Open-Label Safety, Pharmacokinetic, and Efficacy Trial of Sebetralstat (KVD900) in Pediatric Patients (Ages 2-11) With Hereditary Angioedema Type I or II

KVD900-303 is an open-label, multicenter clinical trial in patients aged 2 to 11 years old with HAE Type I or II.

开始日期2024-06-24

申办/合作机构

KalVista Pharmaceuticals Ltd.

NCT05505916

/ Active, not recruiting临床3期

An Open-label Extension Trial to Evaluate the Long-term Safety of KVD900, an Oral Plasma Kallikrein Inhibitor, for On-demand Treatment of Angioedema Attacks in Adolescent and Adult Patients With Hereditary Angioedema Type I or II

This is an open-label, multicenter extension trial to evaluate the long-term safety of KVD900 in patients who are 12 years or older with HAE type I or II.

开始日期2022-10-24

申办/合作机构

KalVista Pharmaceuticals Ltd.

NCT05511922

/ Active, not recruiting临床3期

A Pharmacokinetic Subtrial in Adolescent Patients With Hereditary Angioedema Type I or II Participating in the KVD900-302 Trial

This is a multicenter pharmacokinetic (PK) subtrial to investigate the PK profile of KVD900 (sebetralstat) in adolescent patients 12 to 17 years of age with Hereditary Angioedema (HAE) type I or II.

开始日期2022-10-24

申办/合作机构

KalVista Pharmaceuticals Ltd.

100 项与塞贝特拉司他相关的临床结果

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100 项与塞贝特拉司他相关的转化医学

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100 项与塞贝特拉司他相关的专利（医药）

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项与塞贝特拉司他相关的文献（医药）

2025-04-13·EXPERT OPINION ON PHARMACOTHERAPY

An evaluation of sebetralstat as the first oral on-demand therapy for Hereditary Angioedema

Review

作者: Farkas, Henriette ; Balla, Zsuzsanna

INTRODUCTION:

Hereditary Angioedema (HAE) is a rare genetic disease characterized by sudden episodes of edema that do not respond to conventional treatments. Modern therapies targeting the kallikrein-kinin system aim to alleviate HAE attacks, reduce their frequency and severity, and enhance patients' quality of life. Sebetralstat, a novel oral plasma kallikrein inhibitor, offers a promising option for rapid and effective on-demand treatment of HAE attacks.

AREAS COVERED:

This article evaluates the pharmacokinetics, pharmacodynamics, efficacy, and tolerability of sebetralstat based on developmental studies. We reviewed and analyzed seven pertinent original studies focusing on sebetralstat trials.

EXPERT OPINION:

Oral sebetralstat provides a convenient alternative to injectable treatments, allowing patients to take the drug at the first sign of an attack, improving management of acute symptoms by helping to resolve them quickly. Clinical trials demonstrated that sebetralstat exhibits rapid absorption, effective plasma kallikrein inhibition, and a favorable safety and efficacy profile. Its pharmacokinetic and pharmacodynamic properties suggest its potential for reliable control of HAE attacks.

2025-03-01·Journal of Allergy and Clinical Immunology-In Practice

Novel Long-Term Prophylactic and On-Demand Therapies for Hereditary Angioedema

Article

作者: Banerji, Aleena ; Wu, Ashley Y

Hereditary angioedema (HAE) is a rare genetic disorder caused by C1 inhibitor deficiency or dysfunction, leading to uncontrolled activation of the kallikrein-kinin system, elevated bradykinin levels, and increased vascular permeability, resulting in swelling.Management involves prophylactic therapy to prevent kallikrein activity and on-demand therapy to treat ongoing attacks.New treatments, including donidalorsen and sebetralstat, offer promising alternatives for HAE management.

2025-03-01·JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY

Interplay between on-demand treatment trials for hereditary angioedema and treatment guidelines

Review

作者: Soteres, Daniel F ; Cohn, Danny M ; Craig, Timothy J ; Riedl, Marc A ; Magerl, Markus ; Maurer, Marcus ; Audhya, Paul K ; Lumry, William R ; Bernstein, Jonathan A

Over the past 2 decades, guidelines for the on-demand treatment of hereditary angioedema attacks have undergone significant evolution. Early treatment guidelines, such as the Canadian 2003 International Consensus Algorithm, often gated on-demand treatment by attack location and/or severity. Pivotal trials for on-demand injectable treatments (plasma-derived C1 esterase inhibitor, icatibant, ecallantide [United States only], and recombinant human C1 esterase inhibitor), which were approved in the United States and the European Union between 2008 and 2014, were designed accordingly. Subsequent post hoc analyses of clinical trial data alongside real-world evidence led to a paradigm shift. In 2013, the US Hereditary Angioedema Association guidelines recommended that all attacks, irrespective of location or severity, be considered for treatment as early as possible after onset to minimize morbidity and mortality. This approach remains the cornerstone of current treatment guidelines and has shaped the design of recent clinical trials, such as those for the investigational agents, oral plasma kallikrein inhibitor sebetralstat and oral bradykinin B2 receptor antagonist deucrictibant. This narrative review discusses the evolution of on-demand treatment guidelines, the clinical trial and real-world data that prompted significant revisions, and the subsequent changes to trial designs introduced to facilitate guideline compliance.

183

项与塞贝特拉司他相关的新闻（医药）

2025-08-21

·FiercePharma

Ionis steps into crowded HAE market with FDA approval for Dawnzera

The FDA has signed off on three drugs in the last two months to treat the rare genetic condition hereditary angioedema. The newest to come online is Ionis Pharmaceuticals' Dawnzera. Since 2008, the FDA has approved 11 treatments for a rare genetic condition called hereditary angioedema (HAE), three of which have occurred in the last two months.The latest drug to join this cohort of medicines arrived Thursday with the FDA approval of Ionis Pharmaceuticals’ Dawnzera (donidalorsen). Despite entering a competitive, crowded market, it shouldn’t be difficult for Dawnzera to differentiate itself. As the first RNA-targeted treatment for HAE, it is a first-in-class therapy and further distinguishes itself with its dosing schedule and ability to be injected at home.The U.S. regulator has signed off on Dawnzera for prophylactic use by those age 12 years and older to reduce the likelihood of the sudden, unpredictable episodes of severe swelling in the limbs, face, abdomen and larynx that characterize HAE. The disorder, which affects 7,000 people in the U.S., can be fatal when it strikes the airways and inhibits breathing.Dawnzera was designed to target plasma prekallikrein, a protein that activates inflammatory mediators associated with acute attacks of HAE.Paving the way for approval was a phase 3 trial in which Dawnzera reduced the HAE attack rate by 81% compared to placebo over 24 weeks. The attack rate reduction increased to 87% when measured beyond the second dose of Dawnzera.Dawnzera is the third in a run of recent approvals that give patients new options to combat the disease. The products will take on Takeda’s blockbuster standard of care, an injected treatment called Takhzyro, and BioCryst Pharmaceuticals’ fast-rising oral challenger Orladeyo.“Orladeyo has less benefit than Takhzyro, with respect to reducing attack rates, and it has tolerability issues, particularly (gastrointestinal) because it is oral,” Ionis CEO Brett Monia, Ph.D., said in an interview with Fierce. “With those two drugs alone, we’re seeing that patients are switching from one drug to another trying to get a better treatment. My point is—they’re unsatisfied.”Last month, the FDA endorsed Ekterly, the first approved product from small Massachusetts biotech KalVista Pharmaceuticals, which has become the first oral on-demand medicine to address the symptoms of HAE, while others are delivered by intravenous or subcutaneous administration.Adding to the competition in the HAE prophylactic space is CSL, which scored a June FDA nod for Andembry, a self-administered prefilled pen. The treatment is dosed monthly and inhibits factor XIIa, a plasma protein that plays a key role in triggering the swelling episodes.“It’s a quite different mechanism of action, with respect to the targets its going after—we’re targeting RNA, they’re targeting a protein with an antibody,” Monia said of Andembry. “It looks like a good drug. We think donidalorsen has an overall profile that will be more attractive to many patients.” CSL will be a formidable rival as it has vast experience in the HAE space. Its drugs Berinert and Haegarda, which were approved in 2009 and 2017, respectively, were the premier HAE treatments before Takhzyro became a blockbuster in 2022.Ionis believes Dawnzera’s advantage is in its dosing regimen, which calls for patients to begin with one injection every four weeks, with an option to switch to dosing every eight weeks. In an extension study of Ionis’ phase 3 trial, eight-week dosing performed at the same level as four-week dosing, limiting swelling episodes by 94% versus placebo.Meanwhile, Takhzyro starts patients on a two-week dosing schedule, with the option to switch to every four weeks. Andembry follows a monthly dosing regimen.Ionis will charge $57,462 per dose, which works out to a $747,000 price tag for annual injections, assuming a patient stays on the four-week schedule. While the annual pricing exceeds that charged by Takeda and CSL for their prophylactic treatments, it will be significantly less for patients who shift to the eight-week dosing plan.“We’re right in line with where the market is today,” Kyle Jenne, Ionis’ chief global product strategy officer, said during a post-approval webcast Thursday. “We expect the majority of (physicians) to start patients at every four weeks and then if they’re performing well and are well controlled, they could potentially have the option of moving them to every eight weeks. We’ll have to see what that split looks like over time.” Ionis also pointed to a switch cohort in its phase 3 study that evaluated the performance of Dawnzera in patients previously treated with Takhzyro, Orladeyo or Takeda's C1 inhibitor Cinryze. In switching to Dawnzera, patients reduced their mean HAE attack rate by 62% from prior prophylactic treatment over 16 weeks, with no mean increase in breakthrough attacks observed during the switch.Additionally, a total of 84% of patients surveyed preferred Dawnzera over their prior prophylactic treatment, citing better disease control, less time to administer and less injection site pain or reactions.The switch data are not included on Dawnzera’s label but will “remain important for Ionis’s messaging on market positioning and reimbursement,” according to William Blair analyst Myles Minter, Ph.D.“Overall, we see Dawnzera’s profile as superior to current prophylactic options, with less frequent dosing and at-home auto-injector dosing being further differentiators. We also view Dawnzera’s profile as comparable to CSL Behring’s Andembry,” Minter added in an Aug. 21 note.

临床3期上市批准临床结果

2025-08-12

·药事纵横

2025年7月FDA新药获批速览

本文简单盘点了2025年7月份FDA新药审批情况，看看有哪些药界新星闪亮登场，给生命健康带来了新希望：【SEPHIENCE】公司：PTC Therapeutics 批准日期：2025年7月28日治疗：苯丙酮尿症（PKU）近日，PTC Therapeutics宣布，FDA已批准Sephience（sepiapterin）用于治疗儿童和成人苯丙酮尿症（PKU）患者。此次批准适应症范围广泛，适用于1个月及以上、对sepiapterin有应答的成人和儿童高苯丙氨酸血症（HPA）患者。此次FDA批准主要基于3期APHENITY临床试验中显著的疗效与安全性数据，并在APHENITY长期延伸研究中验证了治疗效果的持续性。其中APHENITY试验的结果已发表在著名医学期刊《柳叶刀》上。分析显示，接受sepiapterin治疗的患者平均苯丙氨酸减少63%。超过80%的患者血液苯丙氨酸水平降低到美国和欧盟对PKU儿童和成人患者苯丙氨酸水平的目标指标以下。【ANZUPGO】公司：LEO Pharma 批准日期：2025年 7月23日治疗：中重度慢性手部湿疹（CHE） LEO Pharma近日宣布，FDA已批准Anzupgo（delgocitinib）乳膏（20 mg/g），用于局部治疗对外用糖皮质激素应答不佳或不适合使用糖皮质激素的中重度慢性手部湿疹（CHE）成人患者。根据新闻稿，Anzupgo乳膏是专门用于治疗中重度慢性手部湿疹成年患者的首个获FDA批准的疗法。Anzupgo是一款“first-in-class”的外用泛JAK抑制剂，可抑制造成慢性炎症皮肤疾病病变的JAK-STAT信息通路的活化。之前公布的DELTA 1和DELTA 2两项临床3期试验，评估了Anzupgo相较于安慰剂用于治疗CHE的安全性和疗效。治疗成功定义为研究者整体评估的慢性手部湿疹治疗成功（IGA-CHE TS）评分为0（皮损清除）或1（皮损几乎清除），且较基线至少提高两级。试验数据显示，在第16周时，Anzupgo治疗组与载体对照组相比，有更大比例的患者达到IGA-CHE治疗成功的标准。DELTA 1中Anzupgo治疗组达到治疗成功标准的患者比例为20%，对照组为10%。在DELTA 2中Anzupgo治疗组达标的患者比例为29%，对照组为7%（两项试验均p≤0.0055）。【Ekterly】公司：KalVista Pharmaceuticals 批准日期：2025年7月3日治疗：遗传性血管性水肿 KalVista制药公司于7月7日宣布，FDA已批准Ekterly(sebetralstat，300mg)片剂，用于治疗成人和12岁及以上儿童患者的遗传性血管性水肿(HAE)急性发作。Sebetralstat是一种口服血浆激肽释放酶抑制剂，靶向激肽释放酶-激肽系统级联。通过抑制高分子量激肽原的裂解，该药可减少缓激肽的产生，从而缓解HAE的症状。值得注意的是，Ekterly是美国FDA批准的首个也是唯一一个用于治疗12岁及以上人群遗传性血管性水肿急性发作的口服按需疗法。此项批准基于随机、三方交叉、3期KONFIDENT试验(ClinicalTrials.gov标识符：NCT05259917)的数据，该试验评估了Sebetralstat在12岁及以上患有1型或2型遗传性血管性水肿(HAE)的儿童和成人中的疗效和安全性。研究参与者被随机分配接受Sebetralstat 300mg、Sebetralstat 600mg或安慰剂治疗。研究结果显示，与安慰剂相比，Sebetralstat 600mg组患者的HAE发作症状缓解速度显著加快。在接受Sebetralstat 600mg治疗的患者中，症状开始缓解的中位时间为2小时(95% CI，1.5-2.8)。结果还显示，Sebetralstat 600mg组在首次服药后12小时内首次出现严重程度减轻的时间（使用患者总体严重程度评分[PGI-S]进行评估）显著快于安慰剂组，且具有统计学意义Sebetralstat 600mg组的严重程度减轻中位时间为9.1小时(95% CI，3.8，未达到)。另外，Sebetralstat 600mg组的发作缓解时间（首次服药后24小时内PGI-S为“无”）显著快于安慰剂组。【Zegfrovy】公司：Dizal Pharma 批准日期：2025年7月2日治疗：表皮生长因子受体(EGFR)外显子20插入突变的局部晚期或转移性非小细胞肺癌 Dizal(迪哲医药)于7月2日宣布，FDA已加速批准Zegfrovy(sunvozertinib，舒沃替尼)用于治疗经FDA批准的检测检测出表皮生长因子受体(EGFR)外显子20插入突变的局部晚期或转移性非小细胞肺癌(NSCLC)成年患者，这些患者的病情在接受铂类化疗期间或之后出现进展。 Zegfrovy已获得FDA的优先审评和突破性疗法认定，是唯一获批的针对EGFR外显子20ins突变NSCLC的靶向口服药物。该适应症基于总体缓解率和缓解持续时间获得加速审批。该适应症的持续审批可能取决于在验证性试验中对临床获益的验证和描述。 FDA还批准赛默飞世尔科技的Oncomine Dx Express Test作为Zegfrovy的伴随诊断，以帮助检测NSCLC患者的EGFR外显子20插入突变。 Zegfrovy是由迪哲医药科学家研发的不可逆EGFR抑制剂，靶向多种EGFR突变，且对野生型EGFR具有选择性。该药物在FDA的获批基于WU-KONG1B试验（ClinicalTrials.gov注册号：NCT03974022）的数据。主要疗效人群包括85例EGFR外显子20插入突变的局部晚期或转移性非小细胞肺癌患者，且在铂类化疗期间或之后病情进展。研究参与者每日一次口服Sunvozertinib 200mg，随餐服用，直至病情进展或出现无法耐受的毒性反应。研究结果显示，确认的总缓解率（主要终点）为46%（95% CI，35-57）。缓解持续时间为11.1个月（95% CI，8.2，无法评估）。【Lynozyfic】公司：Regeneron Pharmaceuticals 批准日期：2025年7月2日治疗：复发或难治性（R/R）多发性骨髓瘤（MM）再生元制药公（Regeneron Pharmaceuticals）司于7月2日宣布，FDA已加速批准Lynozyfic(linvoseltamab-gcpt)用于治疗复发或难治性(R/R)多发性骨髓瘤(MM)成年患者，这些患者既往已接受过至少四种疗法，包括蛋白酶体抑制剂、免疫调节剂和抗CD38单克隆抗体。 Linvoseltamab是一款BCMA/CD3靶向双特异性抗体，旨在将多发性骨髓瘤细胞上的BCMA与T细胞表面表达的CD3连接，以促进T细胞活化和癌细胞杀伤。Lynozyfic采用再生元的VelocImmune技术研发，是一种全人源BCMAxCD3双特异性抗体，旨在将多发性骨髓瘤细胞上的B细胞成熟抗原(BCMA)与表达CD3的T细胞连接起来，从而促进T细胞活化并杀灭癌细胞。 FDA的批准主要基于关键性1/2期LINKER-MM1试验结果，该试验评估了linvoseltamab治疗R/R MM的疗效，共有80名患者参与。由独立审查委员会评估的结果显示，患者的客观缓解率（ORR）达70%，其中45%的患者达到完全缓解（CR）或更佳的应答。患者产生首次缓解的中位时间为0.95个月（范围：0.5至6个月）。此外，中位缓解持续时间（DoR）尚未达到（95% CI：12个月至不可估计）。在中位随访13个月的应答者中，估算的9个月缓解持续率为89%（95% CI：77-95），12个月缓解持续率为72%（95% CI：54-84）。接受推荐剂量治疗的患者中，46%出现了细胞因子释放综合征(3级，< 1%)，54%出现了神经系统毒性，包括免疫效应细胞相关神经毒性(3-4级，8%)。此外，linvoseltamab-gcpt的处方信息带有关于危及生命的细胞因子释放综合征(CRS)和神经毒性(包括ICANS)的黑框警告。由于这些风险，Lynozyfic 仅通过名为 Lynozyfic 风险评估和缓解策略(REMS) 的受限项目提供。新闻稿指出，Lynozyfic是首个获得FDA批准的BCMAxCD3双特异性抗体，可从第14周开始每两周给药一次，如果在完成至少24周的治疗后达到非常好的部分缓解(VGPR)或更佳，则每四周给药一次。该方案包括在递增剂量期间（第一次递增剂量后24小时和第二次递增剂量后24小时）住院以确保安全。 Ref：FDA官网、各药企官网新闻稿。药事纵横投稿须知：稿费已上调，欢迎投稿

临床3期临床结果加速审批临床2期临床成功

2025-08-11

·ir.kalvista.com

KalVista Pharmaceuticals Announces Maintenance of Orphan Designation for Sebetralstat in European Union

Sebetralstat is one of only two hereditary angioedema therapies to maintain orphan designation, underscoring its major contribution to patient care If approved, sebetralstat will be granted 10 years of market exclusivity in EU CAMBRIDGE, Mass. & SALISBURY, England--(BUSINESS WIRE)--Aug. 11, 2025-- KalVista Pharmaceuticals, Inc. (Nasdaq: KALV) today announced that the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA) confirmed maintenance of orphan designation for sebetralstat, underscoring the critical unmet need that sebetralstat addresses in the European Union (EU). Sebetralstat, a novel, oral plasma kallikrein inhibitor, has received a positive CHMP opinion for the treatment of acute attacks of hereditary angioedema (HAE), and the European Commission (EC) final decision is expected by early October. “We are pleased with the decision to maintain EU orphan designation for sebetralstat, which is an uncommon achievement that reflects the significant benefits sebetralstat offers,” said Ben Palleiko, CEO of KalVista. “Orphan status provides benefits that will support the commercialization of sebetralstat in the EU, including 10 years of market exclusivity, as we continue our efforts to bring this important new treatment option to people living with HAE around the world.” The decision to maintain orphan designation was based on a finding of comparable efficacy of sebetralstat to injectable on-demand treatments while offering a major contribution to patient care by reducing the morbidity of HAE attacks. Maintenance of orphan designation provides several important regulatory and financial benefits, including 10 years of market exclusivity in the EU following approval. Notably, sebetralstat is now one of only two HAE medicines to have maintained orphan designation in the EU, highlighting its distinctive position within the HAE treatment landscape. “Maintaining orphan designation for sebetralstat is a recognition of the meaningful impact this therapy can have on people living with HAE,” said Mauro Cancian, MD, PhD, Head of the Allergy Division at the University of Padua in Padova, Italy. “With currently available injectable therapies, many patients delay or avoid treatment due to the hassle and fear of injection-site reactions, often suffering through attacks longer than they need to. Oral sebetralstat has the potential to change that, giving patients the ability to treat attacks early, with confidence, in a way that fits their lifestyle.” About Hereditary Angioedema Hereditary angioedema (HAE) is a rare genetic disease resulting in deficiency or dysfunction in the C1 esterase inhibitor (C1INH) protein and subsequent uncontrolled activation of the kallikrein-kinin system. People living with HAE experience painful and debilitating attacks of tissue swelling in various locations of the body that can be life-threatening depending on the area affected. Treatment guidelines recommend treating attacks as early as possible to prevent progression of swelling and shorten the time to attack resolution, and to consider treatment for all attacks, regardless of anatomic location or severity. About Sebetralstat Sebetralstat is a novel plasma kallikrein inhibitor approved in the United States and United Kingdom under the brand name EKTERLY® for the treatment of HAE attacks in people 12 years of age and older. With ongoing studies exploring its use in children aged two to 11 and multiple regulatory applications under review in key global markets, sebetralstat has the potential to become the foundational therapy for HAE management worldwide. About KalVista Pharmaceuticals, Inc. KalVista Pharmaceuticals, Inc., is a global biopharmaceutical company dedicated to developing and delivering life-changing oral therapies for individuals affected by rare diseases with significant unmet needs. In the U.S., KalVista markets EKTERLY®, the first and only oral on-demand treatment for hereditary angioedema (HAE). The Company has multiple regulatory applications under review in key global markets. For more information about KalVista, please visit www.kalvista.com and follow us on LinkedIn, X, Facebook and Instagram. Forward-Looking Statements This press release contains "forward-looking" statements within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: "anticipate," "intend," "plan," "goal," "seek," "believe," "project," "estimate," "expect," "strategy," "future," "likely," "may," "should," "will" and similar references to future periods. These statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from what we expect. Examples of forward-looking statements include, among others, information relating to our business and business plans, the success of our efforts to commercialize EKTERLY® (sebetralstat), our ability to successfully obtain foreign regulatory approvals for sebetralstat, including approval by the EC, our expectations about the timing of the EC’s final decision, our expectations about the safety and efficacy of sebetralstat and our other product candidates, the timing of clinical trials and their results, our ability to commence clinical studies or complete ongoing clinical studies, including our KONFIDENT-S and KONFIDENT-KID trials, and the ability of EKTERLY to treat HAE. Further information on potential risk factors that could affect our business and financial results are detailed in our filings with the Securities and Exchange Commission, including in our annual report on Form 10-K for the year ended April 30, 2025, our quarterly reports on Form 10-Q, and our other reports that we may make from time to time with the Securities and Exchange Commission. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise. View source version on businesswire.com: https://www.businesswire.com/news/home/20250811716601/en/ Ryan Baker Head, Investor Relations (617) 771-5001 ryan.baker@kalvista.com Molly Cameron Director, Corporate Communications (978) 339-3378 molly.cameron@kalvista.com Source: KalVista Pharmaceuticals, Inc.

孤儿药上市批准

100 项与塞贝特拉司他相关的药物交易

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研发状态

批准上市

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适应症	国家/地区	公司	日期
遗传性血管性水肿	美国	KalVista Pharmaceuticals Ltd.	2025-07-03

未上市

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适应症	最高研发状态	国家/地区	公司	日期
I型和II型遗传性血管性水肿	临床3期	美国	KalVista Pharmaceuticals Ltd.	2022-02-22
I型和II型遗传性血管性水肿	临床3期	日本	KalVista Pharmaceuticals Ltd.	2022-02-22
I型和II型遗传性血管性水肿	临床3期	澳大利亚	KalVista Pharmaceuticals Ltd.	2022-02-22
I型和II型遗传性血管性水肿	临床3期	保加利亚	KalVista Pharmaceuticals Ltd.	2022-02-22
I型和II型遗传性血管性水肿	临床3期	加拿大	KalVista Pharmaceuticals Ltd.	2022-02-22
I型和II型遗传性血管性水肿	临床3期	法国	KalVista Pharmaceuticals Ltd.	2022-02-22
I型和II型遗传性血管性水肿	临床3期	德国	KalVista Pharmaceuticals Ltd.	2022-02-22
I型和II型遗传性血管性水肿	临床3期	希腊	KalVista Pharmaceuticals Ltd.	2022-02-22
I型和II型遗传性血管性水肿	临床3期	匈牙利	KalVista Pharmaceuticals Ltd.	2022-02-22
I型和II型遗传性血管性水肿	临床3期	以色列	KalVista Pharmaceuticals Ltd.	2022-02-22

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临床结果

适应症

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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


NCT05259917 (KONFIDENT, FDA_CDER) 人工标引	临床3期	遗传性血管性水肿	-	EKTERLY 600 mg	蓋窪範膚鑰繭窪齋餘構(夢襯選構鹽積簾選鬱膚) = 齋夢觸餘製膚範鏇鹽積鬱餘餘繭廠構製憲廠衊 (鹽獵獵蓋簾簾製餘繭選 ) 更多	积极	2025-07-03
				placebo	蓋窪範膚鑰繭窪齋餘構(夢襯選構鹽積簾選鬱膚) = 繭餘築獵鏇憲積鹹積餘鬱餘餘繭廠構製憲廠衊 (鹽獵獵蓋簾簾製餘繭選 ) 更多
NCT05505916 (KONFIDENT-S) 人工标引	临床3期	遗传性血管性水肿	16	Sebetralstat	襯願築壓鏇醖餘遞夢繭(遞夢鏇鬱齋築膚遞鹽餘) = 顧積膚鑰醖糧糧夢鬱繭築顧顧窪鬱繭壓糧網衊 (顧獵憲簾鹹獵醖鑰積鹹, 1.0 ~ 34.0) 更多	积极	2025-03-03
NCT05505916 \| NCT05259917 (KONFIDENT-S) 人工标引	N/A	遗传性血管性水肿	19	sebetralstat	鹽廠餘窪積廠窪範餘鏇(鬱艱鏇製範鑰簾淵築淵) = 積廠願鹹繭蓋觸淵醖壓憲製衊願膚遞憲鏇醖築 (製遞觸憲範淵獵製憲醖, 1.0 ~ 52.0) 更多	积极	2025-03-03
NCT05505916 (KONFIDENT-S, Company_Website) 人工标引	临床3期	遗传性血管性水肿	-	Sebetralstat (Participants receiving LTP treated)	壓夢艱範蓋衊醖鬱餘憲(衊願壓鹽遞蓋鑰製鑰鬱) = 觸齋齋淵製夢網憲簾網衊糧憲鹹廠顧醖繭鹹範 (製淵範簾製齋築糧繭衊 ) 更多	积极	2025-02-10
				Sebetralstat (Participants receiving berotralstat treated)	壓夢艱範蓋衊醖鬱餘憲(衊願壓鹽遞蓋鑰製鑰鬱) = 壓齋範築餘鹽糧鏇繭淵衊糧憲鹹廠顧醖繭鹹範 (製淵範簾製齋築糧繭衊 ) 更多
NCT05259917 (KONFIDENT, Company_Website) 人工标引	临床3期	遗传性血管性水肿	-	sebetralstat 300mg	鹹餘簾範簾壓築網壓餘(遞鑰鏇憲願艱鏇網鏇窪) = 壓憲鬱齋製獵鑰淵顧衊壓壓獵製蓋顧製遞鹽膚 (網範遞簾夢壓糧壓餘觸 )	积极	2024-10-28
				Sebetralstat 600mg	鹹餘簾範簾壓築網壓餘(遞鑰鏇憲願艱鏇網鏇窪) = 衊製衊構壓夢蓋壓壓鹽壓壓獵製蓋顧製遞鹽膚 (網範遞簾夢壓糧壓餘觸 )
NCT05259917 (KONFIDENT, ACAAI2024)	临床3期	-	179	Sebetralstat 300mg	鹹網艱艱壓願蓋顧範簾(糧築衊觸築觸衊廠製蓋) = 簾夢襯糧遞鑰積獵壓鑰製繭繭艱範鹹鬱選繭壓 (壓鹽夢獵選構膚獵齋鏇, 6 ~ 140)	积极	2024-10-24
NCT05259917 (KONFIDENT and KONFIDENT-S, ACAAI2024)	临床3期	遗传性血管性水肿	16	Sebetralstat 600mg	憲鬱窪鑰獵鑰顧壓夢蓋(遞餘獵鹹簾廠鏇鹽膚構) = 願簾膚廠醖選艱選醖艱網製網醖窪積網淵選餘 (艱蓋夢膚鏇積鑰鑰鑰鏇, 0.8–6.8)	积极	2024-10-24
NCT05259917 (KONFIDENT, Pubmed) 人工标引	临床3期	遗传性血管性水肿	136	Sebetralstat 300 mg	繭鹽鬱鬱膚顧製鑰製蓋(壓鬱簾齋鹹夢壓鏇艱網) = 醖築選糧構範襯觸繭顧鏇壓製醖夢膚淵積觸壓 (築繭願淵鹽選鬱淵餘選, 0.78 ~ 7.04) 更多	积极	2024-07-04
				Sebetralstat 600 mg	繭鹽鬱鬱膚顧製鑰製蓋(壓鬱簾齋鹹夢壓鏇艱網) = 淵醖淵憲廠遞糧廠構壓鏇壓製醖夢膚淵積觸壓 (築繭願淵鹽選鬱淵餘選, 1.02 ~ 3.79) 更多
NCT05259917 (KONFIDENT, Corporate Publications) 人工标引	临床3期	遗传性血管性水肿	136	Sebetralstat 300 mg	壓膚遞夢顧觸鑰鏇淵築(蓋壓鏇獵鬱膚淵艱淵壓) = 窪願鹹衊廠築獵鬱觸艱鬱遞繭鏇鏇製觸膚鏇鏇 (廠鹽蓋選糧範廠蓋壓築, 1.28 ~ 2.27) 达到更多	积极	2024-02-13
				Sebetralstat 600 mg	壓膚遞夢顧觸鑰鏇淵築(蓋壓鏇獵鬱膚淵艱淵壓) = 膚繭顧願鬱構範夢蓋獵鬱遞繭鏇鏇製觸膚鏇鏇 (廠鹽蓋選糧範廠蓋壓築, 1.33 ~ 2.27) 达到更多
NCT04208412 (CTgov)	临床2期	I型和II型遗传性血管性水肿	84	placebo+KVD900 (600 mg KVD900)	願選憲餘壓衊衊獵壓糧(選鑰鏇廠夢選廠觸顧觸) = 鑰製繭艱繭鏇鏇鹹簾膚鬱廠窪膚襯膚築繭壓蓋 (衊衊醖憲齋鏇淵鑰鹹壓, 齋鏇壓齋顧鑰繭窪構繭 ~ 膚膚膚糧鏇壓艱蓋網築) 更多	-	2023-02-08
				placebo+KVD900 (Placebo)	願選憲餘壓衊衊獵壓糧(選鑰鏇廠夢選廠觸顧觸) = 淵鏇鏇鏇遞廠醖鹹夢顧鬱廠窪膚襯膚築繭壓蓋 (衊衊醖憲齋鏇淵鑰鹹壓, 選糧觸鹽壓膚觸憲醖願 ~ 夢廠憲醖遞鹹築憲繭獵) 更多