主要目的：通过空腹/餐后试验研究，考察中国健康受试者在空腹/餐后状态下单剂量口服嘉亨(珠海横琴)医药科技有限公司研制（河南福森药业有限公司生产）的甲苯磺酸艾多沙班片（规格：60mg）与Daiichi Sankyo Europe GmbH持有并生产的甲苯磺酸艾多沙班片（规格：60mg；商品名：里先安®）后的体内药代动力学特征，评价两制剂的生物等效性。次要目的：考察研究评价单剂量口服甲苯磺酸艾多沙班片（规格：60mg）在中国健康受试者中的安全性。

开始日期2024-08-15

申办/合作机构

嘉亨（珠海横琴）医药科技有限公司

CTR20240747 / CompletedN/A

江苏华阳制药有限公司研制的甲苯磺酸艾多沙班片与Daiichi Sankyo Europe GmbH上市的里先安®在健康受试者中进行的单中心、随机、开放、两制剂、空腹和餐后、单次给药、2序列、4周期、重复交叉生物等效性研究

以江苏华阳制药有限公司生产的甲苯磺酸艾多沙班片（30 mg）为受试制剂，以Daiichi Sankyo Europe GmbH上市的里先安®为参比制剂，考察两制剂在空腹及餐后状态下单次给药的药代动力学参数及相对生物利用度，评价两制剂是否具有生物等效性；同时评价两种制剂在健康人体中的安全性和耐受性。

开始日期2024-07-16

申办/合作机构

江苏华阳制药有限公司

CTR20242149 / CompletedN/A

甲苯磺酸艾多沙班片（60 mg）在健康受试者中的空腹/餐后生物等效性试验

主要目的：在健康男性与女性受试者中于空腹/餐后条件下，评价受试制剂甲苯磺酸艾多沙班片（规格：60 mg，生产商：浙江华海药业股份有限公司）和Daiichi Sankyo Europe GmbH为持证商的参比制剂甲苯磺酸艾多沙班片（里先安，规格：60 mg）的生物等效性。次要目的：观察受试制剂甲苯磺酸艾多沙班片与参比制剂甲苯磺酸艾多沙班片（里先安）在健康受试者中的安全性。

开始日期2024-07-11

申办/合作机构

浙江华海药业股份有限公司

100 项与甲苯磺酸艾多沙班相关的临床结果

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100 项与甲苯磺酸艾多沙班相关的转化医学

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100 项与甲苯磺酸艾多沙班相关的专利（医药）

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2,121

项与甲苯磺酸艾多沙班相关的文献（医药）

2025-04-01·DEN Open

Safety of edoxaban for delayed bleeding in gastrointestinal endoscopic procedures with a high risk of bleeding

Article

作者: Kazunao, Hayashi ; Shibata, Osamu ; Tominaga, Kentaro ; Yokoyama, Junji ; Takahashi, Kazuya ; Satoshi, Ikarasi ; Mizuno, Ken‐ichi ; Kojima, Yuichi ; Kawata, Yuzo ; Terai, Shuji

AbstractObjectivesThere are limited reports on the safety of gastrointestinal endoscopic procedures in individuals taking edoxaban, one of the direct oral anticoagulants. We clarified the incidence of delayed bleeding in patients who were on edoxaban in the perioperative period of gastrointestinal endoscopic procedures with a high risk of bleeding.MethodsThis was an investigator‐initiated, single‐center, open‐label, prospective, single‐arm study. Patients on warfarin or edoxaban undergoing endoscopy with a high risk of bleeding were enrolled from June 2018 to September 2021. Warfarin was replaced with edoxaban in patients on warfarin. Patients taking other direct oral anticoagulants, and antiplatelet drugs, were excluded. The primary endpoint was severe delayed bleeding (Common Terminology Criteria for Adverse Events [CTCAE] grades III–V) and the secondary endpoints included thromboembolism, all adverse events, any delayed bleeding (CTCAE grades I or II), and hospital stay durations.ResultsTwenty‐one patients on edoxaban underwent high‐risk endoscopy. Three cases (14%) experienced CTCAE grade III delayed bleeding, requiring endoscopic hemostasis. No CTCAE grade I‐II delayed bleeding or thromboembolic events occurred. Cholangitis and aspiration pneumonia (conservatively treated) occurred during the hospital stay. The median length of hospital stay was 8 days (range 3—24 days). Patients with delayed bleeding had higher systolic blood pressure at admission and longer hospital stays.ConclusionsThe delayed bleeding incidence in high‐risk endoscopic procedures for patients on edoxaban was acceptable. Higher blood pressure may be associated with increased risk, but further research is needed.

2025-01-01·Journal of Ethnopharmacology

Impact of Banhabaekchulcheonmatang (Banxia Baizhu Tianma Tang) and Hwangryeonhaedoktang (Huang Lian Jie Du Tang) on edoxaban: Herb-drug interaction study in healthy subjects

Article

作者: Kim, Hocheol ; Cho, Hea-Young ; Cho, Seok-Jin ; Cho, Seok-jin ; Kim, Ju Hee ; Song, Jungbin ; Kang, Dong Wook ; Chung, Hyewon

ETHNOPHARMACOLOGICAL RELEVANCEConcurrent use of traditional herbal medicines and conventional drugs, particularly for stroke treatment, is widespread, raising concerns about potential drug interactions.AIM OF THE STUDYThis clinical study aimed to investigate interactions between edoxaban, a direct oral anticoagulant, and two traditional herbal medicines commonly used for stroke: Banhabaekchulcheonmatang (BBCT) and Hwangryeonhaedoktang (HRHDT).MATERIALS AND METHODSKorean healthy volunteers participated in a randomized, open-label, three-period, three-treatment, two-sequence clinical study. Treatments consisted of a single oral dose of edoxaban tablet (60 mg) in the presence or absence of multiple doses of BBCT or HRHDT three times daily for six days. Pharmacokinetic and pharmacodynamic parameters of edoxaban and its active metabolite M4 were assessed following administration of edoxaban alone or in co-administration with BBCT or HRHDT.RESULTSWhen edoxaban was co-administered with BBCT or HRHDT, the area under the curve (AUC) of edoxaban remained unaffected. However, its peak concentrations (C_max) were decreased by 18.5%-28.1%. Similarly, co-administration of edoxaban with BBCT or HRHDT slightly decreased the AUC of M4 and reduced its C_max by 16.8%-27.1%. Results revealed that BBCT and HRHDT had a minor impact on pharmacokinetics of edoxaban and M4. Despite alterations in systemic exposures, all pharmacodynamic parameters of edoxaban derived from activated partial thromboplastin time and prothrombin time were equivalent irrespective of herbal medicine co-administration.CONCLUSIONSThese findings contribute to our understanding of potential interactions between conventional anticoagulants and traditional herbal medicines, highlighting the need for comprehensive evaluation in clinical practice.

2024-12-01·Journal of the American Medical Directors Association

Comparative Effectiveness and Safety of Direct Oral Anticoagulants vs Warfarin among Nursing Home Residents with Atrial Fibrillation: A Retrospective Cohort Study

Article

作者: Alexander, G. Caleb ; Alexander, G Caleb ; Mehta, Hemalkumar B. ; Mehta, Hemalkumar B ; Xiao, Xuya ; An, Huijun

OBJECTIVEResidents of nursing homes are usually excluded from clinical trials, including trials to assess treatments for common conditions such as nonvalvular atrial fibrillation (NVAF). We aimed to quantify the real-world comparative safety and effectiveness of direct-acting oral anticoagulants (DOACs) vs warfarin among nursing home residents with NVAF.DESIGNRetrospective cohort study using 100% national Minimum Data Set and linked Medicare claims from January 2011 through December 2018.SETTING AND PARTICIPANTSLong-term care nursing home residents aged ≥66 years enrolled in fee-for-service Medicare. We included individuals diagnosed with NVAF newly initiating oral anticoagulants.METHODSWe identified exposure to DOACs (apixaban, dabigatran, rivaroxaban, and edoxaban) vs warfarin. Outcomes were hospitalization for ischemic stroke/systemic embolism, major bleeding, pneumonia (negative control outcome), and all-cause death. We used inverse probability of treatment weighting competing risk regression models for clinical outcomes and Cox proportional hazards regression for all-cause death.RESULTSOf 38,983 individuals newly initiating anticoagulants, 19,366 (49.7%) initiated DOACs and 19,617 (50.3%) initiated warfarin. In the inverse probability of treatment weighting analysis, compared with warfarin, there was no statistically significant association between DOAC use and ischemic stroke/systemic embolism [4.5 vs 4.7 events per 100 person-years; adjusted hazard ratio (aHR), 0.94; 95% CI, 0.84-1.05] or major bleeding (12.6 vs 12.4 events per 100 person-years; aHR, 1.03; 95% CI, 0.96-1.10). DOACs use was associated with a modest but statistically significant lower risk of all-cause death (48.1 vs 49.0 events per 100 person-years; IPTW analysis aHR, 0.95; 95% CI, 0.91-0.98).CONCLUSIONS AND IMPLICATIONSAmong nursing home residents with NVAF, DOACs and warfarin were associated with a similar risk of ischemic stroke/systemic embolism and major bleeding. However, the use of DOACs was associated with a slightly reduced risk of all-cause mortality.

项与甲苯磺酸艾多沙班相关的新闻（医药）

2024-11-19

·drugs

Newer Blood Thinner Cuts Odds for Stroke After Heart Valve Surgery

TUESDAY, Nov. 19, 2024 -- Japanese researchers say they have found a pill that works as well as existing medication to prevent blood clots after heart valve surgery, with fewer trips to the doctor. Unlike warfarin , the standard treatment, edoxaban does not require regular monitoring of blood clotting activity and doesn't interact with other meds. "Edoxaban could make life easier for patients recovering from heart valve surgery," said study leader Dr. Chisato Izumi , of the National Cerebral and Cardiovascular Center in Suita, Japan. "Since this medication does not require regular blood tests to monitor anticoagulation activity and can be taken in a fixed dose, without fears of interaction with food or other medications, it reduces the burden on patients and improves their quality of life, especially in those crucial first few months after surgery," she added. Izumi presented her team's findings Monday at a meeting of the American Heart Association in Chicago. Research presented at meetings is considered preliminary until published in a peer-reviewed journal. The U.S. Food and Drug Administration approved edoxaban in 2015 for patients with a form of atrial fibrillation (A-fib) caused by rapid and irregular beating of the heart's top chambers, not a heart valve problem. For this trial, researchers compared its use to warfarin in about 400 patients in Japan who had heart valve replacement surgery. Participants received either edoxaban or warfarin for 12 weeks. Compared to warfarin, edoxaban was as effective -- or even more so -- in preventing stroke and blood clots, researchers said. In all, 0.5% of edoxaban patients had a stroke or embolism compared to 1.5% of those who took warfarin. However, 4.1% in the edoxaban group had major bleeding, compared to 1% of the warfarin group. One patient taking warfarin had a fatal brain hemorrhage, but there were no brain hemorrhages or fatal bleeding in edoxaban patients. None of the edoxaban patients suffered a blood clot in the heart, but 1% of warfarin patients did. Finally, those taking edoxaban did have higher rates of gastrointestinal bleeding than those taking warfarin (2.1% versus 0%). "Our findings show that edoxaban could help prevent blood clots as effectively as warfarin, indicating it is a viable post-surgery treatment alternative to consider for patients who have received a bioprosthetic heart valve replacement," Izumi said in a meeting news release. Researchers said additional study is needed to learn which patients are more likely to bleed if they take edoxaban, and how to reduce that risk. They noted that both patients and doctors knew which medication participants were receiving, which could have biased the results. The study did not include patients whose valves were replaced with man-made devices. Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

上市批准AHA会议临床研究

2024-11-18

·drugs

Certain Painkillers Can Raise Bleeding Risks for People on Blood Thinners

MONDAY, Nov. 18, 2024 -- People on blood thinners have a doubled risk of dangerous internal bleeding if they also take a non-steroidal anti-inflammatory drug (NSAID) like ibuprofen or naproxen, a new study warns. People typically are prescribed blood thinners to treat or prevent strokes , heart attacks, or blood clots in the legs or lungs, researchers said. NSAIDs also are known to thin the blood, and the new study shows that they can increase risk of uncontrolled bleeding in the gut, brain, lungs and bladder if taken alongside a blood thinner. “We found that for patients taking blood thinners for blood clots in the legs or lungs, using NSAIDs doubled the risk of bleeding compared with not using NSAIDs,” said researcher Soren Riis Peterson , a medical student with Aarhus University Hospital in Denmark. “The increased bleeding risk associated with NSAID use was not limited to the digestive tract but also seemed to affect other organ systems.” For the study, researchers analyzed data on nearly 52,000 Danish patients prescribed a blood thinner to treat a blood clot between 2012 and 2022. In Denmark, the NSAIDs diclofenac and naproxen can only be obtained through a prescription. This allowed researchers to track the health of patients who had been prescribed both a blood thinner and an NSAID. Overall, the risk of a bleed was two times higher when people took a blood thinner and an NSAID, compared to just taking a blood thinner, researchers found. The specific risk was four times higher for naproxen, three times higher for diclofenac and nearly twice as high for ibuprofen. Specific bleed risks included: Using NSAIDs with a blood thinner also tripled a person’s risk of anemia, researchers found. The pattern of risk remained similar across a wide variety of blood thinners, including rivaroxaban , apixaban , dabigatran , edoxaban and warfarin , results show. The new study was published Nov. 17 in the European Heart Journal . “For people taking blood thinners for blood clots in their legs or lungs, our research highlights the importance of being cautious when considering NSAIDs for pain or inflammation,” Petersen concluded in a journal news release. “We recommend that patients consult their doctor before taking NSAIDs along with a blood thinner.” In an accompanying editorial, Dr. Robert Storey , a professor of clinical cardiology with the University of Sheffield in the U.K., noted that NSAIDs are widely used, making up about 8% of prescriptions worldwide and often available over-the-counter. “It seems clear that avoiding NSAIDs in combination with [blood thinners] is the safest strategy to avoid excess bleeding risk,” Storey wrote. “However, if this is not possible, what mitigation can be put in place? NSAID prescription should obviously be at the lowest dose and for the shortest time possible, but choice of agent and route may also be important.” Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

AHA会议

2024-11-10

·药筛

山东鲁盛多种维生素(12)获批上市，成都苑东甲磺酸萘莫司他上市申请 | 仿制药周报（11.4-11.10）

统计每周仿制药一致性评价申报、上市申请（11.4-11.10） 1、仿制药上市申请获批药品名称企业名称分类受理号阿戈美拉汀片宝利化（南京）制药有限公司;江苏利泰尔药业有限公司4CYHS2302145阿加曲班注射液海南葫芦娃药业集团股份有限公司4CYHS2300184巴氯芬片重庆士立德医药科技有限公司;福安药业集团庆余堂制药有限公司4CYHS2302507玻璃酸钠滴眼液山东华鲁制药有限公司4CYHS2302277玻璃酸钠滴眼液安徽环球药业股份有限公司4CYHS2301913玻璃酸钠滴眼液安徽环球药业股份有限公司4CYHS2301914布洛芬混悬滴剂天大医药科技（珠海）有限公司;天大药业（珠海）有限公司3CYHS2300001地夸磷索钠滴眼液江苏远恒药业有限公司4CYHS2400248地夸磷索钠滴眼液南京黄龙生物科技有限公司;杭州民生药业股份有限公司4CYHS2300464恩扎卢胺软胶囊Dr. Reddy's Laboratories Limited5.2JYHS2200042二甲双胍恩格列净片天大药业（珠海）有限公司4CYHS2301425法莫替丁注射液四川制药制剂有限公司;成都利尔药业有限公司3CYHS2301317伏立康唑干混悬剂健康元药业集团股份有限公司;深圳市海滨制药有限公司4CYHS2301217复方聚乙二醇电解质散(Ⅱ)南京海纳制药有限公司3CYHS2400148复方聚乙二醇电解质散(Ⅱ)黑龙江博宇制药有限公司;四川科伦药业股份有限公司3CYHS2303588己酮可可碱注射液武汉海特生物制药股份有限公司3CYHS2301000甲氨蝶呤片江苏百奥信康医药科技有限公司;浙江浙北药业有限公司3CYHS2300574聚乙烯醇滴眼液四川海梦智森生物制药有限公司;浙江赛默制药有限公司3CYHS2300897克林霉素磷酸酯外用溶液江苏知原药业股份有限公司4CYHS2300147膦甲酸钠注射液华仁药业股份有限公司3CYHS2301137硫辛酸注射液江苏睿实生物科技有限公司;富祥（大连）制药有限公司4CYHS2301742马来酸阿法替尼片江苏华阳制药有限公司4CYHS2301281马来酸氟伏沙明片上海理想制药有限公司4CYHS2301497麦考酚钠肠溶片山东新时代药业有限公司4CYHS2303659米诺地尔搽剂浙江远力健药业有限责任公司;浙江赛默制药有限公司3CYHS2201287莫匹罗星软膏河南羚锐制药股份有限公司;河南羚锐生物药业有限公司4CYHS2301424帕拉米韦注射液陕西博森生物制药股份集团有限公司3CYHS2302082帕米膦酸二钠注射液仁合益康集团有限公司;河北仁合益康药业有限公司3CYHS2300892屈螺酮炔雌醇片南通联亚药业股份有限公司4CYHS2200412瑞巴派特片福安药业集团宁波天衡制药有限公司;福安药业集团庆余堂制药有限公司4CYHS2301188沙库巴曲缬沙坦钠片山东凤凰制药股份有限公司4CYHS2200423头孢氨苄干混悬剂上海金城素智药业有限公司3CYHS2300839维生素B6注射液江苏润恒制药有限公司3CYHS2402860硝普钠注射液成都新恒创药业有限公司3CYHS2301634熊去氧胆酸胶囊浙江寰领医药科技有限公司;浙江康恩贝制药股份有限公司4CYHS2300582盐酸昂丹司琼片杭州和泽坤元药业有限公司;宁波美诺华天康药业有限公司3CYHS2300909盐酸昂丹司琼片杭州和泽坤元药业有限公司;宁波美诺华天康药业有限公司3CYHS2300910盐酸丙卡特罗口服溶液南京艾德加生物制药科技有限公司;山西同达药业有限公司3CYHS2301169盐酸丙卡特罗口服溶液南京艾德加生物制药科技有限公司;山西同达药业有限公司3CYHS2301170盐酸多巴酚丁胺注射液成都瑞尔医药科技有限公司;太极集团四川太极制药有限公司3CYHS2301571盐酸多巴酚丁胺注射液浙江沣华医药科技有限公司;浙江赛默制药有限公司3CYHS2300301盐酸环喷托酯滴眼液山东绅联药业股份有限公司;北京汇恩兰德制药有限公司4CYHS2300007盐酸乐卡地平片兆科药业（广州）有限公司4CYHS2201840盐酸美金刚片四川宏明博思药业有限公司4CYHS2201963盐酸曲唑酮缓释片山东京卫制药有限公司4CYHS2401448盐酸曲唑酮缓释片山东京卫制药有限公司4CYHS2401449盐酸去氧肾上腺素注射液石家庄四药有限公司3CYHS2300901盐酸去氧肾上腺素注射液南京恒道医药科技股份有限公司;江苏大红鹰恒顺药业有限公司3CYHS2300808伊布替尼胶囊Natco Pharma Limited5.2JYHS2300009依巴斯汀口服溶液湖南金圃医药科技有限公司;南京海纳制药有限公司3CYHS2301495注射用多种维生素(12)山东鲁盛制药有限公司;华北制药股份有限公司4CYHS2201289注射用拉氧头孢钠山东晶辉生物技术有限公司;山东润泽制药有限公司3CYHS2303220注射用拉氧头孢钠山东晶辉生物技术有限公司;山东润泽制药有限公司3CYHS2303219注射用拉氧头孢钠山东晶辉生物技术有限公司;山东润泽制药有限公司3CYHS2303221注射用替考拉宁海南倍特药业有限公司4CYHS2300059注射用替考拉宁四川汇宇制药股份有限公司4CYHS2201552注射用替考拉宁四川汇宇制药股份有限公司4CYHS2201554注射用头孢唑肟钠山东晶辉生物技术有限公司;山东润泽制药有限公司4CYHS2403002注射用头孢唑肟钠山东晶辉生物技术有限公司;山东润泽制药有限公司4CYHS2403004注射用头孢唑肟钠山东晶辉生物技术有限公司;山东润泽制药有限公司4CYHS2403003注射用头孢唑肟钠海南全星制药有限公司4CYHS2301760注射用头孢唑肟钠广州艾奇西新药研究有限公司;福建省福抗药业股份有限公司4CYHS2301641注射用盐酸罗沙替丁醋酸酯郑州维先医药科技有限公司;成都天台山制药股份有限公司3CYHS2301977左卡尼汀口服溶液浙江长典药物技术开发有限公司;浙江凯润药业股份有限公司4CYHS2302108左卡尼汀注射液舒美奇成都生物科技有限公司;四川美大康佳乐药业有限公司4CYHS2301604左卡尼汀注射液舒美奇成都生物科技有限公司;四川美大康佳乐药业有限公司4CYHS2301603左亚叶酸钙注射液浙江普利药业有限公司3CYHS2300334左亚叶酸钙注射液浙江普利药业有限公司3CYHS2300331左亚叶酸钙注射液浙江普利药业有限公司3CYHS2300333左亚叶酸钙注射液浙江普利药业有限公司3CYHS2300332左氧氟沙星滴眼液石家庄凯赛医药科技有限公司;山东海山药业有限公司4CYHS2301194左氧氟沙星片吉林长白山药业集团股份有限公司4CYHS2300552 注：灰色字体部分受理号结论为不批准。 2、一致性评补充申请获批药品名称企业名称受理号阿莫西林胶囊达嘉维康生物制药有限公司;湖南康尔佳生物医药科技有限公司CYHB2350505阿莫西林颗粒四川依科制药有限公司CYHB2350818达肝素钠注射液南京健友生化制药股份有限公司CYHB2450062地西泮注射液安徽长江药业有限公司CYHB2450278二羟丙茶碱注射液天津金耀药业有限公司CYHB2350754非那雄胺片上海现代制药股份有限公司CYHB2350835氟康唑氯化钠注射液辰欣药业股份有限公司CYHB2350856氟哌啶醇注射液山东鲁抗医药集团赛特有限责任公司CYHB2350827复方电解质注射液(Ⅱ)内蒙古白医制药股份有限公司CYHB2350360复方电解质注射液(Ⅱ)内蒙古白医制药股份有限公司CYHB2350358复方电解质注射液(Ⅱ)内蒙古白医制药股份有限公司CYHB2350362复方电解质注射液(Ⅱ)内蒙古白医制药股份有限公司CYHB2350361复方电解质注射液(Ⅱ)内蒙古白医制药股份有限公司CYHB2350359铝碳酸镁咀嚼片江西药都仁和制药有限公司CYHB2350887铝碳酸镁咀嚼片修正药业集团长春高新制药有限公司CYHB2250090尼可地尔片锦州九泰药业有限责任公司CYHB2350792葡萄糖酸钙注射液山东新华制药股份有限公司CYHB2350545秋水仙碱片北京嘉林药业股份有限公司CYHB2350922碳酸氢钠片四川德元药业集团有限公司CYHB1950812碳酸氢钠片四川德元药业集团有限公司CYHB1950813碳酸氢钠片青海制药有限公司CYHB1950589头孢克肟分散片广州白云山医药集团股份有限公司白云山制药总厂CYHB2350538头孢克肟分散片广州白云山医药集团股份有限公司白云山制药总厂CYHB2350539头孢克肟片苏州东瑞制药有限公司;华北制药河北华民药业有限责任公司CYHB2450064盐酸多巴酚丁胺注射液无锡凯夫制药有限公司CYHB2350783注射用苯唑西林钠成都第一制药有限公司;山东二叶制药有限公司CYHB2350726注射用苯唑西林钠成都第一制药有限公司;山东二叶制药有限公司CYHB2350727注射用头孢呋辛钠海南灵康制药有限公司CYHB2450250注射用头孢呋辛钠海南灵康制药有限公司CYHB2450251注射用头孢哌酮钠舒巴坦钠华北制药河北华民药业有限责任公司CYHB2350695注射用头孢哌酮钠舒巴坦钠华北制药河北华民药业有限责任公司CYHB2350696 注：灰色字体部分受理号结论为不批准。 3、新增仿制药上市申请药品名称企业名称分类受理号艾拉莫德片海南合瑞制药股份有限公司4CYHS2403841艾拉莫德片江西科伦药业有限公司;四川科伦药业股份有限公司4CYHS2403842氨溴特罗口服溶液山东龙洋生物医药科技有限公司;湖南嘉恒制药有限公司3CYHS2403800氨溴特罗口服溶液山东龙洋生物医药科技有限公司;湖南嘉恒制药有限公司3CYHS2403801氨溴特罗口服溶液湖南状元制药有限公司;南京海纳制药有限公司3CYHS2403763氨溴特罗口服溶液湖南状元制药有限公司;南京海纳制药有限公司3CYHS2403764巴氯芬片浙江诺得药业有限公司4CYHS2403782贝前列素钠片湖南华纳大药厂股份有限公司4CYHS2403758贝前列素钠片湖南华纳大药厂股份有限公司4CYHS2403759吡拉西坦注射液嘉亨（珠海横琴）医药科技有限公司;河南福森药业有限公司3CYHS2403808吡拉西坦注射液嘉亨（珠海横琴）医药科技有限公司;裕松源药业有限公司3CYHS2403809吡美莫司乳膏浙江华海药业股份有限公司4CYHS2403786丙酸氟替卡松雾化吸入用混悬液湖南先施制药有限公司;浙江赛默制药有限公司4CYHS2403724布比卡因脂质体注射液湖南科伦制药有限公司3CYHS2403793布比卡因脂质体注射液湖南科伦制药有限公司3CYHS2403794醋酸钠林格葡萄糖注射液山西诺成制药有限公司3CYHS2403756地屈孕酮片新疆特丰药业股份有限公司;新疆新姿源生物制药有限责任公司4CYHS2403843地屈孕酮片上海延安药业有限公司;浙江赛默制药有限公司4CYHS2403799二羟丙茶碱注射液江西人可医药科技有限公司;裕松源药业有限公司3CYHS2403765非布司他片多多药业有限公司4CYHS2403806非布司他片多多药业有限公司4CYHS2403807非那雄胺片海南药谷云生物科技有限公司;南京海鲸药业股份有限公司4CYHS2403790非那雄胺片海南药谷云生物科技有限公司;南京海鲸药业股份有限公司4CYHS2403791氟伐他汀钠缓释片杭州泓友医药科技有限公司;华益药业科技（安徽）有限公司4CYHS2403826复方聚乙二醇(3350)电解质口服液云南先施药业有限公司;浙江凯润药业股份有限公司3CYHS2403774复方聚乙二醇(3350)电解质散河北智恒医药科技股份有限公司;石家庄龙泽制药股份有限公司3CYHS2403802复方聚乙二醇电解质散(Ⅱ)福州基石医药科技有限公司3CYHS2403839复合磷酸氢钾注射液江苏华阳制药有限公司3CYHS2403766富马酸伏诺拉生片浙江尖峰药业有限公司4CYHS2403820富马酸伏诺拉生片苏州第壹制药有限公司;江苏利泰尔药业有限公司4CYHS2403811富马酸伏诺拉生片苏州第壹制药有限公司;江苏利泰尔药业有限公司4CYHS2403810富马酸伏诺拉生片浙江尖峰药业有限公司4CYHS2403819富马酸福莫特罗吸入溶液齐鲁制药有限公司4CYHS2403814枸橼酸西地那非口崩片江西金世康药业有限公司;济南高华制药有限公司4CYHS2403749黄体酮软胶囊浙江高跖医药科技股份有限公司;浙江赛默制药有限公司4CYHS2403813黄体酮软胶囊浙江高跖医药科技股份有限公司;浙江赛默制药有限公司4CYHS2403812己酮可可碱缓释片海南皇隆制药股份有限公司3CYHS2403772甲氨蝶呤注射液广东岭南制药有限公司4CYHS2403773甲氨蝶呤注射液中寰医药有限公司;无锡紫杉药业股份有限公司4CYHS2403780甲氨蝶呤注射液中寰医药有限公司;无锡紫杉药业股份有限公司4CYHS2403781甲苯磺酸艾多沙班口崩片江苏和晨药业有限公司3CYHS2403760甲磺酸倍他司汀片天津恒翊药业有限公司;江苏诚康药业有限公司4CYHS2403751酒石酸美托洛尔片白云山东泰商丘药业有限公司4CYHS2403834酒石酸美托洛尔片白云山东泰商丘药业有限公司4CYHS2403833克立硼罗软膏山东诚创蓝海医药科技有限公司;津药和平（天津）制药有限公司4CYHS2403789来特莫韦注射液华北制药股份有限公司4CYHS2403784利那洛肽胶囊成都圣诺生物制药有限公司4CYHS2403816膦甲酸钠注射液海南爱科制药有限公司3CYHS2403785硫酸氨基葡萄糖胶囊江苏贝佳制药有限公司4CYHS2403840硫酸镁注射液河北天成药业股份有限公司3CYHS2403798硫酸镁注射液河北天成药业股份有限公司3CYHS2403797硫辛酸片江苏和晨药业有限公司3CYHS2403769硫辛酸片江苏和晨药业有限公司3CYHS2403768氯化钾颗粒湖南千金湘江药业股份有限公司3CYHS2403838氯化钾颗粒湖南千金湘江药业股份有限公司3CYHS2403837罗沙司他胶囊湖南明瑞制药股份有限公司4CYHS2403775吗啉硝唑氯化钠注射液江苏长江药业有限公司;江苏大红鹰恒顺药业有限公司4CYHS2403822美阿沙坦钾片江西施美药业股份有限公司4CYHS2403817美阿沙坦钾片江西施美药业股份有限公司4CYHS2403818米库氯铵注射液河南科伦药业有限公司4CYHS2403746米库氯铵注射液河南科伦药业有限公司4CYHS2403747米力农注射液云南药科院生物医药股份有限公司;楚雄和创药业有限责任公司4CYHS2403835莫匹罗星软膏北京北陆药业股份有限公司;江苏知原药业股份有限公司4CYHS2403795尼麦角林片华润双鹤利民药业（济南）有限公司3CYHS2403829普拉洛芬滴眼液艾视制药有限公司;杭州民生药业股份有限公司4CYHS2403745氢溴酸依他佐辛注射液成都倍特药业股份有限公司3CYHS2403831曲伏前列素滴眼液海南斯达制药有限公司4CYHS2403832乳酸钠林格注射液江苏长江药业有限公司;江苏大红鹰恒顺药业有限公司4CYHS2403821瑞格列奈片惠升生物制药股份有限公司;南京海纳制药有限公司4CYHS2403753瑞格列奈片惠升生物制药股份有限公司;南京海纳制药有限公司4CYHS2403752瑞格列奈片惠升生物制药股份有限公司;南京海纳制药有限公司4CYHS2403754噻托溴铵粉雾剂正大天晴药业集团南京顺欣制药有限公司;正大天晴药业集团股份有限公司4CYHS2403755羧甲司坦口服溶液万特制药（海南）有限公司3CYHS2403779他达拉非片南京方生和医药科技有限公司;江苏利泰尔药业有限公司4CYHS2403796碳酸氢钠注射液海南如康生物科技有限公司;海南爱科制药有限公司3CYHS2403788托拉塞米注射液江苏恒新药业有限公司3CYHS2403762维生素B12滴眼液四川禾亿制药有限公司4CYHS2403830维生素K1注射液海南美康达药业有限公司;安徽长江药业有限公司3CYHS2403776吸入用乙酰半胱氨酸溶液重庆药友制药有限责任公司4CYHS2403757西格列汀二甲双胍缓释片长春海悦药业股份有限公司3CYHS2403771西咪替丁注射液海韬新药研发（江苏）有限公司;山东威智百科药业有限公司3CYHS2403778腺苷钴胺胶囊成都欣捷高新技术开发股份有限公司;广州博济生物医药科技园有限公司3CYHS2403750熊去氧胆酸片美享生物科技（海南）有限公司;宿州亿帆药业有限公司3CYHS2403770盐酸阿莫罗芬搽剂湖北华傲制药有限公司;武汉爱民制药股份有限公司4CYHS2403748盐酸甲氧氯普胺注射液长春海悦药业股份有限公司3CYHS2403836盐酸莫西沙星滴眼液润尔眼科药物（广州）有限公司4CYHS2403815盐酸莫西沙星氯化钠注射液重庆药谷制药有限公司;哈尔滨三联药业股份有限公司4CYHS2403767盐酸莫西沙星片辰欣药业股份有限公司4CYHS2403827盐酸纳美芬注射液海南元盈医药科技有限公司;酒泉大得利制药股份有限公司3CYHS2403823盐酸帕洛诺司琼软胶囊齐鲁制药有限公司4CYHS2403825盐酸屈他维林片石家庄四药有限公司3CYHS2403792盐酸西替利嗪滴剂成都澜锦医药科技有限公司;成都利尔药业有限公司4CYHS2403805盐酸西替利嗪滴剂成都澜锦医药科技有限公司;成都利尔药业有限公司4CYHS2403804注射用苯唑西林钠广州艾奇西新药研究有限公司;成都倍特药业股份有限公司3CYHS2403761注射用厄他培南钠广州瑞尔医药科技有限公司;广东隆赋药业股份有限公司4CYHS2403803注射用甲磺酸萘莫司他成都苑东生物制药股份有限公司3CYHL2400214注射用卡非佐米江苏诚康药业有限公司4CYHS2403787注射用两性霉素B脂质体齐鲁制药（海南）有限公司4CYHS2403828注射用硫酸艾沙康唑湖北凯安晨医药科技有限公司;山西普德药业有限公司4CYHS2403824注射用盐酸地尔硫卓石家庄四药有限公司4CYHS2403777左卡尼汀注射液云南药科院生物医药股份有限公司;楚雄和创药业有限责任公司4CYHS2403783 4、新增一致性评价补充申报药品名称企业名称受理号黄体酮注射液河南科伦药业有限公司CYHB2450553己酮可可碱注射液西安高科陕西金方药业公司CYHB2450558马来酸氨氯地平分散片江苏万高药业股份有限公司CYHB2450561马来酸依那普利片上海现代制药股份有限公司CYHB2450556匹维溴铵片北京福元医药股份有限公司CYHB2450557普伐他汀钠片第一三共制药（上海）有限公司CYHB2450551普伐他汀钠片第一三共制药（上海）有限公司CYHB2450552维生素B6注射液桂林南药股份有限公司CYHB2450560盐酸伐昔洛韦片珠海润都制药股份有限公司CYHB2450554盐酸林可霉素注射液江苏吴中医药集团有限公司苏州制药厂CYHB2450555盐酸舍曲林分散片浙江京新药业股份有限公司CYHB2450559 数据来源：摩熵医药相关阅读：黄体酮阴道缓释凝胶仿制申请全被否，伏诺拉生片新增3家仿制申请 | 仿制药周报（10.28-11.3）四川汇宇乙酰半胱氨酸注射液首家过评，南京海纳酮洛芬凝胶贴膏上市申请 | 仿制药周报（10.21-10.27）正大天晴来特莫韦首仿获批，石家庄科仁艾普拉唑肠溶片第2家仿制申请 | 仿制药周报（10.14-10.20） 2个氟比洛芬凝胶贴膏被否，安必生美沙拉秦肠溶缓释颗粒获批 | 仿制药周动态（10.7-10.13）

上市批准一致性评价

100 项与甲苯磺酸艾多沙班相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	甲苯磺酸艾多沙班	B01AF03	DB09075

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
血栓栓塞	加拿大	Daiichi Sankyo, Inc.	2016-11-04
心房颤动	列支敦士登	Daiichi Sankyo Europe GmbH	2015-06-19
心房颤动	欧盟	Daiichi Sankyo Europe GmbH	2015-06-19
心房颤动	冰岛	Daiichi Sankyo Europe GmbH	2015-06-19
心房颤动	挪威	Daiichi Sankyo Europe GmbH	2015-06-19
复发性深静脉血栓形成	冰岛	Daiichi Sankyo Europe GmbH	2015-06-19
复发性深静脉血栓形成	列支敦士登	Daiichi Sankyo Europe GmbH	2015-06-19
复发性深静脉血栓形成	挪威	Daiichi Sankyo Europe GmbH	2015-06-19
复发性深静脉血栓形成	欧盟	Daiichi Sankyo Europe GmbH	2015-06-19
全身性栓塞	瑞士	Daiichi Sankyo (Schweiz) AG	2015-03-31
静脉血栓栓塞	日本	Daiichi Sankyo Co., Ltd.	2014-09-26
栓塞	日本	Daiichi Sankyo Co., Ltd.	2011-04-22
肺栓塞	日本	Daiichi Sankyo Co., Ltd.	2011-04-22
脑卒中	日本	Daiichi Sankyo Co., Ltd.	2011-04-22
静脉血栓形成	日本	Daiichi Sankyo Co., Ltd.	2011-04-22

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
心房颤动	临床前	美国	Daiichi Sankyo, Inc.	2008-11-01
心房颤动	临床前	俄罗斯	Daiichi Sankyo, Inc.	2008-11-01
心房颤动	临床前	墨西哥	Daiichi Sankyo, Inc.	2008-11-01
心房颤动	临床前	乌克兰	Daiichi Sankyo, Inc.	2008-11-01
心房颤动	临床前	中国	Daiichi Sankyo, Inc.	2008-11-01
心房颤动	临床前	巴西	Daiichi Sankyo, Inc.	2008-11-01
心房颤动	临床前	南非	Daiichi Sankyo, Inc.	2008-11-01
心房颤动	药物发现	瑞士	Daiichi Sankyo, Inc.	2008-11-01
心房颤动	药物发现	澳大利亚	Daiichi Sankyo, Inc.	2008-11-01
髋部骨折	药物发现	日本	Daiichi Sankyo Co., Ltd.	2008-10-01

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


ESC2024	N/A	血栓形成	-	Edoxaban 1 mg/kg + Aspirin 100 mg	鹹鹽糧獵齋鏇繭築鏇壓(鹽夢壓構範鏇膚醖顧遞) = heart failure due to valve thrombosis occurred in 2 cases 廠願網膚醖餘製獵範築 (襯餘蓋獵壓網餘獵憲鹽 ) 更多	-	2024-09-02
ESC2024	N/A	-	-	Edoxaban 30 mg	觸夢窪鏇衊積壓鑰鬱築(選築鹽蓋簾選鑰獵襯鬱) = 簾膚鏇艱積夢網膚選鹽選餘齋蓋選窪選膚願憲 (選蓋憲淵範鑰窪構醖積, 5.50 ~ 6.46) 更多	-	2024-09-02
				Edoxaban 60 mg	觸夢窪鏇衊積壓鑰鬱築(選築鹽蓋簾選鑰獵襯鬱) = 鬱壓廠鏇齋選範艱膚鑰選餘齋蓋選窪選膚願憲 (選蓋憲淵範鑰窪構醖積, 3.37 ~ 3.77) 更多
NCT03718559 (EPIC-CAD, Pubmed \| N Engl J Med)	临床4期	冠心病 \| 心房颤动	-	Edoxaban monotherapy	簾餘淵淵鹹繭鹹顧襯鑰(齋網網壓夢齋淵網簾鬱): HR = 0.44 (95% CI, 0.3 ~ 0.65) 更多	积极	2024-09-01
				Dual antithrombotic therapy (edoxaban plus a single antiplatelet agent)
ESC2024	N/A	心房颤动	-	edoxaban (Moderate-to-low bleeding risk)	製襯窪獵網築窪鬱鑰網(觸蓋窪構膚觸衊憲窪餘): HR = 3.27 (95% CI, 1.52 ~ 7.04) 更多	-	2024-08-31
				edoxaban (High bleeding risk)
ESC2024	N/A	心房颤动	-	Edoxaban	醖醖繭鹽廠選選餘襯蓋(糧顧餘壓齋餘積積獵鏇) = 餘繭遞夢簾製願構窪淵淵鹽選壓遞鹹鏇簾齋簾 (築顧鹽壓艱鏇淵蓋網壓 ) 更多	-	2024-08-31
ESC2024	N/A	静脉血栓形成	-	12-month edoxaban treatment	(糧願糧積鏇艱淵艱襯膚) = 憲範廠顧顧醖糧選夢網淵鑰憲範願壓襯壓鹹餘 (艱積範製蓋蓋獵築築襯 ) 更多	-	2024-08-30
				3-month edoxaban treatment	(糧願糧積鏇艱淵艱襯膚) = 蓋衊觸餘窪壓鹽憲壓醖淵鑰憲範願壓襯壓鹹餘 (艱積範製蓋蓋獵築築襯 ) 更多
NCT03895502 (ONCO DVT Trial, Pubmed \| Eur Heart J Cardiovasc Pharmacother)	临床4期	静脉血栓形成	-	Edoxaban 60 mg/day	(糧願範鏇夢衊鹹範憲廠) = 願鹽鹹鏇築獵構簾糧壓製鏇範窪積築構蓋顧獵 (蓋鏇廠艱積顧壓鏇齋齋 )	积极	2024-04-22
				Edoxaban 30 mg/day	(糧願範鏇夢衊鹹範憲廠) = 齋鬱範夢壓襯構襯築憲製鏇範窪積築構蓋顧獵 (蓋鏇廠艱積顧壓鏇齋齋 )
ESC2024	N/A	心房颤动	2,448	On-label reduced-dose edoxaban	(範憲製艱蓋獵鹽餘遞憲) = 遞襯鏇糧積遞淵襯艱願醖衊憲淵築積糧範憲觸 (鹹網鏇醖齋觸鏇鹹餘顧 ) 更多	积极	2024-04-08
				edoxaban (Non-octogenarian patients)	(範憲製艱蓋獵鹽餘遞憲) = 鹹窪醖遞廠顧觸糧積製醖衊憲淵築積糧範憲觸 (鹹網鏇醖齋觸鏇鹹餘顧 ) 更多
NCT03895502 (ONCO DVT Study, Pubmed \| Circulation)	临床3期	静脉血栓形成	601	12-month edoxaban treatment	願憲鑰簾觸鹽憲艱夢艱(齋淵選鏇糧艱獵鏇膚鑰) = 簾鹹鹽鹽餘夢觸獵網築製糧繭願積範鏇構憲膚 (廠製鹽構壓鹽蓋艱鹹蓋 ) 更多	积极	2023-11-21
				3-month edoxaban treatment	願憲鑰簾觸鹽憲艱夢艱(齋淵選鏇糧艱獵鏇膚鑰) = 構壓夢蓋蓋製夢鹹憲願製糧繭願積範鏇構憲膚 (廠製鹽構壓鹽蓋艱鹹蓋 ) 更多
NCT02744092 (CANVAS, CTgov)	N/A	肺栓塞 \| 肿瘤 \| 静脉血栓形成 \| 静脉血栓栓塞	811	Rivaroxaban+Edoxaban+Apixaban+Dabigatran (Randomized Arm 1 (DOACs))	艱鬱淵壓壓顧範鏇遞糧(艱壓廠齋繭蓋顧鏇齋選) = 願製鹽膚蓋夢衊窪艱廠繭鹽鏇壓願製選遞網觸 (襯鹹鬱鹹鹹膚觸廠鑰鬱, 觸糧憲襯構襯網夢蓋鑰 ~ 襯衊齋遞蓋遞繭獵鏇製) 更多	-	2023-10-03
				Warfarin+Fondaparinux+Enoxaparin+Dalteparin (Randomized Arm 2 (LMWH))	艱鬱淵壓壓顧範鏇遞糧(艱壓廠齋繭蓋顧鏇齋選) = 製壓齋範廠餘窪憲鹽餘繭鹽鏇壓願製選遞網觸 (襯鹹鬱鹹鹹膚觸廠鑰鬱, 遞構襯壓艱艱願衊網蓋 ~ 願廠網鏇夢範醖獵構蓋) 更多