A Phase III, 12-week, Prospective, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multi-center Study to Determine the Efficacy, Safety, and Tolerability of a Dose of 15 mg Bid of Evenamide as add-on in Patients With Documented Treatment-resistant Schizophrenia, Which is Not Adequately Controlled by a Stable Therapeutic Dose of the Patient's Current Antipsychotic Medication(s)

This is a prospective, 12-week, randomized, double-blind, placebo-controlled study, designed to evaluate the efficacy, safety, and tolerability of a dose of evenamide of 15 mg bid, compared to placebo, as add-on treatment in patients with documented treatment-resistant schizophrenia (TRS) who have prospectively demonstrated inadequate response to their current stable therapeutic dose of an antipsychotic(s). Approximately 400 patients will be randomized equally (1:1) to each of the two treatment groups in this study.

开始日期2026-01-23

申办/合作机构

Newron Pharmaceuticals SpA

100 项与 Evenamide Hydrochloride 相关的临床结果

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100 项与 Evenamide Hydrochloride 相关的转化医学

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100 项与 Evenamide Hydrochloride 相关的专利（医药）

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项与 Evenamide Hydrochloride 相关的文献（医药）

2026-06-01·BIOLOGICAL PSYCHIATRY

Antipsychotic Drug Action, Novel Treatment Targets, and the Failure of Current Clinical Trial Designs in Evaluating New Target Molecules

Review

作者: Uliana, Daniela L ; Grace, Anthony A

The discovery of antipsychotic drugs more than 65 years ago revolutionized the treatment of schizophrenia that was initially based on serendipitous findings with chlorpromazine. This later led to the dopamine (DA) hypothesis, linking hyperdopaminergic states to psychosis. While D₂-based antipsychotics effectively reduce positive symptoms, they fail to address cognitive and negative deficits. Preclinical studies have provided critical insights into schizophrenia pathophysiology and treatment. These studies show that hippocampal hyperactivity and loss of parvalbumin GABAergic (gamma-aminobutyric acidergic) neuron inhibition drive DA system dysregulation, which leads to pathological hyper-responsivity to stimuli. Antipsychotic drugs induce depolarization block in DA neurons that normalizes DA hyperactivity but does not correct upstream hippocampal dysfunction. Preclinical models have also identified potential novel treatments targeting the hippocampal hyperexcitability, including GABA α₅-positive allosteric modulators and evenamide. These compounds may have the ability to restore hippocampal inhibition, normalize positive symptom-related DA activity, and improve cognitive and negative symptoms without D₂-associated side effects. Clinical trial failures of novel agents, such as pomaglumetad, may be a product of prior D₂ antagonist exposure leading to postsynaptic supersensitivity rather than lack of efficacy. This evidence underscores the importance of patient treatment history and the design of trials that account for prior antipsychotic exposure when evaluating new compounds. Targeting upstream pathology in the hippocampus offers a promising approach for developing more effective, side effect-sparing treatments for schizophrenia.

2026-04-01·EUROPEAN NEUROPSYCHOPHARMACOLOGY

Emerging neurobiological targets in psychiatric treatment

Review

作者: Berk, Michael ; Govinnage, Janani ; Giorlando, Frank ; De Zoysa, Agampodi Ishan ; Narayanaswamy, J C ; Dodd, Seetal

Despite significant advancements in psychopharmacology, there are inadequate treatment options for many psychiatric disorders, including major depressive disorder, bipolar disorder, schizophrenia, and anxiety disorders. This review explores emerging neurobiological targets beyond conventional monoaminergic approaches, focusing on sodium channels, Neuropeptide Y (NPY), Neurokinin 1 (NK1) receptors, P2 × 7 purinergic receptors, Sigma-1 receptors, and Orexin. Recent evidence suggests that sodium channel modulators, such as evenamide, may offer therapeutic benefits for treatment-resistant schizophrenia by stabilizing glutamatergic neurotransmission. NPY-based therapies have potential in stress-related disorders, foreshadowing rapid anxiolytic and antidepressant effects through modulation of the stress response. NK1 receptor antagonists, although inconsistent in mood disorders, show promise in addiction treatment by reducing substance cravings. The P2 × 7 receptor, a key regulator of neuroinflammation, has been implicated in mood disorders, and its pharmacological inhibition may provide neuroprotective benefits. Additionally, Sigma-1 receptor agonists, including Blarcamesine and Pridopidine, have shown neuroprotective and cognitive-enhancing properties, making them attractive candidates for psychiatric and neurodegenerative disorders. Orexin receptor antagonists, such as suvorexant and seltorexant, have potential in mood disorders and substance dependence, highlighting the broader therapeutic applications of targeting the orexinergic system. While these emerging therapeutic targets hold promise, challenges remain in translating preclinical findings into effective clinical applications. Large-scale, placebo-controlled trials are necessary to establish their efficacy and safety. The identification of biomarkers for patient stratification will be critical in the hitherto elusive goal of developing precision medicine approaches. Targeted pharmacological interventions offer a path toward more effective, well-tolerated, and potentially individualized treatment options for patients with severe mental illness.

2025-10-01·NEUROPSYCHOPHARMACOLOGY

Evenamide reverses schizophrenia-related dysfunction in a neurodevelopmental animal model

Article

作者: Rachel A. Walsh ; Anthony A. Grace ; Daniela L. Uliana ; Debora Fabris

Schizophrenia is characterized by positive, negative, and cognitive symptoms. However, current D2-based antipsychotic drugs only address primarily positive symptoms. Limbic hippocampus hyperexcitability is a key pathological state of schizophrenia, representing an ideal therapeutic target. Evenamide is a selective voltage-gated sodium channel blocker that reduces neuronal hyperexcitability. We examined the effect of acute evenamide treatment on the hyperdopaminergic state, hippocampal hyperexcitability, social deficits, and recognition memory in the methylazoxymethanol acetate (MAM) neurodevelopmental model. Male and female Sprague-Dawley offspring from dams treated with saline or MAM on gestational day 17 were tested as adults (postnatal day >65). Electrophysiological recordings were made in the ventral tegmental area (VTA) and ventral hippocampus (vHipp) and social approach and novel object recognition were tested. Evenamide (3 mg/kg i.p.) normalized the number of spontaneously active DA neurons in the VTA of female and male MAM rats and reduced pyramidal neuron hyperactivity in the vHipp. The hyperdopaminergic state in the VTA of female and male MAM rats was also rescued by local evenamide injection in the vHipp (1 µM). Systemic evenamide also reversed the recognition memory impairment of female and male MAM rats. For social deficits, only male MAM rats exhibit a reduced social sniffing time that was normalized by evenamide. These findings suggest that evenamide's efficacy in downregulating the hyperdopaminergic state, social deficits, and recognition memory impairment may result from its ability to attenuate vHipp hyperexcitability. Therefore, evenamide could offer a novel therapeutic strategy that is capable of addressing positive, cognitive, and negative symptoms of schizophrenia.

项与 Evenamide Hydrochloride 相关的新闻（医药）

2026-09-08

·newron.com

Newron reports subscription for EUR 5.5 million of shares by investor group as part of up to EUR 38 million total financing to advance Phase 3 evenamide program

Ad hoc announcement pursuant to Art. 53 LR Total proceeds expected to fund global ENIGMA-TRS studies and extend cash runway beyond pivotal 12-week results, supporting development of evenamide as the potential first add-on therapy for treatment-resistant schizophrenia Milan, Italy, and Morristown, NJ, USA, September 8, 2026, 07:00 CEST – Newron Pharmaceuticals S.p.A. (“Newron”, or the “Company”) (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system, today announced that the investor group participating in Newron’s EUR 38 million financing in February 2026 has subscribed to a second tranche of 433,070 shares, corresponding to gross proceeds of EUR 5.5 million, strengthening the Company’s financial position as it advances the ENIGMA-TRS Phase 3 program. Under the agreement, the investor group initially subscribed to up to 779,624 newly issued shares at a subscription price of EUR 19.24 per share, corresponding to gross proceeds of approximately EUR 15 million. A third tranche of EUR 5.5 million is expected to be subscribed no later than November 30, 2026, alongside the progress of the ENIGMA-TRS 1 and 2 pivotal Phase 3 studies. Finally, the investor group is expected to subscribe to an additional number of newly issued shares for further proceeds of EUR 12 million upon disclosure of results from the ENIGMA-TRS studies, conditional upon such results being positive. The 433,070 newly issued shares are expected to be listed and traded on the SIX Swiss Exchange under the same ISIN as the Company’s existing shares (ISIN: IT0004147952) as of today, upon payment and settlement. Furthermore, the new shares are expected to be listed and traded on the Primärmarkt of the Düsseldorf Stock Exchange, as well as traded on the Quotation Board of the Frankfurt Stock Exchange (Xetra). About Newron Pharmaceuticals Newron (SIX: NWRN, XETRA: NP5) is a biopharmaceutical company focused on the development of innovative therapies for patients with diseases of the central and peripheral nervous system. Headquartered in Bresso near Milan, Italy, the Company has a strong track record of advancing neuroscience-based treatments from discovery to market. Newron’s lead compound, evenamide, is a first-in-class glutamate modulator and has the potential to be the first add-on therapy for treatment-resistant schizophrenia (TRS) and for poorly responding patients with schizophrenia. Evenamide is currently developed in the global pivotal ENIGMA-TRS Phase 3 development program. Clinical trial results to date demonstrate the benefits of this drug candidate in the TRS as well as poorly responding patient population, with significant improvements across key efficacy measures increasing over time, as well as a favorable safety profile, which is uncommon for available antipsychotic medications. Newron has signed development and commercialization agreements for evenamide with EA Pharma (a subsidiary of Eisai) for Japan and other Asian territories, as well as Myung In Pharm for South Korea. Newron’s first marketed product, Xadago®/safinamide has received marketing authorization for the treatment of Parkinson’s disease in the European Union, Switzerland, the UK, the USA, Australia, Canada, Latin America, Israel, the United Arab Emirates, Japan and South Korea. The product is commercialized by Newron’s partner Zambon, with Supernus Pharmaceuticals holding marketing rights in the U.S., and Meiji Seika responsible for development and commercialization in Japan and other key Asian territories. For more information, please visit: https://www.newron.com and connect with us on LinkedIn. For more information, please contact: Newron Stefan Weber – CEO; pr@newron.com UK/Europe Simon Conway / Ciara Martin / Natalie Garland-Collins, FTI Consulting; +44 20 3727 1000, SCnewron@fticonsulting.com Switzerland Valentin Handschin, IRF; +41 43 244 81 54, handschin@irf-reputation.ch Germany/Europe Anne Hennecke / Maximilian Schur, MC Services; +49 211 52925227, newron@mc-services.eu USA John Fraunces, LifeSci Advisors, +1 917 355 2395, jfraunces@lifesciadvisors.com Important Notices This document contains forward-looking statements, including (without limitation) about (1) Newron’s ability to develop and expand its business, successfully complete development of its current product candidates, the timing of commencement of various clinical trials and receipt of data and current and future collaborations for the development and commercialization of its product candidates, (2) the market for drugs to treat CNS diseases and pain conditions, (3) Newron’s financial resources, and (4) assumptions underlying any such statements. In some cases, these statements and assumptions can be identified by the fact that they use words such as “will”, “anticipate”, “estimate”, “expect”, “project”, “intend”, “plan”, “believe”, “target”, and other words and terms of similar meaning. All statements, other than historical facts, contained herein regarding Newron's strategy, goals, plans, future financial position, projected revenues and costs and prospects are forward-looking statements. By their very nature, such statements and assumptions involve inherent risks and uncertainties, both general and specific, and risks exist that predictions, forecasts, projections and other outcomes described, assumed or implied therein will not be achieved. Future events and actual results could differ materially from those set out in, contemplated by or underlying the forward-looking statements due to a number of important factors. These factors include (without limitation) (1) uncertainties in the discovery, development or marketing of products, including without limitation difficulties in enrolling clinical trials, negative results of clinical trials or research projects or unexpected side effects, (2) delay or inability in obtaining regulatory approvals or bringing products to market, (3) future market acceptance of products, (4) loss of or inability to obtain adequate protection for intellectual property rights, (5) inability to raise additional funds, (6) success of existing and entry into future collaborations and licensing agreements, (7) litigation, (8) loss of key executive or other employees, (9) adverse publicity and news coverage, and (10) competition, regulatory, legislative and judicial developments or changes in market and/or overall economic conditions. Newron may not actually achieve the plans, intentions or expectations disclosed in forward-looking statements and assumptions underlying any such statements may prove wrong. Investors should therefore not place undue reliance on them. There can be no assurance that actual results of Newron's research programs, development activities, commercialization plans, collaborations and operations will not differ materially from the expectations set out in such forward-looking statements or underlying assumptions. Newron does not undertake any obligation to publicly update or revise forward-looking statements except as may be required by applicable regulations of the SIX Swiss Exchange or the Dusseldorf Stock Exchange where the shares of Newron are listed. This document does not contain or constitute an offer or invitation to purchase or subscribe for any securities of Newron and no part of it shall form the basis of or be relied upon in connection with any contract or commitment whatsoever.

临床3期引进/卖出上市批准

2026-09-08

·BioSpace

Newron Reports Subscription for EUR 5.5 Million of Shares by Investor Group as Part of Up to EUR 38 Million Total Financing to Advance Phase 3 Evenamide Program

Total proceeds expected to fund global ENIGMA-TRS studies and extend cash runway beyond pivotal 12-week results, supporting development of evenamide as the potential first add-on therapy for treatment-resistant schizophrenia MILAN and MORRISTOWN, N.J., Sept. 08, 2026 (GLOBE NEWSWIRE) -- Newron Pharmaceuticals S.p.A. (“Newron”, or the “Company”) (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system, today announced that the investor group participating in Newron’s EUR 38 million financing in February 2026 has subscribed to a second tranche of 433,070 shares, corresponding to gross proceeds of EUR 5.5 million, strengthening the Company’s financial position as it advances the ENIGMA-TRS Phase 3 program. Under the agreement, the investor group initially subscribed to up to 779,624 newly issued shares at a subscription price of EUR 19.24 per share, corresponding to gross proceeds of approximately EUR 15 million. A third tranche of EUR 5.5 million is expected to be subscribed no later than November 30, 2026, alongside the progress of the ENIGMA-TRS 1 and 2 pivotal Phase 3 studies. Finally, the investor group is expected to subscribe to an additional number of newly issued shares for further proceeds of EUR 12 million upon disclosure of results from the ENIGMA-TRS studies, conditional upon such results being positive. The 433,070 newly issued shares are expected to be listed and traded on the SIX Swiss Exchange under the same ISIN as the Company’s existing shares (ISIN: IT0004147952) as of today, upon payment and settlement. Furthermore, the new shares are expected to be listed and traded on the Primärmarkt of the Düsseldorf Stock Exchange, as well as traded on the Quotation Board of the Frankfurt Stock Exchange (Xetra). ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); About Newron Pharmaceuticals Newron (SIX: NWRN, XETRA: NP5) is a biopharmaceutical company focused on the development of innovative therapies for patients with diseases of the central and peripheral nervous system. Headquartered in Bresso near Milan, Italy, the Company has a strong track record of advancing neuroscience-based treatments from discovery to market. Newron’s lead compound, evenamide, is a first-in-class glutamate modulator and has the potential to be the first add-on therapy for treatment-resistant schizophrenia (TRS) and for poorly responding patients with schizophrenia. Evenamide is currently developed in the global pivotal ENIGMA-TRS Phase 3 development program. Clinical trial results to date demonstrate the benefits of this drug candidate in the TRS as well as poorly responding patient population, with significant improvements across key efficacy measures increasing over time, as well as a favorable safety profile, which is uncommon for available antipsychotic medications. Newron has signed development and commercialization agreements for evenamide with EA Pharma (a subsidiary of Eisai) for Japan and other Asian territories, as well as Myung In Pharm for South Korea. Newron’s first marketed product, Xadago®/safinamide has received marketing authorization for the treatment of Parkinson’s disease in the European Union, Switzerland, the UK, the USA, Australia, Canada, Latin America, Israel, the United Arab Emirates, Japan and South Korea. The product is commercialized by Newron’s partner Zambon, with Supernus Pharmaceuticals holding marketing rights in the U.S., and Meiji Seika responsible for development and commercialization in Japan and other key Asian territories. For more information, please visit: and connect with us on LinkedIn . For more information, please contact: Newron Stefan Weber – CEO; pr@newron.com ezstandalone.cmd.push(function () { ezstandalone.showAds(132); }); UK/Europe Simon Conway / Ciara Martin / Natalie Garland-Collins, FTI Consulting; +44 20 3727 1000, SCnewron@fticonsulting.com Switzerland Valentin Handschin, IRF; +41 43 244 81 54, handschin@irf-reputation.ch Germany/Europe Anne Hennecke / Maximilian Schur, MC Services; +49 211 52925227, newron@mc-services.eu USA John Fraunces, LifeSci Advisors, +1 917 355 2395, jfraunces@lifesciadvisors.com ezstandalone.cmd.push(function () { ezstandalone.showAds(133); }); Important Notices This document contains forward-looking statements, including (without limitation) about (1) Newron’s ability to develop and expand its business, successfully complete development of its current product candidates, the timing of commencement of various clinical trials and receipt of data and current and future collaborations for the development and commercialization of its product candidates, (2) the market for drugs to treat CNS diseases and pain conditions, (3) Newron’s financial resources, and (4) assumptions underlying any such statements. In some cases, these statements and assumptions can be identified by the fact that they use words such as “will”, “anticipate”, “estimate”, “expect”, “project”, “intend”, “plan”, “believe”, “target”, and other words and terms of similar meaning. All statements, other than historical facts, contained herein regarding Newron's strategy, goals, plans, future financial position, projected revenues and costs and prospects are forward-looking statements. By their very nature, such statements and assumptions involve inherent risks and uncertainties, both general and specific, and risks exist that predictions, forecasts, projections and other outcomes described, assumed or implied therein will not be achieved. Future events and actual results could differ materially from those set out in, contemplated by or underlying the forward-looking statements due to a number of important factors. These factors include (without limitation) (1) uncertainties in the discovery, development or marketing of products, including without limitation difficulties in enrolling clinical trials, negative results of clinical trials or research projects or unexpected side effects, (2) delay or inability in obtaining regulatory approvals or bringing products to market, (3) future market acceptance of products, (4) loss of or inability to obtain adequate protection for intellectual property rights, (5) inability to raise additional funds, (6) success of existing and entry into future collaborations and licensing agreements, (7) litigation, (8) loss of key executive or other employees, (9) adverse publicity and news coverage, and (10) competition, regulatory, legislative and judicial developments or changes in market and/or overall economic conditions. Newron may not actually achieve the plans, intentions or expectations disclosed in forward-looking statements and assumptions underlying any such statements may prove wrong. Investors should therefore not place undue reliance on them. There can be no assurance that actual results of Newron's research programs, development activities, commercialization plans, collaborations and operations will not differ materially from the expectations set out in such forward-looking statements or underlying assumptions. Newron does not undertake any obligation to publicly update or revise forward-looking statements except as may be required by applicable regulations of the SIX Swiss Exchange or the Dusseldorf Stock Exchange where the shares of Newron are listed. This document does not contain or constitute an offer or invitation to purchase or subscribe for any securities of Newron and no part of it shall form the basis of or be relied upon in connection with any contract or commitment whatsoever.

临床3期上市批准引进/卖出

2026-09-07

·海上衣BIUBIUBIU

CNS这两周：亨廷顿病等到了第一个基因治疗，但Angelman又倒下一个ASO

这两周CNS领域信息量不小。罕见病拿到几个关键批件，也有一个III期意外折戟；发作性睡病赛道突然变得拥挤；还有一起挺值得琢磨的破产资产竞购。罕见病：进展居多，但也有一记重击 Ionis的Zanvastro拿到FDA批准，用于Alexander病。这是一种极罕见的儿童神经退行性疾病，患者基数很小，能走到获批，说明反义寡核苷酸平台在超罕见适应症上的商业化路径已经比较成熟了。 Acadia的DAYBU也拿到欧盟批准，用于雷特综合征(科普下，由X染色体基因突变导致的神经发育障碍性疾病）—这是Acadia在美国拿下同一适应症之后的又一次区域拓展。孤儿药"一个资产打多个地区"的打法越来越常见，本质上是用最小的临床增量换最大的地域覆盖。最重的一条是uniQure。AMT-130已经正式向FDA和英国递交了亨廷顿病基因治疗的上市申请，如果获批，会是全球首个亨廷顿病基因治疗药物，FDA审评节点定在2027年二季度。亨廷顿病此前基本是治疗空白，这一步一旦落地，会直接重新定义整个疾病的治疗范式。不过罕见病这条线不全是好消息。Ultragenyx的apazunersen在Angelman综合征的III期Aspire研究里，主要终点和关键次要终点全部没有达到。这个方向此前预期不低，ASO疗法在这个适应症上已经不是第一次受挫，这次失败会让整个赛道重新审视反义寡核苷酸能否真正逆转这类印记基因疾病的表型。精神神经：老药新用和难治性适应症在推进 Autobahn Therapeutics公布了elunetirom的非临床数据，显示它能促进突触连接和神经元能量代谢，为其抗抑郁机制提供了新的支持证据。 Axsome的AXS-05（也就是已获批用于抑郁症的Auvelity）启动了戒烟适应症的III期研究，完成了首例给药。这是典型的"老药新用"打法，用已验证的安全性数据，换一条低成本的适应症扩展路径。 Newron的evenamide在难治性精神分裂症的关键III期研究完成了入组筛选，主要数据readout定在2027年一季度，如果无所谓专利的话，值得持续跟踪。发作性睡病：突然拥挤的赛道这两周这个细分领域热闹得有点意外。Takeda的ORZEYFUL在日本拿到1型发作性睡病批准；Alkermes公布了alixorexton积极的II期数据，支持其正在推进的III期项目；再往前看，Nxera Pharma因为OX2R激动剂组合在后期临床取得进展，从Centessa那里拿到860万美元里程碑付款。三条线加在一起说明，食欲素受体2激动剂这个机制经过多年验证后，正从"单一玩家探索"变成"多家公司同台竞速"。对还在观望这个靶点的BD团队来说，窗口期可能没有想象中那么长了。诊断端：一条容易被忽略但影响更深远的消息罗氏的Elecsys pTau217血液检测拿到FDA批准，用于阿尔茨海默病评估。血液生物标志物检测如果能大规模替代PET影像和脑脊液穿刺，会直接改变AD药物临床开发的入组效率，以及真实世界的早筛路径。这对所有在做AD疗法的公司——不管是抗Aβ还是抗tau方向——都是基础设施层面的利好。融资并购：困境资产里藏着机会最值得说的是BioXcel Therapeutics申请破产，Teva随后以最高1.25亿美元竞标其神经科学资产。这是典型的困境资产收购：BioXcel手里的资产临床数据和获批状态都还在，只是商业化不及预期导致现金流断裂。对愿意接盘的买家来说，破产程序里的资产往往能拿到比正常BD谈判更有利的估值，尤其适合手里有余粮、想低成本切入美国神经科学商业化渠道的买家。另外两笔融资也值得记一笔：Werewolf Therapeutics和Ambros Therapeutics宣布合并，同步完成1.5亿美元融资，把Neridronate推进到III期治疗CRPS-1（复杂区域疼痛综合征）；NovaGo Therapeutics完成3000万美元B轮，把抗Nogo-A生物制剂推进到急性脊髓损伤的概念验证阶段。两笔钱都指向同一个逻辑：投资人对CNS里"机制明确、患者定义清晰"的细分适应症仍然愿意买单，哪怕大盘对CNS整体估值偏保守。这两周的信息密度，其实体现出几个清晰的分层：超罕见病和基因治疗还在稳步兑现监管里程碑；反义寡核苷酸在复杂神经发育疾病上的失败率依然不低；发作性睡病这类机制相对成熟的赛道已经进入多头竞争；诊断工具的进步，可能比单一药物获批对整个AD领域的影响更长远。对国内做CNS方向BD筛选的团队来说，短期比较值得优先关注的，还是OX2R激动剂这类已经有多方数据验证、机制风险相对较低的资产，以及像BioXcel这样处于困境重组、估值可能被错杀的标的。

孤儿药寡核苷酸临床3期引进/卖出基因疗法

100 项与 Evenamide Hydrochloride 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	Evenamide Hydrochloride	-	-

研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
精神分裂症，难治性	临床3期	阿根廷	Newron Pharmaceuticals SpA	2025-12-16
精神分裂症，难治性	临床3期	巴西	Newron Pharmaceuticals SpA	2025-12-16
精神分裂症，难治性	临床3期	保加利亚	Newron Pharmaceuticals SpA	2025-12-16
精神分裂症，难治性	临床3期	加拿大	Newron Pharmaceuticals SpA	2025-12-16
精神分裂症，难治性	临床3期	哥伦比亚	Newron Pharmaceuticals SpA	2025-12-16
精神分裂症，难治性	临床3期	克罗地亚	Newron Pharmaceuticals SpA	2025-12-16
精神分裂症，难治性	临床3期	捷克	Newron Pharmaceuticals SpA	2025-12-16
精神分裂症，难治性	临床3期	法国	Newron Pharmaceuticals SpA	2025-12-16
精神分裂症，难治性	临床3期	德国	Newron Pharmaceuticals SpA	2025-12-16
精神分裂症，难治性	临床3期	匈牙利	Newron Pharmaceuticals SpA	2025-12-16

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


EUCTR2020-006062-36-CZ (008A, Pubmed \| NEWS 1 \| NEWS 2)	临床2/3期	精神分裂症	291	Evenamide	鬱獵選糧願膚鑰簾遞顧(願範衊鏇鹹鹽窪廠衊網) = 廠淵壓積鹽積範糧糧鬱構鏇壓壓顧顧觸構衊鑰 (鏇網夢窪艱選醖餘醖窪 ) 更多	积极	2024-04-30
EUCTR2020-006062-36-CZ (008A, Pubmed \| NEWS 1 \| NEWS 2)	临床2/3期	精神分裂症	291	安慰剂	鬱獵選糧願膚鑰簾遞顧(願範衊鏇鹹鹽窪廠衊網) = 醖觸簾夢膚鑰網網夢製構鏇壓壓顧顧觸構衊鑰 (鏇網夢窪艱選醖餘醖窪 ) 更多	积极	2024-04-30
EUCTR2020-000437-41-IT (Study 015, Biospace) 人工标引	N/A	精神分裂症，难治性	121	Evenamide	蓋鬱餘膚鏇夢鹹窪積製(網顧醖觸鬱網夢廠鹹夢) = 繭膚衊淵積蓋繭夢艱襯廠築選網築簾築窪淵醖 (壓繭觸鑰糧製觸襯艱蓋 ) 更多	积极	2024-01-04
Study 015 (Corporate Publications) 人工标引	临床2期	精神分裂症，难治性	97	Evenamide	淵範鏇鹹觸鑰製齋襯願(鏇繭選鑰蓋糧築築憲膚) = 襯膚餘鑰觸衊願簾簾築醖廠觸繭齋壓獵獵遞壓 (遞願網簾廠憲構遞鹹襯 ) 更多	积极	2023-05-07
CTRI/2020/09/027537 (Corporate Publications) 人工标引	临床2期	精神分裂症，难治性	161	Evenamide	夢選獵製淵範艱積繭憲(鹽築壓醖鏇獵鬱鏇選襯) = The mean Positive and Negative Syndrome Scale (PANSS) total score, Clinical Global Impression of Severity (CGI-S) rating, and the Strauss-Carpenter Level of Functioning (LOF) total score significantly improved compared to baseline (p<0.001). 鑰鬱鬱淵衊鑰壓遞獵鏇 (簾鬱鬱鬱餘築膚糧鹽願 ) 更多	积极	2023-03-20
CTRI/2020/09/027537 (Corporate Publications) 人工标引	临床2期	精神分裂症，难治性	100	evenamide	壓襯艱鬱餘膚遞網範蓋(簾齋壓鏇獵鹽積糧網積) = The proportion of patients experiencing clinically meaningful improvement (i.e., patients rated at least “much improved”) on the Clinical Global Impression of Change (CGI-C) increased by an additional 10% at one year from the proportion at week six (27%). 網顧鏇艱憲觸廠鑰憲壓 (遞廠廠蓋構餘蓋願齋簾 ) 更多	积极	2023-02-16
Corporate Publications 人工标引	N/A	精神分裂症，难治性	100	evenamide	艱鹽餘簾製願製艱淵積(鏇獵艱築鹹鏇膚鬱選獵) = 鬱願壓餘選鑰鹹襯遞願鏇鹹壓衊遞願襯積鏇鑰 (選築夢壓願廠簾鹹蓋蓋 ) 更多	积极	2022-06-07
NCT01955564 (CTgov)	临床1期	精神分裂症	54	NW-3509a (Cohort 1)	壓鹽膚鬱鑰鬱鬱襯憲餘 = 繭構鏇願壓選壓膚鑰窪窪齋簾簾廠餘鹽鬱膚餘 (鏇繭範壓鬱壓繭鹽夢襯, 窪築蓋鏇廠糧構餘願膚 ~ 鑰蓋餘網築積製艱繭艱) 更多	-	2017-06-20
NCT01955564 (CTgov)	临床1期	精神分裂症	54	NW-3509a (Cohort 2)	壓鹽膚鬱鑰鬱鬱襯憲餘 = 選鹹選願獵廠淵築夢鹹窪齋簾簾廠餘鹽鬱膚餘 (鏇繭範壓鬱壓繭鹽夢襯, 餘遞鏇壓憲襯繭鬱憲顧 ~ 構鹹鬱醖獵壓艱鏇醖糧) 更多	-	2017-06-20