glucarpidase
Trade name: voraxaze
Approved
Jan 17, 2012
Glucarpidase (Voraxaze) is a medication used for the treatment of elevated levels of methotrexate during treatment of cancer patients who have impaired kidney function. Glucarpidase is an enzyme that inactivates methotrexate rapidly after injection. Because this agent reduces systemic levels of methotrexate and could therefore interfere with efficacy, it is not recommended for use in patients with normal or only slightly impaired kidney function or in whom serum levels are normal. The main antidote for methotrexate overdoses prior to the approval of this drug were high doses of folinic acid. However, this agent was not always sufficient at preventing kidney failure due to methotrexate. Glucarpidase also degrades folinic acid so the two should not be used together. — Wikipedia
Clinical trial activity
19 trials · 23 clinical orgs · 2 marketing orgs
Earliest trial started Mar 1, 1992 (NCT00001298)
Timeline
1990s
- Jan 1, 1992
Earliest Phase 1 Sponsor(trial)
2000s
Indications
Approved for
Studied for
- Dermatitis, Atopic · Phase 3
- Drug-Related Side Effects and Adverse Reactions · Phase 2
- Hematologic Neoplasms · Phase 1/Phase 2
- Kidney Diseases · Phase 1
- Leukemia · Phase 1
- Lymphoma · Phase 2
- Lymphoma, Large B-Cell, Diffuse · Phase 2
- Mucositis · Phase 1/Phase 2
- Neoplasms · Phase 2
- Osteosarcoma · Phase 2
- Precursor B-Cell Lymphoblastic Leukemia-Lymphoma · Phase 3
- Skin Diseases · Phase 3
Mechanism of action
- MethotrexateHYDROLYTIC ENZYME
Methotrexate hydrolytic enzyme
- Carboxypeptidase G2Supplementation
cpg2 supplementation
Approval history
- approvedFast trackJan 17, 2012
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Prescription Only
- Multi-specific
- No
Oral
No
Parenteral
Yes
Topical
No
Sources
- WikipediaGlucarpidase ↗
- ChEMBLCHEMBL1863515 ↗
Also known as
- carboxypeptidase g2
- carboxypeptidase g2
- carboxypeptidase-g2
- carboxypeptidase-g2
- folate hydrolase g2
- glucarpidase
- glucarpidase
- glucarpidase
- glucarpidase
- glucarpidase
- glucarpidase
- glucarpidase
- glucarpidase
- glutamate carboxypeptidase
- glutamate carboxypeptidase
- pteroylmonoglutamic acid hydrolase g2
- v0034
- voraxaze
- voraxaze
- voraxaze
- voraxaze
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT05135858 | Phase 1 | Jan 1, 2022 | Assistance Publique - Hôpitaux de Paris, BTG |
| NCT05022797 | Phase 2 | Jul 19, 2021 | BioClever 2005 S.L., BTG, Eurofins, Fundacion CRIS de Investigación para Vencer el Cáncer, NTShub, S.L., University of Texas at Houston |
| NCT04841434 | Phase 1/Phase 2 (Phase 2) | Jun 1, 2021 | Humboldt University |
| NCT04668768 | Phase 2 | Feb 28, 2021 | Temple University |
| NCT03960177 | Early Phase 1 (Phase 1) | May 30, 2019 | BTG, OHSU Knight Cancer Institute, Oregon Health and Science University |
| NCT03684980 | Early Phase 1 (Phase 1) | Oct 31, 2018 | Memorial Sloan-Kettering Cancer Center, University of Alabama, Birmingham |
| NCT01467362 | Phase 3 | Nov 1, 2011 | Pierre Fabre |
| NCT00634322 | Phase 2 | Oct 1, 2008 | BTG, University of Texas at Houston |
| NCT01305655 | Phase 3 | Jul 1, 2008 | Lund University, Nordic Society for Pediatric Hematology and Oncology |
| NCT00727831 | Phase 1/Phase 2 (Phase 2) | Jul 1, 2008 | Cancer Research UK, University of Leeds, University of London |
| NCT00634504 | Phase 1 | May 1, 2008 | BTG |
| NCT02022358 | Phase 2 | Jul 1, 2007 | Richard Scowcroft Foundation, University of London |
| NCT00481559 | N/A | May 30, 2007 | BTG, CTI Clinical Trial and Consulting Services |
| NCT01084148 | Phase 3 | Jan 1, 2007 | Pierre Fabre |
| NCT00424645 | Phase 1/Phase 2 (Phase 2) | Jan 1, 2007 | BTG, University of Texas at Houston |
| NCT01084720 | Phase 3 | Dec 1, 2002 | Pierre Fabre, Wroclaw Medical University |
| NCT00219791 | Phase 2 | Jan 1, 2000 | BTG |
| NCT00018967 | N/A | Nov 1, 1993 | National Cancer Institute (NCI) |
| NCT00001298 | Phase 1 | Mar 1, 1992 | National Cancer Institute (NCI) |