Psychedelic · EMP-01
EMP-01 (oral R-MDMA)
Oral R-MDMA (the R-enantiomer of MDMA), an entactogen engineered to retain MDMA's prosocial serotonergic effects while minimizing dopaminergic/noradrenergic (stimulant) activity. Lead indication social anxiety disorder; also positioned for PTSD. Developed by EmpathBio, an atai (AtaiBeckley) subsidiary.
Also known as: EMP-01, R-MDMA, (R)-3,4-methylenedioxymethamphetamine
- Modality
- Psychedelic
- Chemical class
- substituted amphetamine, entactogen, Methylenedioxyphenethylamine
- DEA schedule
- Schedule I
- Chemistry
- Single enantiomer
- Mechanism
- SERT releaser
- Highest phase
- Phase 2
- Lead indication
- Social anxiety disorder
- Developer
- EmpathBio, Inc. (ATAI)
- Trials
- 1 tracked · 7 sites
Mechanism of action
Oral R-MDMA acts as a monoamine releaser via SERT, preferentially serotonergic with much weaker dopamine/norepinephrine release than racemic MDMA, intended to separate entactogenic/prosocial effects from stimulant effects.
| Target | Action | Affinity |
|---|---|---|
| SERTprimarySLC6A4 | Releaser | —ⓘ |
| DATSLC6A3 | Releaser | —ⓘ |
| NETSLC6A2 | Releaser | —ⓘ |
Formulations
| Formulation | Route | Regimen | Pharmacokinetics |
|---|---|---|---|
| EMP-01 oral 225 mg oral dose; two in-clinic administrations separated by 28 days (no accompanying psychotherapy) in the Phase 2a social anxiety disorder study | Oral | Single dose | — |
Development timeline
- Phase 1 single-ascending-dose trial of oral EMP-01 initiated in healthy volunteers.↗
EMP-01 (oral R-MDMA) for Social anxiety disorder
Phase 2CompletedSocial anxiety disorder indication →
EMP-01 (oral R-MDMA) for social anxiety disorder — lead program. Exploratory Phase 2a (NCT06693609, 70 dosed, 7 UK sites): two 225 mg in-clinic doses 28 days apart without adjunctive psychotherapy. Topline (Apr 2026) met the primary safety objective with large placebo-adjusted symptom reductions at Day 43 (SPIN -11.5, p=0.002; SAFE -15.6, p=0.004; LSAS -11.9). Also positioned for PTSD. New US patent (Dec 2025) extends exclusivity to 2043.
Clinical trials
NCT06693609EMP-01-201Phase 2Completedn=70
Phase 2a Exploratory Trial of EMP-01 in Adults With Social Anxiety Disorder
metsecondarySPIN (Social Phobia Inventory) change at Day 43 (placebo-adjusted) — -11.5 points (Hedges' g 0.84) (0.002)
Exploratory Phase 2a met primary safety objective; large placebo-adjusted symptom reductions. SAFE -15.6 (p=0.004), LSAS -11.9. Responder rate 49% vs ~12-15% placebo; no SAEs.
Conference coverage
EMP-01 appears in 2 CNS Pulse conference abstracts:
Identifiers
Sources
- AtaiBeckley Announces Positive Topline Results from an Exploratory Phase 2a Trial of EMP-01 (oral R-MDMA) in Social Anxiety Disorder — AtaiBeckley / GlobeNewswire
- EMP-01 Phase 2a SAD (NCT06693609) — ClinicalTrials.gov
- EMP-01 Phase 2a SAD results — AtaiBeckley (BioSpace)
- EMP-01: developing treatments for social anxiety disorder — atai Life Sciences
- ir.atai.com — Reference
- biospace.com — Reference