Drug intelligence / Profile preview

reloxaliase

Development stage
Phase 3
Lead developer
Allena Pharmaceuticals
Modality
Replacement Enzymes → Therapeutic Enzymes → Recombinant Proteins and Enzymes
Administration
Oral
01

Overview

Reloxaliase is a first-in-class, orally administered recombinant enzyme therapy designed to treat hyperoxaluria. It is a crystalline formulation of oxalate decarboxylase derived from *Bacillus subtilis* and expressed in *Escherichia coli*. The drug acts locally in the gastrointestinal tract by catalyzing the conversion of oxalate into formate and carbon dioxide, thereby reducing systemic absorption of oxalate and decreasing urinary excretion. Reloxaliase is not systemically absorbed, minimizing potential for systemic toxicity. Its primary indications are enteric hyperoxaluria and primary hyperoxaluria—rare metabolic disorders characterized by elevated urinary oxalate levels that can lead to kidney stones and chronic kidney disease. The drug has received orphan drug designation for these indications[1][2][3][5][6][7].

Other names
oxalate decarboxylase bacillus subtilis strain 168reloxaliase
02

Targets

OxDC (Oxalate decarboxylase)

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