BPL-003 is a new nasal spray treatment developed by Beckley Psytech.
It’s designed for people suffering from treatment-resistant depression (TRD) — a form of depression that doesn’t get better even after trying several standard antidepressants.
The spray contains a fast-acting psychedelic compound called 5-MeO-DMT, also known as mebufotenin.
This substance can temporarily alter how a person experiences mood, time, and sensations.
In the latest Phase 2 clinical trial, BPL-003 showed significant benefits for people with TRD.
Nearly 200 participants from 6 countries, including the US and Europe, took part in this study — the largest ever for this type of psychedelic.
Participants were randomly assigned to receive either:
12 mg of the drug,
8 mg, or
a very small comparison dose of 0.3 mg.
After a single dose, they were monitored over 8 weeks. Researchers used a standard depression scale (MADRS) to measure symptoms on days 2, 8, 29, and 57.
Both 12 mg and 8 mg doses led to significant improvement in depression symptoms, especially by Day 29.
The positive effects started soon after the first dose and lasted up to 8 weeks.
The spray was generally well-tolerated. Most side effects, like nausea, headache, or changes in blood pressure, were mild or moderate. The 8 mg dose caused fewer side effects than the 12 mg dose.
The success of this trial is a big step forward, especially for people who have few or no options left.
The results suggest that a single dose of a fast-acting psychedelic may bring long-lasting relief from depression — something most current antidepressants can't do.
Earlier this year, Beckley Psytech and Atai Life Sciences announced plans to merge. But Atai said it would only move forward if BPL-003 proved to be both safe and effective.
Now that the Phase 2 trial has met those goals, the merger is expected to go ahead. Together, the companies plan to form Atai Beckley, a new leader in psychedelic mental health treatments.
A single 8 mg or 12 mg dose of BPL-003 showed rapid and lasting benefits with only a short clinic visit. That gives us flexibility for future trials. We’re now preparing to discuss the next steps with regulators.Cosmo Feilding Mellen, CEO of Beckley Psytech
Psychedelic treatments are gaining attention in mental health care, especially for conditions like treatment-resistant depression.
Traditional treatments often take weeks to work — if they work at all.
In contrast, psychedelics like BPL-003, psilocybin, and ketamine are showing promise for delivering rapid relief.
Although ketamine is already approved for some forms of depression, BPL-003 could offer another option, especially since it appears to work quickly and doesn't require long clinic visits.
Beckley and Atai plan to meet with health regulators like the U.S. Food and Drug Administration (FDA) to begin designing Phase 3 trials — the final step before a treatment can be approved for public use.
The strong Phase 2 results have also sparked renewed interest from investors. With the companies now merging, they’re preparing to lead the next phase of innovation in psychedelic medicine.
These results support our belief that BPL-003 could offer fast, long-lasting relief with minimal time spent in the clinic. We're excited to move into Phase 3 trials.Srinivas Rao, CEO of Atai Life Sciences
BPL-003 could become a powerful new tool in the fight against depression, especially for people who haven’t had success with other treatments.
While more studies are still needed, this nasal spray is bringing hope — and possibly a new direction — to mental health care.
ClinicalTrials.gov. “A Study to Evaluate the Safety and Efficacy of BPL-003 in Treatment-Resistant Depression.” Last modified June 2025. https://clinicaltrials.gov/study/NCT05870540
GlobeNewswire. “Atai Life Sciences and Beckley Psytech Announce Positive Topline Results from the Phase 2b Study of BPL-003.” July 1, 2025. https://www.globenewswire.com/news-release/2025/07/01/3108164/0/en/atai-Life-Sciences-and-Beckley-Psytech-Announce-Positive-Topline-Results-from-the-Phase-2b-Study-of-BPL-003-in-Patients-with-Treatment-Resistant-Depression.html
GlobeNewswire. “Atai Life Sciences and Beckley Psytech to Combine, Creating a Global Leader in Psychedelic Mental Health Therapies.” June 2, 2025. https://www.globenewswire.com/news-release/2025/06/02/3091657/0/en/atai-Life-Sciences-and-Beckley-Psytech-to-Combine-Creating-a-Global-Leader-in-Psychedelic-Mental-Health-Therapies.html
Clinical Trials Arena. “Atai and Beckley Psytech’s Psychedelic Clears Phase IIb Depression Trial.” July 2025. https://www.clinicaltrialsarena.com/news/atai-beckley-psytech-psychedelic-phase-iib-depression-trial/
Carhart-Harris, Robin L., and David J. Nutt. “Serotonin and Brain Function: A Tale of Two Receptors.” Journal of Psychopharmacology 31, no. 9 (2017): 1091–1120. https://doi.org/10.1177/0269881117725915
(Rh/Swabirah Sulaiman/MSM/SE)