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

NCT06817200

/ Not yet recruitingPhase 2IIT

The Effect of Amantadine as add-on Therapy for Motor Fluctuations in Advanced Parkinson's Disease: a Randomized Double-blinded Placebo-controlled Trial

Motor fluctuations are identified as the most challenging symptoms by parkinson disease patients. A recent post-hoc analysis of ADS-5012 trials (new formulation of ER Amantadine), revealed a significant improvement in OFF-time. No randomized clinical trial has ever specifically investigated to date the effect of amantadine IR on motor fluctuations. The main objective of this study is to evaluate the effect of amantadine (300 mg/day) as add-on therapy for the treatment of motor fluctuations (Off-time) in advanced Parkinson's disease patients versus placebo after 3 months of treatment.

Start Date01 May 2025

Sponsor / Collaborator

Toulouse University Hospital

100 Clinical Results associated with Amantadine Hydrochloride

100 Translational Medicine associated with Amantadine Hydrochloride

100 Patents (Medical) associated with Amantadine Hydrochloride

10,030

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 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.

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

Aliphatic amines – Sensing application in aqueous media using supramolecularly stacked acriflavine dye on graphene oxide

Article

Author: Rajendran, Pavitra ; Selvapalam, Narayanan ; Kannan, Jamuna ; Piramuthu, Lakshminarayanan ; Nagarajan, Erumaipatty Rajagounder ; Sivakumar, Shanmugam

Supramolecularly stacked acriflavine dye on graphene oxide (GO-Acy) was utilized for the first time to detect aliphatic amines, making it a highly sensitive and selective material. This method involved developing a distinctive, discriminative, and highly selective fluorescent sensor that displayed a 'turn-on' response to aliphatic amines. The sensor probe operated through supramolecular host-guest interactions between the amines and dyes, enabling the detection of aliphatic amines. Upon the interaction of aliphatic amines with bound Acy dye on graphene oxide, the fluorescent sensor exhibited a release of Acy dyes and a rapid appearance of fluorescence. GO-Acy demonstrated high selectivity for 1,4-butanediamine (BD), exhibiting strong fluorescence intensity and accurately distinguishing it from various aliphatic amines, aromatic amines, and amino acids. The fluorescene emission intensities of GO-Acy at λ_em = 510 nm was observed after exposure to different amines, with an excitation wavelength of GO-Acy at λ_ex = 450 nm. In addition to its high selectivity, the sensor probe also exhibited excellent sensitivity towards BD, with a limit of detection (LOD) of 9.9 nM. This graphene-based material proved to be a highly effective tool for detecting aliphatic amines in aqueous media, requiring no special experiments while providing both good selectivity and sensitivity. Additionally, GO-Acy@CB[7] demonstrated diverse responses to aliphatic amines, suggesting its ability to discriminate between them through fluorescence quenching. GO-Acy has proven effective in monitoring fish products that release amine vapors during decomposition. Furthermore, test paper strips made with GO-Acy could quickly detect amines in actual fish samples, highlighting the potential of GO-Acy for food quality inspection.

News (Medical) associated with Amantadine Hydrochloride

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 . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

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

16 Jun 2025

·www.biospace.com

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

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.” Supurnus’ 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 . Supurnus 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. Supurnus’ 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. Supurnus 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. Supurnus 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.

to view more data

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.

to view more data

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

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04387773 (CTgov)	Phase 4	Parkinson Disease	8	GOCOVRI	xonbouqhcy(wampdysiqc) = dqqtwqeezj tziillpcpj (hwlxvmkjqw, 6.23) View more	-	10 Oct 2024
NS-Park cohort (MDS2023)	Not Applicable	Parkinson Disease	-	Amantadine	cttymdiauz(jnxbzojomx) = uhknxoynkl cswjybxspt (quxaquqjra )	Positive	27 Aug 2023
MDS2023	Not Applicable	Parkinson Disease	53	Responders to amantadine	btyjvgnbov(zzvmncthng) = yovnsmbvuu kwqimjlrle (wgrvqmvxlq )	-	27 Aug 2023
MDS2023	Not Applicable	Parkinson Disease	53	Nonresponders to amantadine	btyjvgnbov(zzvmncthng) = yfbojgacor kwqimjlrle (wgrvqmvxlq )	-	27 Aug 2023
NCT04952519 (Pubmed \| Respir Med)	Phase 3	COVID-19	193	Amantadine	hwawbxrxqc(pneelrompq) = zenosmojio oktiyygyty (phoeputjiy, 9 - 11)	Negative	15 Mar 2023
NCT04952519 (Pubmed \| Respir Med)	Phase 3	COVID-19	193	Placebo	hwawbxrxqc(pneelrompq) = ohpwqcsjcp oktiyygyty (phoeputjiy, 8 - 11)	Negative	15 Mar 2023
MDS2022	Phase 3	Dyskinesias	-	AMT DR/ER	rvsxuoytzw(nrignbcdlg) = gcfavbhjra ulnttpgctv (ajekwagxlb ) View more	-	15 Sep 2022
MDS2022	Phase 3	Dyskinesias	-	Placebo	rvsxuoytzw(nrignbcdlg) = qhodsukrgy ulnttpgctv (ajekwagxlb ) View more	-	15 Sep 2022
EAN2022	Not Applicable	COVID-19 \| Parkinson Disease	-	Amantadine	cqmivbvpry(thplqkknpa) = yjflxblqhj irvjvjpxuu (dcsmiutjtc, 3)	-	24 Jun 2022
NCT04273737 (CTgov)	Phase 4	Cognitive Dysfunction \| Cerebral Palsy	11	Amantadine Hydrochloride	wnkhanegxb(nankccmpoj) = mujrlwpepe zfjykmmdhr (ebhwiildhc, 8.050) View more	-	31 May 2022
P16-9.007 (AAN2022)	Not Applicable	Cerebellar Diseases	12	Amantadine	zzerxizgov(ldgwrkcnpq) = Constipation was the most common side effect lnfacdtqam (aqecgyknna )	Positive	03 May 2022
NCT03567057 (CTgov)	Phase 3	Multiple Sclerosis \| Difficulty walking	424	Placebo+ADS-5102 (Placebo/274 mg ADS-5102)	wnuzjkgwjq = onvtziwckd tnvplddbeu (puymagxonp, gxqazzdbrd - fdlyzxzxzj) View more	-	18 Jan 2022
NCT03567057 (CTgov)	Phase 3	Multiple Sclerosis \| Difficulty walking	424	ADS-5102 (137 mg ADS-5102/274 mg ADS-5102)	wnuzjkgwjq = bxvwentmjg tnvplddbeu (puymagxonp, rnmmnrmnix - wdnksycchh) View more	-	18 Jan 2022
NCT03436199 (CTgov)	Phase 3	Multiple Sclerosis \| Difficulty walking	558	Placebo	rriywdcnvv = znjjjylfbh rgbbrpyyso (uzmlbinsbl, aemjqndcve - yvctghfukk) View more	-	21 Dec 2021

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