Psychedelics could be FDA-approved this summer

Trump signed Executive Order 14237 ("Accelerating Medical Treatments for Serious Mental Illness") on April 18, directing FDA priority review of psychedelics with Breakthrough Therapy designation and Attorney General review for expedited Schedule I-to-III rescheduling for any substance completing Phase 3 and receiving FDA approval (as reported last issue, the signing had been expected imminently).
The FDA's April 24 announcement issued Commissioner's National Priority Vouchers to COMPASS Pathways (COMP360 psilocybin/TRD), Usona Institute (psilocybin/MDD), and Otsuka/Transcend (methylone/PTSD), plus cleared DemeRx NB's IND for a Phase 1 study of noribogaine (ibogaine's active metabolite, non-hallucinogenic) for alcohol use disorder — the first FDA-authorized clinical study of an ibogaine derivative in the U.S. CNPVs compress NDA review from ~10–12 months to 1–2 months; Eli Lilly's orforglipron was approved in 50 days via the same program.
Psychedelic Alpha notes Resilient Pharmaceuticals' MDMA program did not receive a CNPV, consistent with FDA preference for new submissions over resubmissions following Resilient's (formerly Lykos) August 2024 Complete Response Letter. Otsuka's methylone (TSND-201) is entering Phase 3 — the least mature of the three recipients.
FDA Commissioner Makary told NBC News the first psychedelic approval could come "as soon as this summer"; Scientific American reports RFK Jr. is driving the internal acceleration at FDA.

The EO directs the Attorney General to initiate Schedule I review for any substance completing Phase 3 — beginning the process before final FDA approvability determination, potentially shaving months from the post-approval scheduling delay.
FDA and DEA are directed to establish a Right to Try access pathway for psychedelics, including Schedule I handling authorizations for eligible patients — a novel route outside standard IND or compassionate use processes, per Foley & Lardner. Ibogaine does not yet qualify: the Right to Try Act requires at least one completed Phase 1 trial.
The Transmitter reports the EO targets clinical access, not basic research: only ~900 U.S. researchers hold Schedule I licenses vs. 8,700 for Schedule II–V; rescheduling psilocybin to III would substantially broaden this pool. Counterweight: DEA is concurrently pursuing adding 5-HT2A research proxies DOI and DOC to Schedule I, which would eliminate a major regulatory workaround used by basic neuroscience labs.
HHS announced funded teams for ARPA-H's $139M EVIDENT behavioral health initiative, implementing the EO's mandate to direct at least $50M to state and research programs advancing psychedelic therapies for serious mental illness.

A UCLA-led pilot (n=16) in Journal of Affective Disorders embedded two psilocybin sessions (10 mg then 25 mg) within a 12-session manualized CBT protocol for moderate MDD over 4 months. 9/16 (56%) achieved full remission, sustained at 3-month follow-up; improvement correlated with gains in emotion regulation and cognitive schema change, suggesting synergistic rather than additive effects with CBT.
A University of Victoria analysis of 6,100 Global Psychedelic Survey responses identified 208 participants reporting psychedelic use (primarily psilocybin) for TBI symptoms including cognitive deficits, mood disturbance, and headaches. 90% self-reported at least some improvement — the first human-participant study on psychedelics for TBI; prior data is almost entirely from animal models.
A Nature Mental Health survey of 158 PAT therapists found the strongest favorable outcome predictors were therapeutic alliance, social support, openness, and secure attachment; prior non-psychedelic substance use was the strongest unfavorable predictor. Psilocybin therapists rated preparation and therapeutic presence more highly than ketamine therapists.

A Basel group double-blind crossover trial (n=24) in Neuropsychopharmacology compared three 2C-B doses (10/20/30 mg), MDMA (125 mg), and psilocybin (25 mg) within the same healthy participants — the first direct within-subjects comparison of MDMA and psilocybin at therapeutically relevant doses. 30 mg 2C-B produced entactogenic and prosocial effects comparable to MDMA and psychedelic-type alterations comparable to psilocybin, with lower cardiovascular stimulation than both and shorter duration (~5 h vs. 6.1 h for psilocybin).
Psilocybin was the only compound producing "bad drug effects" and anxiety vs. placebo; only MDMA elevated plasma oxytocin and neurophysin I, indicating its empathogenic effects are oxytocin-mediated while 2C-B's are not. Despite comparable "good drug effect" scores between MDMA and psilocybin, participants never misidentified one as the other — confirming distinct subjective profiles beneath similar positive-effect ratings.

Utah Gov. Spencer Cox signed HB 390, formally authorizing a state-funded clinical trial using psilocybin, MDMA, and DMT for veterans with treatment-resistant PTSD at the University of Utah. (The bill had been awaiting signature as of the April 10 issue.)
Louisiana's House advanced a bill to create a state-run psychedelic therapy research initiative through the Department of Health, authorizing clinical trials with psychedelic compounds under state oversight.

Get Psychedelic Therapy in your inbox