PTSD stands for post-traumatic stress disorder, a trauma-related psychiatric disorder that can develop after exposure to traumatic events and is marked by intrusive memories, avoidance, negative 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.
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.
The American Psychiatric Association will include biomarkers in the next DSM edition, though such markers remain unvalidated for routine clinical use. Research has spanned decades with limited adoption despite potential to guide treatment selection.
New research reveals how ketamine rewires brain receptors to rapidly relieve severe depression, while separate trials demonstrate success with personalized brain stimulation and targeted drug therapy for treatment-resistant cases.
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.
NRx Pharmaceuticals completed an in-person FDA Type C meeting regarding NRX-100, a preservative-free ketamine formulation for suicidal depression. The company received guidance on a path to file a New Drug Application based on existing trial data and Real World Evidence from over 65,000 patients.
NRx Pharmaceuticals completed a Type C meeting with the FDA, receiving guidance to file a New Drug Application for NRX-100 based on existing trial data and real-world evidence from over 65,000 patients, with submission planned for Q2 2026.
NRx Pharmaceuticals completed a Type C meeting with FDA leadership and received oral guidance supporting a New Drug Application for NRX-100 (preservative-free ketamine) based on existing trial data and Real World Evidence from over 65,000 patients.
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 |
|---|---|---|---|
| NCT07570654 |
Redefine Study: A Study Evaluating the Efficacy, Safety, and Tolerability of COMP360 in Participants With Post-traumatic Stress Disorder |
NOT_YET_RECRUITING | PHASE2/PHASE3 |
| NCT07558759 |
Temporal Interference in Psychiatry (TIP): Neuromodulation Using Temporal Interference |
NOT_YET_RECRUITING | NA |
| NCT07548125 |
Using Exercise to Enhance Fear Extinction Learning |
RECRUITING | NA |
| NCT07530432 |
Analysis of Influencing Factors for the Development of PTSD in Emergency Department Trauma Patients |
NOT_YET_RECRUITING | |
| NCT07523685 |
Non-invasive Vagus Nerve Stimulation (nVNS) for Post-Traumatic Stress Disorder (PTSD) |
RECRUITING | NA |
| NCT07506395 |
Group Psilocybin-Assisted Therapy for Post-Traumatic Stress Disorder |
RECRUITING | PHASE1 |
| NCT07502313 |
Evacuation Time and Tourniquet Use as Risk Factors for PTSD in Combat-Related Amputation |
NOT_YET_RECRUITING | |
| NCT07499440 |
Safety and Efficacy of HB-1 for Post-Traumatic Stress Disorder |
NOT_YET_RECRUITING | PHASE2 |
| NCT07482358 |
TCI-Massage Clinical Trial |
ACTIVE_NOT_RECRUITING | NA |
| NCT07473505 |
Integrative Bilateral Cervical Sympathetic Blocks for Trauma-Related Symptoms in Special Operations Veterans: A Prospective Case Series |
RECRUITING |
