PHARMA · RESEARCH

Cryo-EM structures show ketamine physically docking into opioid receptors

A Washington University team solved six cryo-EM structures showing ketamine and PCP bound directly inside the same pocket opioid drugs occupy, not adjacent to it. The finding gives years of behavioral and pharmacological evidence linking ketamine to opioid receptors a direct molecular basis, and it revises a specific claim from the field's own foundational paper on the question.

Research

A trial can be complete years before anyone outside the sponsor knows what it found

Across this desk's coverage this year, CNS and psychiatric trials have repeatedly appeared as completed in registry records while their results remained publicly unavailable. That gap has a name, a legal deadline attached in some cases and none in others, and a compliance record that varies by a factor of five depending on who ran the study. None of it means a trial failed. Almost none of it means nothing.

regulation

Puerto Rico opens a research-policy review on psychedelics and ibogaine. It has not approved any clinical use.

Executive Order 2026-037 creates a scientific advisory committee to study whether Puerto Rico should build a pilot clinical research program for emerging therapies, including psilocybin, MDMA, and ibogaine, with veterans named as a priority population. The order explicitly does not authorize any clinical use of these compounds, a distinction worth stating plainly before the headline runs ahead of it.

The desks

Pharma

The largest ketamine data set for fibromyalgia yet shows durable relief in a third of patients

Fibromyalgia sits entirely outside ketamine's labeled indications, and formulary and prior-authorization decisions for this off-label use have rested on studies of 34 patients or fewer. A new 92-patient retrospective with two years of follow-up is the largest and longest such dataset yet, and it shows both a durable benefit for some patients and a hard ceiling on how many respond at all.

More from pharma
Psychedelics

Oregon's psilocybin program has real evidence now. Regulators may still price it out.

The first peer-reviewed safety and outcomes data from a state-licensed psilocybin program shows strong results: most participants reported benefit, few serious adverse events, and real symptom reductions at three months. The data arrives in the middle of an Oregon Health Authority rulemaking process weighing fee increases that operators say could shut the program down.

More from psychedelics
Cannabis

The federal government drew a chemical line through kratom, by potency, not a blanket ban.

DEA and HHS have moved to temporarily schedule concentrated 7-hydroxymitragynine while explicitly leaving natural kratom leaf alone, using a numeric potency threshold instead of a categorical ban. Where that threshold finally lands, and how it is measured, will determine how much of the existing kratom market ends up scheduled; the public comment window on it closed July 31.

More from cannabis
Digital health

NAMI is building an evaluation standard AI mental health chatbots don't have yet

No regulator currently certifies whether an AI chatbot is safe to use for mental health support. NAMI's expanded partnership with digital psychiatry researcher John Torous, and the live MindBench.ai platform it has already produced, is building that evaluation infrastructure directly, ahead of any formal regulatory framework.

More from digital health

Pipeline

Key programs currently tracked across behavioral health markets · scroll →

Last updated Aug 12, 2026

Approved

Zuranolone (Zurzuvae)

Postpartum depression

Supernus (Biogen collaboration) Marketed for PPD; MDD rejected

Updated Apr 18, 2026

Approved

AXS-05 (Auvelity)

Major depressive disorder

Axsome Therapeutics Marketed

Updated May 9, 2026

Approved

Esketamine (Spravato)

Treatment-resistant depression

Johnson & Johnson Monotherapy label cleared

Updated Feb 27, 2026

Approved

Cobenfy (xanomeline-trospium)

Schizophrenia

Bristol Myers Squibb ARISE adjunctive missed; Alzheimer's trials ongoing

Updated May 15, 2026

Approved

Centanafadine (SIMTRIYO)

ADHD (adults and children 6+, at least 20 kg)

Otsuka FDA-approved July 2026 (first-in-class NDSRI); DEA scheduling pending before launch

Updated Jul 24, 2026

Phase 3

Navacaprant (NMRA-140)

Major depressive disorder

Neumora Therapeutics KOASTAL-2/-3 missed; development discontinued

Updated Jun 15, 2026

Phase 2

Emraclidine

Schizophrenia

AbbVie (Cerevel) Phase 2 failed; program written down

Updated Jan 22, 2026

Phase 3

COMP360 psilocybin

Treatment-resistant depression

Compass Pathways Phase 3 complete; rolling NDA underway

Updated Jul 8, 2026

Phase 3

DT120 (lysergide ODT)

Major depressive disorder

Definium Therapeutics (formerly MindMed) Phase 3 positive; second trial enrolling

Updated Jun 23, 2026

Phase 3

DT120 (lysergide ODT)

Generalized anxiety disorder

Definium Therapeutics (formerly MindMed) Phase 3 positive (Voyage); second pivotal (Panorama) reads out Sept 2026

Updated Aug 12, 2026

Phase 3

MDMA-assisted therapy

PTSD

Resilient Pharmaceuticals (formerly Lykos) Pivotal trials complete; regulatory path unresolved

Updated Jun 6, 2025

Phase 3

HLP003 (deuterated psilocin)

Major depressive disorder

Helus Pharma (formerly Cybin) Breakthrough designation; Phase 3 APPROACH topline expected 2H 2026

Updated Jul 2, 2026

Phase 2

GH001 (inhaled mebufotenin)

Treatment-resistant depression

GH Research Phase 2 positive

Updated Mar 5, 2026

Phase 3

BPL-003 (intranasal mebufotenin)

Treatment-resistant depression

AtaiBeckley Phase 3 initiated; Lilly acquisition announced

Updated Jul 16, 2026

Phase 2

Luvesilocin (RE104)

Postpartum depression

Reunion Neuroscience Breakthrough designation; Phase 3 planned for 2026

Updated Feb 23, 2026

Phase 3

TSND-201 (methylone)

PTSD

Otsuka (formerly Transcend Therapeutics) Phase 3 underway; IMPACT-1 Phase 2 positive; acquired by Otsuka June 2026

Updated Jun 12, 2026

Approved

Epidiolex (cannabidiol)

Epilepsy; behavioral indications explored

Jazz Pharmaceuticals Additional indications under study

Updated Feb 14, 2026

Phase 3

Zygel (CBD transdermal gel)

Fragile X syndrome

Harmony Biosciences RECONNECT readout; FXS program phased out

Updated Feb 24, 2026

Approved

Rejoyn

Major depressive disorder (adjunct)

Otsuka / Click Therapeutics First FDA-cleared MDD app

Updated Apr 4, 2026

Phase 3

CT-155

Schizophrenia (negative symptoms)

Click Therapeutics (Boehringer Ingelheim) CONVOKE Phase 3 positive; commercialization transferred to Click

Updated Apr 9, 2026

Approved

Sleepio / Daylight

Insomnia and anxiety

Big Health Marketed digital therapeutics

Updated Jan 12, 2026

Analysis

PSYCHEDELICS · ANALYSIS

Psilocybin's next indication frontier may be pain. The programs chasing it are not testing the same thing.

Cancer pain, chronic pelvic pain, phantom limb pain, fibromyalgia, migraine: psilocybin trials are now running across a genuinely wide swath of chronic pain medicine. Nearly all of them share the same structural weakness, a pain-scale endpoint that cannot tell whether the drug changed the pain itself or changed how much the pain bothers the patient. That distinction is the entire story.

PSYCHEDELICS · ANALYSIS

Real-world psilocybin data is starting to arrive. It looks a lot more like an SSRI than a breakthrough.

A retrospective study of 19 patients treated under Switzerland's limited medical-use exemption is among the first real-world psilocybin outcome data generated outside a clinical trial. The response and remission rates land close to what ordinary antidepressants achieve in real-world use, not the dramatic figures the field's early trials reported.

DIGITAL HEALTH · ANALYSIS

At-home ketamine's largest dataset reports strong results. Six of seven authors are paid by the company it studies.

A retrospective analysis of 3,041 Mindbloom patients reports high rates of clinical improvement from at-home subcutaneous ketamine, a genuinely under-studied delivery route. The topline numbers are real. So is the conflict of interest, the near-total attrition by the final assessment, and the gap between the headline improvement rate and the much lower remission rate underneath it.

Intelligence

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