Phase 3 Study of Psilocybin for Major Depressive Disorder (MDD)

Usona Institute has completed enrollment of its Phase 3 study, "A Phase 3, Randomized, Double-Blind, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Psilocybin in Adults With Major Depressive Disorder (MDD).

PSIL201

This Phase 2, randomized, double-blind, placebo-controlled study evaluated the safety and efficacy of a single dose of psilocybin to treat major depressive disorder. Psilocybin treatment was administered with psychosocial support, prioritizing optimal set and setting for study participants.

View the Study Results

PSIL102

This Phase 1, two-part study evaluated two important clinical pharmacology questions:

1) Does psilocybin have the potential to delay cardiac repolarization (i.e., prolong the QT interval)?

2) Does consuming a meal prior to administration of psilocybin affect drug absorption?

Breakthrough Therapy Designation

The FDA describes Breakthrough Therapy designation as “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).“ In 2019, the FDA granted Breakthrough Therapy designation to Usona’s Investigational New Drug application for psilocybin as a potential treatment for major depressive disorder.

Expanded Access Policy

We do not offer expanded access at this time.

Psilocybin Overview

Usona has chemically synthesized psilocybin – a naturally occurring compound found in numerous species of Psilocybe mushrooms. For centuries, Indigenous peoples have used these mushrooms for spiritual and cultural purposes.

Psilocybin is known as a “classic psychedelic.”

Classic psychedelics, typically understood to be 5-HT2 agonists such as psilocybin and LSD, can cause intense perceptual changes and an altered state of consciousness that can last for several hours.

Psilocybin Metabolism

When ingested, the phosphate group in the psilocybin molecule is metabolized to produce psilocin, a tryptamine alkaloid with psychoactive effects.

Psilocybin is an investigational drug that has not been approved by the U.S. Food and Drug Administration. Its safety and efficacy have not been established.

Drug Development

Psilocybin