Three authorised, one counted.

Lead Story

Last week we printed one new European psychedelic trial in five weeks. The register Europe actually runs on says three.

CTIS, the clinical trial system for the EU and EEA, carries three psychedelic authorisations between 1 and 26 August. None of the three has a ClinicalTrials.gov record. We checked sponsor, intervention, condition, country and EU CT number, and every query came back empty.

Europe view

ClinicalTrials.gov, Aug 2026

Member state	Trials	Which
Netherlands	Trials1	WhichPosttraumatic Stress Disorder (PTSD), veterans, psilocybin. ARQ National Psychotrauma CentreRegistered 28 Aug 2026 · NCT07792538

Counts countries in the sponsor's registered location list. ClinicalTrials.gov location lists state the sponsor's registered intent, not a regulator's decision. Psychedelic interventional records first posted 1 to 31 August 2026 with an EU or EEA site, on the fourteen-term count list.

Europe view

CTIS, Aug 2026

Member state	Trials	Which
Denmark	Trials1	WhichAnorexia nervosa, psilocybin. Slagelse HospitalDecided 1 Aug 2026 · 2025-524939-39-02
Italy	Trials1	WhichTreatment-Resistant Depression, psilocybin with trazodone. Università di ChietiDecided 14 Aug 2026 · 2025-523346-27-00
Netherlands	Trials1	WhichPost-traumatic stress disorder, adolescents, MDMA. Stichting Amsterdam UMCDecided 26 Aug 2026 · 2024-515184-65-01

Counts member states with a decision on the trial (memberStatesConcerned). Psychedelic trials with a member state decision dated 1 to 31 August 2026, on the same fourteen terms. None of the three has a ClinicalTrials.gov record.

The three CTIS records

Sponsor	Country	Indication	Decision date	Submission	ClinicalTrials.gov
Slagelse Hospital	CountryDenmark	IndicationAnorexia nervosa	Decision date2026-08-01	SubmissionThird (2025-524939-39-02)	ClinicalTrials.govNone found
Università di Chieti	CountryItaly	IndicationTreatment-Resistant Depression	Decision date2026-08-14	SubmissionFirst (2025-523346-27-00)	ClinicalTrials.govNone found
Stichting Amsterdam UMC	CountryNetherlands	IndicationPost-traumatic stress disorder	Decision date2026-08-26	SubmissionSecond (2024-515184-65-01)	ClinicalTrials.govNone found

Submission number is the last two digits of the EU CT number, which count resubmissions of the initial application (EMA CTIS Sponsor Handbook v6.4, section 2.7.2). ClinicalTrials.gov status is the result of sponsor, intervention, condition, country and EU CT number searches on the v2 API on 2026-09-08, every one of which returned a parsed body.

Slagelse Hospital, Denmark. Psilocybin in anorexia nervosa. Decided 1 August, third submission. ClinicalTrials.gov: none.

Università di Chieti, Italy. Psilocybin with trazodone in treatment-resistant depression. Decided 14 August, first submission. ClinicalTrials.gov: none.

Amsterdam UMC, Netherlands. MDMA for adolescents with treatment-resistant PTSD. Decided 26 August, second submission. ClinicalTrials.gov: none.

Our count, and the count everyone in this sector quotes, runs off ClinicalTrials.gov. That register saw one.

The reason is not a lag, or not only a lag. ClinicalTrials.gov is a US legal obligation. A Danish hospital, an Italian university and a Dutch academic centre owe CTIS a record. None of the three owes Washington one; ClinicalTrials.gov obligations follow FDA-regulated products and US exposure, not geography. When a European trial does show up there, something ties it to the US: a regulated product, a US site, or a sponsor choosing a global audience. ARQ's psilocybin trial was authorised on CTIS on 22 June and appeared on ClinicalTrials.gov 67 days later. That is the "one" we printed.

Look at who got missed. All three are academic. The European trials ClinicalTrials.gov does hold skew heavily commercial. There are exceptions, Region Skåne's Swedish psilocybin trial in anorexia sits on both registers. But this August the pattern was clean: the register the sector counts from caught the commercial layer and missed the clinician layer entirely, the layer that built Germany's compassionate use programme with no company behind it.

Our view: any European psychedelic diligence built on ClinicalTrials.gov is short three trials this month and it does not know it. It counts the companies that want US money and misses the clinicians who will decide whether the medicine gets used. That is the competition without the market.

One concession. ClinicalTrials.gov is the better register for the trials it holds: deeper fields, a real API, results posted. The problem is coverage, not quality. It is the wrong map, not a bad one.

Two more facts from the CTIS records. Slagelse was authorised on its third submission of the same application, Amsterdam UMC on its second. Under CTR rules the last two digits of an EU CT number count resubmissions, and an application can only be resubmitted after it was refused, withdrawn, lapsed, expired or ruled invalid. Getting a psychedelic trial through an EU member state is not a one-pass process, and that never shows up in a count either.

From this issue the Data Point carries both registers.

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Signal

Panorama, Definium's second Phase 3 of DT120 in generalised anxiety, reached actual primary completion on 13 August. The registry recorded it on 4 September. No topline. Voyage, the first Phase 3, went from primary completion to topline in 28 days. Thursday is day 28 for Panorama. One difference on the record: Panorama's completion date was set to actual 21 days after the fact with no readout, Voyage's was set after its release. We read nothing into that yet. The Issue 4 call, Panorama smaller than Voyage, stays open.

Helus Pharma, Cybin until the rename, filed a 6-K on 3 September for a Cantor fireside on 11 September. The release states the company operates in Canada, the US, the UK and Ireland. No EU member state. GH Research has filed nothing since 6 August. That release lists posters at ISBD this month and ECNP in October.

The Lilly and AtaiBeckley shareholder vote is today at 17:00 CET, after this issue sends. The ACCC waiting period expires 10 September. Close, if it comes, is Issue 14.

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Data Point

New EU, EEA, UK or CH-sited psychedelic trials registered 1 to 7 September. ClinicalTrials.gov: zero. The query returned two global hits, both false positives on "DMT", a Parkinson's trial reading disease-modifying therapy and a dance-therapy study. CTIS: zero decisions in the window. Both zeros are real zeros. Every query returned a parsed body.

Series to date, ClinicalTrials.gov: 0, 0, 0, 0, 1, 0. CTIS, same six weeks: 1, 0, 1, 0, 1, 0. Six weeks. One register saw one trial, the other saw three. The DMT search term throws oncology false positives on both registers, Terremoto and Eikon. Excluded, and listed in sources.

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Regulator Watch

EMA, MHRA and Swissmedic all published in the window. Zero psychedelic items across the three, verified page loads. The EMA under-evaluation list is still the August file.

NICE and ZIN: failed checks, not zeros, third issue running. NICE guidance-in-development returns 403 on psilocybin, MDMA and esketamine with a "Temporary Service Interruption" page. NICE main search works and shows nothing. ZIN's query API returns 500 on every term, and its web search returns a byte-identical page for esketamine and for a nonsense word. New this week: the G-BA procedures page returns the same content whatever filter is applied, so no control exists there either. Call 8, no HTA before end 2027, stays open with two of three prongs unverifiable, and we say so.

BfArM compassionate use table: 29 rows, one psilocybin row, still ZI Mannheim, valid to 17 June 2027. Call 10 stands.

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The Call

None of the three trials above, Slagelse DANP-RCT, Chieti psilocybin with trazodone, Amsterdam UMC adolescent PTSD, has a ClinicalTrials.gov record by 31 December 2026. Falsifier: any one of the three appears. Scored in the first January issue.

One registration falsifies this and we will print it. It would also be the more interesting outcome. A European hospital trial reaching for American attention is a signal that the clinician layer is starting to think like a sponsor. We do not expect it. We would like to be wrong.

Ten calls open, none resolved this week. Call 7, no EU Phase 3 or EMA pathway within 12 months of close: close not on file, so the clock has not started. Call 11, brenipatide MDD trial recruiting with an EU state by 31 December: still not yet recruiting as of 27 August. Call 12, sixth member state: union unchanged at BE, DE, GR, PL, ES.

All sources for this issue: psychedelicbrief.com/issues/13