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

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

Therapeutic value

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

Expected patient volume per year

Patient volume

< 180

Market share is generally not included unless otherwise stated.

Expected cost per patient per year

There is currently nothing known about the expected cost.

Potential total cost per year

There is currently nothing known about the possible total cost.

Off label use

There is currently nothing known about off label use.

Indication extension

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.