AtaiBeckley Inc. announced positive Phase 2a results for BPL-003, an intranasal treatment for treatment-resistant depression (TRD). The study found that 66.7% of participants experienced an antidepressant response within two days of a single dose, with durable responses observed at 12 weeks for 83% of those receiving the 10 mg dose and 66.7% for the 12 mg dose. The treatment was well tolerated, with no serious adverse events reported, and participants were ready for discharge approximately 100 minutes after dosing.
BPL-003 (mebufotenin benzoate nasal spray) represents a novel approach to treating TRD, which affects an estimated 30% of the nearly 300 million people living with depression globally. The drug is designed to deliver rapid and durable effects from a single dose with a short psychedelic duration. The Phase 2a study involved 12 adults aged 18 to 75 with moderate-to-severe major depressive disorder who had failed at least two prior antidepressants. All participants remained on stable doses of one of four SSRIs—citalopram, escitalopram, sertraline, or fluoxetine—throughout the 12-week study, demonstrating that BPL-003 can be administered alongside existing SSRI therapy without compromising efficacy or safety.
BPL-003 received FDA Breakthrough Therapy Designation in October 2025, which may facilitate expedited development and regulatory review. The company is on track to initiate Phase 3 studies in Q2 2026. AtaiBeckley CEO Srinivas Rao stated that the “66.7% Day 2 response rate with a single intranasal dose…maintained through Week 12 in the 10 mg cohort represents a compelling clinical signal” and that the results “reinforce the potential of BPL-003 to transform the treatment paradigm for TRD.” Chief Medical Officer Dr. Kevin Craig noted that this study provides evidence of integration feasibility in existing psychiatric settings, as “rapid resolution of acute effects and ~100-minute discharge readiness” support incorporation into interventional psychiatry practices.
This article is an AI-assisted summary. All facts and figures are drawn from the original report: https://www.quiverquant.com/news/AtaiBeckley+Announces+Positive+Phase+2a+Results+for+BPL-003+in+Treatment-Resistant+Depression+with+FDA+Breakthrough+Therapy+Designation