Denatonium Acetate Monohydrate Medicine 04 December 2025 Extended indication Denatonium acetate monohydrate monotherapy for treatment of hyperphagia associated with Prader-Willi syndrome in adolescents over 13 years of age, adults and elderly Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Denatonium Acetate Monohydrate Domain Metabolism and Endocrinology Reason of inclusion New medicine (specialité) Main indication Other metabolism and Endocrinology Extended indication Denatonium acetate monohydrate monotherapy for treatment of hyperphagia associated with Prader-Willi syndrome in adolescents over 13 years of age, adults and elderly Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Aardvark Portfolio holder Aardvark Mechanism of action Route of administration Oral Therapeutical formulation Capsule Budgetting framework Extramural (GVS) Centre of expertise Additional remarks TAS2R-agonist Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity ATMP No Submission date November 2026 Expected Registration December 2027 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Er zijn nog geen resultaten bekend. Op dit moment loopt er nog een fase 3 trial (HERO). Duration of treatment Frequency of administration 1 times a day Dosage per administration 200 tot 800mg References NCT06828861 (HERO) Additional remarks Expected patient volume per year Patient volume 10 - 15 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References https://www.nve.nl/aandoening/prader-willi-syndroom Additional remarks Prader-Willi syndroom (PWS) is een zeldzaam aangeboren syndroom. In Nederland worden jaarlijks ongeveer 10 tot 15 kinderen geboren met dit syndroom. Expected cost per patient per year Cost References Additional remarks Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use Indications off label use References Additional remarks Indication extension Indication extensions Indication extensions References Additional remarks Other information Additional remarks