CDEK
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pegaspargase

Trade name: oncaspar

BiologicalapprovedOrphan Drug FDA

Approved

Feb 1, 1994

Pegaspargase, sold under the brand name Oncaspar, is a medication used in the treatment of acute lymphoblastic leukemia (ALL). Often it is used together with anthracycline, vincristine, and corticosteroids. Pegaspargase can be administered either via an intravenous infusion or a intramuscular injection. — Wikipedia

Clinical trial activity

165 trials · 130 clinical orgs · 2 marketing orgs

Phase 1
28
Phase 2
124
Phase 3
54
Phase 4
7

Earliest trial started Jul 1, 1994 (NCT00002590)

Timeline

1980s

  1. Oct 20, 1989

    Orphan Drug Designation

1990s

  1. Jan 1, 1994

    Earliest Phase 2 Sponsor(trial)

  2. Feb 1, 1994

    Leadiant Biosciences, Inc. — Earliest FDA Approval

  3. Feb 1, 1994

    Leadiant Biosciences, Inc. — Marketing Organization

  4. Feb 1, 1994

    Leadiant Biosciences, Inc. — NDA Organization

  5. Feb 1, 1994

    Servier — NDA Secondary Org

  6. Jan 1, 1996

    Earliest Phase 3 Sponsor(trial)

2000s

  1. Jan 1, 2005

    Earliest Phase 1 Sponsor(trial)

Indications

Approved for

Studied for

Mechanism of action

  • AsparagineHYDROLYTIC ENZYME

    Asparagine hydrolytic enzyme

Approval history

  • approvedFeb 1, 1994

Chemistry & pharmacology

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

Oral

No

Parenteral

Yes

Topical

No

Sources

Also known as

  • oncaspar
  • oncaspar
  • oncaspar
  • oncaspar
  • oncaspar
  • pegasparaginase
  • peg-asparaginase
  • peg-asparaginase
  • peg-asparaginase
  • pegaspargase
  • pegaspargase
  • pegaspargase
  • pegaspargase
  • pegaspargase
  • pegaspargase
  • pegaspargase
  • pegaspargase
  • pegaspargase
  • pegaspargase
  • peg e. coli l-asparaginase
  • peg-l-asparaginase
  • peg/l-asparaginase
  • pegylated asparaginase
  • pegylated asparaginase
  • pegylated-asparaginase
  • pegylated l-asparaginase
  • pegylated-l-asparaginase
  • pegylated l-asparaginase erwinia chrysanthemi
  • polyehylene glycol-asparaginase
  • polyethyleneglycol-asparaginase

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07227584Phase 2Apr 30, 2026Harvard University
NCT07072585Phase 2/Phase 3 (Phase 3)Mar 30, 2026National Cancer Institute (NCI)
NCT06953739Phase 3May 1, 2025Nanjing Medical University
NCT06317662Phase 2Jan 26, 2025National Cancer Institute (NCI)
NCT06583083Phase 2Oct 22, 2024Sun Yat-Sen University
NCT06573151Phase 2Sep 1, 2024Jiao Tong University
NCT06554626Phase 2Aug 15, 2024Zhejiang University
NCT06210750Phase 2Aug 9, 2024National Cancer Institute (NCI), SWOG Cancer Research Network
NCT05700448Phase 3Jul 31, 2024CStone Pharmaceuticals
NCT06376721Phase 1/Phase 2 (Phase 2)Apr 14, 2024Capital Medical University
NCT06255795Phase 3Feb 15, 2024Jiao Tong University
NCT06124157Phase 3Jan 22, 2024National Cancer Institute (NCI)
NCT06176027Phase 1/Phase 2 (Phase 2)Dec 30, 2023Government of China, People's Liberation Army of China
NCT06527781Phase 1Nov 27, 2023Government of China, Soochow University
NCT05761171Phase 2Nov 20, 2023National Cancer Institute (NCI)
NCT05848687Phase 1/Phase 2 (Phase 2)Nov 1, 2023Amgen, Department of Defense, Kura Oncology, Inc., Pediatric Oncology Experimental Therapeutics Investigation Consortium, Stanford University
NCT05774028Phase 2Apr 30, 2023Nanjing Medical University
NCT05602194Phase 3Mar 22, 2023National Cancer Institute (NCI)
NCT06314334Phase 2Mar 4, 2023Fudan University
NCT05521087Phase 1Dec 28, 2022—
Showing 20 of 165 trials
Page 1 / 9

Organizations

Research & Development (130)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
National Cancer Institute (NCI)Government544441994
Sun Yat-Sen UniversityAcademic/Hospital141422010
Jiao Tong UniversityAcademic/Hospital10932013
St. Jude Children's HospitalAcademic/Hospital10931998
Harvard UniversityAcademic/Hospital9832005
University of Southern CaliforniaAcademic/Hospital8532002
University of Texas at HoustonAcademic/Hospital7622002
Capital Medical UniversityAcademic/Hospital6622015
Chinese Academy of Medical SciencesAcademic/Hospital6322011
BaxaltaFor profit4022012
EnzonFor profit4122003
Nanjing Medical UniversityAcademic/Hospital4332016
Zhengzhou UniversityAcademic/Hospital4422011
Deutsche Krebshilfe e.V.Academic/Hospital3012010
Guizhou Medical UniversityAcademic/Hospital3022011
Huazhong University of Science and TechnologyAcademic/Hospital3022011
Leadiant Biosciences, Inc.For profit3022009
Peking UniversityAcademic/Hospital3212011
People's Liberation Army of ChinaGovernment3112013
ServierFor profit3312019
130 organizations
Page 1 / 7

Marketing (3)

OrganizationOrg typeRelationshipDate
Leadiant Biosciences, Inc.For profitMKTGFeb 1, 1994
Leadiant Biosciences, Inc.For profitNDAFeb 1, 1994
ServierFor profitNDA2Feb 1, 1994