AtaiBeckley said that it completed an End‑of‑Phase 2 meeting with the FDA regarding BPL‑003 intranasal mebufotenin for the treatment of treatment‑resistant depression (TRD) and that the agency indicated that it supports the company’s plan for Phase 3 trials of the nasal spray and provided feedback on the study design.
In July 2025, Atai and Beckley announced that a Phase 2 trial of BPL-003 in patients with TRD had met its primary endpoint. The FDA granted Breakthrough Therapy designation to BPL-003 for that indication in October 2025. Atai Life Sciences acquired about 35% of Beckley in early 2024, and the combined company was formed in November 2025.
According to AtaiBeckley, the Phase 3 program, which is expected to begin this year, will include two 12-week trials: ReConnection 1 and ReConnection 2. ReConnection 1 is expected to enroll approximately 350 participants and will evaluate single doses of 2 dose strengths of BPL-003 versus placebo. ReConnection 2 is expected to enroll approximately 300 participants and will evaluate two doses of the higher dose strength two weeks apart versus placebo. Both studies will be followed by a 52-week open label extension.
AtaiBeckley CEO Srinivas Rao commented, “Receiving clear guidance from the FDA at this stage is a major milestone for AtaiBeckley and for the BPL‑003 program. This feedback builds on our compelling Phase 2b data as well as the Breakthrough Therapy Designation granted to BPL-003 in October 2025 and firmly positions us to advance a robust Phase 3 clinical program designed to maximize the probability of regulatory and commercial success. With this development, we maintain our conviction that BPL-003 has the potential to offer a rapid, durable and convenient treatment option for the millions of people living with treatment-resistant depression.”
Chief Medical Officer Kevin Craig said, “The Phase 3 program is intentionally designed to reflect how BPL‑003 could be delivered in real‑world interventional psychiatry settings, with a short, approximately 2‑hour in‑clinic, experience and the potential for only a handful of treatments per year. This treatment model directly addresses some of the most significant barriers facing patients and providers today. If approved, BPL‑003 could fit seamlessly within existing interventional psychiatry workflows while offering compelling practice economics that support broad, sustainable uptake.”
Read the AtaiBeckley press release
