Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Rasburicase · 3 trials · 6 indications
Number of patients responding to treatment defined as plasma uric acid levels at Day 3 through Day 7 \<7.5 mg/dl.
| Arm | Type | Description |
|---|---|---|
| Arm A | EXPERIMENTAL | Rasburicase alone given as a single agent for 5 days |
| Arm B | EXPERIMENTAL | Rasburicase alone given as a single agent from Day 1 through Day 3, followed by oral allopurinol given from Day 3 through Day 5 (Day 3 is an overlap) |
| Arm C | ACTIVE_COMPARATOR | Oral allopurinol alone given as a single agent for 5 days |
| Name | Type | Description |
|---|---|---|
| Rasburicase (SR29142) | DRUG | 30-min IV infusion |
| Allopurinol | DRUG | Oral administration |
Inclusion Criteria: 1. Meets high risk or at potential risk for tumor lysis syndrome (TLS): A patient is at high risk for TLS if he/she presents with: * Hyperuricemia of malignancy (plasma uric acid \> 7.5 mg/dL); * A diagnosis of very aggressive lymphoma/leukemia based on the Revised Eur...
Rasburicase is used for hyperuricemia, tumor lysis syndrome, and nutritional and metabolic diseases. It is being studied in oncology settings to manage elevated uric acid levels, particularly in patients at risk for tumor lysis syndrome associated with cancer treatment.
Rasburicase is developed by Sanofi, a global biopharmaceutical company listed on the stock exchange under the ticker SNY. Sanofi is responsible for the clinical development and commercialization of this investigational drug.
Rasburicase is in Phase 2 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. Clinical trials are ongoing to evaluate its safety and efficacy for the treatment of hyperuricemia and related conditions.
Rasburicase has been studied in clinical trials including NCT00230178, a Phase 3 trial comparing it to allopurinol in tumor patients at risk for hyperuricemia and tumor lysis syndrome, and NCT00290992 and NCT00631579, both Phase 2 trials for hyperuricemia. All trials are completed.
No, Rasburicase is not the same as allopurinol. Rasburicase is a recombinant urate oxidase enzyme that breaks down uric acid, while allopurinol is a xanthine oxidase inhibitor that prevents uric acid production. They are different drug classes used for hyperuricemia.