A Crossover Study of Patients With Heart Failure to Compare Natriuretic Effects of Immediate Release Torsemide vs. Extended Release Torsemide Over 12 Hours After Dosing

The goal of this randomized double-blind crossover study is to assess whether a morning dose of the extended release torsemide has a better efficacy than the ordinary immediate release torsemide to induce renal sodium excretion after a salty lunch in patients with stable heart failure. The main questions it aims to answer are:
Are the amounts of excreted sodium in the urine during the 2- and 6-hours' time period after a morning dose of extended release torsemide different from the amounts after the immediate release torsemide.
Are the amounts of excreted sodium in the urine during the 2- and 6-hours' time period after a salty lunch, which will be consumed approximately 6 hours following a morning dose of extended release torsemide, different from the amounts after the immediate release torsemide.
Is the amount of excreted sodium in the urine during the 24 hours' time period after a salty lunch, which will be consumed approximately 6 hours following a morning dose of extended release torsemide, different from the amount after the immediate release torsemide.
Participants will be asked to:
Start taking daily immediate release or extended release torsemide tablets that is provided to them.
Eat the meals with standard contents of sodium that is provided to them and avoid other meals, drinks (except for water) and snacks for the duration of the study.
Collect urine for 24 hours, after approximately one week of the initiation of the study medication.
Go to the clinical research center the day that the 24-hour urine collection is finished and stay there throughout the day to receive standard meals and to have blood and urine samples collected.
Switch torsemide pills to the new one that will be dispensed to them at the clinical research center. If they were taking the immediate release torsemide during the first part, then they will be given the sustained release torsemide and vice versa. The study is double blind; therefore, the subjects, study coordinators, and investigators are unaware of whether each subject is on immediate release torsemide first or on extended release torsemide first.
Collect urine for an additional 12 hours after leaving the clinical research center to be sent to the clinical research center the next morning.
Continue to take the provided meals and to avoid other meals, drinks (except for water) and snacks.
Again, collect urine for 24 hours, after approximately one week, take that to the clinical research center when the 24-hour collection is completed and stay there throughout the day to receive standard meals and to have blood and urine samples collected.
Collect urine for an additional 12 hours to be sent to the clinical research center the next morning.
Researchers will compare the amount of sodium excretion when each subject is taking immediate release torsemide versus the time that the same subject is taking extended release torsemide.

开始日期2024-04-01

申办/合作机构

Sarfez Pharmaceuticals, Inc.

NCT06206512 / Recruiting临床2期

A Crossover, Double-blinded, Two-period, Double Dummy Study to Evaluate the Effects of Extended Release Torsemide in Patients With Chronic Congestive Heart Failure and Symptoms of Overactive Bladder

This research study is being done to compare the effectiveness two drugs: an extended release torsemide (ERT) versus generic immediate release Torsemide (IRT) in reducing the worsening of symptoms of Overactive Bladder (OAB i.e., frequency, urgency, or urgency incontinence) in patients with chronic congestive heart failure (CHF).
This study will include CHF patients who experience worsening OAB) symptoms with use of a loop diuretic. The total duration of the study is about eight weeks with a total of nine visits.
There will be a screening visit that lasts one to two hours. The screening visit includes history and physical exams, blood draws, and urine analysis. If eligible for the study, participants will receive either generic torsemide or extended release torsemide for the first four weeks. Participants will do a virtual research visit on week one, two and three to submit a symptom diary and answer a questionnaire about urinary symptoms. At four weeks, history and physician exam will be done and blood will be collected. Participants will be assigned to receive either extended release torsemide (if they initially received generic torsemide) and generic torsemide (if they initially received extended release torsemide) for the next four weeks. Participants will attend virtual research visits on week five, six and seven to submit a symptom diary and answer a questionnaire about urinary symptoms. At the end of the study in week eight, they will have history and physical exams and blood draws.
Some risks from the study may include side effects of torsemide like acute kidney injury, fluid/electrolyte loss, hypersensitivity reactions and reversible hearing loss/tinnitus.

开始日期2024-04-01

申办/合作机构

Sarfez Pharmaceuticals, Inc.

NCT06117722 / Not yet recruitingN/A

ESTIA: TorasEmide Induced Effect on Quality of Life and Clinical parameterS in paTients With chronIc heArt Failure Receiving Eplerenone. Multicenter, Non-interventional, Prospective, Observational Clinical Study.

Heart failure (HF) is a multisystemic disorder characterized by marked disturbances in the physiology of the circulatory system and a multitude of structural and functional changes in the myocardium that adversely affect the systolic function and diastolic filling of the heart. Heart failure is not a single pathologic diagnosis, but a clinical syndrome consisting of cardiac symptoms (eg, dyspnea, edema of the lower extremities, and fatigue) that may be accompanied by signs (eg, increased jugular venous pressure and peripheral edema).The diagnosis of CKD becomes more likely in patients with a history of myocardial infarction (MI), arterial hypertension, coronary artery disease (CHD), diabetes mellitus, alcohol abuse, chronic kidney disease (CKD), cardiotoxic chemotherapy, and in patients with a family history of cardiomyopathy or of sudden death. The diagnosis of HF requires the presence of HF symptoms and/or signs and objective evidence of cardiac dysfunction.
The main symptoms of HF are symptoms such as shortness of breath at rest or during exercise, difficulty breathing (dyspnea), rapid breathing (tachypnea), difficulty breathing when bending over (bendopnea), orthopnea, paroxysmal nocturnal dyspnea, fatigue , weight gain or weight loss, swelling (of the extremities, scrotum or elsewhere), wheezing, palpitations, syncope, history of Cheyne Stokes breathing during sleep (often reported by the family rather than the patient), cough, drowsiness.
The simplest terminology used to describe HF severity is the New York Heart Association (NYHA) functional classification based on symptom severity and physical activity.
In Greece, it is estimated that the number of patients suffering from HF is 200,000.
In the vast majority of cases, transthoracic echocardiography is the initial cardiac imaging test used to evaluate patients with newly diagnosed or suspected heart failure. Echocardiography is particularly suitable for the evaluation of myocardial structure and function, valvular function and hemodynamic parameters .

开始日期2024-03-01

申办/合作机构

ELPEN Pharmaceutical Co., Inc.

100 项与托拉塞米相关的临床结果

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100 项与托拉塞米相关的转化医学

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100 项与托拉塞米相关的专利（医药）

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517

项与托拉塞米相关的文献（医药）

2024-02-14·BMJ open

Rationale and protocol of the LAQUA-HF trial: a factorial randomised controlled trial evaluating the effects of neurohormonal and diuretic agents on health-status reported outcomes in heart failure patients.

Article

作者: Yasuyuki Shiraishi ; Nobuhiro Ikemura ; Mitsuyoshi Urashima ; Takashi Kohno ; Shintaro Nakano ; Toshikazu Tanaka ; Yuji Nagatomo ; Takenori Ikoma ; Tomohiko Ono ; Yohei Numasawa ; Munehisa Sakamoto ; Kei Nishikawa ; Makoto Takei ; Daihiko Hakuno ; Ryo Nakamaru ; Ikuko Ueda ; Shun Kohsaka

INTRODUCTION:

The current guidelines strongly recommend early initiation of multiple classes of cardioprotective drugs for patients with heart failure with reduced ejection fraction to improve prognosis and health status. However, evidence on the optimal sequencing of approved drugs is scarce, highlighting the importance of individualised treatment plans. Registry data indicate that only a portion of these patients can tolerate all four recommended classes, underscoring the need to establish the favoured sequence when using these drugs. Additionally, the choice between long-acting and short-acting loop diuretics in the present era remains uncertain. This is particularly relevant given the frequent use of angiotensin receptor-neprilysin inhibitor and sodium-glucose cotransporter 2 inhibitor, both of which potentiate natriuretic effects.

METHODS AND ANALYSIS:

In a prospective, randomised, open-label, blinded endpoint method, LAQUA-HF (Long-acting vs short-acting diuretics and neurohormonal Agents on patients' QUAlity-of-life in Heart Failure patients) will be a 2×2 factorial design, with a total of 240 patients randomised to sacubitril/valsartan versus dapagliflozin and torsemide versus furosemide in a 1:1 ratio. Most enrolment sites have participated in an ongoing observational registry for consecutive patients hospitalised for heart failure involved dedicated study coordinators, and used the same framework to enrol patients. The primary endpoint is the change in patients' health status over 6 months, defined by the Kansas City Cardiomyopathy Questionnaire. Additionally, clinical benefit at 6 months defined as a hierarchical composite endpoint will be assessed by the win ratio as the secondary endpoint.

ETHICS AND DISSEMINATION:

The medical ethics committee Keio University in Japan has approved this trial. All participants provide written informed consent prior to study entry. The results of this trial will be disseminated in one main paper and additional papers on secondary endpoints and subgroup analyses.

TRIAL REGISTRATION NUMBER:

UMIN000045229.

2024-01-01·The Canadian journal of hospital pharmacy

Diuretic Strategies in Acute Decompensated Heart Failure: A Narrative Review.

Review

作者: Ben J Wilson ; Duane Bates

Background:

Heart failure is a common condition with considerable associated costs, morbidity, and mortality. Patients often present to hospital with dyspnea and edema. Inadequate inpatient decongestion is an important contributor to high readmission rates. There is little evidence concerning diuresis to guide clinicians in caring for patients with acute decompensated heart failure. Contemporary diuretic strategies have been defined by expert opinion and older landmark clinical trials.

Objective:

To present a narrative review of contemporary recommendations, along with their underlying evidence and pharmacologic rationale, for diuretic strategies in inpatients with acute decompensated heart failure.

Data Sources:

PubMed, OVID, and Embase databases were searched from inception to December 22, 2022, with the following search terms: heart failure, acute heart failure, decompensated heart failure, furosemide, bumetanide, ethacrynic acid, hydrochlorothiazide, indapamide, metolazone, chlorthalidone, spironolactone, eplerenone, and acetazolamide.

Study Selection:

Randomized controlled trials and systematic reviews involving at least 100 adult patients (> 18 years) were included. Trials involving torsemide, chlorothiazide, and tolvaptan were excluded.

Data Synthesis:

Early, aggressive administration of a loop diuretic has been associated with expedited symptom resolution, shorter length of stay, and possibly reduced mortality. Guidelines make recommendations about dose and frequency but do not recommend any particular loop diuretic over another; however, furosemide is most commonly used. Guidelines recommend that the initial furosemide dose (on admission) be 2-2.5 times the patient's home dose. A satisfactory diuretic response can be defined as spot urine sodium content greater than 50-70 mmol/L at 2 hours; urine output greater than 100-150 mL/h in the first 6 hours or 3-5 L in 24 hours; or a change in weight of 0.5-1.5 kg in 24 hours. If congestion persists after the maximization of loop diuretic therapy over the first 24-48 hours, an adjunctive diuretic such as thiazide or acetazolamide should be added. If decongestion targets are not met, continuous infusion of furosemide may be considered.

Conclusions:

Heart failure with congestion can be managed with careful administration of high-dose loop diuretics, supported by thiazides and acetazolamide when necessary. Clinical trials are underway to further evaluate this strategy.

2023-11-17·Therapeutic drug monitoring

A Systematic Critical Review of Clinical Pharmacokinetics of Torasemide.

Article

作者: Abdul Wasay Sherazi ; Ammara Zamir ; Anees Ur Rehman ; Waseem Ashraf ; Imran Imran ; Hamid Saeed ; Abdul Majeed ; Zikria Saleem ; Majid Aziz ; Faleh Alqahtani ; Muhammad Fawad Rasool

PURPOSE:

Torasemide is a potassium-sparing loop diuretic used to treat fluid retention associated with congestive heart failure and kidney and hepatic diseases. This systematic review was conducted to combine all accessible data on the pharmacokinetics (PK) of torasemide in healthy and diseased populations, which may help clinicians avert adverse drug reactions and determine the correct dosage regimen.

METHODS:

Four databases were systematically searched to screen for studies associated with the PK of torasemide, and 21 studies met the eligibility criteria. The review protocol was registered in the PROSPERO database (CRD42023390178).

RESULTS:

A decrease in maximum plasma concentration (Cmax) was observed for torasemide after administration of the prolonged-release formulation in comparison to that after administration of the immediate-release formulation, that is, 1.12 ± 0.17 versus 1.6 ± 0.2 mcg/mL. After administering an oral dose of torasemide, a 2-fold increase in the area under the concentration-time curve (AUC) was reported in patients with congestive heart failure compared with the healthy population. Moreover, the patients with renal failure (clearance < 30 mL/min) showed an increase in value of AUC0-∞ that is, 42.9 versus 8.091 mcg.h-1.mL-1 compared with healthy subjects. In addition, some studies have reported interactions with different drugs, in which irbesartan showed a slight increase in the AUC0-∞ of torasemide, whereas losartan and empagliflozin did not.

CONCLUSIONS:

The current review summarizes all available PK parameters of torasemide that may be beneficial for avoiding drug-drug interactions in subjects with renal and hepatic dysfunction and for predicting doses in patients with different diseases.

项与托拉塞米相关的新闻（医药）

2024-04-01

·信狐药迅

和记黄埔呋喹替尼和赛沃替尼新适应症报上市| 新受理（3.25-3.31）

本周药品注册受理数据，分门别类呈现，一目了然。(3.25-3.31）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呋喹替尼胶囊和记黄埔医药(上海)有限公司2.4CXHS2400024呋喹替尼胶囊和记黄埔医药(上海)有限公司2.4CXHS2400023赛沃替尼片和记黄埔医药(上海)有限公司2.4CXHS2400022赛沃替尼片和记黄埔医药(上海)有限公司2.4CXHS2400021新药临床申请药品名称企业注册分类受理号注射用WP1302百明信康生物技术(浙江)有限公司1CXHL2400318AXT-1003胶囊艾斯拓康医药科技(北京)有限公司1CXHL2400311JAB-30355片北京加科思新药研发有限公司1CXHL2400310JAB-30355片北京加科思新药研发有限公司1CXHL2400309ASP3082注射液安斯泰来(中国)投资有限公司1CXHL2400308HSK42360片西藏海思科制药有限公司1CXHL2400306HSK42360片西藏海思科制药有限公司1CXHL2400305HS-10518胶囊江苏豪森药业集团有限公司1CXHL2400304HS-10518胶囊江苏豪森药业集团有限公司1CXHL2400303SK-08片康臣药业(内蒙古)有限责任公司1CXHL2400317SK-08片康臣药业(内蒙古)有限责任公司1CXHL2400316SK-08片康臣药业(内蒙古)有限责任公司1CXHL2400315HS-10518胶囊江苏豪森药业集团有限公司1CXHL2400302HRS7415片江苏恒瑞医药股份有限公司1CXHL2400301HRS-8080片山东盛迪医药有限公司1CXHL2400300HRS-8080片山东盛迪医药有限公司1CXHL2400299ASKC200搽剂江苏奥赛康药业有限公司2.2CXHL2400321ASKC200搽剂江苏奥赛康药业有限公司2.2CXHL2400320特立帕肽注射液云南先施药业有限公司2.2CXHL2400319磷酸奥司他韦口溶膜甘肃普迪安制药有限公司2.2CXHL2400314磷酸奥司他韦口溶膜甘肃普迪安制药有限公司2.2CXHL2400313磷酸奥司他韦口溶膜甘肃普迪安制药有限公司2.2CXHL2400312BCM875口溶膜上海云晟研新生物科技有限公司2.2CXHL2400324BCM857口溶膜上海云晟研新生物科技有限公司2.2CXHL2400323BCM857口溶膜上海云晟研新生物科技有限公司2.2CXHL2400322HZ211口溶膜浙江和泽医药科技股份有限公司2.2CXHL2400307布洛芬注射液山东新华制药股份有限公司3CYHL2400067布洛芬注射液山东新华制药股份有限公司3CYHL2400066布立西坦片宜昌人福药业有限责任公司3CYHL2400065布立西坦片宜昌人福药业有限责任公司3CYHL2400064GCB-001上海金珂博生物技术有限公司1CXSL2400206GP51801注射液南京济群生物科技有限公司1CXSL2400207注射用聚乙二醇化促血小板生成肽重庆派金生物科技有限公司1CXSL2400205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HDM2005杭州中美华东制药有限公司1CXSL2400203仿制药申请药品名称企业注册分类受理号米诺地尔搽剂山东华铂凯盛生物科技有限公司3CYHS2400977米诺地尔搽剂山东华铂凯盛生物科技有限公司3CYHS2400976己酮可可碱注射液江西远超医药科技有限公司3CYHS2400975注射用尼可地尔福建泽瑞药业有限公司3CYHS2400972注射用尼可地尔福建泽瑞药业有限公司3CYHS2400971氯化钙注射液石家庄四药有限公司3CYHS2400950盐酸溴己新注射液海南全星制药有限公司3CYHS2400948地拉罗司颗粒上海复星医药产业发展有限公司3CYHS2400968托拉塞米注射液北京百美特生物制药有限公司3CYHS2400967托拉塞米注射液北京百美特生物制药有限公司3CYHS2400965盐酸溴己新注射液云南药科院生物医药股份有限公司3CYHS2400963复方电解质醋酸钠注射液南京恩泰医药科技有限公司3CYHS2400960复方电解质醋酸钠注射液南京恩泰医药科技有限公司3CYHS2400959二羟丙茶碱注射液福建品腾药业有限公司3CYHS2400958硝苯地平缓释片(II)河北山姆士药业有限公司3CYHS2400954米诺地尔搽剂嘉实(湖南)医药科技有限公司3CYHS2400953布美他尼注射液卡文迪许(泰州)药业有限公司3CYHS2400947硫酸沙丁胺醇口服溶液浙江恒研医药科技有限公司3CYHS2400946氟哌啶醇片上海理想制药有限公司3CYHS2400944布美他尼注射液成都瑞尔医药科技有限公司3CYHS2400943布美他尼注射液成都瑞尔医药科技有限公司3CYHS2400942重酒石酸去甲肾上腺素注射液海南美康达药业有限公司3CYHS2400940甲硫酸新斯的明注射液湖南埃威格林医药科技有限公司3CYHS2400939甲硫酸新斯的明注射液湖南埃威格林医药科技有限公司3CYHS2400938米诺地尔搽剂广州汇元医药科技有限公司3CYHS2400936二羟丙茶碱注射液石家庄四药有限公司3CYHS2400931福多司坦口服溶液吉林长白山药业集团股份有限公司3CYHS2400919法莫替丁注射液武汉福星生物药业有限公司3CYHS2400916草酸艾司西酞普兰口服滴剂广州一品红制药有限公司3CYHS2400930盐酸依匹斯汀滴眼液润尔眼科药物(广州)有限公司3CYHS2400929盐酸甲氧氯普胺注射液广州合和医药有限公司3CYHS2400928盐酸丙卡特罗干糖浆南京集萃剂鼎医药有限公司3CYHS2400922布洛芬注射液山东新华制药股份有限公司3CYHL2400067米诺地尔搽剂广州汇元医药科技有限公司3CYHS2400926洛索洛芬钠口服溶液北京远方通达医药技术有限公司3CYHS2400913米力农注射液吉林振澳制药有限公司3CYHS2400910维生素B6注射液北京柏雅联合药物研究所有限公司3CYHS2400907布洛芬注射液山东新华制药股份有限公司3CYHL2400066布立西坦片宜昌人福药业有限责任公司3CYHL2400065布立西坦片宜昌人福药业有限责任公司3CYHL2400064氨磺必利口服溶液仁合益康集团有限公司3CYHS2400906呋塞米注射液酒泉大得利制药股份有限公司3CYHS2400905他克莫司胶囊海南合瑞制药股份有限公司4CYHS2400979他克莫司胶囊海南合瑞制药股份有限公司4CYHS2400978马来酸阿伐曲泊帕片杭州九源基因工程股份有限公司4CYHS2400974吸入用乙酰半胱氨酸溶液德全药品(江苏)股份有限公司4CYHS2400973玻璃酸钠滴眼液江西马应龙美康药业有限公司4CYHS2400952醋酸加尼瑞克注射液辰欣药业股份有限公司4CYHS2400951来特莫韦片重庆希韦医药科技有限公司4CYHS2400949吸入用乙酰半胱氨酸溶液海南皇隆制药股份有限公司4CYHS2400970奥卡西平口服混悬液上海奥科远制药有限公司4CYHS2400969骨化三醇软胶囊江苏康缘药业股份有限公司4CYHS2400966酒石酸溴莫尼定滴眼液南京海纳制药有限公司4CYHS2400964普伐他汀钠片浙江诺得药业有限公司4CYHS2400962普伐他汀钠片浙江诺得药业有限公司4CYHS2400961司来帕格片重庆圣华曦药业股份有限公司4CYHS2400957蒙脱石混悬液安徽永生堂药业有限责任公司4CYHS2400956司来帕格片重庆圣华曦药业股份有限公司4CYHS2400955替格瑞洛片安若维他药业泰州有限公司4CYHS2400935替格瑞洛片安若维他药业泰州有限公司4CYHS2400934盐酸莫西沙星滴眼液广东南国药业有限公司4CYHS2400933富马酸卢帕他定片山东华铂凯盛生物科技有限公司4CYHS2400932马来酸氟伏沙明片安徽艾立德制药有限公司4CYHS2400945比索洛尔氨氯地平片宏越科技(湖州)有限公司4CYHS2400941精氨酸培哚普利片石家庄四药有限公司4CYHS2400937盐酸阿罗洛尔片北京福元医药股份有限公司4CYHS2400921盐酸安妥沙星片仁合益康集团有限公司4CYHS2400920琥珀酸普芦卡必利片漯河市汇创医药有限公司4CYHS2400918富马酸丙酚替诺福韦片湖南一格制药有限公司4CYHS2400917苯磺酸氨氯地平片重庆吉斯瑞制药有限责任公司4CYHS2400927左甲状腺素钠片北京福元医药股份有限公司4CYHS2400925左甲状腺素钠片北京福元医药股份有限公司4CYHS2400924磷酸奥司他韦胶囊福建省闽东力捷迅药业股份有限公司4CYHS2400923盐酸达泊西汀片浙江北生药业汉生制药有限公司4CYHS2400915克立硼罗软膏浙江赛默制药有限公司4CYHS2400914美沙拉秦肠溶片湖南慧泽生物医药科技有限公司4CYHS2400912硫酸氨基葡萄糖胶囊广州江正医药科技有限公司4CYHS2400911莫匹罗星软膏深圳市泰力生物医药有限公司4CYHS2400909硫酸镁钠钾口服用浓溶液山东京卫制药有限公司4CYHS2400908进口申请药品名称企业注册分类受理号盐酸BAY 3283142片Bayer AG1JXHL2400076盐酸BAY 3283142片Bayer AG1JXHL2400075PF-07820435片Pfizer Inc.1JXHL2400074PF-07820435片Pfizer Inc.1JXHL2400073PF-07820435片Pfizer Inc.1JXHL2400072PF-07820435片Pfizer Inc.1JXHL2400071MK-0616 片Merck Sharp & Dohme LLC1JXHL2400068Balcinrenone达格列净胶囊AstraZeneca AB1JXHL2400070Balcinrenone达格列净胶囊AstraZeneca AB1JXHL2400069LNP023胶囊Novartis Pharma AG2.4JXHL2400067SasanlimabPfizer Inc.1JXSL2400064Vamorolone口服混悬液Santhera Pharmaceuticals (Deutschland) GmbH5.1JXHS2400026古塞奇尤单抗注射液Janssen-Cilag International NV2.2JXSS2400027古塞奇尤单抗注射液Janssen-Cilag International NV2.2JXSS2400028冻干膀胱灌注用卡介苗（日本株）Japan BCG Laboratory3.1JXSS2400032注射用维恩妥尤单抗Astellas Pharma Europe B.V.3.1JXSS2400031注射用维恩妥尤单抗Astellas Pharma Europe B.V.3.1JXSS2400030帕博利珠单抗注射液Merck Sharp & Dohme LLC3.1JXSS2400033古塞奇尤单抗注射液（静脉输注）Janssen-Cilag International NV2.1;2.2JXSS2400029盐酸芬戈莫德胶囊Dr. Reddy’s Laboratories Limited5.2JYHS2400013中药相关申请无不包含原料药、医用氧、注射用水、氯化钠或葡萄糖注射液等申请，不包含再注册、一次性进口、技术转移、复审申请。

申请上市

2024-03-27

·药闻康策

浙江市级联合（金华）药品集采中选结果出炉

☝ 点击上方一键预约 ☝ 最新最热的医药健康新闻政策关于做好市级联合（金华）药品集中带量采购工作的函省药械采购中心，各设区市医保局，各中选药品生产、配送企业：为积极稳妥做好市级联盟（金华）药品集中采购接续等相关工作，现就有关事项通知如下：一、执行品种市级联合（金华）药品集中采购品种，供应清单具体见附件。二、签订购销协议1.签订方式。各医疗卫生机构和中选企业通过浙江省“智慧医保”招采子系统网上签订购销协议。医疗卫生机构与中选企业通过用户账号登录浙江省“智慧医保”招采子系统，以确认同意的方式完成购销协议的签订，双方网上确认同意即视同签订购销协议。2.签订时间。2024年3月22日9:00至4月10日16:00。三、中选药品挂网和采购1.采购协议周期为2024年3月25日至2025年3月31日。医疗机构应优先采购和使用中选药品，保障完成约定采购量。采购协议周期内若中选药品提前完成约定采购量的，超过部分中选企业仍按中选价进行供应，直至采购周期届满。2.各医疗卫生机构所使用的中选药品必须通过浙江省“智慧医保”招采子系统网上采购，严禁网下采购，按要求结算货款，中选产品货款结算时间最长不超过交货验收合格后次月底。药品生产（配送）企业要及时响应医疗卫生机构采购订单、配送入库等工作，确保中选药品供应顺畅。3.与国家第八批和第九批带量采购重复的左氨氯地平口服常释剂型、阿加曲班注射剂、肝素类注射剂、托拉塞米注射剂、乌拉地尔注射剂等品种执行国家带量采购中选结果。非诺贝特口服常释剂型B组因中选企业放弃，不再续约。原中选产品自本次集采执行日起6个月内中选价格继续在线交易，请相关企业确保产品供应。4.请省药械采购中心和各市医保部门牵头做好管辖医疗机构中选药品网上采购相关工作，加强对中选药品购销协议签订、医保基金预付、采购、配送、使用、回款等各环节的指导和管理服务。5.非主供或备供浙江的第八、九批国家组织药品集中采购中选产品，企业应按不高于中选价格的1.5倍或同品种最高中选价挂网供应，请相关企业于2024年3月29日前通过浙江省“智慧医保”招采子系统“网上材料申报”模块递交“第九批国家组织药品集中采购非主非备药品挂网信息表”，相应调整挂网信息。四、联系方式金华市医疗保障局医药价格和采购处，0579-83470221；地址：金华市双龙南街858号财富大厦18楼;邮政编码：321000。附件：1.浙江省市级联合（金华）药品带量采购中选结果及供应品种清单。 2.第八、九批国家组织药品集中采购非主非备药品挂网信息表。金华市药品耗材集中带量采购联盟委员会办公室（金华市医疗保障局医药价格和采购处代章）2024年3月21日附件：浙江省市级联合（金华）药品带量采购中选结果及供应品种清单.pdf 第八、九批国家组织药品集中采购非主非备药品挂网信息表.docx(来源:华东药械联盟作者:NB诺哥）药闻康策新媒体矩阵微信公众号点击下方一键关注【免责声明】1.“药闻康策”部分文章信息来源于网络转载是出于传递更多信息之目的，并不意味着赞同其观点或证实其内容的真实性。如对内容有疑议，请及时与我司联系。2.“药闻康策”致力于提供合理、准确、完整的资讯信息，但不保证信息的合理性、准确性和完整性，且不对因信息的不合理、不准确或遗漏导致的任何损失或损害承担责任。3.“药闻康策”所有信息仅供参考，不做任何商业交易或医疗服务的根据，如自行使用“药闻康策”内容发生偏差，我司不承担任何责任，包括但不限于法律责任，赔偿责任。欢迎转发分享、点赞、点在看

带量采购

2024-03-26

·米内网

华海药业发威！6个畅销品种大涨超100%，44个新品加速冲刺，3款新药上市可期

精彩内容近日，华海药业的托拉塞米注射液获批，成为公司今年第5款新上市产品。回顾2023年，华海药业实现了大丰收：在重点省市公立医院终端，6个畅销品种销售额大涨超100%；15个新产品获批，为近五年数量之最；8个ANDA文号收入囊中，继续稳守制剂出海第一梯队。目前，华海药业及子公司有17款新药积极推进临床，其中3款离报产仅一步之遥，44个高端仿制药冲刺上市，公司未来可期。神经系统药物再次突围！6个畅销品种大涨超100%浙江华海药业主要从事多剂型的仿制药、生物药、创新药及特色原料药的研发、生产和销售，目前公司的产品覆盖心血管类、精神障碍类、神经系统类、抗感染类等治疗领域。米内网数据显示，在重点省市公立医院终端化学药市场，神经系统药物曾是公司的拳头大类，2020年起被心脑血管系统药物成功突围，近几年公司的神经系统药物再次爆发新活力，2023年再次成为公司的TOP1大类。图1：浙江华海药业的神经系统药物占比变化情况来源：米内网重点省市公立医院药品终端竞争格局表1：2023年浙江华海药业TOP20品种中销售正增长的品种情况来源：米内网重点省市公立医院药品终端竞争格局2023年在重点省市公立医院终端，浙江华海药业有6个品种的销售额增长率超过100%，其中奥氮平、左乙拉西坦、阿立哌唑、艾司西酞普兰和拉莫三嗪为神经系统药物。在众多潜力品种的助力下，公司成为了2023年重点省市公立医院终端抗抑郁药TOP4企业、抗精神病药TOP12企业。2023年大丰收，揽下15个新品！44个高端仿制药在路上近几年华海药业不断拓展产品线，多个亚类市场迎来了首款获批产品，公司的产品矩阵越来越丰富。米内网数据显示，2023年公司共拿下了15个新产品的生产批文，是近五年数量最多的一年，成绩亮眼。表2：近几年华海药业获批的新产品来源：米内网中国申报进度（MED）数据库注射用培美曲塞二钠是华海药业获批的首款抗肿瘤化药。2023年在重点省市公立医院终端抗肿瘤药市场，注射用培美曲塞二钠是注射TOP11产品，销售额超过6亿元。艾司奥美拉唑镁肠溶胶囊是华海药业首款获批的治疗与胃酸分泌相关疾病的化药。2023年在重点省市公立医院终端治疗与胃酸分泌相关疾病的药物市场，艾司奥美拉唑镁肠溶胶囊是内服TOP6产品，销售额接近1.6亿元。赛洛多辛胶囊是华海药业首款获批的泌尿系统化药。2023年在重点省市公立医院终端泌尿系统药物市场，赛洛多辛胶囊是内服TOP6产品。随后在2023年11月，公司的他达拉非片获批，进一步扩大了公司的泌尿系统药物产品线。2024年3月22日NMPA官网发布最新药品获批信息，华海药业的托拉塞米注射液获批，成为了公司今年以来第5个上市的新产品。今年上市的非布司他片、枸橼酸托法替布片和多巴丝肼片也为公司开拓了新市场。非布司他片是公司首款获批的抗痛风制剂。2023年在重点省市公立医院终端抗痛风制剂市场，非布司他片是内服TOP1产品，销售额在1.2亿元以上。枸橼酸托法替布片是公司首款获批的免疫抑制剂。2023年在重点省市公立医院终端免疫抑制剂市场，枸橼酸托法替布片是内服TOP9产品。多巴丝肼片是公司首款获批的抗帕金森氏病药。2023年在重点省市公立医院终端抗帕金森氏病药市场，多巴丝肼片是内服TOP1产品，销售额在1.3亿元以上。表3：2022年至今华海药业及子公司申报上市并在审的新产品来源：米内网中国申报进度（MED）数据库2022年至今华海药业及子公司还有44个高端仿制药的上市申请正在审评审批中，涉及8个大类（17个亚类）。公司将在抗炎药和抗风湿药、止血药、脑血管治疗用药、止泻药和肠道抗炎/抗感染药4个亚类市场迎来新突破。2023年在重点省市公立医院终端，注射用氯诺昔康是抗炎药和抗风湿药注射TOP5产品，尼麦角林片是脑血管治疗用药内服TOP5产品，美沙拉秦肠溶片是止泻药和肠道抗炎/抗感染药内服TOP2产品，这些重磅产品获批后，将助力公司进一步提升市场竞争力。此外，目前国内市场上暂无二甲双胍恩格列净片、二甲双胍恩格列净片(Ⅴ)、二甲双胍恩格列净片(Ⅵ)、卡左双多巴缓释片、达格列净二甲双胍缓释片(Ⅰ)、达格列净二甲双胍缓释片(Ⅲ)、达格列净二甲双胍缓释片(Ⅳ)和坎地沙坦酯氢氯噻嗪片的国产仿制药获批（按产品名统计），华海药业将参与上述8个产品的国内首仿争夺，我们静待好消息的到来。17款新药火速推进，3款上市可期2023年华海药业及子公司共提交了5款1类新药的临床申请，其中HHT109胶囊为首次申报并获批临床，拟用于治疗类风湿关节炎。2024年至今，公司再有两款1类新药申报临床，HB0046注射液和注射用HB0052为首次申报，华海药业的新药管线不断拓宽。表4：华海药业2023年至今申报临床的1类新药来源：米内网中国申报进度（MED）数据库华海药业表示，生物药及创新药业务是公司发展进程中的重要战略布局，也是公司未来发展的新增长点。公司的生物药产品管线以肿瘤与自身免疫为主，眼科、呼吸等其他方面为辅，以“国内首家、同类最优”的研发战略布局新产品开发，目前公司有14款新药（含化学药、生物药）正在积极开展临床，3款已在III期以上临床阶段，离报产仅一步之遥。表5：华海药业部分已在I期以上临床阶段的新药来源：米内网中国临床试验数据库HB0017注射液是一款重组人源化抗人白介素-17单克隆抗体，该新药的银屑病适应症III期临床在2024年2月启动，而强直性脊柱炎适应症已在II期临床阶段。HB0034注射液是国内首个靶向IL-36R的单抗，该新药的中重度泛发性脓疱型银屑病急性发作适应症在2024年2月启动II期临床。据悉，该新药在2023年还获得了美国FDA孤儿药认定用于治疗泛发性脓疱型银屑病。HB0025注射液则是全球领先的靶向PD-L1/VEGF的双特异性融合蛋白，目前该新药晚期子宫内膜癌以及肾癌两大适应症均在II期临床阶段。2024年国采逼近，两个超10亿产品备战2017年12月，华海药业的赖诺普利片、氯沙坦钾片、厄贝沙坦片、福辛普利钠片、盐酸帕罗西汀片、利培酮片、厄贝沙坦氢氯噻嗪片的一致性评价补充申请获批，成为了公司首批过评产品。截至2024年3月26日，华海药业及子公司过评/视同过评的产品数量达到59个，前九批国采合计中标产品23个。图2：华海药业国采中标的产品情况来源：米内网中国上市药品（MID）数据库第十批国采或将在2024年上半年启动，华海药业目前已过评且暂未纳入国采的产品中，左乙拉西坦缓释片、利格列汀片、磷酸西格列汀片、西格列汀二甲双胍片(Ⅱ)、盐酸艾司洛尔注射液和盐酸美金刚口服溶液的竞争企业（原研+过评）已达到5家及以上。表6：竞争企业≥5家的产品注：销售额低于1亿元用*表示来源：米内网中国公立医疗机构药品终端竞争格局在中国城市公立医院、县级公立医院、城市社区中心及乡镇卫生院（简称中国公立医疗机构）终端，利格列汀片和磷酸西格列汀片的销售额均在10亿元以上，且目前由原研企业领军，“国产替代原研”大有可为。华海药业上述产品均为近五年按新分类获批并视同过评的“光脚产品”，新的机遇即将到来，我们拭目以待。稳守制剂出海第一梯队，ANDA文号迈向100个作为制剂出海领军企业，华海药业的ANDA文号储备在业界名列前茅。据公司公告统计，2023年公司拿下了左旋米那普仑缓释胶囊等8个产品的ANDA文号，2024年刚开局又拿下了帕罗西汀缓释片的ANDA文号。米内网数据显示，截至目前华海药业已拥有ANDA文号数量超过90个，有望在今年完成100个的“小目标”。表7：华海药业2023年至今获得的ANDA文号情况（含暂时批准）来源：公司公告、米内网整理华海药业曾在年报资料中提到，针对美国制剂销售方面，公司紧抓销售管理变革，加速ANDA文号获批速度，持续深挖新老产品市场机会，近几年成效显著，2023年上半年公司的美国制剂业务实现销售收入同比增长73.3%。资料来源：米内网数据库、公司公告等注：米内网重点省市公立医院化学药终端竞争格局数据库是以20+省市，近700家样本省市公立医院的化学药采购数据为基础，对化学药全品类进行连续监测的样本省市样本医院数据库；米内网《中国公立医疗机构药品终端竞争格局》，统计范围是：中国城市公立医院、县级公立医院、城市社区中心以及乡镇卫生院，不含民营医院、私人诊所、村卫生室；上述销售额以产品在终端的平均零售价计算。数据统计截至3月26日，如有疏漏，欢迎指正！本文为原创稿件，转载请注明来源和作者，否则将追究侵权责任。投稿及报料请发邮件到872470254@qq.com稿件要求详询米内微信首页菜单栏商务及内容合作可联系QQ：412539092【分享、点赞、在看】点一点不失联哦

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100 项与托拉塞米相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D00382	托拉塞米	C03CA04	DB00214

研发状态

适应症	最高研发状态	国家/地区	公司
心源性水肿	批准上市	日本更多	Mitsubishi Tanabe Pharma Corp. 更多
水肿	批准上市	美国更多	Sarfez Pharmaceuticals, Inc. 更多
高血压	批准上市	日本更多	Taisho Pharmaceutical Co., Ltd. 更多

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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


NCT01457053 (CTgov)	N/A	急性失代偿性心力衰竭	4	Ultrafiltration (Ultrafiltration)	築淵艱鏇鑰構構膚鏇鹽(鑰鏇憲艱構餘夢鹹膚鬱) = 醖獵鹽餘鏇網簾選蓋壓廠醖簾夢積獵鹹顧窪醖 (餘艱鑰鹹鏇鏇餘夢夢鹽, 製齋願糧憲網壓範艱衊 ~ 艱積鬱衊顧鏇獵製繭繭) 更多	-	2015-06-08
				bumetanide+torsemide+furosemide (Diuretic Therapy)	築淵艱鏇鑰構構膚鏇鹽(鑰鏇憲艱構餘夢鹹膚鬱) = 製憲餘鏇觸糧積糧襯願廠醖簾夢積獵鹹顧窪醖 (餘艱鑰鹹鏇鏇餘夢夢鹽, 壓範鬱積鏇積鹹醖夢蓋 ~ 積艱願鬱廠糧壓膚蓋鑰) 更多
ESC2019	N/A	慢性心力衰竭	-	Bumetanide	(壓齋積憲艱膚積網齋顧) = 範網網鏇選齋網壓獵製選鏇鹽餘願廠構顧構積 (餘襯醖製蓋顧夢膚廠醖 )	-	2019-05-27
				Furosemide	(壓齋積憲艱膚積網齋顧) = 淵壓艱艱蓋積窪製鹹製選鏇鹽餘願廠構顧構積 (餘襯醖製蓋顧夢膚廠醖 )
Heart Failure Registries of the European Society of Cardiology (ESC2017)	N/A	心脏衰竭	-	Torasemide	(蓋鹹襯構願網餘壓簾壓) = 膚範壓選鏇繭鹹鹹鹽鏇鹹選遞製鑰憲夢鏇積網 (鹽遞鹽製齋艱膚鹹鹽夢 )	-	2017-08-29
				Furosemide	(蓋鹹襯構願網餘壓簾壓) = 衊簾窪艱糧糧鑰鏇膚願鹹選遞製鑰憲夢鏇積網 (鹽遞鹽製齋艱膚鹹鹽夢 )
NCT02813551 (CTgov)	临床2期	子痫前症	118	Torsemide (Torsemide)	壓鏇繭壓鏇壓獵顧構積(鹹窪鏇鑰衊憲鹽鏇積襯) = 選構淵選鏇遞憲鏇廠鏇簾襯襯簾醖膚製選鹹齋 (膚選艱願齋憲鬱繭淵鹽, 壓鏇糧壓構製網窪艱鬱 ~ 簾衊糧糧餘廠繭廠廠蓋) 更多	-	2019-04-10
				Placebo (Placebo)	壓鏇繭壓鏇壓獵顧構積(鹹窪鏇鑰衊憲鹽鏇積襯) = 廠願網範選衊淵糧製製簾襯襯簾醖膚製選鹹齋 (膚選艱願齋憲鬱繭淵鹽, 繭繭築醖夢襯鹹鑰鹽願 ~ 壓憲餘淵鏇醖鹽網廠網) 更多