FDA signals support for development of psychedelic therapies in mental healthmental health
pharmafile | April 28, 2026 | News story | |Â Â Neurology, mental healthÂ
The US Food and Drug Administration (FDA) has announced a series of measures aimed at supporting the development of psychedelic-based therapies for serious mental health conditions, following a recent executive order focused on improving access to treatment.
The actions include regulatory support for medicines targeting serotonin-2A receptors, a class of compounds being investigated for conditions such as treatment-resistant depression, post-traumatic stress disorder (PTSD) and alcohol use disorder.
According to the FDA, three companies developing therapies based on psilocybin and methylone will receive national priority vouchers intended to help accelerate development timelines. The agency has also cleared an early-phase clinical trial of noribogaine hydrochloride, a derivative of the psychoactive compound ibogaine, for the treatment of alcohol use disorder.
The Phase I study will assess the safety of noribogaine in a controlled clinical setting. The FDA noted that allowing the study to proceed does not indicate that the therapy is safe or effective, and that further evaluation will be required as data emerges.
The move comes amid growing interest in psychedelic therapies as potential options for patients with conditions that are difficult to treat with existing medicines. These include individuals with treatment-resistant depression or substance use disorders, where relapse rates remain high and treatment options are limited.
FDA Commissioner Marty Makary added that while these medicines show potential, their development must be supported by robust clinical evidence.
In parallel, the FDA said it would shortly publish final guidance for companies developing serotonin-2A agonists and related products. The guidance is expected to address challenges in trial design, patient monitoring and data collection, which are considered particularly complex for this class of therapies.
The agency said it will continue to review emerging data as part of its broader efforts to support the development of new treatments for mental health conditions.
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