Initial efficacy testing in a small group of patients with the targeted condition.
The drug development process in psychiatry is a multi-decade journey characterized by high scientific complexity, significant regulatory hurdles, and a historically low success rate compared to other medical fields.
The FDA examines all data to determine if the drug's benefits outweigh its risks.
Safety and dosage testing in a small group of healthy volunteers.
Researchers identify a "target" in the brain—such as a specific receptor—and design molecules to interact with it.
Psychiatric drug development is notoriously difficult, with only about successfully transitioning from Phase I to approval.