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ALLN-346 is an investigational, orally administered, engineered urate oxidase (uricase) designed to degrade urate in the gastrointestinal tract. It is optimized for proteolytic stability and activity in the gut, enabling it to break down uric acid that is secreted from circulation or formed in the intestine. The drug acts locally within the GI tract without systemic absorption. Its primary mechanism of action is enzymatic degradation of uric acid (urate), facilitating extrarenal elimination and reducing hyperuricemia. ALLN-346 has been developed specifically for patients with gout and advanced chronic kidney disease (CKD), a population where traditional urate-lowering therapies are often limited due to safety concerns or reduced efficacy. Clinical studies have shown that oral administration of ALLN-346 significantly reduces serum and urinary uric acid levels, with a strong correlation between effect size and degree of renal impairment[1][4][6][8]. The drug was developed by Allena Pharmaceuticals.
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