VORAXAZE (glucarpidase)
Voraxaze (glucarpidase) is a carboxypeptidase indicated to reduce toxic plasma methotrexate concentrations in adult and pediatric patients. It is specifically used for patients experiencing delayed methotrexate clearance due to impaired renal function. The treatment is intended for individuals with plasma methotrexate concentrations greater than 1 micromole per liter that exceed two standard deviations of the mean excretion curve for the administered dose. It is not recommended for patients with expected clearance levels, as reducing concentrations in these individuals may lead to subtherapeutic methotrexate exposure.
How VORAXAZE Works
Voraxaze is a recombinant bacterial enzyme that functions by hydrolyzing the carboxyl-terminal glutamate residue from folic acid and classical antifolates. Specifically, the drug converts methotrexate into its inactive metabolites, 4-deoxy-4-amino-N10-methylpteroic acid (DAMPA) and glutamate. By facilitating this conversion, the enzyme provides an alternate non-renal pathway for methotrexate elimination. This mechanism is utilized in patients undergoing high-dose methotrexate treatment who have developed renal dysfunction.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2012-01-17
- Patent Cliff
- 2019
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
VORAXAZE Approval History
What VORAXAZE Treats
1 indicationsVORAXAZE is approved for 1 conditions since its original approval in 2012. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Toxic plasma methotrexate concentration in adult and pediatric patients with delayed methotrexate clearance due to impaired renal function
Clinical Trial Registry
4 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04668768 | HM-178 20-1071 | Ph 2 | suspended | HM-178: Assessing Methods for Improvement in Methotrexate Toxicity Management and Detection of Central Nervous System Involvement of Aggressive Lymphoma |
| NCT01305655 NOPHOCPG2 results posted | NOPHO2008CPG2 | Ph 3 | completed | Glucarpidase Effect on Severe Delayed HDM-clearance in Children Treated With High-dose Mtx in ALL |
| NCT00634322 results posted | PR001-CLN-pro012 MDACC #2006-0246 | Ph 2 | terminated | High Dose Methotrexate With Leucovorin Rescue With or Without Glucarpidase in Osteosarcoma |
| NCT00727831 | CDR0000599206 CRUK-BRD/07/004, 2007-002570-58 | Ph 1, Ph 2 | completed | Methotrexate, Glucarpidase, and Leucovorin in Treating Patients With Newly Diagnosed Primary Central Nervous System Lymphoma |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
VORAXAZE FDA Label Details
Indications & Usage
FDA Label (PDF)VORAXAZE is indicated for the treatment of Toxic plasma methotrexate concentration in adult and pediatric patients with delayed methotrexate clearance due to impaired renal function.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment