This section highlights FDA-related milestones and regulatory updates for drugs developed by Aardvark Therapeutics (AARD).
Over the past two years, Aardvark Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
ARD-101 and ARD-201. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
ARD-101 FDA Regulatory Timeline and Events
ARD-101 is a drug developed by Aardvark Therapeutics for the following indication: for Prader-Willi Syndrome.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- ARD-101
- Announced Date:
- March 23, 2026
- Indication:
- for Prader-Willi Syndrome
Announcement
Aardvark Therapeutics, Inc. provided pipeline and business updates.
AI Summary
Aardvark Therapeutics announced voluntary pauses across key programs and gave an update on its pipeline and business plans. The company has paused the Phase 3 HERO and OLE trials of ARD-101, its candidate for treating hyperphagia in people with Prader-Willi Syndrome. Aardvark said it will provide further guidance on that program in the second quarter of 2026. The obesity program for ARD-201, including the POWER and STRENGTH trials, is also on voluntary pause while the company determines next steps tied to ARD-101.
Clinical and preclinical results from the ARD-101 program were published in the journal Molecular Metabolism. Financially, Aardvark reported $110.0 million in cash, cash equivalents, and short-term investments as of December 31, 2025, which it expects will fund operations into the second quarter of 2027. The company said it will offer more detailed direction about both programs in Q2 2026, and those updates will shape future timelines and decisions.
Read Announcement- Drug:
- ARD-101
- Announced Date:
- February 27, 2026
- Indication:
- for Prader-Willi Syndrome
Announcement
Aardvark Therapeutics, Inc announced it is voluntarily pausing the Phase 3 Hunger Elimination or Reduction Objective (HERO) trial. The HERO trial is a Phase 3 randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of ARD-101 as a treatment for hyperphagia in patients with Prader-Willi Syndrome (PWS).
AI Summary
Aardvark Therapeutics announced it is voluntarily pausing the HERO trial, a Phase 3 randomized, double-blind, placebo-controlled study testing ARD-101 for hyperphagia in people with Prader‑Willi syndrome (PWS). The HERO trial was designed to evaluate both the safety and efficacy of ARD-101 as a treatment for the intense, chronic hunger that characterizes PWS.
Because of ongoing work in the ARD-101 program, Aardvark now says it does not expect to report topline HERO results in the third quarter of 2026 as previously planned. The company expects to provide updated timing and further guidance in the second quarter of this year. No additional details about the reason for the pause or its expected duration were disclosed in the announcement.
Read Announcement- Drug:
- ARD-101
- Announced Date:
- February 10, 2026
- Indication:
- for Prader-Willi Syndrome
Announcement
Aardvark Therapeutics, Inc announced that Institutional Review Board (IRB) approval has been granted in the United States for an amended protocol to its ongoing Phase 3 HERO pivotal clinical trial evaluating ARD-101 for the treatment of hyperphagia in individuals with Prader-Willi Syndrome (PWS).
AI Summary
Aardvark Therapeutics announced that an Institutional Review Board (IRB) in the United States has approved an amended protocol for its ongoing Phase 3 HERO pivotal trial of ARD-101, which is being evaluated to treat hyperphagia in people with Prader‑Willi Syndrome (PWS). The approval allows the study to proceed under the updated plan in the U.S.
The amendment is designed to reduce barriers to participation and expand access for those affected by PWS, a rare genetic disorder marked by chronic, insatiable hunger. A key change expands enrollment to younger children who meet eligibility criteria, which could help the trial better capture ARD-101’s potential effects across the PWS population.
Company leadership said enrollment is progressing steadily and remains on track to report topline data in the third quarter of 2026. They expect those results to further inform ARD-101’s potential role as a differentiated treatment for hyperphagia associated with PWS.
Read Announcement- Drug:
- ARD-101
- Announced Date:
- December 10, 2025
- Indication:
- for Prader-Willi Syndrome
Announcement
Aardvark Therapeutics, Inc. announced that the first patient has been dosed in Australia in its Phase 3 HERO pivotal clinical trial assessing ARD-101 for the treatment of hyperphagia in individuals with Prader-Willi syndrome (PWS).
AI Summary
Aardvark Therapeutics announced that the first patient has been dosed in Australia in its Phase 3 HERO pivotal trial of ARD-101 for treating hyperphagia in people with Prader-Willi syndrome (PWS). Clinical sites in Canada and the United Kingdom have received regulatory clearance to enroll, and U.S. sites continue strong enrollment. The randomized, double-blind, placebo-controlled trial plans to enroll about 90 patients across the U.S., Australia, Canada, the U.K. and South Korea. Based on current enrollment momentum, Aardvark is tracking toward a topline data readout in the third quarter of 2026.
All patients who have completed the 12-week trial so far have opted into the Open Label Extension, indicating strong engagement. Australia sites began enrolling in November, and Canada and U.K. sites are expected to start soon. Aardvark believes it can meet its enrollment and timing goals without activating additional EU sites. ARD-101 is an oral, gut-restricted small molecule designed to stimulate gut hormones that may reduce hunger.
Read Announcement- Drug:
- ARD-101
- Announced Date:
- October 22, 2025
- Indication:
- for Prader-Willi Syndrome
Announcement
Aardvark Therapeutics, Inc. announced that it will present poster presentations at ObesityWeek 2025, which is being held on November 4-7, 2025 in Atlanta, Georgia.
Read Announcement- Drug:
- ARD-101
- Announced Date:
- October 8, 2025
- Indication:
- for Prader-Willi Syndrome
Announcement
Aardvark Therapeutics, Inc announces alignment with the U.S. Food and Drug Administration (FDA) on a protocol amendment to the company's Phase 3 HERO trial of ARD-101 for the treatment of hyperphagia associated with Prader-Willi Syndrome (PWS).
AI Summary
Aardvark Therapeutics announced that it has reached agreement with the U.S. Food and Drug Administration on a protocol amendment to its Phase 3 HERO trial of ARD-101 for treating hyperphagia in Prader-Willi Syndrome. The key change lowers the minimum age of participants from 13 to 10 years, expanding the pool of eligible children.
According to Founder and CEO Dr. Tien Lee, including younger patients responds to strong support from the PWS community and evidence that early intervention may offer greater benefit. Aardvark expects to report topline results in the third quarter of 2026, potentially marking a pivotal step toward a new therapy for insatiable hunger in PWS.
ARD-101 is an oral, gut-restricted small molecule that activates bitter taste receptors in the intestine. By triggering release of gut peptides such as GLP-1 and cholecystokinin, it sends satiety signals to the brain. Early studies have shown ARD-101 can reduce hunger alone or alongside existing GLP-1 treatments, and the HERO trial will test its efficacy and safety in the expanded pediatric population.
Read Announcement
ARD-201 FDA Regulatory Events
ARD-201 is a drug developed by Aardvark Therapeutics for the following indication: For the treatment of metabolic obesity and obesity-related conditions.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- ARD-201
- Announced Date:
- August 12, 2025
- Indication:
- For the treatment of metabolic obesity and obesity-related conditions.
Announcement
Aardvark Therapeutics, Inc. announced new positive preclinical data demonstrating the potential of ARD-201 for the treatment of metabolic obesity and obesity-related conditions.
AI Summary
Aardvark Therapeutics announced positive preclinical results for ARD-201 in diet-induced obesity mice. Oral ARD-201 led to about 19% body weight loss after 30 days and slowed weight regain after stopping tirzepatide. When paired with a low tirzepatide dose, the combination outperformed a high tirzepatide dose alone.
The study also found ARD-201 alone maintained weight loss as well as continued high-dose tirzepatide. Being oral and at a lower equivalent human dose, ARD-201 may offer better tolerability and convenience for patients.
Aardvark will start two Phase 2 trials based on these findings. The POWER trial, in late 2025, will test if ARD-201 can prevent weight rebound after stopping GLP-1 receptor agonists. The STRENGTH trial, planned for early 2026, will explore ARD-201’s weight loss effects alone and combined with GLP-1 therapy.
Read Announcement
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