SAN DIEGO, Calif. — October 22, 2026
Aardvark Therapeutics, Inc. (Nasdaq: AARD), a clinical-stage biopharmaceutical company developing small-molecule therapeutics designed to suppress hunger, announced that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold on its Investigational New Drug (IND) application for ARD-101, an investigational treatment for hyperphagia associated with Prader-Willi syndrome (PWS). The decision allows the company to continue advancing the clinical development program, subject to further engagement with the FDA regarding the design of the Phase 3 trial. Aardvark also announced that it will host a webcast on October 23, 2026, to review the available exploratory efficacy and safety data from the terminated Phase 3 Hunger Elimination or Reduction Objective (HERO) trial and its open-label extension (OLE) study. The announcement follows a period of clinical development suspension initiated after reversible electrocardiogram (ECG) changes were observed during routine safety monitoring in a separate study involving healthy volunteers. The FDA’s decision lifts the hold but does not establish ARD-101’s safety or efficacy for treating PWS.
FDA Hold Followed Cardiac Safety Monitoring
Aardvark voluntarily paused dosing in the Phase 3 HERO trial and its OLE study on February 27, 2026, after reversible ECG changes were observed in a separate healthy-volunteer study. In May 2026, the FDA placed the HERO and OLE trials on clinical hold. To address the safety concern, the company conducted an additional ECG study in healthy volunteers and an in vitro cardiac sodium channel (NaV1.5) study, working in alignment with the FDA. According to Aardvark, no cardiac events were observed in the recently completed ECG study at ARD-101 doses of 200 mg and 400 mg twice daily. Following completion of this work, the FDA lifted the clinical hold on the IND application for ARD-101 in PWS. Aardvark Founder and Chief Executive Officer Tien Lee, M.D., said the company was pleased that the hold had been lifted and that the work needed to allow clinical studies to resume had been completed. He also emphasized the continuing unmet needs of people living with PWS and their families. The company plans further discussions with the FDA to align on the Phase 3 trial design before resuming clinical development in patients.
Company to Review Exploratory HERO and OLE Data
Aardvark reported that it has unblinded the data accumulated across the HERO and OLE trials to assess the totality of the available efficacy and safety information. The company plans to discuss these exploratory findings during a live investor conference call and webcast on Friday, October 23, 2026, at 8:00 a.m. Eastern Time. Participants can register for the conference call through the registration link provided in the company’s investor announcement. The live webcast and its archived recording will be available through the Investors section of Aardvark’s website. The release did not disclose detailed efficacy results from the terminated studies, so the webcast is expected to provide additional context on the available dataset. The trials’ termination and the subsequent unblinding mean that the results should be interpreted in the context of the studies’ status and the company’s exploratory review. The FDA’s lifting of the clinical hold permits the development program to move forward, but further regulatory alignment on the Phase 3 design remains anticipated before patient studies resume.
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ARD-101 Targets Hunger-Related Signaling in PWS
ARD-101 is an oral, small-molecule therapeutic designed to stimulate the release of gut-peptide hormones by activating bitter taste receptors. Aardvark is developing the candidate to address hyperphagia, or excessive and persistent hunger, associated with Prader-Willi syndrome, a rare genetic disorder characterized by insatiable hunger. The company’s broader pipeline focuses on small-molecule therapies intended to suppress hunger for PWS and metabolic diseases. Aardvark distinguishes hunger—the discomfort associated with not having eaten recently—from appetite, which it describes as the reward-seeking desire for food. Its research explores therapeutic applications in hunger-associated conditions and potential complementary uses alongside anti-appetite therapies. With the clinical hold lifted, Aardvark intends to continue advancing ARD-101 while working with the FDA on the next Phase 3 study design. ARD-101 remains investigational and has not been approved for commercial use to treat PWS. Additional clinical data and future studies will be needed to further characterize its safety and potential benefit for people living with the disorder.
Source:Aardvark Therapeutics press release
