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erwinia asparaginase

Trade name: Erwinaze

BiologicalapprovedOrphan Drug FDA

Approved

Nov 18, 2011

Asparaginase is an enzyme that is used as a medication and in food manufacturing. As a medication, L-asparaginase is used to treat acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL). It is given by injection into a vein, or muscle. A pegylated version is also available. In food manufacturing it is used to decrease acrylamide. — Wikipedia

Clinical trial activity

38 trials · 33 clinical orgs · 4 marketing orgs

Phase 1
10
Phase 2
25
Phase 3
11
Phase 4
0

Earliest trial started Jan 1, 1996 (NCT00165087)

Timeline

1980s

  1. Jul 30, 1986

    Orphan Drug Designation

1990s

  1. Jan 1, 1996

    Earliest Phase 3 Sponsor(trial)

2000s

  1. Jan 1, 2006

    Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2006

    Earliest Phase 2 Sponsor(trial)

2010s

  1. Nov 18, 2011

    EUSA — Earliest FDA Approval

  2. Nov 18, 2011

    Jazz Pharmaceuticals — Marketing Organization

  3. Nov 18, 2011

    EUSA — NDA Organization

  4. Nov 18, 2011

    Jazz Pharmaceuticals — NDA Secondary Org

  5. Mar 12, 2012

    Organogenesis — NDA Secondary Org

  6. Apr 6, 2012

    Avid Radiopharmaceuticals — NDA Secondary Org

Indications

Approved for

Studied for

Mechanism of action

  • AsparagineHYDROLYTIC ENZYME

    Asparagine hydrolytic enzyme

    Crisantaspase (or Asparaginase) takes advantage of the fact that acute lymphoblastic leukemia cells and some other suspected tumor cells are unable to synthesize the non-essential amino acid asparagine, whereas normal cells are able to make their own asparagine; thus leukemic cells require high amount of asparagine. These leukemic cells depend on circulating asparagine. Asparaginase, however, catalyzes the conversion of L-asparagine to aspartic acid and ammonia. This deprives the leukemic cell of circulating asparagine, which leads to cell death.

Approval history

  • approvedNov 18, 2011

Chemistry & pharmacology

Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Parenteral
Availability
Prescription Only

Oral

No

Parenteral

Yes

Topical

No

Sources

Also known as

  • allogenic red blood cells loaded l-asparaginase
  • asparaginase (erwinia)
  • asparaginase erwinia chrysanthemi
  • asparaginase erwinia chrysanthemi
  • asparaginase erwinia chrysanthemi
  • asparaginase erwinia chrysanthemi
  • asparaginase erwinia chrysanthemi
  • crisantaspase
  • erwinase
  • erwinase
  • erwinaze
  • erwinaze
  • erwinia asparaginase
  • erwinia chrysanthemi
  • ery001
  • ery001
  • l-asparaginase (erwinia)

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07133997Phase 1Nov 26, 2025City of Hope National Medical Center, National Cancer Institute (NCI)
NCT07059975Early Phase 1 (Phase 1)Oct 22, 2025Baylor University
NCT06918431Phase 2Oct 10, 2025City of Hope National Medical Center, National Cancer Institute (NCI)
NCT06738368Phase 2Jun 1, 2025Jazz Pharmaceuticals, University of Washington
NCT06317662Phase 2Jan 26, 2025National Cancer Institute (NCI)
NCT05631327Phase 1Dec 19, 2022Jazz Pharmaceuticals
NCT05192889Phase 1/Phase 2 (Phase 2)Aug 25, 2022AbbVie, St. Jude Children's Hospital
NCT04293562Phase 3Apr 4, 2020National Cancer Institute (NCI)
NCT06336395Phase 2Mar 4, 2020National University of Singapore
NCT04326439Phase 2Jan 24, 2020Emory University
NCT04145531Phase 2/Phase 3 (Phase 3)Nov 30, 2019Jazz Pharmaceuticals, National Cancer Institute (NCI)
NCT03914625Phase 3Jun 29, 2019National Cancer Institute (NCI)
NCT03643276Phase 3Jul 15, 2018Deutsche Krebshilfe e.V., Universitaetsklinikum Schleswig-Holstein
NCT03164057Phase 2Jun 15, 2017St. Jude Children's Hospital
NCT03117751Phase 2/Phase 3 (Phase 3)Mar 29, 2017Bristol-Myers Squibb, Incyte, Shire, St. Jude Children's Hospital
NCT03020030Phase 3Jan 1, 2017Baxalta, Harvard University
NCT02718755Phase 2Dec 1, 2016Jazz Pharmaceuticals, University of Texas at Houston
NCT02723994Phase 2Aug 1, 2016Incyte, National Cancer Institute (NCI), University of California, San Francisco, University of Pennsylvania
NCT02553460Phase 1/Phase 2 (Phase 2)Jan 29, 2016Baylor University, Gateway for Cancer Research, St. Jude Children's Hospital
NCT02647190Phase 1Jan 1, 2016Cornell University, Jazz Pharmaceuticals
Showing 20 of 38 trials
Page 1 / 2

Organizations

Research & Development (33)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Jazz PharmaceuticalsFor profit10542006
National Cancer Institute (NCI)Government9432000
St. Jude Children's HospitalAcademic/Hospital9931997
ERYtech PharmaFor profit3322006
Harvard UniversityAcademic/Hospital3221996
Baylor UniversityAcademic/Hospital2122016
City of Hope National Medical CenterAcademic/Hospital2222025
IncyteFor profit2122016
National University of SingaporeAcademic/Hospital2112012
University of Texas at HoustonAcademic/Hospital2222007
AbbVieFor profit1012022
Assistance Publique - Hôpitaux de ParisAcademic/Hospital1012014
BaxaltaFor profit1012017
Bristol-Myers SquibbFor profit1012017
Centre Leon BerardAcademic/Hospital1012006
Cornell UniversityAcademic/Hospital1112016
Deutsche Krebshilfe e.V.Academic/Hospital1012018
Emory UniversityAcademic/Hospital1112020
Gateway for Cancer ResearchAcademic/Hospital1012016
New York UniversityAcademic/Hospital1012009
33 organizations
Page 1 / 2

Marketing (6)

OrganizationOrg typeRelationshipDate
Avid RadiopharmaceuticalsFor profitNDA2Apr 6, 2012
EUSAFor profitNDANov 18, 2011
Jazz PharmaceuticalsFor profitMKTGNov 18, 2011
Jazz PharmaceuticalsFor profitSYNJun 30, 2021
Jazz PharmaceuticalsFor profitNDA2Nov 18, 2011
OrganogenesisFor profitNDA2Mar 12, 2012