Evenamide Medicine 04 June 2026 Extended indication Evenamide monotherapy for add-on treatment of documented treatment-resistant Schizophrenia in adults and elderly who have inadequate response to their current stable therapeutic dose of an antipsychotic(s). Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Evenamide Domain Neurological disorders Reason of inclusion New medicine (specialité) Main indication Schizophrenia, psychosis, bipolar disorder Extended indication Evenamide monotherapy for add-on treatment of documented treatment-resistant Schizophrenia in adults and elderly who have inadequate response to their current stable therapeutic dose of an antipsychotic(s). Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Newron Portfolio holder Mechanism of action Sodium channel blocker Route of administration Oral Therapeutical formulation Capsule Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity ATMP No Submission date February 2027 Expected Registration March 2028 Orphan drug Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Tijdslijn op basis van IHSI-inschatting. Therapeutic value Current treatment options 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 EudraCT Number: 2020-006062-36; ENIGMA-TRS 2 studie (NCT07184619); ENIGMA-TRS 1 Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks Het is nog onduidelijk wat de inclusiecriteria worden van de fase 3-studie, daarom is het niet mogelijk om een inschatting te maken van het patiëntvolume. 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 No Indication extensions References Additional remarks Other information Additional remarks