Transcend Therapeutics
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.
Drug Pipeline
2TSND-201
PTSD. Methylone (non-hallucinogenic neuroplastogen). Phase 2 IMPACT-1 Part B (n=52, 16 US/UK/IE sites, 4 weekly oral doses, no psychotherapy): met primary endpoint -9.64 CAPS-5 vs placebo (p=0.011). Response 57.1% vs 19.2% (p=0.002); loss of PTSD diagnosis 60.7% vs 30.8% (p=0.014). Results in JAMA Psychiatry Feb 2026. FDA Breakthrough Therapy Designation July 2025. Phase 3 planned 2026.
TSND-201
Major depressive disorder (MDD). Methylone. Early-stage programme; preclinical data published in Neuropsychopharmacology (2025) showing neuroplasticity mechanism via BDNF/mTOR signalling and rapid neuronal growth. Clinical timeline TBD following Phase 3 PTSD launch.
Quick Facts
- Type
- Private Biotech
- Founded
- 2021
- Lead Stage
- Phase III
- HQ
- 220 5th Avenue, New York, NY, USA, United States
- Website
- Visit