No psychedelic drug is approved as a medicine in Ireland, the UK, the EU or the US, as of November 2026. Outside licensed research, psilocybin, LSD, MDMA and DMT are Schedule 1 controlled drugs in both Ireland and the UK.
The trial evidence is real but more modest than the headlines. Psilocybin has two company-announced phase 3 wins in treatment-resistant depression, with small average differences from the comparator. An LSD product has announced phase 3 wins in anxiety and depression. Two forms of 5-MeO-DMT have positive phase 2 trials. In 2024 the US regulator turned down MDMA for PTSD.
In trials, these drugs are given on one or two days, in a clinic, to screened people with trained staff present. That is very different from taking them yourself.
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In the studies below, people are screened before they are accepted. Trials usually exclude people with a personal or family history of psychosis or mania, or with serious heart, kidney, liver or neurological disease.
Participants meet the therapy team before dosing. The dose is a measured, pharmaceutical-grade product. Staff stay with the person through the session, which can last hours. Follow-up sessions help people make sense of what happened.
The UK's Royal College of Psychiatrists says this support matters because distressing material can surface during sessions. Its 2025 position statement concerns clinical and research use only, not recreational use.
COMP360 is a synthetic psilocybin made by Compass Pathways. It is the most advanced psychedelic in development for depression.
Phase 2b (published). The 2022 New England Journal of Medicine trial included 233 adults with treatment-resistant depression. They received one dose of 25 mg, 10 mg or 1 mg, with psychological support. At three weeks, 25 mg reduced depression scores by 6.6 points more than 1 mg on a 60-point scale. The 10 mg dose was not significantly better than 1 mg. Benefit was not clearly sustained at 12 weeks. Suicidal ideation, suicidal behaviour or self-injury occurred in all three dose groups.
Phase 3 (announced, not yet peer-reviewed). Compass has reported two phase 3 trials in press releases:
Both results were statistically significant. But they are smaller than the phase 2b result. An Irish review published in 2026 described the phase 3 effects as "more modest". The company says it expects to complete its US marketing application in late 2026.
DT120 is a pharmaceutical form of LSD made by Definium Therapeutics. Trial registrations still list it under the code MM120.
Phase 2b (published). A 2025 JAMA trial in 198 adults with generalised anxiety disorder tested one dose. At four weeks, 100 micrograms and 200 micrograms reduced anxiety scores more than placebo. Lower doses did not. Visual changes, nausea and headache were common.
Phase 3 (announced, not yet peer-reviewed). The company has reported three phase 3 trials of a single 100 microgram dose against placebo:
The company says it plans to file in the US in the first half of 2027.
5-MeO-DMT produces a short, intense experience. Developers hope this could mean less time in clinic.
GH001 (inhaled). GH001 is developed by GH Research, a company based in Dublin. Its phase 2b trial ran at 16 European sites, including Dublin and Galway. It randomised 81 adults with treatment-resistant depression to GH001 or placebo on a single day. At day 8, depression scores were 15.5 points lower than placebo. Remission was 57.5% versus 0%. The placebo-controlled part lasted only seven days. Results after that came from an open-label extension, with no comparison group. In January 2026, the company said the FDA had lifted a hold on its US trials. It plans phase 3 trials.
BPL-003 (nasal spray). A 2026 JAMA trial by Beckley Psytech included 193 adults with treatment-resistant depression, at sites including the UK. At day 29, a 12 mg dose reduced scores by 5.3 points more than a 0.3 mg dose.
Two phase 3 trials of MDMA with therapy for PTSD, published in 2021 and 2023, reported larger improvements than therapy with placebo.
In June 2024, an FDA advisory committee voted 9 to 2 that the data did not show MDMA was effective. It voted 10 to 1 that benefits did not outweigh risks. FDA reviewers had raised several concerns:
On 9 August 2024, the company, Lykos, said the FDA would not approve MDMA on the data submitted. The FDA asked for another phase 3 trial. We found no approval anywhere since. For treatments that are recommended now, see what guidelines recommend for PTSD.
No, outside a clinical trial.
All of these drugs are Schedule 1 under the Misuse of Drugs Regulations 2017. Schedule 1 is for drugs with no accepted medical use. The list names LSD, psilocin and DMT, and "any fungus containing any proportion of Psilocin". So magic mushrooms are controlled too.
We found no HSE or National Centre for Pharmacoeconomics (NCPE) assessment of any psychedelic. An Irish review in 2026 explains the steps after any EU approval. Each drug would need an NCPE assessment, an HSE funding decision and approval by each hospital.
Esketamine nasal spray (Spravato) is a different drug, related to ketamine. It is licensed in the EU for treatment-resistant depression and is Schedule 3 in Ireland. The HSE approved reimbursement in January 2022.
LSD, MDMA, psilocybin and DMT are Class A drugs and Schedule 1 under the Misuse of Drugs Regulations 2001. Research needs a Home Office licence.
We found no NICE guidance on any of them. The Royal College of Psychiatrists does not recommend their use in routine practice. COMP360 has a place on the UK's Innovative Licensing and Access Pathway, which supports development but is not a licence.
A few countries allow restricted access without full approval. Australia reclassified psilocybin and MDMA for specialist prescribing in 2023. The 2026 Irish review lists restricted schemes in Germany and Czechia too.
On ClinicalTrials.gov, checked 3 November 2026:
A trial is research, not treatment. You may get placebo, and strict entry rules apply. If you are interested, ask your psychiatrist or GP.
During the session. Fear, panic, distressing perceptions and re-living trauma can happen. Nausea and headache are common. MDMA raises blood pressure and heart rate.
Mania and psychosis. A 2026 review of 23 studies found mood-related symptoms, including hypomania, in 5.8% of people in controlled psilocybin trials for depression. Rates were up to 30% in observational studies of people with bipolar disorder. Risk was higher with bipolar I disorder, a family history, other drug use and unsupervised use. If you have bipolar disorder, this matters.
Suicidal thoughts. In the psilocybin phase 2b trial, suicidal ideation worsened in 14%, 17% and 9% of the three dose groups (25 mg, 10 mg, 1 mg). The difference was not statistically significant. The researchers advised clinical vigilance.
Lasting perceptual changes. Hallucinogen persisting perception disorder, where visual changes continue long after use, has been reported, mostly after recreational use.
Long-term effects of repeated use are not well studied.
The trial results above come from a package: screening, a known dose of a known drug, medical monitoring, and therapy before and after. Unsupervised use has none of these. Street drugs may contain something else entirely. Mushroom strength varies.
Trials leave out the people most at risk of serious reactions. These include people with psychosis or bipolar disorder, or a family history of them. In Ireland and the UK, possession and supply are also criminal offences.
If you take an antidepressant, do not stop it suddenly to try something else. Read how to come off antidepressants safely and plan any change with your prescriber.
The pull is understandable, especially if several treatments have not worked. There are licensed options for depression that has not responded. The order of what to try is in depression: what actually works. For anxiety, see what actually works for anxiety.
Talk to your GP or psychiatrist. Ask whether you have had an adequate trial of each treatment, and what the next step would be.
Worried about your own or someone else's drug use? The HSE Drugs and Alcohol Helpline is free on 1800 459 459, weekdays 9.30am to 5.30pm. In the UK, FRANK is on 0300 123 6600, 24 hours a day. If things feel urgent, see what to do in a mental health crisis in Ireland.
No, except within an approved clinical trial. Psilocin, and any fungus containing it, are Schedule 1 controlled drugs under Irish law. No psilocybin medicine has EU approval, and we found no HSE or NCPE assessment.
No. None is licensed in the UK, and NICE has issued no guidance. The Royal College of Psychiatrists says they are not legally available in the UK outside research.
We cannot say. The company plans to complete its US application in late 2026. It has announced no EU or UK application timetable. Any approval would follow review of full data, which has not yet been peer-reviewed.
None of the trials described here tested microdosing. They used full, supervised doses. We have not assessed microdosing evidence in this article.
Esketamine is related to ketamine and can cause dissociation. Unlike the drugs above, it is licensed in Ireland and the UK for treatment-resistant depression. It is given under supervision in a clinic.
This article is general information, not medical advice. It does not recommend any treatment or trial. Talk to your GP, psychiatrist or pharmacist about your own care.
Reviewed by: Proco Team
Last updated: November 2026