Overview
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
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/03/07 | Phase 1 | Recruiting | Shanghai Institute Of Biological Products | ||
2024/01/29 | Phase 4 | Active, not recruiting | |||
2022/03/31 | Phase 1 | Completed | Shanghai Institute Of Biological Products | ||
2021/02/21 | Phase 4 | Completed | |||
2021/02/09 | Phase 4 | Recruiting | |||
2019/04/05 | Phase 2 | Completed | |||
2019/04/02 | Phase 2 | Recruiting | |||
2017/10/06 | Phase 2 | Completed | |||
2012/12/03 | Phase 1 | Completed | |||
2008/05/08 | Phase 3 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Horizon Therapeutics USA, Inc. | 75987-080 | INTRAVENOUS | 8 mg in 1 mL | 8/30/2023 | |
| Savient Pharmaceuticals, Inc. | 54396-801 | INTRAVENOUS | 8 mg in 1 mL | 4/15/2013 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
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