TRYVIO/JERAYGO有望重新定义难治性高血压的治疗-动脉网

TRYVIO/JERAYGO Positioned to Redefine Treatment of Resistant Hypertension

CISION 等信源发布 2025-04-18 05:31

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可切换为仅中文







TRYVIO (aprocitentan) in the US and JERAYGO in

TRYVIO（aprocitentan）在美国和JERAYGO在

Europe

欧洲

present significant market potential as novel therapies for patients with hypertension inadequately controlled by existing treatments. TRYVIO, approved by the FDA in

为现有治疗无法充分控制的高血压患者提供了作为新型疗法的巨大市场潜力。TRYVIO已获得FDA批准。

March 2024

2024年3月

and commercially available since

并且自那时起在市场上有售

October 2024

2024年10月

, targets systemic hypertension in adults not adequately controlled on other drugs.

，用于治疗成人其他药物控制不佳的系统性高血压。

LAS VEGAS

拉斯维加斯

，

April 17, 2025

2025年4月17日

/PRNewswire/ -- DelveInsight's '

/PRNewswire/ -- DelveInsight的 '

TRYVIO/JERAYGO Market Size, Forecast, and Market Insight Report

TRYVIO/JERAYGO 市场规模、预测及市场洞察报告

' highlights the details around TRYVIO/JERAYGO, a dual endothelin receptor antagonist. The report provides product descriptions, patent details, and competitor products (marketed and emerging therapies) of TRYVIO/JERAYGO. The report also highlights the historical and forecasted sales from 2020 to 2034 segmented into 7MM [.

“突出了TRYVIO/JERAYGO（一种双重内皮素受体拮抗剂）的细节。报告提供了TRYVIO/JERAYGO的产品描述、专利详情以及竞争产品（已上市和新兴疗法）。报告还重点介绍了2020年至2034年按7MM[分段的的历史和预测销售额。

the United States

美国

, the EU4 (

，欧盟4（

Germany

德国

，

France

法国

，

Italy

意大利

, and

，以及

Spain

西班牙

), the

），这个

United Kingdom

英国

, and

，以及

Japan

日本

Idorsia Pharmaceuticals' TRYVIO/JERAYGO (aprocitentan) Overview

Idorsia制药的TRYVIO/JERAYGO（aprocitentan）概述

TRYVIO is a once-daily oral medication that acts as a dual endothelin receptor antagonist, blocking the binding of endothelin-1 (ET-1) to both ETA and ETB receptors. This mechanism makes it particularly effective for reducing blood pressure in adults whose hypertension remains uncontrolled with other treatments.

TRYVIO 是一种每日一次的口服药物，作为双重内皮素受体拮抗剂，阻断内皮素-1 (ET-1) 与 ETA 和 ETB 受体的结合。这种机制使其特别适用于其他治疗无法控制高血压的成人降低血压。

TRYVIO also has a low risk of drug-drug interactions..

TRYVIO的药物相互作用风险也很低。

The active ingredient, aprocitentan, is marketed as TRYVIO in

活性成分，阿普罗西坦，以TRYVIO为商品名进行销售。

the United States

美国

, while in the European Union and the UK, it is available under the brand name JERAYGO. Marketing applications are currently under review in

，而在欧盟和英国，它以品牌名JERAYGO上市。营销申请目前正在审核中。

Canada

加拿大

and

和

Switzerland

瑞士

. Notably, TRYVIO is the first oral antihypertensive in a new therapeutic class to receive approval in nearly four decades.

特别是，TRYVIO是近四十年来首个获得批准的新治疗类别的口服抗高血压药。

Drug Name

药品名称

TRYVIO/JERAYGO (aprocitentan)

TRYVIO/JERAYGO（阿普罗西坦）

Molecule type

分子类型

Small molecule

小分子

Developer

开发者

Idorsia Pharmaceuticals

伊多西亚制药公司

Primary Indication

主要适应症

Systemic/resistant hypertension

系统性/难治性高血压

Mechanism of action

作用机制

Dual endothelin receptor antagonist

双内皮素受体拮抗剂

Route of administration

给药途径

Oral

口服

Learn more about TRYVIO/JERAYGO projected market size for resistant hypertension @

了解有关TRYVIO/JERAYGO在顽固性高血压领域的预计市场规模更多信息 @

TRYVIO/JERAYGO Market Potential

TRYVIO/JERAYGO市场潜力

Resistant hypertension is defined as blood pressure that remains above target levels despite the concurrent use of three antihypertensive agents of different classes, ideally including a diuretic, at optimal doses. This condition affects approximately 10-20% of the hypertensive population and is associated with a higher risk of cardiovascular events, stroke, and renal complications.

顽固性高血压的定义是，尽管同时使用了三种不同类别的抗高血压药物（理想情况下包括利尿剂）且剂量最佳，血压仍保持在目标水平以上。这种情况影响约10%-20%的高血压人群，并与较高的心血管事件、中风和肾脏并发症风险相关。

The pathophysiology is often multifactorial, involving factors such as obesity, high salt intake, secondary hypertension causes, and medication nonadherence. Managing resistant hypertension is challenging due to its complex etiology, requiring a more personalized and multidisciplinary approach..

病理生理学常常是多因素的，涉及肥胖、高盐摄入、继发性高血压原因以及药物依从性差等因素。由于其复杂的病因，管理顽固性高血压具有挑战性，需要更加个性化和多学科的方法。

The current treatment paradigm includes intensifying lifestyle interventions, ensuring optimal diuretic use, and exploring secondary causes. In recent years, device-based therapies such as renal denervation and baroreceptor activation therapy have emerged as potential options for select patients, although uptake has been cautious due to mixed clinical trial results.

当前的治疗模式包括加强生活方式干预、确保最佳利尿剂使用以及探索继发原因。近年来，基于器械的疗法（如肾去神经术和压力感受器激活疗法）已成为部分患者的潜在选择，但由于临床试验结果不一，其应用仍较为谨慎。

Pharmaceutical innovation has been relatively limited, but there is renewed interest in novel drug classes such as aldosterone synthase inhibitors, endothelin receptor antagonists, and dual-acting agents. .

制药创新相对有限，但人们对新型药物类别重新产生了兴趣，例如醛固酮合成酶抑制剂、内皮素受体拮抗剂和双重作用药物。

The future market outlook is positive, driven by an aging global population, increasing prevalence of obesity and diabetes, and heightened awareness of cardiovascular risk. We expect the resistant hypertension market to grow steadily, with significant commercial opportunity for both drug developers and medtech innovators offering targeted, evidence-based solutions..

未来市场前景乐观，全球人口老龄化、肥胖和糖尿病患病率增加以及对心血管风险的认识提高推动了市场的增长。我们预计难治性高血压市场将稳步增长，为药物研发者和医疗技术提供有针对性、基于证据解决方案的创新者带来显著的商业机会。

Discover more about the resistant hypertension market in detail @

详细了解顽固性高血压市场更多信息，请访问@

Resistant Hypertension Market Report

抗性高血压市场报告

Emerging Competitors of TRYVIO/JERAYGO

TRYVIO/JERAYGO的新兴竞争对手

Some of the competing emerging key players include

一些竞争中崭露头角的主要参与者包括

AstraZeneca

阿斯利康

(Baxdrostat),

(Baxdrostat)，

Mineralys Therapeutics

矿物治疗公司

(Lorundrostat),

（洛伦司他）

Tenax Therapeutics

坦纳克斯治疗公司

(TNX-103), and others. In

(TNX-103)及其他。在

March 2025

2025年3月

，

Tenax Therapeutics, Inc.

坦纳克斯治疗公司

announced that the FDA had completed its review of the company's revised Phase 3 development strategy for

宣布FDA已完成对公司修订的第三阶段开发策略的审查

TNX-103 (oral levosimendan)

TNX-103（口服左西孟旦）

. This included approval of an amendment to expand patient enrollment and enhance the statistical power of the ongoing

这包括批准一项修正案，以扩大患者入组并增强正在进行的统计功效。

Phase III LEVEL trial

第III期LEVEL试验

, as well as the protocol for

，以及协议

LEVEL-2

二级水平

, Tenax's second registrational Phase III study. The company stated that it now plans to enroll 230 patients in the LEVEL study, boosting the study's statistical power to over 95%. LEVEL-2, a global trial, is expected to launch in 2025.

Tenax的第二项注册性III期研究。该公司表示，目前计划在LEVEL研究中招募230名患者，将研究的统计功效提升至95%以上。LEVEL-2是一项全球性试验，预计将于2025年启动。

在

March 2025

2025年3月

，

Mineralys Therapeutics, Inc.

矿物治疗公司

reported comprehensive results from the Phase II

报告了第二阶段的综合结果

Advance-HTN trial

Advance-HTN 试验

, one of two key studies assessing lorundrostat in patients with confirmed uncontrolled hypertension (uHTN) or resistant hypertension (rHTN). In this trial, the 50 mg dose of lorundrostat achieved an absolute reduction of 15.4 mmHg in blood pressure and a placebo-adjusted reduction of 7.9 mmHg at week 12.

，这是评估洛伦多司他治疗确诊的未控制高血压（uHTN）或难治性高血压（rHTN）患者的两项关键研究之一。在这项试验中，50毫克剂量的洛伦多司他在第12周时实现了血压绝对降低15.4毫米汞柱，校正安慰剂后降低7.9毫米汞柱。

The treatment also showed a favorable safety and tolerability profile, with only minor changes observed in potassium, sodium, and eGFR levels, and a low rate of treatment discontinuation..

该治疗方案还显示出良好的安全性和耐受性，仅观察到钾、钠和肾小球滤过率（eGFR）水平有轻微变化，且治疗中断率较低。

To know more about the number of competing drugs in development, visit @

要了解更多关于正在开发的竞争药物数量的信息，请访问 @

TRYVIO/JERAYGO Market Positioning Compared to Other Drugs

TRYVIO/JERAYGO与其他药物的市场定位比较

Key Milestones of TRYVIO/JERAYGO

TRYVIO/JERAYGO 的关键里程碑

在

March 2025

2025年3月

, Idorsia

，伊多西亚

announced that the US FDA had fully released TRYVIO from its REMS (Risk Evaluation and Mitigation Strategy) requirement. Idorsia is also released from the post-marketing requirement (PMR) to conduct a worldwide descriptive study that collects prospective and retrospective data in women exposed to TRYVIO during pregnancy and/or lactation, as these data are no longer needed.

宣布美国FDA已完全解除TRYVIO的REMS（风险评估与缓解策略）要求。Idorsia也已从上市后要求（PMR）中解除，无需再进行一项全球性描述性研究，该研究旨在收集孕期和/或哺乳期接触TRYVIO的女性的前瞻性及回顾性数据，因为这些数据已不再需要。

Idorsia no longer has post-marketing requirements for TRYVIO..

Idorsia不再有TRYVIO的上市后要求。

在

January 2025

2025年1月

，

Medicines and Healthcare Products Regulatory Agency (MHRA) approved JERAYGO to treat hypertension (high blood pressure) in adults whose blood pressure cannot be adequately controlled by at least three other medicines (also known as resistant hypertension), in the UK.

英国药品和健康产品管理局（MHRA）已批准JERAYGO用于治疗英国那些血压无法通过至少三种其他药物充分控制的成人高血压（也称为顽固性高血压）。

在

July 2024

2024年7月

, Idorsia

，Idorsia

received approval from the European Commission for JERAYGO for the treatment of resistant hypertension in adult patients in combination with at least three antihypertensive medicinal products. The recommended dose is 12.5 mg orally once daily. The dose can be increased to 25 mg once daily for patients tolerating the 12.5 mg dose and in need of tighter blood pressure control. .

收到欧洲委员会关于JERAYGO的批准，用于治疗成年患者的顽固性高血压，与至少三种抗高血压药物联合使用。推荐剂量为每日一次口服12.5毫克。对于耐受12.5毫克剂量且需要更严格血压控制的患者，剂量可增加至每日一次25毫克。

在

March 2024

2024年3月

, Idorsia

，Idorsia

announced that the US Food and Drug Administration (FDA) has approved TRYVIO for the treatment of hypertension in combination with other antihypertensive drugs to lower blood pressure in adult patients who are not adequately controlled on other drugs. The recommended dosage of TRYVIO is 12.5 mg orally once daily, with or without food.

宣布美国食品药品监督管理局（FDA）已批准TRYVIO用于治疗高血压，与其他抗高血压药物联合使用，以降低未通过其他药物充分控制的成年患者的血压。TRYVIO的推荐剂量为每日一次口服12.5毫克，可随餐或不随餐服用。

It was made commercially available in the US in .

它在美国被商业化发售。

October 2024

2024年10月

。

Discover how TRYVIO/JERAYGO is shaping the resistant hypertension treatment landscape @

了解TRYVIO/JERAYGO如何塑造抗性高血压治疗领域 @

TRYVIO/JERAYGO Medication

TRYVIO/JERAYGO 药物

TRYVIO/JERAYGO Market Dynamics

TRYVIO/JERAYGO市场动态

TRYVIO

尝试vio

(also marketed as

（也作为商品销售为

JERAYGO

杰拉伊戈

in select markets) is a promising therapeutic entrant in the treatment landscape for resistant hypertension, representing a novel mechanism of action targeting the

在选定市场中）是治疗难治性高血压领域的一个有前景的治疗新秀，代表了一种针对该问题的全新作用机制。

aldosterone pathway

醛固酮途径

. As a selective aldosterone synthase inhibitor, TRYVIO addresses a key pathophysiological driver in resistant hypertension—aldosterone excess—offering a

作为一种选择性醛固酮合成酶抑制剂，TRYVIO 针对顽固性高血压的一个关键病理生理驱动因素——醛固酮过量——提供了新的治疗选择。

more targeted approach

更加针对性的方法

compared to traditional mineralocorticoid receptor antagonists (MRAs) like

与传统的盐皮质激素受体拮抗剂（MRAs）相比，如

spironolactone or eplerenone

螺内酯或依普利酮

. This differentiation positions TRYVIO as an

. 这种差异化定位使 TRYVIO 成为

important alternative

重要的替代方案

for patients who are intolerant to MRAs or who do not achieve adequate blood pressure control despite existing therapies.

对于无法耐受MRAs或尽管接受现有治疗但血压控制仍不充分的患者。

TRYVIO's entry comes at a time when the hypertension market is seeing

TRYVIO进入市场之际，正值高血压市场迎来新的发展时期

renewed attention toward personalized, mechanism-based treatments

对个性化、机制导向的治疗重新关注

. Early clinical trial data have demonstrated

早期临床试验数据已证明

meaningful reductions in systolic blood pressure

有意义的收缩压降低

with a favorable safety and tolerability profile. This has led to increasing interest among specialists in cardiology and nephrology. TRYVIO's potential to be used alongside

具有良好的安全性和耐受性特征。这引起了心脏病学和肾脏病学专家们的日益关注。TRYVIO 有望与

existing antihypertensive agents

现有的抗高血压药物

without significant drug-drug interactions is a key advantage. However, uptake may be moderated in the short term by p

没有显著的药物相互作用是一个关键优势。然而，短期内吸收可能会受到 p 的影响。

hysician familiarity with MRAs, payer scrutiny on pricing

医生对MRA的熟悉程度，支付方对价格的审查

, and the

，以及

need for broader real-world data

需要更广泛的真实世界数据

to confirm long-term efficacy and safety.

确认长期有效性和安全性。

From a regulatory standpoint, TRYVIO/JERAYGO has

从监管的角度来看，TRYVIO/JERAYGO具有

gained approvals

获得了批准

in several major markets, including the U.S. and EU, with regulatory filings underway in

包括美国和欧盟在内的几个主要市场，监管文件正在审批中，

Asia-Pacific

亚太地区

regions. Payers are cautiously optimistic, with

地区。支付者持谨慎乐观态度，

reimbursement being granted in many geographies

在许多地区获得报销

based on unmet needs and pharmacoeconomic models projecting reductions in cardiovascular events and hospitalizations. That said, its

基于未满足的需求和预测心血管事件和住院率降低的药物经济学模型。也就是说，它的

premium pricing

溢价定价

compared to generics necessitates the generation of robust health economic data to support its value proposition, especially in cost-sensitive healthcare systems.

与仿制药相比，必须生成强有力的健康经济学数据以支持其价值主张，尤其是在对成本敏感的医疗系统中。

Looking ahead, TRYVIO is well-positioned to capture a

展望未来，TRYVIO 有望抓住机遇。

substantial share

相当大的份额

of the resistant hypertension market, particularly as guidelines begin to incorporate newer therapeutic classes. We forecast steady growth driven by

在难治性高血压市场，特别是随着指南开始纳入较新的治疗类别。我们预测，这一增长将受到

expanding physician adoption, increasing diagnosis of resistant hypertension, and potential label expansion

扩大医生采用、增加顽固性高血压的诊断以及潜在的标签扩展

into related indications such as heart failure with preserved ejection fraction (HFpEF).

进入相关适应症，例如射血分数保留的心力衰竭 (HFpEF)。

Strategic partnerships, post-marketing surveillance, and long-term outcome studies

战略合作伙伴关系、上市后监测和长期结果研究

will be critical in shaping TRYVIO's competitive edge and sustaining momentum in a crowded but evolving treatment landscape.

在竞争激烈但不断发展的治疗领域中，塑造TRYVIO的竞争优势并保持发展势头将至关重要。

Dive deeper to get more insight into TRYVIO/JERAYGO's strengths & weaknesses relative to competitors @

深入研究以更深入地了解TRYVIO/JERAYGO相对于竞争对手的优势和劣势 @

TRYVIO/JERAYGO Market Drug Report

TRYVIO/JERAYGO 市场药物报告

Table of Contents

Report Introduction

报告介绍

TRYVIO/JERAYGO: Idorsia Pharmaceuticals

TRYVIO/JERAYGO：Idorsia制药公司

2.1

Product Overview

产品概述

2.2

Other Development Activities

其他开发活动

2.3

Clinical Development

临床开发

2.4

Clinical Trials Information

临床试验信息

2.5

Safety and Efficacy

安全性与有效性

2.6

Product Profile

产品概况

2.7

Market Assessment

市场评估

2.7.1

The 7MM Analysis

7MM分析

2.7.1.1

Cost Assumptions and Rebate

成本假设与回扣

2.7.1.2

Pricing Trends

定价趋势

2.7.1.3

Analogue Assessment

模拟评估

2.7.1.4

Launch Year and Therapy Uptake

上市年份与治疗吸收率

2.7.2

The United States Market Analysis

美国市场分析

2.7.3

EU4 and the United Kingdom Market Analysis

EU4与英国市场分析

2.7.3.1

Germany

德国

2.7.3.2

France

法国

2.7.3.3

Italy

意大利

2.7.3.4

Spain

西班牙

2.7.3.5

英国

2.7.4

Japan Market Analysis

日本市场分析

2.8

Market Drivers

市场驱动因素

2.9

Market Barriers

市场壁垒

2.10

SWOT Analysis

SWOT分析

Key Cross of Marketed Competitors of TRYVIO/JERAYGO

TRYVIO/JERAYGO上市竞争对手的关键十字交叉分析

Key Cross of Emerging Competitors of TRYVIO/JERAYGO

新兴竞争对手的关键交叉点：TRYVIO/JERAYGO

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