Aardvark Therapeutics is a clinical-stage biopharmaceutical company developing oral small-molecule drugs targeting metabolic diseases driven by abnormal hunger. Aardvark's core approach activates Bitter Taste Receptors (TAS2Rs) expressed in the gut, which triggers the natural release of hunger-suppressing hormones — including CCK, GLP-1, and PYY — through the gut-brain axis. The lead drug candidate, ARD-101, is an oral tablet designed to remain largely gut-restricted, stimulating CCK release locally without meaningful systemic exposure. This profile is central to Aardvark's differentiation argument: prior pharma attempts to target CCK systemically failed due to toxicity, including pancreatitis. ARD-101's primary target indication is hyperphagia in Prader-Willi Syndrome (PWS), a rare genetic disorder causing severe, chronic, life-threatening hunger. ARD-101 holds Orphan Drug and Rare Pediatric Disease Designations from the FDA for PWS. Aardvark completed Phase 1 and Phase 2 trials and initiated a Phase 3 trial in late 2024, but voluntarily paused all clinical programs in February 2026 following reversible cardiac observations in a healthy volunteer study, pending FDA discussions. A second program, ARD-201, was a planned fixed-dose combination of ARD-101 and a DPP-4 inhibitor targeting obesity maintenance in GLP-1 therapy patients, but is also paused. Aardvark generates no revenue and funds operations through equity raises, including a February 2025 IPO that raised approximately $87.5M in net proceeds.
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