Extended indication Troriluzole monotherapy for adjunctive treatment of obsessive-compulsive disorder in adults and elderly with an inadequate response to existing standa
Therapeutic value No estimate possible yet
Registration phase No registration expected

Product

Active substance Troriluzol
Domain Neurological disorders
Reason of inclusion New medicine (specialité)
Main indication Other psychiatry
Extended indication Troriluzole monotherapy for adjunctive treatment of obsessive-compulsive disorder in adults and elderly with an inadequate response to existing standard of care treatment.
Manufacturer Biohaven
Mechanism of action Other, see general comments
Route of administration Oral
Therapeutical formulation Capsule
Budgetting framework Extramural (GVS)
Additional remarks Glutamaatremmer

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Particularity Unknown
ATMP Unknown
Submission date September 2025
Orphan drug Unknown
Registration phase No registration expected
Additional remarks Klinische studie vroegtijdig gestopt.

Therapeutic value

Current treatment options SSRIs, clomipramine
Therapeutic value No estimate possible yet

This assessment does not indicate any potential inclusion in the package.

Frequency of administration 2 times a day
Dosage per administration 100 tot 140mg
References NCT04641143 (BHV4157-302); NCT04693351 (BHV4157-303)
Additional remarks Twee capsules van 100mg per dag gedurende de eerste twee weken en vervolgens twee capsules van 140mg per dag vanaf week twee tot en met week tien.

Expected patient volume per year

Patient volume < 50,000

Market share is generally not included unless otherwise stated.

References Radboudumc. Onderzoek naar behandeling voor therapieresistente dwangstoornis. 2021.
Additional remarks In Nederland lijden minstens 100.000 mensen aan een obsessieve-compulsieve stoornis (OCS). Ongeveer de helft van mensen met OCS krijgt medicijnen of heeft deze geprobeerd als onderdeel van de behandeling.

Expected cost per patient per year

Potential total cost per year

Off label use

Off label use Unknown

Indication extension

Indication extensions Unknown

Other information