Uricase, Urate Oxidase

Modality

Therapeutic Use of Uricase

Uric acid can become insoluble after a long period of accumulation in human body and lead to crystallization in joints and serious gout; as for other creatures, who has uricase (urate oxidase) in their body, urate can be transformed to allantoin and easily be dissolved.

Therefore, exogenic uricase has the potential to be developed as an effective therapy for patients with hyperuricaemia and gout.

The FDA has approved the marketing of these two uricases, namely rasburicase and pegloticase. Rasburicase (Elitek), derived from Aspergillus flavus uricase, is produced in Saccharomyces cerevisiae, a yeast strain. As a non-PEGylated uricase, Rasburicase is FDA&EMA-approved for both paediatric and adult patients. It has a half-life of 16-22 hours and is administered intravenously (at a dose of 0.20 mg/kg) daily for up to 7 days.

Pegloticase (Krystexxa) is a PEGylated recombinant uricase with a longer half-life (6.4-13.8 days). Pegloticase, derived from mammalian pig and baboon liver uricase, is produced in Escherichia coli (E. coli) and covalently conjugated to monomethoxy-PEG (mPEG). In 2010, the FDA approved the use of pegloticase in gout patients refractory to conventional therapy. The recommended dose of pegloticase is 8 mg by intravenous infusion every two weeks.

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Uricase Pipelines

Generic name	Brand Name/Altermative name	Expression System	Indications	Manufacturer	Latest stage
Pegloticase	Krystexxa, Puricase, PEG-uricase	E. coil	Refractory gout	Crealta Pharmaceuticals	Approval
Rasburicase	Elitek, Fasturtec, SR29142	Yeast (Saccharomyces cerevisiae)	Hyperuricaemia, Cancer	Sanofi-Aventis Groupe SA	Approval
Rasburicase biosimilar	Tuly	Yeast	Hyperuricaemia	Virchow Group	Approval
PEGylated Recombinant Uricase	1501	Pending Update	Hyperuricaemia	xiuzheng,	Phase II
ALLN-346	Engineered urate oxidase (UrOx）	Pending Update	Gout, Hyperuricaemia, Chronic kidney disease (CKD)	Allena Pharmaceuticals	Phase II
PEGylated Recombinant Uricase	JS103	Pending Update	Hyperuricaemia, gout	Junshi Biosciences	Phase I
Recombinant urate oxidase	Injectable recombinant urate oxidase	E. coil	Hyperuricaemia	Biodoor Biotechnology	Phase II
Pegylated recombinant uricase	HZBio1	E. coil	Gout	Chongqing Paijin Biotechnology;Hangzhou Longda Xinke Bio-pharmaceutical	Phase I/II
Pegadricase	Pegsitacase, URICASE-PEG 20	Yeast	Gout, tumor lysis yndrome (TLS)	EnzymeRx, 3sbio	Phase I
Pegylated recombinant uricase	PRX-115	Plant cell	Refractory gout	Protalix BioTherapeutics	Phase I
Pegylated recombinant uricase	Pending Update	Pending Update	Gout	China National Biotech Group Corporation (CNBG)	Phase I
Recombinant candida utilis uricase	Pending Update	Yeast	Hyperuricaemia	Beijing SL Pharmaceutical	Phase I

Reference:

[1] Schlesinger N, Pérez-Ruiz F, Lioté F. Mechanisms and rationale for uricase use in patients with gout. Nat Rev Rheumatol. 2023 Oct;19(10):640-649. doi: 10.1038/s41584-023-01006-3.

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Uricase, Urate Oxidase

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