Drugs / Pegloticase
Pegloticase
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | KRYSTEXXA | — | 2022-07-07 | fda.gov ↗ |
| Withdrawn | EU (EMA) | Krystexxa | — | 2016-06-30 | europa.eu ↗ |
| Approved | EU (EMA) | Krystexxa | — | 2013-01-08 | europa.eu ↗ |
| Approved | US (FDA) | KRYSTEXXA | — | 2010-09-14 | fda.gov ↗ |
Trials 18 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT05302388 | Apr 2022 → Jan 2023 | — | Shanghai Institute Of Biological Products | Completed | No outcome recorded |
| Phase 1 | NCT01739660 | Dec 2012 → Apr 2013 | end stage renal failure | Savient Pharmaceuticals | Completed | No outcome recorded |
| Phase 24 trials | ||||||
| Phase 2 | NCT03899883 | Jan 2020 → Jun 2023 overdue | diabetic kidney disease, type 2 diabetes mellitus | University of Colorado, Denver | Recruiting | No outcome recorded |
| Phase 2 | NCT02598596 | Dec 2015 → Apr 2020 | gout | Ampel BioSolutions, LLC | Completed | No outcome recorded |
| Phase 2 | NCT00111657 | Dec 2004 → Jul 2009 | gout | John Sundy | Completed | No outcome recorded |
| Phase 2 | NCT00080210 | Mar 2004 → Feb 2005 | gout | Savient Pharmaceuticals | Completed | No outcome recorded |
| Phase 34 trials | ||||||
| Phase 3 | NCT07388498 | Feb 2026 → Jun 2028 expected | gout | Amgen | Recruiting | No outcome recorded |
| Phase 3 | NCT00675103 | May 2008 → Jan 2009 | gout | Savient Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT01356498 | Dec 2006 → Jan 2010 | gout | Savient Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT00325195 | May 2006 → Oct 2007 | gout | Savient Pharmaceuticals | Completed | No outcome recorded |
| Phase 48 trials | ||||||
| Phase 4 | NCT06229145 | Mar 2024 → Jul 2025 | gout | Amgen | Completed | No outcome recorded |
| Phase 4 | NCT04745910 | Apr 2022 → Apr 2026 | cancer, hematopoietic and lymphoid cell neoplasm, tumor lysis syndrome | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 4 | NCT04772313 | Mar 2021 → Aug 2022 | gout | Amgen | Completed | No outcome recorded |
| Phase 4 | NCT04762498 | Jan 2021 → May 2023 | gout | Amgen | Completed | No outcome recorded |
| Phase 4 | NCT04511702 | Oct 2020 → Jan 2024 | gout | Amgen | Completed | No outcome recorded |
| Phase 4 | NCT04087720 | Sep 2019 → Jul 2021 | gout | Amgen | Completed | No outcome recorded |
| Phase 4 | NCT03994731 | Jun 2019 → Mar 2021 | gout | Amgen | Completed | No outcome recorded |
| Phase 4 | NCT03635957 | Sep 2018 → Oct 2019 | gout | Amgen | Completed | No outcome recorded |
Also used as a comparator or background therapy in 2 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2 | NCT03905512 Comparator | May 2019 → Aug 2020 | gout | Selecta Biosciences, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT03303989 Comparator | Jun 2018 → Apr 2020 | gout | University of Alabama at Birmingham | Completed | No outcome recorded |
Press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2023-11-02 | Amgen | AMGEN PRESENTS NEW DATA THAT SHOW BLOOD PRESSURE DECREASES FOR ADULTS TREATED WITH KRYSTEXXA® (PEGLOTICASE) amgen.com ↗ |
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 21 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | pegloticase | “A Study Exploring Efficacy of Pegloticase in Subjects With Asymptomatic Hyperuricemia” NCT05302388 ↗ |
| Known as | Krystexxa | “This trial is to assess efficacy, safety, blood levels and bodily effects of up to 2 dose levels of intravenous (IV) pegloticase (KRYSTEXXA) infusions at every 4 week intervals...” NCT04762498 ↗3“Study of Pegloticase (KRYSTEXXA®) Plus Methotrexate in Patients With Uncontrolled Gout” NCT03635957 ↗ “Pegloticase 8 MG/ML [Krystexxa]” NCT03899883 ↗ |
| Known as | Pegloticasa | ChEMBL registry synonym — accepted as the source's own label CHEMBL1237025 ↗ |
| Known as | Puricase | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00080210 ↗ |
| Modality | Protein / enzyme biologic | “PEG-uricase (a chemically modified recombinant mammalian enzyme that degrades uric acid)” NCT00111657 ↗ |
| Route | Intravenous | “administered IV” NCT00111657 ↗ |