BPL-003 Shows Rapid and Lasting Antidepressant Effects in Treatment-Resistant Depression

Phase 2a data published in Journal of Psychopharmacology; Phase 3 program on track for Q2 2026 initiation

Mar. 17, 2026 at 10:26am

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AtaiBeckley Inc. announced the publication of results from its ongoing Phase 2a study evaluating BPL-003 (mebufotenin benzoate nasal spray) in patients with treatment-resistant depression (TRD). The data, published in the Journal of Psychopharmacology, showed that a single 10 mg intranasal dose of BPL-003 produced a rapid and sustained reduction in depression symptoms over 12 weeks. The company is on track to initiate a Phase 3 program for BPL-003 in TRD in Q2 2026.

Why it matters

Treatment-resistant depression is a major unmet medical need, as many patients do not respond adequately to currently available antidepressants. The rapid and durable effects of BPL-003 demonstrated in this Phase 2a study suggest it could offer a new therapeutic option for patients struggling with TRD.

The details

In the 12-week, open-label Phase 2a trial, a single 10 mg dose of BPL-003 led to a mean 12.6-point reduction in Montgomery–Åsberg Depression Rating Scale (MADRS) scores by Day 2, which was sustained through 12 weeks. Over 50% of patients achieved a response (≥50% MADRS reduction), and nearly two-thirds reached remission (MADRS ≤10) at one or more timepoints. BPL-003 was well-tolerated, with no serious adverse events or treatment withdrawals.

  • Results from the Phase 2a trial were published on March 17, 2026.
  • AtaiBeckley announced a successful End-of-Phase 2 meeting with the FDA in March 2026.
  • The Phase 3 program for BPL-003 in TRD is on track to initiate in Q2 2026.

The players

AtaiBeckley Inc.

A clinical-stage biotechnology company developing rapid-acting, durable and convenient mental health treatments, including BPL-003 for treatment-resistant depression.

Srinivas Rao

Co-Founder and Chief Executive Officer of AtaiBeckley.

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What they’re saying

“The publication of these findings in the Journal of Psychopharmacology is an important scientific milestone. In this first cohort, we saw a rapid 12.6-point mean reduction in MADRS scores by Day 2, which was sustained through 12 weeks on a single dose.”

— Srinivas Rao, Co-Founder and Chief Executive Officer of AtaiBeckley

What’s next

The Phase 3 program for BPL-003 in TRD is on track to initiate in Q2 2026.

The takeaway

The rapid and durable antidepressant effects of BPL-003 demonstrated in this Phase 2a study suggest it could be a promising new treatment option for patients with treatment-resistant depression, an area of significant unmet medical need.