Saroglitazar Medicine 04 June 2026 Extended indication Primary biliary cholangitis. Therapeutic value Total cost Registration phase Clinical trials Product Active substance Saroglitazar Domain Metabolism and Endocrinology Reason of inclusion New medicine (specialité) Main indication Liver diseases Extended indication Primary biliary cholangitis. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Portfolio holder Mechanism of action Receptor agonist Route of administration Oral Therapeutical formulation Tablet Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Fabrikant: Zydus Pharmaceuticals. Werkingsmechanisme: peroxisoomproliferator-geactiveerde receptor (PPAR) agonist. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity ATMP Submission date June 2026 Expected Registration June 2027 Orphan drug Yes Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Tijdslijn op basis van IHSI-inschatting. Therapeutic value Current treatment options Therapeutic value Substantiation Duration of treatment Frequency of administration Dosage per administration References NCT05133336 (EPICS-III) Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References GVS-advies obeticholzuur (Ocaliva®) voor de behandeling van primaire biliaire cholangitis (PBC) (1). Additional remarks De inschatting voor het aantal patiënten met de diagnose PBC in Nederland in 2020 is 2.632 (1). Expected cost per patient per year Cost References Additional remarks Er is nog niets bekend over de mogelijke prijs. 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