Atai Life Sciences and Beckley Psytech Receive Breakthrough Therapy Designation for BPL-003 in Treatment-Resistant Depression
Friday, October 17, 2025
atai Life Sciences and Beckley Psytech have announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to BPL-003, an intranasal formulation of mebufotenin benzoate, for the treatment of adults with treatment-resistant depression (TRD).
BPL-003 is Beckley Psytech’s proprietary intranasal formulation of mebufotenin (5-MeO-DMT) benzoate. It is designed to deliver rapid and durable therapeutic benefits from a single administration and is being developed for treatment-resistant depression and alcohol use disorder. The formulation is protected by patents in the US, UK, and Europe, with further applications under review.
Depression affects nearly 300 million people globally, with around 52 million individuals in Europe and the US. Treatment-resistant depression occurs when a person fails to respond to at least two courses of antidepressant therapy and may affect up to half of those living with depression. It is linked to higher rates of anxiety, cognitive impairment, sexual dysfunction, and a lower quality of life. The condition places a considerable burden on patients, caregivers, and healthcare systems, underscoring the need for new, effective treatment approaches.
The designation is intended to speed up the development of promising treatments for serious or life-threatening conditions where early evidence suggests significant benefits over existing options. It allows enhanced collaboration with the FDA and may help shorten development and review timelines.
BPL-003 is designed to provide rapid and lasting antidepressant effects from a single nasal dose with a short treatment duration. The designation follows positive Phase 2b results from Beckley Psytech’s study in TRD, where a single administration of 8 mg or 12 mg of BPL-003 produced significant and sustained reductions in depressive symptoms within 24 hours, lasting up to eight weeks. Most patients were ready for discharge within 90 minutes after dosing, indicating the potential for the therapy to fit within existing in-clinic treatment settings.
This recognition highlights the potential of BPL-003 to address the unmet needs of patients who do not respond to existing depression treatments. Phase 3 clinical trials are expected to begin in the second quarter of 2026, pending alignment with the FDA.
Source: atai.com
