BPL-003 · program
BPL-003 (intranasal 5-MeO-DMT benzoate) for Alcohol use disorder
Indications for BPL-003: Treatment-resistant depression · Phase 2 Alcohol use disorder · Phase 2
BPL-003 (intranasal mebufotenin / 5-MeO-DMT benzoate) for moderate-to-severe alcohol use disorder. A single 10 mg intranasal dose combined with relapse-prevention psychological support was evaluated in an open-label Phase 2a study (NCT05674929, King's College Hospital, London; 13 enrolled, 12 analyzed). Positive topline reported 2025-01-28: 50% of patients (6/12) maintained complete abstinence over 3 months, mean heavy drinking days fell from 56% to 13% and abstinent days rose from 33% to 81% at Week 12, with no serious or severe adverse events and most patients discharge-ready within ~2 hours. Secondary (non-lead) indication; lead indication is treatment-resistant depression.
Development timeline
- metBPL-003 Phase 2a open-label AUD study positive topline: single 10 mg dose + psychological support cut heavy drinking days (56%->13%) and raised abstinent days (33%->81%) at Week 12, with 50% maintaining complete abstinence over 3 months; well tolerated, no serious/severe AEs.↗
Readouts
- 2025-01-28ReportedTopline datametNCT05674929
BPL-003 Phase 2a open-label AUD study positive topline: single 10 mg dose + psychological support cut heavy drinking days (56%->13%) and raised abstinent days (33%->81%) at Week 12, with 50% maintaining complete abstinence over 3 months; well tolerated, no serious/severe AEs. ↗
Clinical trials in Alcohol use disorder
NCT05674929Phase 2Completedn=13
An Open-Label, Phase 2a Single Dose Study in Patients With Alcohol Use Disorder
metsecondaryComplete abstinence maintained over 3-month follow-up — 6 of 12 patients (50%) maintained complete abstinence over 3 months
Open-label single 10 mg dose of BPL-003 with relapse-prevention psychological support; 50% of analyzed patients maintained complete abstinence across the 3-month observation period (company topline).
metsecondaryMean percentage of heavy drinking days at Week 12 — 56% (pre-dose) -> 13% (Week 12)
Mean percentage of heavy drinking days declined from 56% in the pre-dose period to 13% at Week 12 after a single dose plus psychological support (open-label, n=12 analyzed).
metsecondaryMean percentage of abstinent days at Week 12 — 33% (pre-dose) -> 81% (Week 12); mean alcohol units/day 9.3 -> 2.2
Mean percentage of abstinent days rose from 33% pre-dose to 81% at Week 12 and mean alcohol units/day fell from 9.3 to 2.2; BPL-003 was well tolerated with only mild/moderate AEs, no serious or severe adverse events, and most patients discharge-ready within ~2 hours (open-label, n=12 analyzed).
Formulations
| Formulation | Route | Regimen | Pharmacokinetics |
|---|---|---|---|
| BPL-003 intranasal dry powderAptar Unidose dry-powder intranasal spray device Single intranasal dose; doses of 8 mg and 12 mg studied in Phase 2b TRD (8 mg selected for Phase 3); 1-12 mg range in Phase 1 SAD. | Intranasal | Single dose | t½ 0.33 h · Tmax 0.15 h |
Mechanism of action
Delivers 5-MeO-DMT, a non-selective serotonergic agonist with highest affinity at 5-HT1A and additional 5-HT2A activation; 5-HT2A agonism mediates classic psychedelic effects while potent 5-HT1A agonism shapes its short-acting profile.
| Target | Action | Affinity |
|---|---|---|
| 5-HT1AprimaryHTR1A | Agonist | Ki 1.9 nMⓘ |
| 5-HT2AHTR2A | Agonist | —ⓘ |
← Full BPL-003 compound page (identity, identifiers, all indications)
Sources
- An Open-Label, Phase 2a Single Dose Study in Patients With Alcohol Use Disorder (NCT05674929) — ClinicalTrials.gov
- atai Life Sciences Announces Positive Topline Results from Beckley Psytech's BPL-003 Phase 2a Open-Label Study for Alcohol Use Disorder — atai Life Sciences / Beckley Psytech
- en.wikipedia.org — Reference
- Phase 1, placebo-controlled, single ascending dose trial to evaluate the safety, pharmacokinetics and effect on altered states of consciousness of intranasal BPL-003 (5-MeO-DMT benzoate) in healthy participants — Journal of Psychopharmacology (PMC)