RegulatoryCompany release

FDA lifts ARD-101 clinical hold in Prader-Willi; Aardvark to run open-label trial

🇺🇸 Aardvark Therapeutics, Inc. (AARD) · Fri 13 Nov 2026

Aardvark Therapeutics says the FDA cleared its ARD-101 IND after cardiac safety studies, allowing a 200 mg twice-daily open-label trial, with a development-plan meeting due in Q1 2027.

Aardvark Therapeutics said the US Food and Drug Administration lifted the clinical hold on its investigational new drug application for ARD-101 in October 2026. The candidate is being developed for hyperphagia in Prader-Willi syndrome.

The lifting of the hold followed two studies the agency had required: an ECG study and an in vitro study of the cardiac sodium channel. According to the company, neither showed QRS or QT prolongation at doses of 200 mg or 400 mg twice daily.

The FDA has agreed to an open-label trial at 200 mg twice daily. A meeting with the agency on the overall development plan is scheduled for the first quarter of 2027.

Aardvark gave the update in its third-quarter 2026 report, published on 13 November 2026. In it, the company described exploratory data from the terminated HERO and OLE trials as inconclusive. It also noted a serious cardiac event that the FDA attributed to a CYP2D6 interaction with pitolisant. Cash stood at $60.3 million.

The source material available did not include further detail on the trial design, enrolment, timelines or the data underlying the studies.

What it means for your team

  • The hold was lifted on the strength of dedicated cardiac safety studies, showing the FDA's focus on QT/QRS effects for this programme.
  • The FDA's attribution of a serious cardiac event to a CYP2D6 interaction with pitolisant highlights drug-interaction risk as a safety consideration for ARD-101 studies.
  • The Q1 2027 meeting on the development plan is the next regulatory milestone to watch, and will show how the FDA views the path beyond the open-label study.
  • Exploratory data from the terminated HERO and OLE trials were described as inconclusive, so efficacy evidence remains to be established.

Company's press release (SEC filing): Aardvark Therapeutics, Inc. ↗

Article written by VigiEye from the official source (Aardvark Therapeutics, Inc.). Claims are the company's own. AI-assisted; check the source before acting.

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