Current Psilocybin Clinical Trials
Breakthrough Therapy Designation
Per the FDA, “breakthrough therapy designation is a process designed to expedite the development and review of drugs that are intended to treat a serious condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s).“
Expanded Access Policy
We do not offer expanded access at this time.
Clinical Research of Psilocybin
Clinical use began after Swiss chemist Dr. Albert Hoffman first isolated and synthesized psilocybin in the late 1950s. The next decade saw Sandoz, Ltd. market their drug Indocybin™ worldwide for experimental and psychotherapeutic use.
More than 1,000 papers exploring the effects of classic psychedelics were published in the 1970s. However, ongoing concerns around widespread non-medical use led to psilocybin being placed in the Controlled Substance Act Schedule I category in 1970. This effectively removed it from clinical use or scientific study for the next several decades.
Today, psilocybin remains a controlled substance globally. However, contemporary studies show promise for psilocybin administered in a supportive psychotherapeutic context.