ORZEYFUL / ONZAYFUL Takeda Pharmaceuticals Australia Pty Ltd
Product name
ORZEYFUL / ONZAYFUL
Accepted date
Jul-2026
Active ingredients
oveporexton
Summary of proposed indication
ORZEYFUL / ONZAYFUL (oveporexton) is proposed for the treatment in patients 16 years and older of narcolepsy type 1 (narcolepsy with cataplexy), a sleep disorder that causes excessive daytime sleepiness and sudden episodes of muscle weakness triggered by strong emotions.
Application type
A (new medicine)
Publication date
Jul-2026
Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.
Priority review
Involves faster TGA evaluation of vital and life-saving medicines for which a complete data dossier is available.