calaspargase pegol
Trade name: Asparlas
Recombinant proteinapprovedOrphan Drug FDA
Approved
Dec 20, 2018
Calaspargase pegol, sold under the brand name Asparlas, is a medication for the treatment of acute lymphoblastic leukemia (ALL). It is approved in the United States as a component of a multi-agent chemotherapeutic regimen for ALL in pediatric and young adult patients aged one month to 21 years. — Wikipedia
Clinical trial activity
17 trials · 19 clinical orgs · 1 marketing orgs
Phase 1
6
Phase 2
9
Phase 3
4
Phase 4
0
Earliest trial started Jul 1, 2008 (NCT00671034)
Timeline
1980s
- Oct 20, 1989
Orphan Drug Designation
2010s
Indications
Studied for
- Leukemia · Phase 3
- Leukemia, Lymphocytic, Chronic, B-Cell · Phase 3
- Leukemia, Myeloid, Acute · Phase 2
- Lymphoma · Phase 1
- Lymphoma, Large-Cell, Immunoblastic · Phase 2/Phase 3
- Lymphoma, T-Cell · Phase 2
- Lymphoma, T-Cell, Peripheral · Early Phase 1
- Myelodysplastic Syndromes · Phase 1
- Pancreatic Neoplasms · Phase 1
- Precursor B-Cell Lymphoblastic Leukemia-Lymphoma · Phase 3
- Precursor Cell Lymphoblastic Leukemia-Lymphoma · Phase 3
- Precursor T-Cell Lymphoblastic Leukemia-Lymphoma · Phase 2
Mechanism of action
- L-asparaginaseACTIVATOR
ansB activator
- AsparagineHYDROLYTIC ENZYME
Asparagine hydrolytic enzyme
Hydrolyses L-asparagine which is required by leukemic cells which have low level expression of L-asparagine synthetase.
Approval history
- approvedDec 20, 2018
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Multi-specific
- No
Oral
No
Parenteral
Yes
Topical
No
Sources
- ChEMBLCHEMBL2108728 ↗
- WikipediaCalaspargase pegol ↗
- NCATST9FVH03HMZ ↗
- WikipediaCalaspargase pegol-mknl ↗
Also known as
- calaspargase pegol
- calaspargase pegol
- calaspargase pegol-mknl
- sc-peg asparaginase
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07072585 | Phase 2/Phase 3 (Phase 3) | Mar 30, 2026 | National Cancer Institute (NCI) |
| NCT06561074 | Phase 2 | Feb 28, 2025 | University of Texas at Houston |
| NCT06317662 | Phase 2 | Jan 26, 2025 | National Cancer Institute (NCI) |
| NCT06533748 | Phase 2 | Dec 31, 2024 | Amgen, Pfizer, St. Jude Children's Hospital |
| NCT06390319 | Phase 2 | Dec 31, 2024 | AbbVie, St. Jude Children's Hospital |
| NCT06210750 | Phase 2 | Aug 9, 2024 | National Cancer Institute (NCI), SWOG Cancer Research Network |
| NCT06124157 | Phase 3 | Jan 22, 2024 | National Cancer Institute (NCI) |
| NCT05761171 | Phase 2 | Nov 20, 2023 | National Cancer Institute (NCI) |
| NCT05602194 | Phase 3 | Mar 22, 2023 | National Cancer Institute (NCI) |
| NCT05292664 | Phase 1 | Dec 31, 2022 | AbbVie, Children's Cancer Research Fund United States, Gateway for Cancer Research, Harvard University, Servier, University of Colorado, Denver |
| NCT05581030 | Phase 1 | Sep 16, 2022 | Servier, University of South Florida |
| NCT05192889 | Phase 1/Phase 2 (Phase 2) | Aug 25, 2022 | AbbVie, St. Jude Children's Hospital |
| NCT04953780 | Phase 1 | Nov 1, 2021 | University of Maryland |
| NCT05034627 | Phase 1 | Nov 1, 2021 | Genentech, OHSU Knight Cancer Institute, Oregon Health and Science University, Servier |
| NCT04817761 | Phase 2/Phase 3 (Phase 3) | Jul 7, 2021 | Harvard University, Servier |
| NCT03719105 | Early Phase 1 (Phase 1) | Mar 1, 2019 | New York Medical College, University of Alabama, Birmingham |
| NCT00671034 | N/A | Jul 1, 2008 | National Cancer Institute (NCI) |
Showing 17 of 17 trials
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Organizations
Research & Development (19)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| National Cancer Institute (NCI) | Government | 7 | 7 | 3 | 2008 |
| Servier | For profit | 4 | 1 | 2 | 2021 |
| AbbVie | For profit | 3 | 0 | 2 | 2022 |
| St. Jude Children's Hospital | Academic/Hospital | 3 | 3 | 1 | 2022 |
| Harvard University | Academic/Hospital | 2 | 1 | 2 | 2021 |
| Amgen | For profit | 1 | 0 | 1 | 2024 |
| Children's Cancer Research Fund United States | Academic/Hospital | 1 | 0 | 1 | 2022 |
| Gateway for Cancer Research | Academic/Hospital | 1 | 0 | 1 | 2022 |
| Genentech | For profit | 1 | 0 | 1 | 2021 |
| New York Medical College | Academic/Hospital | 1 | 1 | 1 | 2019 |
| OHSU Knight Cancer Institute | Academic/Hospital | 1 | 1 | 1 | 2021 |
| Oregon Health and Science University | Academic/Hospital | 1 | 0 | 1 | 2021 |
| Pfizer | For profit | 1 | 0 | 1 | 2024 |
| SWOG Cancer Research Network | Academic/Hospital | 1 | 0 | 1 | 2024 |
| University of Alabama, Birmingham | Academic/Hospital | 1 | 0 | 1 | 2019 |
| University of Colorado, Denver | Academic/Hospital | 1 | 0 | 1 | 2022 |
| University of Maryland | Academic/Hospital | 1 | 1 | 1 | 2021 |
| University of South Florida | Academic/Hospital | 1 | 1 | 1 | 2022 |
| University of Texas at Houston | Academic/Hospital | 1 | 1 | 1 | 2025 |
19 organizations
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