psilocybin sublingual (HLP001) / Helus Pharma - LARVOL DELTA

A randomized crossover trial comparing the acute physiological and psychological effects of botanical formulations of oral psilocybin, oral psilocin, and sublingual psilocin. (PubMed, J Psychopharmacol) - P1 | "Oral psilocin may offer tolerability advantages over oral psilocybin. Sublingual psilocin was well tolerated at the dosages tested. Further studies are needed to evaluate botanical formulations and optimize delivery approaches.Clinical trial registration: https://clinicaltrials.gov/study/NCT05317689."

Journal • Psychiatry

Comparing the Effects of Psilocin and Psilocybin in Healthy Adults (clinicaltrials.gov) - P1 | N=20 | Active, not recruiting | Sponsor: University of California, San Francisco | Trial completion date: Mar 2025 ➔ Jul 2025

Trial completion date

Comparing the Effects of Psilocin and Psilocybin in Healthy Adults (clinicaltrials.gov) - P1 | N=20 | Active, not recruiting | Sponsor: University of California, San Francisco | Recruiting ➔ Active, not recruiting

Enrollment closed

Comparing the Effects of Psilocin and Psilocybin in Healthy Adults (clinicaltrials.gov) - P1 | N=20 | Recruiting | Sponsor: University of California, San Francisco | Trial completion date: Dec 2024 ➔ Mar 2025 | Trial primary completion date: Dec 2024 ➔ Mar 2025

Trial completion date • Trial primary completion date

Comparing the Effects of Psilocin and Psilocybin in Healthy Adults (clinicaltrials.gov) - P1 | N=20 | Recruiting | Sponsor: University of California, San Francisco | Not yet recruiting ➔ Recruiting

Enrollment open

Comparing the Effects of Psilocin and Psilocybin in Healthy Adults (clinicaltrials.gov) - P1 | N=20 | Not yet recruiting | Sponsor: University of California, San Francisco

New P1 trial

Cybin Becomes First Psychedelics Company On The NYSE: CEO Explains Everything You Need To Know (Yahoo Finance) - "In May, Cybin received approval to launch a phase 2a clinical trial that will test the company's formulation against a 25mg psilocybin capsule on 40 patients....If successful, the research will continue in a Phase 2b trial on 120 patients, where the safety and efficacy of the product will be assessed. With the sublingual film, the company is hoping to see a rapid onset of action and possibly a shorter duration because bypassing the liver means using far less active substances to achieve the same effects. This thesis will be tested in the Phase 2a trial, which should output its result by the end of the year."

P2a data • CNS Disorders • Depression • Major Depressive Disorder

Cybin Granted IRB Approval for Phase II Clinical Trials of its Sublingual Psilocybin Formulation for the Treatment of Major Depressive Disorder (Businesswire) - "Cybin...announced that the Institutional Review Board ('IRB') at the University of the West Indies Hospital, in Jamaica has granted approval to commence the study of its sublingual psilocybin formulation ('CYB001') in a Phase II clinical trial for patients suffering with Major Depressive Disorder ('MDD'). Commencement of the clinical trial is subject to final confirmation of study material specifications by Jamaica’s Ministry of Health."

New P2 trial • CNS Disorders • Depression • Major Depressive Disorder