Drugs / Glucarpidase
Glucarpidase
also known as
Voraxaze · CPG2 · carboxypeptidase G2 · .gamma.-glu-x carboxypeptidase · CPDG2 · Folate hydrolase g2 · Glucarpidasa
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Voraxaze | — | 2022-01-11 | europa.eu ↗ |
| Approved | US (FDA) | VORAXAZE | — | 2012-01-17 | fda.gov ↗ |
Trials 16 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 02 trials | ||||||
| Phase 0 | NCT03960177 | Mar 2019 → Dec 2025 | osteosarcoma | OHSU Knight Cancer Institute | Completed | No outcome recorded |
| Phase 0 | NCT03684980 | Nov 2018 → Nov 2027 expected | central nervous system non-hodgkin lymphoma | Memorial Sloan Kettering Cancer Center | Active not recruiting | No outcome recorded |
| Phase 13 trials | ||||||
| Phase 1 | NCT05135858 | Sep 2022 → Jan 2025 | primary central nervous system lymphoma | Assistance Publique - Hôpitaux de Paris | Unknown | No outcome recorded |
| Phase 1 | NCT00634504 | May 2008 → Aug 2009 | leukemia, lymphoma, osteosarcoma | BTG International Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00001298 | Mar 1992 → Jan 2001 | kidney disorder | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 1/23 trials | ||||||
| Phase 1/2 | NCT04841434 | Jun 2021 → Dec 2024 | central nervous system non-hodgkin lymphoma | Charite University, Berlin, Germany | Completed | No outcome recorded |
| Phase 1/2 | NCT00727831 | Jul 2008 → Jul 2011 | chemotherapy-induced toxicity, lymphoma, mucositis | University College, London | Completed | No outcome recorded |
| Phase 1/2 | NCT00424645 | Jan 2007 → Jan 2008 | cancer, hematopoietic and lymphoid cell neoplasm | M.D. Anderson Cancer Center | Terminated | No outcome recorded |
| Phase 25 trials | ||||||
| Phase 2 | NCT05022797 | Jul 2021 → Nov 2022 | chemotherapy-induced toxicity, diffuse large B-cell lymphoma | CRIS Cancer Foundation | Terminated | No outcome recorded |
| Phase 2 | NCT04668768 | Apr 2021 → Dec 2024 | lymphoma | Fox Chase Cancer Center | Suspended | No outcome recorded |
| Phase 2 | NCT00634322 | Oct 2008 → Mar 2009 | osteosarcoma | BTG International Inc. | Terminated | No outcome recorded |
| Phase 2 | NCT02022358 | Jul 2007 → Jun 2015 | osteosarcoma, spindle cell sarcoma | University College, London | Terminated | No outcome recorded |
| Phase 2 | NCT00219791 | Jan 2000 → Jun 2003 | neoplasm | BTG International Inc. | Completed | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT01305655 | Jul 2008 → Dec 2014 | acute lymphoblastic leukemia | Nordic Society for Pediatric Hematology and Oncology | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT00018967 | Nov 1993 → Apr 2007 | childhood malignant neoplasm, poisoning | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT00481559 | — | neoplasm | BTG International Inc. | Approved for marketing | No outcome recorded |
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 17 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Glucarpidase | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03684980 ↗ |
| Known as | .gamma.-glu-x carboxypeptidase | ChEMBL registry synonym — accepted as the source's own label CHEMBL1863515 ↗ |
| Known as | carboxypeptidase G2 | “Glucarpidase is a recombinant bacterial enzyme (carboxypeptidase G2) that can convert MTX to non-cytotoxic metabolites (DAMPA).” NCT04668768 ↗ |
| Known as | CPDG2 | “A Trial of Carboxypeptidase-G2 (CPDG2) and Thymidine for the Management of Patients With Methotrexate Toxicity and Renal Dysfunction” NCT00001298 ↗ |
| Known as | CPG2 | “Glucarpidase (CPG2) is a recombinant bacterial rescue enzyme that cleaves circulating MTX into inactive metabolites, reducing plasma MTX concentrations within few minutes.” NCT05135858 ↗2“Glucarpidase (CPG2) Effect on Severe Delayed Methotrexate-clearance in Children Treated With High-dose Methotrexate in Acute Lymphoblastic Leukemia (ALL)” NCT01305655 ↗ “Study of Recombinant Carboxypeptidase G2 (CPG2) for the Management of Patients With Delayed Methotrexate (MTX) Clearance or Intrathecal MTX Overdosage” NCT00219791 ↗ |
| Known as | Folate hydrolase g2 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1863515 ↗ |
| Known as | Glucarpidasa | ChEMBL registry synonym — accepted as the source's own label CHEMBL1863515 ↗ |
| Known as | Voraxaze | “A Phase I/II Study to Investigate the Use of VORAXAZE™ As Intended Intervention in Patients with CNSL” NCT04841434 ↗ |
| Action | Inhibit | “Carboxypeptidase-G2 inactivates methotrexate by hydrolyzing its C-terminal glutamate residue.” NCT00001298 ↗ |
| Modality | Protein / enzyme biologic | “Recombinant Carboxypeptidase G2 (CPG2)” NCT00219791 ↗ |
| Route | Intravenous | “bolus intravenous injection” NCT00481559 ↗ |