A study to assess the effect of Gocovri (extended-release amantidine) to improve disability as assessed by the disability rating scale (DRS) and cognition as assessed by the Montreal Cognitive Assessment (MoCA) test in patients with radiation encephalopathy.

Start Date01 Sep 2025

Sponsor / Collaborator

Weill Medical College of Cornell University

[+1]

NCT06234462

/ RecruitingPhase 2IIT

Feasibility Study of Amantadine for Cognitive Dysfunction in Patients With Long-Covid: A Pilot Randomized Control Trial

Purpose: To decrease symptom burden, improve cognitive function, improve endurance, and decrease fatigue in subjects with post-acute sequelae of COVID-19 (PASC) or "long-hauler" COVID using amantadine. If amantadine use is determined to be efficacious in this population, the findings of this study will be used towards a subsequent randomized control trial.

Start Date01 Jun 2025

Sponsor / Collaborator

The University of Texas Southwestern Medical Center

CTRI/2025/04/085165

/ Not yet recruitingNot ApplicableIIT

Evaluation of efficacy of add on oral amantadine in children and adolescents with subacute sclerosing panencephalitis aged less than 18years: A randomized controlled trial - nil

Start Date21 May 2025

Sponsor / Collaborator

All India Institute of Medical Sciences

100 Clinical Results associated with Amantadine Hydrochloride

100 Translational Medicine associated with Amantadine Hydrochloride

100 Patents (Medical) associated with Amantadine Hydrochloride

8,486

Literatures (Medical) associated with Amantadine Hydrochloride

01 Dec 2025·JOURNAL OF AFFECTIVE DISORDERS

Comparative efficacy of antidepressant augmentation with amantadine vs pramipexole in treatment-resistant unipolar depression: A randomised controlled trial

Article

Author: Mohapatra, Debadatta ; Panigrahi, Sahadeb ; Maiti, Rituparna ; Biswas, Tathagata ; Mishra, Biswa Ranjan ; Mishra, Archana

BACKGROUND:

Augmentation strategies for treatment-resistant depression (TRD) are limited, with strongest evidence for atypical antipsychotics. Given emerging insights into the neurobiology of TRD, new drug classes merit investigation. We hypothesised that augmentation with amantadine (NMDA antagonist) and pramipexole (dopamine agonist) would show comparable efficacy and safety to quetiapine in TRD.

METHODS:

In this open-label trial, 150 patients with TRD were equally randomised to receive amantadine 200 mg/day, pramipexole 37.5 mg/day, or quetiapine 100 mg/day, as augmentation to ongoing sertraline. The Hamilton Depression Rating Scale (HAM-D21) and Clinical Global Impression (CGI)-Severity and CGI-Improvement scales were assessed and compared within and between the groups at baseline, four, and eight weeks. Serum Brain-Derived Neurotrophic Factor (BDNF) and Nerve Growth Factor (NGF) were measured at baseline, four and eight weeks to evaluate and compare neurotrophic changes between the groups alongside clinical response.

RESULTS:

Mixed-model ANOVA revealed significant HAM-D and CGI-S reductions in all three groups over eight weeks (p < 0.001). Between-group analysis revealed pramipexole was significantly better compared to both amantadine and quetiapine on all clinical measures at weeks four and eight (p < 0.001). Amantadine and quetiapine showed comparable efficacy (p > 0.05). BDNF and NGF levels increased significantly within each group (p < 0.001), but between-group differences were non-significant (p > 0.05). The three groups reported similar occurence of adverse events (p = 0.184).

CONCLUSION:

Augmentation with amantadine and pramipexole were safe and effective in TRD. Additionally, pramipexole showed better efficacy to amantadine and quetiapine. Clinical improvements corroborated with improved BDNF and NGF levels. However, larger multi-centric studies are warranted for generalisability. (ClinicalTrials.gov: NCT04936126).

01 Dec 2025·JOURNAL OF COMPUTER-AIDED MOLECULAR DESIGN

Computational exploration and molecular dynamics simulations for investigating the potential inhibitory mechanism of amantadine on the ion channel activity of bovine viral diarrhea virus p7

Article

Author: Chen, Xiaowei ; Wu, Yulong ; Li, Yongfeng ; Zhang, Daolai ; Wang, Xiao ; Liu, Ziwei

Bovine viral diarrhea virus (BVDV) p7 functions as a viroporin for the ion balance and membrane permeabilization. Blocking the function of the viroporin is a promising strategy for the treatment of viral infection. Previous studies have demonstrated that the antiviral drug amantadine inhibits BVDV replication by inhibiting BVDV p7 activity. However, the mechanism by which amantadine acts against BVDV p7 remains unclear. In this study, AlphaFold2, molecular docking and molecular dynamics (MD) simulations were employed to investigate the binding sites of amantadine on BVDV p7. Structural analysis by AlphaFold2 and MD simulations showed that BVDV p7 may undergo antiparallel oligomerization, forming a stable hexamer that generates a pore channel. Notably, residues E21, Y25, L28, and R34 within the channel are likely involved in ion transport. Subsequently, the interaction of amantadine with BVDV p7 hexamer was investigated by docking studies and MD simulations analysis, indicating residues Y25 and L28 by van der Waals forces, alkyl and Pi-Alkyl interactions with amantadine. Importantly, the hydrogen bonding was observed between the -NH₃⁺ group of amantadine and residue Y25. By integrating these findings with the potential hexameric assembly of BVDV p7, we further proposed a potential ion channel model in which E21, Y25 and R34 are hypothesized to selectively recruit and dehydrate ions, while residue L28 acts as a hydrophobic restrictor, limiting the free movement of water. The binding of amantadine to residues Y25 and L28 likely disrupts ion transport. Our findings provide possible structural insights into the BVDV p7 ion channel and offer a mechanistic explanation for the inhibitory of amantadine on BVDV p7-mediated ion channel conductance, though experimental validation remains necessary.

01 Oct 2025·SPECTROCHIMICA ACTA PART A-MOLECULAR AND BIOMOLECULAR SPECTROSCOPY

Cocrystallization of amantadine hydrochloride with nutrient: Insights into directed self- assembly and optimized biopharmaceutical character by integrating theory and experiment

Article

Author: Wu, Zhi-Yong ; Li, Yan-Tuan ; Zhao, Ming-Yu ; Wang, Ling-Yang ; Bu, Fan-Zhi

In order to make full use of the advantages of phenolic acid nutraceutical p-coumaric acid (COA) in cocrystallizing with antiviral medication amantadine hydrochloride (ADH), further get innovative insights into assembling ADH-nutraceutical cocrystal and optimizing biopharmaceutical characters of ADH by combining experiment with theory, a novel cocrystal, ADH-COA, is prepared and structurally characterized. Single-crystal X-ray diffraction confirms that the cocrystal consists of COA and ADH molecules in a 1:2 ratio, building a three-dimensional supramolecular network strengthened by charge-assisted hydrogen bonds and tightly packed patterns, which is distinguished by two distinct conformations H-1 and H-2 arising from neutral COA molecules with different counter-ions of ADH within the lattice. These features endow the cocrystal with promoting charge dispersion and polarity reduction, resulting in 37.11 ∼ 41.39 % solubility reduction under different pH conditions versus raw ADH, contributing to mitigating side effects associated with excessive solubility of ADH. Such change of in vitro property, in turn, optimizes in vivo pharmacokinetics, showcasing the lengthened half-life and enhanced 1.45-fold bioavailability. Emphatically, these experimental findings are corroborated by DFT-based theoretical models, demonstrating some positive correlations between macroscopic properties and microstructures of the cocrystal. Thereby, the dual-optimization of in vivo/vitro properties of ADH allows to be fulfilled through the cocrystallization-driven strategy.

News (Medical) associated with Amantadine Hydrochloride

31 Jul 2025

·www.globenewswire.com

Supernus Pharmaceuticals Completes Acquisition of Sage Therapeutics

Acquisition strengthens Supernus’ leading presence in neuropsychiatric conditions with an innovative commercial product, ZURZUVAE® (zuranolone), and a novel CNS discovery platform, accelerating mid- to long-term revenue and cash flow growth and further diversifying revenue baseROCKVILLE, Md., July 31, 2025 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN) (“Supernus”) today announced that it has successfully completed its previously announced acquisition of Sage Therapeutics, Inc. (Nasdaq: SAGE) (“Sage”). “Sage is an ideal fit in our corporate development strategy, adding a significant fourth growth product to our portfolio and further diversifying our sources of future revenue,” said Jack Khattar, President and CEO of Supernus Pharmaceuticals. “With our proven track record of strong commercial execution along with the expected cost synergies, the acquisition is expected to be accretive in 2026.” Compelling Strategic Rationale Strengthens psychiatry portfolio with ZURZUVAE® (zuranolone) capsules CIV, the first and only FDA-approved oral medicine indicated for the treatment of postpartum depression in adults.Diversifies and increases revenue base and cash flow: Addition of collaboration revenue from net sales of ZURZUVAE (50% of total net revenue Biogen, Inc. records for ZURZUVAE in the U.S. pursuant to a collaboration agreement), andCombined with its three other growth products (Qelbree®, ONAPGO™, and GOCOVRI®), Supernus believes it is poised for significant future growth. Augments Supernus central nervous system discovery platforms and expertise.Strong fit with existing Supernus infrastructure is expected to result in cost synergies of up to $200 million on an annual basis.The acquisition is expected to be accretive in 2026. The Offer and the Merger The Offer and withdrawal rights for all outstanding shares of common stock, par value $0.0001 per share (the “Shares”), of Sage in exchange for (i) $8.50 per Share, net to the seller in cash, subject to any withholding of taxes and without interest (the “Closing Amount”), plus (ii) one non-transferable and non-tradable contingent value right per Share (a “CVR”), which represents the right to receive up to $3.50 per Share upon the satisfaction of specified milestones (as described further in the Offer to Purchase), net to the seller in cash, without interest and subject to any withholding of taxes, pursuant to the CVR Agreement (the Closing Amount plus one CVR collectively, the “Offer Price”), expired as scheduled at one minute following 11:59 p.m., New York time, on July 30, 2025 (the “Expiration Time”). Each CVR paid to Sage stockholders represents a non-transferable and non-tradable contractual contingent right to receive a cash payment of up to $3.50, net to the seller in cash, subject to any withholding of taxes and without interest, upon the achievement of certain milestones in accordance with the terms of the Contingent Value Rights Agreement entered into between Supernus and Equiniti Trust Company, LLC as rights agent, (the “CVR Agreement”). One milestone payment of $0.50 per CVR, net to the seller in cash, subject to any withholding of taxes and without interest, is payable (subject to certain terms and conditions) upon the first commercial sale after Regulatory Approval (as defined in the CVR Agreement) in Japan to a third-party customer of the pharmaceutical product that is marketed in the United States under the name ZURZUVAE and is the subject of the current regulatory filing (including any amended filings based thereon) by Shionogi & Co., Ltd., inclusive of its affiliates, in Japan for Major Depressive Disorder by June 30, 2026. A second milestone payment of $1.00 per CVR, net to the seller in cash, subject to any withholding of taxes and without interest, is payable (subject to certain terms and conditions) if Net Sales (as defined in the CVR Agreement) of ZURZUVAE are equal to or exceed $250 million in the United States during a calendar year on or prior to December 31, 2027. A third milestone payment of $1.00 per CVR, net to the seller in cash, subject to any withholding of taxes and without interest, is payable (subject to certain terms and conditions) if Net Sales (as defined in the CVR Agreement) of ZURZUVAE are equal to or exceed $300 million in the U.S. during a calendar year on or prior to December 31, 2028. A fourth milestone payment of $1.00 per CVR, net to the seller in cash, subject to any withholding of taxes and without interest, is payable (subject to certain terms and conditions) if Net Sales (as defined in the CVR Agreement) of ZURZUVAE are equal to or exceed $375 million in the U.S. during a calendar year on or prior to December 31, 2030. Each milestone may only be achieved once. The maximum amount payable with respect to the CVR issued in respect to each Share is $3.50 in the aggregate. There can be no assurance any payments will be made with respect to any CVR. It is possible that no milestone is achieved and no payment is made with respect to the CVRs. Equiniti Trust Company, LLC, the depositary for the Offer, has advised Supernus that a total of 36,313,509 Shares were validly tendered and not validly withdrawn in the Offer, representing approximately 58 percent of the Shares outstanding. All of the conditions of the Offer have been satisfied, and effective as of the Expiration Time, Supernus and its wholly owned subsidiary, Saphire, Inc. (“Purchaser”), accepted for payment all Shares that were validly tendered and not validly withdrawn in the Offer, and will as promptly as practicable thereafter pay for all such validly tendered Shares. Following the completion of the Offer, Supernus completed the acquisition of Sage through the merger of Purchaser with and into Sage, without a vote of Sage stockholders in accordance with Section 251(h) of the General Corporation Law of the State of Delaware (“DGCL”), with Sage surviving the merger as a wholly owned subsidiary of Supernus. In connection with the merger, each Share not previously purchased in the Offer (other than (i) Shares held by Sage (or held in Sage’s treasury) immediately prior to the effective time of the merger, (ii) any Shares held by Supernus or Purchaser or any direct or indirect wholly owned subsidiary of Supernus or Purchaser immediately prior to the effective time of the merger, or (iii) Shares held by any stockholder who was entitled to appraisal rights under Section 262 of the DGCL and properly exercised and perfected their respective demands for appraisal of such Shares pursuant to Section 262 of the DGCL and, as of the effective time of the merger, has neither effectively withdrawn nor lost their rights to such appraisal and payment under the DGCL with respect to such Shares) was converted into the right to receive the Offer Price, less any applicable withholding taxes and without interest. The Shares will be delisted from the Nasdaq Global Market. Advisors Moelis & Company LLC acted as the exclusive financial advisor to Supernus. Goldman Sachs & Co. LLC acted as the exclusive financial advisor to Sage. Saul Ewing LLP served as legal counsel to Supernus. Kirkland & Ellis LLP served as legal counsel to Sage. About Supernus Pharmaceuticals, Inc. Supernus Pharmaceuticals (the Company) is a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases. Our diverse neuroscience portfolio includes approved treatments for attention-deficit hyperactivity disorder (ADHD), dyskinesia in Parkinson’s disease (PD) patients receiving levodopa-based therapy, hypomobility in PD, postpartum depression (PPD), epilepsy, migraine, cervical dystonia, and chronic sialorrhea. We are developing a broad range of novel product candidates for CNS disorders. For more information, please visit www.supernus.com. Forward-Looking Statements This press release includes forward-looking statements. These statements do not convey historical information but relate to predicted or potential future events that are based upon management's current expectations. These statements are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. In addition to the factors mentioned in this press release, such risks and uncertainties include, but are not limited to, the Company’s ability to sustain and increase its profitability; the Company’s ability to raise sufficient capital to fully implement its corporate strategy; the implementation of the Company’s corporate strategy; the Company’s future financial performance and projected expenditures; the Company’s ability to increase the number of prescriptions written for each of its products, the products of its subsidiaries and products acquired through the acquisition of Sage; the Company’s ability to increase its net revenue from its products, the products of its subsidiaries and products acquired through the acquisition of Sage; the Company’s ability to commercialize its products, the products of its subsidiaries and products acquired through the acquisition of Sage; the Company’s ability to enter into future collaborations with pharmaceutical companies and academic institutions or to obtain funding from government agencies; the Company’s product research and development activities, including the timing and progress of the Company’s clinical trials, and projected expenditures; the Company’s ability to receive, and the timing of any receipt of, regulatory approvals to develop and commercialize the Company’s product candidates; the Company’s ability to protect its intellectual property and the intellectual property of its subsidiaries and operate its business without infringing upon the intellectual property rights of others; the Company’s expectations regarding federal, state and foreign regulatory requirements; the therapeutic benefits, effectiveness and safety of the Company’s product candidates; the accuracy of the Company’s estimates of the size and characteristics of the markets that may be addressed by its product candidates; the Company’s ability to increase its manufacturing capabilities for its products and product candidates; the Company’s projected markets and growth in markets; the Company’s product formulations and patient needs and potential funding sources; the Company’s staffing needs; and other risk factors set forth from time to time in the Company’s filings with the Securities and Exchange Commission made pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934, as amended. The Company undertakes no obligation to update the information in this press release to reflect events or circumstances after the date hereof or to reflect the occurrence of anticipated or unanticipated events. CONTACTS: Jack A. Khattar, President and CEOTimothy C. Dec, Senior Vice President and CFOSupernus Pharmaceuticals, Inc.(301) 838-2591 INVESTOR CONTACT: Peter VozzoICR Healthcare(443) 213-0505peter.vozzo@icrhealthcare.com

Drug ApprovalAcquisitionExecutive Change

07 Jul 2025

·www.prnewswire.com

Traumatic Brain Injury Market to Expand at a CAGR of 10.9% During the Study Period (2020-2034) Fueled by Advances in Treatment and Growing Healthcare Investments | DelveInsight

Pharmaceutical companies have made significant investments in traumatic brain injury drug development, although the late-stage pipeline remains limited. However, several early-phase clinical trials are ongoing, with promising mid- and late-stage trial results expected to expand the traumatic brain injury therapeutic market in the coming years. Historically, moderate-to-severe traumatic brain injuries have been the focus of research efforts, and concussive injuries (mild traumatic brain injuries) have been disregarded. Now, clinical research on mild traumatic brain injuries (mild TBI) is now gaining momentum, marking a crucial shift in their diagnosis, treatment, and long-term effects. LAS VEGAS, July 7, 2025 /PRNewswire/ -- DelveInsight's Traumatic Brain Injury Market Insights report includes a comprehensive understanding of current treatment practices, traumatic brain injury emerging drugs, market share of individual therapies, and current and forecasted market size from 2020 to 2034, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan]. Key Takeaways from the Traumatic Brain Injury Market Report According to DelveInsight's analysis, the market size for traumatic brain injury was found to be USD 1.3 billion in the 7MM in 2024. Among the 7MM, the US captured the highest market in 2024, covering a total 85% of the market, followed by Japan, which is anticipated to grow during the forecast period (2025–2034). In July 2024, SanBio' AKUUGO became the "first brain regeneration therapy" to receive conditional approval in Japan for the treatment of TBI. Among the forecasted emerging therapies, OXE103 is expected to capture the highest market in the 7MM by 2034. According to DelveInsight's assessment in 2024, the 7MM had 4.3 million incident cases of TBI, and these cases are expected to reach 4.5 million by 2034. In the 7MM, males represent a higher percentage of all TBI incident cases. Leading traumatic brain injury companies developing emerging therapies, such as Oxeia Biopharmaceuticals, Hope Biosciences, Oragenics, Cellvation, SHINKEI Therapeutics, and others, are developing novel traumatic brain injury drugs that can be available in the traumatic brain injury market in the coming years. The promising traumatic brain injury therapies in the pipeline include OXE113, HB-AdMSCs, ONP-002, CEVA111, MR-301, and others. Discover more about the mild traumatic brain injury treatment market @ Traumatic Brain Injury Medication Traumatic Brain Injury Market Dynamics The traumatic brain injury market dynamics are expected to change in the coming years. Decades of innovation have led to powerful diagnostic tools like modern CT scanners and MRI machines, which can detect neuro-traumatic disorders more quickly and accurately, providing critical information in the vital hours after injury. In 2024, AKUUGO became the world's first cell therapy approved in Japan for traumatic brain injury (TBI), setting a clinical and regulatory precedent that strengthens the market and opens new avenues for innovation. With growing recognition of TBI as a chronic health condition, particularly in moderate-to-severe cases, there is increasing focus on therapies that address its long-term effects, creating significant opportunities for companies to capture market share and shape the future of TBI treatment. AKUUGO has received multiple regulatory designations, including Sakigake designation (April 2019) and priority review designation (January 2022) from Japan's MHLW, orphan regenerative medicine designation (June 2020) from MHLW, RMAT designation (September 2019) from the US FDA, and ATMP designation (April 2019) from the EMA, recognizing its potential in treating chronic traumatic brain injury. Furthermore, potential therapies are being investigated for the treatment of traumatic brain injury, and it is safe to predict that the treatment space will significantly impact the traumatic brain injury market during the forecast period. Moreover, increased awareness of the silent epidemic of "mild injury", anticipated introduction of emerging therapies with improved efficacy, and a further improvement in the diagnosis trend of mild TBI are expected to drive the growth of the traumatic brain injury market in the 7MM. Most people ( up to 90%) suffer a mild TBI and lack of effective treatments for "mild TBI" on civilian, athlete, and military populations become increasingly apparent. Working together, developers, investors, and academic researchers are making progress in creating efficient medication solutions and addressing this unmet medical need. At present, drug development for concussions (mild TBI) is at an exciting moment, as several key players are targeting this untapped segment of TBI. However, several factors may impede the growth of the traumatic brain injury market. As many as 30% of concussion patients experience persistent post-concussion symptoms and long-term effects—a significantly higher occurrence than one might expect, especially given the limited awareness within the medical community. Despite this, there are currently no FDA-approved treatments for acute concussion, with rest and gradual return to activity remaining the standard of care. However, the development of new treatments is hindered by stringent regulatory requirements and lengthy approval processes, which can stifle innovation. Moreover, the prevalent use of polypharmacy in TBI management increases the risk of adverse drug interactions, side effects, and reduced efficacy, complicating patient care and driving up healthcare costs. Furthermore, traumatic brain injury treatment poses a significant economic burden and disrupts patients' overall well-being and quality of life (QoL). Furthermore, the traumatic brain injury market growth may be offset by failures and discontinuation of emerging therapies, unaffordable pricing (especially for cell therapies), market access and reimbursement issues, and l ow compliance and adherence to the prescribed therapies. In addition, the undiagnosed, unreported cases and the unawareness about the disease may also impact the traumatic brain injury market growth. Traumatic Brain Injury Treatment Market Managing medications for individuals with traumatic brain injury is both complex and rewarding. These challenges are unsurprising given the intricacies of the brain and the many aspects that remain poorly understood. Although there are foundational principles that guide medication use, implementing them has become increasingly difficult due to systemic healthcare constraints, especially those related to reimbursement policies and rehabilitation timelines. Nonetheless, maintaining these principles is essential. TBI treatment involves a combination of medical interventions, rehabilitation, and ongoing support, with approaches tailored to the severity of the injury. This can range from cognitive therapies to surgical procedures such as bilateral decompressive craniotomies. While clinical guidelines provide a framework, they must be individualized for each patient. Currently, treatment often depends on off-label use of various drug classes targeting symptom management, though these approaches frequently face high discontinuation rates. In response to these challenges, numerous companies are actively pursuing more effective therapeutic options to improve outcomes for individuals with TBI. One notable advancement occurred in July 2024, when AKUUGO became the first brain regeneration therapy to receive conditional approval in Japan. This allogeneic cell therapy is intended for patients with chronic motor paralysis resulting from TBI. The company plans to conduct a post-marketing study during the seven-year approval period and aims to begin sales by late 2025, with intentions to pursue Phase III trials in discussions with the US FDA (Food and Drug Administration) and the EMA (European Medicines Agency). To know more about FDA-approved drugs for traumatic brain injury, visit @ Traumatic Brain Injury Treatment Traumatic Brain Injury Pipeline Therapies and Key Companies Some of the drugs in the pipeline include OXE103 (Oxeia Biopharmaceuticals), HB-AdMSCs (Hope Biosciences), ONP-002 (Oragenics), CEVA101 (Cellvation), MR-301 (SHINKEI Therapeutics), and others. OXE103 is a synthetic version of human ghrelin, a naturally occurring hormone. It can easily cross the blood–brain barrier and plays a role in restoring metabolic and energy imbalances in the brain following a concussion. OXE103 specifically targets the hippocampus, a brain region critical for memory and cognitive function. In February 2025, the company announced plans to begin Phase IIb clinical trials for OXE103 later in the year. In June 2024, Oxeia Biopharmaceuticals shared that findings from a study conducted at the University of Kansas Medical Center, examining OXE103's effectiveness in treating subacute concussion, were published in the April issue of Archives of Physical Medicine and Rehabilitation, a journal of the ACRM. HB-AdMSCs are mesenchymal stem cells derived from adipose (fat) tissue and developed using Hope Biosciences' proprietary culturing technology. The company specializes in the culturing and banking of stem cells. In June 2023, UTHealth Houston received a nearly USD 5 million, four-year clinical trial grant from the Department of Defense's CDMRP to study whether intravenous administration of Hope Biosciences' autologous HB-adMSCs can reduce chronic neuroinflammation in patients with severe traumatic brain injury (TBI). In May 2023, preliminary data from a prior Phase I/IIa study involving 24 patients (NCT04063215), sponsored by UTHealth, were presented at the 2023 Cellular Therapies and Transfusion Medicine in Trauma and Critical Care Conference in Scottsdale, Arizona. ONP-002 is a novel, first-in-class enantiomeric neurosteroid in development for mild traumatic brain injury (mTBI), such as concussion. Its intellectual property covers its molecular structure, synthesis, and therapeutic applications. In preclinical models, ONP-002 has shown rapid molecular and behavioral improvements following neuronal injury. In March 2025, Oragenics announced it had submitted an Investigator's Brochure (IB) in preparation for a Phase II clinical trial of ONP-002 in Australia. This step marks significant progress in developing this intranasal neurosteroid as a treatment for mTBI. A proof-of-concept Phase IIb trial is also planned (third quarter of 2025) in the U.S. under an open Investigational New Drug (IND) approved by the FDA. The anticipated launch of these emerging therapies are poised to transform the traumatic brain injury market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the traumatic brain injury market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. Discover more about traumatic brain injury drugs in development @ Traumatic Brain Injury Clinical Trials Recent Developments in the Traumatic Brain Injury Market In March 2025, Oragenics announced the submission of its Investigator's Brochure (IB) application in preparation for its Phase II clinical trial using ONP-002 in Australia. This milestone represents an important step in advancing ONP-002, a novel intranasal neurosteroid, as a potential treatment for mTBI. In February 2025, SanBio announced that it had successfully secured the planned production yield for the second commercial production run of AKUUGO Suspension for Intracranial Implantation, conducted to meet the shipment conditions required for obtaining product approval, in December 2024. In February 2025, Oxeia Biopharmaceuticals announced that it is planning to initiate the Phase IIb trials for OXE103 later in 2025. In February 2025, Oragenics announced a strategic partnership with BRAINBox Solutions, a leader in multi-modality diagnostics for TBI. In January 2025, SanBio entered into a manufacturing agreement with JCR Pharma for the production of AKUUGO. Traumatic Brain Injury Overview Traumatic brain injury (TBI) occurs when the brain is suddenly harmed due to a blow or jolt to the head. It often results from incidents such as vehicle collisions, falls, sports-related accidents, or violent assaults. The severity of injury can vary widely, from minor concussions to severe, lasting brain damage. The initial damage sustained at the moment of impact is referred to as the primary injury, which can affect either a specific region of the brain or the entire organ. While a skull fracture might be present, it's not always the case. During a traumatic event, the brain can move forcefully within the skull, leading to bruising, bleeding, or tearing of nerve tissue. TBI symptoms can be mild, moderate, or severe, depending on the extent of the brain injury. Someone with a mild TBI might stay conscious or briefly lose consciousness for just a few seconds or minutes. Other signs of mild TBI can include headache, dizziness, confusion, blurred or fatigued vision, ringing in the ears, unusual taste in the mouth, tiredness, changes in sleep, mood, or behavior shifts, and difficulties with memory, attention, or thinking. There isn't a single definitive test to diagnose TBI. Instead, doctors evaluate the injury through a combination of medical history, symptoms, physical examination, and imaging studies like neuroimaging. Many individuals with TBI lose consciousness at the time of injury—this may last from mere seconds to minutes, although in severe cases, it can extend to days or even longer. Not all mild TBI cases involve loss of consciousness, but many individuals experience some degree of memory loss around the time of the trauma, which can last from minutes to hours or more. Traumatic Brain Injury Epidemiology Segmentation The traumatic brain injury epidemiology section provides insights into the historical and current traumatic brain injury patient pool and forecasted trends for the 7MM. It helps recognize the causes of current and forecasted patient trends by exploring numerous studies and views of key opinion leaders. The traumatic brain injury market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM, segmented into: Total Incident Cases of TBI Severity-specific Distribution of Incident Cases of TBI Gender-specific Distribution of Incident Cases of TBI Age-specific Distribution of Incident Cases of TBI Scope of the Traumatic Brain Injury Market Report Therapeutic Assessment: Traumatic Brain Injury current marketed and emerging therapies Traumatic Brain Injury Market Dynamics: Key Market Forecast Assumptions of Emerging Traumatic Brain Injury Drugs and Market Outlook Competitive Intelligence Analysis: SWOT analysis and Market entry strategies Unmet Needs, KOL's views, Analyst's views, Traumatic Brain Injury Market Access and Reimbursement Download the report to understand the traumatic brain injury assessment & management devices market @ Traumatic Brain Injury Market Report Table of Contents Related Reports Traumatic Brain Injury Pipeline Traumatic Brain Injury Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key TBI companies, including 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, among others. Traumatic Brain Injury Assessment Devices Market Traumatic Brain Injury Assessment Devices Market Insights, Competitive Landscape and Market Forecast – 2032 report deliver an in-depth understanding of the market trends, market drivers, market barriers, and key traumatic brain injury assessment devices companies including BrainScope Company Inc, NOVASIGNAL CORPORATION, Compumedics Limited, Integra LifeSciences Corporation, Natus Medical Incorporated, InfraScan Inc, Dr. Langer Medical GmbH, RAUMEDIC AG, SyncThink Inc, Imeka, General Electric Company, pro2cool Tectrum, NanoDx, NIHON KOHDEN CORPORATION, Elekta, Advanced Brain Monitoring Inc, Boston Scientific Corporation, ESAOTE SPA, Koninklijke Philips N.V, Vivonics Inc., among others. Alzheimer's Disease Market Alzheimer's Disease Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key Alzheimer's disease companies, including BioVie, AB Science, Cassava Sciences, TauRx Therapeutics, Novo Nordisk, KeifeRx, Eli Lilly, AriBio, Cerecin, Alzheon, Neurim Pharmaceuticals, Syneos Health, Athira Pharma, Annovis Bio, Anavex Life Sciences, AgeneBio, Eisai, among others. Parkinson's Disease Market Parkinson's Disease Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key Parkinson's disease companies, including UCB Biopharma SRL, Novartis, Annovis Bio, Supernus Pharmaceuticals, Inc., Britannia Pharmaceutical, Pharma Two B, Mitsubishi Tanabe Pharma (NeuroDerm), AbbVie, Cerevel Therapeutics, LLC, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . 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Phase 2Orphan DrugCell TherapyDrug Approval

16 Jun 2025

·www.biospace.com

Sage’s Story Comes to ‘Good End’ With Up To $795M Acquisition by Supernus

iStock, master1305 Stifel analysts said the deal “feels like an unremarkable outcome for a company that was once one of the hottest stories in CNS.” Supernus’ offer beats Biogen’s unsolicited bid of about $7.22 per share, which arrived with a thud in late January. Sage Therapeutics has agreed to be acquired by Supernus Pharmaceuticals for up to $795 million, marking a “good end” to the biotech’s story, according to analysts. The deal comes about five months after Sage balked at an unsolicited offer from its Zurzuvae development partner Biogen, which was valued at about $470 million. The companies announced the acquisition Monday morning . Supernus is offering $8.50 per share in cash, or $561 million, at closing. The deal also includes a non-tradable contingent value right (CVR) of $3.50 per share, or $234 million, payable upon certain sales and commercial milestones. That brings the deal, which is expected to close in the third quarter, up to $12 per share in cash or $795 million. Stifel analysts wrote in a note to investors that the deal “feels like an unremarkable outcome for a company that was once one of the hottest stories in [central nervous system disorders].” Nevertheless, it is a “good end” for the company, which had been facing myriad challenges including a lack of strategic control over lead asset Zurzuvae, the analysts said. The postpartum depression drug was developed with Biogen and received a limited label upon approval in August 2023. Sage’s shares rose 36% in premarket trading Monday morning to $9.17. The stock has fallen 41% over the past year after hitting a price of over $90 in 2021. Supernus’ offer beats Biogen’s unsolicited bid of about $7.22 per share, which arrived with a thud in late January. Sage immediately recoiled at the idea, suing Biogen to stop it. Stifel had assumed that Biogen would return with a “sweetened offer,” but that never happened. Either way, Stifel did not voice much hope for Sage continuing on its own. “As we see it, for Sage to create value as an independent company, it would’ve required either a substantial acceleration in the PPD launch, or a surprise to the upside from the pipeline—the latter being a higher risk strategy, and a ‘show me story for the street, that would’ve burned significant capital,” the analysts wrote. The deal does not put much weight in Sage’s pipeline, Stifel added. Supernus noted the potential of Zurzuvae to boost growth and diversify its portfolio. The drug, for postpartum depression, brought in $36.1 million in 2024 and has already taken home $13.8 million for the first quarter. The company also has three approved CNS medicines, Qelbree, ONAPGO and Gocovri, plus five other products. Supernus and partner Biogen will have to significantly grow Zurzuvae sales for shareholders to see any benefit from the CVR. They will receive $1 of the CVR if Zurzuvae reaches $250 million in a calendar year between now and 2027; $1 if it reaches $300 million between now and the end of 2028; and $1 if sales reach $375 million between now and the end of 2030. Another 50 cents per share will be allocated if Zurzuvae is approved in Japan for major depressive disorder and achieves an initial commercial sale there. The FDA declined to grant an indication for MDD, instead keeping the label narrowed to PPD. Sage CEO Barry Greene said in the company’s announcement that the deal concludes a strategic review conducted by the board of directors and he is “confident this deal maximizes value for shareholders.”

AcquisitionDrug Approval

100 Deals associated with Amantadine Hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
D00777	Amantadine Hydrochloride	N04BB01	DB00915

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Drug-induced extrapyramidal side effects	United States	Supernus Pharmaceuticals, Inc.	16 Feb 2018
Parkinsonian Disorders	United States	Supernus Pharmaceuticals, Inc.	24 Aug 2017
Influenza A virus infection	Japan	Sun Pharma Japan Ltd.	27 Nov 1998
Brain Infarction	Japan	Sun Pharma Japan Ltd.	02 Oct 1987
Influenza, Human	China	Wuhan Zhonglian Pharmaceutical Group Co. Ltd.	01 Jan 1981
Parkinson Disease	Japan	Sun Pharma Japan Ltd.	15 Apr 1975

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Difficulty walking	Phase 3	United States	Adamas Pharmaceuticals LLC	29 Mar 2018
Difficulty walking	Phase 3	Canada	Adamas Pharmaceuticals LLC	29 Mar 2018
Multiple Sclerosis	Phase 3	United States	Adamas Pharmaceuticals LLC	29 Mar 2018
Multiple Sclerosis	Phase 3	Canada	Adamas Pharmaceuticals LLC	29 Mar 2018
Dyskinesia, Drug-Induced	Phase 3	United States	Adamas Pharmaceuticals LLC	01 May 2014
Dyskinesia, Drug-Induced	Phase 3	Canada	Adamas Pharmaceuticals LLC	01 May 2014
Radiation induced encephalopathy	Phase 2	United States	Supernus Pharmaceuticals, Inc.	01 Sep 2025

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04387773 (CTgov)	Phase 4	Parkinson Disease	8	GOCOVRI	oukyjvdzsk(qpfhcocwfj) = ifgipqhejk hpsmhdfddv (kjqfefbayi, 6.23) View more	-	10 Oct 2024
MDS2023	Not Applicable	Parkinson Disease	53	Responders to amantadine	nmxxrqbrvn(hxpruupica) = ihbrtjwlve zbttdkpedx (ambzrkbxjm )	-	27 Aug 2023
				Nonresponders to amantadine	nmxxrqbrvn(hxpruupica) = cqtxrkkifi zbttdkpedx (ambzrkbxjm )
NCT04952519 (Pubmed \| Respir Med)	Phase 3	COVID-19	193	Amantadine	ifxistftqo(vcnvtishjx) = znazmlrsop tyyvsbqiyy (zijhgkdzcs, 9 - 11)	Negative	15 Mar 2023
				Placebo	ifxistftqo(vcnvtishjx) = xosxcorqhk tyyvsbqiyy (zijhgkdzcs, 8 - 11)
MDS2022	Phase 3	Dyskinesias	-	AMT DR/ER	azsnhgnjje(uqtxzrcnsv) = ajypzoazgq vcfmevlyig (jnbfmyujhp ) View more	-	15 Sep 2022
				Placebo	azsnhgnjje(uqtxzrcnsv) = btpstgxxyv vcfmevlyig (jnbfmyujhp ) View more
NCT04273737 (CTgov)	Phase 4	Cognitive Dysfunction \| Cerebral Palsy	11	Amantadine Hydrochloride	jquihneorj(nmzcawdgji) = hlyuaoxtsj iryckqzvjj (qafiysxubm, 8.050) View more	-	31 May 2022
NCT03567057 (CTgov)	Phase 3	Multiple Sclerosis \| Difficulty walking	424	Placebo+ADS-5102 (Placebo/274 mg ADS-5102)	kmvzyxrtkt = bwnclodund fjwjknajzo (yqgkxrbggu, yosipvbhag - aluacmwmml) View more	-	18 Jan 2022
				ADS-5102 (137 mg ADS-5102/274 mg ADS-5102)	kmvzyxrtkt = jjswlxblaz fjwjknajzo (yqgkxrbggu, ccwaefuewn - zjtgpzscfk) View more
NCT03436199 (CTgov)	Phase 3	Multiple Sclerosis \| Difficulty walking	558	Placebo	prvnujmatn = adoyaomals unydzzvvpd (kilkjitxkh, htbwowtdyh - toblfdmspa) View more	-	21 Dec 2021
MDS2021	Phase 3	Parkinson Disease	-	Amantadine IR	htgqknsvxp(mjateuklwh) = barccyjdsf klxbmopmxm (mhlwvcafwa )	Positive	17 Sep 2021
				Amantadine IR/ER	htgqknsvxp(mjateuklwh) = xumekcyszb klxbmopmxm (mhlwvcafwa )
NCT02136914 (MDS2021)	Phase 3	Parkinson Disease	-	Amantadine DR/ER	xlqnodgown(irzokhuimj) = tnmmfxivtb cadfmwjope (nlhotczlpe ) View more	Positive	17 Sep 2021
				Placebo	xlqnodgown(irzokhuimj) = bejlrbprwm cadfmwjope (nlhotczlpe )
NCT00779324 (CTgov)	Not Applicable	Aggression \| Brain Injury, Chronic \| Irritable Mood ... View more	168	Amantadine Hydrochloride (Amantadine)	uxxsrsizte = vvpbisyfoy lfghdiigli (vwfcxczitm, vduahhmzau - mpgtupscit) View more	-	10 Sep 2021
				Placebo (Placebo)	uxxsrsizte = mcyqqjkqqq lfghdiigli (vwfcxczitm, rszpvbarzi - yvtbqiyxdn) View more

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