The Food and Drug Administration has greenlighted the use of the psychedelic ingredient in “magic” mushrooms for a drug trial to treat depression.
The federal agency gave the U.S. approval to London-based life sciences startup called Compass Pathways that launched in 2016 under the backing of billionaire Peter Thiel.
Regulatory approvals for the trial have already been given in the U.K., the Netherlands and Canada.
The trial is expected to be a phase IIB dose-ranging study involving 216 patients in 12 to 15 research sites across Europe and North America. The tests will begin in the U.K. later this month and sites in other countries will kick off as soon as regulatory approvals are received.
For years, many psychedelic scientists have been theorizing that hallucinating on so-called magic mushrooms could possibly reboot the brain and clear out negative thoughts that may contribute to depression.
Compass Pathways says psilocybin therapy, which combines a dose of psilocybin, a psychoactive medicine and the active ingredient in “magic mushrooms,” with psychological support has shown promising signals of efficacy and safety as a treatment for depression in academic studies in both the U.K. and U.S.
If the trial is successful, the company said it will be followed by phase III studies.
“Depression is the leading cause of ill-health and disability worldwide, and treatment-resistant depression affects more than 100 million people. It is a huge unmet need and the trial will teach us more about how this new approach might address it,” George Goldsmith, chairman and co-founder of Compass Pathways said in a statement.
Ekaterina Malievskaia, chief medical officer and co-founder of the company, added that the study has been a collaborative effort with scientists, clinicians, patient representatives and regulators from all over the world.
Thiel, who invested an undisclosed amount in 2016, was one of the company’s first high-profile backers.