India, Oct. 22 -- On Thursday, Aardvark Therapeutics, Inc. (AARD), a clinical-stage biopharmaceutical company, said that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold on ARD-101 for hyperphagia in Prader-Willi syndrome.

Prader-Willi syndrome is a rare genetic disorder characterized by insatiable hunger. ARD-101 is an investigational oral small molecule designed to activate bitter taste receptors and stimulate the release of gut-peptide hormones.

Aardvark voluntarily paused dosing in its Phase 3 HERO trial and open-label extension (OLE) study on February 27 subsequent to reversible electrocardiogram (ECG) changes in a separate healthy-volunteer study.

The FDA subsequently imposed a clinical hold on both studies ...