SAGE-217 (oral brexanolone; SAGE Therapeutics/Shionogi) is a novel, next-generation positive allosteric modulator that selectively binds synaptic and extrasynaptic gamma-aminobutyric acid-A (GABA-A) receptors and shares similar pharmacology properties to brexanolone. The drug is being investigated for a number of indications including major depressive disorder, post-partum depression, insomnia, and bipolar depression.
Forecast as having blockbuster potential, SAGE-217 (oral brexanolone; SAGE Therapeutics/Shionogi) is an exciting prospect in the depression pipeline. SAGE-217 is the oral formulation of SAGE Therapeutics’ brexanolone franchise. The drug boasts prominent novelty and targets unmet need in multiple respects: its mechanism of action; its efficacy in post-partum depression (PPD); its rapidacting effects; and its episodic, short-course dosing schedule. The company is investing in a broad development program for SAGE217, encompassing PPD, major depressive disorder (MDD), and MDD with co-morbid insomnia, and there is much enthusiasm for the drug.
LIST OF FIGURES
15 Figure 1: Datamonitor Healthcare’s drug assessment summary of SAGE-217 for depression
16 Figure 2: Datamonitor Healthcare’s drug assessment summary of SAGE-217 for depression
18 Figure 3: SAGE-217 sales for depression in the US, 2017–26
LIST OF TABLES
6 Table 1: SAGE-217 drug profile
8 Table 2: SAGE-217 pivotal Phase III data in severe post-partum depression
12 Table 3: SAGE-217 pivotal Phase II data in major depressive disorder
13 Table 4: SAGE-217 ongoing Phase III trials in depression
14 Table 5: SAGE-217 for depression – SWOT analysis
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