A Phase II/III, multi-center, open-label, extension study to determine the long-term safety, tolerability, and efficacy of evenamide in patients with psychiatric disorders who participated in a previous trial with evenamide. - Evenamide_020

开始日期2021-11-12

申办/合作机构

Newron Pharmaceuticals SpA

CTRI/2021/04/032772

/ Recruiting临床2期

A Phase II, prospective, multi-center, randomized, 4-week, double-blind, placebo-controlled study, designed to determine the safety, tolerability, EEG effects and efficacy of oral doses of 30 mg bid of evenamide (NW-3509) in patients with chronic schizophrenia who are symptomatic on their current second-generation antipsychotic (aripiprazole, clozapine, quetiapine, olanzapine, paliperidone, or risperidone) medication.

开始日期2021-04-19

申办/合作机构

Newron Pharmaceuticals SpA

[+1]

CTRI/2020/09/027959

/ Completed临床2期

An open-label, multi-center, extension study to evaluate the long-term safety, tolerability and preliminary efficacy of evenamide as add-on treatment in patients with treatment-resistant schizophrenia (TRS) not responding adequately to their current antipsychotic medication.

开始日期2020-10-15

申办/合作机构

Newron Pharmaceuticals SpA

[+1]

100 项与 Newron Pharmaceuticals SpA 相关的临床结果

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0 项与 Newron Pharmaceuticals SpA 相关的专利（医药）

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项与 Newron Pharmaceuticals SpA 相关的文献（医药）

2025-03-01·Neuropharmacology

Efficacy and safety of evenamide, a glutamate modulator, added to a second-generation antipsychotic in inadequately/poorly responding patients with chronic schizophrenia: Results from a randomized, double-blind, placebo-controlled, phase 3, international clinical trial

Article

作者: Roy, Arjun ; Hartman, Richard ; Sansi, Francesca ; Chinellato, Giovanni ; Turolla, Alessio ; Anand, Ravi

BACKGROUNDEvenamide, a glutamate modulator, is currently in phase 3 of development as add-on treatment to antipsychotics in patients with inadequate response or treatment-resistant schizophrenia. This study was designed to determine if patients with chronic schizophrenia inadequately responding to a second-generation antipsychotic would benefit from add-on treatment with evenamide at a dose of 30 mg bid.METHODSStudy 008A was a prospective, 4-week, randomized, double-blind, placebo-controlled study evaluating the safety, tolerability, and efficacy of oral doses of evenamide of 30 mg bid in patients with chronic schizophrenia treated at stable therapeutic doses of a second-generation antipsychotic. Outpatients aged ≥18 years, both males and females, with a diagnosis of schizophrenia (DSM-V), who had been receiving antipsychotics for at least 2 years at stable doses, but still symptomatic (PANSS 70-85, CGI-S 4-6, predominant positive symptoms), were eligible for the study. Patients were randomised equally to evenamide 30 mg or placebo, given bid, after completing a 21-day screening period. The primary outcome (change from baseline in PANSS total score) was assessed weekly, with the primary endpoint at 4 weeks.RESULTSA total of 291 patients were enrolled, of which 11 (3·8%) discontinued prematurely, overall. Add-on treatment with evenamide was associated to a statistically significant (the absolute difference of the two treatment groups for the PANSS Total at Day 29, primary efficacy endpoint, was = 2·5 [p-value<0.05] that is associated with a Cohen's d effect size = 0·33) and clinically meaningful benefit compared to placebo across all efficacy measures, and was well tolerated.CONCLUSIONThe demonstration of statistically significant and clinically meaningful benefit of evenamide, a glutamate modulator, as add-on treatment in patients with chronic schizophrenia inadequately responding to their second-generation antipsychotic may represent a new treatment paradigm for this population.

2025-02-12·International Journal of Neuropsychopharmacology

REMARKABLE EFFICACY OF EVENAMIDE, A GLUTAMATE ANTAGONIST, AS AN ADD-ON TO ANTIPSYCHOTICS IN PATIENTS WITH TREATMENT RESISTANT SCHIZOPHRENIA (TRS): RESULTS FROM A ONE-YEAR, OPEN- LABEL, DOSE-COMPARATIVE, RANDOMIZED, TREATMENT TRIAL

作者: Hartman, Richard ; Chinellato, Giovanni ; Anand, *Ravi ; Turolla, Alessio

AbstractBackgroundNumerous findings indicate reduced life-expectancy in patients with TRS, along with multiple morbidities, frequent hospitalizations, indigent status, and increasing costs of care for families and society [1]; no new treatment has emerged since clozapine approval in 1989 [2]. Despite its therapeutic promise, current experience indicates that less than 5% and 15% of TRS patients in the US, and in the EU respectively, receive clozapine [Global Data; 2017]. The vast majority of TRS patients are managed by off-label use of first and second-generation antipsychotics (APs) in conjunction with other psychopharmaceuticals, without showing efficacy [3]. Evenamide, a selective inhibitor of voltage-gated sodium channels, devoid of biological activity at >130 CNS targets, normalizes glutamate release [4,5,6,7] without affecting its basal levels. Preclinical experiments have indicated that it is likely to benefit patients responding inadequately or resistant to APs. Evenamide was evaluated as monotherapy or add-on to APs in animal models in which PPI was impaired using amphetamine, scopolamine, phencyclidine, MK-801, ketamine, or sleep deprivation. It demonstrated efficacy across a broad spectrum of experiments, including models of mania, depression, impulse control loss, and obsessive-compulsive behavior.Aims & ObjectivesTo present final, 1-year results of evenamide treatment in TRS patients unstable on their current AP. This data will demonstrate the unique benefits of glutamate modulation, when added to 5HT2/D2 modulators. It is likely that profound long-lasting efficacy of the combination, observed in shorter trials, will be demonstrated on efficacy variables used to assess patients with schizophrenia, as well as on key characteristics of TRS patients.MethodsThe selection criteria for the study require patients to meet standardized criteria for TRS: non-response to two APs, baseline PANSS total score 70-90 with predominant positive symptoms, at least two moderate core symptoms and functional deficits. Efficacy data (PANSS, CGI-S/C, and LOF) were analyzed using paired t-test to assess changes from baseline to endpoint (1-year) for each dose group and provide descriptive statistics for the responder analyses.ResultsThe high retention rate [82.5% after 6-month] and the low incidence of adverse dropouts [1.9%] indicate the good tolerability of evenamide. Interim analyses at 6-month (mITT=156) and 1-year for the first cohort of 100 patients, indicated that a large proportion of patients improve to an extent that they no longer meet the operational severity criteria for TRS; and a significant proportion can be considered ‘responders’ based on TRRIP definition (>=20% improvement on PANSS maintained for >=12 weeks [8]). Comparison of results available after 6-week, 6-month, and 1-year are likely to indicate a pattern of unique efficacy over time. Furthermore, increasing and long-lasting improvement was observed in all efficacy scales [9,10], with the largest improvement in the 15 and 30 mg bid dose groups. Full, 1-year results, available by the time of the Congress, will be presented demonstrating remarkable efficacy of evenamide at 1-year in TRS patients.DiscussionThis is the first international trial of evenamide add-on to any AP (except clozapine) in patients with TRS. Encouraging results of this study have expedited the conduct of a potentially pivotal, randomized, double-blind, placebo-controlled, 1-year, international study.References1.Kennedy J, Altar CA, Taylor DL Degtiar I, Hornberger JC. The social and economic burden of treatment-resistant schizophrenia: a systematic literature review. International Clinical Psychopharmacology 29(2):p 63-76, March 2014.2.Kane, J, Honigfeld, G, Singer, J, Meltzer, H. Clozapine for the treatment-resistant schizophrenic. A double-blind comparison with chlorpromazine. Arch Gen Psychiatry 1988; 45: 789–96.3.Galling, B., Roldá n, A., Hagi, K., Rietschel, L., Walyzada, F., Zheng, W., Cao, X. L., Xiang, Y. T., Zink, M., Kane, J. M., Nielsen, J., Leucht, S., & Correll, C. U. (2017). Antipsychotic augmentation vs. monotherapy in schizophrenia: systematic review, meta-analysis and meta-regression analysis. World Psychiatry : Official Journal of the World Psychiatric Association (WPA), 16(1), 77–89.4.Moghaddam B, Javitt D. From revolution to evolution: the glutamate hypothesis of schizophrenia and its implication for treatment. Neuropsychopharmacology. 2012 Jan;37(1):4-15.5.Demjaha A, Egerton A, Murray RM, Kapur S, Howes OD, Stone JM, McGuire PK. Antipsychotic treatment resistance in schizophrenia associated with elevated glutamate levels but normal dopamine function. Biol Psychiatry. 2014 Mar 1;75(5):e11-3.6.Mouchlianitis E, Bloomfield MA, Law V, Beck K, Selvaraj S, Rasquinha N, Waldman A, Turkheimer FE, Egerton A, Stone J, Howes OD. Treatment-resistant schizophrenia patients show elevated anterior cingulate cortex glutamate compared to treatment-responsive. Schiz. Bull. 2016 May;42(3):744-52.7.Howes, O. D., McCutcheon, R., Agid, O., de Bartolomeis, A., van Beveren, N. J., Birnbaum, M. L., Bloomfield, M. A., Bressan, R. A., Buchanan, R. W., Carpenter, W. T., Castle, D. J., Citrome, L., Daskalakis, Z. J., Davidson, M., Drake, R. J., Dursun, S., Ebdrup, B. H., Elkis, H., Falkai, P., Fleischacker, W. W., … Correll, C. U. (2017). Treatment-Resistant Schizophrenia: Treatment Response and Resistance in Psychosis (TRRIP) Working Group Consensus Guidelines on Diagnosis and Terminology. The American journal of psychiatry, 174(3), 216–229.8.Anand R, Forrest EC, Hartman RD, Graham SM, Faravelli L (2018) T48. Antipsychotic efficacy of evenamide (NW-3509) is due to modulation of glutamatergic dysregulation. Schizophr Bull 44(Suppl1):S132.9.Anand R., Giuliani R., Turolla A., Chinellato G., Hartman R. Addition of evenamide, a glutamate release inhibitor, to patients with treatment resistant schizophrenia (TRS) on an antipsychotic is effective and associated with long-term efficacy. SIRS 2023-poster.10.Anand, R., Turolla, A., Chinellato, G., Roy, A., & Hartman, R. D. (2023). Phase 2 results indicate evenamide, a selective modulator of glutamate release, is associated with clinically important long-term efficacy when added to an antipsychotic in patients with treatment-resistant schizophrenia. Int J Neuropsychopharmacology, 26(8), 523–528.

2025-02-12·International Journal of Neuropsychopharmacology

EVENAMIDE, AS AN ADD-ON TO ANTIPSYCHOTICS, PRODUCES LONG- LASTING CLINICALLY MEANINGFUL BENEFIT AND CONVERTS TREATMENT- RESISTANT SCHIZOPHRENIA (TRS) PATIENTS INTO A RESPONSIVE STATE: 6-MONTH RESULTS FROM AN ONGOING INTERNATIONAL RANDOMIZED STUDY

作者: Chinellato, Giovanni ; Sansi, Francesca ; Anand, *Ravi ; Turolla, Alessio ; Giuliani, Rodolfo

AbstractIntroductionFirst-and-second-generation antipsychotics (APs) are widely used in patients with treatment-resistant schizophrenia (TRS), alone or in combination with other 5-HT2/D2-blocking APs, although AP polypharmacy shows no evidence of benefit [1]. In addition, the long-term usage of APs requires frequent dose adjustments due to development of intolerance and relapses [2], representing a major burden for patients, caregivers, and healthcare providers. TRS develops in ~30% of patients within 5 years of treatment, resulting in increased morbidity, suicidality, and mortality. Findings from neurochemistry, neurometabolism, and functional imaging studies in TRS patients indicate abnormalities in glutamatergic rather than dopaminergic neurotransmission [3, 4, 5]. Evenamide, a selective inhibitor of voltage-gated sodium channels, is devoid of biological activity at >130 CNS targets, normalizes glutamate release without affecting basal levels, and demonstrated benefits in animal models of psychosis as monotherapy and as an add on to APs.Aim & ObjectivesStudies 014/015 were designed to evaluate the safety and preliminary efficacy of evenamide given orally at 3 fixed doses (7.5, 15 and 30 mg bid) in patients with TRS not responding to a therapeutic dose of an AP (except clozapine). Assessment of efficacy was based on changes of PANSSCGI-S/C and functioning (Strauss-Carpenter LOF), while tolerability was assessed based on all safety measures.MethodsStudy 014 is a 6-week, randomized, open-label, rater-blinded, international study with completers continuing assigned doses for an additional 46 weeks in an ongoing extension study (Study 015). At baseline, patients were moderately to severely ill (CGI-S of 4 to 6), with a PANSS total score of 70-90 and predominant positive symptoms (PANSS positive total score >=20), along with functional deficits (GAF =<50). Efficacy ratings were performed by a trained psychiatrist blinded to the evenamide dose. Data from all 3 doses were combined into a single group and analyzed to assess the responder rate, maintenance of the response up to 6 months and conversion of TRS patients already on an AP into a responsive state, according to the operational severity selection criteria.ResultsThe high roll-over rate (94.4%) in Study 015 and the low incidence of treatment-emergent adverse events indicate the good tolerability of evenamide. Furthermore, 6-month efficacy results confirmed the increasing and sustained improvement in all efficacy scales as seen in the cohort of the first 100 patients randomized [6,7]. During this period, more than 65% of the patients who achieved a clinically meaningful benefit (>=20% improvement on PANSS total score) at 6-week preserved their response at 6-month. In addition, ~40% of the patients no longer met the operational severity criteria for TRS used to select patients for the study, and no relapses or clinically important worsening over 6-month were observed. Detailed results from further analyses will be presented at the Congress.DiscussionEncouraging long-term results of this study have expedited the design of a phase 3, potentially pivotal, randomized, double-blind, placebo-controlled, 1-year, international study to assess efficacy and safety of two doses (15 and 30 mg bid) of evenamide as add-on treatment in TRS patients not benefiting from their current AP.References1.Galling, B., Roldá n, A., Hagi, K., Rietschel, L., Walyzada, F., Zheng, W., Cao, X. L., Xiang, Y. T., Zink, M., Kane, J. M., Nielsen, J., Leucht, S., & Correll, C. U. (2017). Antipsychotic augmentation vs. monotherapy in schizophrenia: systematic review, meta-analysis and meta-regression analysis. World Psychiatry : Official Journal of the World Psychiatric Association (WPA), 16(1), 77–89.2.Robinson, D., Woerner, M. G., Alvir, J. M., Bilder, R., Goldman, R., Geisler, S., Koreen, A., Sheitman, B., Chakos, M., Mayerhoff, D., & Lieberman, J. A. (1999). Predictors of relapse following response from a first episode of schizophrenia or schizoaffective disorder. Archives General Psychiatry, 56(3), 241–247.3.Moghaddam B, Javitt D. From revolution to evolution: the glutamate hypothesis of schizophrenia and its implication for treatment. Neuropsychopharmacology. 2012 Jan;37(1):4-15. doi: 10.1038/npp.2011.181. Epub 2011 Sep 28. PMID: 21956446; PMCID: PMC3238069.4.Demjaha A, Egerton A, Murray RM, Kapur S, Howes OD, Stone JM, McGuire PK. Antipsychotic treatment resistance in schizophrenia associated with elevated glutamate levels but normal dopamine function. Biol Psychiatry. 2014 Mar 1;75(5):e11-3. doi: 10.1016/j.biopsych.2013.06.011. Epub 2013 Jul 25. PMID: 23890739.5.Mouchlianitis E, Bloomfield MA, Law V, Beck K, Selvaraj S, Rasquinha N, Waldman A, Turkheimer FE, Egerton A, Stone J, Howes OD. Treatment-Resistant Schizophrenia Patients Show Elevated Anterior Cingulate Cortex Glutamate Compared to Treatment-Responsive. Schizophr Bull. 2016 May;42(3):744-52. doi: 10.1093/schbul/sbv151. Epub 2015 Dec 17. PMID: 26683625; PMCID: PMC4838083.6.Anand R., Giuliani R., Turolla A., Chinellato G., Hartman R. Addition of evenamide, a glutamate release inhibitor, to patients with treatment resistant schizophrenia (TRS) on an antipsychotic is effective and associated with long-term efficacy. SIRS 2023-poster.7.Anand, R., Turolla, A., Chinellato, G., Roy, A., & Hartman, R. D. (2023). Phase 2 results indicate evenamide, a selective modulator of glutamate release, is associated with clinically important long-term efficacy when added to an antipsychotic in patients with treatment-resistant schizophrenia. Int J Neuropsychopharmacology, 26(8), 523–528.

项与 Newron Pharmaceuticals SpA 相关的新闻（医药）

2025-04-22

·PRNewswire

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

临床3期上市批准引进/卖出临床2期

2025-04-11

·生物制品圈

下一个赛道来自“精分”？强生、BMS、再鼎、绿叶竞逐

精神病领域有望迎来下一个重磅药物。4月9日晚，强生宣布已完成对Intra - cellular的收购，通过此次收购，强生不仅将卢美哌隆（lumateperone）纳入囊中，还包括具有同类最优潜力的临床阶段管线，进一步丰富了其在精神健康领域的布局。据悉，此前强生豪掷146亿美元收购中枢神经系统（CNS）治疗药物的企业Intra - cellular。这一金额超过了强生自己在2024年创下的全球医药企业收购金额记录。强生天价收购Intra-cellular，主要目标就是拿下具有两大类精神疾病适应症的卢美哌隆，其销售业绩表现强劲，从2020年的2281万美元增长至2023年的4.64亿美元，2024年预计达到6.85亿美元。本次，强生对Intra-Cellular的收购，只是CNS领域蓬勃发展的一个缩影。精神类药物市场正成为全球药企新的竞争焦点，也带起了该赛道的风口，达成的收购金额呈现上涨趋势，其中Karuna是以140亿美元被BMS收购，艾伯维以87亿美元收购Cerevel 。MNC对CNS的兴趣还在延续，2025年1月渤健宣布将总估值为4.42亿美元“抄底”Sage。不过，高价押注CNS赛道能否真正带来预期的市场回报？CNS“难啃的骨头”相较于传统优势领域（如肿瘤、免疫）竞争白热化，CNS领域仍有大量未被满足的临床需求。然而CNS的药物研发领域一直被认为是医药行业的“硬骨头”，从机制不明，到动物模型难验证、临床开发难，每一项都是CNS药物开发的拦路虎。2024年11月，艾伯维宣布其收购 Cerevel的核心药物——用于治疗精神病症状急性加重的精神分裂症新药Emraclidine的两项EMPOWER临床试验失败。同年，Neumora精神分裂症治疗药物NMRA-266因临床前数据显示该药物引发了兔子的抽搐被FDA叫停试验。NMRA-266 是 M4 毒蕈碱受体的高选择性正变构调节剂；2024年9月，Neurocrine的精神分裂症药物luvadaxistat二次临床II期失败，最终决定停止开发luvadaxistat（NBI-1065844）。而在此之前，罗氏和丹麦灵北制药都曾宣布终止相关管线。接连的试验失败凸显了CNS药物研发的高风险特性，也表明这一领域的药物以及更广泛的新神经科学项目背后机制的复杂性远超预期。收购公告中，强生强调了自身在神经科学领域近70年的经验，拥有多款商业化的神经类药物，其中抗抑郁鼻腔喷雾剂Spravato在2024年销售额突破10亿美元，研管线中还有两款III期临床产品seltorexant和aticaprant。2024年Q3更新的研发管线中，强生终止了3个CNS临床研究项目，分别是seltorexant治疗阿尔茨海默病的2期临床研究、P2X7拮抗剂治疗双相障碍的2期临床研究以及JNJ-0376治疗帕金森病的I期临床研究。可见即使手握可观盈利产品的强生，也面临CNS的研发困境。2024年，强生神经科学业务营收71.15亿美元，在创新制药业务中占比仅12.5%，远低于肿瘤业务的36.48%和免疫业务的31.30%。收购Intra-Cellular不仅能助力强生在神经领域的发展，还囊括一款50亿美元的重磅炸弹。卢美哌隆2019年首次获得FDA批准，治疗精神分裂症，2021年12月又获批了双相情感障碍适应症。在这两大适应症的支撑下，卢美哌隆已经展现出了不菲的商业化潜力。2023年，其销售额已经达到4.62亿美元，同比增长86%；2024年继续增长，前三季度销售额达到4.82亿美元，预计全年最高可达6.85亿美元。值得一提的是，卢美哌隆还将继续快速增长。就在2024年底，Intra-Cellular向FDA提交了卢美哌隆的第3项新适应症上市申请，用于重度抑郁症（MDD）的辅助治疗。MDD的潜在患者人数要远多于精分和双相。根据强生披露的数据，全球超过10亿人——即每8人中就有1人患有神经精神或神经退行性疾病。而在美国，大约240万成年人患有精神分裂症，610万成年人患有双相情感障碍，2100万成年人患有MDD。因此，强生对Caplyta寄予厚望，预计其销售峰值将达到50亿美元。研发难且热情不减根据Frost & Sullivan的预测，全球神经科学药物市场规模将从2022年的1600亿美元增长到2028年的2200亿美元。尽管开发CNS药物具有较大的难度和风险，但由于市场进入壁垒高，且空间潜力巨大，仍吸引着许多药企抢滩布局。技术进步也是推动CNS领域发展的重要因素，2024年9月，BMS宣布Karuna的核心产品KarXT获美国FDA批准上市，它是数十年来首个获批的全新机制的精神分裂症治疗药物。此次批准使BMS在神经科学和精神病学领域获得了重要的立足点。值得一提的是，再鼎医药拥有KarXT大中华区市场的权益，据再鼎医药披露的信息，中国约有80万精神分裂症患者。有望于2024年到2025年上半年获得研究的关键数据，并在中国内地提交KarXT用于精神分裂症的新药上市申请。据悉，除了治疗精神分裂症以外，KarXT目前正在进行注册临床试验，评估治疗阿尔茨海默病精神病的效果，预计2026年获得数据。此外，BMS认为KarXT在其他适应症方面也具有潜力，包括I型双相情感障碍和阿尔茨海默病躁动症。有分析师估计，BMS的KarXT已进入FDA的精神分裂症治疗程序，其销售额可能高达60亿美元。在KarXT身后，全球已进入临床Ⅲ期或注册申请阶段的抗精神分裂症药物已有9款，包括三菱制药的roluperidone、丹麦灵北制药与恩华药业的Lu AF35700、SyneuRx的苯甲酸钠、Newron的依文酰胺、勃林格殷格翰的iclepertin等。此外，国内药企绿叶制药自研的瑞可妥（Rykindo）是一种利培酮微球产品，分别于2021年、2023年在中国、美国获批上市，用于治疗精神分裂症和双相情感障碍，是首个由中国药企自主研发并在美获批的中枢神经系统新药。在CNS领域，绿叶制药还有数款已上市产品或在研管线，彰显出极为强劲的竞争力。识别微信二维码，添加生物制品圈小编，符合条件者即可加入生物制品微信群！请注明：姓名+研究方向！版权声明本公众号所有转载文章系出于传递更多信息之目的，且明确注明来源和作者，不希望被转载的媒体或个人可与我们联系(cbplib@163.com)，我们将立即进行删除处理。所有文章仅代表作者观不本站。

并购临床2期临床3期

2025-02-15

·药智网

百亿精分药赛道「再起风云」

在中枢神经系统领域（CNS），精神分裂症药物的发展和应用是一个重要方面。2024年，CNS领域大爆发，精神分裂症迎来破冰，数十年来首个用于治疗成人精神分裂症的新药Cobenfy获批上市。 2025年，CNS赛道持续火热：先是LB Pharmaceuticals宣布其潜在“first-in-class”苯甲酰胺类抗精神分裂症药物2期试验达到终点，即将迈入3期阶段，随后强生又以146亿美元收购Intra-Cellular，获得其重磅抗精神分裂症药物Caplyta。这些新动态无疑将为精神分裂症药物市场注入新的活力，进一步推动市场的发展变革。 1 前景广阔，短板待补据世界卫生组织2022年发布的数据，全球约2400万人患精神分裂症，流行率为0.33%，成年人群中为0.45%。2023年全球精神分裂症药物市场规模达到81.8亿美元。全球精神分裂症药物市场复合年增长率为5.26%，到2032年市场规模将达到129.7亿美元。这一规模的形成，是长期以来精神分裂症患者群体对药物需求的集中体现。众多制药企业针对这一病症研发并投入市场的各类药物，共同构成了这一庞大的市场体量。图1 三代抗精神分裂症药物图片来源：开源证券研报抗精神分裂症药物分三代，第一代抗精神分裂症药主要是以氯丙嗪、奋乃静、氟奋乃静、三氟拉嗪、舒必利为代表的脑内多巴胺D2受体阻断药，由于这一类药会非选择性地阻断多巴胺受体，常常引发严重副反应。第二代抗精神分裂症药是以氯氮平、奥氮平、利培酮、齐拉西酮为代表的D2/D3/D4受体拮抗剂和5-HT 2A受体拮抗剂，第二代药物相较于第一代药物减少了副作用，但仍会引发代谢综合征，高泌乳素血症等症状。第三代抗精神分裂症药物是以卢美哌隆、阿立哌唑、依匹哌唑以及卡利拉嗪为代表的D2/D3受体部分激动剂、5-HT 2A受体激动剂或拮抗剂和5-HT 1A受体部分激动剂，第三代抗精神病药对精神分裂症的治疗靶点扩展到D2受体阻断之外，以探索D2受体部分激动剂和新靶点如D3、5-HT1A、5-HT7和mGlu2/3受体的抗精神病作用。从全球精神分裂症患者数量及药物市场规模的增长态势，到三代抗精神分裂症药物的特性与局限，不难看出，尽管精神分裂症药物市场前景广阔，但在满足患者需求上仍有提升空间。 2 精分新药，蓄势待发据不完全统计，全球有超过300款精神分裂症创新药在研，其中创新药318款，改良型新药54款。除已经获批上市的Cobenfy外，还有10款新药处于临床3期获注册申请阶段（下表1），有望在2025年获批上市。表1 全球进入注册申请和临床3期阶段的抗精神分裂药物（部分）数据来源：药智数据其中，Brilaroxazine是一种Reviva Pharmaceuticals研发的新化学实体，对关键的血清素和多巴胺受体具有高亲和力和选择性，这些受体与包括精神分裂症、银屑病和间质性肺病在内的多种疾病的病理生理密切相关。2024年12月16日，Reviva Pharmaceuticals公布了Brilaroxazine的3期临床试验数据，结果显示精神分裂症小分子疗法Brilaroxazine3期临床结果积极。 Evenamide是一种口服的新化学实体，具有独特的作用机制，能够使异常钠通道活性诱导的谷氨酸释放正常化，特异性靶向电压门控钠离子通道，用于治疗精神分裂症。2024年4月30日，Newron Pharmaceuticals宣布Evenamide的潜在关键性临床试验008A取得了积极的顶线结果，达到2/3期临床主要终点，Newron指出，evenamide有望成为自氯氮平在1989年获批以来，首款针对治疗抵抗性精神分裂症的新疗法。 Olanzapine作为第二代的新型抗精神病药，作用于脑内D2受体和大脑皮质前额叶、边缘叶5-HT2A和D3受体，用于治疗精神分裂症。Olanzapine long acting injectable采用Medincell专有的共聚合物（copolymer）技术SteadyTeq，只需每月一针，能够稳定、持续地释放奥氮平。2024年5月8日，梯瓦和Medincell宣布其Olanzapine long acting injectabl在治疗精神分裂症成年患者的3期临床试验SOLARIS中达到主要终点，后续有望成功上市。 3 百舸争流，谁主沉浮？ CNS市场规模巨大，吸引各大MCN持续加码。强生长期致力于CNS领域。在产品层面，旗下艾司氯胺酮鼻喷雾剂自2019年获批联合口服抗抑郁药治疗难治性抑郁症后，又于2020年获批新适应症，市场增长迅猛，2023年销售额同比大增84.22%至6.89亿美元，预计2027年销售峰值可观。 1月13日，强生以146亿美元收购Intra-Cellular Therapies公司，获得其重磅抗精神分裂症药物Caplyta，该药分别在2019年、2021年获批用于成人精神分裂症与双相抑郁，且已提交辅助治疗重度抑郁症补充新药申请，若获批意义重大，强生预计其峰值年销售额可达50亿美元。此外，在研药物方面，KOR抑制剂Aticaprant处于Ⅲ期临床，有望达10亿-50亿美元销售额峰值；Caplyta的氘化形式ITI-1284处于Ⅱ期临床，针对广泛性焦虑症、阿尔茨海默病等。另有Lenrispodun（ITI-214）等多款药物处于不同临床阶段。艾伯维在CNS领域布局则更加深入。在精神分裂症领域，Vraylar表现出色，2024年全年销售额达32.67亿美元，同比增长18.4%；在偏头痛方面，Botox、Ubrelvy、Qulipta各展身手，Ubrelvy 2024年销售额10.06亿美元，同比增长23.4%，Qulipta全年销售额6.58亿美元，同比增长61.3%；帕金森病领域，Vyalev于2024年10月17日获美国FDA批准，成为首款基于左旋多巴的皮下24小时持续输注疗法，且还有处于Ⅲ期临床的D1/D5选择性激动剂Tavapadon。此外，艾伯维在CNS领域进行了多项BD交易，通过14亿美元收购Aliada Therapeutics，获处于1期临床的抗焦谷氨酸化β淀粉样蛋白（3pE-Aβ）抗体ALIA-1758，用于阿尔茨海默病研究；2024年5月与Gilgamesh Pharmaceuticals达成20亿美元合作，致力于开发针对情绪障碍和焦虑症等精神疾病的新一代疗法；从Cerevel Therapeutics获得的Emraclidine，作为潜在“best-in-class”的下一代抗精神病药物，针对精神分裂症和阿尔茨海默病进行Ⅱ期临床试验。 BMS也在CNS领域进行了重大投入，2023年12月豪掷140亿美元收购Karuna，从而收获数十年来精神分裂症领域的“First in Class”新药Cobenfy。2021年6月靶向tau蛋白的抗体候选药物PRX005在美国获得独家许可，并于2024年初开启2期临床试验；2024年5月，BMS与Prothena合作项目PRX019获全球许可，FDA已于2023年12月批准其IND申请，Prothena计划2024年底前启动1期临床试验。 4 结语 2025年，精神分裂症药物研发领域机遇与挑战并存。Cobenfy已率先破冰，众多潜力新药蓄势待发。参考资料 1.开源证券研报 2.艾伯维官网、强生官网、BMS官网、药智网等各种公开资料声明：本内容仅用作医药行业信息传播，为作者独立观点，不代表药智网立场。如需转载，请务必注明文章作者和来源。对本文有异议或投诉，请联系maxuelian@yaozh.com。责任编辑 | 史蒂文合作、投稿、转载开白 | 马老师 18323856316（同微信）阅读原文，是受欢迎的文章哦

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