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 · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Voraxaze | — | 2022-01-11 | europa.eu ↗ |
| Filed | EU (EMA) | Voraxaze® | methotrexate toxicity | 2020-08-17 | “today announced the European Medicines Agency (EMA) has accepted for review a Marketing Authorisation Application (MAA) for Voraxaze® (glucarpidase).” serb.com ↗ “In August of 2020 BTG submitted a Marketing Authorisation Application for Voraxaze® (glucarpidase) with the European Medicines Agency (EMA)” serb.com ↗ “application for marketing approval for glucarpidase in the European Union, which was submitted to the European Medicines Agency” serb.com ↗ |
| Approved | US (FDA) | VORAXAZE | — | 2012-01-17 | fda.gov ↗ |
Trials 16
| 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 Stop: Enrollment |
| 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 Stop: Enrollment |
| Phase 2 | NCT04668768 | Apr 2021 → Dec 2024 | lymphoma | Fox Chase Cancer Center | Suspended | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT00634322 | Oct 2008 → Mar 2009 | osteosarcoma | BTG International Inc. | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT02022358 | Jul 2007 → Jun 2015 | osteosarcoma, spindle cell sarcoma | University College, London | Terminated | No outcome recorded Stop: Enrollment |
| 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 |
News releases announcing trial results or a regulatory action · 12
| Date | Issuer | Release |
|---|---|---|
| 2025-01-13 | Orphan Australia | Results Newly published study shows that Voraxaze® can improve clinical outcomes in patients with high-dose methotrexate induced acute kidney injury serb.com ↗
Researchers from Mass General Brigham and Harvard Medical School (Boston, MA) analyzed data from more than 700 adult patients with MTX-AKI across 28 major U.S. cancer centersi and found that patients who received Voraxaze® had significantly higher odds of kidney recovery as well as faster time to kidney recovery compared to those who did not receive Voraxaze®. |
| 2023-03-15 | Orphan Australia | Results New economic analysis of Voraxaze® (glucarpidase) in patients with delayed methotrexate elimination serb.com ↗
Simulations based on the model showed that for each patient with delayed elimination of HDMTX due to impaired renal function, timely treatment with Voraxaze® resulted in cost savings compared with hemodialysis or delayed Voraxaze® treatment. |
| 2022-06-09 | Orphan Australia | Results Four Independent Studies of Voraxaze® Published at European Hematology Conference 2022 serb.com ↗
None of the patients required hospital admission during treatment. |
| 2022-01-14 | Orphan Australia | Regulatory SERB receives EU approval for Voraxaze® (glucarpidase) as Rescue Therapy for High Dose Methotrexate Toxicity serb.com ↗
14 January 2022 – SERB and BTG Specialty Pharmaceuticals announced that the European Commission has granted marketing authorisation for Voraxaze® (glucarpidase) to reduce toxic plasma methotrexate concentration in adults and children (aged 28 days and older) with delayed methotrexate elimination or at risk of methotrexate toxicity. |
| 2021-11-30 | Orphan Australia | Regulatory SERB receives positive CHMP opinion for Voraxaze® (glucarpidase) as Rescue Therapy for High Dose Methotrexate Toxicity serb.com ↗
This positive CHMP opinion for Voraxaze is an important step toward offering a reliable and specific rescue therapy for cancer patients in Europe who experience toxic methotrexate concentrations. |
| 2021-09-27 | Orphan Australia | Regulatory BTG Specialty Pharmaceuticals advances global regulatory program for glucarpidase, sold as Voraxaze® in the US serb.com ↗
The Japanese Ministry of Health, Labour and Welfare granted this authorization based on the efficacy and safety results of clinical studies conducted in Japan and overseas, including an investigator-initiated study known as CPG2-PII funded by the Japan Medical Association. |
| 2020-11-12 | Orphan Australia | Results Initial study results show feasibility of outpatient methotrexate administration with planned-use Voraxaze® (glucarpidase) during COVID-19 pandemic serb.com ↗
The initial findings are encouraging, as none of the enrolled patients required hospital admission, and all patients treated with this protocol requested to continue treatment in the outpatient setting. |
| 2020-08-17 | Orphan Australia | Regulatory European Medicines Agency has accepted for review a marketing authorisation application for Voraxaze serb.com ↗
BTG Specialty Pharmaceuticals, a division of Boston Scientific (NYSE:BSX), today announced the European Medicines Agency (EMA) has accepted for review a Marketing Authorisation Application (MAA) for Voraxaze® (glucarpidase). |
| 2019-02-14 | Orphan Australia | Results A Retrospective Study of Medicare claim data shows patients treated with Voraxaze® had shorter hospitalizations and lower mortality serb.com ↗ |
| 2012-09-05 | Orphan Australia | Regulatory CMS grants new prospective reimbursement for Voraxaze® serb.com ↗
BTG International Inc., the specialist healthcare company, today announces that the Centers for Medicare & Medicaid Services (CMS) has granted a temporary New Technology Add-on Payment (NTAP) for Voraxaze® (glucarpidase), effective 1 October 2012. |
| 2012-06-04 | Orphan Australia | Results BTG announces data presentation on Voraxaze® (glucarpidase) at the American Society of Clinical Oncology Annual Meeting serb.com ↗
At the first measurement (median 15 minutes post-Voraxaze®) serum methotrexate was reduced by a median of 99% relative to the pre- Voraxaze® baseline. |
| 2012-01-18 | Orphan Australia | Regulatory BTG plc: Voraxaze® (glucarpidase) receives US regulatory approval serb.com ↗
BTG plc (LSE: BGC), the specialist healthcare company, today announces that it has received regulatory approval from the US Food and Drug Administration (FDA) for its Biologics License Application (BLA) for Voraxaze®(glucarpidase). |
All press releases naming this drug 20 releases
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 NCT05135858 ↗ |
| 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 ↗ |