Drugs / Rasburicase
Rasburicase
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | ELITEK | — | 2009-10-16 | fda.gov ↗ |
| Approved | US (FDA) | ELITEK | — | 2002-07-12 | fda.gov ↗ |
| Approved | EU (EMA) | Fasturtec | — | 2001-02-23 | europa.eu ↗ |
Trials 22
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials · 1 met primary | ||||||
| Phase 1 | NCT01323335 | Mar 2009 → Jan 2014 | — | National Institute on Aging (NIA) | Completed | No outcome recorded |
| Phase 1 | NCT00513474 | Jan 2008 → Feb 2013 | graft versus host disease, leukemia, myelodysplastic syndrome, myelodysplastic/myeloproliferative neoplasm +1 | Massachusetts General Hospital | Completed | Met primary |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT00360438 | Jul 2006 → Apr 2007 | leukemia, lymphoma, tumor lysis syndrome | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 27 trials | ||||||
| Phase 2 | NCT01564277 | Sep 2011 → May 2015 | Burkitt lymphoma, acute lymphoblastic leukemia, acute myeloid leukemia with 11q23 abnormalities, acute myeloid leukemia with abnormal bone marrow eosinophils inv(16)(p13q22) or t(16;16)(p13;q22) +3 | Roswell Park Cancer Institute | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT01200485 | Apr 2011 → Jul 2016 | leukemia, lymphoma | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT00628628 | Jan 2008 → May 2012 | tumor lysis syndrome | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT00290992 | Jun 2005 → Apr 2006 | metabolic disease | Sanofi | Completed | No outcome recorded |
| Phase 2 | NCT00057811 | Jun 2004 → Oct 2009 | Burkitt lymphoma, childhood acute lymphoblastic leukemia, diffuse large B-cell lymphoma, large B-cell lymphoma +1 | Children's Oncology Group | Completed | No outcome recorded |
| Phase 2 | NCT00631579 | Apr 2003 → Jun 2004 | leukemia, lymphoma | Sanofi | Completed | No outcome recorded |
| Phase 2 | NCT00664144 | Jul 2002 → Jan 2005 | — | Sanofi | Terminated | No outcome recorded Stop: Enrollment |
| Phase 34 trials · 1 met primary | ||||||
| Phase 3 | NCT00921375 | Feb 2010 → Dec 2011 | — | Virchow Group | Completed | No outcome recorded |
| Phase 3 | NCT00607152 | Oct 2007 → Jan 2009 | — | Sanofi | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT00230178 | Apr 2004 → Dec 2007 | cancer, tumor lysis syndrome | Sanofi | Completed | Met primary |
| Phase 3 | NCT00199043 | May 2003 → May 2008 | adult acute lymphoblastic leukemia | Goethe University | Completed | No outcome recorded |
| Phase 46 trials | ||||||
| Phase 4 | NCT05312268 | Jun 2022 → Oct 2024 | gout | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Unknown | No outcome recorded |
| Phase 4 | NCT04349306 | May 2020 → Mar 2021 | lymphoma | Sanofi | Completed | No outcome recorded |
| Phase 4 | NCT00302653 | Feb → Nov 2006 | — | Sanofi | Completed | No outcome recorded |
| Phase 4 | NCT00230217 | Mar 2004 → Jul 2006 | neoplasm, tumor lysis syndrome | Sanofi | Completed | No outcome recorded |
| Phase 4 | NCT00651911 | Jul 2003 → Jul 2004 | tumor lysis syndrome | Sanofi | Completed | No outcome recorded |
| Phase 4 | NCT00563771 | Mar 2003 → Jan 2004 | — | Sanofi | Completed | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT03395977 | Jan 2018 → Dec 2019 | essential hypertension | Erasme University Hospital | Completed | No outcome recorded |
| — | NCT01931527 | Jul 2006 → Jun 2008 | abdominal obesity-metabolic syndrome, obesity disorder | Washington University School of Medicine | Completed | No outcome recorded |
| Comparator or background therapy3 trials | ||||||
| Phase 2 | NCT00756964 Comparator | Oct 2008 → Jul 2011 | — | University of Florida | Completed | No outcome recorded |
| Phase 2/3 | NCT01046825 Background | Sep 2010 → Aug 2023 overdue | neoplasm of mature B-cells | St. Jude Children's Research Hospital | Active not recruiting | No outcome recorded |
| Phase 4 | NCT04745910 Background | Apr 2022 → Apr 2026 | cancer, hematopoietic and lymphoid cell neoplasm, tumor lysis syndrome | M.D. Anderson Cancer Center | Completed | No outcome recorded |
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 28 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | rasburicase | “rasburicase 0.20 mg/kg/day by intravenous (IV) over 30 minutes for 1 to 5 days according to the level of plasma uric acid or Investigator's clinical judgement” NCT04349306 ↗24“TULY (rasburicase) 0.20 mg/kg body weight intravenously for 4 days” NCT00921375 ↗ “Use of rasburicase may preclude the need for HCO3” NCT01046825 ↗ |
| Known as | Elitek | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201594 ↗ |
| Known as | Fasturtec | “A Multi-center, Randomized, Open-label, Active-controlled Clinical Trial to Evaluate the Efficacy and Safety of Rasburicase (Fasturtec®) in the Prevention and Treatment of...” NCT00607152 ↗ |
| Known as | Rasburicasa | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201594 ↗ |
| Known as | Rasuritek | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201594 ↗ |
| Known as | SR29142 | “Safety and efficacy of rasburicase (SR29142) in a Japanese phase II study.” PMID 19076979 ↗ Feb 20094“rasburicase (SR29142)” NCT00290992 ↗ “Rasburicase (SR29142)” NCT00664144 ↗ “Rasburicase (SR29142)” NCT00230217 ↗ “Rasburicase (SR29142)” NCT00230178 ↗ |
| Known as | TULY | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00921375 ↗ |
| Known as | urate oxidase | “received recombinant urate oxidase at .20 mg/kg for 5 consecutive days” PMID 24530972 ↗ Feb 2014 |
| Action | Inhibit | “Rasburicase to lower serum uric acid” NCT00756964 ↗ |
| Modality | Protein / enzyme biologic | “received recombinant urate oxidase at .20 mg/kg for 5 consecutive days” PMID 24530972 ↗ Feb 2014 |
| Route | Intravenous | “Given IV” NCT00057811 ↗ |