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asparaginase

Trade name: elspar

Biologicalapproved

Approved

Jan 10, 1978

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

139 trials · 141 clinical orgs · 2 marketing orgs

Phase 1
13
Phase 2
95
Phase 3
50
Phase 4
14

Earliest trial started Jan 1, 1990 (NCT00002499)

Timeline

1970s

  1. Jan 10, 1978

    Merck — Earliest FDA Approval

  2. Jan 10, 1978

    Merck — Marketing Organization

  3. Jan 10, 1978

    Merck — NDA Organization

  4. Jan 10, 1978

    Recordati — NDA Secondary Org

1990s

  1. Jan 1, 1990

    Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 1993

    Earliest Phase 3 Sponsor(trial)

  3. Jan 1, 1999

    Earliest Phase 1 Sponsor(trial)

Indications

Approved for

Studied for

Mechanism of action

  • AsparagineHYDROLYTIC ENZYME

    Asparagine hydrolytic enzyme

Approval history

  • approvedJan 10, 1978

Chemistry & pharmacology

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

Oral

No

Parenteral

Yes

Topical

No

Sources

Also known as

  • asp6858
  • asparaginase
  • asparaginase
  • asparaginase
  • asparaginase
  • asparaginase
  • asparaginase
  • asparaginase
  • asparaginase
  • asparaginase (e. coli)
  • asparaginase e. coli
  • colaspase
  • crasnitin
  • e.coli asparaginase
  • elspar
  • elspar
  • escherichia coli l-asparaginase
  • l-asparaginase
  • l-asparaginase
  • l-asparaginase
  • l-asparagine
  • l-asparagine
  • l-asparagine
  • l-asparagine amidohydrolase
  • lsa4

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06583083Phase 2Oct 22, 2024Sun Yat-Sen University
NCT06099366Phase 2Jan 15, 2024Sungkyunkwan University
NCT06527781Phase 1Nov 27, 2023Government of China, Soochow University
NCT06676293N/AAug 1, 2023Chang Gung University
NCT05681260Phase 3Feb 6, 2023Anhui Medical University, Capital Medical University, Central South University, Children's Cancer Group, China, Hebei University, Henan Provincial Cancer Hospital, Huazhong University of Science and Technology, Jiao Tong University, Nanjing Medical University, Shandong University, Shenzhen University, Sichuan University, Sun Yat-Sen University, Tianjin Medical University, Tongji University, Wuhan Children's Hospital, Zhejiang University, Zhengzhou University
NCT05008666Phase 2Dec 1, 2021Sun Yat-Sen University
NCT04414969Phase 2Jun 25, 2020Central South University, Department of Lymphoma and Hematology, Hunan Cancer Hospital
NCT04440267Phase 2Jun 20, 2020Chinese Academy of Medical Sciences, Peking University
NCT04292743Phase 1May 31, 2020ERYtech Pharma, Georgetown University
NCT04293562Phase 3Apr 4, 2020National Cancer Institute (NCI)
NCT06336395Phase 2Mar 4, 2020National University of Singapore
NCT04230330Phase 1Dec 12, 2019Bristol-Myers Squibb, Government of Singapore
NCT04127227Phase 2Oct 9, 2019Sun Yat-Sen University
NCT03817320Phase 1Feb 12, 2019Children's Hospital Los Angeles, Takeda, University of Southern California
NCT03668392Phase 2Dec 31, 2018Gruppo Italiano Malattie EMatologiche dell'Adulto, University of Roma La Sapienza
NCT03674242Phase 2/Phase 3 (Phase 3)Dec 31, 2018ERYtech Pharma
NCT03665441Phase 3Sep 30, 2018Assistance Publique - Hôpitaux de Paris, ERYtech Pharma, Harvard University
NCT03599960Phase 2Sep 30, 2018Centre Henri Becquerel, University of Burgundy, University of Franche-Comté, University of Montreal
NCT03349281Phase 1Sep 30, 2018Takeda, University of Miami
NCT03384654Phase 2May 14, 2018Johnson and Johnson
Showing 20 of 139 trials
Page 1 / 7

Organizations

Research & Development (141)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
National Cancer Institute (NCI)Government473541992
ERYtech PharmaFor profit11942006
St. Jude Children's HospitalAcademic/Hospital9831993
J. W. Goethe UniversityAcademic/Hospital7721993
Harvard UniversityAcademic/Hospital6521996
PETHEMA FoundationAcademic/Hospital5511996
Sun Yat-Sen UniversityAcademic/Hospital5422014
Badalona Hospital Germans Trias i PujolAcademic/Hospital4011996
Gruppo Italiano Malattie EMatologiche dell'AdultoAcademic/Hospital4422000
Cornell UniversityAcademic/Hospital3311990
Erasmus University RotterdamAcademic/Hospital3031999
MedacFor profit3322008
Medical Research CouncilGovernment3211993
National Institutes of Health (NIH)Government3221992
National University of SingaporeAcademic/Hospital3222008
The Christie NHS Foundation TrustAcademic/Hospital3011998
University of PennsylvaniaAcademic/Hospital3032002
University of Southern CaliforniaAcademic/Hospital3122002
Associazione Italiana Ematologia Oncologia PediatricaAcademic/Hospital2122000
Central South UniversityAcademic/Hospital2122020
141 organizations
Page 1 / 8

Marketing (3)

OrganizationOrg typeRelationshipDate
MerckFor profitMKTGJan 10, 1978
MerckFor profitNDAJan 10, 1978
RecordatiFor profitNDA2Jan 10, 1978