A Second Dose of AtaiBeckley's 5-MeO-DMT Drug Also Beat Depression, Trial Data Shows
AtaiBeckley (Nasdaq: ATAI) — the company Eli Lilly is paying up to $3.8 billion to acquire for BPL-003, its synthetic 5-MeO-DMT drug — has open-label extension data worth flagging that predates this site's coverage. Announced Nov 10, 2025: patients who got an initial active dose (8 mg or 12 mg) in the core Phase 2b study, then a second 12 mg dose eight weeks later, hit 63% response and 48% remission by Week 8 of the extension, for treatment-resistant depression. Two doses eight weeks apart produced antidepressant effects lasting up to four months. That data helped lock in the 8 mg dose for the pivotal Phase 3 program, branded ReConnection, now underway — though topline results aren't expected until around 2029.
Worth being precise about which company is which here, since it's an easy mix-up (one we briefly made ourselves pulling this together): 5-MeO-DMT is being developed in parallel by two separate companies with two separate drugs — AtaiBeckley's intranasal BPL-003 and GH Research's inhaled GH001 — and the datasets aren't interchangeable. Full trial history, including both programs side by side, is in our trials tracker.
This is business and clinical-trial reporting, not medical advice. BPL-003 remains investigational and is not FDA-approved for any use.