Aardvark Therapeutics Advances PWS Therapy, Targets GLP-1 Discontinuation with Novel Obesity Candidate

NEW YORK, NY – November 13, 2025

Aardvark Therapeutics is making significant strides in the treatment of metabolic diseases, announcing positive updates on its lead candidate for Prader-Willi Syndrome (PWS) and unveiling promising preclinical data for a novel obesity candidate, ARD-201. The company’s strategy focuses on addressing unmet needs in both rare genetic disorders and the broader obesity market, positioning it for potential growth in a rapidly evolving healthcare landscape.

Addressing the Unmet Need in Prader-Willi Syndrome

Aardvark’s lead candidate, ARD-101, is being developed for the treatment of hyperphagia – a constant, insatiable hunger – associated with PWS. The company recently reported encouraging updates on its Phase 3 HERO trial, with topline data expected in the third quarter of 2026. Importantly, Aardvark has received alignment from the FDA to lower the minimum age of eligibility for the trial to 10 years old, potentially expanding the addressable patient population. Enrollment is currently open for an Open Label Extension (OLE) trial.

“PWS presents a significant challenge for patients and their families,” said one expert in rare disease development. “Finding effective therapies to manage hyperphagia and improve quality of life is critical.” The PWS treatment landscape is currently characterized by limited options, with a growing need for innovative therapies. Competitors like Rhythm Pharmaceuticals (with setmelanotide) and Soleno Therapeutics (with VYKAT XR) are also pursuing treatments for this debilitating condition, creating a competitive but hopeful environment for PWS patients. The market is estimated at $980 million in 2025, projected to reach $1.59 billion by 2032.

Beyond PWS: Targeting Obesity with ARD-201

Aardvark is broadening its focus with the development of ARD-201, a novel oral combination therapy designed to address metabolic obesity. Preclinical data presented by the company demonstrates that ARD-201 effectively reduces body weight, improves glucose control, and preserves lean mass. What sets ARD-201 apart is its potential to tackle a key challenge in obesity management: the issue of treatment discontinuation and subsequent weight regain, particularly among patients coming off GLP-1 receptor agonists (GLP-1 RAs).

The combination therapy utilizes ARD-101, activating gut-based signaling pathways to promote satiety, combined with sitagliptin, a DPP-4 inhibitor that extends the effects of gut hormones. “The preclinical data is compelling,” noted one metabolic disease researcher. “The ability to not only achieve weight loss but also maintain it after stopping a GLP-1 RA is a significant advantage.” Studies show that approximately 49% of patients discontinue GLP-1 RA therapy within one year, with a substantial portion regaining weight after stopping treatment.

A Strategic Approach to Market Dynamics

The potential for ARD-201 to address GLP-1 RA discontinuation rates positions Aardvark in a unique space within the growing obesity market. While GLP-1 RAs like Ozempic and Wegovy have demonstrated remarkable efficacy, their high cost, injectable formulation, and potential for side effects contribute to significant discontinuation rates. “There's a clear need for therapies that can help patients maintain weight loss after coming off these injectable medications,” explained an endocrinologist. “An oral option with a novel mechanism of action could be a game-changer.”

ARD-201 is being developed with a two-pronged approach. A Phase 2 POWER trial is planned to evaluate its ability to prevent weight regain in patients discontinuing GLP-1 RA therapy, with interim data expected in the second half of 2026. A second Phase 2 STRENGTH trial will assess weight loss with ARD-201 as a monotherapy and in combination with GLP-1 RA therapy. The company hopes that ARD-201 will not only offer an alternative for patients who don't respond to GLP-1 RAs but also serve as a complementary therapy for those seeking to maintain their weight loss long-term.

Financial Outlook and Future Prospects

Aardvark Therapeutics reported a cash position of $126.4 million as of September 30, 2025, providing sufficient funding to support operations into 2027. The company’s commitment to innovation and its strategic focus on addressing unmet needs in metabolic diseases position it for continued growth and success. The leadership team has recently been bolstered with strategic hires in key scientific, commercial, regulatory, and legal functions. “The company is well-positioned to capitalize on the growing demand for effective and sustainable obesity treatments,” concluded one industry analyst. “Their pipeline diversification and commitment to innovation make them a company to watch.”