Aardvark Therapeutics: FDA lifts clinical hold on ARD-101 for Prader-Willi Syndrome
The FDA lifted the clinical hold on the Investigational New Drug application for Aardvark's ARD-101 for hyperphagia in Prader-Willi Syndrome, and Aardvark said clinical development may resume. Resumption still depends on further engagement with the FDA on the Phase 3 trial design, and the company describes the Phase 3 HERO trial and its open-label extension as terminated.
Key points
- FDA lifted the clinical hold on the ARD-101 IND, following a hold placed in May 2026 on the HERO and OLE trials
- Dosing in the HERO trial was voluntarily paused on February 27, 2026 after reversible ECG changes in a separate healthy-volunteer study
- A recent ECG study observed no cardiac events at ARD-101 doses of 200 mg and 400 mg twice daily
- Aardvark will host a webcast on October 23, 2026 at 8:00 a.m. ET to review exploratory Phase 3 HERO and OLE data
The filing
Written by AI on Nov 9, 2026, 11:43 AM ET, from this filing only. Written later: this filing was briefed after the fact, when past filings were added to the site, so the brief may be read with hindsight; the filing itself is the record of what was known on October 22, 2026.
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