Source: AtaiBeckley press release, November 10, 2025

One of the biggest questions about any fast-acting depression treatment is what happens as the effect fades. This extension followed people from the large Phase 2b trial of BPL-003 (see the July 2025 post) and gave everyone a second dose. By this point atai Life Sciences and Beckley Psytech had merged to form AtaiBeckley.

The study

Design: an 8-week open-label extension (OLE) of the Phase 2b trial (NCT05870540). In the original trial, people had randomly received a single dose of 12 mg, 8 mg or 0.3 mg (a comparison dose too small to have much effect) without knowing which.
Participants: 107 of the 126 eligible people who completed the original trial chose to continue, about 85%. All had moderate-to-severe treatment-resistant depression.
Dosing: everyone received a 12 mg intranasal dose of BPL-003 eight weeks after their first dose, regardless of how they were doing.
Measures: depression scores were compared with each person's baseline at the start of the original trial, up to eight weeks after the second dose (week 16 overall).

What it found

People who first received 8 mg (23 people): depression scores fell by an average of 22.3 points from the original baseline. At week 16, 81% met criteria for response and 67% for remission.
Everyone whose first dose was active, 8 or 12 mg (60 people): scores fell by an average of 19.0 points. 63% were in response and 48% in remission at week 16.
People who first received the 0.3 mg comparison dose (47 people): scores fell by 14.0 points after their first real dose, similar to what single active doses produced in the original trial.
Duration: two doses, eight weeks apart, gave antidepressant effects lasting up to about four months in total.

Safety

Side effects: most were mild or moderate, happened on dosing day, and were brief. The most common were nausea, headache, nasal pain or discomfort, raised blood pressure and anxiety.
One serious event: one person had a serious drug-related adverse event eight days after their second dose, which resolved with additional in-patient monitoring and support. No other serious drug-related events were reported.
Recovery: on average, people met discharge criteria within two hours.

Limitations

Open-label: everyone knew they were receiving the active medicine
Results are descriptive, based only on people who chose to continue, which may favour those who were doing well
No comparison group in the extension phase
Reported in a company announcement, not yet a peer-reviewed paper

What this means, and doesn't

The results point toward a model of occasional repeat sessions rather than a single dose. They also helped confirm 8 mg as the dose taken into Phase 3 trials. Still, an open-label extension can show a pattern but can't prove it. That will take controlled trials.

The serious event, days after dosing, is a reminder that this medicine asks for real care and follow-up beyond the session itself.

For those working with 5-MeO-DMT outside clinical settings, the findings echo a familiar pattern. Some people feel complete after one experience, while others find that a second, months later, helps them go deeper or anchor what shifted. There's no right number, and pacing should always stay with the individual.

Research summaries are for education, not medical advice. Considering 5-MeO-DMT yourself?
Start with Safety & Screening.