Single-center, Randomized, Double-blind, Placebo-controlled Clinical Trial for the Safety, Tolerability and Efficacy of Ularitide in Cirrhosis Patients With Refractory Ascites.

This clinical trial intends to investigate the safety, tolerability and efficacy of ularitide on the renal response in patients with liver cirrhosis and refractory ascites for a maximum exposure duration of 48 hours, through a randomized, placebo-controlled, double-blind, single-center trial.

开始日期2020-08-01

申办/合作机构

University of Aarhus

[+1]

EUCTR2018-004871-11-DE / Unknown status临床2期

RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED DOSE ESCALATION STUDY OF ULARITIDE FOLLOWED BY A 42-HOUR INFUSION FOR THE TREATMENT OF ACUTE KIDNEY INJURY (AKI) IN PATIENTS POST CARDIAC SURGERY - TRUST

开始日期2019-09-05

申办/合作机构

Cardiorentis AG

100 项与乌拉立肽相关的临床结果

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100 项与乌拉立肽相关的转化医学

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100 项与乌拉立肽相关的专利（医药）

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项与乌拉立肽相关的文献（医药）

2021-11-12·Danish medical journal4区 · 医学

Ularitide as treatment of refractory ascites in cirrhosis- a study protocol for a randomised trial.

4区 · 医学

Article

作者: Watson, Hugh ; Meyer, Markus ; Gantzel, Rasmus Hvidbjerg ; Aagaard, Niels Kristian ; Mazgareanu, Stefan ; Jepsen, Peter ; Holzmeister, Johannes ; Grønbæk, Henning

INTRODUCTION Ascites is a frequent complication to cirrhosis. When ascites becomes refractory to standard diuretic pharmacotherapy, patients are facing a median survival of less than one year and most likely a need for frequent hospitalisations due to large-volume paracentesis or complications. An unmet need exists for new and improved treatments of refractory ascites and the present study investigates the potential of the natriuretic peptide ularitide for this indication. METHODS We aim to investigate the effects, safety and tolerability of ularitide as treatment of refractory ascites in cirrhosis patients in a randomised, double-blind, placebo-controlled trial. Participants receive ularitide or placebo as a continuous intravenous infusion during hospitalisation as an add-on to any diuretic treatment. Clinical end points include increase in diuresis and natriuresis, reduction in body weight and waist circumference, safety end points, as well as changes in plasma concentrations of renal and systemic response biomarkers and hormones. CONCLUSION This study will provide evidence concerning the potential of ularitide in treating cirrhosis patients with refractory ascites. FUNDING This investigator-initiated trial is supported by ADS AIPHIA Development Services AG. TRIAL REGISTRATION Clinicaltrials.gov (NCT04311489) and EU Drug Regulating Authorities Clinical Trials (EudraCT: 2019-002268-28). The trial will be conducted in accordance with good clinical practice, the Declaration of Helsinki and applicable demands from Danish authorities.

2021-05-01·The Journal of comparative neurology3区 · 医学

Variation of pro‐vasopressin processing in parvocellular and magnocellular neurons in the paraventricular nucleus of the hypothalamus: Evidence from the vasopressin‐related glycopeptide copeptin

3区 · 医学

Article

作者: Otubo, Akito ; Satoh, Keita ; Itoi, Keiichi ; Ueda, Yasumasa ; Kawakami, Natsuko ; Maejima, Sho ; Takanami, Keiko ; Talukder, Ashraf H. ; Oti, Takumi ; Sakamoto, Tatsuya ; Sakamoto, Hirotaka ; Morris, John F.

Abstract:

Arginine vasopressin (AVP) is synthesized in parvocellular‐ and magnocellular neuroendocrine neurons in the paraventricular nucleus (PVN) of the hypothalamus. Whereas magnocellular AVP neurons project primarily to the posterior pituitary, parvocellular AVP neurons project to the median eminence (ME) and to extrahypothalamic areas. The AVP gene encodes pre‐pro‐AVP that comprises the signal peptide, AVP, neurophysin (NPII), and a copeptin glycopeptide. In the present study, we used an N‐terminal copeptin antiserum to examine copeptin expression in magnocellular and parvocellular neurons in the hypothalamus in the mouse, rat, and macaque monkey. Although magnocellular NPII‐expressing neurons exhibited strong N‐terminal copeptin immunoreactivity in all three species, a great majority (~90%) of parvocellular neurons that expressed NPII was devoid of copeptin immunoreactivity in the mouse, and in approximately half (~53%) of them in the rat, whereas in monkey hypothalamus, virtually all NPII‐immunoreactive parvocellular neurons contained strong copeptin immunoreactivity. Immunoelectron microscopy in the mouse clearly showed copeptin‐immunoreactivity co‐localized with NPII‐immunoreactivity in neurosecretory vesicles in the internal layer of the ME and posterior pituitary, but not in the external layer of the ME. Intracerebroventricular administration of a prohormone convertase inhibitor, hexa‐d‐arginine amide resulted in a marked reduction of copeptin‐immunoreactivity in the NPII‐immunoreactive magnocellular PVN neurons in the mouse, suggesting that low protease activity and incomplete processing of pro‐AVP could explain the disproportionally low levels of N‐terminal copeptin expression in rodent AVP (NPII)‐expressing parvocellular neurons. Physiologic and phylogenetic aspects of copeptin expression among neuroendocrine neurons require further exploration.

2019-03-01·Current opinion in cardiology4区 · 医学

Update on the diagnosis and management of acute heart failure

4区 · 医学

Review

作者: Gouda, Pishoy ; Ezekowitz, Justin A

PURPOSE OF REVIEW:

To highlight the advances in the diagnosis and management of acute heart failure (AHF) from recent clinical trials and observational studies.

RECENT FINDINGS:

We highlight date from recent studies examining the use of novel biomarkers (micro RNAs, osteopontin, insulin-like growth-factor binding protein-7) for the diagnosis of AHF. In addition, we summarize the evidence for novel pharmacological therapies including: serelaxin, ularitide, clevidipine, urocortins, BMS-986231, TRB027, vericiguat, omecamtiv, and torsemide. Finally, we explore the evidence behind the use of novel management algorithms.

SUMMARY:

Despite many advances in understanding the pathophysiology of AHF, there is currently insufficient evidence to suggest changes to standards of care.

项与乌拉立肽相关的新闻（医药）

2024-03-02

·PRNewswire

Global Acute Heart Failure (AHF) Therapeutics Research Report 2022-2024 and 2030: Conventional Therapies Leave Considerable Unmet Needs, Novel Treatments Offer a Ray of Hope

DUBLIN, March 1, 2024 /PRNewswire/ -- The "Acute Heart Failure (AHF) Therapeutics: Global Strategic Business Report" report has been added to ResearchAndMarkets.com's offering. Global Acute Heart Failure (AHF) Therapeutics Market to Reach $2.9 Billion by 2030 The global market for Acute Heart Failure (AHF) Therapeutics estimated at US$599.7 Million in the year 2022, is projected to reach a revised size of US$2.9 Billion by 2030, growing at a CAGR of 21.7% over the analysis period 2022-2030. Cardiac Glycosides, one of the segments analyzed in the report, is projected to record a 22.3% CAGR and reach US$762.4 Million by the end of the analysis period. Taking into account the ongoing post pandemic recovery, growth in the B-Blockers segment is readjusted to a revised 25.1% CAGR for the next 8-year period. The acute heart failure (AHF) market has been significantly impacted by the COVID-19 pandemic and the looming global recession. Despite the challenges, diuretics and vasodilators remain the first-line therapy for AHF, although the efficacy of other known drugs for AHF is limited, hindering their widespread use. Market insights and trajectories indicate a complex landscape influenced by these factors, with varying degrees of competitive market presence among players worldwide in 2022. Recent market activity reflects ongoing efforts to size the AHF market and adapt to the evolving healthcare landscape. Looking ahead, the market outlook suggests continued focus on addressing the challenges posed by COVID-19 and economic uncertainties while exploring opportunities for innovation and growth in AHF therapeutics. The U.S. Market is Estimated at $163.4 Million, While China is Forecast to Grow at 30.4% CAGR The Acute Heart Failure (AHF) Therapeutics market in the U.S. is estimated at US$163.4 Million in the year 2022. China, the world's second largest economy, is forecast to reach a projected market size of US$841.2 Million by the year 2030 trailing a CAGR of 30.4% over the analysis period 2022 to 2030. Among the other noteworthy geographic markets are Japan and Canada, each forecast to grow at 16.3% and 18.4% respectively over the 2022-2030 period. Within Europe, Germany is forecast to grow at approximately 17.1% CAGR. Led by countries such as Australia, India, and South Korea, the market in Asia-Pacific is forecast to reach US$433.4 Million by the year 2030. MARKET OVERVIEW Influencer Market Insights World Market Trajectories Market Outlook Recent Market Activity Sizing the AHF Market Acute Heart Failure - An Overview of the Disease and Available Therapeutics Diuretics and Vasodilators - The First Line Therapy for AHF Other Known Drugs for AHF - Lower Efficacy Thwarts Use Acute Heart Failure (AHF) Therapeutics - Global Key Competitors Percentage Market Share in 2022 (E) Competitive Market Presence - Strong/Active/Niche/Trivial for Players Worldwide in 2022 (E) Impact of Covid-19 and a Looming Global Recession MARKET TRENDS & DRIVERS Conventional Therapies Leave Considerable Unmet Needs Novel Treatments Offer a Ray of Hope Key AHF Therapeutics in the Pipeline Serelaxin Nears Trial Readout form RELAX-AHF-2 Ularitide - A Novel Drug in Development for AHF The Litany of Drug Failures Expands, Emphasis on Prevention Grows Other Promising Drugs under Development Research Findings Kidney Dysfunction - Predictor of Acute Heart failure Genetic Influence on Heart Disease among African Americans Higher Body Mass Index - A Key Risk Factor for AHF Supplemental Oxygen Therapy May not be for All Cases of AHF Macro Growth Drivers Alarming Levels of Cardiovascular Disease (CVD) Prevalence: Key Growth Driver for AHF Therapeutics Ballooning Elderly Population: The Vital Growth Driver for AHF Therapeutics FOCUS ON SELECT PLAYERS (Total 93 Featured) Bayer AG (Germany) Bristol-Myers Squibb Company (USA) Cardiorentis AG (Switzerland) CVie Therapeutics Limited (Taiwan) Cytokinetics, Inc. (USA) Merck & Co. (USA) Novartis AG (Switzerland) Orion Corporation (Finland) PhaseBio Pharmaceuticals, Inc. (USA) For more information about this report visit About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. Media Contact: Research and Markets Laura Wood, Senior Manager [email protected] For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716 Logo: SOURCE Research and Markets

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB05034

研发状态

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适应症	最高研发状态	国家/地区	公司	日期
急性失代偿性心力衰竭	临床3期	美国	Cardiorentis AG	2012-07-01
急性失代偿性心力衰竭	临床3期	阿根廷	Cardiorentis AG	2012-07-01
急性失代偿性心力衰竭	临床3期	比利时	Cardiorentis AG	2012-07-01
急性失代偿性心力衰竭	临床3期	巴西	Cardiorentis AG	2012-07-01
急性失代偿性心力衰竭	临床3期	加拿大	Cardiorentis AG	2012-07-01
急性失代偿性心力衰竭	临床3期	捷克	Cardiorentis AG	2012-07-01
急性失代偿性心力衰竭	临床3期	爱沙尼亚	Cardiorentis AG	2012-07-01
急性失代偿性心力衰竭	临床3期	芬兰	Cardiorentis AG	2012-07-01
急性失代偿性心力衰竭	临床3期	法国	Cardiorentis AG	2012-07-01
急性失代偿性心力衰竭	临床3期	德国	Cardiorentis AG	2012-07-01

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT01661634 (TRUE-AHF, Pubmed) 人工标引	临床3期	心脏衰竭	2,157	Ularitide	觸遞積憲齋憲齋願選構(鑰窪構襯夢願鑰簾網鏇) = 餘糧憲艱艱窪獵憲選願艱鏇製網衊夢遞衊鏇壓 (壓築淵獵獵糧構範鑰願 )	积极	2017-05-18
				Placebo	觸遞積憲齋憲齋願選構(鑰窪構襯夢願鑰簾網鏇) = 窪顧壓觸淵範願糧鹹鏇艱鏇製網衊夢遞衊鏇壓 (壓築淵獵獵糧構範鑰願 )