Overview
Rasburicase is a recombinant urate-oxidase enzyme produced by a genetically modified Saccharomyces cerevisiae strain. The cDNA coding for rasburicase was cloned from a strain of Aspergillus flavus.
Background
Rasburicase is a recombinant urate-oxidase enzyme produced by a genetically modified Saccharomyces cerevisiae strain. The cDNA coding for rasburicase was cloned from a strain of Aspergillus flavus.
Indication
For treatment of hyperuricemia, reduces elevated plasma uric acid levels (from chemotherapy)
Associated Conditions
- Hyperuricemia
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2022/04/05 | Phase 4 | Recruiting | |||
2021/02/09 | Phase 4 | Recruiting | |||
2020/04/16 | Phase 4 | Completed | |||
2018/01/10 | Not Applicable | Completed | Erasme University Hospital | ||
2013/08/29 | Not Applicable | Completed | |||
2012/03/27 | Phase 2 | Terminated | |||
2011/03/25 | Phase 1 | Completed | National Institute on Aging (NIA) | ||
2010/09/13 | Phase 2 | Completed | |||
2008/09/22 | Phase 2 | Completed | |||
2008/04/22 | Phase 2 | Terminated |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 2/23/2001 | ||
Authorised | 2/23/2001 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| FASTURTEC POWDER FOR SOLUTION FOR INFUSION 1.5 mg/vial | SIN12055P | INJECTION, POWDER, FOR SOLUTION | 1.5 mg/vial | 8/27/2002 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Rasburicase for injection | 国药准字SJ20180024 | 生物制品 | 注射剂 | 4/13/2023 | |
| Rasburicase for injection | 国药准字SJ20181018 | 生物制品 | 注射剂 | 4/13/2023 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| FASTURTEC rasburicase (rys) 1.5mg powder for injection vial with diluent | 80836 | Medicine | A | 7/30/2002 |