Depression is a common mental illness worldwide, including in Japan, where over 5 million people (4.2% of the population) suffer from the illness. Furthermore, an estimated 20,000 people in Japan commit suicide every year owing to mental illness, commonly depression, and this is a social issue that needs to be addressed immediately.
Globally antidepressant medication is the mainstay of treatment for depression and various antidepressants are available as therapeutic options for depression. But the prevalence or burden of depressive disorders has continued to increase despite available treatment. This shows that the current treatment for depression may be insufficient. New therapeutic drugs with novel mechanisms of action could be expected to address the unmet needs of this patient population.
S-812217 (zuranolone) is an investigational oral synthetic neuroactive steroid, which was developed by modification of the endogenous neuroactive steroid allopregnanolone and acts as a positive allosteric modulator of the γ-aminobutyric acid–gated chloride channel (GABA_A) receptor. This compound is currently under clinical development for the treatment of MDD and PPD in adults by Sage Therapeutics, Inc., and Biogen, Inc. in the US (SAGE-217) and for MDD by Shionogi & Co., Ltd in Japan.
I would like to show the results of clinical trials of S-812217 (zuranolone) conducted in Japan and introduce the characteristics of this investigational compound.