Drug Development

Psilocybin

Current Psilocybin Clinical Trials

PSIL201

This is the first Phase 2, randomized, double-blind, placebo-controlled study of single-dose psilocybin to treat major depressive disorder. The study is designed around a non-directive, supportive psychotherapeutic framework, prioritizing set and setting.

Usona’s Psilocybin for MDD clinical trial, PSIL201 is currently closed to enrollment. We are currently analyzing the data of this study and look forward to sharing results with you once available.

For more information, please see ct.gov.

PSIL201 LTFU

The PSIL201 Long Term Follow Up (LTFU) study is a 1 year observational follow up study of participants to assess symptoms of major depressive disorder at 6 months post intervention in participants treated with a single-dose of either psilocybin or niacin (active-controlled) in the PSIL201 study.

For more information, please see ct.gov.

PSIL102 TQT

The PSIL102 TQT study is a safety study evaluating a supratherapeutic dose of psilocybin on cardiac repolarization in healthy volunteers.

This study is currently open to enrollment.

For more information, please see ct.gov.

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.