Sedogen LLC (USA), a parent-led biopharmaceutical company focused on Prader-Willi syndrome, announced the issuance of US Patent 12,589,098 by the US Patent and Trademark Office, covering pharmaceutical formulations of diazoxide for the reduction of behavioral symptoms in Prader-Willi syndrome. The patent, issued March 31, 2026, and expiring June 6, 2034, protects a method-of-use and formulation approach targeting food-related behavioral manifestations — including persistent preoccupation with food — that represent a core and clinically difficult dimension of PWS pathology.
Prader-Willi syndrome is a rare neurodevelopmental disorder arising from the absence of expression of paternally inherited imprinted genes on chromosome 15q11-q13, occurring in approximately 1 in 16,000 births. The genetic disruption produces a multisystem phenotype that includes intellectual disability, growth hormone deficiency, hypogonadism, and hyperphagia — a state of chronic, compulsive hunger that drives the food-related behavioral symptoms the Sedogen patent specifically addresses. Diazoxide is a small-molecule potassium channel activator with an established pharmacological history; the protected claims cover its formulation and application within the PWS behavioral symptom context rather than the compound itself, consistent with a repurposing strategy. The clinical development status of Sedogen’s diazoxide formulation program and any disclosed trial data remain undisclosed in the available source material.
The PWS therapeutic field has attracted a range of mechanistic approaches, several of which share functional overlap with Sedogen’s diazoxide formulation strategy in targeting hyperphagia and its behavioral sequelae. Soleno Therapeutics (USA) has advanced diazoxide choline controlled-release (DCCR) as a distinct formulation of the same active moiety, securing approval in the US for hyperphagia in PWS under the trade name Vykat XR in March 2025. Soleno’s program represents the most proximate mechanistic comparator to the Sedogen patent given the shared reliance on diazoxide pharmacology, though the two programs represent separate formulation and intellectual property strategies. The degree to which the respective patent estates interact or compete is not determinable from the available source material.