Research · United States
After the MDMA rejection: how psychedelic developers are rethinking their trials
Science magazine examines the regulatory lessons every psilocybin and ibogaine sponsor is now trying to absorb.
Science's deep dive on the post-Lykos psychedelic landscape walks through what other sponsors — Compass Pathways, Usona, atai, MindMed — are changing in their pivotal trial designs to avoid the same fate. The throughline is blinding, real-world functional unblinding, and how to prove a drug works when patients almost always know they got it.
The piece is honest about the structural tension: the very intensity that may make psychedelics therapeutic is also what makes them nearly impossible to test against placebo by the conventional FDA playbook.
Read Science's full investigation for the regulatory and design specifics.
Mental Hum is a reading list, not a publisher. The summary above is our own editorial framing; the reporting and analysis live at the source.
If reading this brought something up for you —
Call or text 988 for the Suicide & Crisis Lifeline. See all crisis resources.