ELITEK (rasburicase)
Elitek is a recombinant urate-oxidase indicated for the initial management of plasma uric acid levels in pediatric and adult patients. It is used in patients with leukemia, lymphoma, and solid tumor malignancies who are receiving anticancer therapy expected to result in tumor lysis. The medication is indicated only for a single course of treatment.
How ELITEK Works
In humans, uric acid is the final step in the catabolic pathway of purines. Rasburicase functions by catalyzing the enzymatic oxidation of uric acid, which is poorly soluble. This process converts the uric acid into allantoin, an inactive and more soluble metabolite.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2002-07-12
- Patent Cliff
- 2009
- Routes
- INTRAVENOUS
- Dosage Forms
- VIAL
ELITEK Approval History
What ELITEK Treats
3 indicationsELITEK is approved for 3 conditions since its original approval in 2002. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Leukemia
- Lymphoma
- Solid Tumor Malignancies
ELITEK Boxed Warning
HYPERSENSITIVITY REACTIONS, HEMOLYSIS, METHEMOGLOBINEMIA, AND INTERFERENCE WITH URIC ACID MEASUREMENTS WARNING: HYPERSENSITIVITY REACTIONS, HEMOLYSIS, METHEMOGLOBINEMIA, AND INTERFERENCE WITH URIC ACID MEASUREMENTS See full prescribing information for complete boxed warning . Hypersensitivity Reactions: Elitek can cause serious and fatal hypersensitivity reactions including anaphylaxis. Immediately and permanently discontinue Elitek if a serious hypersensitivity reaction occurs ( 4 , 5.1 , 6.2 )...
WARNING: HYPERSENSITIVITY REACTIONS, HEMOLYSIS, METHEMOGLOBINEMIA, AND INTERFERENCE WITH URIC ACID MEASUREMENTS WARNING: HYPERSENSITIVITY REACTIONS, HEMOLYSIS, METHEMOGLOBINEMIA, AND INTERFERENCE WITH URIC ACID MEASUREMENTS See full prescribing information for complete boxed warning . Hypersensitivity Reactions: Elitek can cause serious and fatal hypersensitivity reactions including anaphylaxis. Immediately and permanently discontinue Elitek if a serious hypersensitivity reaction occurs ( 4 , 5.1 , 6.2 ). Hemolysis: Do not administer Elitek to patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency. Immediately and permanently discontinue Elitek if hemolysis occurs. Screen patients at higher risk for G6PD deficiency (e.g., patients of African or Mediterranean ancestry) prior to starting Elitek therapy ( 4 , 5.2 ). Methemoglobinemia: Elitek can result in methemoglobinemia in some patients. Immediately and permanently discontinue Elitek if methemoglobinemia occurs ( 4 , 5.3 ). Interference with uric acid measurements: Elitek enzymatically degrades uric acid in blood samples left at room temperature. Collect blood samples in prechilled tubes containing heparin and immediately immerse and maintain sample in an ice water bath. Assay plasma samples within 4 hours of collection ( 5.4 ). Hypersensitivity Reactions Elitek can cause serious and fatal hypersensitivity reactions including anaphylaxis. Immediately and permanently discontinue Elitek in patients who experience a serious hypersensitivity reaction [see Contraindications (4) , Warnings and Precautions (5.1) , Adverse Reactions (6.2) ] . Hemolysis Do not administer Elitek to patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency. Immediately and permanently discontinue Elitek in patients developing hemolysis. Screen patients at higher risk for G6PD deficiency (e.g., patients of African or Mediterranean ancestry) prior to starting Elitek [see Contraindications (4) , Warnings and Precautions (5.2) ]
ELITEK Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in ELITEK's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications ELITEK treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to ELITEK
3 of 9FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
5 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04745910 | 2020-0330 NCI-2020-13890, 2020-0330 | Ph 4 | completed | Pegloticase for the Reduction of Uric Acid in Patients With Tumor Lysis Syndrome |
| NCT01200485 results posted | 2010-0284 NCI-2012-01889 | Ph 2 | completed | Rasburicase in Patients at High Risk for Tumor Lysis Syndrome (TLS) During Cycle-2 |
| NCT01564277 results posted | I 197711 NCI-2011-03231, I 197711 | Ph 2 | terminated | Rasburicase and Allopurinol in Treating Patients With Hematologic Malignancies |
| NCT00513474 results posted | CDR0000558480 MGH-07-071, DFCI-07-071 | Ph 1 | completed | Rasburicase in Preventing Graft-Versus-Host Disease in Patients With Hematologic Cancer or Other Disease Undergoing Donor Stem Cell Transplant |
| NCT00756964 RasbAKI results posted | WIRB 20081132 | Ph 2 | completed | Lowering Serum Uric Acid to Prevent Acute Kidney Injury |
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.
ELITEK FDA Label Details
Indications & Usage
FDA Label (PDF)ELITEK is indicated for the treatment of Leukemia; Lymphoma; Solid Tumor Malignancies.
WARNING: HYPERSENSITIVITY REACTIONS, HEMOLYSIS, METHEMOGLOBINEMIA, AND INTERFERENCE WITH URIC ACID MEASUREMENTS WARNING: HYPERSENSITIVITY REACTIONS, HEMOLYSIS, METHEMOGLOBINEMIA, AND INTERFERENCE WITH URIC ACID MEASUREMENTS See full prescribing information for complete boxed warning . Hypersensitivi...
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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