A phase 3 validation study of zuranolone in Japan
Latest Information Update: 10 Oct 2024
At a glance
- Drugs Zuranolone (Primary)
- Indications Major depressive disorder
- Focus Therapeutic Use
Most Recent Events
- 10 Oct 2024 Status changed to completed, according to a Shionogi media release.
- 27 Sep 2024 According to a Shionogi media release, primary endpoint (change from baseline in the HAM-D total score) has been met.
- 27 Sep 2024 According to a Shionogi media release, company announced that Shionogi submitted today a New Drug Application (NDA) in Japan for zuranolone, a treatment in development for major depressive disorder (MDD). The NDA submission is based on data from the Phase 3 program conducted by Shionogi in Japan.