Lorundrostat Medicine 04 December 2025 Extended indication Lorundrostat monotherapy for add-on treatment of uncontrolled and resistant Hypertension in adults and elderly who are taking between 2 and 5 antihypertensive medications. Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Lorundrostat Domain Cardiovascular diseases Reason of inclusion New medicine (specialité) Main indication Other medication for cardiovascular diseases Extended indication Lorundrostat monotherapy for add-on treatment of uncontrolled and resistant Hypertension in adults and elderly who are taking between 2 and 5 antihypertensive medications. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Mineralys Portfolio holder Mineralys Mechanism of action Route of administration Oral Therapeutical formulation Tablet Budgetting framework Extramural (GVS) Centre of expertise Additional remarks MLS-101 (lorundrostat) is designed to reduce aldosterone levels by inhibiting CYP11B2, the enzyme responsible for producing the hormone, without the untoward effects of blocking the mineralocorticoid receptor. MLS-101 has high selectivity (374:1 for CYP11B2:CYP11B1) for the synthesis of aldosterone without affecting cortisol. Registration Registration route Centralised (EMA) Type of trajectory Particularity ATMP No Submission date February 2026 Expected Registration March 2027 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options In de richtlijnen voor de behandeling van hypertensie van de ESC/ESH (2013) wordt geadviseerd om bij patiënten met therapieresistente hypertensie een vierde middel aan de behandeling toe te voegen uit een klasse van antihypertensiva met een ander (partieel) werkingsmechanisme dan de middelen die de patiënt reeds gebruikt (Sever, 2011). Hierbij worden met name de toevoeging van lage dosis van een aldosteron-receptorblokkers, een α-blokker, maar ook hogere dosis van met name thiazidediuretica (in het bijzonder chloortalidon) genoemd. Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration Dosage per administration References NCT05769608 (ADVANCE-HTN); NCT06153693 (LAUNCH-HTN) Additional remarks Expected patient volume per year Patient volume 10,000 - 25,000 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References https://www.ntvg.nl/artikelen/behandelopties-voor-therapieresistente-hypertensie (1) expertopinie (2) Additional remarks De prevalentie van TRH is 10 tot 15%. Hogere leeftijd, chronische nierinsufficiëntie, obesitas, diabetes mellitus en Afrikaanse afkomst vergroten het risico op TRH. Geschat wordt dat slechts 10% van de patiënten met TRH ‘ware’ therapieresistentie heeft. De verwachting is dat er 10.000 tot 25.000 patiënten in aanmerking zullen komen. 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