rasburicase
Trade name: Elitek
Approved
Jul 12, 2002
Rasburicase, sold under the brand name Elitek in the US and Fasturtec in the EU, is a medication that helps to clear uric acid from the blood. It is a recombinant version of urate oxidase, an enzyme that metabolizes uric acid to allantoin. Urate oxidase is known to be present in many mammals but does not naturally occur in humans. Rasburicase is produced by a genetically modified Saccharomyces cerevisiae strain. The complementary DNA (cDNA) coding for rasburicase was cloned from a strain of Aspergillus flavus. — Wikipedia
Clinical trial activity
26 trials · 17 clinical orgs · 2 marketing orgs
Earliest trial started Jul 1, 2002 (NCT00664144)
Timeline
2000s
- Oct 11, 2000
Orphan Drug Designation
- Jan 1, 2002
Earliest Phase 2 Sponsor(trial)
- Jul 12, 2002
Sanofi-Synthelabo — Earliest FDA Approval
- Jul 12, 2002
Sanofi-Synthelabo — Marketing Organization
- Jul 12, 2002
Sanofi-Synthelabo — NDA Organization
- Jul 12, 2002
Sanofi-Aventis — NDA Secondary Org
- Jan 1, 2003
Earliest Phase 3 Sponsor(trial)
- Jan 1, 2006
Earliest Phase 1 Sponsor(trial)
Indications
Approved for
Studied for
- Burkitt Lymphoma · Phase 2
- Gout · Phase 4
- Graft vs Host Disease · Phase 1
- Healthy Volunteers · Phase 1
- Hyperuricemia · Phase 4
- Leukemia · Phase 2
- Leukemia, Lymphocytic, Chronic, B-Cell · Phase 3
- Leukemia, Myeloid, Acute · Phase 2
- Leukemia, Myeloid, Chronic-Phase · Phase 2
- Lymphoma · Phase 4
- Lymphoma, B-Cell · Phase 2/Phase 3
- Lymphoma, Large B-Cell, Diffuse · Phase 2
- Lymphoma, Large-Cell, Immunoblastic · Phase 2
- Lymphoma, Non-Hodgkin · Phase 3
- Multiple Myeloma · Phase 1
- Myelodysplastic Syndromes · Phase 2
- Myeloproliferative Disorders · Phase 1
- Neoplasms · Phase 4
- Nutritional and Metabolic Diseases · Phase 2
- Precursor B-Cell Lymphoblastic Leukemia-Lymphoma · Phase 2
- Precursor Cell Lymphoblastic Leukemia-Lymphoma · Phase 2
- Tumor Lysis Syndrome · Phase 4
Mechanism of action
- Urate oxidaseSupplementation
Urate oxidase supplementation
Approval history
- approvedJul 12, 2002
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Prescription Only
- Multi-specific
- No
Oral
No
Parenteral
Yes
Topical
No
Sources
- WikipediaRasburicase ↗
- NCATS08GY9K1EUO ↗
- ChEMBLCHEMBL1201594 ↗
Also known as
- elitek
- elitek
- elitek
- elitek
- fasturtec
- fasturtec
- fasturtec
- rasburicase
- rasburicase
- rasburicase
- rasburicase
- rasburicase
- rasburicase
- rasburicase
- rasburicase
- rasburicase
- sr-29142
- urate oxidase
- urate oxidase
- urate oxidase
- uricase
- uricase
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT05312268 | Phase 4 | May 15, 2022 | Sun Yat-Sen University |
| NCT04745910 | Phase 4 | Dec 31, 2021 | University of Texas at Houston |
| NCT04765995 | Phase 1 | Mar 1, 2021 | Chinese Academy of Medical Sciences, Hangzhou Grand Biologic Pharmaceutical, Inc. |
| NCT04349306 | Phase 4 | Apr 30, 2020 | Sanofi |
| NCT03395977 | N/A | Jan 3, 2018 | Erasmus University Rotterdam, University of Lyon |
| NCT01564277 | Phase 2 | Sep 1, 2011 | National Cancer Institute (NCI), State University of New York, Buffalo |
| NCT01200485 | Phase 2 | Apr 1, 2011 | Sanofi, University of Texas at Houston |
| NCT01046825 | Phase 2/Phase 3 (Phase 3) | Sep 9, 2010 | St. Jude Children's Hospital |
| NCT00921375 | Phase 3 | Feb 1, 2010 | Virchow Group |
| NCT01323335 | Phase 1 | Mar 31, 2009 | National Institute on Aging (NIA) |
| NCT00756964 | Phase 2 | Oct 1, 2008 | University of Florida |
| NCT00628628 | Phase 2 | Jan 1, 2008 | Sanofi, University of Texas at Houston |
| NCT00513474 | Phase 1 | Jan 1, 2008 | Harvard University |
| NCT00607152 | Phase 3 | Oct 1, 2007 | Sanofi |
| NCT00360438 | Phase 1/Phase 2 (Phase 2) | Jul 1, 2006 | Sanofi, University of Texas at Houston |
| NCT01931527 | N/A | Jul 1, 2006 | Washington University in St. Louis |
| NCT00302653 | Phase 4 | Feb 1, 2006 | Sanofi, Sanofi-Aventis |
| NCT00290992 | Phase 2 | Jun 1, 2005 | Sanofi |
| NCT00057811 | Phase 2 | Jun 1, 2004 | National Cancer Institute (NCI) |
| NCT00230178 | Phase 3 | Apr 1, 2004 | Sanofi |
Organizations
Research & Development (17)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Sanofi | For profit | 13 | 10 | 3 | 2002 |
| University of Texas at Houston | Academic/Hospital | 4 | 4 | 2 | 2006 |
| National Cancer Institute (NCI) | Government | 2 | 1 | 1 | 2004 |
| Chinese Academy of Medical Sciences | Academic/Hospital | 1 | 0 | 1 | 2021 |
| Erasmus University Rotterdam | Academic/Hospital | 1 | 1 | 1 | 2018 |
| Hangzhou Grand Biologic Pharmaceutical, Inc. | Government | 1 | 1 | 1 | 2021 |
| Harvard University | Academic/Hospital | 1 | 1 | 1 | 2008 |
| J. W. Goethe University | Academic/Hospital | 1 | 1 | 1 | 2003 |
| National Institute on Aging (NIA) | Government | 1 | 1 | 1 | 2009 |
| Sanofi-Aventis | For profit | 1 | 0 | 1 | 2006 |
| State University of New York, Buffalo | Academic/Hospital | 1 | 1 | 1 | 2011 |
| St. Jude Children's Hospital | Academic/Hospital | 1 | 1 | 1 | 2010 |
| Sun Yat-Sen University | Academic/Hospital | 1 | 1 | 1 | 2022 |
| University of Florida | Academic/Hospital | 1 | 1 | 1 | 2008 |
| University of Lyon | Academic/Hospital | 1 | 0 | 1 | 2018 |
| Virchow Group | For profit | 1 | 1 | 1 | 2010 |
| Washington University in St. Louis | Academic/Hospital | 1 | 1 | 1 | 2006 |
Marketing (3)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Sanofi-Aventis | For profit | NDA2 | Jul 12, 2002 |
| Sanofi-Synthelabo | For profit | MKTG | Jul 12, 2002 |
| Sanofi-Synthelabo | For profit | NDA | Jul 12, 2002 |