If you live with severe PTSD or depression that hasn't lifted after years of treatment, you may have read that MDMA- or psilocybin-assisted therapy is "almost here." Then you look for it and find it is still out of reach.
Access to psychedelic therapy is limited less by the science than by how these substances are classified. Psilocybin and MDMA are still in Schedule I of the UN's 1971 Convention on Psychotropic Substances, the category for substances judged to have very limited, if any, medical use. That listing is older than the current clinical trials, and it still shapes what national regulators feel they can allow.
This month, the European Platform for Integration of MDMA in Mental Health Care (EPIC), where I lead clinical implementation and training, sent a written submission to the UN expert panel reviewing the international drug control system. Below is what we argued, and what it could mean for patients.
Why is psychedelic therapy so hard to access?
Mainly because psilocybin and MDMA are still classified internationally as having little or no medical value, even as trials report benefit.
The 1971 Convention has two aims: to make controlled substances available for medical and scientific purposes, and to prevent their diversion and misuse. For psychedelic medicines, the second aim has dominated. Every research shipment needs import and export permits, every study needs special licenses, and many health authorities read Schedule I as a simple "no."
The trial evidence has kept moving. In a phase 3 trial of 104 people with moderate to severe PTSD, 71.2% of those who received MDMA-assisted therapy no longer met criteria for PTSD, compared with 47.6% of those who received the same therapy with a placebo. In a trial of 233 people with treatment-resistant depression, a single 25 mg dose of psilocybin, given with psychological support, reduced depression scores more than a 1 mg dose after three weeks. You can read more about the PTSD research in my post on how MDMA-assisted therapy is changing PTSD treatment.
Where do MDMA and psilocybin therapy stand in 2026?
Both treatments are now before the US Food and Drug Administration (FDA), and a few countries have already opened limited legal access.
Psilocybin for treatment-resistant depression. Compass Pathways is submitting its application to the FDA on a rolling basis, with a priority voucher that can shorten review. The company expects a US launch in the first half of 2027, if the FDA approves it and the Drug Enforcement Administration reschedules psilocybin.
MDMA for PTSD. The FDA declined the first application in August 2024 and asked for more data. Resilient Pharmaceuticals, formerly Lykos Therapeutics, resubmitted it in August 2026.
Australia. Since 1 July 2023, authorized psychiatrists can prescribe MDMA for PTSD and psilocybin for treatment-resistant depression.
Czech Republic. Since 1 January 2026, the law has allowed therapeutic psilocybin in specialized healthcare facilities, with treatment expected to begin once funding rules are settled.
In the US, psilocybin and MDMA remain illegal under federal law, and in New York, outside approved research. Dozens of other psychedelic drug programs are now in clinical trials, many of them based on Schedule I substances.
What did EPIC ask the UN expert panel to change?
We asked the panel to make the treaties' medical purpose work in practice for mental health care, using flexibility the treaties already contain. Article 7 of the 1971 Convention already allows Schedule I substances to be used for limited medical purposes by authorized people in approved settings; Australia and the Czech Republic have used it.
Our five recommendations, in brief:
Recognize the unmet need. As many as two-thirds of veterans who receive the leading psychotherapies for PTSD keep their diagnosis after treatment, and only about a third of people with depression reach remission on their first antidepressant. We asked UN bodies to include psychiatric conditions in their work on access to controlled medicines, with priority for countries carrying heavy burdens of war trauma, including Ukraine.
Update the science behind the schedules. We asked the World Health Organization to review psilocybin, MDMA and similar substances against current trial evidence, and to start a review automatically whenever a controlled substance reaches late-stage trials or national approval anywhere.
Make research rules proportionate. Schedule I status adds months and cost before a single patient is treated. We asked for licensing for approved clinical research to be no more burdensome than for Schedule II drugs, and for faster import and export permits for trial supplies.
Learn from access programs without adding barriers. Countries that open access should report safety and diversion data through their existing monitoring systems, so evidence of safe use can inform future decisions without delaying patients.
Include harm reduction. Many people use these substances outside clinical settings. We asked for drug checking, peer and crisis support, and psychological integration services to be recognized as part of a balanced system of care.
What does this mean if you're hoping for psychedelic therapy?
International reviews move slowly. None of this makes psilocybin or MDMA legal outside approved research or programs. Over the coming years, it could affect how quickly treatments that pass national review reach the people who need them.
A submission is a recommendation, not a decision. The panel and the Commission on Narcotic Drugs may adopt some, all, or none of it. FDA approval in the US is not guaranteed, and even approved treatments will likely be delivered in specialized settings, at first to a limited number of patients. Psychedelic therapy is not right for everyone; people with certain medical or psychiatric histories may be advised against it.
If you are living with trauma or depression that hasn't responded to treatment, trauma-focused therapy can be worth revisiting with a clinician who knows the newer options. If you have had psychedelic experiences, in a trial, a retreat, or on your own, psychedelic integration therapy is a place to make sense of them.
How I work with this
I'm Ingmar Gorman, PhD, a clinical psychologist licensed in New York who offers telehealth psychotherapy and psychedelic integration therapy. I have served as a clinical trial investigator in psychedelic treatment research, co-founded Fluence, where I led psychedelic therapist training from 2019 to 2025, and lead clinical implementation and training at EPIC.
I don't provide psychedelics or advice on sourcing or dosing. I work with people living with trauma and depression, and with people making sense of psychedelic experiences, wherever they are in that process.
Frequently asked questions
Why are psilocybin and MDMA in Schedule I?
They were placed in Schedule I of the 1971 UN Convention on Psychotropic Substances, the category for substances judged to have very limited, if any, medical use. Those listings predate the modern clinical trials of psilocybin and MDMA as treatments.
Is MDMA-assisted therapy for PTSD approved in the US?
Not yet. The FDA declined the first application in August 2024, and Resilient Pharmaceuticals, formerly Lykos Therapeutics, resubmitted it in August 2026. Outside approved research, MDMA remains illegal under US federal law.
When might psilocybin therapy be available in the US?
Compass Pathways expects to launch its psilocybin treatment for treatment-resistant depression in the first half of 2027. That depends on FDA approval and on the Drug Enforcement Administration rescheduling psilocybin.
Where is psychedelic therapy legal today?
Australia has allowed authorized psychiatrists to prescribe MDMA for PTSD and psilocybin for treatment-resistant depression since July 2023. The Czech Republic has allowed therapeutic psilocybin in specialized healthcare facilities since January 2026. In New York, psilocybin and MDMA remain illegal outside approved research.
Can a therapist help if I'm interested in psychedelic therapy?
Yes. A therapist trained in psychedelic integration can help you think through whether these treatments might suit you, prepare for a clinical trial, or make sense of a past experience. A therapist should not supply psychedelics or advise on sourcing or dosing.
Talk it through
If you are living with trauma or depression, or want to talk through a psychedelic experience, I offer telehealth sessions for adults residing in New York State. Book a free 30-minute consultation.
This post is for educational purposes only. It is not medical or legal advice and is not a substitute for individual care.
References
European Platform for Integration of MDMA in Mental Health Care (EPIC). Making the medical purpose of the 1971 Convention work for mental health care: written contribution to the Expert Panel established pursuant to Commission on Narcotic Drugs resolution 68/6. October 2026. https://epicmentalhealth.eu
Convention on Psychotropic Substances, 1971. United Nations.
Mitchell JM, et al. MDMA-assisted therapy for moderate to severe PTSD: a randomized, placebo-controlled phase 3 trial. Nature Medicine. 2023;29:2473-2480. https://psychiatry.ucsf.edu/news/mdma%E2%80%99s-latest-trial-results-offer-hope-patients-ptsd
Goodwin GM, et al. Single-dose psilocybin for a treatment-resistant episode of major depression. New England Journal of Medicine. 2022;387:1637-1648.
Steenkamp MM, et al. Psychotherapy for military-related PTSD: a review of randomized clinical trials. JAMA. 2015;314:489-500. https://nyulangone.org/news/cures-ptsd-often-remain-elusive-war-veterans
Rush AJ, et al. Acute and longer-term outcomes in depressed outpatients requiring one or several treatment steps: a STAR*D report. American Journal of Psychiatry. 2006;163:1905-1917.
Compass Pathways. Second quarter and first half 2026 financial results and business highlights. August 5, 2026. https://www.biospace.com/press-releases/compass-pathways-announces-second-quarter-and-first-half-2026-financial-results-and-business-highlights
HCPLive. MDMA-assisted therapy NDA resubmitted to FDA for PTSD. August 10, 2026. https://www.hcplive.com/view/mdma-assisted-therapy-nda-resubmitted-fda-ptsd
Pharmafile. Australia's TGA approves psychedelics to treat mental health conditions. 2023. https://pharmafile.com/news/australia-s-tga-approves-psychedelics-treat-mental-health-conditions/
National Institute of Mental Health, Czech Republic (NUDZ). Official statement on the availability of psilocybin treatment. March 23, 2026. https://www.nudz.cz/en/news-and-events/official-statement-on-the-availability-of-psilocybin-treatment