Which post-traumatic stress disorder drugs are in Phase 3?

Phase 3 (or later) programs for post-traumatic stress disorder include Brexpiprazole, Lysergide D-tartrate (MM120 / LSD) and Methylone (TSND-201).

What are the next post-traumatic stress disorder trial readouts?

Upcoming catalysts include Psilocybin (COMP360) (third quarter 2026) and Lysergide D-tartrate (MM120 / LSD) (2027).

How many clinical trials are recruiting for post-traumatic stress disorder?

85 drug-interventional post-traumatic stress disorder trials are currently recruiting participants, out of 482 registered interventional trials.

Anxiety & Trauma Disorders

Post-traumatic stress disorder drug pipeline

ICD-11 6B40
MeSH D013313

6 compounds from 5 companies are in active clinical development for post-traumatic stress disorder, including 3 at Phase 3 or beyond.

6Compounds

5Companies

3Phase 3+

2Upcoming readouts

88Trials recruiting

Filed (NDA) 1
Phase 3 2
Phase 2/3 1
Phase 2 1
Discontinued 1

Mechanisms: Small molecule (3) · Psychedelic (3)

Pipeline data compiled July 2026 · every fact sourced.

Upcoming readouts & recent results

third quarter 2026AnticipatedPsilocybin (COMP360)RegulatoryNCT07570654
Pivotal Phase 2b/3 PTSD trial (REDEFINE / NCT07570654) planned to start; FDA accepted the IND on 2026-01-07. ↗
2027AnticipatedLysergide D-tartrate (MM120 / LSD)Registry results
Phase 3 Haven study of DT120 ODT in PTSD expected to initiate in 2027 ↗
2025-09-20ReportedBrexpiprazoleRegulatorymissed
FDA issues Complete Response Letter for brexpiprazole + sertraline sNDA in PTSD ↗
2024-12-09ReportedBNC210 (soclenicant)Full resultsmetNCT04951076
ATTUNE full results published in NEJM Evidence; hepatic enzyme elevations flagged. ↗
2024-11-19ReportedPsilocybin (COMP360)Topline datametNCT05312151
Open-label Phase 2 PTSD study showed durable CAPS-5 improvement through 12 weeks (-29.5 points from a 47.5 baseline) after a single 25mg dose; no serious adverse events. ↗
2023-09-29ReportedBNC210 (soclenicant)Topline datametNCT04951076
Phase 2b ATTUNE met its primary CAPS-5 endpoint in PTSD (p=0.048). ↗

See the full catalyst calendar →

Compounds in development (6)

Compound	Company	Phase	Status	Mechanism
Brexpiprazole	Otsuka Pharmaceutical Co., Ltd.	Filed (NDA)	Discontinued	D2 Partial agonist
Lysergide D-tartrate (MM120 / LSD)	Definium Therapeutics, Inc.	Phase 3	Active	5-HT2A Partial agonist
Methylone (TSND-201)BTDCNPV	Otsuka Pharmaceutical Co., Ltd.	Phase 3	Recruiting	SERT Releaser
Psilocybin (COMP360)	COMPASS Pathways plc	Phase 2/3	Active	5-HT2A Partial agonist
BNC210 (soclenicant)Fast Track	Neuphoria Therapeutics, Inc.	Phase 2	Suspended	alpha7 nAChR NAM
TNX-102 SL (cyclobenzaprine HCl sublingual)BTD	Tonix Pharmaceuticals Holding Corp.	Discontinued	Discontinued	H1 receptor Antagonist

Trials recruiting now (85)

85 drug-interventional post-traumatic stress disorder trials recruiting now, of 482 registered interventional trials. Browse all on ClinicalTrials.gov →

Phase 4The Effects of Orexin Antagonism on Fear Extinction in PTSD
Suvorexant, Placebo
VA Office of Research and Developmentn=40,120United States · 2 sitesStarted Jun 2026NCT06788522
Phase 4Cervical Plexus Hydrodissection With D5W Versus NS for Treatment-Resistant PTSD
Dextrose 5% in water bilateral injection, Normal saline bilateral injection
Dr. Dean Reeves Clinicn=50United States · 4 sitesStarted May 2026NCT07382596
Phase 4Atomoxetine and Executive Function in PTSD
Atomoxetine, Placebo
VA Office of Research and Developmentn=160United States · 1 siteStarted Apr 2026NCT06573970
Phase 4Ketamine for Pain, Opioid Use, and Mental Health in Orthopedic Trauma Patients
Ketamine, standard general anesthesia
Texas Tech University Health Sciences Centern=90United States · 2 sitesStarted Nov 2025NCT06903819
Phase 4Computational Assessment of GABA Receptor Modulation in PTSD
Lorazepam 1 mg tablet, Placebo tablet
VA Office of Research and Developmentn=150United States · 1 siteStarted Jul 2025NCT06852469
Phase 4The Effect of Outpatient Ketamine Infusion on Chronic Neuropathic Pain and PTSD
Ketamine, Magnesium sulfate, Ketamine + Magnesium sulfate
Margaux M. Salas, PhDn=30United States · 1 siteStarted Oct 2024NCT06414356
Phase 4Methylphenidate for the Treatment of PTSD With Associated Neurocognitive Complaints
Methylphenidate, Placebo
VA Office of Research and Developmentn=70United States · 3 sitesStarted Feb 2024NCT05776056
Phase 4Mismatch vs. Standard Intervention During Memory Reconsolidation Blockade With Propranolol: Effect on Psychophysiological Reactivity During Traumatic Imagery
Propranolol
Massachusetts General Hospitaln=80United States · 1 siteStarted Jun 2023NCT05853627
Phase 4Suvorexant: A Dual Orexin Receptor Antagonist for Treating Sleep Disturbance in Posttraumatic Stress
Suvorexant
VA Office of Research and Developmentn=190United States · 4 sitesStarted Aug 2019NCT03642028
Phase 3Sleep Disturbances in Children and Adolescents With Post-traumatic Stress Disorder (PTSD): a Randomized Double-blind Placebo-controlled Trial to Investigate the Efficacy of Pediatric Prolonged-release Melatonin
pediatric, prolonged released melatonin, Placebo
University Hospital, Strasbourg, Francen=120France · 1 siteStarted Jan 2027NCT07418554
Phase 3Phase 3 Evaluation of TSND-201 for the Treatment of PTSD (EMPOWER-1)
TSND-201, Placebo
Transcend Therapeutics, Inc.n=300United States · 32 sitesStarted Apr 2026Tracked: Methylone (TSND-201)NCT07456696
Phase 3MDMA-assisted Massed Prolonged Exposure for PTSD
3,4 Methylenedioxymethamphetamine
Healing Breakthroughn=20United States · 1 siteStarted Oct 2024NCT06117306

Showing the 12 most advanced of 85 recruiting drug trials · see all on ClinicalTrials.gov →

Frequently asked

How many drugs are in development for post-traumatic stress disorder?: 6 compounds from 5 companies are in active clinical development for post-traumatic stress disorder, including 3 at Phase 3 or beyond.
Which post-traumatic stress disorder drugs are in Phase 3?: Phase 3 (or later) programs for post-traumatic stress disorder include Brexpiprazole, Lysergide D-tartrate (MM120 / LSD) and Methylone (TSND-201).
What are the next post-traumatic stress disorder trial readouts?: Upcoming catalysts include Psilocybin (COMP360) (third quarter 2026) and Lysergide D-tartrate (MM120 / LSD) (2027).
How many clinical trials are recruiting for post-traumatic stress disorder?: 85 drug-interventional post-traumatic stress disorder trials are currently recruiting participants, out of 482 registered interventional trials.