预约演示

更新于：2025-05-16

Iloperidone

伊潘立酮

更新于：2025-05-16

概要

基本信息

药物类型

小分子化药

别名

1-[4-[3-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1- piperidinyl]propoxy]-3-methoxyphenyl]ethanone、4'-(3-(4-(6-fluoro-1,2-benzisoxazol-3-yl)piperidino)propoxy)-3'-methoxyacetophenone、Fanaptum

+ [10]

靶点

5-HT2A receptor x D2 receptor

作用方式

拮抗剂

作用机制

5-HT2A receptor拮抗剂(5-羟色胺2A受体拮抗剂)、D2 receptor拮抗剂(多巴胺D2受体拮抗剂)

治疗领域

其他疾病神经系统疾病

在研适应症

躁郁症1型躁狂精神分裂症

非在研适应症

急性精神分裂症情绪易怒原发性肥大性骨关节病+ [3]

原研机构

Novartis Pharma AG

在研机构

Novartis AG

Vanda Pharmaceuticals, Inc.

Probiomed SA de CV

非在研机构

Novartis Pharmaceuticals Corp.

权益机构

Novartis AG

Vanda Pharmaceuticals, Inc.Aventis SA

+ [1]

最高研发阶段批准上市

首次获批日期

美国 (2009-05-06),

精神分裂症

最高研发阶段(中国)-

特殊审评-

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结构/序列

分子式C24H27FN2O4

InChIKeyXMXHEBAFVSFQEX-UHFFFAOYSA-N

CAS号133454-47-4

关联

项与伊潘立酮相关的临床试验

NCT06961968

/ Not yet recruiting临床3期

A Multicenter, Open-Label, Relapse Prevention Study in Patients With Schizophrenia Receiving Iloperidone Long-Acting Injection (LAI)

The purpose of this research is to evaluate the relative exposure of iloperidone long-acting injection (LAI) compared to oral iloperidone in patients with schizophrenia.

开始日期2025-05-01

申办/合作机构

Vanda Pharmaceuticals, Inc.

NCT06494397

/ Not yet recruiting临床1期

Crossover Bioequivalence Study of 12 mg VHX-896 and Iloperidone Tablets Under Steady-State Conditions

Study to compare the pharmacokinetics and pharmacodynamics of VHX-896 and iloperidone and evaluate the safety and tolerability of VHX-896 and iloperidone in patients with schizophrenia or bipolar I disorder under steady state conditions.

开始日期2024-07-01

申办/合作机构

Vanda Pharmaceuticals, Inc.

NCT05648591

/ Recruiting临床4期

Open-label Safety Study of a 1-year 8 to 24 mg/Day Dose Regimen of Iloperidone (FANAPT®) in Adolescent Patients With Schizophrenia or Bipolar I Disorder

To evaluate the safety and tolerability of iloperidone in adolescent patients with schizophrenia or bipolar I disorder for up to 52 weeks of treatment.

开始日期2023-05-24

申办/合作机构

Vanda Pharmaceuticals, Inc.

100 项与伊潘立酮相关的临床结果

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100 项与伊潘立酮相关的转化医学

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100 项与伊潘立酮相关的专利（医药）

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442

项与伊潘立酮相关的文献（医药）

2025-05-01·EUROPEAN NEUROPSYCHOPHARMACOLOGY

Antipsychotic drug dosing and study discontinuation in schizophrenia: A systematic review and dose-response meta-analysis

Review

作者: Wu, Hui ; Leucht, Stefan ; Lin, Xiao ; Tian, Jing ; Siafis, Spyridon ; Schneider-Thoma, Johannes

BACKGROUND:

High discontinuation rates compromise the effectiveness of treatment regimens for schizophrenia, because consistent medication adherence is essential for the efficacy of antipsychotics. Understanding the relationship between antipsychotic doses and discontinuation rates is important. This study explores this relationship to identify doses that maximize treatment adherence and minimize discontinuation.

METHODS:

We systematically searched multiple electronic databases for fixed-dose RCTs assessing 20 antipsychotics in patients with acute exacerbation of schizophrenia and related disorders. We analyzed dose-response relationships using a one-stage dose-response meta-analysis within a frequentist framework, employing restricted cubic splines to model the relationships. The primary outcome was discontinuation for any reason, and secondary outcomes were discontinuation due to inefficacy and side effects.

RESULTS:

Analysis of 136 trials involving 44,126 participants revealed various dose-response relationships for antipsychotics. For the primary outcome, all-cause discontinuation, amisulpride, cariprazine, olanzapine (Zyprexa), and quetiapine demonstrated U-shaped curves, indicating optimal dosing thresholds where further increases in dosage led to heightened discontinuation rates, possibly due to side effects. Aripiprazole, asenapine, brexpiprazole, clozapine, paliperidone, and risperidone (Risperdal) had plateaus, suggesting no additional benefit from increasing doses beyond specific points. For haloperidol, iloperidone, lumateperone, lurasidone, sertindole, and ziprasidone, the dose-response curves did not reach a plateau within the examined doses. Inefficacy discontinuation curves were similar to total discontinuation. Most discontinuation for side-effects curves showed sharp increases in side-effects associated with higher doses.

CONCLUSION:

Dose discontinuation curves varied between the antipsychotics and included U-shaped, monotonic, and hyperbolic patterns. Future studies should consistently present disease-related and side-effect-related dropouts due to adverse events separately.

2025-04-01·Journal of intensive care medicine

Risk Stratification of QTc Prolongation in Critically Ill Patients Receiving Antipsychotics for the Management of Delirium Symptoms

Review

作者: Rosen, Jordan H. ; Celano, Christopher M. ; Karlson, Rebecca A. ; Huffman, Jeff C. ; Sadlonova, Monika ; Beach, Scott R. ; Ramirez Gamero, Andres F. ; Funk, Margo C.

Background:

Patients experiencing significant agitation or perceptual disturbances related to delirium in an intensive care setting may benefit from short-term treatment with an antipsychotic medication. Some antipsychotic medications may prolong the QTc interval, which increases the risk of potentially fatal ventricular arrhythmias. In this targeted review, we describe the evidence regarding the relationships between antipsychotic medications and QTc prolongation and practical methods for monitoring the QTc interval and mitigating arrhythmia risk.

Methods:

Searches of PubMed and Cochrane Library were performed to identify studies, published before February 2023, investigating the relationships between antipsychotic medications and QTc prolongation or arrhythmias.

Results:

Most antipsychotic medications commonly used for the management of delirium symptoms (eg, intravenous haloperidol, olanzapine, quetiapine) cause a moderate degree of QTc prolongation. Among other antipsychotics, those most likely to cause QTc prolongation are iloperidone and ziprasidone, while aripiprazole and lurasidone appear to have minimal risk for QTc prolongation. Genetic vulnerabilities, female sex, older age, pre-existing cardiovascular disease, electrolyte abnormalities, and non-psychiatric medications also increase the risk of QTc prolongation. For individuals at risk of QTc prolongation, it is essential to measure the QTc interval accurately and consistently and consider medication adjustments if needed.

Conclusions:

Antipsychotic medications are one of many risk factors for QTc prolongation. When managing agitation related to delirium, it is imperative to assess an individual patient's risk for QTc prolongation and to choose a medication and monitoring strategy commensurate to the risks. In intensive care settings, we recommend regular ECG monitoring, using a linear regression formula to correct for heart rate. If substantial QTc prolongation (eg, QTc > 500 msec) is present, a change in pharmacologic treatment can be considered, though a particular medication may still be warranted if the risks of discontinuation (eg, extreme agitation, removal of invasive monitoring devices) outweigh the risks of arrhythmias.

Aims:

This review aims to summarize the current literature on relationships between antipsychotic medications and QTc prolongation and to make practical clinical recommendations towards the approach of antipsychotic medication use for the management of delirium-related agitation and perceptual disturbances in intensive care settings.

2024-10-01·iScience

Few-shot meta-learning applied to whole brain activity maps improves systems neuropharmacology and drug discovery

Article

作者: Wang, Xin ; Haggarty, Stephen J. ; Ding, Yanyun ; Zhang, Wenchong ; Liu, Zhen ; Li, Honglin ; Zhang, Jin ; Haggarty, Stephen J ; Zeng, Shangzhi ; Cao, Yi ; Shi, Peng ; Cheng, Shuk Han ; Luo, Xuan

In this study, we present an approach to neuropharmacological research by integrating few-shot meta-learning algorithms with brain activity mapping (BAMing) to enhance the discovery of central nervous system (CNS) therapeutics. By utilizing patterns from previously validated CNS drugs, our approach facilitates the rapid identification and prediction of potential drug candidates from limited datasets, thereby accelerating the drug discovery process. The application of few-shot meta-learning algorithms allows us to adeptly navigate the challenges of limited sample sizes prevalent in neuropharmacology. The study reveals that our meta-learning-based convolutional neural network (Meta-CNN) models demonstrate enhanced stability and improved prediction accuracy over traditional machine-learning methods. Moreover, our BAM library proves instrumental in classifying CNS drugs and aiding in pharmaceutical repurposing and repositioning. Overall, this research not only demonstrates the effectiveness in overcoming data limitations but also highlights the significant potential of combining BAM with advanced meta-learning techniques in CNS drug discovery.

项与伊潘立酮相关的新闻（医药）

2025-05-07

·PRNewswire

Vanda Pharmaceuticals Reports First Quarter 2025 Financial Results

Fanapt® Q1 2025 total prescriptions (TRx) increased 14% compared to Q1 2024 Fanapt® Q1 2025 new to brand prescriptions (NBRx) increased nearly threefold compared to Q1 2024 Bysanti™ (milsaperidone) NDA for bipolar I disorder and schizophrenia accepted for filing; PDUFA target action date of February 21, 2026 Tradipitant NDA for motion sickness accepted for filing; PDUFA target action date of December 30, 2025 Imsidolimab BLA in generalized pustular psoriasis expected to be submitted in 2025 WASHINGTON, May 7, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced financial and operational results for the first quarter ended March 31, 2025. Continue Reading Fanapt® TRx and NBRx "Vanda has entered a new growth phase with multiple commercialized products and a rich innovative pipeline. Fanapt commercial growth has accelerated, reaching multi-year highs, with weekly prescriptions surpassing 2,000 at the end of April as an increasing number of prescribers are adding Fanapt to their therapeutic armamentarium," said Mihael H. Polymeropoulos, M.D., Vanda's President, CEO and Chairman of the Board. "Our recent new drug application filings for tradipitant and Bysanti are a testament to our productive research and development pipeline. The addition of imsidolimab alongside Ponvory establishes an anti-inflammatory franchise that we believe has significant growth potential. These accomplishments have been possible because of our talented employees, who for the first time surpassed 400 in number, a 22-year high." Financial Highlights Total net product sales from Fanapt®, HETLIOZ® and PONVORY® were $50.0 million in the first quarter of 2025, a 5% increase compared to $47.5 million in the first quarter of 2024. Fanapt® net product sales were $23.5 million in the first quarter of 2025, a 14% increase compared to $20.6 million in the first quarter of 2024. HETLIOZ® net product sales were $20.9 million in the first quarter of 2025, a 4% increase compared to $20.1 million in the first quarter of 2024. PONVORY® net product sales were $5.6 million in the first quarter of 2025, a decrease of 18% compared to $6.8 million in the first quarter of 2024. Net loss was $29.5 million in the first quarter of 2025 compared to net loss of $4.1 million in the first quarter of 2024. The net loss in the first quarter of 2025 reflects expenses associated with the payment of $15.0 million related to the exclusive, global license agreement with AnaptysBio, Inc. (Anaptys) for the development and commercialization of imsidolimab and increased commercial activities. Cash, cash equivalents and marketable securities (Cash) was $340.9 million as of March 31, 2025, representing a decrease to Cash of $33.7 million compared to December 31, 2024. The decrease to Cash reflects the payment of $15.0 million during the first quarter of 2025 related to the exclusive, global license agreement with Anaptys for the development and commercialization of imsidolimab. Key Operational Highlights – Commercial Fanapt® (iloperidone) Fanapt® was approved in the second quarter of 2024 for the acute treatment of bipolar I disorder. Vanda initiated the commercial launch of Fanapt® in this indication in the third quarter of 2024. In the first quarter of 2025, as compared to the first quarter of 2024, total prescriptions (TRx)1 increased by approximately 14% and Fanapt® net product sales increased by 14%. Additionally, new patient starts, as reflected by new to brand prescriptions (NBRx),1 increased by nearly threefold in the same period. Fanapt® total prescriptions (TRx) for the week of April 25, 2025 reached the milestone of 2,000, making Fanapt® one of the fastest growing atypical antipsychotics.1 Vanda has also announced an expansion of its psychiatry sales force to approximately 300 representatives. HETLIOZ® (tasimelteon) Through the first quarter of 2025, HETLIOZ® continues to retain the largest portion of market share despite generic competition for over two years.2 PONVORY® (ponesimod) Vanda initiated the commercial launch of PONVORY® for the treatment of relapsing forms of multiple sclerosis in the third quarter of 2024. In April 2025, new patient prescriptions reached a new record high since the initiation of Vanda's commercial launch. Vanda has re-enforced the PONVORY® sales leadership team and announced an expansion of its PONVORY® sales force to approximately 40 representatives. Key Operational Highlights – Regulatory & Clinical Development Key Regulatory Milestones Tradipitant New Drug Application (NDA) for motion sickness accepted for filing by the U.S. Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) target action date of December 30, 2025. Fanapt® Marketing Authorization Application (MAA) for bipolar I disorder and schizophrenia submitted to the European Medicines Agency (EMA) in Q4 2024. HETLIOZ® MAA in Smith-Magenis syndrome (SMS) submitted to the EMA in Q4 2024. Bysanti™ NDA for bipolar I disorder and schizophrenia accepted for filing by the FDA with a PDUFA target action date of February 21, 2026. Imsidolimab Biologics License Application (BLA) in generalized pustular psoriasis (GPP) expected to be submitted to the FDA in 2025. Key Clinical Highlights Fanapt® (iloperidone) Schizophrenia: A Phase III program for the long acting injectable (LAI) formulation of Fanapt® in the treatment of schizophrenia in relapse prevention is ongoing. Hypertension: Vanda initiated a study of the Fanapt® LAI as a once-a-month injectable for uncontrolled hypertension and plans to begin enrolling patients soon. Bysanti™ (milsaperidone) The NDA for Bysanti™ for the acute treatment of bipolar I disorder and the treatment of schizophrenia was accepted for filing by the FDA with a PDUFA target action date of February 21, 2026. Exclusivity for Bysanti™, including pending patent applications, could extend into the 2040s. Bysanti™ is a new chemical entity, which was initially identified as an active metabolite of iloperidone. Vanda discovered that milsaperidone, when administered orally, quickly interconverts to iloperidone. In clinical studies, milsaperidone and iloperidone have been shown to be bioequivalent at both low and high doses, administered both in single and multiple dose studies. The results of these clinical studies will be presented in late May, at the 2025 American Society of Clinical Psychopharmacology annual meeting in Scottsdale, Arizona. The Bysanti™ Phase III clinical study for use as a once-daily adjunctive treatment for major depressive disorder (MDD) is ongoing. Results are expected in 2026. HETLIOZ® (tasimelteon) HETLIOZ® clinical programs in pediatric insomnia and delayed sleep phase disorder (DSPD) are ongoing. Vanda's MAA for HETLIOZ® and HETLIOZ LQ® for SMS is pending with the EMA. PONVORY® (ponesimod) Investigational New Drug (IND) applications for PONVORY® in the treatments of psoriasis and ulcerative colitis were accepted by the FDA in the fourth quarter of 2024. Tradipitant The NDA for tradipitant for the treatment of motion sickness was accepted for filing by the FDA with a PDUFA target action date of December 30, 2025. In the fourth quarter of 2024, Vanda initiated a clinical trial to study tradipitant in the prevention of vomiting induced by a GLP-1 analog, Wegovy (semaglutide). Results are expected in the third quarter of 2025. Imsidolimab In February 2025, Vanda announced it entered into an exclusive, global license agreement with Anaptys for the development and commercialization of imsidolimab (IL-36R antagonist mAb). A BLA for GPP is expected to be submitted to the FDA in 2025. Early-Stage Program Highlights VQW-765, an alpha-7 nicotinic acetylcholine receptor partial agonist, is currently in clinical development for the treatment of acute performance anxiety in social situations. Vanda expects to initiate the Phase III program in 2025. The IND application for VCA-894A in the treatment of Charcot-Marie-Tooth disease, axonal, type 2S (CMT2S), an inherited peripheral neuropathy for which there is no available treatment, was accepted by the FDA in 2024. Previously in 2023, VCA-894A was granted Orphan Drug Designation for the same indication. The Phase I clinical study for VCA-894A expects to enroll the patient by mid-2025. GAAP Financial Results Net loss was $29.5 million in the first quarter of 2025 compared to net loss of $4.1 million in the first quarter of 2024. Diluted net loss per share was $0.50 in the first quarter of 2025 compared to diluted net loss per share of $0.07 in the first quarter of 2024. 2025 Financial Guidance Vanda is reiterating its 2025 total revenues guidance and updating its 2025 financial guidance to include year-end 2025 Cash. Vanda expects to achieve the following financial objectives in 2025: Conference Call Vanda has scheduled a conference call for today, Wednesday, May 7, 2025, at 4:30 PM ET. During the call, Vanda's management will discuss the first quarter 2025 financial results and other corporate activities. Investors can call 1-800-715-9871 (domestic) or 1-646-307-1963 (international) and use passcode number 9941754. A replay of the call will be available on Wednesday, May 7, 2025, beginning at 8:30 PM ET and will be accessible until Wednesday, May 14, 2025 at 11:59 PM ET. The replay call-in number is 1-800-770-2030 for domestic callers and 1-609-800-9909 for international callers. The passcode number is 9941754. The conference call will be broadcast simultaneously on Vanda's website, . Investors should click on the Investors tab and are advised to go to the website at least 15 minutes early to register, download, and install any necessary software or presentations. The call will also be archived on Vanda's website for a period of 30 days. References IQVIA Prescription Data Based on blended data analysis About Vanda Pharmaceuticals Inc. 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 and follow us on X @vandapharma. CAUTIONARY NOTE REGARDING FORWARD LOOKING STATEMENTS Various statements in this press release, including, but not limited to, the guidance provided under "2025 Financial Guidance" above and statements regarding the growth potential of Vanda's anti-inflammatory franchise; Vanda's plans for pursuit of FDA approval of Bysanti™ for the acute treatment of bipolar I disorder and the treatment of schizophrenia, tradipitant for the treatment of motion sickness, and imsidolimab for the treatment of GPP, and the related timelines; Vanda's plans for pursuit of EMA approval of Fanapt® for the treatment of bipolar I disorder and schizophrenia and HETLIOZ® and HETLIOZ LQ® for the treatment of SMS; Vanda's clinical development plans and expected timelines for Fanapt® LAI as a once-a-month injectable for uncontrolled hypertension, Bysanti™ for the treatment of MDD, VQW-765 for the treatment of acute performance anxiety in social situations, and VCA-894A for the treatment of CMT2S; the expected timing of the results of the tradipitant clinical trial for the prevention of vomiting induced by Wegovy; and the potential to extend patent exclusivity for Bysanti™ into the 2040s are "forward-looking statements" under the securities laws. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Forward-looking statements are based upon 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, Vanda's ability to continue to grow its business; Vanda's ability to obtain regulatory approval and execute a successful commercial launch of imsidolimab, and increase PONVORY® revenue; the FDA's ability to complete its reviews of, and reach decisions with respect to, the NDAs for Bysanti™ and tradipitant by their respective PDUFA target action dates; Vanda's ability to complete and submit the BLA for imsidolimab in 2025; Vanda's ability to obtain EMA approval of the MAAs for Fanapt® and HETLIOZ® and HETLIOZ LQ®, Vanda's ability to begin enrolling patients in the Fanapt® LAI study within the specified timeframe; Vanda's ability to complete the Phase III clinical study for Bysanti™ for MDD and receive results in 2026; Vanda's ability to complete the clinical trial of tradipitant for the prevention of vomiting induced by Wegovy and receive results in the third quarter of 2025; Vanda's ability to initiate the Phase III program for VQW-765 in 2025; Vanda's ability to enroll the CMT2S patient in the Phase I clinical study for VCA-894A by mid-2025; and Vanda's ability to satisfy the conditions necessary to extend Bysanti™'s patent exclusivity into the 2040s. 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 various risks and uncertainties that affect Vanda's business and market, particularly those identified in the "Cautionary Note Regarding Forward-Looking Statements", "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Vanda's most recent Annual Report on Form 10-K, as updated by Vanda's subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the U.S. Securities and Exchange Commission, which are available at . All written and verbal forward-looking statements attributable to Vanda or any person acting on its behalf are expressly qualified in their entirety by the cautionary statements contained or referred to herein. Vanda cautions investors not to rely too heavily on the forward-looking statements Vanda makes or that are made on its behalf. The information in this press release is provided only as of the date of this press release, and Vanda undertakes no obligation, and specifically declines any obligation, to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. Corporate Contact: Kevin Moran Senior Vice President, Chief Financial Officer and Treasurer Vanda Pharmaceuticals Inc. 202-734-3400 [email protected] Jim Golden / Jack Kelleher / Dan Moore Collected Strategies [email protected] Follow us on X @vandapharma SOURCE Vanda Pharmaceuticals Inc. 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临床1期引进/卖出上市批准临床3期申请上市

2025-05-05

·药明康德

潜在“first-in-class”免疫疗法组合显著延长癌症患者生命；创新抗体获FDA突破性疗法认定……

潜在“first-in-class”LAG-3组合疗法显著延长癌症患者生命Immutep公司今日宣布，其2b期临床试验TACTI-003（KEYNOTE-C34）患者队列B取得积极结果：中位总生存期（OS）达17.6个月。该队列旨在评估eftilagimod alfa（efti）联合默沙东（MSD）的抗PD-1疗法Keytruda（pembrolizumab）作为复发/转移性头颈部鳞状细胞癌（HNSCC）患者一线治疗方案的效果，受试者为PD-L1表达综合阳性评分（CPS）低于1的人群。截至2025年3月31日，评估人群（N=31）的成熟中位OS为17.6个月，显著优于当前标准治疗方案在CPS＜1患者中的历史数据（10.7~11.3个月）。LAG-3蛋白能够调控T淋巴细胞和抗原呈现细胞（APCs）的信号通路，在适应性免疫反应中起到重要作用。Efti是一种潜在“first-in-class”可溶性LAG-3融合蛋白。通过与APC表面的主要组织相容性复合体II（MHC II）相结合，能够激活APCs，这会激活和增殖CD8阳性细胞毒性T细胞、CD4阳性辅助性T细胞、树突状细胞、NK细胞和单核细胞，提升患者对癌症抗原的免疫反应。此外，Efti还能上调IFN-γ和CXCL10等关键生物分子的表达，进一步增强免疫系统对抗癌症的能力。Keytruda通过阻断具有免疫抑制功能的PD-1信号通路，增强T细胞的抗癌免疫反应。两种疗法具有互补的作用机制。别构调节胰岛素信号通路，创新抗体获FDA突破性疗法认定Rezolute公司今日宣布，美国FDA已授予其在研疗法ersodetug突破性疗法认定，用于治疗肿瘤性高胰岛素血症（HI）所导致低血糖。Ersodetug是一种全人源化单克隆抗体，可与肝脏、脂肪和肌肉中胰岛素受体上的独特别构位点结合。该抗体通过调节胰岛素的结合、信号和活性来抵消体内胰岛素升高的影响，从而将葡萄糖水平维持在正常范围内。由于ersodetug作用于胰腺下游，因此有潜力成为普适性疗法，用于治疗因先天性或获得性HI所致的低血糖。这一突破性疗法认定的授予是基于ersodetug在整个临床开发项目中的试验数据，以及其治疗机制在肿瘤性HI中的适用性。此前发表的2b期临床试验结果显示，ersodetug能显著改善先天性HI患者的低血糖，且伴有良好的安全性和耐受性。Rezolute计划于2025年年中启动针对肿瘤性HI患者的注册性研究，预计将在2026年下半年公布顶线结果。治疗I型双相情感障碍，FDA接受创新小分子疗法新药申请Vanda Pharmaceuticals今日宣布，美国FDA已受理其为在研疗法Bysanti（milsaperidone）递交的新药申请（NDA），用于治疗1型双相情感障碍（BP-I）和精神分裂症。FDA预计在2026年2月21日前完成审评。Bysanti是一种新化学实体。Vanda发现，经口服给药后，milsaperidone可迅速转化为iloperidone（一种已上市抗精神病药物）。临床研究显示，在低剂量和高剂量下，无论是单次给药还是多次给药，milsaperidone与iloperidone的生物等效性均已被证实。Bysanti在治疗BP-I相关的躁狂或混合发作，以及精神分裂症方面的疗效与安全性，获得了iloperidone说明书中所列举的临床研究的支持，包括两项急性精神分裂症发作研究、一项针对BP-I躁狂或混合发作的研究，以及一项精神分裂症复发预防研究。此外，Bysanti的安全性也得到了iloperidone临床研究中数千名患者数据的支持。Milsaperidone独特的物理和化学性质使其适合在未来开发为长效注射剂型。Bysanti属于非典型抗精神病药物类别，显示出对α1肾上腺素能受体的高亲和力，同时也作用于某些5-羟色胺和多巴胺受体，这些受体被认为与其治疗效应密切相关。参考资料：[1] Vanda Announces Bysanti™ NDA Filing; FDA Decision Expected in Early 2026. Retrieved May 5, 2025, from https://www.prnewswire.com/news-releases/vanda-announces-bysanti-nda-filing-fda-decision-expected-in-early-2026-302445753.html[2] Immutep’s Efti in Combination with KEYTRUDA® (pembrolizumab) Drives Strong Overall Survival in Head and Neck Cancer with CPS <1. Retrieved May 5, 2025, from https://www.immutep.com/detail/immutep-s-efti-in-combination-with-keytruda-r-pembrolizumab-drives-strong-overall-survival-in-head-and-neck-cancer-with-cps-1.html[3] Rezolute Receives Breakthrough Therapy Designation from FDA for Ersodetug in the Treatment of Hypoglycemia Due to Tumor Hyperinsulinism. Retrieved May 5, 2025, from https://www.globenewswire.com/news-release/2025/05/05/3074006/0/en/Rezolute-Receives-Breakthrough-Therapy-Designation-from-FDA-for-Ersodetug-in-the-Treatment-of-Hypoglycemia-Due-to-Tumor-Hyperinsulinism.html免责声明：本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。分享，点赞，在看，聚焦全球生物医药健康创新

突破性疗法免疫疗法临床结果临床2期

2025-05-05

·PRNewswire

Vanda Announces Bysanti™ NDA Filing; FDA Decision Expected in Early 2026

WASHINGTON, May 5, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that the U.S. Food and Drug Administration (FDA) informed Vanda that the New Drug Application (NDA) for Bysanti™ (milsaperidone) has been filed, and that at this time no potential review issues have been identified. The FDA has set February 21, 2026 as the target date for decision on this application. Bysanti™ is a new chemical entity, which was initially identified as an active metabolite of iloperidone. Vanda has discovered that milsaperidone, when administered orally, quickly interconverts to iloperidone. In clinical studies, milsaperidone and iloperidone have been shown to be bioequivalent at both low and high doses, administered both in single and multiple dose studies. The results of these clinical studies will be presented in late May, at the 2025 American Society of Clinical Psychopharmacology annual meeting in Scottsdale, Arizona. The efficacy and safety of Bysanti™ for the indications of bipolar I manic and mixed episodes and schizophrenia are supported by the clinical studies described on the iloperidone prescribing information. These include two studies in acute episodes of schizophrenia, one study in bipolar I disorder with manic or mixed episodes, and one relapse prevention study in schizophrenia. The safety of Bysanti™ is further supported by data in several thousand patients exposed to iloperidone in clinical studies, as well as the post marketing iloperidone experience, with more than 80,000 patient year exposures. The unique physical and chemical properties of milsaperidone make it amenable to the development of lipid esters that could allow the future development of long acting injectable formulations. Bysanti™ is currently under development in a clinical study as a once-a-day adjunctive treatment of major depressive disorder (MDD) for patients with inadequate response on their current treatment. Results are expected in 2026. Bysanti™ is eligible for 5 year regulatory data exclusivity if approved by the FDA. Current Bysanti™ related patent applications, if issued, would extend into the 2040's. Bysanti™ belongs to the class of atypical antipsychotics showing strong affinity to the alpha 1 adrenergic receptor, in addition to certain serotonin and dopamine receptors that are believed to explain its therapeutic effects. "The extraordinary discovery of bioequivalence to iloperidone, of this novel chemical entity, allows for the efficient development of Bysanti™ and opens new opportunities to further explore additional therapeutic applications of this molecule," said Dr. Mihael Polymeropoulos, Vanda's President, CEO and Chairman of the Board. About Bysanti™ Bysanti™ is a new chemical entity that belongs in the class of atypical antipsychotic drugs. If approved, Bysanti™ could be available for sale in the US in 2026. Bysanti™ is believed to achieve its therapeutic effect by interacting with a host of neurotransmitter receptors in the brain, including the alpha-adrenergic receptor, serotonin receptors and dopamine receptors. Exclusivity, including pending patent applications, could extend into the 2040s. About Vanda Pharmaceuticals Inc. 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 and follow us on X @vandapharma. CAUTIONARY NOTE REGARDING FORWARD LOOKING STATEMENTS Various statements in this press release, including, but not limited to, statements regarding the potential to develop long acting injectable formulations of Bysanti™, the expected timing of the clinical study results for Bysanti™ in MDD, Bysanti™'s mechanism of action, the potential commercial availability of Bysanti™, the potential to extend patent exclusivity for Bysanti™ into the 2040s, the potential to develop additional therapeutic applications for Bysanti™, and the anticipated timing of the completion of the FDA's review of the Bysanti™ NDA are "forward-looking statements" under the securities laws. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Forward-looking statements are based upon 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, Vanda's ability to complete its clinical study in MDD and report results in 2026, Vanda's assumptions regarding how Bysanti™ achieves its therapeutic effect, Vanda's ability to obtain regulatory approval for Bysanti™ for the acute treatment of bipolar I disorder and schizophrenia and initiate its commercial launch in 2026, Vanda's ability to satisfy the conditions necessary to extend Bysanti™'s patent exclusivity into the 2040s, Vanda's ability to identify additional indications for Bysanti™ and the FDA's ability to complete its review of, and reach a decision with respect to, the Bysanti™ NDA by February 21, 2026. 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 various risks and uncertainties that affect Vanda's business and market, particularly those identified in the "Cautionary Note Regarding Forward-Looking Statements", "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Vanda's most recent Annual Report on Form 10-K, as updated by Vanda's subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the U.S. Securities and Exchange Commission, which are available at . All written and verbal forward-looking statements attributable to Vanda or any person acting on its behalf are expressly qualified in their entirety by the cautionary statements contained or referred to herein. Vanda cautions investors not to rely too heavily on the forward-looking statements Vanda makes or that are made on its behalf. The information in this press release is provided only as of the date of this press release, and Vanda undertakes no obligation, and specifically declines any obligation, to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. Corporate Contact: Kevin Moran Senior Vice President, Chief Financial Officer and Treasurer Vanda Pharmaceuticals Inc. 202-734-3400 [email protected] Jim Golden/Jack Keleher/Dan Moore Collected Strategies [email protected] SOURCE Vanda Pharmaceuticals Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

申请上市

100 项与伊潘立酮相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D02666	伊潘立酮	N05AX14	DB04946

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
躁郁症1型	美国	Vanda Pharmaceuticals, Inc.	2024-04-02
躁狂	美国	Vanda Pharmaceuticals, Inc.	2024-04-02
精神分裂症	美国	Vanda Pharmaceuticals, Inc.	2009-05-06

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
急性精神分裂症	临床3期	美国	Vanda Pharmaceuticals, Inc.	2005-11-18
急性精神分裂症	临床3期	印度	Vanda Pharmaceuticals, Inc.	2005-11-18
原发性肥大性骨关节病	临床2期	美国	Vanda Pharmaceuticals, Inc.	2022-06-01
帕金森病	临床2期	美国	Vanda Pharmaceuticals, Inc.	2022-06-01
情绪易怒	临床2期	美国	Novartis Pharmaceuticals Corp.	2013-07-01
入睡和睡眠障碍	临床2期	美国	Novartis Pharmaceuticals Corp.	2013-07-01
创伤后应激障碍	临床2期	美国	Novartis Pharmaceuticals Corp.	2013-07-01

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临床结果

适应症

分期

评价

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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


NCT00254202 (CTgov)	临床3期	急性精神分裂症	593	Iloperidone (Iloperidone)	鹽襯蓋顧糧鏇築齋窪鏇(築憲膚範觸網餘膚壓構) = 膚鏇構醖築鏇鑰積鹹夢鹽窪醖構範餘窪夢鏇築 (鏇壓顧鑰齋製網製願製, 1.03) 更多	-	2024-12-13
				Ziprasidone (Ziprasidone)	鹽襯蓋顧糧鏇築齋窪鏇(築憲膚範觸網餘膚壓構) = 鏇鬱觸淵觸簾願願憲鬱鹽窪醖構範餘窪夢鏇築 (鏇壓顧鑰齋製網製願製, 1.44) 更多
NCT04819776 (CTgov)	临床3期	躁狂 \| 躁郁症1型	417	Iloperidone (Iloperidone)	鏇觸鬱窪夢衊積觸繭憲(膚夢醖顧繭齋齋糧憲醖) = 鏇窪夢鑰繭願醖構網醖網鹽遞構顧衊憲顧鹹艱 (艱蓋遞齋夢繭鹹壓築蓋, 0.64) 更多	-	2024-04-16
				Iloperidone Placebo (Placebo)	鏇觸鬱窪夢衊積觸繭憲(膚夢醖顧繭齋齋糧憲醖) = 顧築憲構壓糧壓願繭壓網鹽遞構顧衊憲顧鹹艱 (艱蓋遞齋夢繭鹹壓築蓋, 0.63) 更多
NCT01291511 (REPRIEVE, CTgov)	临床3期	精神分裂症	635	Iloperidone (Iloperidone)	鑰遞築膚顧繭衊醖製糧(網夢遞醖艱獵艱築繭膚) = 淵襯憲遞觸糧構膚鏇選繭範鹹獵淵簾鑰鹹窪選 (願繭艱鹹窪遞獵衊簾顧, 夢築遞壓膚鬱簾齋構糧 ~ 窪積窪網鏇淵淵範築蓋) 更多	-	2023-07-17
				Placebo (Placebo)	鑰遞築膚顧繭衊醖製糧(網夢遞醖艱獵艱築繭膚) = 糧艱窪壓憲鹽觸餘鏇鏇繭範鹹獵淵簾鑰鹹窪選 (願繭艱鹹窪遞獵衊簾顧, 簾積願鏇夢艱鬱鏇遞襯 ~ 鹽壓憲廠壓膚窪積醖齋) 更多
NCT01917318 (CTgov)	临床2期	入睡和睡眠障碍 \| 创伤后应激障碍 \| 情绪易怒	1	Placebo+Iloperidone (Iloperidone / Placebo)	顧壓膚網鏇鏇遞積範壓(製繭選憲鏇觸築廠艱窪) = 顧廠襯膚網窪範鏇糧餘蓋獵網鏇獵積夢憲膚淵 (觸壓艱願鬱壓網鹽淵積, 顧繭範觸鹹製壓構築鏇 ~ 鹽糧築艱窪觸襯窪壓壓) 更多	-	2020-01-31
				Placebo+Iloperidone (Placebo / Iloperidone)	積簾繭壓獵構壓壓廠壓 = 繭製觸遞糧鹹蓋廠顧觸糧壓製襯製製簾觸鹹鏇 (鹽醖窪願夢夢築築構鏇, 膚齋選遞廠艱淵鏇製壓 ~ 範簾膚網積蓋觸構願齋) 更多
NCT01920802 (CTgov)	临床4期	-	31	olanzapine (Olanzapine)	獵鹹範範淵範積醖積範(齋網蓋襯餘膚築衊鹹夢) = 製艱壓選鬱鹽鏇艱繭簾餘淵網襯製壓窪淵網齋 (醖憲網鹽窪觸艱構鏇願, 1.0) 更多	-	2017-03-20
				iloperidone (Iloperidone)	獵鹹範範淵範積醖積範(齋網蓋襯餘膚築衊鹹夢) = 鏇觸襯鬱衊醖範淵壓鬱餘淵網襯製壓窪淵網齋 (醖憲網鹽窪觸艱構鏇願, 0.7) 更多
NCT01291511 (REPRIEVE, Pubmed \| CNS Drugs) 人工标引	临床3期	精神分裂症	303	Iloperidone	繭願鏇襯獵夢襯蓋築憲(鹽糧簾繭淵糧餘製範築) = 餘簾襯襯鬱網築鏇淵壓獵繭鹽糧襯鑰顧糧網蓋 (簾獵壓淵艱壓觸膚鹽鏇 ) 更多	积极	2016-08-01
				Placebo	繭願鏇襯獵夢襯蓋築憲(鹽糧簾繭淵糧餘製範築) = 獵製簾鹽醖鹹鑰鏇鑰艱獵繭鹽糧襯鑰顧糧網蓋 (簾獵壓淵艱壓觸膚鹽鏇 ) 更多
NCT01929889 (CTgov)	临床4期	分裂情感性障碍 \| 精神分裂症	19	Iloperidone	製鬱蓋顧鹽選鬱製鹽積(積艱憲選餘廠鏇蓋廠醖) = 遞衊鏇繭襯製鬱鹹鏇糧醖鑰蓋鏇構憲遞鬱壓膚 (憲齋廠繭鏇製糧鏇壓淵, 3.742) 更多	-	2015-07-10
NCT01207414 (i-FANS, CTgov)	临床4期	精神分裂症	501	iloperidone (Iloperidone Gradual Switch)	醖蓋製膚憲鹹積鬱鹹夢(夢鏇鹽簾構願餘簾廠艱) = 繭範淵鹹膚選艱範構憲構醖醖艱鬱鏇夢顧餘簾 (膚鹹夢廠鏇齋鏇艱網繭, 1.1244) 更多	-	2013-03-15
				iloperidone (Iloperidone Immediate Switch)	醖蓋製膚憲鹹積鬱鹹夢(夢鏇鹽簾構願餘簾廠艱) = 淵醖繭鑰遞蓋憲齋襯鑰構醖醖艱鬱鏇夢顧餘簾 (膚鹹夢廠鏇齋鏇艱網繭, 1.3300) 更多