Comparative Study of Fluoxetine, Acamprosate, and Their Combination in patients with co-occurring Depression and Alcohol Dependence: A Randomized Controlled Trial - NIL

开始日期2026-09-01

申办/合作机构-

NCT07204977

/ Recruiting临床1期IIT

Acamprosate in C9orf72 Hexanucleotide Repeat Expansion Amyotrophic Lateral Sclerosis (ACALS)

Background:
Amyotrophic lateral sclerosis (ALS) is a disorder that damages nerve cells in the brain and spinal cord. It can cause muscle weakness, paralysis, and loss of movement. The symptoms grow worse over time. Half of all people with ALS live only 3 to 5 years after diagnosis. Current drug treatments can slow the progress of the disease, but they cannot stop or reverse it.
Objective:
To test a study drug (acamprosate) in people with ALS with a mutation in the C9orf72 gene.
Eligibility:
People aged 18 years and older with ALS. They must have a mutation in the C9orf72 gene.
Design:
Participants will have 13 visits over 32 weeks. Five visits will be at the clinic, and 8 visits will be by phone.
Participants will have a baseline visit of up to 3 days. They will have a physical exam with blood tests. They will have imaging scans and tests of their breathing ability. Their memory, thinking, and behavior will be assessed. They will have a neurologic exam to check their reflexes, strength, balance, eyes, and coordination. They will complete questionnaires about their daily life. They will have a lumbar puncture to collect fluid from the area around the spinal cord.
Acamprosate is a pill taken by mouth. Participants will take 2 pills by mouth 3 times a day with meals for 24 weeks. They will record their doses and any missed doses in a diary.
Baseline tests will be repeated during follow-up clinic visits. These tests may be spread out over 3 days.
During phone visits, participants will talk about how they are doing. They will review their diary with researchers.

开始日期2026-02-02

申办/合作机构

National Institute of Neurological Disorders & Stroke

100 项与阿坎酸钙相关的临床结果

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100 项与阿坎酸钙相关的转化医学

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100 项与阿坎酸钙相关的专利（医药）

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项与阿坎酸钙相关的文献（医药）

2026-11-01·DRUG AND ALCOHOL DEPENDENCE

Nationwide trends of six medications for alcohol use disorder prescriptions post-discharge in patients hospitalized with alcohol-associated liver disease between 2015 and 2024

Article

作者: Yeo, Yee Hui ; Zhang, Wei ; Ting, Peng-Sheng ; Chan, Shu-Yen ; Yang, Hsien Yao

INTRODUCTION:

Alcohol associated liver disease (ALD) carries a high risk of hospitalization and recidivism, yet post-discharge medications for alcohol use disorder (MAUD) are not universally prescribed. MAUD prescriptions have been associated with reduced recidivism and hepatic decompensation. However, national data on prescribing patterns is limited. We examined ten-year trends in six MAUD prescriptions after hospitalization for ALD.

METHODS:

We identified 150,241 US adults hospitalized with ALD between 2015 and 2024 using electronic health records from TriNetX. Outcomes included annual prevalence, incidence rate, and incidence proportion of post-discharge MAUD prescriptions. FDA-approved agents included disulfiram, acamprosate, and naltrexone; off-label agents included topiramate, baclofen, and gabapentin. Trends were assessed using Joinpoint regression with annual percentage change (APC) and average annual percentage change (AAPC). Subgroup analyses were stratified by cirrhosis status and sex.

RESULTS:

FDA-approved MAUD had consistently lower prescription rates than off-label agents over the past decade. From 2015-2024, disulfiram was the only FDA-approved agent with a declining trend, while acamprosate (AAPC 20.35%) and naltrexone (AAPC 17.83%) demonstrated significant increases for new prescriptions. By 2024, the prevalence of FDA-approved and off-label MAUD prescriptions were 17.98% and 41.96%, respectively. Patients with cirrhosis had lower prescribing rates but exhibited greater relative increases in FDA-approved MAUD prescriptions. Women were more likely to receive off-label prescriptions, though both sexes showed similar upward trends.

CONCLUSION:

Post-discharge MAUD prescribing for ALD has risen significantly, but less than 20% of patients receive FDA-approved MAUD. Expanding access to evidence-based medications is critical to improve outcomes in this high-risk population.

2026-10-01·Journal of Obstetrics and Gynaecology Canada

SOGC Clinical Practice Guideline No. 471: Alcohol and Pregnancy

Review

作者: Christie, Janet ; Allen, Victoria ; Thompson, Heather ; Cook, Jocelynn L ; Chandrasekaran, Nirmala ; Ouellet, Annie

OBJECTIVE:

To establish national standards of care for screening and counselling pregnant women and individuals of reproductive age regarding alcohol consumption and alcohol use disorder.

INTENDED USERS:

Health care providers who care for pregnant women and women of childbearing age.

TARGET POPULATION:

Pregnant women and women of childbearing age and their families.

EVIDENCE:

Medline, EMBASE, and CENTRAL databases were searched for "alcohol use and pregnancy". The results were filtered for a publication date between October 2018 and February 2026. The search terms were developed using the MeSH terms and key words including: pre-pregnancy, pregnant, breast feeding, lactation, female, women, preconception care, prenatal care, Fetal Alcohol Spectrum Disorder, prenatal alcohol exposure, drinking behavior, alcohol abstinence, alcohol drinking, binge drinking, Alcohol-Related Disorders, alcoholism, alcohol consumption, alcohol abuse, benzodiazepines, disulfiram, naltrexone, acamprosate, ondansetron, topiramate, cyanamide, calcium carbimide, alcohol deterrents, disease management, detoxification, Alcoholics Anonymous, alcohol counselling, harm reduction, pre-pregnancy care, prenatal care, incidence, prevalence, epidemiological monitoring, brief intervention. Clinical trials, observational studies, reviews, systematic reviews and meta-analysis, guidelines, and conference consensus were included. The table of evidence from the search that supports the recommendations is included as Appendix B.

VALIDATION METHODS:

The authors rated the quality of evidence and strength of recommendations using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. See online Appendix A (Tables A1 for definitions and A2 for interpretations of strong and conditional recommendations).

BENEFITS, HARMS, AND COSTS:

Implementation of the recommendations in these guidelines may increase obstetrical care provider recognition of alcohol consumption and problematic alcohol use among women of childbearing age or who are pregnant using validated screening tools and brief intervention approaches. Obstetrician-gynecologists should be given priority access to healthcare professionals with expertise in alcohol cessation for their patients in order to support optimal health and pregnancy outcomes. As they are already responsible for the urgent management of pregnancy-related complications, they must be able to rely on expedited referral pathways to ensure timely interventions.

SUMMARY STATEMENTS:

RECOMMENDATIONS: (Recommendations IN BOLD are new to this guideline update; an overview of the updated supporting literature for all recommendations is provided in Appendix B).

2026-09-20·ALCOHOL AND ALCOHOLISM

Pharmacological interventions for alcohol use disorder on quality of life: a meta-analysis of randomized controlled trials

Review

作者: Kim, Paul ; Fluyau, Dimy ; Revadigar, Neelambika

Abstract:

Aims:

Quality of life (QoL), a critical factor for sustaining recovery from alcohol use disorder (AUD), has been examined as an AUD-related outcome in randomized controlled trials (RCTs) that evaluated pharmacotherapy for AUD. This review evaluates the efficacy of this therapy in improving mental and physical health-related QoL.

Methods:

RCTs were identified across seven databases. Study quality was evaluated using the Cochrane risk-of-bias tool for randomized trials version 2. A systematic review with meta-analysis was conducted. The review adhered to Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines and was registered with PROSPERO (CRD420261277890).

Results:

Eighteen RCTs with 4376 participants were evaluated. Naltrexone was linked to improvements in both mental QoL (d = 0.30, 95% CI: 0.08–0.52) and physical QoL (d = 0.16, 95% CI: 0.01–0.31). Nalmefene improved physical QoL (d = 0.13, 95% CI: 0.02–0.25) but not mental QoL (d = 0.18, 95% CI: −0.004 to 0.354). Topiramate showed no improvement in either domain. However, further analysis indicated that topiramate was associated with a small improvement in physical QoL, which could correlate with a reduced percentage of heavy drinking days. Interpret these findings with caution. Acamprosate, sertraline, and psilocybin were associated with improved mental or physical QoL, whereas ketamine, varenicline, levetiracetam XR, and quetiapine were not. Interpretation is limited to single trials—no eligible RCTs reporting the specified QoL outcomes for disulfiram.

Conclusions:

Certain medications for AUD are linked with improved mental and physical QoL, but evidence remains limited. Future RCTs should assess QoL and establish whether improvements are clinically meaningful.

项与阿坎酸钙相关的新闻（医药）

2026-10-13

·医药观澜

3家创新药公司完成新一轮融资！

根据公开信息，上周（10月5日~10月11日），全球范围内有至少3家致力于创新药研发的新锐公司宣布完成新一轮融资。通过梳理，这些获得资本青睐的新锐公司正在开发的产品包括小分子、细胞疗法、基因疗法等等。 RougeTx 融资轮次：A轮融资金额：5800万美元 10月6日，RougeTx宣布正式成立，并完成5800万美元A轮融资。RougeTx是一家临床前阶段生物技术公司，正在开发创新小分子疗法，以恢复周细胞功能障碍驱动的疾病中的血管稳定性。周细胞调节血管生成并支持血管完整性和功能。公司先导项目针对遗传性出血性毛细血管扩张症（HHT）以及与血管稳定性疾病相关的其他适应症。本轮融资将支持先导项目RTX-001推进至HHT的首次人体临床开发，该产品旨在通过恢复周细胞附着来稳定脆弱血管。HHT由异常血管形成（即动静脉畸形）引起，可导致反复鼻出血和胃肠道出血、缺铁、慢性贫血以及可能影响主要器官的严重并发症。通过其periSCOPE平台，RougeTx正在将血管生物学的深入理解应用于HHT以外的领域，以识别由血管不稳定驱动的疾病中的新治疗机会。该平台旨在基于共同的潜在生物学机制支持小分子疗法管线。 SereNeuro Therapeutics 融资轮次：Pre-Seed轮融资金额：未披露 10月5日，开发非阿片类疼痛疗法的临床前阶段生物技术公司SereNeuro Therapeutics宣布完成超额认购的Pre-Seed轮融资。本轮融资将推进公司先导项目SN101进入新药临床试验（IND）申报所需活动，并支持其第二个项目SN102。SN101是一种即用型非阿片类疗法，由诱导多能干细胞（iPSC）衍生的纯化人类痛觉神经元组成，通过单次注射进入受影响关节，旨在缓解慢性关节疼痛同时保留关节结构，并已展示临床前概念验证。SN101细胞携带天然人类背根神经节（DRG）神经元的完整疼痛通道特征，包括Nav1.7、Nav1.8和Nav1.9——大多数干细胞衍生神经元缺乏这些通道。SN102是一种针对三叉神经痛和其他神经病理性疼痛的基因疗法，旨在从神经元本身降低疼痛信号传导，无需阿片类药物且不麻木其他感觉。 Consano Bio 融资轮次：未披露融资金额：超过1500万美元 10月5日，临床阶段生物技术公司Consano Bio宣布完成超额认购融资，募集资金超过1500万美元的目标，以支持其先导在研疗法C-1101的临床开发。融资将用于完成正在进行的C-1101随机双盲1期临床试验（C-1101-101），并继续开发和加强C-1101及其他资产的组合。该研究正在澳大利亚和美国招募慢性疼痛性腰骶神经根病（LSR，即慢性坐骨神经痛）患者。2026年8月，FDA授予C-1101治疗LSR的快速通道资格。C-1101是一种新型血小板来源的多蛋白生物治疗药物，旨在通过调节炎症并刺激和增强损伤部位的细胞修复来治疗LSR。该产品含有恒定浓度的细胞因子、生长因子和基质蛋白，旨在帮助触发人体自然愈合反应。通过硬膜外注射给药，C-1101旨在将超生理浓度的这些蛋白直接递送至神经损伤部位。期待在资本的助力下，更多前沿疗法和技术能够更快惠及患者。参考资料： [1]各公司官网及公开资料版权说明：本文欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权或其他合作需求，请联系wuxi_media@wuxiapptec.com。免责声明：本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。

临床1期快速通道基因疗法临床申请

2026-10-06

·RecodeX

SereNeuro Therapeutics完成超额认购种子前轮：非阿片类疼痛赛道火热，iPSC衍生痛觉神经元能否走出差异化路径

非阿片类疼痛赛道正在经历一场罕见的资本共振。公司CEO Daniel Saragnese称，据其观察，非阿片类疼痛疗法是今年生物技术领域最活跃的角落之一，出现了一次IPO、九位数融资和药企授权交易；该判断尚无独立第三方数据验证。公司CEO称这些资本活动几乎都围绕同一家族钠通道寻求症状缓解。当资本把Nav1.7、Nav1… 非阿片类疼痛赛道正在经历一场罕见的资本共振。公司CEO Daniel Saragnese称，据其观察，非阿片类疼痛疗法是今年生物技术领域最活跃的角落之一，出现了一次IPO、九位数融资和药企授权交易；该判断尚无独立第三方数据验证。公司CEO称这些资本活动几乎都围绕同一家族钠通道寻求症状缓解。当资本把Nav1.7、Nav1.8、Nav1.9这几个离子通道变成最拥挤的靶点时，一个更根本的问题被推到了台前：如果只是阻断疼痛信号，关节里的病理过程仍然在继续，患者得到的究竟是治疗，还是一次又一次的暂时沉默？ SereNeuro Therapeutics给出的答案是把活的人类感觉神经元直接送进关节。这家总部横跨马里兰州巴尔的摩和亚利桑那州凤凰城的临床前生物技术公司，于2026年10月5日宣布完成超额认购的种子前融资。公司通稿称，其核心项目SN101是一种由诱导多能干细胞（iPSC）衍生的纯化人类痛觉神经元构成的即用型非阿片类疗法，通过单次注射进入受累关节，设计目标是缓解慢性关节疼痛并保留关节结构；该产品描述尚无独立第三方验证。投资方为两家马里兰州风险投资机构和一位医生投资者。与常规的股权融资叙事不同，本轮交易中，合格投资者通过马里兰州生物技术投资激励税收抵免结构参与投资，并适用位于联邦机会区公司可获得的增强可退还税率。SereNeuro的东巴尔的摩站点正位于这一机会区内。这意味着，这笔种子前融资的资本效率，部分建立在地理位置与州级政策工具的重叠之上，而非单纯的估值逻辑。字段内容公司 SereNeuro Therapeutics, Inc. 轮次种子前轮金额未披露投资方两家马里兰州风险投资机构、一位医生投资者总部 Baltimore, Maryland / Phoenix, Arizona 创始人 Daniel Saragnese（CEO，联合创始人）、Xinzhong Dong（联合创始人、科学顾问）、Gabsang Lee（联合创始人）、Zhuolun (Poppy) Wang（联合创始人、科学顾问）官网 www.sereneuro.comSN101不是小分子，而是一群携带完整钠通道身份的活细胞理解SN101的差异化，需要先回到一个技术细节。多数干细胞衍生神经元在分化过程中会丢失疼痛信号传导所需的关键钠通道。公司CEO称SN101细胞携带原生人类背根神经节（DRG）神经元的完整疼痛通道身份，即Nav1.7、Nav1.8和Nav1.9。这是SereNeuro整个技术叙事的支点：如果这些通道确实以功能性状态存在，SN101就不是在阻断某一个靶点，而是在植入一套完整的疼痛感知单元。这种“用细胞本身作为疗法”的逻辑，与当前非阿片类疼痛领域的主流策略形成结构性差异。如CEO所述，行业主流是在寻找更精准的通道阻断剂，而SereNeuro选择把这些通道连同细胞一起递送进去。前者是抑制信号，后者是替换或重建信号处理单元。两者在生物学层面并不构成直接竞争，但在临床终点上终将相遇：能否在缓解疼痛的同时改变关节的退行性进程。公司通稿称SN101已展示临床前概念验证，并正推进至IND申报支持性研究阶段；该概念验证数据尚未公开披露具体模型与终点，尚无独立第三方验证。这意味着，SN101目前仍处于一个关键验证窗口：它需要证明，活细胞进入关节后不仅能存活，还能以可控的方式发挥功能，且不会引发免疫排斥或异位放电。从模型到药物的意外转向，构成科学叙事的核心 SN101的起源故事带有典型的学术转化色彩。据联合创始人、科学顾问Xinzhong Dong表述，他与Gabsang Lee最初的目标是建立一个人类iPSC来源的外周痛觉神经元模型，足够纯净、足够特异，以控制神经元亚型，从而发现新的非阿片类疼痛药物靶点。Dong的原话是：“它从来不是用来做药的。我们在测试细胞功能以验证模型。当时有一个关节疼痛模型可用，当我们把细胞放进关节后，看到了一个我们并未打算寻找的治疗效果。那个观察变成了SN101。” 这段叙述的信息增量在于，它解释了SN101为何以一种非典型的方式出现：不是从靶点出发设计药物，而是从工具细胞出发意外观察到疗效。这种路径在细胞治疗领域并不罕见，但它同时意味着，公司需要在后续开发中补上传统药物研发的许多步骤，包括作用机制的系统性阐明、剂量爬坡、安全性窗口和制造工艺锁定。一个从意外观察中诞生的候选疗法，其转化风险往往不在生物学可行性，而在可重复性和可制造性。联合创始人团队中，Gabsang Lee拥有D.V.M.和Ph.D.背景，Zhuolun (Poppy) Wang担任科学顾问，Tea Soon Park担任细胞治疗负责人。从团队构成看，SereNeuro在iPSC分化和神经科学层面具备学术深度，但公司未披露CEO Daniel Saragnese在细胞治疗产业化方面的具体履历。对于一家即将进入IND申报支持性研究的公司而言，制造工艺、质量控制和监管沟通能力将很快变得与科学能力同等重要。SN102把基因疗法引入三叉神经痛，但依赖非稀释性资金推进 SereNeuro的第二条管线SN102是一种基因疗法，针对三叉神经痛及其他神经病理性疼痛。据联合创始人、科学顾问Zhuolun (Poppy) Wang表述，其目标是“a single treatment that turns down pain signaling in trigeminal neuralgia and other neuropathic pain, from the neurons themselves, without opioids and without numbing everything else”。 SN102的资金结构值得单独审视。公司通稿称，2026年9月，在本轮融资完成后，SereNeuro获得了首个NIH小企业创新研究（SBIR）资助，用于支持SN102，属于NIH HEAL Initiative。该项目的资助方是美国国立卫生研究院国家牙科和颅面研究所，奖项编号为R43DE035747。R43是SBIR第一阶段的编号，通常意味着项目仍处于早期可行性验证阶段。公司通稿同时声明，资助内容不代表NIH官方观点。从资本结构看，SereNeuro正在同时使用股权融资和非稀释性资金推进两条管线。SN101由种子前轮融资支持，SN102则主要由NIH SBIR资助推进。这种安排降低了单一项目的资金压力，但也带来一个隐含约束：SBIR第一阶段资助的金额通常有限，且要求明确的里程碑交付。SN102能否进入第二阶段，取决于第一阶段的数据质量。而SN101的IND申报支持性研究，则需要消耗本轮未披露金额的股权融资。两条管线在资金上相对独立，但在公司整体资源分配上仍存在竞争。马里兰州的税收抵免结构，让这笔融资的资本效率难以直接比较本轮融资的一个容易被忽略但重要的细节，是投资方通过马里兰州生物技术投资激励税收抵免结构参与投资，并适用联邦机会区的增强可退还税率。这意味着，投资者的一部分回报来自州级税收抵免，而非单纯的公司股权增值。这种结构对SereNeuro有两层含义。第一，它降低了投资者的实际出资成本，使得一家临床前公司在种子前阶段更容易吸引本地资本。第二，它意味着本轮融资的“超额认购”不能直接与硅谷式种子轮的超额认购进行横向比较。当投资回报的一部分来自税收政策时，资本进入的动机可能混合了财务回报与政策套利。对于公司而言，这并不构成负面信号，但它提示外部观察者：这笔融资的市场化程度，需要用后续轮次中非税收驱动资本的参与来验证。公司总部横跨巴尔的摩和凤凰城，东巴尔的摩站点位于联邦机会区内。这种双城布局在生物技术公司中并不常见。通稿未解释凤凰城站点的具体功能，也未说明两个站点之间的研发分工。公司被再生医学联盟选中在2026年10月5日（当地时间）的Cell & Gene Meeting on the Mesa上做Innovation Spotlight展示，地点为凤凰城Arizona Biltmore。凤凰城站点可能承担一定的对外展示和合作功能，但这一推断仅基于时间与地点的重合，公司未披露具体信息。竞争格局：避开钠通道阻断剂的拥挤，但进入细胞治疗的无人区如CEO所述，非阿片类疼痛领域今年的资本活动几乎都围绕同一家族钠通道寻求症状缓解。但SereNeuro的SN101并不直接与这些通道阻断剂竞争。它选择了一条更接近细胞治疗和再生医学的路径。这种定位的优势在于差异化叙事清晰：当行业在讨论如何更精准地阻断疼痛信号时，SereNeuro在讨论如何用活细胞重建疼痛感知单元并同时保护关节结构。但劣势同样明显：据公开资料，细胞治疗在疼痛领域的临床验证仍处于早期阶段，该判断为编辑分析，尚待系统检索验证。使用iPSC衍生的痛觉神经元作为治疗性细胞，仍是一个未经临床验证的概念。公司通稿称SN101为first-in-class，但未披露支持该定位的对照数据，尚无独立第三方验证。 SN101的关节内单次注射路径与现有注射疗法在给药方式上可比，但其活细胞属性使其在结构保护终点上面临与现有疗法不同的验证要求。对于一款尚未进入临床试验的候选疗法而言，疼痛缓解与结构保护两个终点的验证路径都相当漫长。投资逻辑：税收抵免、NIH资助与临床前管线的资本效率 SereNeuro本轮融资的资本逻辑，需要放在其具体的资金来源结构里理解。公司同时使用马里兰州生物技术投资激励税收抵免、联邦机会区增强可退还税率，以及NIH SBIR非稀释性资助。SN101由种子前轮股权融资支持，SN102由NIH SBIR第一阶段资助推进。这种安排使公司在临床前阶段能够以较低股权稀释推进两条管线，但每一笔资金都带有明确的政策或里程碑约束。从已披露的融资结构看，本轮投资方为两家马里兰州风险投资机构和一位医生投资者，且通过税收抵免结构参与。从已披露的投资者组合看，本轮融资呈现本地资本早期支持的特征，而非全国性医疗基金的重注，该判断为编辑分析，尚待后续轮次验证。医生投资者的参与可能带来临床视角，但通稿未披露其具体身份和专业领域。SereNeuro本轮通过税收抵免结构吸引本地资本，后续轮次能否吸引具备细胞治疗产业化经验的机构投资者，将是一个关键观察点。资金用途：IND申报支持性研究是第一个可验证的里程碑公司披露，本轮融资将推进核心项目SN101至IND申报支持性活动，包括制造与临床前研究，并支持第二个项目SN102。对于SereNeuro而言，SN101的IND申报支持性研究面临一个特殊挑战：iPSC衍生细胞疗法的制造工艺远比小分子复杂。细胞纯度、批次间一致性、冻存与复苏后的活性、以及关节内注射后的细胞存活与功能维持，都需要在GMP条件下建立可重复的工艺。公司通稿未披露其制造策略是自建产能还是依赖CDMO，也未披露SN101的细胞剂量和关节内注射的具体操作方案。这些信息缺口意味着，SN101从临床前概念验证到IND申报之间的距离尚无法从公开材料判断。 SN102方面，NIH SBIR第一阶段资助的获得是一个正向信号，但第一阶段资助通常用于概念验证，距离临床试验仍有相当距离。基因疗法在神经病理性疼痛中的应用仍处于非常早期的阶段，递送载体、靶向性和长期安全性都是未解问题。风险与待验证假设：活细胞进入关节后，故事才刚刚开始 SereNeuro面临的风险可以从三个层面拆解。第一层是融资透明度风险。公司宣布完成“超额认购”的种子前融资，但未披露具体金额。在生物技术融资中，未披露金额的超额认购并不罕见，但它使得外部观察者无法判断这笔资金能否真正支撑SN101完成IND申报支持性研究。第二层是生物学验证风险。SN101的核心假设是，iPSC衍生的痛觉神经元在进入关节后能够存活、整合并发挥疼痛调节功能，同时不引发免疫排斥或异常放电。从已披露的“携带Nav1.7、Nav1.8和Nav1.9通道”这一技术特征看，公司强调的是细胞的身份保真度，但身份保真度与治疗功能之间仍存在距离。从生物学原理看，携带完整钠通道的神经元既可能调节疼痛，也可能在某些条件下放大疼痛信号，该风险为编辑分析，尚待IND申报支持性研究评估。第三层是制造与监管风险。SN101作为疼痛适应症的iPSC衍生细胞疗法，其监管路径尚无直接先例，公司未披露是否已与FDA进行pre-IND会议，该信息缺口为本项目特有风险。公司通稿未披露SN101的监管路径是作为细胞治疗产品、组织工程产品还是组合产品申报。从已披露的“2026年9月获得NIH SBIR资助”和“2026年10月5日在Cell & Gene Meeting on the Mesa做Innovation Spotlight展示”这两个事实看，SereNeuro正在积极建立其在再生医学领域的可见度。但可见度不等于验证。SN101的真正考验将出现在IND申报支持性研究的数据读出时：活细胞进入关节后，能否以可重复的方式证明其治疗价值，并说服监管机构允许其进入人体试验。验证边界与可复核指标本文涉及的“首个、唯一、最大、领先”、订单、出货、性能等表述，如无另行说明，均是公司、创始人或投资方在现有公开材料中的披露口径；RecodeX未在本次采集材料中找到独立审计或第三方测试结论，因而不将其视为已经独立确认的事实。文中的产业协同、竞争位置和商业路径属于基于已披露产品与融资用途的编辑分析，不代表相关结果已经实现。技术侧应核验第三方测试条件、样本规模、良率、稳定性及与可比方案一致口径的结果；商业侧应核验去重后的付费客户、可执行合同、收入确认、复购率以及订单转化；资本与产业协同应以工商股权、关联交易、联合开发、采购或量产文件为准。 RecodeX 极客视：SereNeuro把一群携带完整钠通道身份的活细胞送进关节，这个想法足够反主流——当整个行业都在寻找更精准的通道阻断剂时，它选择把通道连同细胞一起递送。但“超额认购”的种子前轮没有披露金额，临床前概念验证没有披露数据，IND申报支持性研究没有披露制造策略。在疼痛这个被阿片类药物危机重塑的赛道里，差异化叙事只是入场券，活细胞能否在关节里证明自己，才是SereNeuro真正的融资后第一课。信息来源本文在采集与核验阶段引用了以下公开来源，按站点去重列出；来源内容归原发布方所有，其口径不代表 RecodeX 的核实结论。 prnewswire.com sereneuro.com news.google.com biospace.com morningstar.com

IPO

2026-10-05

·PRNewswire

SereNeuro Therapeutics Closes Oversubscribed Pre-Seed Financing to Advance Non-Opioid Pain Pipeline

Lead program SN101, a first-in-class non-opioid iPSC-derived therapy for chronic joint pain, moves toward IND-enabling studies BALTIMORE and PHOENIX, Oct. 5, 2026 /PRNewswire/ -- SereNeuro Therapeutics, a preclinical-stage biotechnology company developing non-opioid therapies for pain, today announced the close of its oversubscribed pre-seed financing. The round advances the company's lead program, SN101, toward Investigational New Drug (IND)-enabling activities and supports its second program, SN102. Continue Reading SereNeuro Therapeutics founding team (left to right): Zhuolun (Poppy) Wang, Ph.D., co-founder; Tea Soon Park, Ph.D., Head of Cell Therapy; Xinzhong Dong, Ph.D., co-founder; Gabsang Lee, D.V.M., Ph.D., co-founder; and Daniel Saragnese, MBA, CEO and co-founder. Photo courtesy of SereNeuro Therapeutics. The syndicate included two Maryland-based venture firms and a physician investor. Qualifying investors structured their investments through Maryland's Biotechnology Investment Incentive Tax Credit at the enhanced refundable rate available to companies located in a federal Opportunity Zone, which includes SereNeuro's East Baltimore site. "Non-opioid pain therapeutics have become one of the most active corners of biotech this year, with an IPO, nine-figure financings, and pharma licensing deals, nearly all of it chasing one family of sodium channels for symptom relief," said Daniel Saragnese, MBA, CEO and co-founder of SereNeuro Therapeutics. "SereNeuro brings a different biology to the same problem. SN101 is made of living human sensory neurons that carry the full pain-channel identity of a native human dorsal root ganglion, or DRG, neuron: Nav1.7, Nav1.8, and Nav1.9, which most stem-cell-derived neurons lack. SN101 cells are designed to relieve pain and preserve the joint. This capital, with the non-dilutive funding we continue to secure, carries SN101 toward the manufacturing and preclinical studies an IND requires." SN101 is an off-the-shelf, non-opioid therapy made of purified human pain-sensing neurons derived from induced pluripotent stem cells (iPSCs). Delivered by a single injection into the affected joint, it is designed to relieve chronic joint pain while preserving joint structure, and it has demonstrated preclinical proof of concept. The technology was developed by co-founders Xinzhong Dong, Ph.D., Gabsang Lee, D.V.M., Ph.D., and Zhuolun (Poppy) Wang, Ph.D. "Gabsang and I began this collaboration to build a human iPSC-derived model of peripheral pain-sensing neurons, pure and specific enough to control for neuron subtype, so we could discover new non-opioid pain drug targets. It was never meant to be a drug. We were testing the cells' function to validate the model. A joint pain model was available, and when we put the cells into the joint, we saw a therapeutic effect we had not set out to find. That observation became SN101," said Xinzhong Dong, Ph.D., co-founder and scientific advisor. SN102, the company's second program, is a gene therapy for trigeminal neuralgia and other neuropathic pain. "Our goal with SN102 is a single treatment that turns down pain signaling in trigeminal neuralgia and other neuropathic pain, from the neurons themselves, without opioids and without numbing everything else," said Zhuolun (Poppy) Wang, Ph.D., co-founder and scientific advisor. In September 2026, after the financing closed, SereNeuro received its first NIH Small Business Innovation Research (SBIR) award, supporting SN102 through the Helping to End Addiction Long-term® Initiative, or NIH HEAL Initiative, an NIH-wide effort to speed scientific solutions to the opioid crisis, including non-addictive treatments for pain. SereNeuro's pipeline is built for that purpose. The company was also selected by the Alliance for Regenerative Medicine to present an Innovation Spotlight at the 2026 Cell & Gene Meeting on the Mesa, taking place today: Date: Monday, October 5, 2026 Time: 2:30 p.m. MST (5:30 p.m. EDT) Location: Frank Lloyd Wright Ballroom G, Arizona Biltmore, Phoenix About SereNeuro Therapeutics SereNeuro Therapeutics is a preclinical-stage biotechnology company developing first-in-class non-opioid therapies for pain, including iPSC-derived neuron therapies and gene therapies, led by SN101. For more information, visit . SereNeuro's SN102 program is supported by the National Institute of Dental and Craniofacial Research of the National Institutes of Health under Award Number R43DE035747. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. Media Contact Daniel Saragnese, MBA, CEO and co-founder [email protected] +1 410-205-9387 SOURCE SereNeuro Therapeutics, Inc. 21% more press release views with Request a Demo

基因疗法

100 项与阿坎酸钙相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D02780	阿坎酸钙	N07BB03	DB00659

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
酗酒	美国	Forest Laboratories, Inc.	2004-07-29

未上市

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
暴食症	临床3期	美国	Forest Laboratories LLC	2007-04-01
精神分裂症	临床3期	美国	Forest Laboratories LLC	2006-09-01
创伤后应激障碍	临床2期	-	Synchroneuron, Inc.	2016-06-01
Tourette 综合征	临床2期	美国	Synchroneuron, Inc.	2015-04-01
迟发性运动障碍	临床2期	美国	Synchroneuron, Inc.	2014-02-01
甲基苯丙胺依赖	临床2期	美国	Forest Laboratories LLC	2007-07-01

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临床结果

适应症

分期

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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


AASLD2025	N/A	纤维化	1,418	Naltrexone	夢繭構觸衊積齋餘選膚(構遞願鑰鏇廠鹽蓋鬱齋): HR = 0.95 (95.0% CI, 0.79 ~ 1.15) 更多	积极	2025-11-07
				Acamprosate
AASLD2025	N/A	酒精性肝疾病	63	Acamprosate	窪餘餘蓋廠壓糧範壓鏇(壓積餘觸遞遞窪選餘製) = 襯壓糧齋襯廠積製醖蓋鹽襯憲壓夢艱觸蓋觸窪 (繭築選餘範艱衊醖膚齋 )	积极	2025-11-07
				Gabapentin	窪觸構顧窪鏇膚蓋壓選(鬱襯窪範製糧鹹壓觸鹽) = 顧鑰網網積獵鹽窪餘淵願齋簾襯獵餘餘遞廠鹹 (遞構壓顧襯壓夢鏇願選 ) 更多
AASLD2025	N/A	酒精性肝疾病	113,000,000	disulfiram	糧構選簾壓鬱獵範壓衊(觸積醖獵製窪積壓構顧) = 網顧鏇繭築膚憲顧衊夢衊繭壓觸淵窪鬱顧鹹憲 (廠膚選築齋窪衊鬱遞鏇 ) 更多	积极	2025-11-07
				acamprosate	糧構選簾壓鬱獵範壓衊(觸積醖獵製窪積壓構顧) = 衊鹽鹽遞鏇夢構積窪膚衊繭壓觸淵窪鬱顧鹹憲 (廠膚選築齋窪衊鬱遞鏇 ) 更多
NCT03818191 (CTgov)	临床4期	酒精使用障碍	288	Acamprosate (Acamprosate)	獵鑰艱簾窪夢廠餘願繭 = 膚齋網鹹觸餘淵鏇鬱鹹觸壓積獵築夢繭築積範 (鬱觸齋齋膚繭艱鏇襯繭, 蓋淵鑰鹽鹽網艱壓簾構 ~ 醖壓廠積簾蓋積鹽齋蓋) 更多	-	2024-12-17
				Placebo (Placebo)	獵鑰艱簾窪夢廠餘願繭 = 齋簾鏇膚醖網觸遞鬱蓋觸壓積獵築夢繭築積範 (鬱觸齋齋膚繭艱鏇襯繭, 選網壓選鹽憲築餘醖鬱 ~ 醖構糧齋憲艱鏇遞壓選) 更多
AASLD2024	N/A	酒精性肝疾病	206,252	Pharmacological cessation therapies	夢齋鬱艱鬱糧構鬱構餘(繭餘鑰鹹鏇鏇選廠範鹽) = 鬱窪壓鹹願淵獵蓋鹹鹽艱顧觸鹹鑰網廠網構範 (衊製觸繭構鏇鬱選鏇鏇 ) 更多	积极	2024-11-15
AASLD2024	N/A	酒精使用障碍	39,182	Disulfiram	觸蓋蓋願艱簾窪顧衊夢(鏇窪鬱窪網獵醖範壓廠) = 鹽觸鹽簾構鏇遞夢積選獵淵艱觸醖獵範夢膚製 (簾獵顧窪積遞繭鬱窪網, 4.07 ~ 4.54) 更多	积极	2024-11-15
				Acamprosate	觸蓋蓋願艱簾窪顧衊夢(鏇窪鬱窪網獵醖範壓廠) = 鏇鹹醖鹹製餘窪齋蓋淵獵淵艱觸醖獵範夢膚製 (簾獵顧窪積遞繭鬱窪網, -0.02 ~ 1.56) 更多
DDW 12024 \| DDW 22024 \| DDW 32024 \| DDW 42024	N/A	酒精性肝疾病	-	Naltrexone	網艱簾夢餘範鹽廠網淵(鹽糧鬱膚鹹餘選簾醖顧) = the rate of AUD medication discontinuation for adverse events was similar in both groups (14% vs 12%) and none were stopped due to suspected DILI 蓋網築鑰積鹹遞襯襯廠 (衊遞鑰製衊積衊壓壓糧 ) 更多	-	2024-05-20
				Acamprosate
NCT04287920 (CTgov)	临床2期	酒精使用障碍 \| 酒精性肝炎 \| 酒精性肝疾病	12	Acomprosate (Alcohol-related Liver Disease and AUD, MELD-NA Less Than 20)	淵積構衊繭觸獵艱網夢 = 鹽齋製遞範餘鏇遞網膚鹽膚鬱夢鹹獵鏇膚製獵 (製憲範齋願鏇襯膚廠築, 鹹衊顧遞衊積觸鏇夢衊 ~ 餘繭憲鏇艱醖蓋積餘壓) 更多	-	2022-12-20
				Acomprosate (Alcohol-related Liver Disease and AUD, MELD-NA More Than 20)	淵積構衊繭觸獵艱網夢 = 簾積構艱獵構鏇醖鬱糧鹽膚鬱夢鹹獵鏇膚製獵 (製憲範齋願鏇襯膚廠築, 鹽範餘獵壓觸範願壓鹽 ~ 膚觸簾網衊選繭遞網齋) 更多
NCT02998151 (CTgov)	早期临床1期	脆性X综合征	29	placebo (Placebo)	衊願憲壓醖網選製鏇觸(齋鏇願鹽簾遞構積壓顧) = 淵築憲獵壓觸顧鏇鹹觸艱鹹鏇餘齋選蓋觸網範 (齋夢遞窪憲簾鏇範艱積, .0265) 更多	-	2021-11-24
				Acamprosate (Acamprosate)	衊願憲壓醖網選製鏇觸(齋鏇願鹽簾遞構積壓顧) = 醖餘鏇膚襯膚鑰窪鹹膚艱鹹鏇餘齋選蓋觸網範 (齋夢遞窪憲簾鏇範艱積, 0.0252) 更多
NCT00466661 (CTgov)	临床4期	酗酒 \| 躁郁症 \| 躁郁症2型	33	Acamprosate (Acamprosate)	顧膚築憲鹹築蓋餘膚顧(淵簾鹹鏇憲網衊繭膚壓) = 鹽醖蓋憲構膚製製憲觸醖淵網觸淵夢觸鹽艱衊 (築築範網簾醖選鹹選鹽, 廠窪廠醖鏇鏇顧膚選醖 ~ 構淵獵艱廠鬱鏇構鹽窪) 更多	-	2018-12-14
				Placebo (Placebo)	顧膚築憲鹹築蓋餘膚顧(淵簾鹹鏇憲網衊繭膚壓) = 顧醖淵鑰簾積膚糧憲艱醖淵網觸淵夢觸鹽艱衊 (築築範網簾醖選鹹選鹽, 蓋鹹齋選繭觸獵簾餘繭 ~ 糧鏇選範積夢獵齋鬱壓) 更多