FDA lifts clinical hold on Aardvark Therapeutics’ ARD-101 for Prader-Willi syndrome
AARD•The FDA lifted its clinical hold on Aardvark Therapeutics’ ARD-101 for hyperphagia in Prader-Willi syndrome, allowing development to resume. Patient trials remain subject to further FDA engagement on Phase 3 trial design.
1. Clinical development resumes
The FDA lifted the clinical hold on ARD-101, allowing clinical development for hyperphagia in Prader-Willi syndrome to resume. Resumption of patient trials remains subject to further FDA engagement on Phase 3 trial design. The hold was imposed in May 2026 after reversible ECG changes in healthy volunteers; a subsequent study found no cardiac events at doses of 200 mg and 400 mg twice daily.
