Psychedelic · TSND-201

Methylone (TSND-201)

Phase 3Transcend Therapeutics, Inc.
  • Breakthrough Therapy
  • Commissioner's National Priority Voucher

Methylone (3,4-methylenedioxy-N-methylcathinone, bk-MDMA), an entactogen/neuroplastogen developed as TSND-201 for PTSD. Releases serotonin, norepinephrine and dopamine without direct 5-HT2A agonism, producing shorter, milder effects than MDMA. Transcend was acquired by Otsuka (completed 15 Jun 2026).

Also known as: TSND-201, Methylone, bk-MDMA

Data current as of

Key facts

Modality
Psychedelic
Chemical class
Substituted cathinone, Methylenedioxyphenethylamine
DEA schedule
Schedule I
Chemistry
Racemic
Mechanism
SERT releaser
Highest phase
Phase 3
Lead indication
Post-traumatic stress disorder
Developer
Transcend Therapeutics, Inc.
Designations
Breakthrough Therapy, Commissioner's National Priority Voucher
Trials
3 tracked · 1 recruiting · 60 sites

Mechanism of action#

Methylone is a substrate-type releaser at the serotonin, norepinephrine and dopamine transporters (SERT/NET/DAT) with no direct 5-HT2A/2C activity; downstream it engages BDNF/mTOR signaling ('neuroplastogen'), enhancing fear-extinction learning.

TargetActionAffinity
SERTprimarySLC6A4Releaser—ⓘ
DATSLC6A3Releaser—ⓘ
NETSLC6A2Releaser—ⓘ

Formulations#

FormulationRouteRegimenPharmacokinetics
TSND-201 oral (IMPACT-1)proprietary oral formulation of methylone
Four once-weekly oral dosing sessions (150 mg on day 1, then 100 mg on days 8, 15, 22) in the Phase 2 IMPACT-1 PTSD trial
OralOnce weeklyt½ 6.4 h · Tmax 2 h

Development timeline#

Apr 25Jul 25Oct 25Jan 26Apr 26Jul 26TodayPhase 1/219 Feb 2025 — phase change — IMPACT-1 (NCT05741710) met primary endpoint: placebo-adjusted CAPS-5 -9.64 at Day 64 (p=0.011).Phase 227 Mar 2026 — Acquisition — Otsuka Pharmaceutical agrees to acquire Transcend Therapeutics for up to $1.225B6 Mar 2026 — Trial registered — Phase 3 EMPOWER-1 trial of TSND-201 for PTSD registered on ClinicalTrials.gov18 Feb 2026 — readout (met) — IMPACT-1 Phase 2 results published in JAMA Psychiatry: TSND-201 efficacious in PTSD10 Jul 2025 — phase change — FDA granted Breakthrough Therapy Designation for TSND-201 in PTSD.Phase 315 Jun 2026 — phase change — Otsuka completed acquisition of Transcend Therapeutics; program continues under Otsuka.12 Jun 2026 — Acquisition — Otsuka completes acquisition of Transcend Therapeutics27 Apr 2026 — Commissioner's National Priority Voucher (CNPV) — FDA awards Commissioner's National Priority Voucher (CNPV) for TSND-201 in PTSD2 Apr 2026 — phase change — Phase 3 EMPOWER-1 (NCT07456696) initiated/recruiting for PTSD.2 Apr 2026 — Trial started — Phase 3 EMPOWER-1 trial of TSND-201 for PTSD begins (actual start date)
Phase change Readout Event UpcomingHover a marker for details.
Phase 3Apr 2026 – Jun 2026
  1. Otsuka completed acquisition of Transcend Therapeutics; program continues under Otsuka.↗
  2. AcquisitionOtsuka completes acquisition of Transcend Therapeutics↗
  3. Commissioner's National Priority Voucher (CNPV)FDA awards Commissioner's National Priority Voucher (CNPV) for TSND-201 in PTSD↗
  4. Phase 3 EMPOWER-1 (NCT07456696) initiated/recruiting for PTSD.
  5. Trial startedPhase 3 EMPOWER-1 trial of TSND-201 for PTSD begins (actual start date)
Phase 2Jul 2025 – Mar 2026
  1. AcquisitionOtsuka Pharmaceutical agrees to acquire Transcend Therapeutics for up to $1.225B↗
  2. Trial registeredPhase 3 EMPOWER-1 trial of TSND-201 for PTSD registered on ClinicalTrials.gov
  3. metIMPACT-1 Phase 2 results published in JAMA Psychiatry: TSND-201 efficacious in PTSD↗
  4. FDA granted Breakthrough Therapy Designation for TSND-201 in PTSD.↗
Phase 1/2Feb 2025
  1. IMPACT-1 (NCT05741710) met primary endpoint: placebo-adjusted CAPS-5 -9.64 at Day 64 (p=0.011).↗

Methylone (TSND-201) for Post-traumatic stress disorder#

Phase 3RecruitingPost-traumatic stress disorder indication →

TSND-201 (methylone) for PTSD. Phase 1/2 IMPACT-1 met its primary endpoint (placebo-adjusted CAPS-5 -9.64 at Day 64, p=0.011; published in JAMA Psychiatry). FDA Breakthrough Therapy granted 10 Jul 2025; pivotal Phase 3 EMPOWER-1 began enrolling Apr 2026. Otsuka completed acquisition of Transcend 15 Jun 2026.

Readouts

  • 2026-02-18ReportedFull resultsmet

    IMPACT-1 Phase 2 results published in JAMA Psychiatry: TSND-201 efficacious in PTSD ↗

Clinical trials#

NCT07456696EMPOWER-1Phase 3Recruitingn=300

Phase 3 Evaluation of TSND-201 for the Treatment of PTSD (EMPOWER-1)

Started Apr 2026· Primary completion Dec 2027· 32 sites across 1 country

United States

NCT06215261IMPACT-2Phase 2Completedn=62

Safety and Efficacy of Methylone for PTSD (IMPACT-2)

Started Apr 2024· Primary completion Sept 2025· 12 sites across 3 countries

United StatesAustraliaUnited Kingdom

NCT05741710IMPACT-1Phase 1/2Completedn=79

A Study to Assess Methylone in the Treatment of PTSD (IMPACT-1)

Started Mar 2023· Primary completion Feb 2025· 16 sites across 3 countries

United StatesUnited KingdomIreland

metprimaryCAPS-5 change at Day 64 (placebo-adjusted) — -9.64 points (0.011)

Response 57.1% vs 19.2% (p=0.002), remission 32.1% vs 11.5%, loss of diagnosis 60.7% vs 30.8%. Published in JAMA Psychiatry.

Conference coverage#

TSND-201 appears in 3 CNS Pulse conference abstracts:

Sources#

  1. An Evaluation of the Safety and Efficacy of TSND-201 for the Treatment of PTSD (EMPOWER-1) — ClinicalTrials.gov
  2. Efficacy and Safety of the Neuroplastogen TSND-201 for the Treatment of PTSD: A Randomized Clinical Trial (IMPACT-1) — JAMA Psychiatry / PMC
  3. clinicaltrials.gov — ClinicalTrials.gov
  4. transcendtherapeutics.com — Reference
  5. transcendtherapeutics.com — Reference
  6. transcendtherapeutics.com — Reference
  7. IMPACT-1 (NCT05741710) — ClinicalTrials.gov
  8. Jones et al. Efficacy and Safety of the Neuroplastogen TSND-201 for the Treatment of PTSD: A Randomized Clinical Trial. JAMA Psychiatry 2026;83(5):469-477 — JAMA Psychiatry
  9. Otsuka Pharmaceutical Completes Acquisition of Transcend Therapeutics — Otsuka Pharmaceutical
  10. Otsuka Pharmaceutical to Acquire Transcend Therapeutics — Otsuka Pharmaceutical Co., Ltd.
Show all 13 sources
  1. Transcend Therapeutics Announces Completion of Acquisition by Otsuka Pharmaceutical — Transcend Therapeutics, Inc.
  2. Transcend Therapeutics Receives Breakthrough Therapy Designation for TSND-201 (methylone) for PTSD — Transcend Therapeutics
  3. Transcend Therapeutics Receives FDA National Priority Voucher for TSND-201 in PTSD — Transcend Therapeutics