Pegloticase
- Generic Name
- Pegloticase
- Brand Names
- Krystexxa
- Drug Type
- Biotech
- CAS Number
- 885051-90-1
- Unique Ingredient Identifier
- R581OT55EA
- Background
Pegloticase is a porcine recombinant PEGylated uricase indicated for the treatment of chronic gout in adult patients that do not respond to other types of therapies. Pegloticase has a similar activity to rasburicase, an enzyme that metabolizes uric acid to allantoin. In gout patients treated with pegloticase, the conversion of uric acid to allantoin leads to lower plasma uric acid concentrations.
Pegloticase has a longer terminal elimination half-life thanks to the addition of a polyethylene glycol (PEG) group. Therefore therapeutic drug levels can be maintained with infrequent and relatively low pegloticase doses. The PEG group also gives pegloticase a lower potential to induce an immune response. However, cases of anaphylaxis and infusion reactions have been reported in patients treated with this drug. Pegloticase was approved by the FDA in 2014, and in 2022, the drug label included the co-administration of pegloticase and methotrexate.
- Indication
Pegloticase is a PEGylated uric acid specific enzyme indicated for the treatment of chronic gout in adult patients refractory to conventional therapy.
- Associated Conditions
- Chronic, refractory Gout
A Phase Ib Clinical Trial of Peguricase for Injection With Methotrexate in Patients With Uncontrolled Gout.
- First Posted Date
- 2024-03-07
- Last Posted Date
- 2024-03-07
- Lead Sponsor
- Shanghai Institute Of Biological Products
- Target Recruit Count
- 36
- Registration Number
- NCT06298071
- Locations
- 🇨🇳
The First Affiliated Hospital of Bengbu Medical College, Bengbu, Anhui, China
A Trial to Investigate the Non-inferiority of Pegloticase Administered Every 4 Weeks (Q4W) With MTX Compared With Every 2 Weeks (Q2W) With MTX in Participants With Uncontrolled Refractory Gout
- First Posted Date
- 2024-01-29
- Last Posted Date
- 2025-02-20
- Lead Sponsor
- Amgen
- Target Recruit Count
- 262
- Registration Number
- NCT06229145
- Locations
- 🇺🇸
The University of Alabama at Birmingham (UAB), Birmingham, Alabama, United States
🇺🇸Orthopedic Physicians Alaska - Rheumatology and Infusion, Anchorage, Alaska, United States
🇺🇸Arizona Arthritis and Rheumatology, Tucson, Arizona, United States
A Study Exploring Efficacy of Pegloticase in Subjects With Asymptomatic Hyperuricemia
- Conditions
- Asymptomatic Hyperuricemia
- Interventions
- First Posted Date
- 2022-03-31
- Last Posted Date
- 2023-12-27
- Lead Sponsor
- Shanghai Institute Of Biological Products
- Target Recruit Count
- 45
- Registration Number
- NCT05302388
- Locations
- 🇨🇳
The first affiliated hospital of Bengbu medical college, Bengbu, Anhui, China
A Phase 4, Open-label Study of KRYSTEXXA® (Pegloticase) Co-administered With Methotrexate (MTX) in Patients With Uncontrolled Gout (FORWARD OL)
- Conditions
- Uncontrolled GoutChronic Gout
- Interventions
- First Posted Date
- 2021-02-21
- Last Posted Date
- 2024-10-09
- Lead Sponsor
- Amgen
- Target Recruit Count
- 50
- Registration Number
- NCT04762498
- Locations
- 🇺🇸
ProHealth Research Center, Doral, Florida, United States
🇺🇸Biopharma Informatic, LLC, Houston, Texas, United States
🇺🇸Napa Research Center, Pompano Beach, Florida, United States
Pegloticase for the Reduction of Uric Acid in Patients With Tumor Lysis Syndrome
- Conditions
- Hematopoietic and Lymphoid Cell NeoplasmMalignant Solid NeoplasmTumor Lysis Syndrome
- Interventions
- First Posted Date
- 2021-02-09
- Last Posted Date
- 2024-12-05
- Lead Sponsor
- M.D. Anderson Cancer Center
- Target Recruit Count
- 10
- Registration Number
- NCT04745910
- Locations
- 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States
A Study to Compare the Efficacy of SEL-212 to KRYSTEXXA® in Gout Participants Refractory to Conventional Therapy
- First Posted Date
- 2019-04-05
- Last Posted Date
- 2023-10-17
- Lead Sponsor
- Selecta Biosciences, Inc.
- Target Recruit Count
- 170
- Registration Number
- NCT03905512
- Locations
- 🇺🇸
Panax Clinical Research, Miami Lakes, Florida, United States
🇺🇸Great Lakes Clinical Trials, Chicago, Illinois, United States
🇺🇸DJL Clinical Research, Charlotte, North Carolina, United States
Uric Acid Lowering Trial in Youth Onset T2D
- Conditions
- Diabetic Kidney DiseaseHyperuricemiaDiabetes Mellitus, Type 2Type2 DiabetesDiabetic NephropathiesDiabetesType 2 Diabetes MellitusDiabetes Complications
- Interventions
- First Posted Date
- 2019-04-02
- Last Posted Date
- 2023-02-09
- Lead Sponsor
- University of Colorado, Denver
- Target Recruit Count
- 10
- Registration Number
- NCT03899883
- Locations
- 🇺🇸
Children's Hospital Colorado, Aurora, Colorado, United States
REduCing Immunogenicity to PegloticasE (RECIPE) Study
- Conditions
- Gout Chronic
- Interventions
- First Posted Date
- 2017-10-06
- Last Posted Date
- 2022-03-16
- Lead Sponsor
- University of Alabama at Birmingham
- Target Recruit Count
- 35
- Registration Number
- NCT03303989
- Locations
- 🇺🇸
University of Alabama at Birmingham, Birmingham, Alabama, United States
Study to Assess Pegloticase (KRYSTEXXA®) in Patients on Hemodialysis
- First Posted Date
- 2012-12-03
- Last Posted Date
- 2013-10-25
- Lead Sponsor
- Savient Pharmaceuticals
- Target Recruit Count
- 12
- Registration Number
- NCT01739660
- Locations
- 🇺🇸
Davita Clinical Research, Minneapolis, Minnesota, United States
Re-exposure Study of Pegloticase Intravenous (i.v.) in Symptomatic Gout Patients
- Conditions
- Chronic Gout Refractory to Conventional Therapy
- Interventions
- First Posted Date
- 2008-05-08
- Last Posted Date
- 2011-06-28
- Lead Sponsor
- Savient Pharmaceuticals
- Target Recruit Count
- 7
- Registration Number
- NCT00675103
- Locations
- 🇺🇸
University of Chicago- Dept. Biological Services, Chicago, Illinois, United States
🇺🇸The Center for Rheumatology and Bone Research, Wheaton, Maryland, United States
🇺🇸Duke University Medical Center, Durham, North Carolina, United States
Drug Development Updates
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