Traumatic Brain Injury(TBI) Pipeline Insights

DelveInsight’s, “Traumatic Brain Injury - Pipeline Insight, 2025” report provides comprehensive insights about 20+ companies and 22+ pipeline drugs in Traumatic Brain Injury 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

 

Traumatic Brain Injury: Understanding

Traumatic Brain Injury: Overview

Traumatic brain injury (TBI) occurs when an external force, such as a blow, bump, or jolt to the head or body, causes damage to the brain. This injury can range from mild, with temporary cognitive or physical impairments, to severe, potentially resulting in permanent disability or death. TBI can be classified as primary, where the damage is immediate, or secondary, where damage develops over time due to processes triggered by the initial trauma. The effects of TBI can impact various aspects of brain function, including thinking, movement, communication, and behavior. Prompt diagnosis and treatment are crucial for minimizing long-term consequences and improving recovery outcomes. TBI can also lead to long-term complications, such as memory loss, mood disorders, and difficulty concentrating. In severe cases, it may cause loss of consciousness or persistent vegetative states. Rehabilitation plays a critical role in recovery, involving physical therapy, speech therapy, and cognitive rehabilitation to help individuals regain lost functions. Preventive measures, such as wearing helmets and seatbelts, are essential in reducing the risk of TBI.

 

Symptoms of traumatic brain injury (TBI) can vary widely depending on the severity of the injury. They may include headaches, confusion, dizziness, memory problems, nausea, and changes in mood or behavior. In more severe cases, symptoms can involve loss of consciousness, seizures, difficulty speaking or moving, and even coma. Immediate medical attention is crucial, as some symptoms may worsen over time. Even mild symptoms can indicate a more serious underlying issue, requiring careful monitoring and assessment. Other symptoms of TBI may include blurred vision, sensitivity to light or sound, trouble sleeping, and ringing in the ears. Cognitive impairments such as difficulty concentrating, processing information, or making decisions can also occur. Emotional changes, like irritability, anxiety, or depression, are common after TBI and can persist for months or even years. In some cases, individuals may experience post-traumatic stress disorder (PTSD) or other psychological conditions. Early intervention and a comprehensive treatment plan can help manage symptoms and improve the likelihood of recovery.

 

The pathophysiology of traumatic brain injury (TBI) involves both primary and secondary mechanisms of injury. The primary injury occurs immediately upon impact, causing direct damage to brain tissue, blood vessels, and neurons. This can lead to contusions, lacerations, and axonal shearing. Secondary injury develops over time and is a result of the body's response to the initial trauma, including inflammation, oxidative stress, and disruptions in blood flow, which can worsen brain damage. These processes can lead to increased intracranial pressure, neuronal death, and long-term neurological deficits. Additionally, the secondary injury cascade may involve the release of excitatory neurotransmitters, such as glutamate, which can further damage neurons and disrupt cellular function. Disruption of the blood-brain barrier may also contribute to swelling and the infiltration of harmful substances into the brain. Increased intracranial pressure, if left untreated, can lead to herniation and compromise vital brain structures. Understanding these mechanisms is crucial for developing targeted therapies to mitigate the damage and promote recovery after TBI. 

 

There are no approved disease-specific treatment for TBI patients, although several new molecules are under investigation. Treatment with several agents like Anti-anxiety medication, Anticoagulants, Anticonvulsants, Antidepressants, Diuretics, Muscle relaxants, and Stimulants can help manage symptoms. Since the treatment landscape is devoid of any effective curative treatment options, any significant development in this direction is expected to create a tectonic impact on the existing market scenario. Some of the drugs in the pipeline include VAS203 (Ronopterin) (Vasopharm GmbH), PNT001 (Pinteon Therapeutics), among others. Additionally, research is focusing on neuroprotective agents, stem cell therapies, and gene therapy as potential avenues for addressing the underlying mechanisms of TBI. Early-phase clinical trials are exploring compounds that target neuroinflammation, oxidative stress, and neuronal repair, with hopes of improving recovery outcomes.

 

"Traumatic Brain Injury- Pipeline Insight, 2025" report by DelveInsight outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Traumatic Brain Injury pipeline landscape is provided which includes the disease overview and Traumatic Brain Injury treatment guidelines. The assessment part of the report embraces, in depth Traumatic Brain Injury 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, Traumatic Brain Injury 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 Traumatic Brain Injury R&D. The therapies under development are focused on novel approaches to treat/improve Traumatic Brain Injury.

 

Traumatic Brain Injury Emerging Drugs Chapters

This segment of the Traumatic Brain Injury 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.

 

Traumatic Brain Injury Emerging Drugs

• ONP-002: Oragenics, Inc.

ONP-002 is a First-in-Class Enantiomeric-Neurosteroid being developed for the treatment of mild Traumatic Brain Injury (mTBI) aka concussion. ONP-002 diffuses intracellularly to induce steroid receptors found in neurons, glia, and the endothelium of the blood brain-barrier. The induction of the ONP-002 receptors activates multiple gene response elements leading to the production of mRNA transcripts and subsequently proteins that reduce inflammation, oxidative stress, and swelling. In addition, ONP-002 induces macro-autophagy to reduce the build-up of extra- and intra-cellular debris that can cause chronic neurological diseases associated with dementia. Currently, the drug is in the Phase II stage of its development for the treatment of Traumatic Brain Injury.

 

• MR-301: SHINKEI Therapeutics, Inc

MR-301 – Amantadine HCl Intravenous (IV) Solution is SHINKEI’s most advanced program. Amantadine HCl is one of the most commonly prescribed off-label medications for patients with prolonged disorders of consciousness after TBI. Amantadine HCl increases dopamine availability in the synapse by inhibiting the activation of dopaminergic receptors. Amantadine HCl has been approved as a prescription oral product in the U.S since 1966 and, as such, has a long history of safe use in the U.S. and globally. Preliminary studies in preclinical models and patients with TBI have suggested that amantadine may promote functional recovery with high levels of safety. Currently, the drug is in Phase II stage of its development for the treatment of Traumatic Brain Injury.

 

• ACD 856: AlzeCure

ACD 856 is a small molecule, positive allosteric modulator of Trk receptors, which mediate the effects of BDNF, NGF, and other neurotrophic factors. ACD856 increases the kinase activity of Trk receptors and enhances the effects of BDNF or NGF on survival, neuronal function, and synaptic plasticity. This is intended to make up for loss of BDNF and NGF signaling that occurs in AD. This compound is taken orally. The compound improves mitochondrial function and increases BDNF expression in cells, and shows antidepressant activity in mice. Currently, the drug is in Phase I stage of its development for the treatment of Traumatic Brain Injury.

 

• AP-188: Algernon Pharmaceutical

AP-188 (N,N-Dimethyltryptamine, or DMT) is a potential treatment for stroke and traumatic brain injury (TBI) recovery. DMT is a naturally occurring compound that is part of the tryptamine family, which also includes psilocybin and psilocin. DMT is naturally occurring and found in plants and animals and is expressed naturally in humans in times of great physiological stress, including cardiac arrest and childbirth. It is assumed to have roles in cell protection, regeneration, and immunity as well. The drug is a sigma receptor agonist, and some evidence points to sigma receptor binding as a critical factor in the drug’s protective actions. Psychedelic drugs as a class have also demonstrated an ability to promote neuritogenesis both in vivo and in vitro. The effects are believed to be through agonism of the 5-HT2A receptor, although other receptors, including sigma, may be involved. DMT increases expression of Brain Derived Neurotropic Factor (BDNF), which promotes neuroplasticity: a key factor in the brain’s ability to form and reorganize synaptic connections, which are needed for healing following a brain injury. DMT is also known to bind to a number of other receptors, including various 5-HT, dopamine, adrenergic, and trace amine receptors. Currently, the drug is in Phase I stage of its development for the treatment of Traumatic Brain Injury.

Further product details are provided in the report……..

 

Traumatic Brain Injury: Therapeutic Assessment

This segment of the report provides insights about the different Traumatic Brain Injury drugs segregated based on following parameters that define the scope of the report, such as:

 

Major Players in Traumatic Brain Injury

There are approx. 20+ key companies which are developing the therapies for Traumatic Brain Injury. The companies which have their Traumatic Brain Injury drug candidates in the most advanced stage, i.e. Phase II include, Oragenics, Inc.

 

Phases

DelveInsight’s report covers around 22+ 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

Traumatic Brain Injury 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.

 

Traumatic Brain Injury: Pipeline Development Activities 

The report provides insights into different therapeutic candidates in Phase III, II, I, preclinical and discovery stage. It also analyses Traumatic Brain Injury 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 Traumatic Brain Injury drugs.

 

Traumatic Brain Injury Report Insights

• Traumatic Brain Injury Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

 

Traumatic Brain Injury 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 Traumatic Brain Injury drugs?
• How many Traumatic Brain Injury drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Traumatic Brain Injury?
• What are the key collaborations (Industry–Industry, Industry–Academia), Mergers and acquisitions, licensing activities related to the Traumatic Brain Injury 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 Traumatic Brain Injury and their status?
• What are the key designations that have been granted to the emerging drugs?