pegloticase
Trade name: krystexxa
Approved
Sep 14, 2010
Pegloticase is a medication for the treatment of severe, treatment-refractory, chronic gout. It is a third line treatment in those in whom other treatments are not effective or are not tolerated. The drug is administered by infusion intravenously. Since October 2023, Amgen Inc. has been the marketer of pegloticase in the U.S. — Wikipedia
Clinical trial activity
23 trials · 20 clinical orgs · 3 marketing orgs
Earliest trial started Mar 1, 2004 (NCT00080210)
Timeline
2000s
- Feb 21, 2001
Orphan Drug Designation
- Jan 1, 2004
Savient Pharmaceuticals — Earliest Phase 2 Sponsor(trial)
- Jan 1, 2006
Savient Pharmaceuticals — Earliest Phase 3 Sponsor(trial)
2010s
- Sep 14, 2010
Savient Pharmaceuticals — Earliest FDA Approval
- Sep 14, 2010
Horizon Pharma — Marketing Organization
- Sep 14, 2010
Savient Pharmaceuticals — NDA Organization
- Sep 14, 2010
Horizon Therapeutics, LLC — NDA Secondary Org
- Jan 1, 2012
Savient Pharmaceuticals — Earliest Phase 1 Sponsor(trial)
Indications
Approved for
Studied for
- Chronic Kidney Disease-Mineral and Bone Disorder · Phase 1
- Diabetes Complications · Phase 2
- Diabetes Mellitus · Phase 2
- Diabetes Mellitus, Type 2 · Phase 2
- Diabetic Nephropathies · Phase 2
- Hyperuricemia · Phase 2
- Kidney Transplantation · Phase 4
- Lymphoma · Phase 4
- Neoplasms · Phase 4
- Tumor Lysis Syndrome · Phase 4
Mechanism of action
- Uric acidOXIDATIVE ENZYME
Uric acid oxidative enzyme
It's a recombinant uricase, which catalysis the oxidation of uric acid to allantoin, approved for the treatment of chronic gout
- Dual oxidase 1Supplementation
DUOX1 supplementation
Approval history
- approvedSep 14, 2010
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Prescription Only
- Multi-specific
- No
Oral
No
Parenteral
Yes
Topical
No
Sources
- WikipediaPegloticase ↗
- NCATSR581OT55EA ↗
- ChEMBLCHEMBL1237025 ↗
Also known as
- krystexxa
- krystexxa
- krystexxa
- krystexxa
- methoxypolyethylene glycol uricase
- methoxypolyethylene glycol uricase
- methoxypolyethylene glycol uricase
- methoxypolyethylene glycol uricase
- pegloticase
- pegloticase
- pegloticase
- pegloticase
- pegloticase
- pegloticase
- pegloticase
- pegloticase
- peg-uricase
- polyethylene glycol-uricase
- polyethylene glycol-uricase
- puricase
- puricase
- puricase
- puricase
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07236476 | Phase 2 | Oct 9, 2024 | Luye Pharma |
| NCT06229145 | Phase 4 | Mar 18, 2024 | Amgen |
| NCT06629376 | Phase 1 | Nov 20, 2023 | Sunshine Lake Pharma Co., Ltd. |
| NCT06298071 | Phase 1 | Mar 3, 2023 | Bengbu Medical College, Chengdu Fifth People's Hospital, China National Biotec Group Co., Ltd, Henan Medical University |
| NCT05302388 | Phase 1 | Mar 28, 2022 | Bengbu Medical College, China National Biotec Group Co., Ltd |
| NCT04745910 | Phase 4 | Dec 31, 2021 | University of Texas at Houston |
| NCT04772313 | Phase 4 | Mar 8, 2021 | Horizon Therapeutics, LLC |
| NCT04762498 | Phase 4 | Jan 26, 2021 | Horizon Therapeutics, LLC |
| NCT04511702 | Phase 4 | Oct 2, 2020 | Horizon Therapeutics, LLC |
| NCT04087720 | Phase 4 | Sep 9, 2019 | Horizon Pharma |
| NCT03994731 | Phase 4 | Jun 13, 2019 | Horizon Pharma |
| NCT03899883 | Phase 2 | Jun 1, 2019 | University of Colorado, Denver |
| NCT03905512 | Phase 2 | Mar 28, 2019 | Selecta Biosciences, Inc. |
| NCT03635957 | Phase 2 | Sep 26, 2018 | Horizon Pharma |
| NCT03303989 | Phase 2 | May 24, 2018 | University of Alabama, Birmingham, University of Michigan |
| NCT03388515 | Phase 1 | Oct 9, 2017 | Sunshine Lake Pharma Co., Ltd., Zhejiang University |
| NCT02598596 | Phase 2 | Dec 1, 2015 | Ampel BioSolutions, LLC, IND 2 Results LLC |
| NCT01739660 | Phase 1 | Dec 1, 2012 | Davita Clinical Research, Savient Pharmaceuticals |
| NCT00675103 | Phase 3 | May 1, 2008 | Savient Pharmaceuticals |
| NCT01356498 | Phase 3 | Dec 1, 2006 | Savient Pharmaceuticals |
Organizations
Research & Development (20)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Savient Pharmaceuticals | For profit | 6 | 5 | 3 | 2004 |
| Horizon Pharma | For profit | 3 | 3 | 2 | 2018 |
| Horizon Therapeutics, LLC | For profit | 3 | 3 | 1 | 2020 |
| Bengbu Medical College | Academic/Hospital | 2 | 0 | 1 | 2022 |
| China National Biotec Group Co., Ltd | For profit | 2 | 2 | 1 | 2022 |
| Sunshine Lake Pharma Co., Ltd. | For profit | 2 | 2 | 1 | 2017 |
| Amgen | For profit | 1 | 1 | 1 | 2024 |
| Ampel BioSolutions, LLC | For profit | 1 | 1 | 1 | 2015 |
| Chengdu Fifth People's Hospital | Academic/Hospital | 1 | 0 | 1 | 2023 |
| Davita Clinical Research | For profit | 1 | 0 | 1 | 2012 |
| Duke University | Academic/Hospital | 1 | 1 | 1 | 2004 |
| Henan Medical University | Academic/Hospital | 1 | 0 | 1 | 2023 |
| IND 2 Results LLC | For profit | 1 | 0 | 1 | 2015 |
| Luye Pharma | For profit | 1 | 1 | 1 | 2024 |
| Selecta Biosciences, Inc. | For profit | 1 | 1 | 1 | 2019 |
| University of Alabama, Birmingham | Academic/Hospital | 1 | 1 | 1 | 2018 |
| University of Colorado, Denver | Academic/Hospital | 1 | 1 | 1 | 2019 |
| University of Michigan | Academic/Hospital | 1 | 0 | 1 | 2018 |
| University of Texas at Houston | Academic/Hospital | 1 | 1 | 1 | 2021 |
| Zhejiang University | Academic/Hospital | 1 | 0 | 1 | 2017 |
Marketing (3)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Horizon Pharma | For profit | MKTG | Sep 14, 2010 |
| Horizon Therapeutics, LLC | For profit | NDA2 | Sep 14, 2010 |
| Savient Pharmaceuticals | For profit | NDA | Sep 14, 2010 |