Psilocybin for Peripartum

1 paper and 1 clinical trial exploring psilocybin as a treatment for peripartum.

CompoundClassic Psychedelic

Psilocybin

Psilocybin is a naturally occurring tryptamine psychedelic that acts as a prodrug to psilocin, a potent 5-HT2A receptor agonist. It is the furthest advanced psychedelic in clinical development, with two positive Phase III trials in treatment-resistant depression and expanding regulated access in Australia, Germany, and US states.

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IndicationApproximately 15-20% of women experience postpartum depression worldwide.

Peripartum

Peripartum depression, including postpartum depression (PPD), is a significant mental health issue affecting new mothers, characterised by severe mood changes following childbirth. Current research into psychedelic treatments, particularly with compounds like esketamine and psilocybin, shows promising potential to alleviate depressive symptoms in this demographic.

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Academic Research

1 paper

Open Accessindividual

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous RE104: A Double-Blind, Randomized, Single Ascending Dose Placebo-Controlled Study

This double-blind, randomised, placebo-controlled Phase I study (n=48) evaluates the safety, pharmacokinetics, and psychoactive effects of RE104 (psilocybin analog; Luvesilocin; a prodrug of 4-OH-DiPT) in healthy adults with prior psychedelic experience. RE104 was well tolerated up to 40 mg with no serious adverse events, and plasma levels of its active form correlated with subjective drug effect and mystical experience scores. The compound produced psilocybin-like effects with a shorter duration (3-4 hours), supporting further therapeutic investigation.

Published: July 21, 2025
Journal: Journal of Clinical Psychopharmacology
Authors: Ludbrook, G., Bryson, N., Taylor, B., Hocevar-Trnka, J., Johnson, M. W., Hirman, J., Morrish, G., Alexander, R., Pollack, M.

Clinical Trials

1 trial

CompletedPhase I

A Double-Blind, Randomized, Placebo-Controlled Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Single, Ascending, Subcutaneous Doses of FT-104 HCl In Healthy Volunteers Safety, Tolerability, and Pharmacokinetics of Subcutaneous FT-104 HCl (SAIL-101)

Double-blind, randomised, placebo-controlled single-ascending subcutaneous dose PK and safety study in healthy volunteers (n≈48; cohorts of 8, 6 active + 2 placebo) of FT-104 HCl (psilocybin formulation).

Started: July 20, 2022
Type: interventional
Blinding: single
Randomized: Yes
Registry ID: ACTRN12622000713796

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Psilocybin for Peripartum

Psilocybin

Peripartum

Academic Research

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous RE104: A Double-Blind, Randomized, Single Ascending Dose Placebo-Controlled Study

Clinical Trials

A Double-Blind, Randomized, Placebo-Controlled Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Single, Ascending, Subcutaneous Doses of FT-104 HCl In Healthy Volunteers Safety, Tolerability, and Pharmacokinetics of Subcutaneous FT-104 HCl (SAIL-101)

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Psilocybin for Peripartum

Psilocybin

Peripartum

Academic Research

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous RE104: A Double-Blind, Randomized, Single Ascending Dose Placebo-Controlled Study

Clinical Trials

A Double-Blind, Randomized, Placebo-Controlled Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Single, Ascending, Subcutaneous Doses of FT-104 HCl In Healthy Volunteers Safety, Tolerability, and Pharmacokinetics of Subcutaneous FT-104 HCl (SAIL-101)

Explore further