DelveInsight’s “Traumatic Brain Injury Pipeline Insight 2025” report provides comprehensive insights about 20+ companies and 22+ pipeline drugs in Tthe raumatic Brain Injury pipeline landscape. It covers the Traumatic Brain Injury pipeline drug profiles, including clinical and nonclinical stage products. It also covers the Traumatic Brain Injury pipeline therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

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Key Takeaways from the Traumatic Brain Injury Pipeline Report

• In June 2025, Hope Biosciences announced a study is to establish the safety and investigate the potential treatment effect of an intravenous infusion of HB-adMSCs (Hope Biosciences adipose-derived mesenchymal stem cells) on brain structure, neurocognitive/functional outcomes, and neuroinflammation after traumatic brain injury.
• In June 2025, Merz Pharmaceuticals GmbH conducted a study is to determine whether a single treatment with administration of 400 Units NT 201 (botulinum toxin) is superior to placebo (no medicine) for the treatment of lower limb spasticity caused by stroke or traumatic brain injury (Main Period). Participants will be assigned to the treatment groups by chance and neither the participants nor the research staff who interact with them will know the allocation.
• In June 2025, Ipsen organized a study is to assess the safety and efficacy of increasing doses of IPN10200 with the aim to evaluate the Pharmacodynamics (PD) profile of IPN10200 and to establish the total IPN10200 doses(s) that offer the best efficacy/safety profile when used for the treatment of Adult upper limb (AUL) spasticity.
• DelveInsight’s Traumatic Brain Injury pipeline report depicts a robust space with 20+ active players working to develop 22+ pipeline therapies for Traumatic Brain Injury treatment.
• The leading Traumatic Brain Injury Companies such as Oragenics, Inc, SHINKEI Therapeutics, Inc, AlzeCure, Algernon Pharmaceutical, Mitochon Pharmaceuticals, Hoth Therapeutics, Biomed Industries, Inc, BioArctic, Tiziana Life Sciences, TikoMed AB, Levolta Pharmaceuticals, Inc, Boulder BioScience, LLC, International Stem Cell Corporation, Revalesio Corporation, Teleport Pharmaceuticals and others.
• Promising Traumatic Brain Injury Pipeline Therapies such as Flortaucipir F18, NE3107, Amantadine Hydrochloride, VAS203, SB623 cells, Rivastigmine, VAS203, Dexanabinol and others.

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Traumatic Brain Injury Emerging Drugs Profile

• 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.

The Traumatic Brain Injury Pipeline Report Provides Insights into

• The report provides detailed insights about companies that are developing therapies for the treatment of Traumatic Brain Injury with aggregate therapies developed by each company for the same.
• It accesses the Different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for Traumatic Brain Injury Treatment.
• Traumatic Brain Injury Companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.
• Traumatic Brain Injury Drugs under development based on the stage of development, route of administration, target receptor, monotherapy or combination therapy, a different mechanism of action, and molecular type.
• Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement and financing details for future advancement of the Traumatic Brain Injury market

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Traumatic Brain Injury Companies

Oragenics, Inc, SHINKEI Therapeutics, Inc, AlzeCure, Algernon Pharmaceutical, Mitochon Pharmaceuticals, Hoth Therapeutics, Biomed Industries, Inc, BioArctic, Tiziana Life Sciences, TikoMed AB, Levolta Pharmaceuticals, Inc, Boulder BioScience, LLC, International Stem Cell Corporation, Revalesio Corporation, Teleport Pharmaceuticals and others.

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

Traumatic Brain Injury Products have been categorized under various Molecule types such as

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

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Scope of the Traumatic Brain Injury Pipeline Report

• Coverage- Global
• Traumatic Brain Injury Companies- Oragenics, Inc, SHINKEI Therapeutics, Inc, AlzeCure, Algernon Pharmaceutical, Mitochon Pharmaceuticals, Hoth Therapeutics, Biomed Industries, Inc, BioArctic, Tiziana Life Sciences, TikoMed AB, Levolta Pharmaceuticals, Inc, Boulder BioScience, LLC, International Stem Cell Corporation, Revalesio Corporation, Teleport Pharmaceuticals and others.
• Traumatic Brain Injury Pipeline Therapies- Flortaucipir F18, NE3107, Amantadine Hydrochloride, VAS203, SB623 cells, Rivastigmine, VAS203, Dexanabinol and others.
• Traumatic Brain Injury Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination
• Traumatic Brain Injury Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III

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Table of Contents

1. Introduction
2. Executive Summary
3. Traumatic Brain Injury: Overview
4. Pipeline Therapeutics
5. Therapeutic Assessment
6. Traumatic Brain Injury– DelveInsight’s Analytical Perspective
7. Late Stage Products (Phase III)
8. Drug Name: Company Name
9. Drug profiles in the detailed report…..
10. Mid Stage Products (Phase II)
11. ONP-002: Oragenics, Inc.
12. Drug profiles in the detailed report…..
13. Early Stage Products (Phase I)
14. ACD 856: AlzeCure
15. Drug profiles in the detailed report…..
16. Preclinical and Discovery Stage Products
17. Drug Name: Company Name
18. Drug profiles in the detailed report…..
19. Inactive Products
20. Traumatic Brain Injury Key Companies
21. Traumatic Brain Injury Key Products
22. Traumatic Brain Injury- Unmet Needs
23. Traumatic Brain Injury- Market Drivers and Barriers
24. Traumatic Brain Injury- Future Perspectives and Conclusion
25. Traumatic Brain Injury Analyst Views
26. Traumatic Brain Injury Key Companies
27. Appendix

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