NCI-2014-00631, s15-00970 | Ph 3 | active not recruiting | Blinatumomab in Treating Younger Patients With Relapsed B-cell Acute Lymphoblastic Leukemia |
| NCT03914625 | NCI-2019-02187 NCI-2019-02187, AALL1731 | Ph 3 | active not recruiting | A Study to Investigate Blinatumomab in Combination With Chemotherapy in Patients With Newly Diagnosed B-Lymphoblastic Leukemia |
| NCT02883049 results posted | NCI-2011-03797 NCI-2011-03797, S12-01254 | Ph 3 | active not recruiting | Combination Chemotherapy in Treating Young Patients With Newly Diagnosed High-Risk B Acute Lymphoblastic Leukemia and Ph-Like TKI Sensitive Mutations |
| NCT02981628 | AALL1621 NCI-2016-01494, AALL1621 | Ph 2 | recruiting | Inotuzumab Ozogamicin in Treating Younger Patients With B-Lymphoblastic Lymphoma or Relapsed or Refractory CD22 Positive B Acute Lymphoblastic Leukemia |
| NCT03007147 | AALL1631 NCI-2016-01588, AALL1631 | Ph 3 | active not recruiting | Imatinib Mesylate and Combination Chemotherapy in Treating Patients With Newly Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia |
| NCT02003222 results posted | NCI-2013-02229 NCI-2013-02229, ECOG-E1910 | Ph 3 | active not recruiting | Combination Chemotherapy With or Without Blinatumomab in Treating Patients With Newly Diagnosed BCR-ABL-Negative B Lineage Acute Lymphoblastic Leukemia |
| NCT00558519 results posted | CALGB-10403 CALGB-10403, ECOG C10403 | Ph 2 | completed | Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Acute Lymphoblastic Leukemia |
| NCT01190930 results posted | AALL0932 NCI-2011-02599, CDR0000683227 | Ph 3 | active not recruiting | Risk-Adapted Chemotherapy in Treating Younger Patients With Newly Diagnosed Standard-Risk Acute Lymphoblastic Leukemia or Localized B-Lineage Lymphoblastic Lymphoma |
| NCT02723994 | INCB 18424-269 AALL1521 | Ph 2 | completed | A Phase 2 Study of Ruxolitinib With Chemotherapy in Children With Acute Lymphoblastic Leukemia |
| NCT05157971 | 21134 NCI-2021-09185, 21134 | Ph 1 | recruiting | Venetoclax and a Pediatric-Inspired Regimen for the Treatment of Newly Diagnosed B Cell Acute Lymphoblastic Leukemia |
| NCT05700448 | CS1001-306 | Ph 3 | not yet recruiting | Study of Sugemalimab (or Placebo) Plus PGemOx Regimen in Participants With Extranodal NK/T-Cell Lymphoma |
| NCT01574274 results posted | 11-001 | Ph 2 | active not recruiting | SC-PEG Asparaginase vs. Oncaspar in Pediatric Acute Lymphoblastic Leukemia (ALL) and Lymphoblastic Lymphoma |
| NCT03020030 | 16-001 | Ph 3 | active not recruiting | Treatment of Newly Diagnosed Acute Lymphoblastic Leukemia in Children and Adolescents |
| NCT03571321 | IRB17-1110 | Ph 1 | recruiting | Ruxolitinib and Chemotherapy in Adolescents and Young Adults With Ph-like Acute Lymphoblastic Leukemia |
| NCT07072585 | AALL2331 NCI-2025-02230, AALL2331 | Ph 2, Ph 3 | not yet recruiting | Testing the Addition of Daratumumab to Chemotherapy for Treating Patients With Newly-Diagnosed T-Cell Lymphoblastic Leukemia (T-ALL) and T-Cell Lymphoblastic Lymphoma (T-LL) |
| NCT02553460 results posted | TINI NCI-2015-01493 | Ph 1, Ph 2 | active not recruiting | Total Therapy for Infants With Acute Lymphoblastic Leukemia (ALL) I |
| NCT03117751 | TOT17 NCI-2017-00582 | Ph 2, Ph 3 | active not recruiting | Total Therapy XVII for Newly Diagnosed Patients With Acute Lymphoblastic Leukemia and Lymphoma |
| NCT07227584 | 25-533 | Ph 2 | not yet recruiting | ALL Backbone in AYAs |
| NCT05192889 results posted | RAVEN NCI-2022-00304 | Ph 1, Ph 2 | active not recruiting | Trial Treating Relapsed Acute Lymphoblastic Leukemia With Venetoclax and Navitoclax |
| NCT04546399 | NCI-2020-06813 NCI-2020-06813, AALL1821 | Ph 2 | recruiting | A Study to Compare Blinatumomab Alone to Blinatumomab With Nivolumab in Patients Diagnosed With First Relapse B-Cell Acute Lymphoblastic Leukemia (B-ALL) |
| NCT05660473 | IIT2022052 | Ph 2 | recruiting | Pediatric-inspired Regimen Combined With Venetoclax for Adolescent and Adult Patients With de Novo Philadelphia Chromosome-Negative Acute Lymphoblastic Leukemia |
| NCT05521087 | CR109192 75276617ALE1003, 2022-000380-46 | Ph 1 | withdrawn | A Study of JNJ-75276617 in Combination With Conventional Chemotherapy for Pediatric and Young Adult Participants With Relapsed/Refractory Acute Leukemias |
| NCT03643276 | AIEOP-BFM ALL 2017 | Ph 3 | recruiting | Treatment Protocol for Children and Adolescents With Acute Lymphoblastic Leukemia - AIEOP-BFM ALL 2017 |
| NCT03844360 | Antineoplastic Drugs001 | Ph 4 | recruiting | Dose Individualization of Antineoplastic Drugs and Anti-Infective Drug in Children With Hematoplastic Disease |
| NCT03792256 results posted | AINV18P1 NCI-2019-02774 | Ph 1 | completed | Palbociclib in Combination With Chemotherapy in Treating Children With Relapsed Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma (LL) |
| NCT04365036 | B2020-040-01 | Ph 3 | recruiting | A Multicenter, Phase 3, Randomized Trial of Sequencial Chemoradiotherapy with or Without Toripalimab (PD-1 Antibody) in Newly Diagnosed Early-Stage Extranodal Natural Killer/T Cell Lymphoma, Nasal Type (ENKTL) |
| NCT02828358 results posted | NCI-2016-00973 NCI-2016-00973, s17-00488 | Ph 2 | completed | Azacitidine and Combination Chemotherapy in Treating Infants With Acute Lymphoblastic Leukemia and KMT2A Gene Rearrangement |
| NCT01228331 | CDR0000686545 2009-012758-18 | Ph 2, Ph 3 | completed | Clofarabine or High-Dose Cytarabine and Pegaspargase in Children with ALL |
| NCT06554626 | IIT20240070C | Ph 2 | recruiting | Blinatumomab Plus Venetoclax Sequenced With Inotuzumab Ozogamicin in Treating B-ALL |
| NCT06527781 | 2023-PK-PD5K3-14 | Ph 1 | completed | A Study of PD5K3 in Healthy Adult Volunteers |
| NCT00557193 results posted | AALL0631 NCI-2009-00313, CDR0000573996 | Ph 3 | completed | Combination Chemotherapy With or Without Lestaurtinib in Treating Younger Patients With Newly Diagnosed Acute Lymphoblastic Leukemia |
| NCT06210750 | NCI-2023-09521 NCI-2023-09521, S2306 | Ph 2 | withdrawn | Adding Targeted Drugs to Usual Chemotherapy for Adults With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia (T-ALL) and T-Cell Lymphoblastic Lymphoma (T-LBL) |
| NCT06376721 | TREC2024-KY016 | Ph 1, Ph 2 | recruiting | Linperlisib Combined With Camrelizumab and Pegaspargase in Advanced or Relapsed/Refractory NK/T-cell Lymphoma |
| NCT03962465 ALL-001 | 21417 | Ph 1 | active not recruiting | Phase I Study of Inotuzumab With Augmented BFM Re-Induction for Patients With Relapsed/Refractory B-cell ALL |
| NCT01005914 results posted | IRB00004913 OHSU-4913, ENZON-OHSU-4913 | Ph 2 | terminated | Pegaspargase and Combination Chemotherapy in Treating Patients With Newly Diagnosed Acute Lymphoblastic Leukemia |
| NCT01700946 results posted | ALLR18 NCI-2012-00587 | Ph 2 | completed | Therapy for Pediatric Relapsed or Refractory Precursor B-Cell Acute Lymphoblastic Leukemia and Lymphoma |
| NCT00671034 results posted | AALL07P4 NCI-2009-00317, CDR0000594340 | Ph 3 | completed | Calaspargase Pegol or Pegaspargase and Combination Chemotherapy in Treating Younger Patients With Newly Diagnosed High-Risk Acute Lymphoblastic Leukemia |
| NCT00866307 results posted | AALL08P1 NCI-2009-01169, CDR0000636174 | Ph 1 | completed | Pegaspargase and Combination Chemotherapy in Treating Younger Patients With Newly Diagnosed High-Risk Acute Lymphoblastic Leukemia (Closed to Accrual 4-22-2011) |
| NCT01483690 results posted | T2009-003 | Ph 1, Ph 2 | terminated | A Pilot Study of Decitabine and Vorinostat With Chemotherapy for Relapsed ALL |
| NCT00720109 results posted | NCI-2009-00312 NCI-2009-00312, AALL0622 | Ph 2, Ph 3 | completed | Dasatinib and Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Acute Lymphoblastic Leukemia |
| NCT02535806 results posted | MERCY01 | Ph 2 | terminated | Four Drug Reinduction With Bortezomib for Relapsed or Refractory ALL or LL in Children and Young Adults |
| NCT02533323 | SYSUCC-NK/T-5010 | Ph 2 | terminated | P-Gemox Regimen as First-line Chemotherapy in NK/T Lymphoma Patiens |
| NCT02359162 | SYSUCC-NK-308 | Ph 3 | terminated | Efficacy and Safety Study of P-Gemox vs.EPOCH as First-line Chemotherapy to Treat NK/T-cell Lymphoma With Early Stage |
| NCT00882206 results posted | 2008LS112 0810M50401, MT2008-29R | Ph 2 | terminated | Pre-reinductive Decitabine and Vorinostat in Relapsed Lymphoblastic Lymphoma or Acute Lymphoblastic Leukemia |
Showing 50 of 54 trials
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ONCASPAR FDA Label Details
Indications & Usage
FDA Label (PDF)ONCASPAR is indicated for the treatment of Acute Lymphoblastic Leukemia; Hypersensitivity.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment