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

10,021

Literatures (Medical) associated with Amantadine Hydrochloride

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.

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 Sep 2025·Current computer-aided drug design

Molecular Dynamics Simulation of SARS-CoV-2 E Ion Channel: The Study of Lone Protein and its Conformational Changes in Complex with Potential Cage Inhibitors

Article

Author: Tkachenko, Ilya Michailovich ; Ivleva, Elena Alexandrovna ; Shiryaev, Vadim Andreevich ; Zaborskaya, Maria Sergeevna ; Osyanin, Vitaly Alexandrovich ; Klimochkin, Yuri Nikolaevich

Background::

The coronavirus E ion channel has previously been studied as a potential target for antiviral therapy, with several compounds found to bind to the channel. However, these compounds have low activity, searching for effective E ion channel inhibitors of great importance.

Objective::

This study aimed to develop a computational approach for designing ligands for the coronaviral E ion channel and identify potential inhibitors based on this approach.

Methods::

The structure of the E-ion channel was refined using molecular dynamics, and the pore responsible for binding cage compounds was selected as the inhibitor-binding site. Potential inhibitor structures were identified using molecular docking, and their binding was confirmed using molecular dynamics simulations.

Results::

A number of potential SARS E ion channel inhibitors have been identified, and the binding modes and possible mechanisms of action of these inhibitors have been clarified.

Conclusion::

This study presents a computational approach that can be used to design ligands for E ion channels and identify potential inhibitors, providing valuable insights into the development of new antiviral therapies. The behavior of the E protein pentamer of SARS-CoV-2 in its native environment was investigated using Molecular Dynamics (MD), resulting in an equilibrated structure that could be used to develop new inhibitors through molecular docking. Simulation of the MD of E-channel complexes with amantadine analogues allowed for the identification of the main types of ligand-protein interactions that are responsible for the good binding of ligands within the channel's inner chamber.

News (Medical) associated with Amantadine Hydrochloride

29 May 2025

·www.prnewswire.com

INBRIJA Positioned for Stronger Market Penetration as Demand Grows for Inhaled Parkinson's Therapy| DelveInsight

INBRIJA, a dopamine replacement therapy for off periods in Parkinson's disease, holds significant market potential due to its ability to provide rapid relief from motor symptoms. With the increasing prevalence of Parkinson's globally, the demand for effective treatments is growing. INBRIJA offers a novel, non-oral alternative, positioning it well in the market for patients who struggle with traditional therapies. LAS VEGAS, May 29, 2025 /PRNewswire/ -- DelveInsight's " INBRIJA Market Size, Forecast, and Market Insight Report" highlights the details around INBRIJA, which consists of a dry powder formulation of levodopa for oral inhalation with the INBRIJA inhaler. The report provides product descriptions, patent details, and competitor products (marketed and emerging therapies) of INBRIJA. The report also highlights the historical and forecasted sales from 2020 to 2034 segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. Acorda Therapeutics' INBRIJA (Levodopa) Overview INBRIJA is an inhalable dry powder formulation of levodopa designed for use with the INBRIJA inhaler. The medication is delivered via white hypromellose capsules, each containing 42 mg of levodopa in a spray-dried powder form, along with excipients such as 1,2-dipalmitoyl-sn-glycero-3-phosphocholine (DPPC) and sodium chloride. Levodopa, the active ingredient in INBRIJA, is an aromatic amino acid with the chemical name (2S)-2-amino-3-(3,4-dihydroxyphenyl)propanoic acid. Its molecular formula is C₉H₁₁NO₄, and it has a molecular weight of 197.19 g/mol. INBRIJA is indicated for the intermittent relief of OFF episodes in patients with Parkinson's disease who are already receiving treatment with carbidopa/levodopa. It is not intended to replace regular carbidopa/levodopa therapy but is used to reduce OFF periods and improve motor symptoms. Each therapeutic capsule is used with a specially designed plastic inhaler featuring a blue body, blue cap, and a white mouthpiece. Patients may use INBRIJA up to five times per day, with the maximum daily dose limited to 420 mg. Learn more about INBRIJA projected market size for Parkinson's disease @ INBRIJA Market Potential Parkinson's disease is a chronic and progressive neurological condition that primarily affects the ability to control movement. It is caused by the gradual loss of dopamine-producing neurons in the brain, particularly in the substantia nigra—a region vital for regulating voluntary muscle activity. According to DelveInsight, there were approximately 3 million diagnosed prevalent cases of Parkinson's disease across the 7MM in 2024, with the United States accounting for about 45% of these. Although there is currently no cure, symptom management involves a mix of medications and supportive therapies. Treatment typically includes physical, occupational, and speech therapy, and certain patients may benefit from surgical interventions. Complementary therapies are also sometimes used to help manage specific symptoms. Commonly used drugs for Parkinson's include levodopa, dopamine agonists, MAO-B inhibitors, COMT inhibitors, amantadine, anticholinergics, and adenosine A2A receptor antagonists. These medications primarily aim to alleviate motor symptoms, which significantly impact patients' quality of life. DelveInsight estimates the Parkinson's disease market in the 7MM to have been worth USD 3.5 billion in 2024. DelveInsight's analysis forecasts market growth due to the introduction of emerging therapies, expecting a rise in market size during the study period (2020–2034). The anticipated increase in market size is driven by advancements in treatment options, greater healthcare access, and a rising prevalence of the condition, which together foster higher demand for innovative and effective therapies. Discover more about the Parkinson's disease market in detail @ Parkinson's Disease Market Report Emerging Competitors of INBRIJA Some of the emerging competitors to INBRIJA in the Parkinson's disease treatment landscape include Solengepras (Cerevance) , Buntanetap (Annovis Bio) , Prasinezumab (Roche/Protherna) , JOTROL (Jupiter Neurosciences), Glovadalen (UCB Biopharma), and others. In April 2025, Cerevance reported that the pivotal Phase III ARISE trial evaluating Solengepras as an adjunctive treatment for Parkinson's disease was ongoing, with topline results expected in the first half of 2026. Cerevance's GPR6 antagonist, Solengepras, did not meet its primary endpoint in the Phase II ASCEND trial as a monotherapy for early, untreated Parkinson's disease patients, demonstrating only a modest and statistically non-significant improvement compared to placebo, as reported at AD/PD 2025. According to the results presented at AD/PD 2025, Buntanetap has been shown to prevent cognitive decline across the entire treated ITT population. In patients with existing cognitive impairment, it improved cognitive performance along with MDS-UPDRS, WAIS, and CGI-S scores. A meeting with the US FDA to discuss the future development strategy is scheduled for the second Quarter of 2025. The ATLANTIS Phase II trial design for glovadalen was presented at AD/PD 2025, highlighting its potential as a Parkinson's treatment. As a D1PAM, it boosts dopamine signaling without directly activating receptors. To know more about the number of competing drugs in development, visit @ INBRIJA Market Positioning Compared to Other Drugs Key Milestones of INBRIJA In March 2023, Acorda Therapeutics announced that Esteve Pharmaceuticals launched INBRIJA 33 mg (levodopa inhalation powder, hard capsules) in Spain. Esteve launched INBRIJA in Germany in mid-2022. In September 2019, Acorda Therapeutics announced that the European Commission (EC) granted marketing authorization for INBRIJA 33 mg inhalation powder, hard capsules. In Europe, INBRIJA is indicated for the intermittent treatment of episodic motor fluctuations (OFF episodes) in adult patients with Parkinson's disease treated with a levodopa/dopa-decarboxylase inhibitor. The Marketing Authorization approves INBRIJA for use in the 28 countries of the European Union, as well as Iceland, Norway, and Liechtenstein. In December 2018, INBRIJA was approved by the US FDA for intermittent treatment of OFF Episodes in people with Parkinson's taking carbidopa/levodopa. Discover how INBRIJA is shaping the Parkinson's disease treatment landscape @ INBRIJA Inhaler INBRIJA Market Dynamics INBRIJA is a medication used to manage "off" periods in patients with Parkinson's disease who are on a stable regimen of oral levodopa. The market dynamics surrounding INBRIJA are influenced by several factors, including the growing demand for innovative treatments for Parkinson's disease, an aging global population, and the increasing recognition of the importance of managing off periods in patients with Parkinson's. As the number of Parkinson's disease patients continues to rise globally, particularly with the aging Baby Boomer generation, the market for Parkinson's disease therapies is expanding, offering significant growth potential for medications like INBRIJA. One of the key drivers for INBRIJA's market is the unmet need for effective treatments for off periods. Traditional oral levodopa, the mainstay of Parkinson's treatment, can lose efficacy over time, leading to motor fluctuations that result in off periods, during which patients experience a worsening of symptoms such as tremors and rigidity. INBRIJA provides an alternative in the form of an inhaled levodopa treatment that acts rapidly to help manage these periods, offering patients a faster-acting option compared to oral medications. This positioning appeals to both patients and healthcare providers who are looking for ways to improve the quality of life for people with Parkinson's. Despite its promising potential, INBRIJA faces challenges in the market. The primary hurdle is its relatively high cost compared to traditional levodopa treatments, which could limit its accessibility, particularly in regions with limited healthcare resources. Additionally, the need for an inhaler device and potential issues related to device handling and patient compliance could also impact market penetration. Moreover, INBRIJA competes with other therapeutic options in the Parkinson's space, including dopamine agonists and other adjunctive treatments, which means ongoing education and marketing efforts are required to differentiate its unique benefits. In terms of market opportunities, INBRIJA could benefit from increased awareness among healthcare providers about the drug's role in improving patient outcomes during off periods. Collaborations with Parkinson's disease advocacy groups and patient education initiatives could help drive adoption. Furthermore, expanding indications or seeking approval for additional uses could open up new revenue streams and bolster INBRIJA's position in the Parkinson's treatment market. Overall, while the market for INBRIJA faces challenges, the growing demand for better management of Parkinson's symptoms presents opportunities for continued growth and adoption. Dive deeper to get more insight into INBRIJA's strengths & weaknesses relative to competitors @ INBRIJA Market Drug Report Table of Contents Related Reports Parkinson's Disease Market Parkinson's Disease Market Insights, Epidemiology, and Market Forecast – 2034 report deliver 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, Cerevance, among others. Parkinson's Disease Pipeline Parkinson's Disease Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key Parkinson's disease companies, including Cerevel Therapeutics, Inhibikase Therapeutics, Neuraly, Peptron, Biogen, Roche, Brain Neurotherapy Bio, Inc., Modag, Annovis Bio Inc., BioVie Inc., United Neuroscience Ltd., Luye Pharma Group, AbbVie, UCB Biopharma SRL, InnoMedica Schweiz AG, Integrative Research Laboratories AB, H. Lundbeck A/S, Shanghai WD Pharmaceutical Co., Ltd., Cerevance Beta, Inc., Nobilis Therapeutics Inc., BlueRock Therapeutics, Taiwan Mitochondrion Applied Technology Co., Ltd., among others. Cell and Gene Therapy in Parkinson's Disease Market Cell and Gene Therapy in Parkinson's Disease Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key cell and gene therapy in Parkinson's disease companies including MeiraGTx, Hope Biosciences, Sumitomo Pharma, Prevail Therapeutics, BlueRock Therapeutics, Voyager Therapeutics, among others. Parkinson's Disease Psychosis Market Parkinson's Disease Psychosis 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 psychosis companies, including Sumitomo Pharma America Inc., Vanda Pharmaceuticals, Acadia Pharmaceuticals Inc., Otsuka America Pharmaceutical, Lundbeck LLC, Jazz Pharmaceuticals, Alkahest Inc., Sandoz, Sio Gene Therapies, Axovant Sciences Ltd, 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 2Clinical ResultDrug ApprovalPhase 3

22 Apr 2025

·www.prnewswire.com

XADAGO/EQUFINA Set to Revolutionize Parkinson's Disease Treatment Landscape | DelveInsight

As a selective monoamine oxidase B (MAO-B) inhibitor, XADAGO offers a unique mechanism of action that complements traditional therapies, potentially improving motor function and reducing "off" time in patients. The increasing prevalence of Parkinson's disease and the growing demand for effective therapies create a substantial market opportunity for XADAGO, particularly in regions with aging populations. LAS VEGAS, April 22, 2025 /PRNewswire/ -- DelveInsight's " XADAGO/EQUFINA Market Size, Forecast, and Market Insight Report" highlights the details around XADAGO/EQUFINA, an inhibitor of monoamine oxidase B (MAO-B) indicated as an adjunctive treatment to levodopa/carbidopa in patients with Parkinson's disease experiencing "off" episodes. The report provides product descriptions, patent details, and competitor products (marketed and emerging therapies) of XADAGO/EQUFINA. The report also highlights the historical and forecasted sales from 2020 to 2034 segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. Newron Pharmaceuticals/Eisai/Meiji Seika Pharma's XADAGO/EQUFINA (safinamide) Overview XADAGO is a monoamine oxidase B (MAO-B) inhibitor used alongside levodopa/carbidopa to help manage "off" episodes in individuals with Parkinson's disease. While its exact mode of action in treating Parkinson's is not fully understood, it is thought to work by inhibiting MAO-B, thereby reducing dopamine breakdown. This leads to increased dopamine levels and enhanced dopaminergic activity in the brain. XADAGO contains the active ingredient safinamide in the form of a mesylate salt and is available in 50 mg and 100 mg film-coated oral tablets. Each tablet provides either 65.88 mg or 131.76 mg of safinamide mesylate, equivalent to 50 mg or 100 mg of the safinamide base. The medication is marketed as XADAGO in the United States and Europe and under the name EQUFINA in Japan. Learn more about XADAGO/EQUFINA projected market size for Parkinson's disease @ XADAGO/EQUFINA Market Potential Parkinson's disease is a progressive neurological disorder that mainly impairs movement control. It results from the slow degeneration of dopamine-producing neurons in the brain, especially in the substantia nigra, a region crucial for managing voluntary motor function. According to estimates by DelveInsight, there were 2.7 million diagnosed prevalent cases of Parkinson's disease in the 7MM in 2023, with the United States accounting for around 45% of these cases. While a cure for Parkinson's remains elusive, a combination of pharmacological and non-pharmacological therapies is used to manage symptoms. Physical, occupational, and speech therapies form key components of treatment, and surgical procedures may benefit select patients. Additionally, complementary therapies are sometimes employed to help address particular symptoms. Frequently prescribed medications for Parkinson's include levodopa, dopamine agonists, MAO-B inhibitors, COMT inhibitors, amantadine, anticholinergics, and adenosine A2A antagonists. These treatments primarily target motor symptoms, which are a major concern for those affected. DelveInsight reports that the Parkinson's disease market in the 7MM was valued at USD 3.2 billion in 2023. The market is expected to grow over the forecast period (2020–2034), fueled by the launch of new therapies, increasing prevalence, better access to healthcare, and rising demand for more advanced and effective treatment options. Discover more about the Parkinson's disease market in detail @ Parkinson's Disease Market Report Emerging Competitors of XADAGO/EQUFINA Some of the drugs in the pipeline include Solengepras (Cerevance), Minzasolmin (UCB Biopharma SRL/Novartis), Buntanetap (Annovis Bio), and others. Buntanetap has successfully completed Phase III trials for early-stage Parkinson's disease. Annovis Bio has scheduled a meeting with the FDA in Q1 2025 to determine the development path forward for Buntanetap in the treatment of Parkinson's disease. Buntanetap is also being developed for Alzheimer's disease, Lewy Body Dementia, and other neurodegenerative disorders. In November 2024, Cerevance announced the dosing of the first patient in its pivotal Phase III ARISE trial, evaluating solengepras as a potential adjunctive treatment for Parkinson's disease. Cerevance expects to report topline data in the first half of 2026. In December 2021, UCB partnered with Novartis to globally co-develop and co-commercialize UCB0599, a pioneering alpha-synuclein misfolding inhibitor currently in Phase II clinical trials for Parkinson's disease. To know more about the number of competing drugs in development, visit @ XADAGO/EQUFINA Market Positioning Compared to Other Drugs Key Milestones of XADAGO/EQUFINA In April 2020, Newron Pharmaceutical acknowledged that US WorldMeds, who held the US commercialization rights for the licensed drug, XADAGO, as a sub licensee of Zambon, had entered into a definitive agreement with Supernus Pharmaceuticals under which Supernus would acquire the CNS portfolio of US WorldMeds, including the US rights to XADAGO In November 2019, Eisai announced that it had launched the EQUFINA 50mg tablets for the indication of improvement of the wearing-off phenomenon in patients with Parkinson's disease under treatment with a drug containing levodopa in Japan. Manufacturing and marketing approval of EQUFINA was obtained in September 2019. In April 2017, Eisai Co., Ltd. and Meiji Seika Pharma announced entering into a license agreement for the commercialization of safinamide (development code: ME2125) to treat Parkinson's disease in Japan and Asia. In March 2017, Newron Pharmaceuticals announced the US FDA approval of XADAGO to treat Parkinson's disease as an add-on therapy to levodopa/carbidopa for patients experiencing "off" episodes. In March 2016, Zambon announced a strategic agreement with US WorldMeds to commercialize Newron's lead compound, XADAGO, to treat Parkinson's disease in the US. In February 2015, XADAGO was approved in the European Union as an add-on therapy to levodopa, alone or in combination with other Parkinson's medications, in mid-late stage PD patients with motor fluctuations. XADAGO/EQUFINA Patent Details XADAGO tablets are currently protected by three XADAGO patents with US patent numbers 8,076,515, 8,278,485, and 8,283,380, which expire between June 2027 and December 2028 and are listed in the FDA's publication, Approved Drug Products with Therapeutic Equivalence Evaluations, commonly referred to as the Orange Book. The company has a license agreement with Zambon S.p.A., Newron's partner, related to the XADAGO Patents, and as a new chemical entity, XADAGO is under the 5-year FDA exclusivity period that expires on March 21, 2022. In May 2017, Zambon filed a worldwide patent under the patent number WO2017207587A1. The invention relates to pharmaceutical compositions comprising safinamide and, more particularly, to taste-masked particles comprising said active ingredient or pharmaceutically acceptable salts thereof, oral dosage forms that include said particles, and a process for preparing them. Discover how XADAGO/EQUFINA is shaping the Parkinson's disease treatment landscape @ XADAGO 50mg XADAGO/EQUFINA Market Dynamics XADAGO, marketed as EQUFINA in some regions (notably in South Korea and Japan), is a once-daily oral selective MAO-B inhibitor used as an add-on treatment for Parkinson's disease patients experiencing "off" episodes while on a stable dose of levodopa. The drug's unique dual mechanism of action—MAO-B inhibition and modulation of glutamate release—offers both dopaminergic and non-dopaminergic effects, positioning it as a differentiated product in the PD adjunctive therapy landscape. This has helped it carve a niche in markets where patients are inadequately controlled by levodopa alone, particularly those in mid-to-late-stage PD. The global market dynamics for XADAGO/EQUFINA are shaped by a mix of competitive intensity, regional adoption trends, and payer dynamics. In the U.S. and Europe, the drug has faced stiff competition from generic MAO-B inhibitors (like selegiline and rasagiline) and newer Parkinson's disease therapies, including COMT inhibitors, dopamine agonists, and extended-release levodopa formulations. Despite this, its favorable safety profile and once-daily dosing have supported its uptake in certain patient segments, especially in Europe. Market penetration has been slower in the U.S. due to both reimbursement hurdles and physician preference for more established adjunctive treatments. In Asia, particularly Japan and South Korea, EQUFINA has demonstrated stronger market performance thanks to focused commercial strategies and a high unmet need for effective "off time" management. Meiji Seika Pharma and Eisai, the regional marketing partners, have successfully leveraged the drug's differentiated profile in clinician education, which has led to growing adoption among neurologists. In Japan, where the aging population is rapidly expanding and Parkinson's prevalence is rising, EQUFINA has benefited from both demographic tailwinds and formulary access. Looking ahead, the market outlook for XADAGO/EQUFINA depends on several strategic levers, including lifecycle management, regional partnerships, and real-world evidence generation. The manufacturer's ability to expand into new geographies, secure favorable reimbursement, and differentiate against both generics and newer entrants will be critical. Moreover, as Parkinson's disease treatment moves toward more personalized approaches, XADAGO/EQUFINA may find sustained relevance in specific subpopulations, particularly those requiring a balance of efficacy and tolerability. Dive deeper to get more insight into XADAGO/EQUFINA's strengths & weaknesses relative to competitors @ XADAGO/EQUFINA Market Drug Report Table of Contents Related Reports Parkinson's Disease Market Parkinson's Disease Market Insights, Epidemiology, and Market Forecast – 2034 report deliver 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, Cerevance, among others. Parkinson's Disease Pipeline Parkinson's Disease Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key Parkinson's disease companies, including Cerevel Therapeutics, Inhibikase Therapeutics, Neuraly, Peptron, Biogen, Roche, Brain Neurotherapy Bio, Inc., Modag, Annovis Bio Inc., BioVie Inc., United Neuroscience Ltd., Luye Pharma Group, AbbVie, UCB Biopharma SRL, InnoMedica Schweiz AG, Integrative Research Laboratories AB, H. Lundbeck A/S, Shanghai WD Pharmaceutical Co., Ltd., Cerevance Beta, Inc., Nobilis Therapeutics Inc., BlueRock Therapeutics, Taiwan Mitochondrion Applied Technology Co., Ltd., among others. Cell and Gene Therapy in Parkinson's Disease Market Cell and Gene Therapy in Parkinson's Disease Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key cell and gene therapy in Parkinson's disease companies including MeiraGTx, Hope Biosciences, Sumitomo Pharma, Prevail Therapeutics, BlueRock Therapeutics, Voyager Therapeutics, among others. Parkinson's Disease Psychosis Market Parkinson's Disease Psychosis 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 psychosis companies, including Sumitomo Pharma America Inc., Vanda Pharmaceuticals, Acadia Pharmaceuticals Inc., Otsuka America Pharmaceutical, Lundbeck LLC, Jazz Pharmaceuticals, Alkahest Inc., Sandoz, Sio Gene Therapies, Axovant Sciences Ltd, 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 3Drug ApprovalLicense out/inPhase 2

18 Mar 2025

·www.neurolixis.com

18 March 2025 - Neurolixis Publishes Positive Phase 2A Trial Results for NLX-112 in Parkinson’s Disease

Neurolixis today announced the publication of the results from its successful Phase 2A proof-of-concept clinical trial of NLX-112 (befiradol) in Parkinson’s disease. The findings, published in the prestigious journal 𝘔𝘰𝘷𝘦𝘮𝘦𝘯𝘵 𝘋𝘪𝘴𝘰𝘳𝘥𝘦𝘳𝘴, highlight NLX-112’s potential as a first-in-class, non-dopaminergic therapy with dual efficacy in addressing both levodopa-induced dyskinesia (LID) and motor impairment in Parkinson’s patients. The randomized, double-blind, placebo-controlled trial, supported by The Michael J. Fox Foundation and Parkinson’s UK, evaluated NLX-112 in patients with troubling LID. The study successfully met its primary endpoint of safety and tolerability, as well as its secondary endpoint of significantly reducing LID. Notably, NLX-112 also demonstrated anti-parkinsonian effects, significantly improving motor function in study participants. See the full publication (Open Access): 𝗡𝗟𝗫-𝟭𝟭𝟮 𝗿𝗮𝗻𝗱𝗼𝗺𝗶𝘇𝗲𝗱 𝗣𝗵𝟮𝗔 𝘁𝗿𝗶𝗮𝗹: 𝘀𝗮𝗳𝗲𝘁𝘆, 𝘁𝗼𝗹𝗲𝗿𝗮𝗯𝗶𝗹𝗶𝘁𝘆, 𝗮𝗻𝘁𝗶-𝗱𝘆𝘀𝗸𝗶𝗻𝗲𝘁𝗶𝗰 𝗮𝗻𝗱 𝗮𝗻𝘁𝗶-𝗽𝗮𝗿𝗸𝗶𝗻𝘀𝗼𝗻𝗶𝗮𝗻 𝗲𝗳𝗳𝗶𝗰𝗮𝗰𝘆. 𝘔𝘰𝘷𝘦𝘮𝘦𝘯𝘵 𝘋𝘪𝘴𝘰𝘳𝘥𝘦𝘳𝘴, 2025 (https://doi-org.sutd.idm.oclc.org/10.1002/mds.30175) 𝗔 𝗡𝗼𝘃𝗲𝗹 𝗠𝗲𝗰𝗵𝗮𝗻𝗶𝘀𝗺 𝗼𝗳 𝗔𝗰𝘁𝗶𝗼𝗻: Unlike current Parkinson’s treatments that target the dopamine system, NLX-112 acts on the serotonin (5-HT) system, as a highly selective full activator of 5-HT1A receptors. This unique mechanism differentiates NLX-112 from previous serotonergic drugs and is believed to underlie its dual efficacy in reducing dyskinesia and improving motor function. The promising results from this Phase 2A trial support further development of NLX-112 as a transformative therapy for movement disorders. Neurolixis is actively planning next steps in the clinical development program to advance NLX-112 toward potential regulatory approval. 𝗔𝗯𝗼𝘂𝘁 𝗣𝗮𝗿𝗸𝗶𝗻𝘀𝗼𝗻’𝘀 𝗗𝗶𝘀𝗲𝗮𝘀𝗲 𝗮𝗻𝗱 𝗥𝗲𝗹𝗮𝘁𝗲𝗱 𝗠𝗼𝘃𝗲𝗺𝗲𝗻𝘁 𝗗𝗶𝘀𝗼𝗿𝗱𝗲𝗿𝘀: Parkinson’s disease is the second most common neurodegenerative disorder, affecting over 10 million people worldwide. Levodopa, the mainstay treatment for Parkinson’s, often leads to debilitating dyskinesias (involuntary movements) after prolonged use. Up to 80% of patients develop LID within ten years of levodopa therapy. Current treatments for LID, such as amantadine, are limited by side effects and variable efficacy, underscoring the need for new therapeutic options. As well as Parkinson’s disease, other disorders also involve dysfunction in the basal ganglia, a brain region critical for coordinating movement. Such disorders include spinocerebellar ataxia, Huntington’s disease, essential tremor and dystonia, and lead symptoms such as tremors, rigidity, and impaired motor control.

Phase 2Clinical Result

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

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	ahrtboqxyt(ubcbnsunnj) = kfoklagdec wxzzpputiz (dfcrxeqiis, 6.23) View more	-	10 Oct 2024
NS-Park cohort (MDS2023)	Not Applicable	Parkinson Disease	-	Amantadine	ckcpvztjux(awodixwude) = migqnfqjij ivsmmwdwpz (yqqseefeie )	Positive	27 Aug 2023
MDS2023	Not Applicable	Parkinson Disease	53	Responders to amantadine	gfweymppyg(stbfispllx) = xlcjljlxkr mhcprqkeom (fnmvqmdhnr )	-	27 Aug 2023
MDS2023	Not Applicable	Parkinson Disease	53	Nonresponders to amantadine	gfweymppyg(stbfispllx) = xwkskeyzhq mhcprqkeom (fnmvqmdhnr )	-	27 Aug 2023
NCT04952519 (Pubmed \| Respir Med)	Phase 3	COVID-19	193	Amantadine	elbsslbhtr(lsxesziiqa) = flvwlyfyum tneblixgwf (rtheodvlmy, 9 - 11)	Negative	15 Mar 2023
NCT04952519 (Pubmed \| Respir Med)	Phase 3	COVID-19	193	Placebo	elbsslbhtr(lsxesziiqa) = ywyguugkrw tneblixgwf (rtheodvlmy, 8 - 11)	Negative	15 Mar 2023
MDS2022	Phase 3	Dyskinesias	-	AMT DR/ER	tdbkavmqvy(bmqclvzyqj) = gfcdtklsrq ujqzirpjdk (xnxumnojwm ) View more	-	15 Sep 2022
MDS2022	Phase 3	Dyskinesias	-	Placebo	tdbkavmqvy(bmqclvzyqj) = voghqrfdcy ujqzirpjdk (xnxumnojwm ) View more	-	15 Sep 2022
EAN2022	Not Applicable	COVID-19 \| Parkinson Disease	-	Amantadine	viunuiiopr(drfughbhjb) = ffynftpups frngdycpnd (sdompoybrn, 3)	-	24 Jun 2022
NCT04273737 (CTgov)	Phase 4	Cognitive Dysfunction \| Cerebral Palsy	11	Amantadine Hydrochloride	dbxwrwmjlx(aacrbubisc) = tylgcaluzv uurvbyoekc (mbfcmibgyy, 8.050) View more	-	31 May 2022
P16-9.007 (AAN2022)	Not Applicable	Cerebellar Diseases	12	Amantadine	sgqvvpwtxr(vkhbxbwxvz) = Constipation was the most common side effect bxgpieuryl (wduprqdjtt )	Positive	03 May 2022
NCT03567057 (CTgov)	Phase 3	Multiple Sclerosis \| Difficulty walking	424	Placebo+ADS-5102 (Placebo/274 mg ADS-5102)	jtvrapvcpt = nsoqdtqics kitmsubmvp (hshqikpfwk, tkklxysbsv - jdgyuzzywh) View more	-	18 Jan 2022
NCT03567057 (CTgov)	Phase 3	Multiple Sclerosis \| Difficulty walking	424	ADS-5102 (137 mg ADS-5102/274 mg ADS-5102)	jtvrapvcpt = ttvdpcsyuo kitmsubmvp (hshqikpfwk, rkbhabssdo - tbgkjbqyti) View more	-	18 Jan 2022
NCT03436199 (CTgov)	Phase 3	Multiple Sclerosis \| Difficulty walking	558	Placebo	eiimvmqbgm = uubskefajh vyebcmvxyk (nfnyjewdty, scmnenwxyt - ncztxdxziv) View more	-	21 Dec 2021

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