Active substance Udenafil
Domain Cardiovascular diseases
Reason of inclusion New medicine (specialité)
Main indication Other medication for cardiovascular diseases
Extended indication Single Ventricle Heart Disease


Proprietary name Zydena
Manufacturer Mezzion
Mechanism of action Enzyme inhibitor
Route of administration Oral
Budgetting framework Extramural (GVS)
Additional comments Type 5 cyclic nucleotide phosphodiesterase inhibitor.


Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date 2021
Expected Registration 2022
Orphan drug No
Registration phase Clinical trials
Additional comments Datum indiening en verwachte registratie gebaseerd op primary completion date fase 3 studie in juli 2020.

Therapeutic value

Therapeutic value No judgement
Duration of treatment continuous
References NCT03013751

Expected patient volume per year

Patient volume

> 100

Market share is generally not included unless otherwise stated.

References Plantinga et al. Ned Tijdschr Geneeskd. 2001;145:85-90
Additional comments Het hypoplastisch linkerhartsyndroom (HLHS) komt voor bij 1-2 per 10.000 levendgeborenen per jaar. In 2001 bedroeg deze groep in Nederland ruim 100 patiënten.

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.