MDMA (the active ingredient in ecstasy) got rejected by the FDA in 2024 and needs more data before resubmission. Psilocybin (magic mushrooms' active compound) is years away from even applying for approval. Congress hasn't passed any bills to reschedule these drugs federally. Every pathway to approval or rescheduling hits a wall before 2027.
MDMA NDA (Lykos/MAPS): FDA issued a Complete Response Letter in August 2024; resubmission faces supplemental data requirements and a hostile advisory committee posture. No resubmission date is confirmed. Psilocybin: no NDA filed; earliest possible approval is 2028+. Ibogaine analogs: Phase 2 stage at best. Congressional rescheduling: no bill has passed committee. Every approval pathway has at least one active blocking condition. The resolve date of 2026-12-31 subsumes the earlier 2026-07-31 duplicate prediction (item 4 below), making that item redundant. Confidence set at 0.82: the only realistic surprise path is an accelerated MDMA resubmission accepted under a new FDA leadership posture, assessed as low-probability.