AtaiBeckley reports Phase 2a CNS Drugs results: BPL-003 (mebufotenin benzoate) gives rapid, durable antidepressant response in TRD on SSRIs

BPL-003 (mebufotenin benzoate), an intranasal 5-HT1A and 5-HT2A agonist, showed rapid and durable antidepressant effects in treatment-resistant depression (TRD) participants who stayed on stable SSRI therapy. In this Phase 2a open-label, single-center Part 2 analysis (12 adults), 66.7% of participants achieved an antidepressant response by Day 2 after a single dose, based on a MADRS reduction threshold. Response durability was reported through Day 85, with 83% (10 mg cohort) and 66.7% (12 mg cohort) maintaining response, alongside mean MADRS score improvements toward remission levels. AtaiBeckley reports BPL-003 was generally well tolerated with no serious adverse events and an average discharge readiness of about 100 minutes post-dose. The release also notes Phase 3 planning for initiation in Q2 2026 and that BPL-003 has FDA Breakthrough Therapy designation.