Posttraumatic stress disorder is a trauma- and stressor-related mental disorder that can follow exposure to threatened death, serious injury, or violence, with persistent re-experiencing, avoidance, mood/cognition changes, and hyperarousal.
Otsuka Pharmaceutical said its U.S. subsidiary plans to acquire Transcend Therapeutics for $700 million, with up to $525 million more tied to sales milestones. The deal would add TSND-201, a methylone-based PTSD drug now moving into Phase 3 testing in the U.S.
Trump signed an executive order to speed FDA review of ibogaine and other psychedelic drugs and said the U.S. would dedicate $50 million to ibogaine research. The FDA is also preparing priority vouchers and steps toward the first U.S. human trials, while ibogaine remains linked to serious heart risks.
Alzamend Neuro reports pharmacodynamic data showing AL001 may have a distinct brain interaction profile compared to lithium carbonate, with potential tolerability advantages. The Phase II trial analysis suggests AL001 affects key brain metabolites differently while maintaining lithium's core mechanism of action. Further confirmatory studies are planned to validate these initial findings.
Silo Pharma said the Japan Patent Office issued a Notice of Allowance for a patent application covering SPC-15, its intranasal PTSD therapeutic. The allowed application covers composition and method claims, with formal patent grant expected to follow.
Enveric Biosciences reports positive preclinical results for lead candidate EB-003 showing efficacy in depression and PTSD models. The company has completed pre-IND studies and received FDA feedback for streamlined IND submission, with plans for Phase 1 trials in 2026. New BRET assay data demonstrates EB-003's engagement of therapeutic signaling pathways while independent research supports separation from hallucinogenic effects.
Clinical trials show psychedelic substances like psilocybin, LSD and MDMA combined with therapy can effectively treat depression, anxiety and addiction. Several substances are in Phase III trials, with esketamine already approved for treatment-resistant depression. Research suggests these treatments may work with fewer doses than traditional medications.
Compass Pathways announced positive Phase 3 data for COMP360 psilocybin therapy in treatment-resistant depression, showing statistically significant improvements in depression scores and durability through 26 weeks, with plans to file for FDA approval in Q4 2026.
Compass Pathways reports positive Phase 3 results for synthetic psilocybin in treatment-resistant depression, while a Phase 2 trial demonstrates rapid antidepressant effects from single-dose DMT. Both studies show modest efficacy signals amid growing pharmaceutical interest in psychedelic compounds.
Compass Pathways' COMP360 synthetic psilocybin met primary endpoints in Phase 3 trials for treatment-resistant depression, with the company planning to submit a new drug application in Q4 2026.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07396974 |
Increasing Treatment Access in Trauma Exposed Children: Developing an Adapted Step One Intervention (RCT) |
NOT_YET_RECRUITING | NA |
| NCT07396935 |
Increasing Treatment Access in Trauma Exposed Children: Developing an Adapted Step One Intervention (Pilot) |
NOT_YET_RECRUITING | NA |
| NCT07250061 |
Self-Help Cognitive Processing Therapy (CPT)/Women Veterans Network (WoVeN) Study |
NOT_YET_RECRUITING | NA |
| NCT07176273 |
Adaptive Decision-making And Personalized Treatment for PTSD (ADAPT-PTSD) |
RECRUITING | NA |
| NCT07108608 |
Adaptation of Written Exposure Therapy in Substance Treatment |
NOT_YET_RECRUITING | NA |
| NCT07105345 |
Exploring Efficacy of Multi-Mode Cognitive Processing Therapy (CPT) for PTSD |
RECRUITING | NA |
| NCT07055633 |
Improving Cognitive Rehabilitation Outcomes |
RECRUITING | NA |
| NCT06989957 |
Psilocybin and Methylenedioxymethamphetamine (MDMA) for Post-traumatic Stress Disorder (PTSD) |
RECRUITING | PHASE1 |
| NCT06945497 |
School-based Practices in Arts and Resilience for Kids |
NOT_YET_RECRUITING | NA |
| NCT06820138 |
Focused Ultrasound for PTSD in Veterans |
NOT_YET_RECRUITING | PHASE2 |
