Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous RE104: A Double-Blind, Randomized, Single Ascending Dose Placebo-Controlled Study.
Journal of clinical psychopharmacology July 21, 2025 Guy Ludbrook, Nathan Bryson, Beatrix Taylor et al. 2 citations
A single subcutaneous dose of RE104, a prodrug of the synthetic psychedelic 4-OH-DiPT, was generally safe and well-tolerated in 48 healthy adults with prior psychedelic experience. Doses from 5 to 40 mg produced no serious adverse events or deaths; most side effects were mild to moderate and occurred under supervision. The drug appeared rapidly in the blood, with peak levels reached in 1.0 to 1.25 hours and a half-life of 2.72 to 4.12 hours. Exposure increased proportionally with dose. Plasma levels correlated with drug effects and mystical experiences, and higher doses produced more complete mystical experiences. The psychoactive experience lasted 3 to 4 hours, shorter than psilocybin, suggesting a favorable therapeutic profile.