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FDA lifts clinical hold on Aardvark’s ARD-101 for Prader-Willi Syndrome
AARDAardvark Therapeutics, Inc.
The U.S. Food and Drug Administration has lifted the clinical hold on Aardvark Therapeutics’ Investigational New Drug application for ARD-101, allowing the resumption of clinical development for hyperphagia in Prader-Willi Syndrome. The hold was placed in May 2026 following reversible ECG changes observed in healthy volunteers; subsequent safety studies showed no cardiac events at doses up to 400 mg twice daily. Aardvark plans to engage with the FDA on Phase 3 trial design and will host a webcast on October 23, 2026, to review data from the terminated HERO and OLE trials. Aardvark Therapeutics is a clinical-stage biopharmaceutical company developing small-molecule therapeutics for hunger-associated disorders.