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 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:
- 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.
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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.
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