Imminent Approval of Psilocybin

In the last few years, we have seen a flurry of research activity and momentum building for psilocybin treatments to address unmet patient needs. We are starting to see innovation in application methodology, a steady stream of clinical studies, and growing investments across the industry. 

Psilocybin Studies

Currently, psilocybin is a Schedule I drug classified by the FDA, meaning that there is no acceptable medical use, but there are seventy-five studies listed on clinicaltrials.gov, some in as late of a stage as Phase IV, so FDA-approval seems to be imminent. One such company, Florida-based Psilera, is currently receiving funding to prepare for the legalization of psilocybin.

Indications and Patents

Unlike the other compounds we’ve discussed in previous blog posts, (ketamine, MDMA) psilocybin has an expansive list of indications that are being studied including anorexia nervosa, nicotine dependence, alcohol use disorder, and many more. This catalog of potential indications equals opportunity for drug development. While we know that psilocybin can be grown, it’s important to note that natural products vary substantially – so the FDA-approved version will most likely be synthetic. Although psilocybin is a natural compound and therefore cannot be patented, biotech companies will be developing their own synthesis processes and delivery methods to apply for patents.

Application Ingenuity

Psilera, mentioned earlier, is working with various partners to develop patient-friendly administration types. A patent-pending transdermal patch containing dimethyltryptamine is presently in a Phase IV clinical trial. Innovative delivery methods such as these transdermal patches of a natural psychoactive substance could lead to a revolutionary new line of psychiatric medicines.

Research Sponsorship

A good portion of the sponsorship for research is coming from Compass Pathways, who raised an additional $144 million in April 2021 after securing an initial $146 million in September 2020. The company was formed back in 2016 is listed on the Nasdaq as CMPS and is currently hovering around a market capitalization of $1.24 billion USD. Compass Pathways is committed to accelerating patient access to innovative mental health therapies like psychedelics. In addition to sponsoring clinical trials, Compass Pathways also offers a therapist training program.

Future Potential

All though psilocybin is currently an FDA Schedule I drug, the extensive list of potential indications and the number of studies in progress are very promising. A number of inventive approaches have already been developed and investors are backing psilocybin innovators. This all comes off the momentum of increasing public support as evident by numerous cities across four states – CA, CO, MA and OR – who have decriminalized the substance.