 The efficacy of brexanolone was shown in two clinical studies in participants who received a 60-hour continuous intravenous infusion of brexanolone or placebo and were then followed for four weeks.The FDA approved allopregnanolone based on evidence from three clinical trials, conducted in the United States, (Trial 1/NCT02942004, Trial 3/NCT02614541, Trial 2/ NCT02942017) of 247 women with moderate or severe postpartum depression.The FDA granted the application for brexanolone priority review designation, breakthrough therapy designation, and granted approval of allopregnanolone to Sage Therapeutics, Inc.

Allopregnanolone is the name of the molecule commonly used in the literature when it is discussed as an endogenous neurosteroid.