TheraRadar
Data updated: May 26, 2026

Erwinaze (asparaginase erwinia chrysanthemi)

Approved 2011-11-17
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
14
Years on Market

Details

Status
Disc
First Approved
2011-11-17
Routes
Intravenous, Intramuscular
Dosage Forms
For Injection

Companies

Jazz Pharmaceuticals, Inc.
Active Ingredient: asparaginase Erwinia chrysanthemi

Erwinaze Approval History

2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
1 FDA actions from 2011 to 2011
Nov 2011 ORIGINAL
Update · CBER biologic (Purple Book)

What Erwinaze Treats

1 FDA approvals

Originally approved for its first indication in 2011 .

  • Other (1)
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Clinical Trial Registry

11 trials
Trial Sponsor ID Phase Status Title
NCT06317662 NCI-2024-01994 NCI-2024-01994, AALL2321 Ph 2 recruiting Testing the Addition of the Anti-cancer Drug Venetoclax and/or the Anti-cancer Immunotherapy Blinatumomab to the Usual Chemotherapy Treatment for Infants With Newly Diagnosed KMT2A-rearranged or KMT2A-non-rearranged Leukemia
NCT06738368 RG1124788 NCI-2024-09417, FHIRB0020869 Ph 2 recruiting Etoposide, Prednisone, Vincristine, Cyclophosphamide, and Doxorubicin (DA-EPOCH) With or Without Rituximab Plus Recombinant Erwinia Asparaginase (JZP458) for the Treatment of Newly Diagnosed Ph Negative B-Acute Lymphoblastic Leukemia or T Acute Lymphoblastic Leukemia
NCT04293562 AAML1831 NCI-2020-00546, AAML1831 Ph 3 recruiting A Study to Compare Standard Chemotherapy to Therapy With CPX-351 and/or Gilteritinib for Patients With Newly Diagnosed AML With or Without FLT3 Mutations
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
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
NCT07133997 24738 NCI-2025-05656, 24738 Ph 1 recruiting Recombinant Erwinia Asparaginase and Venetoclax in Combination With Blinatumomab for the Treatment of Relapsed or Refractory CD19 Positive B-cell Acute Lymphoblastic Leukemia
NCT06918431 24442 NCI-2025-02184, 24442 Ph 2 recruiting Asparaginase Erwinia Chrysanthemi With Chemotherapy for the Treatment of High-Risk Adults With Newly Diagnosed Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma
NCT02723994 INCB 18424-269 AALL1521 Ph 2 completed A Phase 2 Study of Ruxolitinib With Chemotherapy in Children With Acute Lymphoblastic Leukemia
NCT02553460 results posted TINI NCI-2015-01493 Ph 1, Ph 2 active not recruiting Total Therapy for Infants With Acute Lymphoblastic Leukemia (ALL) I
NCT02521493 results posted AAML1531 NCI-2015-00324, AAML1531 Ph 3 active not recruiting Response-Based Chemotherapy in Treating Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndrome in Younger Patients With Down Syndrome
NCT01643408 results posted 100EUSA12 Ph 2 completed A Study of Erwinaze Administered Intravenously in Patients Who Had an Allergy to Frontline Asparaginase Therapy
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

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.

Erwinaze FDA Label Details

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Data Sources

FDA Approval: BLA125359 → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.