A Phase III/IV Factorial Randomized Double-blind Trial to Compare the Addition of Dapagliflozin vs Placebo and Rosuvastatin/Ezetimibe Versus Pitavastatin in Patients With HIV on Integrase Strand Transfer Inhibitor-based Antiretrovirals With Elevated Metabolic Risk

People with HIV are at a higher risk of cardiovascular diseases (CVD) due to the effects of the virus and its treatment. Integrase strand transfer inhibitors (INSTIs), a common HIV treatment, are associated with increased CVD risk and metabolic issues, such as weight gain and high blood pressure. Sodium-glucose cotransporter 2 (SGLT2) inhibitors, however, have been working well in reducing CVD events and hospitalizations due to heart failure, irrespective of diabetes presence. They also help in reducing weight and blood pressure. Pitavastatin has shown to work in lowering CVD events in people with HIV, but its availability is limited. This benefit is thought to be common to all statins, but this has not yet been confirmed. This study will examine the impact of dapagliflozin vs. placebo on metabolic parameters in people with HIV with high metabolic risk who are on INSTI-based ART.

开始日期2024-08-01

申办/合作机构

Kirby Institute

NCT06450366 / Not yet recruiting临床3期

A Phase 3, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of MK-0616 Compared With Ezetimibe or Bempedoic Acid or Ezetimibe and Bempedoic Acid in Adults With Hypercholesterolemia

The main purpose of this study is to assess whether MK-0616 is superior to ezetimibe or bempedoic acid or ezetimibe + bempedoic acid in reducing LDL-C in participants with hypercholesterolemia, and to evaluate its safety and tolerability. The primary study hypotheses are MK-0616 is superior to ezetimibe, bempedoic acid, and ezetimibe + bempedoic acid on mean percent change from baseline in LDL-C at week 8.

开始日期2024-07-15

申办/合作机构

Merck Sharp & Dohme LLC

CTR20241438 / RecruitingN/A

依折麦布片人体生物等效性研究

本试验旨在研究健康受试者单次空腹和餐后口服由华润赛科药业有限责任公司研制、生产的依折麦布片（10 mg）的药代动力学特征；以MSD International GmbH（Singapore Branch）生产的依折麦布片（益适纯®，10 mg）为参比制剂，比较两制剂中药动学参数Cmax、AUC0-t、AUC0-∞，评价两制剂的人体生物等效性，并观察两制剂在健康受试者中的安全性。

开始日期2024-05-08

申办/合作机构

华润赛科药业有限责任公司

100 项与依折麦布相关的临床结果

登录后查看更多信息

100 项与依折麦布相关的转化医学

登录后查看更多信息

100 项与依折麦布相关的专利（医药）

登录后查看更多信息

3,973

项与依折麦布相关的文献（医药）

2024-03-01·Journal of pharmaceutical and biomedical analysis

A study on cholesterol-cholesteryl ester metabolic homeostasis and drug intervention in hyperlipidemic hamsters using UHPLC-MS/MS

Article

作者: Wang, Zhiquan ; Zheng, Bowen ; Wang, Zhe ; Zhang, Jinlan ; Lin, Miao

Hyperlipidemia is a global metabolic disorder characterized by dysregulation of lipid metabolism. This dysregulation is closely associated with the altered homeostasis of cholesterol-cholesteryl ester (CE) metabolism in systemic circulation, and some organs. Additionally, the relationship between oxidized cholesteryl ester (oxCE) and the disease has also gained attention. Currently, there is a lack of comprehensive research on the alterations in cholesterol-CE metabolism in the context of hyperlipidemia, as well as the characteristics of lipid-lowering agents in regulating this metabolic state. Therefore, 40 oxCEs were identified in the hamster liver sample, and novel ultrahigh performance liquid chromatography-tandem mass spectrometry (UHPLC-MS/MS) methods were established for simultaneous analysis of cholesterol, 57 CEs, and 40 oxCEs in the serum, liver, adipose tissue, and intestine of hyperlipidemic hamsters. This study investigated the metabolic alterations between cholesterol-CE/oxCE in hyperlipidemic hamsters and those treated with lipid-lowering agents, including the Niemann-Pick-C1 like-1 protein (NPC1L1) inhibitor ezetimibe and the acyl coenzyme A: cholesterol acyltransferase (ACAT) inhibitor avasimibe. The study findings demonstrate metabolic disorders in cholesterol-CE/oxCE homeostasis in hyperlipidemic hamsters. Lipid-lowering agent therapy can improve the metabolic dysregulation caused by hyperlipidemia, with distinct characteristics: ezetimibe is more effective in reducing cholesterol, while avasimibe is more effective in reducing CEs/oxCEs. Eight potential biomarkers indicating the dysregulation of cholesterol-CE metabolism caused by hyperlipidemia and its improvement by lipid-lowering agents have been identified in the serum. This study offers new insights into the hyperlipidemia pathophysiology and the mechanisms of lipid-lowering agents from a novel perspective on cholesterol-CE/oxCE metabolic homeostasis.

2024-03-01·Indian heart journal

Traditional and novel non-statin lipid-lowering drugs

Review

作者: Jain, Peeyush

Non-statin drugs find utility in the management of dyslipidaemia in mixed dyslipidaemia, patients with statin intolerance, and when guidelines directed low-density lipoprotein cholesterol (LDL-C) target cannot be achieved despite maximally tolerated statin. The most definite indication of fenofibrate monotherapy is fasting serum triglyceride >500 mg/dl to reduce the risk of acute pancreatitis It offers a modest reduction in cardiovascular events. The statin-ezetimibe combination is commonly used for lipid lowering particularly after ACS. Fish oils reduce serum triglycerides by about 25 %. EPA (and not DHA) seems to have cardioprotective effects. Despite cardiovascular outcome benefits, bile-exchange resins have limited use due to poor tolerance. Bempedoic acid added to maximally tolerated statin therapy is approved to lower LDL-C in adults with primary hypercholesterolemia or mixed dyslipidaemias, HeFH, in patients with ASCVD who require additional lowering of LDL-C, and in patients who are statin-intolerant. Inclisiran is a long-acting double-stranded small interfering RNA (siRNA) that inhibits the transcription of PCSK-9 leading to a decrease in PCSK9 generation in hepatocytes and an increase in LDL receptor expression in the liver cell membrane leading to about 50 % reduction in serum LDL-C levels. Lomitapide lowers plasma levels of all ApoB-containing lipoproteins, including VLDL, LDL, and chylomicrons by inhibiting the enzyme microsomal triglyceride transfer protein (MTP) and approved for the treatment of adult patients with homozygous familial hypercholesterolemia (HoFH). Close monitoring for hepatotoxicity is required. Mipomersen is a single-stranded synthetic antisense oligonucleotide (ASO) that affects the production and secretion of apoB-containing lipoproteins with demonstrated efficacy in both homozygous and heterozygous FH patients. It is approved for restricted use due to risk of hepatotoxicity. Pelacarsen is an antisense oligonucleotide that reduces the production of apo(a) in the liver.

2024-03-01·Annals of vascular surgery

Update About the Management of Low-Density Lipoprotein Cholesterol and Hypertriglyceridemia in Lower Extremity Peripheral Artery Disease Patients: Consensus of the French Society of Vascular Medicine and the French Society for Vascular and Endovascular Surgery

Article

作者: Pernod, Gilles ; Gaertner, Sébastien ; Ezzaki, Khalil ; Lejay, Anne ; Picquet, Jean ; Tribout, Laurent ; Boge, Gudrun ; Chleir, Franck ; Magnou, Betty ; Loric, Tiphanie ; Lanéelle, Damien ; Mounier-Vehier, Claire ; Tissot, Anne ; Hertault, Adrien ; Feugier, Patrick ; Behar, Thomas ; Moukarzel, Alain ; Lacroix, Philippe ; Zarca, Charles ; Nasr, Bahaa ; Kaladji, Adrien ; Brisot, Dominique ; Soudet, Simon ; Gaudout, Céline ; Elias, Marie ; Zuber, Anne ; Bérard, Xavier ; Detriché, Grégoire ; Wautrecht, Jean-Claude ; Laffont, Joëlle ; Maillard, Jean-Patrick ; Fiori, Sandrine ; Georg, Yannick ; Bura-Rivière, Alessandra ; Madika, Anne-Laure ; Chakfé, Nabil ; Perez-Martin, Antonia ; Gaillard, Catherine ; Sabatier, Jean ; Nelzy, Marie-Line ; Mahé, Guillaume ; Laroche, Jean-Pierre ; Le Hello, Claire ; Bonnin, Christophe ; Phelipot, Jacques-Yves ; Goueffic, Yann ; Choquenet, Clarisse ; Nicolini, Philippe ; Coscas, Raphael ; Constans, Joël ; Jean-Baptiste, Elixène ; Miserey, Gilles ; Malloizel-Delaunay, Julie ; Breteau, Christophe ; Gauthier, Charles-Emmanuel ; Sprynger, Muriel

BACKGROUND:

A French intersociety consensus on behalf the Société Française de Médecine Vasculaire and the Société de Chirurgie Vasculaire et Endovasculaire was proposed in 2021 for the management of patients with lower extremity peripheral artery disease (LEAD). Recent studies have been published and an update of this consensus about the management of low-density lipoprotein cholesterol (LDLc) and hypertriglyceridemia was required.

METHODS:

A steering committee of 12 vascular physicians and surgeons defined questions of interest about LDLc and hypertriglyceridemia management. A French expert panel voted the proposals. Consensus was considered to have been achieved if more than 80% of the responses corresponded to either "Agreement" or "Disagreement".

RESULTS:

Among the 56 experts who were asked to participate, 46 (82%) accepted. After the first round of the Delphi procedure, the 4 proposals reached consensus. The following suggestions and recommendations were approved: 1. For LEAD patients treated by the highest tolerated statin dose ± ezetimibe and who have an LDLc ≥0.70 g/L, we recommend adding a proprotein convertase subtilisin/kexin type 9 inhibitor. 2. For LEAD patients treated by statin and who have elevated triglyceride level between ≥150 mg/dL and ≤500 mg/dL, we suggest adding Icosapent Ethyl. 3. Before adding Icosapent Ethyl in LEAD patients treated with statin, we suggest looking for symptoms that may suggest atrial fibrillation. 4. For LEAD patients treated by Icosapent Ethyl and who have symptoms that suggest atrial fibrillation, we recommend performing an electrocardiogram.

CONCLUSIONS:

This update will help clinicians to improve LEAD patient management.

225

项与依折麦布相关的新闻（医药）

2024-06-11

·GlobeNewswire-Health Care

NewAmsterdam Pharma Announces Issuance of Composition of Matter Patent for Obicetrapib by the United States Patent and Trademark Office

-- New patent extends patent term for obicetrapib until July 2043 -- NAARDEN, the Netherlands and MIAMI, June 11, 2024 (GLOBE NEWSWIRE) -- NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS or “NewAmsterdam” or the “Company”), a late-stage, clinical biopharmaceutical company developing oral, non-statin medicines for patients at risk of cardiovascular disease (“CVD”) with elevated low-density lipoprotein cholesterol (“LDL-C”), for whom existing therapies are not sufficiently effective or well-tolerated, today announced that the United States Patent and Trademark Office (“USPTO”) has issued U.S. Patent No. 12,006,305, titled “Salts of Obicetrapib and Processes for their Manufacture and Intermediates Thereof.” The newly issued patent contains claims covering amorphous obicetrapib hemicalcium, the solid form that will be used in the Company’s products and will be listed in the FDA’s “Orange Book” as a drug substance patent, if any such products are approved. The issuance of this composition of matter patent provides intellectual property (“IP”) protection for obicetrapib until July 2043. The USPTO has now issued or allowed a total of nine patents covering obicetrapib and its uses. “We are excited to announce that obicetrapib has been granted our third-generation composition of matter patent by the USPTO, which extends obicetrapib’s IP protection and exclusivity until July 2043, more than 9 years beyond our previous second-generation patent expiration in 2034,” said Michael Davidson, M.D., Chief Executive Officer of NewAmsterdam. “There continues to be a need for a safe, efficacious, oral, and potent LDL-lowering therapy. Securing robust patent protection for obicetrapib enables us both to continue the execution of multiple ongoing pivotal Phase 3 trials, as well as reap the potential benefits of obicetrapib’s scientific innovation years beyond potential FDA approval.” About Obicetrapib Obicetrapib is a novel, oral, low-dose CETP inhibitor that NewAmsterdam is developing to overcome the limitations of current LDL-lowering treatments. In each of the Company’s Phase 2 trials, ROSE2, TULIP, ROSE, and OCEAN, evaluating obicetrapib as monotherapy or combination therapy, the Company observed statistically significant LDL-lowering combined with a side effect profile similar to that of placebo. The Company is conducting two Phase 3 pivotal trials, BROADWAY and BROOKLYN, to evaluate obicetrapib as a monotherapy used as an adjunct to maximally tolerated lipid-lowering therapies to provide additional LDL-lowering for CVD patients and TANDEM, to evaluate obicetrapib and ezetimibe as a fixed-dose combination. The Company began enrolling patients in BROADWAY in January 2022, in BROOKLYN in July 2022, and in TANDEM in March 2024; completing enrollment of BROOKLYN in April 2023 and BROADWAY in July 2023. The Company also commenced the Phase 3 PREVAIL cardiovascular outcomes trial in March 2022, which is designed to assess the potential of obicetrapib to reduce occurrences of major adverse cardiovascular events, including cardiovascular death, non-fatal myocardial infarction, non-fatal stroke and non-elective coronary revascularization. NewAmsterdam completed enrollment of PREVAIL in April 2024 and randomized over 9,500 patients. About NewAmsterdam NewAmsterdam Pharma (Nasdaq: NAMS) is a late-stage biopharmaceutical company whose mission is to improve patient care in populations with metabolic diseases where currently approved therapies have not been adequate or well tolerated. We seek to fill a significant unmet need for a safe, well-tolerated and convenient LDL-lowering therapy. In multiple phase 3 studies, NewAmsterdam is investigating obicetrapib, an oral, low-dose and once-daily CETP inhibitor, alone or as a fixed-dose combination with ezetimibe, as LDL-C lowering therapies to be used as an adjunct to statin therapy for patients at risk of CVD with elevated LDL-C, for whom existing therapies are not sufficiently effective or well tolerated. Forward-Looking Statements Certain statements included in this document that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements generally are accompanied by words such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “would,” “plan,” “predict,” “potential,” “seem,” “seek,” “future,” “outlook” and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements regarding the Company’s intellectual property and its ability to enforce, and sufficiency of, its patents, business and strategic plans, the Company’s commercial opportunity, the therapeutic and curative potential of the Company’s product candidate, the Company’s clinical trials and the timing for enrolling patients, the timing and forums for announcing data, the achievement and timing of regulatory approvals, and plans for commercialization. These statements are based on various assumptions, whether or not identified in this document, and on the current expectations of the Company’s management and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as and must not be relied on as a guarantee, an assurance, a prediction, or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and may differ from assumptions. Many actual events and circumstances are beyond the control of the Company. These forward-looking statements are subject to a number of risks and uncertainties, including changes in domestic and foreign business, market, financial, political, and legal conditions; risks related to the approval of the Company’s product candidate and the timing of expected regulatory and business milestones, including potential commercialization; ability to negotiate definitive contractual arrangements with potential customers; the impact of competitive product candidates; ability to obtain sufficient supply of materials; global economic and political conditions, including the Russia-Ukraine and Israel-Hamas conflict; the effects of competition on the Company’s future business; and those factors described in the Company’s public filings with the Securities Exchange Commission. Additional risks related to the Company’s business include, but are not limited to: uncertainty regarding outcomes of the Company’s ongoing clinical trials, particularly as they relate to regulatory review and potential approval for its product candidate; risks associated with the Company’s efforts to commercialize a product candidate; the Company’s ability to negotiate and enter into definitive agreements on favorable terms, if at all; the impact of competing product candidates on the Company’s business; intellectual property related claims; the Company’s ability to attract and retain qualified personnel; ability to continue to source the raw materials for its product candidate. If any of these risks materialize or the Company’s assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. There may be additional risks that the Company does not presently know or that the Company currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. In addition, forward-looking statements reflect the Company’s expectations, plans, or forecasts of future events and views as of the date of this document and are qualified in their entirety by reference to the cautionary statements herein. The Company anticipates that subsequent events and developments may cause the Company’s assessments to change. These forward-looking statements should not be relied upon as representing the Company’s assessment as of any date subsequent to the date of this communication. Accordingly, undue reliance should not be placed upon the forward-looking statements. Neither the Company nor any of its affiliates undertakes any obligation to update these forward-looking statements, except as may be required by law. Company ContactMatthew PhilippeP: 1-917-882-7512matthew.philippe@newamsterdampharma.com Media ContactSpectrum Science on behalf of NewAmsterdamBryan BlatsteinP: 1-917-714-2609bblatstein@spectrumscience.com Investor ContactPrecision AQ on behalf of NewAmsterdamAustin MurtaghP: 1-212-698-8696Austin.Murtagh@precisionaq.com

临床3期临床结果AHA会议临床2期

2024-06-07

·GlobeNewswire-Health Care

NewAmsterdam Pharma Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

NAARDEN, the Netherlands and MIAMI, June 07, 2024 (GLOBE NEWSWIRE) -- NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS or “NewAmsterdam” or the “Company”), a late-stage, clinical biopharmaceutical company developing oral, non-statin medicines for patients at risk of cardiovascular disease (“CVD”) with elevated low-density lipoprotein cholesterol (“LDL-C”), for whom existing therapies are not sufficiently effective or well-tolerated, today announced that the Compensation Committee of NewAmsterdam’s Board of Directors approved the grant of inducement share options covering an aggregate of 90,000 of NewAmsterdam’s ordinary shares to five non-executive new hires. The share options were granted as an inducement material to the employees’ acceptance of employment with NewAmsterdam pursuant to the NewAmsterdam Pharma Company N.V. 2024 Inducement Plan (the “2024 Inducement Plan”) and in accordance with Nasdaq Listing Rule 5635(c)(4). The share options have an exercise price per share equal to $18.92, which represents the closing market price on the Nasdaq Stock Market of the Company’s ordinary shares on, June 3, 2024, the grant date. The shares subject to the options will vest over four years, with 25% of the shares vesting on the one-year anniversary of the applicable vesting commencement date and the balance of the shares vesting in a series of 36 equal monthly installments thereafter, subject to each employee’s continued service with NewAmsterdam on such vesting dates. The options are subject to the terms and conditions of the 2024 Inducement Plan and the terms and conditions of an option award agreement covering the grant. About NewAmsterdamNewAmsterdam Pharma (Nasdaq: NAMS) is a late-stage biopharmaceutical company whose mission is to improve patient care in populations with metabolic diseases where currently approved therapies have not been adequate or well tolerated. We seek to fill a significant unmet need for a safe, well-tolerated and convenient LDL-lowering therapy. In multiple phase 3 studies, NewAmsterdam is investigating obicetrapib, an oral, low-dose and once-daily CETP inhibitor, alone or as a fixed-dose combination with ezetimibe, as LDL-C lowering therapies to be used as an adjunct to statin therapy for patients at risk of CVD with elevated LDL-C, for whom existing therapies are not sufficiently effective or well tolerated. Company ContactMatthew PhilippeP: 1-917-882-7512matthew.philippe@newamsterdampharma.com

临床3期

2024-06-03

·信狐药迅

仿制药申请6个品规发通知件；临床申请品种均默示许可| 新获批（5.27-6.2）

每周药品注册获批数据，分门别类呈现，一目了然。(5.27-6.2）小编收到有些用户反应，不想收到咱们每周文章的推送提醒，而有些用户又特别需要这个提醒，在小编强烈要求下，我们给力的程序员终于实现了可以关闭提醒的功能，这个绝对全网独一家喔，不想收到提醒的，只要在信狐药迅对话框内回复关键词“拒收文章提醒”，那么就可以不受推送的打扰啦!新药上市申请药品名称企业注册分类受理号依沃西单抗注射液康方赛诺医药有限公司1CXSS2300061地舒单抗注射液山东博安生物技术股份有限公司3.3CXSS2300014精蛋白锌赖脯胰岛素混合注射液(50R)江苏万邦生化医药集团有限责任公司3.3CXSS2200071国;CXSS2200071人凝血酶原复合物深圳市卫光生物制品股份有限公司3.4CXSS2200091国;CXSS2200091新药临床申请药品名称企业注册分类受理号盐酸杰克替尼片苏州泽璟生物制药股份有限公司1CXHL2400298盐酸杰克替尼片苏州泽璟生物制药股份有限公司1CXHL2400297盐酸希美替尼片中国科学院上海药物研究所1CXHL2400288D-1553片益方生物科技(上海)股份有限公司1CXHL2400287ABP1618片上海爱博医药科技有限公司1CXHL2400285ABP1618片上海爱博医药科技有限公司1CXHL2400284FC084CSA片中山医诺维申新药研发有限公司1CXHL2400283FC084CSA片中山医诺维申新药研发有限公司1CXHL2400282替古索司他片信达生物制药(苏州)有限公司1CXHL2400278替古索司他片信达生物制药(苏州)有限公司1CXHL2400277替古索司他片信达生物制药(苏州)有限公司1CXHL2400276盐酸安罗替尼胶囊正大天晴药业集团股份有限公司2.4CXHL2400295盐酸安罗替尼胶囊正大天晴药业集团股份有限公司2.4CXHL2400294盐酸安罗替尼胶囊正大天晴药业集团股份有限公司2.4CXHL2400293吸入用盐酸溴己新溶液江苏正大清江制药有限公司3CYHL2400062吸入用盐酸溴己新溶液江苏正大清江制药有限公司3CYHL2400061酒石酸匹莫范色林胶囊江苏艾立康医药科技有限公司3CYHL2400060拉米地坦片江苏恩华药业股份有限公司3CYHL2400059拉米地坦片江苏恩华药业股份有限公司3CYHL2400058氟比洛芬凝胶贴膏浙江百代医药科技有限公司4CYHL2400057注射用重组酰化胰高血糖素样肽2类似物重庆派金生物科技有限公司1CXSL2400204注射用DB-1305映恩生物制药(苏州)有限公司1CXSL2400196DP303c注射液石药集团巨石生物制药有限公司1CXSL2400195DP303c注射液石药集团巨石生物制药有限公司1CXSL2400194贝伐珠单抗注射液百奥泰生物制药股份有限公司2.2CXSL2400202贝伐珠单抗注射液百奥泰生物制药股份有限公司2.2CXSL2400201仿制药申请药品名称企业注册分类受理号阿瑞匹坦注射液江苏康禾生物制药有限公司3CYHS2302273盐酸丙美卡因滴眼液合肥立方制药股份有限公司3CYHS2301650注射用拉氧头孢钠江苏江丰医药科技有限公司3CYHS2300871左氧氟沙星注射液河北天成药业股份有限公司3CYHS2300402左氧氟沙星注射液河北天成药业股份有限公司3CYHS2300401注射用青霉素钠成都天之翼尚品医药科技有限公司3CYHS2300019国;CYHS2300019注射用青霉素钠成都天之翼尚品医药科技有限公司3CYHS2300018国;CYHS2300018注射用青霉素钠成都天之翼尚品医药科技有限公司3CYHS2300017国;CYHS2300017左氧氟沙星注射液国仁健康制药(北京)有限公司3CYHS2202080国;CYHS2202080醋酸维持液南京恩泰医药科技有限公司3CYHS2201921国;CYHS2201921醋酸维持液南京恩泰医药科技有限公司3CYHS2201920国;CYHS2201920地氯雷他定口服溶液锦州奥鸿药业有限责任公司3CYHS2201876盐酸氨溴索滴剂北京民康百草医药科技有限公司3CYHS2201643国;CYHS2201643阿立哌唑口服溶液沈阳天邦药业有限公司3CYHS2201311国;CYHS2201311铝碳酸镁混悬液浙江寰领医药科技有限公司3CYHS2201322国;CYHS2201322奥硝唑片福安药业集团烟台只楚药业有限公司3CYHS2201100国;CYHS2201100多种微量元素注射液(I)洋浦京泰药业有限公司3CYHS2200906国;CYHS2200906阿立哌唑口腔崩解片瑞阳制药股份有限公司3CYHS2200439国;CYHS2200439吸入用布地奈德混悬液艾特美(苏州)医药科技有限公司4CYHS2302443氧武汉润桦辉氧气气瓶检验有限责任公司4CYHS2301933普拉洛芬滴眼液广东华南药业集团有限公司4CYHS2300908多索茶碱注射液山东鲁抗医药集团赛特有限责任公司4CYHS2300616硝酸异山梨酯注射液山东新时代药业有限公司4CYHS2300442马昔腾坦片上海上药睿尔药品有限公司4CYHS2300472乙酰半胱氨酸颗粒河北龙海药业有限公司4CYHS2300348骨化三醇软胶囊四川科伦药业股份有限公司4CYHS2300302乙酰半胱氨酸颗粒四川海梦智森生物制药有限公司4CYHS2300251乙酰半胱氨酸颗粒四川海梦智森生物制药有限公司4CYHS2300250拉考沙胺注射液舒美奇成都生物科技有限公司4CYHS2300206拉考沙胺注射液舒美奇成都生物科技有限公司4CYHS2300205盐酸多柔比星脂质体注射液齐鲁制药(海南)有限公司4CYHS2300202盐酸多柔比星脂质体注射液齐鲁制药(海南)有限公司4CYHS2300201他达拉非片江西施美药业股份有限公司4CYHS2300217他达拉非片江西施美药业股份有限公司4CYHS2300216他达拉非片江西施美药业股份有限公司4CYHS2300215他克莫司颗粒杭州中美华东制药有限公司4CYHS2300146他达拉非片浙江康恩贝制药股份有限公司4CYHS2300061依折麦布片山东丹红制药有限公司4CYHS2300031国;CYHS2300031吡仑帕奈片江苏康缘药业股份有限公司4CYHS2202172国;CYHS2202172吡仑帕奈片江苏康缘药业股份有限公司4CYHS2202171国;CYHS2202171硫酸羟氯喹片苏州长征-欣凯制药有限公司4CYHS2202067国;CYHS2202067恩他卡朋片福建省宝诺医药研发有限公司4CYHS2202051国;CYHS2202051磷酸特地唑胺片齐鲁制药(海南)有限公司4CYHS2202036国;CYHS2202036间苯三酚注射液亚宝药业集团股份有限公司4CYHS2202024国;CYHS2202024他达拉非片好医生药业集团有限公司4CYHS2202010国;CYHS2202010卡贝缩宫素注射液海南中和药业股份有限公司4CYHS2201993国;CYHS2201993非布司他片涿州东乐制药有限公司4CYHS2201938国;CYHS2201938孟鲁司特钠颗粒山东华铂凯盛生物科技有限公司4CYHS2201928国;CYHS2201928甲磺酸雷沙吉兰片浙江华海药业股份有限公司4CYHS2201914国;CYHS2201914马来酸茚达特罗吸入粉雾剂健康元药业集团股份有限公司4CYHS2201835国;CYHS2201835注射用唑来膦酸浓溶液山东新时代药业有限公司4CYHS2201794国;CYHS2201794盐酸昂丹司琼注射液石家庄四药有限公司4CYHS2201678国;CYHS2201678盐酸昂丹司琼注射液石家庄四药有限公司4CYHS2201677国;CYHS2201677盐酸奥洛他定滴眼液艾尔健康眼药(辽宁)有限公司4CYHS2201628国;CYHS2201628醋酸加尼瑞克注射液深圳翰宇药业股份有限公司4CYHS2201612国;CYHS2201612酒石酸溴莫尼定滴眼液艾尔健康眼药(辽宁)有限公司4CYHS2201598国;CYHS2201598甲钴胺片浙江京新药业股份有限公司4CYHS2201586国;CYHS2201586西格列汀二甲双胍片(II)惠升生物制药股份有限公司4CYHS2201496国;CYHS2201496西格列汀二甲双胍片(I)惠升生物制药股份有限公司4CYHS2201495国;CYHS2201495注射用氯诺昔康知和(山东)大药厂有限公司4CYHS2201438国;CYHS2201438枸橼酸坦度螺酮片江苏百奥信康医药科技有限公司4CYHS2201415国;CYHS2201415熊去氧胆酸胶囊绍兴来多科技有限公司4CYHS2201412国;CYHS2201412盐酸莫西沙星滴眼液广州仁恒医药科技股份有限公司4CYHS2201299国;CYHS2201299注射用哌拉西林钠他唑巴坦钠福安药业集团庆余堂制药有限公司4CYHS2201229国;CYHS2201229注射用哌拉西林钠他唑巴坦钠福安药业集团庆余堂制药有限公司4CYHS2201228国;CYHS2201228注射用哌拉西林钠他唑巴坦钠福安药业集团庆余堂制药有限公司4CYHS2201226国;CYHS2201226头孢地尼胶囊海南日中天制药有限公司4CYHS2201279国;CYHS2201279酒石酸美托洛尔片翎耀生物科技(上海)有限公司4CYHS2201191国;CYHS2201191酒石酸美托洛尔片翎耀生物科技(上海)有限公司4CYHS2201190国;CYHS2201190碳酸镧咀嚼片仁合益康集团有限公司4CYHS2201134国;CYHS2201134碳酸镧咀嚼片仁合益康集团有限公司4CYHS2201133国;CYHS2201133盐酸达泊西汀片瑞阳制药股份有限公司4CYHS2201132国;CYHS2201132盐酸达泊西汀片瑞阳制药股份有限公司4CYHS2201131国;CYHS2201131吡仑帕奈片西安远大科创医药科技有限公司4CYHS2201092吡仑帕奈片西安远大科创医药科技有限公司4CYHS2201091头孢克洛干混悬剂苏州第三制药厂有限责任公司4CYHS2200891国;CYHS2200891缬沙坦氨氯地平片(Ⅰ)宁波科尔康美诺华药业有限公司4CYHS2200835国;CYHS2200835钆贝葡胺注射液上海司太立制药有限公司4CYHS2200367国;CYHS2200367丙酸氟替卡松雾化吸入用混悬液上海方予健康医药科技有限公司4CYHS2200372国;CYHS2200372甲钴胺片北京春风药业有限公司4CYHS2102249国;CYHS2102249进口申请药品名称企业注册分类受理号盐酸替洛利生片Bioprojet Pharma5.1JXHS2300058盐酸替洛利生片Bioprojet Pharma5.1JXHS2300057醋酸氟氢可的松片ASPEN PHARMA TRADING LIMITED5.1JXHS2300033依西美坦片Cipla Ltd.5.2JYHS2200048国;JYHS2200048达格列净片M/s Cipla Ltd.5.2JYHS2101019国;JYHS2101019Balcinrenone达格列净胶囊AstraZeneca AB1JXHL2400064Balcinrenone达格列净胶囊AstraZeneca AB1JXHL2400063TAR-210Janssen Research & Development, LLC2.2;2.4JXHL2400065呼吸道合胞病毒减毒活疫苗Sanofi Pasteur Inc.1.1JXSL2400058MK-7240注射用浓溶液Merck Sharp & Dohme LLC1JXSL2400063MK-7240注射液Merck Sharp & Dohme LLC1JXSL2400062BudigalimabAbbVie Inc.1JXSL2400061中药相关申请药品名称企业注册分类受理号柴桂解感颗粒山东中医药大学1.1CXZL2400016温肺定喘颗粒山东康众宏医药科技开发有限公司1.1CXZL2400015注：橙色字体部分结论为不批准或收到通知件；

申请上市临床申请生物类似药

100 项与依折麦布相关的药物交易

登录后查看更多信息

外链

KEGG	Wiki	ATC	Drug Bank
D01966	依折麦布	C10AX09	DB00973

研发状态

批准上市

10 条最早获批的记录,

后查看更多信息

适应症	国家/地区	公司	日期
纯合子家族性高胆固醇血症	美国	Organon & Co.	2002-10-25
原发性高胆固醇血症	美国	Organon & Co.	2002-10-25
谷甾醇血症	美国	Organon & Co.	2002-10-25

未上市

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
高胆固醇血症	临床3期	加拿大	Schering-Plough Corp.	2007-08-01
高胆固醇血症	临床3期	加拿大	Merck Frosst Canada Ltd.	2007-08-01
高胆固醇血症	临床3期	加拿大	Sunnybrook Health Sciences Centre	2007-08-01
杂合子家族性高胆固醇血症	临床3期	-	Organon & Co.	2005-08-01
动脉粥样硬化	临床3期	-	Organon & Co.	2003-05-01
冠心病	临床3期	-	Organon & Co.	2003-05-01
家族性混合型高脂血症	临床3期	-	Organon & Co.	2002-12-01
高甘油三酯血症	临床3期	-	Organon & Co.	2002-12-01
纯和子谷甾醇血症	临床3期	-	Organon & Co.	2002-07-01
II型高脂蛋白血症	临床3期	-	Organon & Co.	2002-07-01

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04638400 (CTgov)	临床4期	动脉粥样硬化 \| 肥胖 \| 高胆固醇血症 ... 更多	10	Simvastatin 40mg (Simvastatin)	製衊繭遞鏇廠膚蓋繭觸(鏇鑰憲餘廠壓衊壓顧鏇) = 淵積鏇蓋構顧鏇遞範獵範膚蓋簾遞顧繭遞壓齋 (獵壓夢鹹襯齋窪獵築網, 鹹鹽築遞獵積醖構鹹淵 ~ 網網衊簾衊衊窪鬱廠糧) 更多	-	2024-01-23
				Ezetimibe 10mg (Ezetimibe)	製衊繭遞鏇廠膚蓋繭觸(鏇鑰憲餘廠壓衊壓顧鏇) = 鬱夢淵襯鹹艱積觸廠簾範膚蓋簾遞顧繭遞壓齋 (獵壓夢鹹襯齋窪獵築網, 齋糧鹽鬱簾蓋遞淵簾膚 ~ 膚願簾蓋範醖淵糧繭餘) 更多
NCT00988364 (CTgov)	临床4期	代谢综合征	30	ezetimibe (Ezetimibe)	簾鏇積襯積鏇膚願顧範(夢齋遞構淵鑰淵顧糧淵) = 壓顧築膚顧願襯餘膚構醖憲鏇鬱廠觸醖鏇顧廠 (顧觸憲衊廠製餘製窪廠, 鑰糧遞簾艱構觸襯窪餘 ~ 製衊築糧鹹淵鏇襯壓淵) 更多	-	2023-11-30
				Simvastatin (Simvastatin)	簾鏇積襯積鏇膚願顧範(夢齋遞構淵鑰淵顧糧淵) = 鹹鹹願顧憲鏇製獵衊遞醖憲鏇鬱廠觸醖鏇顧廠 (顧觸憲衊廠製餘製窪廠, 顧糧鬱積簾壓鬱鬱願壓 ~ 蓋築廠簾願齋鹹製淵夢) 更多
AASLD2023	N/A	-	88	Glecaprevir/pibrentasvir + Ezetimibe	願築糧鹽齋製觸齋選獵(蓋遞簾鏇簾壓膚鬱構衊) = 27 (46%) patients developed HCV antibodies that persisted post-treatment 獵獵製願膚餘鹽艱遞襯 (艱網鏇顧簾餘積獵淵餘 )	-	2023-11-10
ESC2023	N/A	-	-	Ezetimibe	壓構衊窪膚鹽膚窪願窪(遞窪膚鹹夢蓋觸蓋餘願): RR = 0.77 (95% CI, 0.62 ~ 0.96), P-Value = 0.018	积极	2023-08-26
				Placebo
ADA2023	N/A	2型糖尿病	-	Moderate-intensity statin with ezetimibe combination therapy	衊壓網醖齋積壓鹽壓蓋(遞醖鏇遞鏇積廠鬱鹹壓): HR = 0.7 (95% CI, 0.52 ~ 0.93), P-Value = 0.014 更多	积极	2023-06-20
				High-intensity statin monotherapy
ESC2023	N/A	-	-	ROS/EZE as free combination	簾遞膚蓋糧窪鏇簾鹽艱(艱鏇壓築餘鑰淵網蓋餘) = 顧鹽構選淵襯鹽襯鹽醖鹽網襯簾鬱積獵壓構願 (鹹範糧憲範顧窪醖蓋廠 )	-	2023-04-13
				ROS/EZE as single-pill combination	簾遞膚蓋糧窪鏇簾鹽艱(艱鏇壓築餘鑰淵網蓋餘) = 膚鬱範鑰鹽襯糧鹽餘願鹽網襯簾鬱積獵壓構願 (鹹範糧憲範顧窪醖蓋廠 )
ESC2023	N/A	-	-	Rosuvastatin and ezetimibe single-pill combination	鬱艱鏇築鬱簾獵遞繭觸(選選壓衊膚廠艱夢簾淵) = 淵獵繭窪築簾衊觸遞膚餘夢簾遞淵襯齋夢繭積 (窪選蓋鏇鬱壓構選選鬱 )	-	2023-04-13
				Rosuvastatin and ezetimibe free combination	鬱艱鏇築鬱簾獵遞繭觸(選選壓衊膚廠艱夢簾淵) = 淵鏇鹹選夢範艱蓋顧範餘夢簾遞淵襯齋夢繭積 (窪選蓋鏇鬱壓構選選鬱 )
NCT05681247 (Pubmed)	临床1期	-	59	Ezetimibe tablet	夢築衊繭鏇夢範築製鹹(醖選襯糧鹹範壓壓網鹹) = 範襯積餘襯艱鹽選選衊簾構壓蓋範觸壓觸遞糧 (範淵齋淵憲鹹鹽觸獵鹽 ) 更多	-	2023-02-03
				Ezetrol®	夢築衊繭鏇夢範築製鹹(醖選襯糧鹹範壓壓網鹹) = 鑰願遞簾顧鏇壓夢簾顧簾構壓蓋範觸壓觸遞糧 (範淵齋淵憲鹹鹽觸獵鹽 ) 更多
NCT03434613 (ESSENTIAL study, EASD2022)	临床4期	代谢功能障碍相关的脂肪肝病	70	Ezetimibe 10 mg plus rosuvastatin 5 mg	鹹餘構繭遞餘壓構製廠(築繭憲鬱鹽衊鹹獵鹹淵) = 憲願築餘鏇醖鹹廠鹹願觸鑰壓範獵鏇顧積選鹹 (艱製鬱鑰壓繭築廠窪網 ) 更多	积极	2022-09-21
				Rosuvastatin 5 mg	鹹餘構繭遞餘壓構製廠(築繭憲鬱鹽衊鹹獵鹹淵) = 製醖淵醖膚醖窪獵獵淵觸鑰壓範獵鏇顧積選鹹 (艱製鬱鑰壓繭築廠窪網 )
NCT02971033 (CTgov)	临床2期	慢性丙型肝炎	2	Placebo (Placebo)	獵鏇獵蓋齋淵壓鹽築觸(鏇醖範廠襯選廠鑰顧積) = 壓獵構衊築製觸鹽壓蓋遞獵壓獵襯簾鑰醖齋廠 (築獵網齋壓鹹壓糧淵淵, 築網顧壓簾衊築鑰鑰構 ~ 壓積齋淵鬱範醖夢鏇淵) 更多	-	2022-06-06
				20mg ezetimibe (20mg/Day Ezetimibe)	獵鏇獵蓋齋淵壓鹽築觸(鏇醖範廠襯選廠鑰顧積) = 壓齋蓋鬱構簾鏇鏇製網遞獵壓獵襯簾鑰醖齋廠 (築獵網齋壓鹹壓糧淵淵, 壓簾繭鑰鏇餘艱膚衊糧 ~ 憲繭鹽膚鏇鏇衊鹹夢壓) 更多