Psychedelic · EMP-01

EMP-01 (oral R-MDMA)

Phase 2EmpathBio, Inc. (ATAI)

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

Data current as of

Key facts

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.

TargetActionAffinity
SERTprimarySLC6A4Releaser—ⓘ
DATSLC6A3Releaser—ⓘ
NETSLC6A2Releaser—ⓘ

Formulations#

FormulationRouteRegimenPharmacokinetics
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
OralSingle dose—

Development timeline#

20222023202420252026TodayPhase 212 Feb 2026 — phase change — Phase 2a SAD trial completed; positive topline (large SPIN/SAFE/LSAS improvements).15 Apr 2025 — phase change — Phase 2a exploratory SAD study (NCT06693609) initiated; first patient dosed announced May 2025.17 Feb 2021 — Partnership — EmpathBio (atai) and Bionomics MOU for joint feasibility assessment of EMP-01 + BNC210 in PTSDPhase 127 Sept 2022 — phase change — Phase 1 single-ascending-dose trial of oral EMP-01 initiated in healthy volunteers.
Phase change Readout Event UpcomingHover a marker for details.
Phase 2Feb 2021 – Feb 2026
  1. Phase 2a SAD trial completed; positive topline (large SPIN/SAFE/LSAS improvements).↗
  2. Phase 2a exploratory SAD study (NCT06693609) initiated; first patient dosed announced May 2025.↗
  3. PartnershipEmpathBio (atai) and Bionomics MOU for joint feasibility assessment of EMP-01 + BNC210 in PTSD↗
Phase 1Sept 2022
  1. 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

Started Apr 2025· Primary completion Feb 2026· 7 sites across 1 country

United Kingdom

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:

Sources#

  1. AtaiBeckley Announces Positive Topline Results from an Exploratory Phase 2a Trial of EMP-01 (oral R-MDMA) in Social Anxiety Disorder — AtaiBeckley / GlobeNewswire
  2. EMP-01 Phase 2a SAD (NCT06693609) — ClinicalTrials.gov
  3. EMP-01 Phase 2a SAD results — AtaiBeckley (BioSpace)
  4. EMP-01: developing treatments for social anxiety disorder — atai Life Sciences
  5. ir.atai.com — Reference
  6. biospace.com — Reference
  7. Joint feasibility assessment of Bionomics' BNC210 and EmpathBio's MDMA derivative EMP-01 treatment regimen for PTSD — PR Newswire / Bionomics Limited