Psychedelics 2025: Breakthrough treatments - complex regulations
Psychedelics in 2025: Psychedelic medicine in the US has reached a crucial inflection point as of May 2025, with ketamine firmly established in mainstream treatment, psilocybin progressing toward potential FDA approval, and MDMA facing regulatory setbacks. Ketamine received expanded FDA approval as monotherapy for treatment-resistant depression in January 2025, while psilocybin therapy is accessible through licensed service centers in Oregon and Colorado with COMPASS Pathways' Phase 3 trial results expected by mid-2025. MDMA faces additional years of development after the FDA rejected Lykos Therapeutics' application in August 2024.