On September 22, 2023, the U.S. Food and Drug Administration (FDA) approved Exxua™ (gepirone hydrochloride) extended-release tablets as a novel treatment for major depressive disorder (MDD) in adult patients. More than 80 million Americans are affected by clinical symptoms of depression. Many patients treated with an antidepressant medication either do not achieve a satisfactory response or experience bothersome side effects, emphasizing the importance of developing new therapies. Exxua™ is the first new chemical entity (NCE) to selectively target serotonin 1A (5HT1A) receptors to relieve depressive symptoms. Activation of this receptor has been linked to the mediation of mood disorders and suicide risk. Most alternative treatment options target a variety of serotonin receptors, some of which are responsible for the side effects of those medications. By limiting the mechanism to a single serotonin receptor, Exxua™ has demonstrated a more favorable side effect profile. In clinical trials, Exxua™ showed no significant adverse effect on sexual function, blood pressure, heart rate, weight or liver function. This new approval will offer an effective new treatment option for adult patients with major depressive disorder who have been unable to tolerate alternative medications’ side effects. It is only approved for use in adults and has not been studied in pediatric patients. Exxua™ is expected to be available for patients in early 2024.