Vanda制药公司宣布启动Thetis研究，这是一项评估NEREUS™预防GLP-1受体激动剂诱发呕吐的临床试验

发布时间：2026-04-08来源：PR Newswire

WASHINGTON

华盛顿

，

April 8, 2026

2026年4月8日

/PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq:

/PRNewswire/ -- Vanda Pharmaceuticals Inc.（Vanda）（纳斯达克：

VNDA

越南语

) today announced the initiation of Thetis, a clinical trial evaluating NEREUS™ (tradipitant) for the prevention of vomiting in patients receiving glucagon-like peptide-1 (

）今天宣布启动Thetis临床试验，评估NEREUS™（tradipitant）在预防接受胰高血糖素样肽-1（

GLP-1

) receptor agonist therapies. NEREUS™ was recently approved for the prevention of vomiting induced by motion.

）受体激动剂疗法。NEREUS™最近被批准用于预防由运动引起的呕吐。

GLP-1

receptor agonists, including semaglutide and tirzepatide, have transformed the treatment of type 2 diabetes and obesity. However, gastrointestinal side effects, particularly nausea and vomiting, remain a significant challenge for many patients and are a leading cause of treatment discontinuation or dose reduction.

受体激动剂，包括司美格鲁肽和替西帕肽，已经改变了2型糖尿病和肥胖症的治疗方法。然而，胃肠道副作用，特别是恶心和呕吐，对许多患者来说仍然是一个重大挑战，也是治疗中断或剂量减少的主要原因。

Recent studies and approvals in the .

近年来的研究和批准。

GLP-1

space further underscore this. Last month, a 'high dose' of Wegovy was approved by the U.S. Food and Drug Administration (FDA) on the basis of providing additional weight-loss benefits, yet it comes with the tradeoff that the top two reported adverse effects of nausea and vomiting for this high dose are of increased frequency compared to the previously approved Wegovy maximum dose..

空间进一步强调了这一点。上个月，美国食品和药物管理局（FDA）批准了“高剂量”的Wegovy，原因是其能够提供额外的减重益处，但这种高剂量的前两大报告不良反应——恶心和呕吐的发生频率相比之前批准的Wegovy最高剂量有所增加，成为了权衡利弊的因素。

GLP-1

receptor agonists offer significant benefits, but vomiting and nausea can severely impact patient adherence and quality of life,' said Mihael H. Polymeropoulos, M.D., President CEO and Chairman of the Board of Vanda Pharmaceuticals. 'NEREUS™ has demonstrated potent antiemetic effects in prior clinical studies.

“受体激动剂提供了显著的益处，但呕吐和恶心会严重影响患者的依从性和生活质量，”Vanda制药公司总裁、首席执行官兼董事会主席米哈埃尔·H·波利梅罗普洛斯博士说道。“NEREUS™在之前的临床研究中已显示出强大的止吐效果。”

We are excited to advance this program, which has the potential to improve tolerability and allow more patients to fully benefit from these important therapies.'.

我们很高兴推进这个项目，该项目有潜力提高耐受性，并使更多患者能够充分受益于这些重要的治疗方法。

The Thetis study is a multicenter, randomized, double-blind, placebo-controlled trial that will evaluate the efficacy and safety of oral tradipitant in patients initiated at a high dose of a

Thetis研究是一项多中心、随机、双盲、安慰剂对照试验，将评估口服tradipitant在高剂量起始患者中的疗效和安全性。

GLP-1

receptor agonist. The primary endpoint is the proportion of patients free from vomiting episodes during the treatment period.

受体激动剂。主要终点是在治疗期间无呕吐发作的患者比例。

The Phase 2 study, as previously announced in Vanda's press release dated November 15, 2025, was similar in design where patients were pre-treated with either tradipitant or placebo before administering a 1 mg injection of Wegovy

2025年11月15日，Vanda公司在新闻稿中宣布的第二阶段研究设计相似，患者在注射1毫克Wegovy之前，预先接受曲匹匹坦或安慰剂治疗。

, a dose that normally takes 9 weeks of titration to reach. The phase 2 study succeeded and met its primary endpoint, with only 29.3% of tradipitant-treated participants (17/58) experiencing vomiting compared to 58.6% on placebo (34/58) (p=0.0016), representing a 50% relative reduction. The study also met the key secondary endpoint of the proportion of participants with vomiting and significant nausea at 22.4% in the tradipitant group (13/58) versus 48.3% on placebo (28/58) (p=0.0039)..

，这一剂量通常需要9周的滴定才能达到。二期研究取得成功并达到了主要终点，仅29.3%的接受tradipitant治疗的参与者（17/58）出现呕吐，而安慰剂组为58.6%（34/58）（p=0.0016），相对减少了50%。研究还达到了关键的次要终点，即tradipitant组中出现呕吐和严重恶心的参与者比例为22.4%（13/58），而安慰剂组为48.3%（28/58）（p=0.0039）。

Vanda expects topline results from the Thetis study by Q4 2026. Following completion of the Thetis study, additional study data may be required prior to approval of a New Drug Application (NDA).

Vanda预计将在2026年第四季度获得Thetis研究的初步结果。在Thetis研究完成后，在新药申请（NDA）获批之前可能需要额外的研究数据。

References

参考文献

See

看见

full U.S. NEREUS Prescribing Information, available at:

完整的美国NEREUS处方信息，可访问：

www.nereus.us

。

See

看见

full U.S. Wegovy Prescribing Information, available at:

完整的美国Wegovy处方信息，可访问：

https://www.novo-pi.com/wegovy.pdf

。

See

看见

Vanda Pharmaceuticals Reports Positive Results for Tradipitant in Preventing

Vanda Pharmaceuticals 报告了 Tradipitant 在预防方面的积极结果

GLP-1

Induced Nausea and Vomiting, available at:

诱导的恶心和呕吐，可从以下网址获取：

https://www.prnewswire.com/news-releases/vanda-pharmaceuticals-reports-positive-results-for-tradipitant-in-preventing-

glp-1

GLP-1

-induced-nausea-and-vomiting-302617739.html

-诱导的恶心和呕吐-302617739.html

。

About NEREUS™

关于NEREUS™

NEREUS™ (tradipitant) is a neurokinin-1 receptor antagonist licensed by Vanda from Eli Lilly and Company. NEREUS™ is approved for the acute prevention of vomiting induced by motion in adults, and is currently in clinical development for a variety of indications, including gastroparesis and the prevention of nausea and vomiting induced by .

NEREUS™（tradipitant）是一种神经激肽-1受体拮抗剂，由Vanda从礼来公司获得许可。NEREUS™被批准用于急性预防成人因运动引发的呕吐，并且目前正针对多种适应症进行临床开发，包括胃轻瘫以及预防恶心和呕吐。

GLP-1

receptor agonists. Full NEREUS™ Prescribing Information can be found at:

受体激动剂。完整的NEREUS™处方信息可在以下网址找到：

https://www.nereus.us

。

About Vanda Pharmaceuticals Inc.

关于万达制药公司

Vanda is a leading global biopharmaceutical company focused on the development and commercialization of innovative therapies to address high unmet medical needs and improve the lives of patients. For more on Vanda Pharmaceuticals Inc., please visit

万达是一家领先的全球生物制药公司，专注于开发和商业化创新疗法，以满足未被满足的医疗需求并改善患者的生活。欲了解有关万达制药公司的更多信息，请访问

www.vandapharma.com

and follow us on X @vandapharma.

关注我们在X平台上的账号 @vandapharma。

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

关于前瞻性陈述的谨慎声明

Various statements in this press release, including, but not limited to, statements regarding the design, objectives and potential outcomes of the Thetis clinical trial; the potential benefits, effectiveness and safety of NEREUS™ (tradipitant) for the prevention of vomiting in patients receiving GLP‑1 receptor agonist therapies; the significance of results from prior clinical studies; the expected timing of topline results from the Thetis study; and the risk that additional study data may be required prior to approval of an NDA, are 'forward‑looking statements' within the meaning of the securities laws.

本新闻稿中的各种声明，包括但不限于关于Thetis临床试验的设计、目标和潜在结果的声明；NEREUS™（tradipitant）在预防接受GLP-1受体激动剂治疗的患者呕吐方面的潜在益处、有效性和安全性；以往临床研究结果的重要性；Thetis研究顶线结果的预期时间；以及在NDA获批之前可能需要更多研究数据的风险，均属于证券法意义上的“前瞻性声明”。

All statements other than statements of historical fact are statements that could be deemed forward‑looking statements. Forward‑looking statements are based on current expectations and assumptions that involve risks, changes in circumstances and uncertainties. Important factors that could cause actual results to differ materially from those reflected in Vanda's forward-looking statements include, among others, risks inherent in clinical development, including the risk that the Thetis trial may not demonstrate efficacy or safety consistent with prior studies, may not meet its primary or secondary endpoints, or may experience delays; variability in patient response to therapy; regulatory considerations affecting the development of NEREUS™ for additional indications; and the risk that additional study data may be required prior to approval of an NDA.

所有非历史事实的陈述都可能被视为前瞻性陈述。前瞻性陈述基于当前的预期和假设，这些预期和假设涉及风险、环境变化和不确定性。可能导致实际结果与Vanda的前瞻性陈述中反映的结果存在重大差异的重要因素包括但不限于：临床开发中固有的风险，包括Thetis试验可能无法证明与先前研究一致的有效性或安全性、可能无法达到其主要或次要终点，或可能经历延迟；患者对治疗的反应差异；影响NEREUS™针对其他适应症开发的监管考量；以及在NDA批准之前可能需要更多研究数据的风险。

Therefore, no assurance can be given that the results or developments anticipated by Vanda will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Vanda. Forward‑looking statements in this press release should be evaluated together with the risks and uncertainties de.

因此，无法保证万达预期的结果或发展将会实现，或者即使基本上实现了，它们将对万达产生预期的后果或影响。本新闻稿中的前瞻性声明应结合所提及的风险和不确定性进行评估。

www.sec.gov

。

All forward‑looking statements attributable to Vanda or any person acting on its behalf are expressly qualified in their entirety by the cautionary statements set forth herein. Vanda cautions investors not to place undue reliance on forward‑looking statements. The information contained in this press release is provided as of the date hereof, and Vanda undertakes no obligation, and expressly disclaims any obligation, to update or revise any forward‑looking statements, whether as a result of new information, future events, or otherwise, except as required by law..

所有可归因于Vanda或代表其行事的任何人的前瞻性声明，均以本文所述的警示声明为准，明确适用于全部内容。Vanda提醒投资者不要过分依赖前瞻性声明。本新闻稿中包含的信息是截至本日期提供的，Vanda不承担更新或修改任何前瞻性声明的义务，并明确声明不承担此义务，除非法律要求，无论是由于新信息、未来事件或其他原因。

Corporate Contact:

公司联系人：

Kevin Moran

凯文·莫兰

Senior Vice President, Chief Financial Officer and Treasurer

高级副总裁、首席财务官兼财务主管

Vanda Pharmaceuticals Inc.

万达制药公司

202-734-3400

[email protected]

电子邮件地址

Jim Golden / Jack Kelleher / Dan Moore

吉姆·戈登 / 杰克·凯勒赫 / 丹·摩尔

Collected Strategies

收集的策略

[email protected]

电子邮件地址

关注我们在X平台 @vandapharma

SOURCE Vanda Pharmaceuticals Inc.

来源：Vanda Pharmaceuticals Inc.

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