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| Withdrawn | EU (EMA) | Krystexxa | — | 2016-06-30 | europa.eu ↗ |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
| 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 · 1 met primary | ||||||
| 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 | Met primary |
| Phase 48 trials · 1 met primary · 1 missed | ||||||
| Phase 4 | NCT06229145 | Mar 2024 → Jul 2025 | gout | Amgen | Completed | Missed primary |
| 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 | Met primary |
| Phase 4 | NCT03635957 | Sep 2018 → Oct 2019 | gout | Amgen | Completed | No outcome recorded |
| Comparator or background therapy2 trials | ||||||
| Phase 2 | NCT03905512 Comparator | May 2019 → Aug 2020 | gout | Selecta Biosciences, Inc. | Completed | Missed primary |
| Phase 2 | NCT03303989 Comparator | Jun 2018 → Apr 2020 | gout | University of Alabama at Birmingham | Completed | Met primary |
News releases announcing trial results or a regulatory action · 5
| Date | Issuer | Release |
|---|---|---|
| 2024-11-14 | Amgen | Results AMGEN PRESENTS NEW DATA ACROSS RARE INFLAMMATORY DISEASES AT ACR 2024 amgen.com ↗
New data showcase reduction in disease activity by UPLIZNA® (inebilizumab-cdon) in Immunoglobulin G4-Related Disease (IgG4-RD) and support shorter infusion times for KRYSTEXXA® (pegloticase) co-administered with weekly oral methotrexate 15 mg. |
| 2024-06-12 | Amgen | Results AMGEN TO PRESENT INNOVATIVE RHEUMATOLOGY RESEARCH AT EULAR 2024 amgen.com ↗
Key presentations include the first findings showing dazodalibep improved major biomarkers in Sjögren's disease, as well as data on treatment outcomes for uncontrolled gout based on a post-hoc analysis of the MIRROR trial for KRYSTEXXA ® (pegloticase) with methotrexate. |
| 2023-11-02 | Amgen | Results AMGEN PRESENTS NEW DATA THAT SHOW BLOOD PRESSURE DECREASES FOR ADULTS TREATED WITH KRYSTEXXA® (PEGLOTICASE) amgen.com ↗
Amgen (NASDAQ:AMGN) today announced new data for KRYSTEXXA ® (pegloticase) showing a decrease in blood pressure during treatment of adults living with chronic gout refractory to oral urate-lowering treatment − uncontrolled gout − both with and without chronic kidney disease (CKD). |
| 2023-11-01 | Amgen | Results AMGEN TO PRESENT DATA AT ACR 2023 ACROSS EXPANDED RHEUMATOLOGY PIPELINE AND PORTFOLIO amgen.com ↗
Additionally, new real-world data showing a significant uptake in the use of KRYSTEXXA ® (pegloticase) with methotrexate or other immunomodulators by clinicians following the U.S. labeling update, will be delivered at the meeting. |
| 2020-09-30 | Sobi, Inc. | Results Sobi and Selecta Biosciences announce topline data of SEL-212 from the phase 2 COMPARE study supporting the potential for important clinical improvement in patients with Chronic Refractory Gout sobi.com ↗
Numerically higher response rate for SEL-212 versus pegloticase during primary endpoint of months 3 and 6 combined; statistically significant higher response rate for SEL-212 versus pegloticase during month 3 |
All press releases naming this drug 5 releases
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 ↗ |