A Bioequivalence study of a randomized, open-label, single dose, full replicated crossover design with four-period, two-treatment, and two-sequence of Ezetimibe and Atorvastatin 10/40 mg film-coated tablets relative to ATOZET (10 MG/40 MG) in healthy Thai participants under fasting condition

开始日期2026-06-22

申办/合作机构

Bio-innova Co., Ltd

NCT07474649

/ Not yet recruiting临床3期

Effects of Bempedoic Acid/Ezetimibe/High-intensity Statin on Plaque Regression and Stabilisation of Coronary Atherosclerosis Among Patients Without Cardiovascular Events

The overall objective of the trial is to evaluate the effect of the triple therapy consisting of bempedoic acid (BA), ezetimibe (EZE), and high-intensity atorvastatin or rosuvastatin on changes in coronary plaque burden and plaque morphology in patients with coronary atherosclerosis without significant obstructive coronary artery disease and without prior history of an ischemic vascular event.

开始日期2026-06-01

申办/合作机构

Daiichi Sankyo Co., Ltd.

NCT07462715

/ Not yet recruiting临床4期IIT

Does Short-term or Long-term Statin Use Protect the Heart and Brain During Exposure to Bushfire Smoke? A Parallel-group Statin Trial With Cross-over, Order-randomised Smoke Exposure vs Filtered Air Among Healthy Australian Adults.

The goal of this clinical trial is to test whether statins can protect the heart and brain from the biological stress and inflammatory responses caused by breathing bushfire smoke in healthy adult volunteers aged 18-64 years. The main questions it aims to answer are:
1. Does short-term statin use (2 days) reduce bushfire smoke-induced changes in heart rate variability, blood pressure, arterial stiffness, inflammation and oxidative stress markers, and cognitive function?
2. Does long-term statin use (≥12 months) reduce bushfire smoke-induced changes in heart rate variability, blood pressure, arterial stiffness, inflammation and oxidative stress markers, and cognitive function?
The study includes two streams:
Stream 1:short-term statin use (2 days) where participants receive either statin tablets (80mg atorvastatin) or placebo; Stream 2: long-term statin use (≥12 months) where participants include those already taking statins (≥12 months) with statin-naïve individuals.
Participants will:
* Attend two 3½-hour visits to a Climate Hut, which are approximately 4 weeks apart, where they will spend 2 hours exposed to either filtered air or simulated dilute bushfire smoke (average particulate matter (PM2.5) concentration of 300μg/m^3) in randomised order;
* Have continuous heart monitoring with ECG leads and blood pressure checks every 15 minutes during each visit
* Provide urine, saliva, and nose swab samples before and after each exposure, plus follow-up samples the next morning
* Complete cognitive tests (reaction time, memory tasks) and postural balance measurements during exposure
* Complete questionnaires about anxiety levels, symptoms, diet, and health status
* Have blood samples collected and pulse wave velocity measurements (assessing arterial stiffness) immediately after each exposure session.
Potential risks include time commitment, muscle pain from statins, eye irritation or throat discomfort from smoke exposure, and minor discomfort from blood collection.

开始日期2026-05-01

申办/合作机构

Menzies Research Institute

100 项与阿托伐他汀钙相关的临床结果

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100 项与阿托伐他汀钙相关的转化医学

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100 项与阿托伐他汀钙相关的专利（医药）

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7,039

项与阿托伐他汀钙相关的文献（医药）

2026-03-01·AMERICAN JOURNAL OF HYPERTENSION

High-Intensity Atorvastatin and 24-Hour Blood Pressure in Obstructive Sleep Apnea: A Randomized, Double-Blind, Placebo-Controlled Pilot Study

Article

作者: Karim, Shahid ; Wright, R Scott ; Somers, Virend K ; Vungarala, Soumya ; Covassin, Naima ; Bock, Joshua M ; Singh, Prachi ; Louis, Erik St ; Bukartyk, Jan ; Sompalli, Sreeja

Abstract:

Background:

Obstructive sleep apnea (OSA) is a risk factor for hypertension and some evidence suggests this risk may not be mitigated with positive airway pressure. Low-intensity statin therapy can modestly reduce blood pressure (BP). In this exploratory analysis, we examined if six months of high-intensity statin therapy could lower resting or ambulatory BP in patients with OSA.

Methods:

39 patients with OSA (13F, age = 49 ± 9yrs, body mass index = 32.9 ± 4.2kg/m2, apnea-hypopnea index = 22.2 ± 12.4 events/hour) were randomized to high-intensity atorvastatin or placebo. BP was assessed using seated, “office” measurements and in 20-minute intervals over 24 consecutive hours at three timepoints (baseline, three- and six-months post-randomization). Participants maintained a diary denoting sleep and wake times for analysis. Changes (Δ) in BP from baseline were assessed and adjusted for adherence to participants’ intervention (atorvastatin or placebo) as well as to their treatment for OSA (yes or no).

Results:

There were no between-group differences in baseline BP variables (P = .09-.96). At three months, the changes in resting (P = .74-.87), 24 hour mean (P = .54-.96), daytime (P = .70-.96), nor nighttime (P = .74-.96) BP did not differ between groups. Similarly, the changes in resting (P = .23-.92), 24 hour mean (P = .51-.82), daytime (P = .17-.78), and nighttime (P = .51-1.00) BP did not differ between groups following six months of their respective intervention.

Conclusions:

Our data suggest that high-intensity atorvastatin does not lower resting or ambulatory BP in patients with OSA relative to a placebo. Thus, it does not appear that atorvastatin is a viable adjunct intervention for BP reduction in patients with OSA.

Registration:

URL: https://www.clinicaltrials.gov; Unique identifier: NCT03308578.

2026-03-01·CPT-Pharmacometrics & Systems Pharmacology

Retrieval Augmented Generation ( RAG ) for Evaluating Regulatory Compliance of Drug Information and Clinical Trial Protocols

Article

作者: Waikar, Shreyas ; Ramanathan, Murali ; Bhat, Amruta Gajanan

ABSTRACT:

The purpose was to evaluate retrieval‐augmented generative (RAG) artificial intelligence (AI) methods for assessing the regulatory compliance of drug information and adherence to best practices in clinical trial protocols. Integrated systems containing RAG and large language model (LLM) components were employed to evaluate drug information and clinical trial protocols. The drug information for adalimumab, insulin glargine, atorvastatin calcium, sertraline, and alprazolam was evaluated for compliance with Food and Drug Administration (FDA) clinical pharmacology guidance for indications, use in specific populations, and warnings and precautions. The reasons for the withdrawal of rofecoxib, valdecoxib, and troglitazone were elicited. The clinical trial protocol evaluation system was used to assess a Phase‐2a clinical trial protocol of Rifafour in tuberculosis with the FDA E9 and E9 (R1) guidance documents. The RAG system correctly identified the indications, use in specific populations, and warnings and precautions for adalimumab, insulin glargine, atorvastatin calcium, sertraline, and alprazolam. The drug information was evaluated against the requirements in the guidance documents, confirming compliance when present and providing explanations for deficiencies. The causes underlying the withdrawal of rofecoxib, valdecoxib, and troglitazone were explained. The clinical protocol summary included study design, population definitions, treatments, dose levels, and route of administration. The summary of the statistical analysis plan included primary/secondary endpoints, statistical tests, pharmacokinetic parameters, and handling of missing data and outliers. The findings aligned with manual protocol reviews. RAG‐based AI methods can improve the usefulness of LLMs in document‐restricted settings and are a promising approach for evaluating the compliance of clinical pharmacology documents.

2026-02-03·Journal of the American Heart Association

Recurrent Symptomatic Hemorrhage in Cerebral Cavernous Malformations After Discontinuation of Atorvastatin or Placebo

Article

作者: Alcazar‐Felix, Roberto J. ; Sader, Georgio ; Sorrentino, Matthew ; Stadnik, Agnieszka ; Shenkar, Robert ; Flemming, Kelly D. ; Thompson, Richard E. ; Ali, Bader ; Girard, Romuald ; Polster, Sean P. ; Liao, James K. ; Lee, Justine ; Awad, Issam A. ; Hanley, Daniel F.

Background:

A recent randomized prospective controlled trial demonstrated that atorvastatin for up to 2 years was safe but did not significantly alter rebleeding in cerebral cavernous malformations. However, any consequences of discontinuing atorvastatin remain unknown. We hypothesized that symptomatic hemorrhage (SH) recurs more frequently in cerebral cavernous malformations after discontinuation of atorvastatin than placebo.

Methods:

We conducted a 12‐month posttreatment follow‐up of patients enrolled in the Atorvastatin Therapy in Cavernous Angiomas with Symptomatic Hemorrhage Exploratory Proof of Concept (AT CASH EPOC) trial (41 randomized to atorvastatin, 39 to placebo) to identify potential recurrent SH after trial drug discontinuation. Every SH was adjudicated by review of imaging and corresponding symptoms. Patients were excluded from follow‐up for <90% compliance with study drug, for its discontinuation <3 months after trial enrollment, for statin reinitiation <3 months after discontinuation, or for lack of follow‐up. Cases were censored during follow‐up upon cerebral cavernous malformation resection/radiation or later statin reinitiation.

Results:

Follow‐up included 33 patients who had been randomized to placebo and 32 who had taken atorvastatin. Four SH events occurred at 3, 49, 84, and 225 days after atorvastatin discontinuation, and 1 SH at 395 days after discontinuing placebo. There was significantly lower symptomatic hemorrhage‐free survival in the atorvastatin‐discontinuation group (log‐rank χ 2 =4.136, P =0.042). The hazard ratio was 0.162 (95% CI, 0.027–0.977) for placebo versus atorvastatin discontinuation.

Conclusions:

Discontinuation of atorvastatin was associated with a higher risk of recurrent SH compared with placebo discontinuation. Additional studies are warranted to confirm this hypothesis‐generating observation, examine potential mechanisms, and how best to mitigate this risk.

REGISTRATION:

URL: https://www.clinicaltrials.gov ; Unique identifier: NCT02603328.

1,368

项与阿托伐他汀钙相关的新闻（医药）

2026-04-02

·药时代

高质量盈利+创新硬实力，“超级Biotech”亿腾嘉和来了

正文共：3612字 8图预计阅读时间：9分钟 3月刚闭幕的全国两会上，生物医药产业因首次在政府工作报告中被列入“新兴支柱产业”而一跃成为热点话题。十数年间，生物医药产业已然实现了从“战略性培育赛道”向“国民经济核心增长极”的历史性跨越；行业价值定位也从“管线故事驱动”转向“创新硬实力+业绩确定性+发展可持续性”的综合考量。这一背景下，开创性完成港股18A首单反向收购的亿腾嘉和（6998.HK）在合并后高效整合，率先展现出“超级Biotech”的核心特质——以创新管线驱动长期增长，以成熟产品筑牢现金流底盘。亿腾嘉和也凭借研发和商业化双向赋能新战略，成为生物医药产业转型期难得的标杆样本。搭建BIC/FIC的核心竞争管线降低研发风险亿腾嘉和制定了BIC/FIC的管线布局策略，紧紧围绕未满足的临床需求，搭建高度差异化产品，覆盖心血管代谢、肿瘤、自身免疫病三大核心治疗领域，目前已披露的10款核心在研产品，其中3款进入临床阶段的产品正在加速推进，预期未来每年还将有3个分子进入IND申报。公司已建立大分子抗体药物和小核酸药物两大研发平台，其中，大分子抗体药物研发平台具备从靶点发现到成药性评估的全链条研发能力，技术覆盖杂交瘤、噬菌体展示、抗体工程等核心环节，重点布局双/多抗、TCE、ADC等多种药物分子形式。小核酸药物研发平台以序列设计、化学修饰、靶向递送三大核心技术为基础，布局siRNA和ASO等多种小核酸药物类型。重磅产品GB268（PD-1/CTLA-4/VEGF）被视为肿瘤免疫治疗革命性的产品，有潜力成为继PD-1之后肿瘤免疫治疗重要的里程碑。 GB268的一个重要的差异化设计在于其CTLA-4 臂的独特表位是一个partial blocker, 具有部分阻断功能，而且CTLA-4的结合依赖于PD-1的表达，只有在PD-1高表达的活化T细胞上才能观察到显著的CTLA-4阻断活性，这一独特的分子设计可显著降低CTLA-4抑制带来的外周毒性。另一个差异化点是三个靶点的抗体活性都经过了精细的调控，CTLA-4及PD-1 臂的抗体活性都有不同程度的弱化，以期更好地匹配VEGF抗体在临床上的高剂量需求，从而实现三个靶点的疗效与安全性的平衡。此外，通过高度富集到肿瘤微环境TME，GB268可优先结合到PD-1阳性的T细胞, 通过靶向PD-1，解除其对T细胞的免疫抑制；同时阻断CTLA-4通路，进一步解除免疫抑制，促进T细胞活化与增殖，并通过靶向VEGF有效抑制肿瘤血管生成，重塑肿瘤微环境，减少肿瘤细胞的侵袭与转移。这样多靶点的协同机制，有望高效抑制肿瘤免疫逃逸，实现免疫激活与肿瘤微环境重塑的双重功效，提升晚期实体瘤治疗效果。在人源化小鼠模型中，GB268表现出比PD-1/VEGF双抗，PD-1/CTLA-4双抗，以及三个靶点单抗联用更优的抗肿瘤活性，有望在PD-1/VEGF双抗基础上进一步提升疗效，覆盖包括肺癌、结直肠癌、肝癌、胃癌、乳腺癌等主要瘤种在内的广泛实体瘤患者群体，取代其成为肿瘤免疫治疗领域新的巨星。近年来，国产PD-(L)1/VEGF双抗跻身全球顶级创新资产，目前全球尚无该靶点三抗获批，临床阶段仅三款产品（含GB268），稀缺性显著。GB268整合免疫检查点双重阻断与抗血管生成，有望突破肺癌、肝癌等实体瘤治疗瓶颈。在全球免疫检查点抑制剂市场持续扩容且PD-1单药同质化严重的环境下，GB268三抗将承接双抗赛道红利并打开全新市场空间，商业化潜力不可限量。 GB268在2025年7月获 NMPA 临床批件，8月份完成首例患者入组，已完成剂量递增，最高爬坡剂量30mg/kg，没有DLT，展示出其良好安全性。目前进入临床I期扩展阶段，并计划在今年下半年ESMO公布单药I期临床数据，Q4开展单药II期的临床试验。同时计划于今年Q3启动多瘤肿多个队列联合用药的临床研究。基于小核酸前沿技术，亿腾嘉和为慢病治疗领域带来创新产品。其中进展最快的EDP167已进入临床II期。EDP167是一款靶向ANGPTL3的siRNA药物，在I期临床已展现出优异的降脂疗效与良好的安全性, 有潜力成为同类最佳（BIC）的全面降低致动脉粥样硬化血脂谱的药物，具体数据将在今年召开的医学年会上披露。 EDP167靶向肝脏血管生成素样蛋白3（ANGPTL3），通过精准、持久地沉默肝脏中ANGPTL3的生成，可实现对LDL-C和甘油三酯（TG）水平的双重强力降低。尤为重要的是，其作用机制独立于LDL受体（LDLR）途径，突破了传统降脂药物（包括他汀和PCSK9抑制剂）依赖于LDLR的局限性，该特点为血脂异常疾病的患者提供了重要的创新治疗选择，具有广阔的应用场景。 EDP167的HoFH适应症II期临床于今年2月启动，预计Q4完成主要终点评估，III期临床计划2027年Q1启动，有机会成为首个获批HoFH适应症的国产原研siRNA创新药物。此外，混合型高脂血症计划今年Q3启动 II期临床研究，目前在该适应症的国产siRNA药物中，研发进度位列第二，处于第一梯队。亿腾嘉和第三款已进入临床阶段的产品是GB261（CD3/CD20）双抗。与其他CD20/CD3双抗相比，GB261凭借低亲和力CD3结合并保留Fc功能的差异化设计，提高安全性的同时以多种机制更好地杀死肿瘤细胞，某些经过其他CD20/CD3治疗失败的患者仍可从GB261获益。其在B细胞淋巴瘤患者中已完成临床I/II期剂量爬坡，数据显示出良好的安全性和有效性。2025年亿腾嘉和与CandidTherapeutics达成战略合作，已在全球范围内启动4项自身免疫性疾病临床研究，共同推动临床开发进程。同时， GB261单药的II期临床研究也计划于今年Q2启动，并递交联合用药IND申请。临床前管线中，EDP001（CD3/CD19/CD19/BCMA）聚焦自免蓝海领域。作为一款靶向CD3/CD19/CD19/BCMA的高度创新性的四特异性T细胞衔接器（Tetra-specificTCE），具有独特分子设计，采用两个抗CD19的纳米抗体，分别靶向CD19的两个不同表位，使其对CD19阳性的B细胞有极强的结合能力；并同步靶向BCMA，实现双靶点覆盖，能够对CD19阳性B细胞以及BCMA阳性浆细胞都进行深度清除，以期从根源上抑制自身免疫反应，达到长期缓解的临床治疗效果，具有BIC潜力。EDP001临床前数据将在4月份的AACR大会发布。手握多条差异化产品管线的亿腾嘉和，正在全力加速推进各项重要管线的临床研究和国际合作，这对企业自身的造血机制和盈利能力带来了更高的要求。亿腾嘉和的商业化能力，能否为后续的研发带来源源不断的“枪支弹药”？硬核业绩：现金流为盾，创新增长为矛根据公司2026年3月27日发布的2025年度业绩，亿腾嘉和展现了“超级Biotech”的财务稳健性与增长确定性： ‌营收与利润双稳‌：全年实现营业收入‌24.9亿元‌，持续三年站稳20亿+量级，展现出成熟的商业化运营能力；净利润‌4亿元，实现三年稳步增长，经调整EBITDA（经调整息税折旧摊销前盈利）达‌9.5亿元‌，凸显了其高效运营和自我造血能力，在不少biotech依然挣扎在生存线之时更显难能可贵。 ‌现金流跨越式增长‌：截至2025年末，公司现金及现金等价物达‌10.5亿元‌，这其中包含与嘉和战略合并带来的8.9亿元现金补充，筑牢财务安全垫的同时也为后续研发投入和业务拓展提供了充足“弹药”。在产品销售端，亿腾嘉和的7款商业化产品呈现出“经典产品稳盘，创新产品突破”的格局。三款原研经典产品稳可信®、希刻劳®和亿瑞平®持续贡献稳定现金流。稳可信®在中国万古霉素市场占主导地位，市场份额78.7%，因其为特殊使用级抗生素，采纳部门和专家意见后未被纳入第十一批国家药品集中采购目录，再次展现其原研和品牌药的竞争壁垒和专业价值。儿科呼吸道感染治疗领先品牌希刻劳®，其干混悬剂的“小草莓”形象深入人心，备受患者信赖。希刻劳®多年来始终在头孢克洛零售渠道销售中占据显著领先地位。亿瑞平®作为最新一代ICS雾化吸入剂，兼具疗效更快、抗炎作用更持久、安全性更高的优势，与希刻劳在儿童市场具有良好的协同效应。四款创新药强势上位，加速助推业绩增长。乳腺癌创新产品景助达® （恩替司他片）和汝佳宁®（盐酸来罗西利片），成功新增纳入2025版《国家基本医疗保险、生育保险和工伤保险药品目录》，有望实现更多患者触达和销量的飞跃；两者都定位于乳腺癌领域中占比最大的HR+/HER2-的细分赛道，在商业化路径与临床定位上亦将形成协同效应，具备进一步放量空间。心血管重磅产品唯思沛®是中国上市首个可以降低心血管事件风险的降甘油三酯药物。2025年，唯思沛®覆盖1500名心内科PCI手术医生，惠及约2万名PCI术后患者，全面降低了PCI术后再次复发风险。中国每年约有160万台PCI手术，如能覆盖5% PCI术后人群，则每年增量可观，市场空间巨大。唯思沛®是京东双十一原研血脂用药第4名，仅次于立普妥、可定和益适纯。稳可达®作为全球首款针对慢性肝病相关血小板减少症的升血小板药物，2025年成功转入医保常规目录乙类，具备稳定放量的产品特征。乘政策东风启蜕变新程在当前的产业调整升级周期中，市场对企业的评判标准已从单纯的故事描绘，转向对高质量盈利及创新硬实力的综合考核。亿腾嘉和完美契合了“支柱产业”所要求的可持续发展与内生增长逻辑。 2026年两会将生物医药行业定性为“新兴支柱产业”，绝非简单的口号，而标志着产业逻辑的深刻重构：从“烧钱培育”走向“价值兑现”，从“跟风创新”走向“原始引领”。亿腾嘉和（6998.HK）通过一场成功的资本与产业整合，率先完成了向“超级Biotech”的蜕变——它用扎实的业绩证明了‌商业化造血能力‌，用具有国际竞争力的管线展示了‌持续创新生命力‌，用充沛的现金储备保障了‌穿越周期的定力‌。在产业政策东风、支付环境改善、出海机遇打开的多重利好下，亿腾嘉和这类已具备完整价值链和财务健康度的企业，无疑正处于从“优秀”迈向“卓越”的关键拐点，有望成为生物医药新支柱时代下，最具代表性的价值成长标杆之一。点击了解亿腾嘉和最新资讯！

免疫疗法抗体药物偶联物并购临床申请

2026-04-01

·Avantgrade先锋笔记

1亿美元押注口服减肥药：这家由辉瑞“毕业生”创立的公司，凭什么挑战诺和诺德？

2026年3月31日，科罗拉多州博尔德——一家名不见经传的生物技术公司Ambrosia Biosciences宣布完成1亿美元B轮融资，投资方包括Blue Owl Healthcare Opportunities、Redmile Group、Deep Track Capital等知名机构。这笔融资将用于推进其口服小分子GLP-1药物进入一期临床试验，同时继续开发GIP和amylin两个靶点的小分子项目。在诺和诺德、礼来等巨头已经占据先发优势的GLP-1赛道上，一家成立仅两年的初创公司凭什么获得资本如此青睐？ “辉瑞系”创业天团：从裁员中涅槃重生 Ambrosia的故事，始于一次被迫的“毕业”。这家公司的创始团队是一群前Array BioPharma的化学家。2019年，辉瑞以114亿美元收购Array BioPharma，这批科学家随之加入辉瑞。然而2024年，作为辉瑞业务重组的一部分，他们被裁撤。但命运的转折往往藏在看似糟糕的境遇里。这批被裁撤的化学家没有四散，而是选择集体创业，成立了Ambrosia Biosciences。Array联合创始人Kyle Lefkoff担任公司董事会主席。 “公司30名员工大部分来自Array，”CEO Nick Traggis在接受Endpoints News采访时表示。这意味着Ambrosia拥有一支经验丰富、配合默契的药物化学团队，这在初创公司中是极为稀缺的资产。他们的目标很明确：利用在小分子药物发现领域的专长，开发治疗肥胖和代谢疾病的口服小分子药物。 Ambrosia的研发策略颇具特色——不为每个患者开发一种药物，而是开发多种药物自由组合。本轮融资将用于推进三个小分子项目：与诺和诺德的口服Wegovy（多肽）不同，Ambrosia走的是小分子口服路线。Traggis表示，他们正在为每个受体开发单独的小分子药物，计划将这些药物开发成多种药片，然后根据患者情况量身定制剂量组合。这一策略可能有助于减少副作用，实现个性化治疗。技术路线：避开辉瑞的“坑”，走礼来的路小分子GLP-1药物的研发并非坦途。就在Ambrosia融资前不久，辉瑞刚刚宣布放弃其小分子GLP-1候选药物danuglipron——原因是在剂量优化研究中，一名受试者出现了可能由药物引起的肝损伤。这并非辉瑞第一次在此折戟。此前，辉瑞的另一款小分子GLP-1药物lotiglipron也因疗效和副作用问题被终止开发。辉瑞的挫折让小分子GLP-1赛道蒙上了一层阴影。那么Ambrosia凭什么认为自己能成功？关键差异在于技术路径。辉瑞的danuglipron是在对280万种化合物进行筛选后发现的，采用的是一种“正变构调节剂”策略。而Ambrosia则押注于结构生物学与计算化学的结合。 2017年，研究人员利用冷冻电子显微镜确定了GLP-1受体的三维分子结构，这是一个关键突破。礼来的分子生物学家Kyle Sloop表示，研究人员现在可以使用计算机建模来模拟分子与受体的相互作用，预测哪些结构最有可能适合，而不必制造每一个分子来测试潜力。礼来的小分子GLP-1候选药物orforglipron就是这条技术路径的产物。2023年公布的2期试验结果显示，每天服用一次orforglipron的人平均体重减轻了高达14.7% ，与司美格鲁肽的结果大致相当。 Ambrosia希望复制礼来的成功路径，同时通过靶向变构位点实现差异化——即寻找GLP-1激素靶向的受体位点之外的其他位点，使分子能够结合并触发受体的信号传导。理想情况下，这种药物会优先激活细胞的胰岛素调节通路，但避免与当前肽类药物副作用（恶心、呕吐、腹泻）相关的第二种信号传导。竞争格局：前有巨头，后有追兵如果说减肥药是一场马拉松，Ambrosia才刚刚站上起跑线，而领跑者已经跑出了很远。诺和诺德的口服Wegovy（多肽，非小分子）今年商业化开局“火爆”；礼来的orforglipron即将获批上市，尽管其III期临床数据显示减重效果从早期的14.7%下降至11.2%，但仍被视为小分子GLP-1赛道最有力的竞争者；Structure Therapeutics已进入后期临床阶段。此外，还有一批与Ambrosia类似的biotech正在追赶： •Kailera Therapeutics（计划IPO） •Verdiva Bio •Corxel（年初融资2.87亿美元）值得注意的是，后三家公司均从中国药物研发机构引进候选分子。这反映出中国已成为减肥药早期创新的重要源头。在更广泛的GLP-1赛道，竞争更为激烈。根据摩熵医药数据，截至2025年8月，全球174个肥胖适应症研发管线中，来自中国的占比近80% 。战略思考：要做口服减肥药中的“立普妥” 面对如此激烈的竞争，Ambrosia选择了一条务实的道路。公司新董事会成员、Blue Owl Capital的副总裁Sara Clarke明确表示，Ambrosia希望走的是“best-in-class”路线，而非“first-in-class”。这是一个聪明的类比。在降血脂药物领域，第一个他汀类药物并非最成功，第五个获批的也不是——最终赢家是辉瑞的立普妥（Lipitor）。立普妥的故事至今仍是医药界的商业传奇。它由华纳-兰伯特公司研发，1996年获批时，市场上已有4款他汀类药物。辉瑞凭借强大的销售能力和对药物优势的精准定位（更低的有效起始剂量、额外的降胆固醇功效），将立普妥打造成“重磅之王”，累计为辉瑞贡献超过1000亿美元销售额。而辉瑞收购立普妥的过程，更是一场经典的“投机”操作。1999年，当华纳-兰伯特准备与美国家庭产品公司合并时，辉瑞动用合作中的规避条款，以18亿美元终止了这笔交易，随后通过股权置换将立普妥收入囊中——名义上支付900亿美元，实际上没有现金流出，还获得了华纳-兰伯特的现金资产。 Ambrosia希望成为口服减肥药领域的“立普妥”——不是第一个，但可能是最好的那个。 CEO Nick Traggis还透露了另一条务实策略：寻求与大药企合作。他表示，“我们已经在与这个领域的主要玩家沟通。随着我们接近临床阶段，这些对话的规模将会扩大。” 战略思考：要做口服减肥药中的“立普妥” 从更宏观的视角看，小分子GLP-1药物的研发承载着行业对更便捷、更可及的治疗方案的期待。目前市面上的GLP-1药物主要分为两类：注射型多肽（如司美格鲁肽注射液）：疗效确切，但需要注射，患者依从性受限口服多肽（如口服司美格鲁肽）：需要高剂量使用，必须在空腹时服用，且只能饮用少量液体小分子药物理论上具有明显优势：生产成本更低——多肽药物合成工艺复杂，小分子可大规模化学合成服药更便利——无需空腹等复杂要求更易与其他药物联用——可开发成复方制剂但挑战同样严峻：靶点选择性——小分子与GLP-1受体的结合亲和力通常低于多肽安全性——辉瑞danuglipron的肝毒性问题敲响了警钟疗效差距——orforglipron III期临床减重效果从早期的14.7%下降至11.2%，与注射型药物存在差距 Septerna Therapeutics首席执行官Jeff Finer的判断或许最为中肯：小分子GLP-1药物将与注射药物共存，而非取代它们。

2026-03-31

·EndPoints

Colorado biotech Ambrosia lands $100M for oral GLP-1

A nascent biotech in the suburbs of Denver has convinced investors to commit $100 million to develop an oral small molecule in one of the most competitive fields in drug development. Ambrosia Biosciences snagged the Series B to fund development of three small molecules directed against the most popular targets in the weight loss drug bonanza: GLP-1, GIP and amylin. The Series B is expected to get all three into the clinic, CEO Nick Traggis said in an interview with Endpoints News . The GLP-1 is slated to enter Phase 1 in Australia early next year, he said. Backers of the funding round, disclosed Tuesday morning, include Blue Owl Healthcare Opportunities, Redmile Group, Deep Track Capital, Janus Henderson Investors, Samsara BioCapital, BVF Partners and Boulder Ventures. With its lead drug just now on the cusp of human testing, the Boulder, CO-based biotech is multiple years behind Novo Nordisk, Eli Lilly and other drugmakers fighting for a spot in the oral GLP-1 race. Novo’s oral Wegovy, which is a peptide rather than a small molecule, has been off to a blistering commercial start this year. Lilly, meanwhile, expects an approval any day for its candidate orforglipron. Structure Therapeutics is entering the late stages of development, as are others. The startup will also have to go up against many well-funded biotechs, including IPO hopeful Kailera Therapeutics , Verdiva Bio and Corxel , which raised $287 million earlier this year. Those three companies all snagged their investigational medicines from drug discovery shops in China, where many obesity drug candidates now originate. The proliferation of oral weight loss contenders has amplified the best-in-class versus first-in-class debate, which many industry leaders compare to the statin race. The first statin was not the biggest commercial success. Nor was the fifth approved one. It was Pfizer’s Lipitor. Ambrosia hopes to take the best-in-class route, new board member Sara Clarke, a VP at Blue Owl Capital, said in a press release. If its name is any indication, Ambrosia believes it can weather the competition. According to Ancient Greek mythology, ambrosia was a magical fruit of the gods, thought to have healing properties and prevent weakness. Ambrosia’s focus on well known targets appears to veer off from an original intention of going after “class B GPCRs,” Traggis told Endpoints at the time of an initial $16 million Series A in August 2024. “We’re not just gonna rip off another” molecule, he said then. “There is some novel work to be done here.” In an interview on Tuesday, Traggis said the biotech is still working on “more novel” GPCR targets, but Ambrosia isn’t disclosing those just yet. “We look at what’s being done in the peptide space as a way to validate targets. The native form of the hormones are these longer chain peptides, so that’s a good way for us to see what’s working well as a drug,” Traggis said. “I would use amylin as a good example of ‘Hey, here’s a newer target that’s been validated by some early peptide readouts that proves this is worth putting a big effort into on the small molecule side,'” the CEO added. The company will likely seek pharma partnerships to get to market, and obesity is just the beginning for its pipeline. Traggis said obesity is the “most straightforward story to tell” when raising capital. “We’re talking to all the regular suspects in this space already. They’re very aware of our programs, and as we move closer to the clinic, I think those conversations will increase in magnitude, if you will,” Traggis said. Ambrosia was born in 2024 after a team of former Array BioPharma chemists were let go by parent company Pfizer as part of a broad restructuring . Array cofounder Kyle Lefkoff is chair of Ambrosia’s board. Most of the company’s 30 employees come from Array, Traggis said.

临床1期

100 项与阿托伐他汀钙相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D02258	阿托伐他汀钙	C10AA05	DBSALT000011

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
心脏衰竭	美国	Upjohn Manufacturing Ireland Unlimited Co.	2007-03-02
心绞痛	美国	Upjohn Manufacturing Ireland Unlimited Co.	2005-09-21
心肌梗塞	美国	Upjohn Manufacturing Ireland Unlimited Co.	2005-09-21
脑卒中	美国	Upjohn Manufacturing Ireland Unlimited Co.	2005-09-21
杂合子家族性高胆固醇血症	美国	Upjohn Manufacturing Ireland Unlimited Co.	2002-10-18
家族性高胆固醇血症	日本	Astellas Pharma, Inc.	2000-03-10
家族性高胆固醇血症	日本	Viatris Pharmaceutical GK	2000-03-10
家族性高胆固醇血症	日本	Pfizer Inc.	2000-03-10
冠状动脉疾病	中国	北京嘉林药业股份有限公司	1999-01-01
高胆固醇血症	澳大利亚	Aspen Pharmacare Australia Pty Ltd.	1997-09-25
高血压	澳大利亚	Aspen Pharmacare Australia Pty Ltd.	1997-09-25
纯合子家族性高胆固醇血症	美国	Upjohn Manufacturing Ireland Unlimited Co.	1996-12-17
II a型高脂蛋白血症	美国	Upjohn Manufacturing Ireland Unlimited Co.	1996-12-17
IIb型高脂蛋白血症	美国	Upjohn Manufacturing Ireland Unlimited Co.	1996-12-17
III型高脂蛋白血症	美国	Upjohn Manufacturing Ireland Unlimited Co.	1996-12-17
IV型高脂蛋白血症	美国	Upjohn Manufacturing Ireland Unlimited Co.	1996-12-17
原发性高胆固醇血症	美国	Upjohn Manufacturing Ireland Unlimited Co.	1996-12-17

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
获得性免疫缺陷综合征	临床3期	泰国	Pfizer Inc.	2014-01-01
免疫重建炎性综合征	临床3期	泰国	Pfizer Inc.	2014-01-01
结核	临床3期	泰国	Pfizer Inc.	2014-01-01
2型糖尿病	临床3期	马来西亚	GSK Plc	2011-12-01
2型糖尿病	临床3期	墨西哥	GSK Plc	2011-12-01
2型糖尿病	临床3期	菲律宾	GSK Plc	2011-12-01
2型糖尿病	临床3期	俄罗斯	GSK Plc	2011-12-01
2型糖尿病	临床3期	韩国	GSK Plc	2011-12-01
2型糖尿病	临床3期	泰国	GSK Plc	2011-12-01
1型糖尿病	临床3期	美国	Pfizer Inc.	2010-10-01

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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


NCT04747847 (CTgov)	早期临床1期	冠状动脉闭塞 \| 粘膜皮肤淋巴结综合征	5	Atorvastatin+anakinra	鑰遞廠壓積網艱糧願鹽 = 餘繭積窪積廠鹽構窪糧淵觸鹹製廠簾餘鑰淵鏇 (糧夢簾廠選鹹簾夢鹹觸, 網淵廠簾糧襯顧壓淵醖 ~ 淵艱積餘築糧壓壓鏇繭) 更多	-	2026-02-25
NCT05761444 (Pubmed \| BMC Cardiovasc Disord)	临床4期	动脉粥样硬化	137	Ezetimibe 10mg/Atorvastatin 40mg combination therapy	積鑰艱膚觸衊餘襯夢獵(觸襯夢鏇鹹積衊觸壓糧) = 獵築鹹艱鹽選醖鏇築衊獵積襯廠築積觸蓋選製 (遞繭顧簾遞積糧顧製淵 ) 更多	积极	2026-02-11
				Atorvastatin 40mg statin alone	積鑰艱膚觸衊餘襯夢獵(觸襯夢鏇鹹積衊觸壓糧) = 窪衊糧醖鏇鬱鑰築獵憲獵積襯廠築積觸蓋選製 (遞繭顧簾遞積糧顧製淵 ) 更多
NCT02603328 (AT CASH EPOC, Pubmed \| J Am Heart Assoc)	临床1/2期	中枢神经系统海绵状血管瘤	65	Atorvastatin	鏇觸窪網鬱齋願艱鬱願(夢網願製夢鏇積鹽醖廠) = 齋願廠獵願鬱願構餘齋構膚艱網衊醖糧廠憲鹽 (蓋鹽膚艱鹹夢衊醖膚網 )	积极	2026-02-03
				Placebo	鏇觸窪網鬱齋願艱鬱願(夢網願製夢鏇積鹽醖廠) = 顧顧選製餘襯築窪醖膚構膚艱網衊醖糧廠憲鹽 (蓋鹽膚艱鹹夢衊醖膚網 )
NCT02943590 (STOP-CA, Pubmed \| JAMA Cardiol)	临床2期	淋巴瘤	300	Atorvastatin 40 mg	製鹽遞網鬱製鬱繭鹹選(積繭鬱艱憲齋襯構廠衊) = 膚廠選選衊憲齋鹹觸遞壓觸鹹衊膚構積夢願觸 (網艱憲選醖衊醖夢網蓋 ) 更多	积极	2025-11-08
				Placebo	製鹽遞網鬱製鬱繭鹹選(積繭鬱艱憲齋襯構廠衊) = 蓋遞願壓鏇鬱壓襯壓獵壓觸鹹衊膚構積夢願觸 (網艱憲選醖衊醖夢網蓋 ) 更多
NCT05567068 (Pubmed \| Front Pharmacol)	临床2期	溃疡性结肠炎	54	5-ASA plus Atorvastatin	糧簾夢鑰網醖繭顧淵醖(夢製構遞構鏇餘齋遞餘): P-Value = 0.027 更多	积极	2025-10-29
				5-ASA plus placebo
NCT01988571 (Preventing Anthracycline Cardiovascular Toxicity With Statins, Pubmed \| JAMA Netw Open)	临床3期	乳腺癌 \| 淋巴瘤	238	Atorvastatin 40 mg	憲簾遞範淵壓衊鹽製夢(鹹製齋艱廠鏇鹹獵蓋築) = 鏇醖繭簾憲糧艱製艱鑰蓋簾憲願網築壓遞糧鏇 (簾遞鹽憲顧製艱廠鹽願, 2.69 ~ 6.79) 更多	积极	2025-10-21
				Placebo	憲簾遞範淵壓衊鹽製夢(鹹製齋艱廠鏇鹹獵蓋築) = 遞鑰艱齋醖簾膚夢構築蓋簾憲願網築壓遞糧鏇 (簾遞鹽憲顧製艱廠鹽願, 1.71 ~ 5.54) 更多
NCT02603328 (AT CASH EPOC, Pubmed \| Neurosurgery)	临床2期	海绵状血管瘤	100	Atorvastatin	齋範願簾獵簾獵蓋膚構(網艱淵顧憲顧選製窪衊) = 選網觸餘範醖構壓簾築鏇鑰範壓糧衊膚窪餘窪 (窪獵壓廠齋遞憲鏇衊觸, 65.0)	不佳	2025-10-21
				Placebo	齋範願簾獵簾獵蓋膚構(網艱淵顧憲顧選製窪衊) = 繭製艱齋鬱築築鑰繭繭鏇鑰範壓糧衊膚窪餘窪 (窪獵壓廠齋遞憲鏇衊觸, 94.0)
NCT03308578 (Pubmed \| Am J Hypertens)	临床2期	阻塞性睡眠呼吸暂停综合征	39	High-Intensity Atorvastatin	網壓蓋鏇簾鑰鏇網襯顧(願築憲憲廠顧鹹廠簾鹽): P-Value = 0.51 更多	不佳	2025-10-10
				Placebo
NCT02603328 (AT CASH EPOC, CTgov)	临床1/2期	出血 \| 中枢神经系统海绵状血管瘤	80	Atorvastatin (Treatment)	鏇壓淵糧鹹鬱簾選鏇窪(構製製鑰鏇鏇糧構構遞) = 衊鑰淵遞願餘範遞艱廠鹹淵願膚膚簾鏇製築窪 (選觸鏇網餘艱築繭構廠, 9.77) 更多	-	2025-08-22
				Placebo (Placebo)	鏇壓淵糧鹹鬱簾選鏇窪(構製製鑰鏇鏇糧構構遞) = 糧築網獵遞繭簾齋淵膚鹹淵願膚膚簾鏇製築窪 (選觸鏇網餘艱築繭構廠, 10.08) 更多
IRCT20200825048515N36 (ESMO_GI2025)	临床3期	毒性	64	Atorvastatin 40 mg daily	遞積鏇遞糧鏇壓顧鏇簾(襯鏇鏇廠衊築鑰夢顧蓋) = 廠齋願鹹鏇糧夢積願廠艱範鏇醖醖鹽襯積簾觸 (憲窪製鑰範壓獵鏇糧淵 ) 更多	不佳	2025-07-03
				Placebo	遞積鏇遞糧鏇壓顧鏇簾(襯鏇鏇廠衊築鑰夢顧蓋) = 遞遞鑰獵鏇襯遞鏇簾積艱範鏇醖醖鹽襯積簾觸 (憲窪製鑰範壓獵鏇糧淵 ) 更多