A Phase 2A Randomized Double-Blind Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Varoglutamstat (PQ912) in Patients With Early Alzheimer's Disease With a Stage-Gate to Phase 2B (VIVA-MIND)

This is a Phase 2A multi-center, randomized, double blind, placebo-controlled, parallel group study of varoglutamstat, with a stage gate to Phase 2B.
In Phase 2A there will be adaptive dosing evaluation of three dose levels with exposure to varoglutamstat or placebo for a minimum of 24 weeks, with preliminary evaluation of both cognitive function and pharmacodynamic changes on EEG spectral analysis in approximately 180 participants.
In the event that the stage gate for Phase 2B is reached, then Phase 2B will assesses efficacy and longer-term safety in a larger study group, i.e., 414.

开始日期2021-11-15

申办/合作机构

Vivoryon Therapeutics NV

[+1]

NCT02389413

/ Completed临床2期

A Phase 2A Multicentre, Randomised, Double Blind, Placebo-Controlled, Parallel-Group Safety and Tolerability Study of PQ912 in Subjects With Early Alzheimer's Disease

The aim of this study is to evaluate the safety, tolerability and preliminary efficacy of PQ912 in subjects with Mild Cognitive Impairment (MCI) due to Alzheimers Disease (AD) or mild dementia due to AD.

开始日期2015-03-01

申办/合作机构

Vivoryon Therapeutics NV

[+1]

NCT02190708

/ Completed临床1期

A Phase I, Open Label Study to Assess the Effects of PQ912 on the Pharmacokinetics of Midazolam and Omeprazole in Healthy Male Subjects

Midazolam is a rapid-acting benzodiazepine, with a short half-life (approximately 1.9 hours) and is primarily metabolised by CYP3A.
Omeprazole is a selective proton pump inhibitor substrate used to reduce gastric acid secretion. Omeprazole is primarily metabolised by CYP2C19.
Midazolam and omeprazole are both used as probe drugs in clinical pharmacology studies to evaluate clinical CYP3A and CYP2C19 drug interactions, respectively. Furthermore the EMA and the FDA guidance on drug interactions recommend the use of these drugs for such evaluations.
The aim of this study is to assess the effect of PQ912 on the PK of midazolam and omeprazole. In vitro studies have demonstrated that PQ912 inhibits several CYP enzymes, including CYP3A4 and CYP2C19 and at the expected exposure levels in patients, has the potential to inhibit these enzymes in-vivo. This study is therefore planned to investigate the potential changes in the PK of midazolam and omeprazole due to the effect of PQ912 at steady-state. In clinical practice it is likely that co-administration of PQ912 with other drugs that are metabolised via the CYP3A and/or CYP2C19 enzymes will occur. This study will provide important information for the requirement of dose adjustments or contraindications in these circumstances.

开始日期2014-06-01

申办/合作机构

Vivoryon Therapeutics NV

[+1]

100 项与 Varoglutamstat 相关的临床结果

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100 项与 Varoglutamstat 相关的转化医学

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100 项与 Varoglutamstat 相关的专利（医药）

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项与 Varoglutamstat 相关的文献（医药）

2026-04-14·ChemMedChem

Benzimidazole as a Versatile Scaffold for Developing Neurotherapeutics Against Neurodegenerative Diseases

Review

作者: Tiwari, Prashant ; Dubey, Sonal ; Barnwal, Nivedita

Neurodegenerative diseases (NDs) such as Alzheimer's disease (AD), Parkinson's disease (PD), Huntington's disease (HD), and amyotrophic lateral sclerosis (ALS) are characterized by progressive neuronal loss, leading to severe cognitive and motor dysfunction. Benzimidazole, a privileged heterocyclic scaffold, has emerged as a promising pharmacophore in modulating key pathological targets across these disorders. In AD, benzimidazole derivatives inhibit cholinesterases, glycogen synthase kinase‐3β (GSK‐3β), and glutaminyl cyclase (QC), thereby addressing cholinergic dysfunction, tau phosphorylation, and amyloid aggregation. In PD and HD, they act as monoamine oxidase‐B (MAO‐B) inhibitors, dopamine D1/D2 receptor modulators, and N‐methyl D‐aspartate receptor antagonists, improving dopaminergic signalling and reducing excitotoxicity. In ALS, benzimidazoles regulate acetylcholine dysfunction and inhibit receptor‐interacting protein kinase 1 (RIPK1), limiting neuroinflammation and cell death. Preclinical studies demonstrate potent enzyme inhibition, often with IC 50 values in the nanomolar to micromolar range, alongside favourable ADMET properties enabling blood‐brain barrier penetration. Clinically, the glutaminyl cyclase inhibitor Varoglutamstat has advanced to Phase II trials for AD, while Riluzole remains the only food and drug administration (FDA)‐approved benzimidazole drug for ALS. The structural versatility of benzimidazoles supports their development as multi‐target‐directed ligands, addressing overlapping mechanisms such as protein aggregation, oxidative stress, and neuroinflammation. Emerging strategies including hybrid molecules, nanocarrier delivery, and AI‐driven design may accelerate their clinical translation.

2025-12-01·Alzheimers & Dementia

Generalizability of digital speech and language assessments in MCI/mild AD across four non‐English languages

Article

作者: Schaeffer, Michael ; Xu, Mengdan ; Cormack, Francesca K ; Wenzkowski, Christine ; Lillo, Martina De ; Fuchs, Katharina ; Spilka, Michael J. ; Robin, Jessica

Abstract:

Background:

Neurodegenerative diseases affect speech production. Previous studies show various acoustic and linguistic changes in Mild Cognitive Impairment (MCI) and Alzheimer's disease (AD) speech patterns, such as more pauses and lower usage of nouns. However, most research has focused on English speakers. This analysis examines speech features in MCI and AD patients across four languages to determine if digital speech assessments yield comparable results across different languages.

Method:

This study included 244 patients with MCI or mild AD enrolled in the Phase 2b VIVIAD trial of varoglutamstat, in four language groups: Danish ( n =84), German ( n =59), Dutch ( n =40), and Spanish ( n =61). A picture description task was administered to all patients at baseline using instructions in their respective languages. Five speech features including number of picture objects described, number of nouns, speech rate, pronoun‐to‐noun ratio and average of word length were chosen based on previous analyses of speech patterns in MCI/AD, and a composite score was calculated combining the five measures. We tested the interrelationships among the features in each language and examined whether the speech features were related to another measure of cognitive function, the Mini‐Mental State Exam (MMSE). Associations were examined using a correlational approach.

Result:

There was variation in the magnitudes of the correlations between speech features in the different languages, but the directions of the associations were generally consistent across the four languages in the study. In all four languages, significant correlations with the MMSE were found with both the composite score (‐0.46 ≤ r ≤ ‐0.26) and the object content score (0.27 ≤ r ≤ 0.42).

Conclusion:

Together, these results indicate that there are consistent interrelationships among different speech features across languages. In addition, in the four languages examined, the speech composite score and the number of objects correctly described related to a standard measure of cognition, the MMSE. These results suggest that digital measures of speech and language in MCI/AD are generalizable across languages and relate to cognitive ability more generally. In addition, a composite score of multiple speech features may be more sensitive to cognitive impairment than individual speech metrics.

2025-12-01·Alzheimers & Dementia

The VIVA‐MIND study: Topline Results from Phase 2 RCT of Varoglutamstat in Early AD

Article

作者: Messer, Karen ; Lama, Nicola ; Revta, Carolyn ; Weber, Frank ; Balasubramanian, Archana ; Pol, Alessandra ; Edland, Steven D ; Wenzkowski, Christine ; Jacobs, Diane M. ; Wassmann, Tanja ; Meyer, Antje ; Duehring, Jasmin ; Schell‐Mader, Sylvia ; Leger, Gabriel C ; Schaeffer, Michael ; Zhang, Jing ; Lupo, Jody‐Lynn ; Feldman, Howard H. ; MacKelfresh, Andrew ; Quach, Natalie E

Abstract:

Background:

Varoglutamstat (PQ912) is an oral small molecule inhibitor of glutaminyl cyclases which reduces the pyroglutamate formation of Aβ and CCL2. Preclinical and Ph1 trials support this Ph2 evaluation in early AD. Our objectives included selecting the highest safe and well‐tolerated dose of varoglutamstat with futility analysis at 24 weeks (Ph2A) followed by seamless evaluation of longer‐term safety and efficacy at 72 weeks at this dose (Ph2B).

Method:

Participants with biomarker confirmed early AD were randomized to varoglutamstat or placebo. A sequential design tested 3 descending doses (600mg, 300mg, 150mg BID) using a continuous Pocock safety boundary. A Stage Gate futility analysis of the first 180 subjects at 24 weeks was designed to guide the decision from Ph2A‐B (Figure 1). The Ph2B primary endpoint was CDR‐sum‐of‐boxes (CDR‐SB), with secondary endpoints CFC2, ABC score, spectral EEG, FAQ, ADAS‐Cog‐13, and NPI.

Result:

Table 1 presents baseline characteristics of the 109 randomized and dosed participants. The first dose cohort of varoglutamstat 600mg or placebo did not cross the safety boundary in Ph2A, supporting this dose selection for all participants thereafter. An abbreviated futility analysis was conducted after the trial was terminated prematurely for administrative reasons, with the provisional result of ‘halt enrollment’(yellow) (Figure 1). There were 74% of participants who completed week 24 and 31% week 72 (Figure 2). There were no significant differences between varoglutamstat and placebo in LS mean squares from baseline to week 72 in CDR‐SB (‐0.05 [95% CI ‐1.03, 0.92]), CFC2 (0.97 [95% CI ‐3.34, 5.28]), ABC score (0.10 [95% CI ‐0.10, 0.30]), FAQ (‐0.60 [95% CI ‐4.22, 3.01]), ADAS‐Cog‐13 (2.03 [95% CI ‐2.29, 6.36]); or NPI (‐3.09 [95% CI ‐7.81, 1.62]). At least one TEAE during treatment was reported in 84.9% varoglutamstat and 76.8% placebo with treatment discontinuations due to AE 11.3% varoglutamstat and 3.4% placebo. Severe TEAEs occurred with similar frequencies across arms. Frequency of SAEs/AESIs was 18.9/1.9% varoglutamstat versus 8.9%/5.4% placebo.

Conclusion:

Varoglutamstat was safe and well‐tolerated in this VIVA‐MIND early AD RCT. Efficacy assessment did not demonstrate any significant treatment benefits however, the available sample was limited. Biomarker results and PK/PD are pending.

103

项与 Varoglutamstat 相关的新闻（医药）

2026-06-11

·BioSpace

Vivoryon Therapeutics N.V. to Report Q1 2026 Financial Results on June 11, 2026

Vivoryon Therapeutics N.V. to Report Q1 2026 Financial Results on June 11, 2026 Halle (Saale) / Munich, Germany, June 8, 2026 - Vivoryon Therapeutics N.V. (Euronext Amsterdam: VVY; NL00150002Q7) ( Vivoryon ), a clinical stage company developing small molecule medicines for inflammatory and fibrotic disorders, with a primary focus on kidney diseases, today announced that it will publish its first quarter financial results for the period ended March 31, 2026 on Thursday, June 11, 2026. The Company’s next financial and business update conference call / webcast will be held in conjunction with the publication of its H1 results, anticipated in August. ### About Vivoryon Therapeutics N.V. Vivoryon is a clinical stage biotechnology company focused on developing innovative small molecule-based medicines for the treatment of inflammatory and fibrotic disorders of the kidney. Driven by its passion for ground-breaking science and innovation, the Company strives to improve patient outcomes by changing the course of severe diseases through modulating the activity and stability of pathologically relevant proteins. Vivoryon’s most advanced program, varoglutamstat, a proprietary, first-in-class orally available QPCT/L inhibitor, is being evaluated to treat diabetic kidney disease. Vivoryon Forward Looking Statements This press release includes forward-looking statements, including, without limitation, those regarding the business strategy, management plans and objectives for future operations of Vivoryon Therapeutics N.V. (the “Company”), estimates and projections with respect to the market for the Company’s products and forecasts and statements as to when the Company’s products may be available. Words such as “anticipate,” “believe,” “estimate,” “expect,” “forecast,” “intend,” “may,” “plan,” “project,” “predict,” “should” and “will” and similar expressions as they relate to the Company are intended to identify such forward-looking statements. These forward-looking statements are not guarantees of future performance; rather they are based on the Management’s current expectations and assumptions about future events and trends, the economy and other future conditions. The forward-looking statements involve a number of known and unknown risks and uncertainties. These risks and uncertainties and other factors could materially adversely affect the outcome and financial effects of the plans and events described herein. The Company’s results of operations, cash needs, financial condition, liquidity, prospects, future transactions, strategies or events may differ materially from those expressed or implied in such forward-looking statements and from expectations. As a result, no undue reliance should be placed on such forward-looking statements. This press release does not contain risk factors. Certain risk factors that may affect the Company’s future financial results are discussed in the published annual financial statements of the Company. This press release, including any forward-looking statements, speaks only as of the date of this press release. The Company does not assume any obligation to update any information or forward-looking statements contained herein, save for any information required to be disclosed by law. For more information, please contact: Vivoryon Therapeutics N.V. Dr. Manuela Bader, Director IR & Communication Email: IR@vivoryon.com LifeSci Advisors Sandya von der Weid Tel: +41 78 680 05 38 Email: svonderweid@lifesciadvisors.com Attachment 20260608_Q1 2026 NoR

财报

2026-06-11

·BioSpace

Vivoryon Therapeutics N.V. Reports Q1 2026 Financial Results and Provides Business Update

Vivoryon Therapeutics N.V. Reports Q1 2026 Financial Results and Provides Business Update Compelling kidney function data and meta-analysis from two Phase 2 studies with varoglutamstat presented at WCN 2026 Pronounced treatment effect in high-risk patients, including those with diabetes and lower baseline eGFR supporting plans to advance development in stage 3b/4 diabetic kidney disease (DKD) Company continues to prioritize strategic partnering objectives; active due diligence processes underway with multiple parties Financial guidance reconfirmed: Vivoryon expects cash and cash equivalents to be sufficient for funding operations into Q4 2026 Halle (Saale) / Munich, Germany, June 11 , 2026 - Vivoryon Therapeutics N.V. (Euronext Amsterdam: VVY; NL00150002Q7) ( Vivoryon ), a clinical stage company developing small molecule medicines for inflammatory and fibrotic disorders, with a primary focus on kidney diseases, today announced financial results for the three-month period ended March 31, 2026, and provided a corporate update. "In Q1 2026 our focus remained on strategic discussions with potential partners to support the Phase 2b development of varoglutamstat in advanced DKD. We continue to make substantial progress and remain actively engaged with multiple parties who, like us, understand the need for disease-modifying therapeutics that could improve or stabilize kidney function,” said Frank Weber, MD, CEO of Vivoryon. “We have consistently shown that varoglutamstat improves kidney function in elderly patients, in particular those with diabetes, and have established a large pre-clinical and clinical data set to de-risk the planned Phase 2b program. Taken together, these data give us further confidence that, through its differentiated mechanism of action targeting fibrotic and inflammatory pathways, varoglutamstat could have a transformative role in preventing progression of life-limiting kidney diseases.” Q1 2026 and Post-Period Updates Strategic Priorities Vivoryon’s key strategic priority for 2026 is to secure the funding necessary to advance varoglutamstat into a Phase 2b clinical study in patients with advanced DKD stage 3b/4 in order to confirm the compelling data observed in the VIVIAD and VIVA-MIND studies. Throughout the reporting period and recent months, the Company has continued to engage in active discussions and due diligence under CDA with multiple potential biopharma partners and strategic investors. Varoglutamstat Program Vivoryon’s varoglutamstat Phase 2 program has shown highly consistent, statistically significant and clinically meaningful improvement of kidney function (eGFR) versus placebo in two independent randomized double-blind placebo-controlled studies, VIVIAD and VIVA-MIND. The Company is planning to confirm these results in a dedicated Phase 2b clinical study in patients with DKD stage 3b/4. Initiation of the Phase 2b and all future studies is subject to additional funding and/or partnership, which Vivoryon continues to actively explore. On March 28, 2026, Vivoryon presented a poster at the World Congress of Nephrology (WCN) in Yokohama, Japan, providing an update on the growing body of evidence validating glutaminyl cyclases (QPCT/L) as promising targets in DKD. The analyses underscored previous reports showing that the effect of varoglutamstat on eGFR observed in VIVIAD and VIVA-MIND was greater in elderly participants with diabetes compared to elderly participants without diabetes. In participants with diabetes and lower baseline eGFR (mean 60 mL/min/1.73m 2 ), the effect size was comparable or higher than in the total population of participants with diabetes. Additionally, analysis of data from a DKD mouse model showed significant improvements of inflammation, glomerulosclerosis and kidney function. These results further support Vivoryon’s rationale for a dedicated Phase 2b clinical study in patients with advanced DKD stage 3b/4. The Company has actively expanded the pre-clinical data set around varoglutamstat’s mechanism of action (MOA) and recent studies have further elucidated the molecular mechanisms underlying the substantial benefits reported from the VIVIAD and VIVA-MIND studies. On April 22, 2026, the Company published on its website a pre-recorded webcast contextualizing these new data. The webcast includes new data on the role of QPCT and QPCTL in inflammation and fibrosis, including revealing their newly discovered role in collagen maturation, the disruption of which is a key factor in fibrosis, as well as new data on the existing medical need in kidney disease and the positive effect of varoglutamstat treatment on specialized blood-filtering kidney cells (podocytes). The webcast is available here: Proposed clinical development plan in DKD The Company is planning to conduct a randomized, placebo-controlled Phase 2b study in patients with advanced DKD stage 3b/4 to confirm the compelling effects of varoglutamstat on kidney function observed in the VIVAD and VIVA-MIND Phase 2 studies in elderly patients. Initiation of the Phase 2b and all future studies is subject to additional funding and/or partnership, which Vivoryon continues to actively explore. Financial Results for the First Quarter of 2026 No Revenues were generated in the three months ended March 31, 2026. Research and development expenses decreased by EUR 0.3 million to EUR 0.9 million in the three months ended March 31, 2026, compared to EUR 1.2 million in the three months ended March 31, 2025. This decrease is primarily attributable to EUR 0.2 million lower third-party expenses due to the ramp-down of the Phase 2b clinical studies VIVIAD and VIVA-MIND, reflecting EUR 0.1 million lower clinical costs and EUR 0.1 million lower manufacturing costs. General and administrative expenses were EUR 0.9 million in the three months ended March 31, 2026, compared to EUR 1.3 million in the three months ended March 31, 2025. The EUR 0.4 million decrease was primarily attributable to lower personnel expenses of EUR 0.2 million and reduced legal costs of EUR 0.2 million. The decline in personnel expenses was mainly due to a EUR 0.2 million reduction in share-based payment expenses. The net loss for the three months ended March 31, 2026 was EUR 1.8 million compared to EUR 2.5 million for the three months ended March 31, 2025. As of March 31, 2026, Vivoryon held cash and cash equivalents of EUR 4.0 million compared to cash and cash equivalents of EUR 5.6 million as of December 31, 2025. Outlook & financial guidance As published on April 23, 2026, the issuance date of its annual Financial Statements 2025, the Company expects, based on its most recent financial and business plan, that its existing cash and cash equivalents will be sufficient to fund its operating plans into the fourth quarter of 2026, subject to the occurrence of unforeseen circumstances and without taking into account any funds from the SEPA as well as other potential additional financing transactions, if any. This cash runway guidance reflects an overall reduction in cash utilization while prudently investing in preparing to execute on the Company’s kidney disease strategy. The initiation of the Phase 2b DKD study and all future studies is subject to further additional funding and/or partnership, which the Company continues to actively explore. The viability of the Company’s business beyond its current guidance is dependent on its ability to raise additional funds to finance its operations which also depends on the success of its research and development activities such as those focusing on exploring opportunities in kidney disease. The Company expects to have continued operating losses for the foreseeable future and the need to raise additional capital to finance its future operations. The Company has concluded that the ability to continue as a going concern in the financial year 2026, as stated in the Company‘s Annual Report 2025 published on April 23, 2026, depends on the ability to generate additional funding. Please refer to the Company’s Annual Report 2025 for further information. Conference call and webcast The Company’s next financial and business update conference call / webcast will be held in conjunction with the publication of its H1 results, anticipated in August. ### About Vivoryon Therapeutics N.V. Vivoryon is a clinical stage biotechnology company focused on developing innovative small molecule-based medicines for the treatment of inflammatory and fibrotic disorders of the kidney. Driven by its passion for ground-breaking science and innovation, the Company strives to improve patient outcomes by changing the course of severe diseases through modulating the activity and stability of pathologically relevant proteins. Vivoryon’s most advanced program, varoglutamstat, a proprietary, first-in-class orally available QPCT/L inhibitor, is being evaluated to treat diabetic kidney disease. Vivoryon Forward Looking Statements This press release includes forward-looking statements, including, without limitation, those regarding the business strategy, management plans and objectives for future operations of Vivoryon Therapeutics N.V. (the “Company”), estimates and projections with respect to the market for the Company’s products and forecasts and statements as to when the Company’s products may be available. Words such as “anticipate,” “believe,” “estimate,” “expect,” “forecast,” “intend,” “may,” “plan,” “project,” “predict,” “should” and “will” and similar expressions as they relate to the Company are intended to identify such forward-looking statements. These forward-looking statements are not guarantees of future performance; rather they are based on the Management’s current expectations and assumptions about future events and trends, the economy and other future conditions. The forward-looking statements involve a number of known and unknown risks and uncertainties. These risks and uncertainties and other factors could materially adversely affect the outcome and financial effects of the plans and events described herein. The Company’s results of operations, cash needs, financial condition, liquidity, prospects, future transactions, strategies or events may differ materially from those expressed or implied in such forward-looking statements and from expectations. As a result, no undue reliance should be placed on such forward-looking statements. This press release does not contain risk factors. Certain risk factors that may affect the Company’s future financial results are discussed in the published annual financial statements of the Company. This press release, including any forward-looking statements, speaks only as of the date of this press release. The Company does not assume any obligation to update any information or forward-looking statements contained herein, save for any information required to be disclosed by law. For more information, please contact: Vivoryon Therapeutics N.V. Dr. Manuela Bader, Director IR & Communication Email: IR@vivoryon.com LifeSci Advisors Sandya von der Weid Tel: +41 78 680 05 38 Email: svonderweid@lifesciadvisors.com Attachment 2026-06-11_VVY_Q1_2026

临床2期财报

2026-05-23

·阿尔茨海默病研究

失败率99.6%却仍前赴后继：全球押注阿尔茨海默病的企业图谱

关键词：阿尔茨海默病，仑卡奈单抗，多纳奈单抗，甘露特钠，卫材，渤健，礼来，疾病修饰治疗，研发投入，卫生经济学keyword：Alzheimer's, lecanemab, donanemab, sodium oligomannate, Eisai, Biogen, Eli Lilly, disease-modifying therapy, R&D investment, health economics开拓性起点：他克林开启AD药物研发的"烧钱时代" 1993年，Warner-Lambert公司研发的他克林（Tacrine）获FDA批准，成为史上首个AD治疗药物，标志着制药行业对AD领域大规模商业投入的正式开端[1]。此后三十年，全球逾300种候选药物相继折戟，累计投入超过6000亿美元，失败率高达99.6%[2]。北京医药行业协会援引礼来高管表态："我们在AD领域已投入超过80亿美元，其中过去10年尤为集中"，揭示了该赛道惊人的资本消耗密度[3]。进入2020年代，仑卡奈单抗与多纳奈单抗相继获批，让这场漫长的"烧钱马拉松"终于迎来曙光，也催动2024年AD领域并购交易规模同比暴增780%[4]。主要企业投入总览企业国家代表产品渤健 Biogen 美国阿杜那单抗、仑卡奈单抗礼来 Eli Lilly 美国多纳奈单抗（Kisunla）卫材 Eisai 日本仑卡奈单抗（Leqembi）罗氏 Roche 瑞士甘特单抗、曲替奈单抗强生 J&J 美国 tau疫苗合作管线 AC Immune 瑞士 tau疫苗、Aβ抗体绿谷医药中国甘露特钠（九期一）通化金马/长春华洋中国琥珀八氢氨吖啶片恒瑞医药中国 SHR-1707（抗Aβ抗体）先声药业中国 SIM0408（已终止）润佳医药中国 LX1001（基因治疗）图 1（Figure 1）：全球AD研发企业投入规模柱状图及信息综述图图示纵轴为投入金额，横轴列出渤健、礼来、卫材、罗氏、强生、AC Immune及中国企业绿谷、通化金马、恒瑞等9家企业的估算投入；中间板块以六色数据卡呈现全球累计投入6000亿美元、失败率99.6%、中国在研34款等核心数据；底部时间轴分国际与中国两栏展示各企业代表产品。渤健与卫材：联手共闯，代价最重渤健（Biogen，官方中文译名"渤健"）是AD研发史上累计投入最多、跌落最深又最终翻身的企业。其与卫材（Eisai）联合开发的阿杜那单抗（Aduhelm）历时10余年，2021年争议性获批后因疗效存疑、定价高达56,000美元/年遭遇强烈批评，最终于2024年宣告退市，双方合计损失估算逾30亿美元[5]。痛定思痛，两家公司将资源全力压注于仑卡奈单抗（Leqembi），2023年获FDA完全批准，2024年Q2销售额已达63亿日元（约4.3亿美元），同比增长逾120%[6]。渤健在AD领域的累计投入估算超60亿美元，是全球在该领域烧钱最多的单一企业[7]。礼来：多纳奈单抗后来居上礼来（Eli Lilly）的多纳奈单抗（Kisunla）以TRAILBLAZER-ALZ 2的III期成功为基础，2024年7月获FDA批准，定价32,000美元/年[8]。礼来累计AD研发支出估算超50亿美元，官方披露"过去10年在AD领域投入80多亿美元"[3]。其独特优势在于多纳奈单抗设计了"清除后停药"策略——当脑内淀粉样蛋白降至阈值后可终止给药，47%受试者在1年内实现CDR-SB零进展[9]。2024年底，多纳奈单抗获中国NMPA批准上市，成为首个在中国上市的Aβ靶向疾病修饰药物，进一步打开了中国1700万患者的巨大市场[10]。罗氏与AC Immune：失败后转型罗氏（Roche）在AD领域经历了两次大型III期试验失败——甘特单抗（Gantenerumab）在两项试验中均未达终点，合计损失估算超20亿美元[11]。痛定思痛后，罗氏转而开发"脑穿梭"（BrainShuttle）技术平台，将曲替奈单抗（Trontinemab）与转铁蛋白受体偶联，大幅提升血脑屏障穿透效率，2025年已启动III期研究，有望成为下一代高效Aβ靶向药[12]。AC Immune成立于2003年，专注于AD全链条管线，已累计融资逾4.35亿美元，并与武田制药签署最高22亿美元的tau疫苗开发协议（含1亿美元预付款），以"小而精"模式深耕AD赛道[13][14]。中国企业：多路并进，喜忧参半中国AD药物研发正处于"突围关键期"，现有在研药物34款，覆盖化学小分子、抗体、基因治疗等多条技术路线[15]。绿谷医药的甘露特钠胶囊（九期一，GV-971）2019年附条件获批，开创中国原创AD新药先例，累计投入逾40亿元人民币；但因确证性临床数据滞后、产品一度停产，2025年12月被复星医药以14.12亿元收购控股，命运几经起伏[16][17]。通化金马/长春华洋自主研发的琥珀八氢氨吖啶片是国家1.1类化学新药，具有双重胆碱酯酶抑制功能，2015年启动III期临床，2023年8月完成揭盲，结果显示达到ADAS-cog主要终点且呈阳性，是国内最接近上市审批的原创小分子AD新药之一[18]。恒瑞医药已将抗Aβ抗体SHR-1707推进临床阶段，并在2023年年报中将AD列为神经科学核心布局方向[19]。先声药业曾于2021年以超5亿美元引进Vivoryon公司的SIM0408（varoglutamstat，靶向N3pE淀粉样蛋白），但2025年6月宣布终止该项目研发，折射出AD药物开发的高风险现实[20]。润佳医药则专注于基因治疗方向，开发LX1001（靶向APOE4的AAV基因治疗候选药），临床进展在国内同类项目中居于前列，代表了中国AD研发向前沿生物治疗领域跨越的尝试[15]。参考文献 [1] Watkins PB, et al. "Hepatotoxic effects of tacrine administration in patients with Alzheimer's disease." JAMA vol. 271,13 (1994): 992–998. https://doi.org/10.1001/jama.1994.03510370044031 [2] 美迪西医药. "阿尔茨海默病新药破局进行时，美迪西助力穿越研发'死亡谷'." medicilon.com.cn, 2024. https://www.medicilon.com.cn/hang-ye-zi-xun/alzheimer.shtml [3] 北京医药行业协会. "信息周报20250313——AD领域累计投入80亿美元." bppa.org.cn, 2025. http://www.bppa.org.cn/xhdt/173.html [4] Pharmaceutical Technology. "Alzheimer's R&D resurgence driven by acquisitions in 2025YTD." pharmaceutical-technology.com, 2025. https://www.pharmaceutical-technology.com/analyst-comment/alzheimers-r-d-resurgence-acquisitions/ [5] Piller C. "Blots on a field? A neuroscience image sleuth finds signs of fabrication in scores of Alzheimer's articles." Science (2022). https://doi.org/10.1126/science.add9993 [6] BioArctic AB. "Leqembi revenue more than doubled – totaled JPY 6.3 billion in Q2 2024." stocktitan.net, 2024. https://www.stocktitan.net/news/BIOA/leqembi-revenue-more-than-doubled-totaled-jpy-6-3-billion-in-the-i250wv44qrui.html [7] van Dyck CH, et al. "Lecanemab in Early Alzheimer's Disease." New England Journal of Medicine vol. 388,1 (2023): 9–21. https://doi.org/10.1056/NEJMoa2212948 [8] Pharmaphorum. "Lilly gets FDA OK for Alzheimer's drug, cites cost advantage." pharmaphorum.com, 2024. https://pharmaphorum.com/news/lilly-gets-fda-ok-alzheimers-drug-cites-cost-advantage [9] Sims JR, et al. "Donanemab in Early Symptomatic Alzheimer's Disease: The TRAILBLAZER-ALZ 2 Randomized Clinical Trial." JAMA vol. 330,6 (2023): 512–527. https://doi.org/10.1001/jama.2023.13239 [10] 东方财富. "礼来阿尔茨海默病新药在中国获批上市." eastmoney.com, 2024. https://wap.eastmoney.com/a/202412193273314457.html [11] Roche. "HY 2021 Results: R&D Pipeline Update including gantenerumab." assets.roche.com, 2021. https://assets.roche.com/f/176343/x/b22c1da373/irp210722-a.pdf [12] BioPharma Dive. "Roche, following setbacks, turns to its next Alzheimer's drug." biopharmadive.com, 2024. https://www.biopharmadive.com/news/roche-alzheimers-brain-shuttle-trontinemab/709917/ [13] Inside Precision Medicine. "Takeda Signs Deal Worth $2.2 Billion with AC Immune for Alzheimer's Vaccine." insideprecisionmedicine.com, 2023. https://www.insideprecisionmedicine.com/topics/precision-medicine/takeda-signs-deal-worth-2-2-billion-with-ac-immune-for-alzheimers-vaccine/ [14] Startupticker. "AC Immune raises USD 43.5 million." startupticker.ch, 2022. https://www.startupticker.ch/en/news/ac-immune-raises-usd-43-5-million [15] 摩熵医药（PharmNex）. "千万阿尔茨海默患者未满足的临床需求，国内企业布局AD研发管线." pharnexcloud.com, 2024. https://www.pharnexcloud.com/zixun/sd_7932 [16] 21财经. "复星医药14亿入局阿尔茨海默病，缘何选择押注绿谷'九期一'？" 21jingji.com, 2025. https://www.21jingji.com/article/20251215/herald/c58682589a7cbe33a2a2f2b58d2c1f37.html [17] 新京报. "全球138种阿尔茨海默病药物研发竞速，中国药企闯关'死亡谷'." bjnews.com.cn, 2025. https://m.bjnews.com.cn/detail/1752573610168540.html [18] 通化金马. "国家1.1类化学药琥珀八氢氨吖啶片III期临床试验揭盲结果公告." 东方财富, 2023. https://wap.eastmoney.com/a/202309202853133947.html [19] 恒瑞医药. "江苏恒瑞医药股份有限公司2023年年度报告." 同花顺, 2024. https://notice.10jqka.com.cn/api/pdf/b4516a830bd79588_1713351896/ [20] 先声药业停研报道. "先声AD管线消失、绿谷九期一停产：阿尔茨海默病药研连遭重挫." 新浪财经, 2025. https://finance.sina.com.cn/stock/zqgd/2025-06-26/doc-infcmcya6895693.shtml 本文内容来自公开信息及研究文献，不代表临床建议。如需投稿、转载、商务合作后台留言，回复有一定延迟敬请谅解。辅助编辑：腾讯元宝or（GPT、Gemini、Claude等）扫码加入ima知识库，获取本公众号所有文献全文资料，AI问答了解更多信息，文献实时更新

100 项与 Varoglutamstat 相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
轻度痴呆	临床2期	中国	Vivoryon Therapeutics NV	2022-04-26
轻度痴呆	临床2期	中国	江苏先声药业有限公司	2022-04-26
轻度痴呆	临床2期	中国	Haupt Pharma Wülfing GmbH	2022-04-26
轻度认知障碍	临床2期	丹麦	Vivoryon Therapeutics NV	2020-07-06
轻度认知障碍	临床2期	丹麦	Nordic Bioscience A/S	2020-07-06
轻度认知障碍	临床2期	德国	Vivoryon Therapeutics NV	2020-07-06
轻度认知障碍	临床2期	德国	Nordic Bioscience A/S	2020-07-06
轻度认知障碍	临床2期	荷兰	Nordic Bioscience A/S	2020-07-06
轻度认知障碍	临床2期	荷兰	Vivoryon Therapeutics NV	2020-07-06
轻度认知障碍	临床2期	波兰	Vivoryon Therapeutics NV	2020-07-06

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临床结果

适应症

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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


NCT03919162 (VIVA-MIND, CTgov)	临床2期	阿尔茨海默症	112	PQ912 (PQ912)	鹽願鹹範繭艱鑰積膚鏇 = 鑰築觸積襯範廠構膚製壓齋選夢壓夢製淵遞簾 (齋鹹製築窪憲鏇憲蓋餘, 憲鬱簾衊網膚範鏇蓋鏇 ~ 鹽齋選壓顧積鏇廠膚鹽) 更多	-	2025-12-12
				Placebo (Placebo)	鹽願鹹範繭艱鑰積膚鏇 = 鬱願衊壓蓋鏇膚網構築壓齋選夢壓夢製淵遞簾 (齋鹹製築窪憲鏇憲蓋餘, 衊膚鏇鬱襯蓋憲願鑰鹹 ~ 構願廠衊鹽醖憲簾顧積) 更多
NCT03919162 (VIVA-MIND, GlobeNewswire) 人工标引	临床2期	阿尔茨海默症	-	Varoglutamstat	艱願齋顧蓋壓觸壓鹹齋(繭憲網製齋壓廠選衊顧) = no clinically meaningful and no statistically significant differences between varoglutamstat 600mg BID and placebo 簾獵餘壓壓齋鹹淵積鏇 (鏇艱餘選鏇鏇衊鹹膚窪 ) 更多	积极	2024-12-09
				placebo
NCT04498650 (VIVIAD, ASN2024)	临床2期	阿尔茨海默症 \| 轻度认知障碍	259	Varoglutamstat 300 mg	遞壓鹹淵鹽衊觸醖艱選(憲鬱鬱製鹽壓淵醖淵膚) = 製艱襯膚壓築憲憲觸構糧構繭憲網網鹹選鹹衊 (鑰廠鏇餘遞淵獵鹹廠窪 )	积极	2024-10-25
				Varoglutamstat 600 mg	積製鏇壓繭衊糧鏇餘鑰(醖鏇淵構鹹淵鹽製鹹繭) = 醖憲鹽窪鏇觸鹹製選齋鹹廠夢蓋廠願襯糧鏇顧 (襯鏇糧獵積網顧餘鑰襯 ) 更多
NCT04498650 (VIVIAD, GlobeNewswire \| ASN2024)	临床2期	阿尔茨海默症 \| 糖尿病肾病	32	Varoglutamstat	膚夢遞餘製衊觸襯夢糧(壓繭鹽艱鹽蓋獵鏇繭構) = 構鏇網蓋簾窪艱鑰醖窪艱遞蓋艱齋廠構壓糧築 (廠觸襯遞壓網憲餘願鏇 )	积极	2024-10-25
				placebo	膚夢遞餘製衊觸襯夢糧(壓繭鹽艱鹽蓋獵鏇繭構) = 糧鹹餘餘醖蓋觸獵積鏇艱遞蓋艱齋廠構壓糧築 (廠觸襯遞壓網憲餘願鏇 )
NCT04498650 (VIVIAD, GlobeNewswire) 人工标引	临床2期	肾脏疾病 CCL2 Expression	-	Varoglutamstat 600mg BID	鹽鑰壓選遞願鏇繭觸窪(鑰願壓範顧鬱鬱鬱鏇積) = 鑰選夢願衊積膚構鹽餘艱獵簾網壓選選壓鹹鏇 (淵糧餘範獵壓鹹蓋淵網 ) 更多	积极	2024-09-12
NCT04498650 (VIVIAD, Corporate Publications) 人工标引	临床2期	阿尔茨海默症	250	Varoglutamstat	願窪願範製鹹遞齋積窪(蓋願衊獵願蓋網觸觸淵) = 選窪醖鏇獵衊憲壓壓範範獵襯衊膚廠膚醖觸膚 (積鏇選範製艱觸範觸淵 ) 更多	积极	2022-07-31
NCT02389413 (Pubmed \| Alzheimers Res Ther) 人工标引	临床2期	阿尔茨海默症	120	PQ912	鏇齋鹹糧夢蓋夢願艱鏇(憲範鑰選衊觸鏇膚蓋餘) = There was no significant difference between treatments in the number of subjects with (serious) adverse events, although there were slightly more patients with a serious adverse event in the PQ912 group compared to placebo. 蓋膚顧範廠襯鹹積獵網 (膚餘網獵選鏇鑰憲觸鑰 ) 更多	积极	2018-10-12
				Placebo