Post-traumatic Stress Disorder (PTSD) - Pipeline Insight, 2024

This “Post-traumatic Stress Disorder (PTSD) - Pipeline Insight, 2024” report provides comprehensive insights about 20+ companies and 20+ pipeline drugs in Post-traumatic Stress Disorder (PTSD) pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

Geography Covered

• Global coverage

Post-traumatic Stress Disorder (PTSD): Understanding

Post-traumatic Stress Disorder (PTSD): Overview

Post-traumatic stress disorder (PTSD) is a disabling psychiatric disorder that results from being exposed to real or threatened injury, death, and sexual assault. It is associated with functional and cognitive impairment. Early diagnosis and intervention are necessary for effective treatment and to minimize the long-term outcomes associated with PTSD. PTSD is a disorder that develops in some people who have experienced a shocking, scary, or dangerous event. It is natural to feel afraid during and after a traumatic situation. Fear is a part of the body’s “fight-or-flight” response, which helps us avoid or respond to potential danger. People may experience a range of reactions after trauma, and most people recover from initial symptoms over time. Those who continue to experience problems may be diagnosed with PTSD. Anyone can develop PTSD at any age. This includes combat veterans and people who have experienced or witnessed a physical or sexual assault, abuse, an accident, a disaster, or other serious events. People who have PTSD may feel stressed or frightened, even when they are not in danger.

The pathophysiology of Post-traumatic stress disorder involves alterations in the neurotransmitter and neurohormonal functioning. Individuals with PTSD have shown to have normal to low levels of cortisol and elevated levels of corticotropin-releasing factor (CRF) despite their ongoing stress. CRF stimulates the release of norepinephrine by the anterior cingulate cortex, which leads to an increased sympathetic response, which manifests as increased heart rate, blood pressure, increased arousal, and startle response. PTSD is associated with the change in the neurophysiology and anatomy of the brain. The size of the hippocampus is reduced, and the amygdala (processing emotions and modulating fear response) is overly reactive in individuals with PTSD. The medial prefrontal cortex (inhibitory control over the emotional reactivity of amygdala) appears to be smaller and less responsive in patients with PTSD.

Post-traumatic stress disorder is a complex phenomenon, and it is necessary to evaluate for any co-existing psychiatric illness in the patient. After a detailed history is obtained, the next step is to have a thorough mental status examination, which helps confirm the behavioral, emotional, and cognitive aspects of PTSD. On the mental status examination, the patient would likely mention poor sleep and concentration, frequent nightmares and flashbacks related to the event, guilt or negative emotions associated with the reminder, avoidance, and increased vigilance. Post-traumatic stress disorder is a disabling consequence after a traumatic event, and early detection and intervention are necessary for planning the management. Studies have shown that both psychotherapy and pharmacotherapy are effective. Trauma-focused psychotherapy is considered as the first-line treatment effective in adults as well as children, and it includes trauma-focused CBT (cognitive-behavioral therapy), eye movement desensitization and reprocessing (EMDR), cognitive processing therapy, and imaginal exposure. Studies have shown that daytime PTSD symptoms improve even after a single session of CBT. The therapy has shown to shorten the course of those who will recover. However, it does not change the long-term outcome. Selective serotonin reuptake inhibitors (SSRI) and serotonin-norepinephrine reuptake inhibitors (SNRI) are the first-line drug of choice for the treatment of PTSD. Sertraline and paroxetine are Food and Drug Administration (FDA)-approved medications for adults.

"Post-traumatic Stress Disorder (PTSD) - Pipeline Insight, 2024" report outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Post-traumatic Stress Disorder (PTSD) pipeline landscape is provided which includes the disease overview and Post-traumatic Stress Disorder (PTSD) treatment guidelines. The assessment part of the report embraces, in depth Post-traumatic Stress Disorder (PTSD) commercial assessment and clinical assessment of the pipeline products under development. In the report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, Post-traumatic Stress Disorder (PTSD) collaborations, licensing, mergers and acquisition, funding, designations and other product related details.

Report Highlights

The companies and academics are working to assess challenges and seek opportunities that could influence Post-traumatic Stress Disorder (PTSD) R&D. The therapies under development are focused on novel approaches to treat/improve Post-traumatic Stress Disorder (PTSD).

Post-traumatic Stress Disorder (PTSD) Emerging Drugs Chapters

This segment of the Post-traumatic Stress Disorder (PTSD) report encloses its detailed analysis of various drugs in different stages of clinical development, including Phase III, II, I, Preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases.

Post-traumatic Stress Disorder (PTSD) Emerging Drugs

TNX-102: Tonix Pharmaceuticals, Inc.

TNX-102 SL is a small, rapidly-disintegrating, under the tongue (sublingual) product candidate containing cyclobenzaprine HCl. The unique patented formulation has been designed to optimize the delivery and absorption of cyclobenzaprine for the therapeutic benefit of improving sleep quality, while minimizing the potential residual effects of oral formulations of cyclobenzaprine. As a multifunctional agent with potent binding and antagonist activities at the serotonin2A, α1-adrenergic, histaminergic-H1, and muscarinic-M1 receptors, TNX-102 SL is in clinical development and has active IND’s as a daily bedtime treatment for fibromyalgia, PTSD, alcohol use disorder and agitation in Alzheimer’s disease (AAD). TNX-102 SL for AAD has been designated by the FDA a Fast Track development program. Currently, the drug is in phase III stage for the treatment of post-traumatic stress disorder.

Methylone (TSND-201): Transcend Therapeutics

Methylone, identified as a rapid-acting neuroplastogen, has been shown to swiftly trigger the expression of neuroplasticity genes, including BDNF, in brain regions associated with the pathophysiology of conditions like PTSD, depression, and other central nervous system disorders. This effect is particularly significant given the challenges posed by PTSD, MDD, and anxiety, which stem from deficiencies in the brain circuitry responsible for emotional learning and processing. Currently, the drug is in Phase II stage of its clinical trial for the treatment of PTSD.

BXCL501: BioXcel Therapeutics

BXCL501, developed by BioXcel Therapeutics, is an innovative neuroscience clinical asset with a novel mechanism of action targeting symptoms like agitation. This investigational, proprietary, orally dissolving film formulation contains dexmedetomidine, a selective alpha-2 receptor agonist. BXCL501 aims to address stress-related behaviors such as agitation and has shown promising anti-agitation results in various clinical trials across neuropsychiatric disorders. Currently, the drug is in Phase I stage of its clinical trial for the treatment of PTSD.

Post-traumatic Stress Disorder (PTSD): Therapeutic Assessment

This segment of the report provides insights about the different Post-traumatic Stress Disorder (PTSD) drugs segregated based on following parameters that define the scope of the report, such as:

Major Players in Post-traumatic Stress Disorder (PTSD)

• There are approx. 20+ key companies which are developing the therapies for Post-traumatic Stress Disorder (PTSD). The companies which have their Post-traumatic Stress Disorder (PTSD) drug candidates in the most advanced stage, i.e. Phase III include, Tonix Pharmaceuticals, Inc.

Phases

DelveInsight’s report covers around 20+ products under different phases of clinical development like

• Late stage products (Phase III)
• Mid-stage products (Phase II)
• Early-stage product (Phase I) along with the details of
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates

Route of Administration

Post-traumatic Stress Disorder (PTSD) pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as

• Oral
• Intravenous
• Subcutaneous
• Parenteral
• Topical
• Molecule Type

Products have been categorized under various Molecule types such as

• Recombinant fusion proteins
• Small molecule
• Monoclonal antibody
• Peptide
• Polymer
• Gene therapy
• Product Type

Drugs have been categorized under various product types like Mono, Combination and Mono/Combination.

Post-traumatic Stress Disorder (PTSD): Pipeline Development Activities

The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Post-traumatic Stress Disorder (PTSD) therapeutic drugs key players involved in developing key drugs.

Pipeline Development Activities

The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Post-traumatic Stress Disorder (PTSD) drugs.

Post-traumatic Stress Disorder (PTSD) Report Insights

• Post-traumatic Stress Disorder (PTSD) Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

Post-traumatic Stress Disorder (PTSD) Report Assessment

• Pipeline Product Profiles
• Therapeutic Assessment
• Pipeline Assessment
• Inactive drugs assessment
• Unmet Needs

Key Questions

Current Treatment Scenario and Emerging Therapies:

• How many companies are developing Post-traumatic Stress Disorder (PTSD) drugs?
• How many Post-traumatic Stress Disorder (PTSD) drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Post-traumatic Stress Disorder (PTSD)?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Post-traumatic Stress Disorder (PTSD) therapeutics?
• What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for Post-traumatic Stress Disorder (PTSD) and their status?
• What are the key designations that have been granted to the emerging drugs?

Key Players

• Tonix Pharmaceuticals, Inc.
• Pop Test Oncology LLC
• H. Lundbeck A/S
• Bionomics Limited
• Alto Neuroscience
• Transcend Therapeutics

Key Products

• TNX-102
• PT150
• Lu AG06466
• BNC210
• ALTO-100
• Methylone (TSND-201)

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