Psychedelics at a Tipping Point: Phase 3 Wins, Big Pharma Bets & State Laws Move

A double-blind RCT of inhaled 5-MeO-DMT (GH001) in 81 treatment-resistant depression patients across 16 European sites found 57% remission vs. 0% placebo at 8 days; psychoactive effects lasted only 9–14 minutes, and 87% of initial remitters maintained remission at 6-month follow-up. No psychotherapy was paired with the drug.
A Johns Hopkins RCT (n=82) found a single high-dose psilocybin session plus CBT produced 40.5% 6-month smoking abstinence vs. 10% for nicotine patches. Key limitations: no blinding, 89% white, 65% with prior psychedelic experience.
COMPASS Pathways' second Phase 3 trial of COMP360 synthetic psilocybin (COMP006) met its primary endpoint in treatment-resistant depression, following the first Phase 3 success in February 2026. Two successful readouts now support an FDA submission pathway.
Q1 2026 also produced Phase 2a data for IV DMT (SPL026) showing significant MDD reduction; Helus Pharma is developing HLP004 based on SPL026 insights for generalized anxiety disorder.

A McGill-led mega-analysis in Nature Medicine pooled 11 independent fMRI datasets across 267 participants and 5 psychedelics (psilocybin, LSD, DMT, mescaline, ayahuasca), identifying a shared brain signature: increased functional connectivity between transmodal networks (default mode, frontoparietal, limbic) and unimodal networks (visual, somatomotor), plus altered subcortical-cortical coupling involving the thalamus, caudate, and putamen.
LSD and psilocybin showed near-identical connectivity profiles; DMT produced the strongest perturbations; ayahuasca was more idiosyncratic. Bayesian hierarchical modeling found within-network disintegration was weaker and more selective than prior single-site studies suggested.

Virginia Gov. Abigail Spanberger signed HB 1347 and SB 379, which will automatically reschedule FDA-approved psilocybin formulations under state law at the Board of Pharmacy's next quarterly meeting following federal scheduling action, applying specifically to clinician-administered formulations.
Connecticut's Senate passed SB 191 35–0, expanding its psilocybin/MDMA clinical trial program to all adults (previously limited to veterans and first responders), administered through a state medical school under an IRB, with the sunset clause tied to DEA approval removed. Bill heads to the House.
The Missouri House passed HB 1717 by 137–11 after four years of attempts, directing the Dept. of Mental Health to fund $2M in psilocybin and ibogaine research grants for veterans, first responders, and end-of-life patients. Ibogaine was added via floor amendment; bill advances to the Senate.
Utah passed HB 390 with bipartisan support authorizing a clinical research trial at the University of Utah using psilocybin, MDMA, and DMT for veterans with treatment-resistant PTSD; the bill is awaiting Gov. Spencer Cox's signature. Utah's veteran suicide rate is 50% above the national average.

Sen. Tim Sheehy (R-MT), with bipartisan co-sponsors Gallego (D-AZ), Duckworth (D-IL), and Boozman (R-AR), introduced SB 4220 to establish an Office of Novel Therapeutics within the VA, tasked with developing clinical standards, workforce training, and Centers of Excellence for psychedelic therapies ahead of FDA approval. The bill mandates coordination with FDA, HHS, CMS, DOD, and DEA and requires annual Congressional reporting.
After no drug company agreed to Texas's terms — which required an FDA approval plan, Texas corporate presence, a $50M match, and 20% revenue share — the state will proceed with state-funded ibogaine trials through UTHealth Houston and UTMB alone. Legal experts note statutory constraints may require legislative fixes to release the $50M without a private partner; total program costs are estimated above $100M. FDA cardiac safety concerns over ibogaine-associated arrhythmia and its Schedule I status remain unresolved.

Otsuka Pharmaceuticals acquired a $1.2B MDMA analog program, marking a significant Big Pharma commitment to the psychedelic space following Lykos Therapeutics' August 2024 FDA rejection for MDMA-assisted therapy in PTSD. Lykos continues conducting FDA-requested additional trials.
COMPASS Pathways and Definium are preparing NDA filings with COMPASS's two successful COMP360 Phase 3 readouts expected to anchor the first formal psilocybin NDA submission to the FDA.

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