Post-traumatic Stress Disorder Clinical Trials and Pipeline 2025: EMA, PDMA, FDA Approvals, Medication, NDA Approval, Therapies, ROA, MOA and Companies by DelveInsight

(Albany, USA) DelveInsight's 'Post-traumatic Stress Disorder Pipeline Insight 2025' report provides comprehensive global coverage of available, marketed, and pipeline PTSD therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the post-traumatic stress disorder pipeline domain.

DelveInsight's post-traumatic stress disorder pipeline report depicts a robust space with 25+ active players working to develop 25+ pipeline therapies for post-traumatic stress disorder treatment.

Key Takeaways from the Post-traumatic Stress Disorder Pipeline Report
• DelveInsight's post-traumatic stress disorder pipeline report depicts a robust space with 25+ active players working to develop 25+ pipeline therapies for post-traumatic stress disorder treatment.
• Key post-traumatic stress disorder companies such as Aptinyx, Nobilis Therapeutics Inc., Jazz Pharmaceuticals, COMPASS Pathways, Bionomics Limited, Boehringer Ingelheim, Otsuka Pharmaceutical Development & Commercialization, Inc., Halucenex Life Sciences, Bionorica SE, MAPS Europe B.V., Hoffmann-La Roche, Praxis Precision Medicines, Alto Neuroscience, H. Lundbeck A/S, Tonix Pharmaceuticals, Inc., Psy Therapeutics Inc, Chronos Therapeutics, Mydecine Innovations Group, ATAI LIFE SCIENCES N.V., Acer Therapeutics, Alzamend Neuro, Inc., Innovation1 Biotech Inc., Lophora, Virpax Pharmaceuticals, Alto Neuroscience, VistaGen, ANANDA Scientific, Bright Minds Biosciences, and others are evaluating novel post-traumatic stress disorder drug candidates to improve the treatment landscape.
• Promising post-traumatic stress disorder pipeline therapies in various stages of development include NYX-783, NBTX-001, JZP150, Psilocybin, BNC210, BI 1358894, Brexpiprazole, BX-1, MDMA, Balovaptan, PRAX-114, ALTO-100, Lu AG06466, TNX-102, PSY-05, TrkB Modulator, MYCO-001, EMP-01 / MDMA derivative, ACER-801, AL001, Psilocin Prodrug, PES200, ALTO-100, ALTO-202, Liquid StructureTM, and others.
• In March 2025, Alzamend Neuro, Inc. (Nasdaq: ALZN) ("Alzamend"), a clinical-stage biopharmaceutical company focused on developing novel products for the treatment of Alzheimer's disease ("Alzheimer's"), bipolar disorder ("BD"), major depressive disorder ("MDD") and post-traumatic stress disorder ("PTSD"), today announced its plans to initiate a highly anticipated phase II clinical study of AL001 for treatment of patients with PTSD in the fourth quarter of 2025. This study follows the successful completion of a head coil by Tesla Dynamic Coils BV, a key component of the clinical trial.
• In January 2025, Transcend Therapeutics announced an Evaluation of the Safety and Efficacy of Methylone for the Treatment of PTSD IMPACT-2 (Investigation of Methylone for Post-Traumatic Stress Disorder [PTSD])
• In August 2024, Lykos Therapeutics ("Lykos"), a company dedicated to transforming mental healthcare, announced that the U.S. Food and Drug Administration ("FDA") has issued a complete response letter ("CRL") for the new drug application ("NDA") for midomafetamine capsules for the treatment of post-traumatic stress disorder ("PTSD") in adults. The FDA communicated that it had completed its review of the NDA and determined that it could not be approved based on data submitted to date. The FDA has requested that Lykos conduct an additional Phase 3 trial to further study the safety and efficacy of midomafetamine. Lykos plans to request a meeting with the FDA to ask for reconsideration of the decision and to further discuss the agency's recommendations for a resubmission seeking regulatory approval for midomafetamine capsules.
• In June 2024, Otsuka Pharmaceutical, Co. Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) announce the U.S. Food and Drug Administration (FDA) has determined that the supplemental New Drug Application (sNDA) for brexpiprazole in combination with sertraline for the treatment of adults with post-traumatic stress disorder (PTSD) is sufficiently complete to permit a substantive review. The FDA has assigned the application for a Prescription Drug User Fee Act (PDUFA) target action date of February 8, 2025.
• In October 2022, Acer Therapeutics Inc. announced the expansion of ACER-801 (osanetant) into a new indication for the reduction of the frequency and severity of acute stress disorder and post-traumatic stress disorder (PTSD).
• In September 2022, atai Life Sciences N.V., which is developing EMP-01, a 3,4-methylenedioxy-methamphetamine (MDMA) derivative for the treatment of post-traumatic stress disorder (PTSD) and other indications, announced it's Phase 1 study has received regulatory and ethics

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The post-traumatic stress disorder pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage post-traumatic stress disorder products, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the post-traumatic stress disorder pipeline landscape.

Post-traumatic Stress Disorder Overview
Post-traumatic stress disorder (PTSD) is defined as "the complicated physical, cognitive, emotional, and behavioral consequences of psychological trauma." It is distinguished by intrusive thoughts, nightmares, flashbacks to previous traumatic events, avoidance of traumatic reminders, hypervigilance, and sleep disruption, all of which contribute to significant social, occupational, and interpersonal dysfunction. Post-traumatic stress disorder causes include intense fear, helplessness, and horror.
Symptoms of PTSD can appear as soon as a month after a stressful event, but they can also appear years later. These post-traumatic stress disorder symptoms cause significant problems in social and work situations and relationships. They can also impair one's ability to perform routine daily tasks. There are four types of post-traumatic stress disorder symptoms: intrusive recollections, avoidance, unfavorable changes in thinking and mood, and changes in physical and emotional reactions. Symptoms can vary over time and between individuals.
For post-traumatic stress disorder diagnosis, the doctor will most likely perform a physical exam to rule out any medical issues that may be causing the symptoms - a psychological evaluation that includes a discussion of the signs and symptoms, as well as the event or events that precipitated them - and will employ criteria from the Diagnostic and Statistical Manual of Mental Disorders (DSM-5).

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A snapshot of the Post-traumatic Stress Disorder Pipeline Drugs mentioned in the report:
• Brexpiprazole: Otsuka Pharmaceutical
• NBTX-001: Nobilis Therapeutics
• BNC 210: Bionomics
• BI 1358894: Boehringer Ingelheim
• BX-1: Bionorica SE
• Lu AG06466: H. Lundbeck A/S

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Post-traumatic Stress Disorder Therapeutics Assessment
The post-traumatic stress disorder pipeline report proffers an integral view of the post-traumatic stress disorder emerging novel therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration.

Scope of the Post-traumatic Stress Disorder Pipeline Report
• Coverage: Global
• Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination
• Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III
• Therapeutics Assessment By Route of Administration: Inhalation, Intranasal, Intravenous, Parenteral, Subcutaneous, Oral
• Therapeutics Assessment By Molecule Type: Antibody, Antisense oligonucleotides, Immunotherapy, Monoclonal antibody, Peptides, Protein, Recombinant protein, Small molecule, Stem Cell, Vaccine
• Therapeutics Assessment By Mechanism of Action: Dopamine D2 receptor partial agonists, Serotonin 1A receptor partial agonists, Serotonin 2A receptor antagonists, NMDA receptor antagonists, Alpha7 nicotinic acetylcholine receptor antagonists, Monoacylglycerol lipase inhibitors, TRPC4 cation channel inhibitors, TRPC5 cation channel inhibitors, CB1 agonists, CB2 agonists
• Key Post-traumatic Stress Disorder Companies: Aptinyx, Nobilis Therapeutics Inc., Jazz Pharmaceuticals, COMPASS Pathways, Bionomics Limited, Boehringer Ingelheim, Otsuka Pharmaceutical Development & Commercialization, Inc., Halucenex Life Sciences, Bionorica SE, MAPS Europe B.V., Hoffmann-La Roche, Praxis Precision Medicines, Alto Neuroscience, H. Lundbeck A/S, Tonix Pharmaceuticals, Inc., Psy Therapeutics Inc, Chronos Therapeutics, Mydecine Innovations Group, ATAI LIFE SCIENCES N.V., Acer Therapeutics, Alzamend Neuro, Inc., Innovation1 Biotech Inc., Lophora, Virpax Pharmaceuticals, Alto Neuroscience, VistaGen, ANANDA Scientific, Bright Minds Biosciences, and others.
• Key Post-traumatic Stress Disorder Pipeline Therapies: NYX-783, NBTX-001, JZP150, Psilocybin, BNC210, BI 1358894, Brexpiprazole, BX-1, MDMA, Balovaptan, PRAX-114, ALTO-100, Lu AG06466, TNX-102, PSY-05, TrkB Modulator, MYCO-001, EMP-01 / MDMA derivative, ACER-801, AL001, Psilocin Prodrug, PES200, ALTO-100, ALTO-202, Liquid StructureTM, and others.

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Table of Contents
1. Post-traumatic Stress Disorder Pipeline Report Introduction
2. Post-traumatic Stress Disorder Pipeline Report Executive Summary
3. Post-traumatic Stress Disorder Pipeline: Overview
4. Analytical Perspective In-depth Commercial Assessment
5. Post-traumatic Stress Disorder Pipeline Therapeutics
6. Post-traumatic Stress Disorder Pipeline: Late Stage Products (Pre-registration)
7. Post-traumatic Stress Disorder Pipeline: Late Stage Products (Phase III)
7.1 Brexpiprazole: Otsuka Pharmaceutical Development & Commercialization
8. Post-traumatic Stress Disorder Pipeline: Mid Stage Products (Phase II)
8.1 BNC 210: Bionomics
9. Post-traumatic Stress Disorder Pipeline: Early Stage Products (Phase I)
9.1 Lu AG06466: H. Lundbeck A/S
10. Post-traumatic Stress Disorder Pipeline Therapeutics Assessment
11. Inactive Products in the Post-traumatic Stress Disorder Pipeline
12. Company-University Collaborations (Licensing/Partnering) Analysis
13. Key Companies
14. Key Products in the Post-traumatic Stress Disorder Pipeline
15. Unmet Needs
16. Market Drivers and Barriers
17. Future Perspectives and Conclusion
18. Analyst Views
19. Appendix

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