ZURZUVAE
ZURZUVAE (zuranolone) is a once-daily oral pill co-developed by Sage Therapeutics and Biogen that acts as a positive allosteric modulator of GABA-A receptors — the brain's primary inhibitory receptors — to rapidly restore neural balance during depressive episodes. Unlike traditional antidepressants that require continuous daily dosing, zuranolone is given as a short 14-day course intended to reset dysregulated neural circuits. It is the first oral therapy specifically approved for postpartum depression (PPD) and is also being studied as an adjunct to standard antidepressants in major depressive disorder (MDD).
Upcoming catalysts
Programs
Postpartum Depression
Postpartum depression (PPD) affects approximately 1 in 8 new mothers in the US, causing persistent sadness, difficulty bonding with the infant, and in severe cases suicidal ideation; the condition is linked in part to the rapid drop in neurosteroids following delivery. ZURZUVAE is the first oral therapy specifically approved for PPD, given as a 14-day course — unlike the prior IV brexanolone (Zulresso), which required a 60-hour inpatient infusion and saw minimal uptake due to access barriers.
Major Depressive Disorder
MDD is a leading cause of disability worldwide; roughly 30% of patients fail to achieve remission on first-line SSRIs or SNRIs, and there is substantial interest in non-monoamine mechanisms. This Phase 3 trial tests a 14-day zuranolone course added to ongoing antidepressants in MDD patients, with two prior MDD trials (MOUNTAIN, WATERFALL) having missed primary endpoints — making trial design and patient selection critical; enrollment completion in 2026 anchors the Q1 2027 topline readout.