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# FDA Gives Allena Drug Orphan Status
- URL: https://www.fdaweb.com/fda-gives-allena-drug-orphan-status/
- Published: 2016-05-05T12:00:00.000Z
- Updated: 2026-09-14T21:00:11.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5135582

FDA has granted an orphan drug designation for Allena Pharmaceuticals’ ALLN-177, oxalate decarboxylase, for treating pediatric hyperoxaluria. The company says that the compound is being developed to treat patients with disorders of oxalate metabolism. There currently are no effective treatments for hyperoxaluria in children, it says, and the orphan drug designation highlights an increasing recognition that kidney stones and other complications of hyperoxaluria are a pediatric problem.

ALLN-177 is described as an orally-administered, recombinant oxalate-degrading enzyme. It is said to target oxalate in the gastrointestinal tract in an effort to reduce the burden of both dietary and endogenously produced oxalate. It reportedly has the potential to decrease the oxalate available systemically for deposition as calcium oxalate crystals or stones in the kidneys, as well as reduce the incidence of calcium oxalate related complications. ALLN-177 is currently being tested in two clinical trials in adult patients, Allena says.