FILSPARI将通过其革命性的治疗方式改变肾病护理-动脉网

FILSPARI to Transform Kidney Disease Care with Its Revolutionary Treatment Approach

CISION 等信源发布 2025-05-28 05:31

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FILSPARI holds strong market potential as the first FDA-approved non-immunosuppressive therapy for IgA nephropathy, a rare kidney disease with significant unmet needs. As more patients and providers seek disease-modifying options, FILSPARI is well-positioned to capture substantial market share, especially with favorable long-term data..

FILSPARI 作为首个获 FDA 批准的非免疫抑制疗法，用于治疗 IgA 肾病这种存在显著未满足需求的罕见肾病，具有强大的市场潜力。随着越来越多的患者和医疗提供者寻求疾病修饰疗法，FILSPARI 凭借良好的长期数据，有望占据可观的市场份额。

LAS VEGAS

拉斯维加斯

，

May 27, 2025

2025年5月27日

/PRNewswire/ -- DelveInsight's '

/PRNewswire/ -- DelveInsight的

FILSPARI Market Size, Forecast, and Market Insight Report

FILSPARI 市场规模、预测及市场洞察报告

' highlights the details around FILSPARI, the first and only oral, once-daily, non-immunosuppressive therapy approved in both the US and

“突出了围绕FILSPARI的细节，这是首个也是唯一一个在美国和

Europe

欧洲

for IgAN. The report provides product descriptions, patent details, and competitor products (marketed and emerging therapies) of FILSPARI. The report also highlights the historical and forecasted sales from 2020 to 2034 segmented into 7MM [

针对IgAN。该报告提供了FILSPARI的产品描述、专利细节以及竞争产品（已上市和新兴疗法）。报告还重点介绍了2020年至2034年期间的历史和预测销售额，按7MM细分。

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

Travere Therapeutics' FILSPARI (sparsentan) Overview

Travere Therapeutics的FILSPARI（sparsentan）概述

FILSPARI (sparsentan) is a once-daily oral treatment that uniquely targets two key pathways, endothelin-1 and angiotensin II (also known as DEARA), in the progression of IgA nephropathy. It is the first approved non-immunosuppressive therapy for this condition. Endothelin-1 and angiotensin II contribute to kidney function decline by promoting inflammation and fibrosis, altering podocyte structure, causing podocyte loss, and increasing the permeability of the glomerular filtration barrier. .

FILSPARI（斯帕森坦）是一种每日一次的口服治疗药物，独特地靶向IgA肾病进展中的两个关键途径：内皮素-1和血管紧张素II（也称为DEARA）。它是首个获批用于该疾病的非免疫抑制疗法。内皮素-1和血管紧张素II通过引发炎症和纤维化、改变足细胞结构、导致足细胞丢失以及增加肾小球滤过屏障的通透性，从而导致肾功能下降。

Additionally, both are vasoconstrictors that narrow blood vessels and raise pressure in the glomeruli. The drug received accelerated approval based on its ability to reduce proteinuria. Due to potential safety concerns, it is distributed under the FILSPARI Risk Evaluation and Mitigation Strategy (REMS) program.

此外，两者都是通过收缩血管来提高肾小球内压力的血管收缩剂。该药物因能够减少蛋白尿而获得了加速批准。由于潜在的安全性问题，它是在FILSPARI风险评估与缓解策略（REMS）计划下进行分发的。

In .

在。

Europe

欧洲

, it is marketed by CSL Vifor, and in

，它由CSL Vifor公司销售，并且在

Japan

日本

by Renalys Pharma. Results from the registration-enabling study are expected in the second half of 2025.

由Renalys Pharma公司负责。注册启用研究的结果预计将在2025年下半年公布。

Drug Name

药品名称

FILSPARI (sparsentan)

FILSPARI（斯帕森坦）

Molecule type

分子类型

Small molecule

小分子

Developer

开发者

Travere Therapeutics

旅行者治疗公司

Primary Indication

主要适应症

Immunoglobulin A nephropathy

免疫球蛋白A肾病

FILSPARI MoA

FILSPARI 作用机制

ETAR antagonist; AT1R antagonist

ETAR拮抗剂；AT1R拮抗剂

Route of administration

给药途径

Oral

口服

Learn more about FILSPARI projected market size for IgAN @

了解有关FILSPARI对IgAN预计市场规模的更多信息 @

FILSPARI IgA Nephropathy

FILSPARI IgA肾病

IgA nephropathy (IgAN) is an autoimmune disorder that disrupts kidney function by damaging the small blood vessels responsible for filtration. This damage is caused by an abnormal protein that harms the glomeruli, the kidneys' main filtering units. According to DelveInsight, there were approximately.

IgA肾病（IgAN）是一种自身免疫性疾病，通过损害负责过滤的小血管来破坏肾功能。这种损害是由一种异常蛋白质引起的，该蛋白质会伤害肾脏主要的过滤单位——肾小球。根据DelveInsight的数据，大约有。

415,000

diagnosed prevalent cases of IgAN across the seven major markets in 2024, and this number is projected to grow at a

2024年在七大主要市场中诊断出的IgAN流行病例数，预计这一数字将以...速度增长。

CAGR of 0.6%

复合年均增长率（CAGR）为0.6%

through 2034. Current standard care involves the use of ACE inhibitors and angiotensin II receptor blockers (ARBs), primarily to manage associated symptoms like hypertension.

通过2034年。目前的标准护理涉及使用ACE抑制剂和血管紧张素II受体阻滞剂（ARBs），主要用于管理高血压等相关症状。

Currently, only a few drugs have been approved for IgAN treatment, including

目前，只有少数药物被批准用于IgAN的治疗，包括

VANRAFIA

范拉菲亚

(Atrasentan) and

(阿曲生坦) 和

FABHALTA

法布哈塔

(Iptacopan) by Novartis,

诺华公司的(Iptacopan)，

FILSPARI

菲尔斯帕里

(Sparsentan) by Travere Therapeutics, and

由Travere Therapeutics研发的（Sparsentan），以及

TARPEYO/KINPEYGO

塔普约/金佩约

(budesonide) by Asahi Kasei (Calliditas Therapeutics), among others. The treatment landscape is expected to undergo major changes between 2024 and 2034, driven by the introduction of innovative therapies. DelveInsight estimates the IgAN market across the seven key regions was valued at around

(布地奈德) 由旭化成（Calliditas Therapeutics）等公司生产。预计治疗领域将在2024年至2034年间因创新疗法的引入而发生重大变化。DelveInsight估计，IgAN市场在七大关键区域的价值约为

USD 730 million

7.3亿美元

in 2024 and is projected to grow at a strong CAGR of 30.5% from 2025 to 2034.

在2024年，并预计从2025年到2034年将以30.5%的强劲复合年增长率增长。

With targeted treatment options for IgAN only recently emerging and a pressing need for therapies that can delay progression to end-stage kidney disease (ESKD), significant advancements in this area are likely to profoundly reshape the market in the coming years.

随着针对IgAN的靶向治疗方案最近才开始出现，且迫切需要能够延缓进展至终末期肾病（ESKD）的疗法，这一领域的重要进展很可能在未来几年深刻重塑市场。

Discover more about the IgAN market in detail @

详细了解 IgAN 市场更多信息 @

IgA Nephropathy Market Assessment

IgA肾病市场评估

Emerging Competitors of FILSPARI

FILSPARI的新兴竞争对手

Key companies advancing therapies for IgA nephropathy include

推进IgA肾病治疗的关键公司包括

Novartis

诺华

(Zigakibart/FUB523),

F. Hoffmann-La Roche and Ionis Pharmaceuticals

F. 霍夫曼-拉罗什公司和伊奥尼斯制药公司

(Sefaxersen/RG6299/IONIS-FB-LRx),

（Sefaxersen/RG6299/IONIS-FB-LRx），

AstraZeneca's Alexion Pharmaceuticals

阿斯利康的亚力兄制药

(ULTOMIRIS),

Vera Therapeutics

维拉治疗学

(Atacicept),

（阿塔西普），

Vertex Pharmaceuticals

顶点制药公司

(Povetacicept),

（Povetacicept），

Otsuka Pharmaceutical

大塚制药

(Sibeprenlimab),

西贝普雷单抗，

Biogen

渤健公司

(Felzartamab),

（Felzartamab），

Arrowhead Pharmaceuticals

箭头制药公司

(ARO-C3),

NovelMed

新药

(NM8074),

Q32 Bio

Q32 生物科技

(ADX-097),

Walden Biosciences

沃尔登生物科学

(WAL0921), and

(WAL0921)，以及

Takeda Pharmaceutical

武田药品工业公司

(TAK-079), among others.

（TAK-079），以及其他。

在

April 2025

2025年4月

，

Vera Therapeutics

维拉治疗公司

announced it had completed patient enrollment for its pivotal

宣布已完成关键性的患者招募工作

Phase III ORIGIN trial

三期起源试验

assessing atacicept in IgA nephropathy. The previous month, Otsuka Pharmaceutical submitted a Biologics License Application (BLA) to the FDA for sibeprenlimab, a monoclonal antibody aimed at inhibiting APRIL (A PRoliferation-Inducing Ligand) in adults with IgAN.

评估atacicept治疗IgA肾病的效果。上个月，大冢制药向FDA提交了sibeprenlimab的生物制品许可申请（BLA），这是一种旨在抑制APRIL（增殖诱导配体）的单克隆抗体，用于治疗成年IgAN患者。

Additionally, in

此外，在

July 2022

2022年7月

, the European Commission granted

，欧盟委员会批准了

Orphan Drug Designation (ODD)

孤儿药认定 (ODD)

to BION-1301 for primary IgAN, offering regulatory benefits to support its European development. Strengthening its renal pipeline,

针对原发性IgAN的BION-1301，提供监管优势以支持其欧洲开发。加强其肾脏病管道，

Novartis

诺华

acquired

获得的

Chinook Therapeutics

奇努克治疗公司

在

August 2023

2023年8月

for up to

长达

$3.5 billion

35亿美元

, adding

，添加

zigakibart

and other late-stage kidney-focused assets to its portfolio.

并将其他晚期肾脏相关资产纳入其投资组合。

To know how does FILSPARI compare to other treatments for IgA nephropathy, visit @

要了解FILSPARI与其他IgA肾病治疗方法的比较，请访问@

FILSPARI Approval Date

FILSPARI 批准日期

Key Milestones of FILSPARI

FILSPARI的关键里程碑

在

November 2024

2024年11月

，

FILSPARI was approved by the MHRA for primary IgAN treatment, and sparsentan received approval in

FILSPARI 获得 MHRA 批准用于治疗原发性 IgAN，而 sparsentan 也获得了批准。

Germany

德国

for the same indication.

用于相同的适应症。

在

September 2024

2024年9月

，

the FDA granted full approval for FILSPARI to slow kidney function decline in IgAN patients, based on positive long-term results from the PROTECT Study.

基于PROTECT研究的积极长期结果，FDA完全批准FILSPARI用于减缓IgAN患者的肾功能下降。

在

April 2024

2024年4月

, CSL Vifor and Travere Therapeutics

，CSL Vifor 和 Travere Therapeutics

received Conditional Marketing Authorization (CMA) from the European Commission for FILSPARI in the EU, targeting adults with IgAN and significant proteinuria.

欧盟委员会已授予FILSPARI在欧盟的附条件上市许可（CMA），用于治疗患有IgAN和显著蛋白尿的成人。

在

February 2023

2023年2月

，

the US FDA granted accelerated approval to FILSPARI (sparsentan) to reduce proteinuria in adults with primary IgAN at risk of rapid progression, with priority review.

美国食品药品监督管理局（FDA）授予FILSPARI（sparsentan）加速批准，用于减少有快速进展风险的原发性IgAN成人患者的蛋白尿，并给予优先审查。

Discover how FILSPARI is shaping the IgAN treatment landscape @

发现FILSPARI如何塑造IgAN治疗领域 @

FILSPARI IgAN

FILSPARI Market Dynamics

FILSPARI市场动态

FILSPARI, developed by Travere Therapeutics, represents a significant advancement in the treatment of IgA Nephropathy, a rare and chronic autoimmune kidney disease. Approved under the FDA's accelerated approval program in early 2023, FILSPARI is the

FILSPARI由Travere Therapeutics公司开发，代表了在治疗IgA肾病（一种罕见且慢性的自身免疫性肾病）方面的重要进展。FILSPARI于2023年初通过FDA的加速批准计划获得批准，是

first non-immunosuppressive therapy

首次非免疫抑制疗法

specifically targeting proteinuria in IgAN. It is a dual endothelin angiotensin receptor antagonist (DEARA), a novel mechanism that distinguishes it from

专门针对IgAN中的蛋白尿。它是一种双重内皮素血管紧张素受体拮抗剂（DEARA），这是一种新颖的机制，使其区别于其他药物。

conventional RAAS inhibitors

传统RAAS抑制剂

. Its market entry has been notable for both its scientific innovation and potential to reshape the standard of care for IgAN, particularly in patients at high risk of progression to end-stage kidney disease (ESKD).

其市场准入因其科学创新和重塑IgAN护理标准的潜力而备受关注，尤其是在高风险进展为终末期肾病（ESKD）的患者中。

The market dynamics are influenced by multiple factors, including the

市场动态受到多种因素的影响，包括

unmet need in IgAN

IgAN未满足的需求

, the

，这个

orphan drug designation

孤儿药认定

, and the

，以及

limited competition

有限竞争

in the space. Prior to FILSPARI's launch, treatment was largely supportive, focusing on blood pressure control and proteinuria reduction via ACE inhibitors or ARBs.

在空间中。在FILSPARI推出之前，治疗主要是支持性的，重点是通过ACE抑制剂或ARB控制血压和减少蛋白尿。

FILSPARI's

菲尔斯帕里的

ability to deliver greater proteinuria reduction

实现更显著的蛋白尿减少的能力

without the side effects associated with corticosteroids or immunosuppressants provides a compelling clinical and commercial value proposition.

没有与皮质类固醇或免疫抑制剂相关的副作用，提供了令人信服的临床和商业价值主张。

Competition is evolving, with several companies advancing novel IgAN therapeutics.

竞争正在演变，几家公司正在推进新型IgAN疗法。

Calliditas Therapeutics' TARPEYO (budesonide)

Calliditas Therapeutics的TARPEYO（布地奈德）

was approved ahead of FILSPARI for a similar indication, but works through a corticosteroid pathway. Other players are also advancing programs, suggesting the market could become more segmented based on patient profile and mechanism of action. FILSPARI's differentiated profile, especially its

在FILSPARI之前获批用于类似适应症，但通过皮质类固醇途径起作用。其他公司也在推进相关项目，表明市场可能会根据患者特征和作用机制进一步细分。FILSPARI的独特特性，尤其是其

dual-acting mechanism and oral administration

双效机制和口服给药

, positions it favorably among nephrologists and specialists, but maintaining this edge will require strong real-world evidence and ongoing clinical data.

，使其在肾病学家和专科医生中处于有利地位，但保持这一优势需要强有力的真实世界证据和持续的临床数据。

From a market access and adoption standpoint, Travere has made early efforts in

从市场准入和采用的角度来看，Travere已经做出了早期的努力。

physician education, patient support programs, and collaboration with nephrology groups

医生教育、患者支持计划以及与肾病学团体的合作

to accelerate uptake. However, broader adoption will depend on

加速普及。然而，更广泛的采用将取决于

securing favorable formulary placements, long-term safety data, and sustained efficacy

确保有利的处方集位置、长期安全数据和持续有效性

in delaying disease progression. As I

在延缓疾病进展方面。正如我

gAN awareness grows and diagnosis rates improve

随着GAN意识的增强和诊断率的提高

through genetic and biomarker testing, the addressable patient population may expand, offering a significant growth opportunity for FILSPARI over the next 5–10 years.

通过基因和生物标志物检测，可治疗的患者群体可能会扩大，为FILSPARI在未来5到10年内提供显著的增长机会。

Dive deeper to get more insight into FILSPARI's strengths & weaknesses relative to competitors @

深入研究，以更深入地了解FILSPARI相对于竞争对手的优势和劣势 @

FILSPARI MoA

FILSPARI 作用机制

Table of Contents

Report Introduction

报告介绍

FILSPARI: Travere Therapeutics

FILSPARI：Travere Therapeutics

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

价格趋势

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

欧盟4国与英国市场分析

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 FILSPARI

FILSPARI上市竞争对手的关键交叉点

Key Cross of Emerging Competitors of FILSPARI

新兴竞争对手的关键交叉点

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– 2025

report provides comprehensive insights about the pipeline landscape, including clinical and non-clinical stage products and the key chronic kidney disease companies, including

报告提供了关于研发管线格局的全面见解，包括临床和非临床阶段的产品以及主要的慢性肾病公司，包括

KBP Biosciences, Eli Lilly and Company, Novo Nordisk, Prokidney, Boryung Pharmaceutical,

KBP生物科学、礼来公司、诺和诺德、Prokidney、宝龄富锦药业

among others.

其中包括。

About DelveInsight

关于DelveInsight

DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve.

DelveInsight是一家领先的商业咨询和市场研究公司，专注于生命科学领域。它通过提供全面的端到端解决方案来支持制药公司以提升其业绩。通过我们的订阅平台PharmDelve，您可以轻松获取所有医疗保健和制药市场研究报告。

。

联系我们

Shruti Thakur

info@delveinsight.com

+14699457679

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SOURCE DelveInsight Business Research, LLP

来源：DelveInsight商业研究公司

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