MDMA

Schedule I in US; FDA rejected Lykos NDA August 2024; Transcend/Otsuka methylone analog in Phase 3

MDMA (3,4-methylenedioxymethamphetamine) is an entactogen under investigation for PTSD treatment. Lykos Therapeutics' application for FDA approval was rejected in August 2024. Related compound methylone (via Transcend Therapeutics, acquired by Otsuka in March 2026) is in Phase 3.

Event stream

2026-03-31 retraction
Three Lykos MDMA therapy papers retracted from Psychopharmacology our coverage
2026-03-31 retraction
Three Lykos MDMA therapy papers retracted from Psychopharmacology our coverage
2026-03-27 acquisition
Otsuka acquires Transcend Therapeutics for up to 1.225B our coverage
2026-03-27 acquisition
Otsuka acquires Transcend Therapeutics for up to 1.225B our coverage

Coverage

Week in Review: The EPIsoDE Trial, a $1.2B Acquisition, and the State of State Policy 2026-04-03 Otsuka Pays $1.2 Billion for Methylone Developer Transcend 2026-03-31 Psychopharmacology Retracts Three Lykos MDMA Papers 2026-03-31 Trial Tracker: What's Moving in Early 2026 2026-03-30 Where MAPS Is Now 2026-03-30

Related

Lykos TherapeuticsMAPS (Multidisciplinary Association for Psychedelic Studies)MDMA-Assisted TherapyFDA