Health · Pharma & Biotech · 2 hrs ago
Usona seeks FDA approval for psilocybin depression treatment
Usona has applied to the US FDA to approve psilocybin for treating depression.
The nonprofit filed its request on Monday, and rival company Compass Pathways said it plans to apply within two weeks.
Psilocybin is a psychedelic first obtained from so-called magic mushrooms, and the proposed treatments use synthetic versions.
US approval could come by the end of 2026 or early 2027, though the FDA has not yet decided.
Depression affects more than 300 million people worldwide, and at least one-third of those with the condition do not improve with available antidepressants.
Clinical trials indicate that psilocybin may reduce symptoms quickly and that benefits may last after a single dose, but treatment requires specialist supervision.
The companies' competition over patents and sales could shape treatment prices and access if a drug is approved.
The Usona Institute formally asked the US Food and Drug Administration on Monday to approve psilocybin for treating depression.
Competitor Compass Pathways said the next day that it would submit its own application in two weeks.
The article says synthetic versions of psilocybin could be approved in the United States later this year or early in 2027.
The companies are expected to compete over commercialization and patents, which could affect treatment prices and access.
- Who
- The Usona Institute, a nonprofit founded by Bill Linton, submitted the request. Compass Pathways is a competitor planning its own application.
- What
- Usona asked the FDA for approval to use psilocybin to treat depression.
- When
- Monday, November 2, 2026.
- Where
- The United States; the request was made to the FDA.
- Why
- To make psilocybin available as a treatment for depression.
This story does not have two clearly opposing sides.
The Usona Institute formally submitted its request to the FDA for approval of psilocybin to treat depression.
Compass Pathways announced that it would submit its own application in two weeks.
- Applicant
- Usona Institute
- Regulator
- US Food and Drug Administration
- Treatment sought
- Psilocybin for depression
- Competitor
- Compass Pathways
- Possible approval window
- Later in 2026 or early 2027