A 12-week, Double-blind, Randomised, Placebo-controlled, Multicentre Trial to Evaluate Efficacy and Tolerability of Antistax® Film Coated Tablets, 720 mg/Day Orally, in Male and Female Patients Suffering From Chronic Venous Insufficiency

To assess the efficacy and tolerability of Antistax film coated tablets in patients with chronic venous insufficiency (CVI, CEAP Classification: Clinical class 3 and 4a).

开始日期2009-03-01

申办/合作机构

Boehringer Ingelheim GmbH

NCT02191254 / Completed临床3期

A 12-week, Double-blind, Randomised, Placebo-controlled, Multicentre Trial to Evaluate Efficacy and Tolerability of Antistax® Film Coated Tablets, 360 mg/Day Orally, in Male and Female Patients Suffering From Chronic Venous Insufficiency

Study to assess the efficacy and tolerability of Antistax® film-coated tablets in patients with chronic venous insufficiency (CVI, Clinical condition, Etiology, Anatomic location, Pathophysiology (CEAP) Classification: Clinical Class 3, or 4a)

开始日期2004-04-01

申办/合作机构

Boehringer Ingelheim GmbH

NCT02191163 / Completed临床2期

A 17 Week, Randomised, Double-blind, Placebo Controlled Cross-over Trial to Evaluate the Efficacy of Antistax® Film Coated Tablets (Extr. Vitis Vinifera Siccum), 360 mg/Day p.o. in Improving Microcirculation of the Skin in the Leg of Male and Female Patients Suffering From Chronic Venous Insufficiency

Study to determine the efficacy and safety of Antistax® film coated tablets in improving microcirculation of the skin in the leg of patients with chronic venous insufficiency (CVI)

开始日期2002-04-01

申办/合作机构

Boehringer Ingelheim GmbH

100 项与葡萄叶提取物相关的临床结果

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100 项与葡萄叶提取物相关的转化医学

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100 项与葡萄叶提取物相关的专利（医药）

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项与葡萄叶提取物相关的文献（医药）

2019-04-01·Die Pharmazie4区 · 医学

Therapeutic approach to chronic venous insufficiency - clinical benefits of red-vine-leaf-extract AS 195 (Antistax^®).

4区 · 医学

Review

作者: Schuett, T. ; Stuecker, M. ; Rabe, E. ; Meyer, K. ; Ottillinger, B.

Background: Chronic Venous Disorders or Diseases (CVD) of the lower extremities are a common finding affecting almost 90 % of an adult population. CVD includes varicose veins with a prevalence of approx. 25 %, overlapping with Chronic Venous Insufficiency (CVI) with a prevalence of approx. 17% in the adult population. CVI is characterized by venous pathology and objective signs like edema, skin changes or venous leg ulcers. Objective: To review and evaluate non-clinical and clinical data on a standardised herbal product containing flavonoids (AS195; Antistax^®) and to put them into a perspective with the pathophysiology of CVD. Methods: Literature available on non-clinical pharmacology and clinical studies with AS195 in CVI of the lower extremities was reviewed and described. Conclusion: Antistax^® is a well-described herbal product with standardised starting materials and manufacturing process. Its active ingredients accumulate in the venous intima, preserve the endothelial barrier function, and inhibit the inflammatory and prothrombotic cascade behind the progression of CVD. Its efficacy was analysed in adequately planned and executed clinical trials in patients with mild to moderately severe CVD (CEAP C1s to C4). AS195 showed a statistically significant and clinically relevant efficacy over placebo: in objective endpoints like volumetry of lower leg edema, but also in outcomes directly relevant for patients like tension and heaviness of the legs, tingling, and pain. Supportive studies confirmed and validated these results also for the broader population treated in daily practice. AS195 was well tolerated in studies and in everyday therapy. There are no known interactions with other medications. In the later stages, it can be used in combination with compression, complementing the beneficial haemodynamic effects of compression at a cellular level. AS195 is an addition to compression and closes a therapeutic gap especially in patients, who cannot use compression stockings, but still require CVD therapy.

2017-09-01·International Journal of Angiology

Management of Varicose Veins and Chronic Venous Insufficiency in a Comparative Registry with Nine Venoactive Products in Comparison with Stockings

Article

作者: Cornelli, U ; Dugall, M ; Luzzi, R ; Feragalli, B ; Corsi, M ; Hosoi, M ; Pellegrini, L ; Ledda, A ; Cesarone, M R ; Agus, G ; Belcaro, G ; Ricci, A ; Cotellese, R ; Errichi, B M

AbstractThe aim of this registry study was to compare products used to control symptoms of CVI. Endpoints of the study were microcirculation, effects on volume changes, and symptoms (analogue scale). Pycnogenol, venoruton, troxerutin, the complex diosmin-hesperidin, Antistax, Mirtoselect (bilberry), escin, and the combination Venoruton-Pycnogenol (VE-PY) were compared with compressions.No safety or tolerability problems were observed. At inclusion, measurements in the groups were comparable: 1,051 patients completed the registry. Best performers: Venoruton, Pycnogenol, and the combination VE-PY produced the best effects on skin flux. These products and the combination VE-PY better improved PO2 and PCO2. The edema score was decreased more effectively with the combination and with Pycnogenol. Venoruton; Antistax also had good results. Considering volumetry, the best performers were the combination PY-VE and the two single products Venoruton and Pycnogenol. Antistax results for edema were also good. The best improvement in symptoms score were obtained with Pycnogenol and compression. A larger decrease in oxidative stress was observed with Pycnogenol, Venoruton, and with the VE-PY combination. Good effects of Antistax were also observed. Parestesias were lower with Pycnogenol and with Antistax. Considering the need for interventions, the best performers were Pycnogenol, VE-PY, and compression. The efficacy of Pycnogenol and the combination are competitive with stockings that do not have the same tolerability in warmer climates. A larger and more prolonged evaluation is suggested to evaluate cost-efficacy (and non-interference with drugs) of these products in the management of CVI. The registry is in progress; other products are in evaluation.

2016-02-01·Pharmacology Research & Perspectives4区 · 医学

The red‐vine‐leaf extract AS195 increases nitric oxide synthase–dependent nitric oxide generation and decreases oxidative stress in endothelial and red blood cells

4区 · 医学

ArticleOA

作者: Grau, Marijke ; Stabenow, Christina Julia Annika ; Bölck, Birgit ; Bloch, Wilhelm ; Bizjak, Daniel Alexander

AbstractThe red‐vine‐leaf extract AS195 improves cutaneous oxygen supply and the microcirculation in patients suffering from chronic venous insufficiency. Regulation of blood flow was associated to nitric oxide synthase (NOS)‐dependent NO (nitric oxide) production, and endothelial and red blood cells (RBC) have been shown to possess respective NOS isoforms. It was hypothesized that AS195 positively affects NOS activation in human umbilical vein endothelial cells (HUVECs) and RBC. Because patients with microvascular disorders show increased oxidative stress which limits NO bioavailability, it was further hypothesized that AS195 increases NO bioavailability by decreasing the content of reactive oxygen species (ROS) and increasing antioxidant capacity. Cultured HUVECs and RBCs from healthy volunteers were incubated with AS195 (100 μmol/L), tert‐butylhydroperoxide (TBHP, 1 mmol/L) to induce oxidative stress and with both AS195 and TBHP. Endothelial and red blood cell–nitric oxide synthase (RBC‐NOS) activation significantly increased after AS195 incubation. Nitrite concentration, a marker for NO production, increased in HUVEC but decreased in RBC after AS195 application possibly due to nitrite scavenging potential of flavonoids. S‐nitrosylation of RBC cytoskeletal spectrins and RBC deformability were increased after AS195 incubation. TBHP‐induced ROS were decreased by AS195, and antioxidative capacity was significantly increased in AS195‐treated cells. TBHP also reduced RBC deformability, but reduction was attenuated by parallel incubation with AS195. Adhesion of HUVEC was also reduced after AS195 treatment. Red‐vine‐leaf extract AS195 increases NOS activation and decreases oxidative stress. Both mechanisms increase NO bioavailability, improve cell function, and may thus account for enhanced microcirculation in both health and disease.

项与葡萄叶提取物相关的新闻（医药）

2024-06-01

·药融圈

一年做95项license交易，全球仿制药巨头也有春天

注：本文不构成任何投资意见和建议，以官方/公司公告为准；本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及），不代表平台立场。任何文章转载需得到授权。来自德国🇩🇪史达德（STADA）集团，承载着严谨的德国药剂师基因的制药企业。公司始于1895年，一群远见卓识的药剂师携手在德累斯顿创立德国药剂师协会，这标志着史达德的诞生。该集团名字源自“Standardpr ParateDeutscher Apotheker”，即药剂师所制造的标准产品的代称。 STADA目前拥有11466名员工，其中7000+名技术研发人员，在1903年就首次制定了从药用原料、生产工艺到药品包装全过程的标准化生产法规。公司聚焦于仿制药、特药、消费者健康三大模块。史达德在2023年保持增长势头，销售额和利润均实现两位数增长。集团销售额增长14%，达37.3亿欧元。得益于通胀压力之下商品成本的改善以及稳定可靠的供应，调整后息税折旧及摊销前利润（EBITDA）增长19%，达8.02亿欧元。公司在2023财年做了95项许可交易（licensing deals）来促进业务纵深。2023年仿制药业务部门同比增加6%业绩，达15亿欧元。贡献业绩的产品有抗凝药物阿哌沙班、糖尿病药物西格列汀、止痛领域的他喷他多、用于移植患者的他克莫司，以及用于逆转肌肉松弛剂效果的舒更葡糖钠。新特药领域在2023年增长25%，增速为几大业务之最；目前为7.49亿欧元。产品包括多款生物类似药（biosimilar）（雷珠单抗、阿达木单抗、贝伐珠单抗、特立帕肽）。Uzpruvo（乌司奴单抗，Ustekinumab）的生物类似药即将上市，目前已经获批，等待欧洲市场原研药物专利过期。2023年上半年，史达德在药品可及性方面取得重大进展。美国食品药品监督管理局批准（FDA）从史达德位于德国尤特森的一家工厂向美国出口重组人红细胞生成素（EPO）。欧盟也几近同时确认位于越南绥和的新工厂符合要求严格的欧洲《药品生产质量管理规范》（GMP）标准，这为向欧洲出口提供了持续可靠的供应保障。与此同时，位于罗马尼亚图尔达供应链中心建设进展顺利；该中心投资超过5000万欧元，将大幅提升史达德在欧洲的供应链网络能力。在帕金森疾病（PD）领域，史达德的Lecigon pump成功结合三种经过验证的活性药物成分（levodopa + carbidopa + entacapone），用于治疗晚期帕金森病。该药品近期已在保加利亚、爱尔兰、西班牙和瑞士等更多国家上市，已有超千名患者使用；本品最早由LobSor Pharmaceuticals AB开发，相关专利WO-2016036308。药融云数据www.pharnexcloud.com；改良新药新复方在肾脏病学领域，欧盟批准的首个用于治疗罕见、慢性和致残性肾病IgA肾病的药物Kinpeygo（其他商品名Nefecon/Tarpeyo，4mg布地奈德靶向迟释胶囊）正在惠及更多患者。药融云数据www.pharnexcloud.com显示：Kinpeygo/Nefecon/Tarpeyo采用肠溶包衣，Nefecon/Tarpeyo这种改良新药的新剂型，可将布地奈德特异性递送至回肠的派尔集合淋巴结（负责产生分泌性免疫球蛋白A）处。胶囊溶解后，三层包衣微丸持续稳定释放布地奈德，高浓度覆盖整个靶区域。本品首创的瑞典公司Calliditas成立于2004年，产品最早购买权益于瑞典乌普萨拉大学（Uppsala University）两位教授那里。（中国等市场，云顶新耀持有相关权益，IgA肾病亟需新药：布地奈德改良新药美国加速获批）在2022年第4季度首次成为德国市场第一大OTC供应商。2020年从葛兰素史克（GSK）手中收购15个在欧销售的药品与保健品牌，2023年从赛诺菲收购多个欧洲国家的知名消费者健康品牌(Antistax、Lomudal、Omnivit和Opticrom滴眼液等)，构建多元化营养矩阵。1996年首度进入中国大陆。2021年，史达德在上海设立大中华区总部，显示出对中国大陆市场的高度重视。2024年5月28日，再来一单交易！来自中国的百奥泰生物制药股份有限公司（上交所代码：688177）与STADA Arzneimittel AG就BAT2506（一款参照欣普尼®戈利木单抗开发的生物类似药）签署授权许可及商业化协议，STADA将拥有BAT2506在欧盟、英国、瑞士以及其他部分欧洲国家市场的独占的商业化权益。根据协议条款，百奥泰将负责BAT2506的研发、生产以及商业化供应，STADA将负责BAT2506在欧盟、英国、瑞士以及其他部分欧洲国家市场的商业化。在达到相应的里程碑事件后，百奥泰可获得首付款加上里程碑款总金额最高至1.575亿美元，以及净销售额的两位数百分比作为收入分成。附，分享：此前3月底，公开了STADA集团年报。发送仿制药（请正确复制）至下方药融圈微信公众号后台可获得原文件。仅供学习交流分享！参考：NMPA/CDE；药融云数据www.pharnexcloud.com；FDA/EMA/PMDA；相关公司公开披露；https://www.stada.com/;2023年财报，https://www.stada.com/media/8669/fy2023-annual-report-stada.pdf；https://www.stadabeijing.com/；Pharmaceutical Executive, Pharma 50 Insight: The Accelerating Growth of Specialty Markets. Waseem Noor and Michael Kleinrock, 2022. https://www.pharmexec.com/；史达德2023年销售额和利润继续保持两位数增长，https://mp.weixin.qq.com/s/32m0q02jGSjblg7tk7f_Ow；www.bio-thera.com；本稿中不再涵盖其俄罗斯业务，该业务由史达德在其前俄罗斯子公司（AO Nizhpharm、OOO Aqualor、Dialogfarma LLC和OOO Hemofarm）中的股权组成，这些股权已于2023年9月转让给史达德集团之外的另一家公司；等等。本文仅用于向医疗卫生专业人士提供科学信息，不代表平台立场，不作任何用药推荐活动推荐 8月 • NDC2024生物医药创新者峰会关键词：小分子，XDC，多肽及GLP-1热点话题，200+行业专家（点击下方图片查看详情）▼【关于药融圈】药融圈PRHub旨在帮助生物医药科技型企业进行品牌推广及商务拓展服务，针对客户的真实需求制定系统化解决方案，通过“翻译-降维-场景化”将客户的品牌信息以直白易懂的方式被公众知悉，同时在流量渠道覆盖100万+垂直用户基础上实现合作目的，帮助合作伙伴完成从品牌开始到商务为终的闭环营销服务。我们已经完成了数十场线下1000人规模的生物医药研发类会议，涵盖小分子新药，大分子新药，改良型新药，BD跨境交易等多个领域，服务了百余家上市/独角兽/生物技术/制药企业。

生物类似药专利到期引进/卖出

2023-08-15

·FiercePharma

Stada in 'exploratory talks' about possible sale, CEO says, but nothing is certain

Early this month, Bloomberg reported that Stada Arzneimittel’s private equity owners were weighing options for the drugmaker, including a possible sale. Speculation that Stada Arzneimittel may be looking for a buyout has largely been confirmed after the company’s CEO said as much in a recent German-language news story. Responding to recent acquisition rumors, Stada CEO Peter Goldschmidt told the German Press Agency, “Whether and when STADA might be sold is solely the decision of our owners; Bain Capital and Cinven.” From the company’s view, Goldschmidt said, “our owners are in an orientation phase in which initial exploratory talks are taking place.” A Stada press representative emailed a translated version of the remarks early Tuesday along with the company's second-quarter results. Goldschmidt added that he doesn’t expect a decision before 2024. Additionally, the company's investors “have no pressure to sell,” the CEO pointed out. "What speaks in favor of a sale process is that it is common for financial investors to exit after five to six years,” Goldschmidt opined. Early this month, Bloomberg reported that Stada’s private equity owners were weighing options for the drugmaker, including a possible sale. At the time, sources close to the talks told Bloomberg the sale could value Stada at 10 billion euros or more. Bain and Cinven agreed to buy Stada for 5.3 billion euros in 2017. The deal gave the private equity firms control of what was one of the last independent generic-drug businesses in Europe. Goldschmidt's comments came as Stada reported first-half sales growth of 16% to 2.1 billion euros. The company is tracking to a record annual profit of 1 billion euros this year, the company said. Stada has been busy in recent months, both filling out its medicine chest and bolstering drug production abroad. In mid-July, Stada dropped an undisclosed sum on a range of Sanofi consumer health brands with “well-established” footholds in places such as Belgium, Germany, Hungary, Spain and the U.K., plus Nordic countries. The deal covered several brands, including the pain relief med Antistax, the allergy eye drops Lomudal and Opticrom, Omnivit vitamins and painkillers AAS and Dolalgial plus Bila-Git for gallbladder complaints. The purchase marked the “next step” in Stada’s quest to grow in the European consumer health market, the company’s Western Europe and Germany head Stephan Eder said in a statement at the time. In late November, Stada became the first international medicines company to build a plant in Romania in more than 30 years. At the time, Stada broke ground on a pill manufacturing facility in the Aries Industrial Park in Turda, which was set to create 375 jobs and to go online by the end of 2024.

并购生物类似药

2023-07-12

·FiercePharma

Stada raids Sanofi's medicine chest once more, picking up clutch of consumer health brands in Europe

Despite repeat over-the-counter sales to Stada Arzneimittel, Sanofi continues to operate its own large consumer healthcare venture. Two years after it enriched itself with 16 Sanofi drugs, Germany’s Stada Arzneimittel is purchasing another clutch of consumer health brands across multiple European countries. Stada is dropping an undisclosed sum on a range of Sanofi consumer health products with “well-established” footholds in places such as Belgium, Germany, Hungary, Spain and the U.K., plus Nordic countries. The deal covers several brands, including the pain relief med Antistax, the allergy eye drops Lomudal and Opticrom, Omnivit vitamins and painkillers AAS and Dolalgial plus Bila-Git for gallbladder complaints, Stada said Wednesday. Stada will finance the transaction with a mix of cash from its balance sheet and existing debt facilities. It aims to close the deal in the fourth quarter of 2023. The purchase marks the “next step” in Stada’s quest to grow in the European consumer health market, the company’s Western Europe and Germany head Stephan Eder said in a statement “Stada’s extensive sales, marketing and distribution network throughout Europe, along with our long-established partnerships with pharmacists, will enable the group to grow these brands by also developing additional offerings,” he added. Consumer healthcare comprises one of three pillars in Stada’s business alongside specialty medicines and generics. The company operates predominantly in Western European countries. Two summers ago, Stada struck a similar deal with Sanofi for more than a dozen consumer health brands spanning 13 European countries. That portfolio purchase covered cold and flu meds, skincare and food supplement brands. Prior to that, Stada in early 2020 tapped GSK for 15 over-the-counter drugs in a deal worth at least 300 million euros ($325 million). For GSK, the asset sale was part of a broader ambition to spin out its consumer healthcare business into the standalone company Haleon, which formally flew the nest in July 2022. That move formed part of a broader spinoff trend across the industry, with similar maneuvers having been charted by Johnson & Johnson with its OTC spinoff Kenvue, Pfizer and Mylan with Viatris and Novartis’ ongoing effort to hive off Sandoz. Despite repeat over-the-counter sales to Stada, Sanofi continues to operate its own large consumer healthcare venture. The division was a key revenue driver for the French pharma in 2023’s first quarter, growing sales 11.2% to 1.5 billion euros (about $1.7 billion).

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100 项与葡萄叶提取物相关的药物交易

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研发状态

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适应症	国家/地区	公司	日期
静脉曲张	德国	Boehringer Ingelheim GmbH	-

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适应症	最高研发状态	国家/地区	公司	日期
慢性静脉功能不全	药物发现	-	Boehringer Ingelheim GmbH	2004-04-01

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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


NCT00855179 (Pubmed \| Eur J Vasc Endovasc Surg)	临床3期	慢性静脉功能不全	248	Red-vine-leaf extract (AS195)	襯製選鬱襯鏇壓糧鬱艱(艱遞鏇夢醖蓋選鬱餘醖): P-Value = 0.0268 更多	-	2011-04-01
				Placebo