This roundup highlights several FDA actions in July related to therapeutics for psychiatric illness. For information on approvals in other specialties during 2026, see our FDA Drug Approvals page.

First-in-Class Drug Approved for Attention-Deficit/Hyperactive Disorder (ADHD)

The FDA approved centanafadine (Simtriyo, Otsuka), a once-daily extended-release capsule, for the treatment of ADHD in adults and children aged 6 years or older who weigh at least 20 kg. It is the first and only approved norepinephrine, dopamine, and serotonin reuptake inhibitor for the treatment of ADHD in these populations. The approval was supported by four phase 3 clinical trials involving children and adults. The drug is expected to be available commercially later this year.

Digital ADHD Therapeutic Earns Breakthrough Device Designation

A digital treatment for children with ADHD (Cenextra, Sky Therapeutics) received Breakthrough Device designation in June. A collection of arcade-style video games, Cenextra is designed to engage children in cognitive exercises that can strengthen executive functioning. The device — the first ADHD treatment to receive the designation — was approved based on evidence from two clinical trials, with additional studies underway, the developers at Florida State University said in a statement.

Robotic System Cleared to Guide Transcranial Magnetic Stimulation (TMS)

The FDA granted 510(k) clearance to the Zeta TMS Robotic System (Zeta Surgical), which provides real-time positioning of TMS coils with submillimeter accuracy. TMS is used for treatment-resistant depression, obsessive-compulsive disorder, posttraumatic stress disorder, addiction disorders, and other psychiatric conditions, the company said in a statement. The system tracks patient movement during a session and adjusts the coil to guide targeted delivery and can be set up in under a minute in most clinical settings.

Guidance Finalized for Psychedelic Drug Development

Final FDA guidance on the design of clinical trials for psychedelic drugs for psychiatric and substance use disorders and other conditions was published in June. The guidance addresses functional unblinding, recommending that trials include blinded central raters, expectancy questionnaires, and alternatives to inert placebo. For chronic conditions such as major depressive disorder, the agency recommended investigators assess long-term treatment efficacy and monitor for symptom recurrence. The guidance — first proposed in 2023 — also sets expectations for safety monitoring and abuse potential assessment.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.