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Psychiatric disorders are a leading cause of disability worldwide, calling for an urgent need for new treatments, early detection, early intervention, and precision medicine. Drug discovery and development in psychiatry continues to expand in new and exciting areas, with several new medications approved for psychiatric indications by the U.S. Food and Drug Administration (FDA) in the last 5 years. In this review, the authors summarize recent new drug approvals and new molecular mechanisms in Phase 1–3 clinical development for psychiatric disorders. Advances in human genetics-driven target identification, emergent technologies such as artificial intelligence-enabled drug discovery, digital health technologies, and biomarker tools and strategies for testing novel mechanisms are highlighted. There continues to be a need for research focused on understanding the natural history, developmental trajectory, and pathophysiology of psychiatric disorders to identify new molecular and circuit-based targets. Looking to the future, a vision of precision psychiatry is emerging, taking advantage of advances in genetics, digital technology, and multimodal biomarkers to accelerate the development of next-generation therapies for individuals living with mental illnesses.

New directions in psychiatric drug development: promising therapeutics in the pipeline