The FDA Just Approved the First Clinical Trial for Psilocin

The FDA Just Approved the First Clinical Trial for Psilocin

Filament Health Corp. (OTCQB: FLHLF) (NEO: FH) just received FDA authorization to begin the first clinical trial using naturally sourced psychedelic substances. The phase 1 trial is led by the Translational Psychedelic Research Program (TrPR) at the University of California San Francisco (UCSF). The approval is for the direct administration of psilocin. The first trial will include 20 healthy subjects.

Psilocin Will be Administered Directly

Psilocybin needs to convert into psilocin to become active in the human body.

The psilocin will be given orally and/or under the tongue. The first phase examines the effects of Filament’s three proprietary botanical drug candidates: PEX010 (oral psilocybin), PEX020 (oral psilocin), and PEX030 (sublingual psilocin).

The New Method Could Yield Therapeutic Benefits

Filament’s trial looks to see if direct administration of psilocin could yield therapeutic benefits. Filament is looking to see if such administration could bring quicker onset times, increased consistency, better bioavailability, and lessened side effects.

FDA Psilocin

Photo by Diane Serik on Unsplash

“We are excited to announce this milestone as validation of our ability to cultivate variable psychedelic biomass and transform it into pharmaceutical-grade drug candidates. Our innovative technology has allowed us to create IP-protected botanical drug candidates of oral psilocin, sublingual psilocin, and oral psilocybin, and to enter them into an FDA-approved natural psychedelic clinical trial. Our candidates enjoy significant IP protection, unlike most other psychedelics currently under clinical investigation.”

Chief Executive Officer, Benjamin Lightburn

Filament Health is an All-Natural Company

Filament Health is a drug discovery and extraction technology company. Their goal is to treat mental health conditions through FDA-approved psychedelic extracts. Psilo Scientific, a subsidiary of Filament, will grow and harvest lab-grown and regeneratively harvested plants. The extracts will come from these plants.

FDA Psilocin

Photo by National Cancer Institute on Unsplash

“My team and I are very excited to begin dosing Filament’s drug candidates in our clinic. The oral and sublingual administration presents an opportunity to learn about psilocin’s effects compared to psilocybin and perhaps set a new standard for psychedelic-assisted therapy.”

Dr. Josh Woolley, MD/Ph.D., Director of TrPR and the study’s Principal Investigator

However, not a single synthetic manufacturer has produced a stable formulation of psilocin for a clinical trial. That being said, Filament Health is a leading, exclusively natural psychedelic drug development company.

For more information about psilocin visit, https://filament.health/psilocybin-vs-psilocin/.

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