Lead program: Phase III

Transcend Therapeutics

Data updated June 26, 2026

220 5th Avenue, New York, NY, USA, United States

1 Drug Candidate

Transcend Therapeutics is a private, New York-based clinical-stage company developing TSND-201 (methylone), a rapid-acting neuroplastogen for PTSD and other neuropsychiatric conditions. Founded in 2021 by Blake Mandell (CEO), Kevin Ryan (AlleyCorp), and Dr. Benjamin Kelmendi (Yale), the company raised $41.5M from investors including the US Department of Defense. TSND-201 is non-hallucinogenic (no 5-HT2A activity) and requires no structured psychotherapy. Its Phase 2 IMPACT-1 trial met the primary endpoint (March 2025, published JAMA Psychiatry Feb 2026) and the FDA granted Breakthrough Therapy Designation in July 2025. Phase 3 programme is planned for 2026.

Pipeline Intelligence

Developer Momentum

Programme tracker

Active candidates: 1
Active programmes: 1
Lead stage: Phase III
Forecast coverage: 1 of 1

Latest sourced update

Transcend announces completion of acquisition by Otsuka

Jun 12, 2026 - Press release - Transcend Therapeutics - TSND-201 (Methylone) / TSND-201 Phase 3 Programme (PTSD)

Next known catalyst

Phase III topline

Q1 2028 - TSND-201 (Methylone) / TSND-201 Phase 3 Programme (PTSD) - Confidence: 60%

4 sources0 pipeline-linked trials0 pipeline-linked papers

Development Programmes

TSND-201 (Methylone)

Phase III

PTSD

Post-traumatic stress disorder

Programme Tracker

PTSD

Primary: US (FDA)

Phase IIIActive

Forecast

Phase III topline - Likely: Q1 2028

TSND-201 is now in Phase 3 for PTSD. EMPOWER-1 (NCT07456696) is recruiting, with 300 estimated participants and estimated primary completion in December 2027. Transcend published IMPACT-1 Phase 2 data in JAMA Psychiatry, received FDA Breakthrough Therapy Designation in July 2025 and a Commissioner's National Priority Voucher in April 2026, and completed its acquisition by Otsuka in June 2026.

Milestones

Phase II topline

Completed

Actual: Mar 1, 2025

IMPACT-1 Phase 2 positive topline results: CAPS-5 −8.00 (Day 10), −9.64 (Day 64); response 57.1% vs 19.2% placebo; remission 32.1% vs 11.5%; loss of PTSD diagnosis 60.7% vs 30.8%; no hallucinations; NCT05741710

Why it matters: TSND-201 is methylone (bk-MDMA) — a monoamine reuptake inhibitor/releaser distinct from MDMA. Unlike MDMA, it lacks serotonin syndrome risk and cardiovascular concerns. IMPACT-1 showed large, durable effect sizes published in JAMA Psychiatry (February 2026) — the first positive RCT of a synthetic entactogen for PTSD in a leading psychiatric journal.

Watch next: Phase 3 primary endpoint readout; NDA timeline under Otsuka

JAMA Psychiatry - TSND-201 randomized Phase 2 PTSD trial(Publication)[Verified]JAMA Psychiatry - TSND-201 randomized Phase 2 PTSD trial(Publication)[Verified]

Regulatory review accepted

Completed

Actual: Jul 1, 2025

FDA Breakthrough Therapy Designation (BTD) granted for PTSD

Why it matters: BTD accelerates FDA development and review. Combined with the JAMA Psychiatry publication and Phase 3 initiation, BTD positions TSND-201 as the leading non-MDMA psychedelic-adjacent PTSD candidate.

Transcend receives FDA Breakthrough Therapy Designation for TSND-201 in PTSD(Press release)[Verified]Transcend receives FDA National Priority Voucher for TSND-201 in PTSD(Press release)[Verified]

Funding milestone

Completed

Actual: Mar 27, 2026

Otsuka Pharmaceutical announces acquisition of Transcend for $700M upfront + $525M milestones ($1.225B total); expected close Q2 2026

Why it matters: Otsuka's $1.225B acquisition is the largest psychedelic/entactogen company acquisition to date, confirming Big Pharma confidence in the PTSD drug-assisted therapy space and providing Transcend full commercial and regulatory resources to execute Phase 3.

Watch next: Acquisition close Q2 2026; Phase 3 interim analysis results

Transcend announces completion of acquisition by Otsuka(Press release)[Verified]

Recorded Events

Mar 27, 2026: Funding milestone

Jul 1, 2025: Regulatory review accepted

Mar 1, 2025: Phase II topline