This study evaluates the management of subjects with Standard of Care (SOC) when admitted to the Emergency Department (ED) with hyperkalemia (potassium value ≥ 5.5 mmol/L). Demographics and medical history data, including previous ED visits and/or hospital admissions for hyperkalemia and reason for current ED admission, will be recorded. Subjects who receive an intervention/treatment for hyperkalemia will have study-related potassium values determined at 30 minutes, 1, 2, and 4 hours after the start of treatment. Subjects who receive no intervention/treatment during the initial 4-hour period will have a study-related potassium value determined 4 hours after the baseline potassium measurement. Available data obtained as part of SOC management will include physical examinations, vital signs, fluid intake and urine output, ECGs, clinical laboratory data, and results of chest x-rays. Data regarding the subject's chief complaint upon admission to the ED, the possible cause of the subject's hyperkalemia, and admitting and discharge diagnosis will be recorded; the subject's overall discharge summary will also be collected.

开始日期2015-10-31

申办/合作机构

ZS Pharma, Inc.

NCT02609841

/ CompletedN/A

POtassium and Cardiac Rhythm Trends in MaintENance HemoDialysis (PORTEND): A Multicenter, Prospective, Observational Study

This study assesses serum potassium and cardiac rhythm trends in subjects with end stage renal disease (ESRD) who are on 3 times weekly maintenance hemodialysis for at least 60 days. Dialysate K (relative potassium concentration in dialysate) must be stable for 2 weeks prior to enrollment.The number of subjects on 3K or higher dialysate will be limited to 60, with the remainder of the subjects on 1K or 2K dialysate.

开始日期2015-09-30

申办/合作机构

ZS Pharma, Inc.

NCT02163499

/ Completed临床3期

Multicenter, Multi-Dose, Open-Label Maintenance of Long-Term Safety and Efficacy of Sodium Zirconium Cyclosilicate (ZS) in Hyperkalemia

The Open-Label Maintenance Study contains an Acute Phase, in which subjects will be dosed with ZS 10 g three times daily (tid) for 24 to 72 hours, followed by a long-term Maintenance Phase.

开始日期2014-06-30

申办/合作机构

ZS Pharma, Inc.

100 项与 ZS Pharma, Inc. 相关的临床结果

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0 项与 ZS Pharma, Inc. 相关的专利（医药）

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项与 ZS Pharma, Inc. 相关的文献（医药）

2019-01-01·American journal of nephrology

Efficacy and Safety of Sodium Zirconium Cyclosilicate for Treatment of Hyperkalemia: An 11-Month Open-Label Extension of HARMONIZE

Article

作者: Kosiborod, Mikhail ; Lerma, Edgar V ; Roger, Simon D ; Packham, David K ; Spinowitz, Bruce S ; Singh, Bhupinder ; Al-Shurbaji, Ayman

Background: Sodium zirconium cyclosilicate (SZC; formerly ZS-9) is a selective potassium (K⁺) binder for treatment of hyperkalemia. An open-label extension (OLE) of the HARMONIZE study evaluated efficacy and safety of SZC for ≤11 months. Methods: Patients from HARMONIZE with point-of-care device i-STAT K⁺ 3.5–6.2 mmol/L received once-daily SZC 5–10 g for ≤337 days. End points included achievement of mean serum K⁺ ≤5.1 mmol/L (primary) or ≤5.5 mmol/L (secondary). Results: Of 123 patients who entered the extension (mean serum K⁺ 4.8 mmol/L), 79 (64.2%) completed the study. The median daily dose of SZC was 10 g (range 2.5–15 g). The primary end point was achieved by 88.3% of patients, and 100% achieved the secondary end point. SZC was well tolerated with no new safety concerns. Conclusion: In the HARMONIZE OLE, most patients maintained mean serum K⁺ within the normokalemic range for ≤11 months during ongoing SZC treatment.

2018-06-03·Current medical research and opinion4区 · 医学

The prevalence of hyperkalemia in the United States

4区 · 医学

Article

作者: Mu, Fan ; Betts, Keith A. ; McDonald, Evangeline ; Tang, Wenxi ; Woolley, J. Michael ; Wu, Eric Q.

OBJECTIVE:

The retrospective study aimed to estimate prevalence of hyperkalemia using a large US commercial claims database.

METHODS:

Adults with serum potassium lab data (2010 to 2014) and ≥1 calendar year of data were included from a large US commercial claims database. Hyperkalemia was defined as ≥2 serum potassium measurements >5.0 mEq/L or one hyperkalemia diagnosis code (ICD-9-CM, 276.7) or one sodium polystyrene sulfonate fill. Hyperkalemia prevalence was estimated for the overall population and subgroups with hyperkalemia-related comorbidities by calendar year. Hyperkalemia prevalence was also standardized to the US population to estimate the number of US adults with hyperkalemia.

RESULTS:

The analysis included 2,270,635 patients (2010-2014). The annual prevalence of hyperkalemia in the overall population was 1.57% in 2014, with higher rates observed in patients with chronic kidney disease (CKD), heart failure, diabetes and hypertension. Among patients with CKD and/or heart failure, the 2014 annual prevalence was 6.35%. Among patients with hyperkalemia, 48.43% had CKD and/or heart failure in 2014. The prevalence of hyperkalemia was higher in patients with more severe CKD, as well as older patients and men. Extrapolating those results to the US population supports that 1.55% or 3.7 million US adults had hyperkalemia in 2014.

CONCLUSIONS:

An estimated 3.7 million US adults had hyperkalemia in 2014, and this prevalence rate has increased since 2010. In patients with CKD and/or heart failure, the annual prevalence of hyperkalemia was 6.35% in 2014, and about half of all patients with hyperkalemia have either CKD and/or heart failure.

2018-01-01·JAMA cardiology1区 · 医学

Error in Author Affiliations

1区 · 医学

Article

作者: Nicolas Girerd ; João Ferreira ; Faiez Zannad

Iona Y. Millwood, DPhil; Derrick A. Bennett, PhD; Michael V. Holmes, PhD; Ruth Boxall, MSc; Yu Guo, MSc; Zheng Bian, MSc; Ling Yang, PhD; Sam Sansome, BSc; Yiping Chen, DPhil; Huaidong Du, PhD; Canqing Yu, PhD; Alex Hacker, MA; Dermot F. Reilly, PhD; Yunlong Tan, MBBS; Michael R. Hill, PhD; Junshi Chen, MD; Richard Peto, FRS; Hongbing Shen, PhD; Rory Collins, FRS; Robert Clarke, MD; Liming Li, MPH; Robin G. Walters, PhD; Zhengming Chen, DPhil; for the China Kadoorie Biobank Collaborative Group

项与 ZS Pharma, Inc. 相关的新闻（医药）

2025-10-16

·Pharmaceutical Technology

AstraZeneca doubles Lokelma output with $445m Texas plant expansion

Analysis by GlobalData’s Pharma Intelligence Centre forecasts annual global sales of Lokelma to reach $938m by 2031. Mats Wiklund via Shutterstock.com. AstraZeneca has unveiled a newly expanded manufacturing facility in Texas to the tune of $445m, as the drugmaker aims to meet increasing demand for hyperkalaemia treatment Lokelma (sodium zirconium cyclosilicate). The near half a billion-dollar expansion at AstraZeneca’s manufacturing facility in Coppell, Texas, adds a new 9,000ft² building, which will house two production lines. The investment will also fund upgrades for drug substance and drug product laboratory testing, along with additional space for warehousing and administration. Overall, AstraZeneca says the expansion will double the production of Lokelma. Lokelma is an oral suspension treatment that lowers potassium levels in the blood. The drug was US Food and Drug Administration (FDA)-approved in 2018, three years after being acquired by AstraZeneca in a takeover of ZS Pharma for $2.7bn. Lokelma generated $542m in 2024, an increase of 32% from 2023. Analysis by GlobalData’s Pharma Intelligence Centre forecasts annual global sales to reach $938m by 2031. GlobalData is the parent company of Pharmaceutical Technology . AstraZeneca’s Texas facility, which employs more than 250 people, is the sole supplier of Lokelma to more than 50 countries, including the US. GlobalData Strategic Intelligence US Tariffs are shifting - will you react or anticipate? Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis. By GlobalData Learn more about Strategic Intelligence “Our manufacturing facility in Coppell serves as both a critical pillar in global healthcare and has played an important role in supporting the local workforce over the past 10 years. The expansion underscores our commitment to patients and support for Texas’ long-term vision for scientific growth and innovation,” said Jim Fox, AstraZeneca’s senior vice president of Americas Supply Operations. The $445m investment into Coppell comes a week after AstraZeneca commenced construction on its new $4.5bn active pharmaceutical ingredient (API) manufacturing facility in Virginia. The work in both Coppell and Virginia is part of a wider $50bn outlay by the company to bolster manufacturing capabilities in the US by 2030. Decreasing reliance on drugs manufactured overseas has been a key ambition of the Trump administration. In May, Trump signed an executive order that will streamline the path for pharma companies to build new US drug manufacturing production sites and improve inspection times for US facilities. The FDA then launched a scheme that would make it easier for new facilities to be approved in August 2025. AstraZeneca is one of many non-US big pharma companies to turn its attention to the US. Swiss big pharma Roche outlaid $50bn worth of investment in the US, which will generate more than 1,000 jobs in new and expanded facilities. British drugmaker GSK said it would invest $30bn in the US over the next five years. Pharmaceutical Technology Excellence Awards - The Benefits of Entering Gain the recognition you deserve! The Pharmaceutical Technology Excellence Awards celebrate innovation, leadership, and impact. By entering, you showcase your achievements, elevate your industry profile, and position yourself among top leaders driving pharmaceutical advancements. Don’t miss your chance to stand out—submit your entry today! Nominate Now

上市批准并购

2025-10-15

·FiercePharma

AstraZeneca to spend $445M to boost production of Lokelma at Texas plant

AstraZeneca will spend $445 million to upgrade it plant in Coppell, Texas, which is the company's lone site that produces hyperkalemia drug Lokelma. With sales of potential blockbuster Lokelma scaling up, AstraZeneca is bolstering its production of the hyperkalemia treatment with a $445 million injection of funds.The investment will increase the capabilities of AZ’s manufacturing facility in Coppell, Texas, which is the company’s lone site in the world that produces Lokelma.AZ will build a new 9,000-square-foot building at the complex and add two production lines, doubling its capacity to manufacture the treatment. The investment also will support upgrades for drug substance production and lab testing, as well as additional warehouse and administrative space, the company said in an Oct. 15 release.“Our manufacturing facility in Coppell serves as both a critical pillar in global healthcare and has played an important role in supporting the local workforce over the past 10 years,” Jim Fox, AZ’s Americas supply operations chief, said in the release. The outlay is part of AZ’s $50 billion investment in the United States over the next five years, which it unveiled earlier this year. Last week, the company broke ground on a $4.5 billion active pharmaceutical ingredient (API) facility near Richmond, Virginia.AZ’s Texas facility, which employs 250 and is five miles north of Dallas Fort Worth International Airport, came under scrutiny when the FDA twice rejected applications for approval of Lokelma because of manufacturing issues.The oral suspension treatment, which lowers the potassium levels in the blood, was finally approved in 2018, three years after AZ obtained it in a $2.7 billion buyout of ZS Pharma. In the first half of this year, Lokelma generated sales of $328 million, which were up 31% year over year. A key competitor in the market is CSL’s Veltassa, which was approved a decade ago.

上市批准并购

2024-05-23

·药通社

绝地翻盘：阿斯利康的转型与管线建设

对话决策层！如何打剂型差和产品差？产品立项和开发如何塑造壁垒？创新药企业都是产品为王，产品决定一个企业的胜败。小企业的成功靠产品，中型企业的成功靠一条产品管线，而大企业的成功靠管线管理——不同管线的推陈出新、各管线内产品的生命周期维持与延续。管线强则企业强，管线差则企业弱，制药巨头亦是如此。本文以阿斯利康为例，介绍管线管理的重要性、以及管线搭建与维护的方法。因为创新乏力，管线青黄不接，阿斯特拉与捷利康在1998年进行了合并，组建了阿斯利康。通过合并与整合，两个公司的资源与能力产生了很大的协同性，并推出了洛赛克（奥美拉唑）的迭代品耐信（埃索美拉唑，奥美拉唑的一种手性单体），形成以了以消化、中枢神经、抗肿瘤、心血管，呼吸和抗感染为特色的六大管线，具体产品如下表所示：虽然合并之后，阿斯利康的管线得到了明显的强化，业绩在强化销售力量和耐信等核心产品的带动下，实现了持续、稳步增长，但是创新乏力的问题并未得到解决，专利悬崖始终是挥之不去的阴影。2010年之后，阿斯利康陷入了爆品后时代的危机——销售额下滑，产品管线青黄不接，研发管线储备不足，股价一蹶不振。在阿斯利康最黑暗的时候，辉瑞曾两次报价欲收购该公司。然而令阿斯利康更为气愤的是，辉瑞对这家百年巨头的两次报价均远远不及新生的“牛犊”艾尔建。这样的阿斯利康，要么接受被收购的命运，要么背水一战——逐步完成管线的升级与延伸。幸运的是，阿斯利康在至暗的时刻迎来了救世主——总裁Pascal Soriot和研发副总裁Mene Pangalos。Pascal Soriot霸气回绝了辉瑞的收购邀约，并放出豪言，要让阿斯利康的销售额在未来的十年里翻两倍，随后便对阿斯利康进行了大刀阔斧地改革。Mene Pangalos则提出5R决策框架，在该框架的影响下，阿斯利康的研发效率在短短几年间发生了显著的变化，研发成功率几乎翻了5倍。The 5R framework2012年10月，原罗氏首席运营官Pascal Soriot加入了阿斯利康，出任阿斯利康的CEO。2013年3月，阿斯利康制定了实现销售额恢复增长和建立科学领导者地位的战略目标，其核心内容包括以下六点：1）扭转因专利悬崖和收入下滑所致的不利局面，驱动业绩恢复增长；2）加速二期临床管线的开发，以扩充三期临床管线的规模和提升生物制品管线的潜力；3）坚定不移地推出专科药，以抹平阿斯利康在普药领域的历史优势；4）通过各地团队的共同努力和获取全球认可的科学集群，以创新和差异化定位的科研重塑阿斯利康的研发平台；5）显著性简化业务，提高生产力，建立支持长期成功的文化；6）利用商务拓展和收购机遇，强化产品管线。为了达成该战略目标，阿斯利康停掉了大量夕阳性领域的产品研发，聚焦于朝阳性的领域。在开发新分子实体的同时，也不断投资产品的生命周期管理（如，开发埃索美拉唑新剂型、新规格、新用法、新适应症、新复方、OTC等）。为了支持研发，阿斯利康大幅增加了研发投入，平均研发投入强度从2008-2012年间的16.4%，迅速提升至2013-2017年间的25.5%；为了在专利悬崖之下提振业绩，阿斯利康也大幅增加了销售投入，通过在专利悬崖效应不显著的区域市场提升销售力量来最大化产品价值。为此，该公司的平均市场&一般管理费投入强度从2008-2012年间的34.2%，迅速提高至2013-2017年间的50.2%（在跨国巨头中，几乎已是最高水平）。除此以外，阿斯利康还以“不惜血本”的态度引进、投资或收购产品或管线资产。在2013-2017年间，阿斯利康收购了Ardea Biosciences、百时美施贵宝的糖尿病业务部门、Amplimmune、Spirogen、Pearl Therap、Omthera Pharma、Definiens、ZS pharma、阿特维斯在北美的呼吸系统品牌药管线，控股了Acerta Pharma，总合同金额高达140亿美元。除了企业兼并，阿斯利康还花掉了41亿美元，用以授权引进了纳洛西醇、罗沙司他、monalizumab（phase 3）等20多个产品或研发项目。高强度的研发投入、高强度的销售费用和高频率的收购，必然导致阿斯利康的利润下跌。平均净利润水平从2008-2012年间的15.3%下降至2013-2017年间的10.7%，加之销售额的逐渐下滑，年平均净利润也从2008-2012年间的48.71亿美元下降至25.81亿美元。为此，阿斯利来不得不在2016年进行资产重组，剥离大量的非核心资产套现，以推动战略的继续执行。2016年阿斯利康集中甩出的资产：2016年2月，将高血压药非洛地平和单硝酸异山梨酯缓释片的中国权益以5亿美元卖给康哲；2016年3月，将便秘药Naloxegol的欧洲权益卖给ProStrakan，交易金额未知；2016年4月，将痛风药lesinurad的美国权益以2.65亿美元卖给Ironwood；2016年6月，将麻醉部门的区域权益以7.7亿美元转让给Aspen；2016年6月，将痛风药lesinurad的欧洲和拉美权益以2.3亿美元卖给Gruenenthal；2016年8月，将小分子感染部门以15.75亿美元卖给辉瑞；2016年7月，将tralokinumab和brodalumab以10亿美元卖给Leo pharma；2016年10月，将在研的IL-23单抗MEDI2070以15.2亿美元卖给艾尔建；2016年10月，将在研的COPD药物AZD7986以1.5亿美元卖给强生子公司；2016年10月，将Rhinocourt Aqua的美国以外权益以3.3亿美元卖给强生子公司；2016年10月，将艾塞那肽的中国权益以1亿美元卖给三生制药。通过资产重组，阿斯利康完成了二次战略聚焦，不仅大幅压缩了人员规模，而且显著提升了资产利用率和运营效率。经过资产的重组，阿斯利康仅剩下抗肿瘤、心血管&代谢、呼吸三条特色管线，2017年总销售额分别为40.42亿美元，72.66亿美元和47.06亿美元，其它无法归类、低收益或专利失效的产品，进行了集中化管理，总销售额为41.56亿美元。因为资产的大量剥离和长期的产品管线青黄不接，阿斯利康的销售收入在2017年达到2004年以来的历史低谷，仅为201.52亿美元。但相比2012年，阿斯利康不仅基本完成了产品管线的推陈出新，而且研发管线中储备了多个高潜力值的产品。经过2016年的资产重组，阿斯利康放弃了夕阳性的抗感染、消化管线，整合了心血管和糖尿病等普药管线，强化了朝阳性的抗肿瘤管线。随着管线的不断强化，阿斯利康在随后的几年里，大量甩出了老旧的产品权益或管线资产，用以套现并换取新的管线资源。除此以外，阿斯利康为了最大化资产的价值，除了生命周期管理（如奥拉帕利开发新适应症、新疗法），还将部分产品的权益授权给了其它公司。例如，将奥拉帕利的部分适应症权益授权给默沙东，让其与Keytruda形成捆绑销售，从而提升经济效益。2017年的形势虽然有了明显的好转，但仍需坚持才能达到战略意义上的成功。为此，阿斯利康在研发投入强度保持不变的前提下，大幅增加了产品引进的强度。2018-2022年间，阿斯利康的项目交易总金额达329亿美元，引进了Evusheld（Cilgavimab/tixagevimab）、Vimovo（奥美拉唑/碳酸氢钠）、Wainua（eplontersen）、Andexxa（andexanet alfa）、Enhertu（trastuzumab deruxtecan）、新冠疫苗等产品，以及Sipavibart（phase 3）、camizestrant（phase 3）、ceralasertib（phase 3）、IPH5201（phase 2）、monalizumab（phase 3）等重要研发项目。除此以外，阿斯利康在此期间还兼并了5家公司，总合同金额约为425亿美元。通过对Alexion的收购，阿斯利康不仅快速布局了罕见病，还成为了赛道的领头羊。经过10年的苦心经营，阿斯利康的变化是显而易见的。通过对老化的、非核心的产品的剥离与出售，产品管线实现了推陈，通过内部研发、投资引进、交易并购等多重方式，产品管线又实现了出新。如今的阿斯利康，不仅形成了以抗肿瘤、心血管&肾病与代谢、呼吸与免疫、疫苗与免疫、罕见病为特色的五大管线。而且还在抗肿瘤、罕见病等领域建立了领先的优势，不论是产品管线还是研发管线的稀缺性都有了显著的提升。正因为此，最近两年来，阿斯利康逐渐降低了销售投入，市场&一般管理费支出已经下降至销售额的42%左右。对于创新药企业而言，现有的产品管线只能代表过去和现在的成功，而能代表未来的是研发管线。所以，相比现有产品，研发管线是影响企业市值高低的最重要因素。根据阿斯利康2023年年报披露的数据，该公司一共有178个产品处于研发管线中，项目高度聚焦于抗肿瘤、生物制药和罕见病三大领域，其中处于开发晚期阶段的新分子实体有17个，123个新分子实体或产品生命周期管理的项目处于临床二期或三期阶段。因为阿斯利康逐渐形成了强大产品管线和研发管线，股价也一路飙升，2023年的市值已相比2014年翻了两倍有余，销售额方面，该公司2023年的总营收达458亿美元，相比2014年几乎也翻了两倍，Soriot成功兑现了他的承诺。本文作者：魏利军，北京药眼信息咨询有限公司创始人，著有《跨国药企成功启示录》和《仿制药企兴衰启示录》，本文内容来自正在撰写新书《制药企业的战略设计与产线规划》中的实例。因为内容是初稿，可能存在表达和内容的轻微偏误，欢迎广大朋友提供宝贵的意见。推荐阅读

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100 项与 ZS Pharma, Inc. 相关的药物交易

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100 项与 ZS Pharma, Inc. 相关的转化医学

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