Capivasertib

Extended indication	Autosomal Dominant Polycystic Kidney Disease (ADPKD).
Therapeutic value	No estimate possible yet
Registration phase	No registration expected

Product

Active substance	Lixivaptan
Domain	Metabolism and Endocrinology
Reason of inclusion	New medicine (specialité)
Main indication	Metabolic diseases
Extended indication	Autosomal Dominant Polycystic Kidney Disease (ADPKD).
Route of administration	Oral
Therapeutical formulation	Capsule
Budgetting framework	Extramural (GVS)

Registration route	Centralised (EMA)
ATMP	No
Orphan drug	Yes
Registration phase	No registration expected
Additional remarks	De fabrikant heeft in juli 2022 aangegeven in een persbericht dat de klinische studies gestopt zijn vanwege het ontstaan van leverenzymstoornissen.

Current treatment options	Tolvaptan
Therapeutic value	No estimate possible yet
Substantiation	Het is sterk de verwachting dat dit middel een gelijk effect heeft als de huidige standaard tolvaptan op het beloop van ADPKD.
Frequency of administration	2 times a day
References	NCT04152837

Patient volume	< 180 Market share is generally not included unless otherwise stated.

Patient volume

< 180

Market share is generally not included unless otherwise stated.

There is currently nothing known about the expected cost.

There is currently nothing known about the possible total cost.

There is currently nothing known about off label use.

There is currently nothing known about indication extensions.

There is currently no futher information available.