预约演示

更新于：2025-12-09

Iloperidone

伊潘立酮

更新于：2025-12-09

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

NCT07090161

/ Recruiting临床2期

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Iloperidone for the Treatment of Participants With Uncontrolled Hypertension

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Iloperidone for the Treatment of Participants with Uncontrolled Hypertension

开始日期2025-09-15

申办/合作机构

Vanda Pharmaceuticals, Inc.

NCT06961968

/ Recruiting临床3期

A Multicenter, Double-Blind, Randomized Withdrawal Study in Patients With Schizophrenia Receiving Either Iloperidone Long-Acting Injection (LAI) or Placebo Injection

The purpose of this research is to evaluate the efficacy of dosing iloperidone long-acting injection (LAI) compared to placebo in preventing the exacerbation of symptoms in patients with schizophrenia.

开始日期2025-05-14

申办/合作机构

Vanda Pharmaceuticals, Inc.

NCT06494397

/ Completed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2024-07-11

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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337

项与伊潘立酮相关的文献（医药）

2025-11-02·Expert Opinion On Drug Safety

Drug-induced erectile dysfunction: a real-world pharmacovigilance study using the FDA adverse event reporting system database

Article

作者: Zhang, Rui ; Li, Dongxuan ; Du, Qian ; Zhu, Jun ; Wang, Yalan ; Dai, Liyang ; Liu, Songqing ; Wu, Fan ; Zhang, Tongyan

BACKGROUND:

The comprehensive quantitative and comparative risk data of drug-induced erectile dysfunction (ED) are still lacking, and this study aims to supplement this information.

RESEARCH DESIGN AND METHODS:

We reviewed all the ED reports in the FDA Adverse Event Reporting System (FAERS) database from 2004 to 2023 and summarized a potential ED culprit-drug list and its corresponding reporting frequency. The reporting odds ratio (ROR) method was used to conduct disproportionality analysis.

RESULTS:

A total of 20,098 ED reports were retrieved from the FAERS database, which recorded 734 different ED culprit-drugs, involving 74 drug classes. Finasteride was the drug with the highest reporting frequency, and urologicals was the drug class with the highest reporting frequency. In disproportionality analysis, 209 drugs with positive signals showed a close relationship with ED occurrence, among which finasteride was the drug with the highest signal strength. Among 209 drugs with positive signals, 27 were compound preparations, and the risk level of compound preparations was usually higher than their single active ingredient.

CONCLUSIONS:

Our study integrated quantitative and comparative ED risk data of 734 drugs by using the FAERS database, which can provide reference information for regulators, medical personnel, and others involved in drug management and use.

2025-11-02·CLINICAL TOXICOLOGY

QT interval prolongation in acute antipsychotic poisoning: systematic review and recommendations

Review

作者: Wong, Anselm ; Berling, Ingrid ; Ferrer Dufol, Ana Maria Alicia ; Mackenzie, Constance Alexa ; Yates, Christopher ; Hayes, Bryan D ; Isbister, Geoffrey K ; Hatten, Benjamin W ; Hoffman, Robert S ; Gosselin, Sophie ; Heyerdahl, Fridtjof ; Stanton, Matt ; Lonati, Davide ; Roberts, Darren M ; Hoegberg, Lotte C G ; Smith, Angela ; Paasma, Raido ; Othong, Rittirak

INTRODUCTION:

Antipsychotic medications are often associated with QT interval prolongation, which can lead to ventricular dysrhythmias, including torsade de pointes. However, unstable or significant dysrhythmic events are rare. Evidence-based recommendations on the assessment and management of poisoned patients at risk for QT interval prolongation are lacking. Current practice often involves costly and lengthy cardiac monitoring, leading to delayed disposition of the patient from emergency departments or prolonged monitoring times in other hospital units. To address this issue, the QT Interval Prolongation in Clinical Toxicology Workgroup was formed by the Clinical Toxicology Recommendations Collaborative to develop evidence-based recommendations for the management and treatment of QT interval prolongation in acute overdose patients. This article reports our findings on patients with antipsychotic poisoning.

METHODS:

A systematic review of the literature regarding QT interval prolongation in all acute overdoses was undertaken, and the evidence was summarized for antipsychotic medication overdose. Voting statements were drafted using a predetermined format for monitoring the QT interval and use of continuous cardiac monitoring. A two-round modified Delphi method was used to reach a consensus. The strength of consensus was measured using the disagreement index as defined by the RAND/UCLA Appropriateness Method.

RESULTS:

From the 327 articles that were included in the systematic review of QT interval prolongation in all acute overdoses, a total of 55 articles were relevant to antipsychotic medication-induced QT prolongation in acute overdose. Medications with more than three articles were reviewed individually for recommendations, whilst medications with less than three were grouped together for discussion as miscellaneous. Individual medication recommendations were made for amisulpride (15 articles), thioridazine (11 articles), ziprasidone (eight articles) and quetiapine (13 articles), whilst consensus statements based on limited data were made for acute ingestions of clozapine, haloperidol, iloperidone, pimozide, pipamperone, olanzapine and risperidone (14 articles in total). The electrocardiogram is suggested as a risk assessment tool for ingestion of all antipsychotic medication. We recommend continuous cardiac monitoring for patients ingesting more than amisulpride 2 g, thioridazine 1 g, and ziprasidone 3 g. We suggest continuous cardiac monitoring for the above-mentioned medications for lower dose ingestions as well as for ingestions of haloperidol, iloperidone, pimozide and pipamperone. We do not suggest continuous cardiac monitoring for acute clozapine and risperidone poisoning, and do not recommend continuous cardiac monitoring for the QT interval in acute olanzapine or quetiapine poisoning. The need for ongoing cardiac monitoring should be guided by an individual risk assessment considering the medication and dose ingested, the time since ingestion, as well as other factors such as heart rate or co-ingestions.

DISCUSSION:

The quality of evidence for the risk of QT interval prolongation and torsade de pointes is heterogeneous among different antipsychotics and inherently constrains the recommendations. Available data suggest that amisulpride, thioridazine and ziprasidone are associated with QT interval prolongation and torsade de pointes, while the risk is likely overstated for quetiapine, olanzapine and risperidone. Ongoing research is needed to improve management strategies for acute antipsychotic overdose-induced QT interval prolongation and dysrhythmias.

CONCLUSIONS:

The QT Interval Prolongation in Clinical Toxicology Workgroup recommends the use of screening electrocardiograms in all patients with acute antipsychotic medication overdose and cardiac monitoring in patients with at-risk overdoses from thioridazine, amisulpride, and ziprasidone. The QT Interval Prolongation in Clinical Toxicology Workgroup suggests the same approach for patients with overdoses of haloperidol, iloperidone, pipamperone and pimozide. The risk of torsade de pointes is likely overstated for acute antipsychotic medication overdose as a general class group, and concern should rather focus on a few specific medications.

2025-09-01·ANNALS OF PHARMACOTHERAPY

An Evaluation of Iloperidone for Mania in Bipolar I Disorder

Review

作者: Caskey, Kelen ; Nelson, Leigh Anne

Objective::

To review the efficacy of iloperidone for mania associated with bipolar I disorder and discuss its safety profile (eg, QTc prolongation, orthostatic hypotension, and metabolic adverse effects).

Data sources::

Literature was identified using PubMed (1966-September 2024), OVID (1984-November 2024), and clinicaltrials.gov. Search terms included iloperidone, bipolar disorder, and mania.

Study selection and data extraction::

The study included trials evaluating iloperidone for treating bipolar mania.

Data synthesis::

In one phase 3 study, iloperidone demonstrated significant improvement in mania symptoms at day 28 on all primary (ie, Young Mania Rating Scale) and secondary outcomes (Clinical Global Impression-Severity/Change scales) compared to placebo. Iloperidone was well tolerated, with tachycardia, dizziness, dry mouth, alanine aminotransferase elevation, nasal congestion, increased weight, and somnolence reported as common adverse effects.

Relevance to patient care and clinical practice in comparison to existing drugs::

Since there are no head-to-head studies comparing iloperidone with other second-generation antipsychotics for bipolar mania, other treatment considerations drive medication selection. Iloperidone is unavailable in a generic formulation; thus, its use will be associated with higher costs. It is dosed twice daily, which may negatively impact adherence. Iloperidone is associated with a moderate risk of QTc prolongation, metabolic adverse effects, and orthostatic hypotension, which will limit its use in certain patient populations. QTc prolongation is dose related, so drug interactions involving CYP2D6 and CYP3A4 inhibition can have serious consequences.

Conclusion::

In the pivotal trial, iloperidone was effective in treating adults with an acute manic or mixed episode associated with bipolar I disorder and was safe and well tolerated.

项与伊潘立酮相关的新闻（医药）

2025-10-29

·PRNewswire

Vanda Pharmaceuticals Reports Third Quarter 2025 Financial Results

Fanapt® Q3 2025 net product sales increased by 31% to $31.2 million compared to Q3 2024 BysantiTM (milsaperidone) NDA for bipolar I disorder and schizophrenia under review by the FDA; PDUFA target action date of February 21, 2026 Tradipitant NDA for motion sickness under review by the FDA; PDUFA target action date of December 30, 2025 Imsidolimab BLA in generalized pustular psoriasis expected to be submitted in Q4 2025 Vanda announced collaborative framework with the FDA for resolution of certain disputes Re-review of Vanda's sNDA for HETLIOZ ® for the treatment of jet lag disorder by January 7, 2026 WASHINGTON, Oct. 29, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced financial and operational results for the third quarter ended September 30, 2025. "This quarter reflects strong commercial execution, with total net product sales reaching $56.3 million, up 18% year-over-year, led by a 31% increase in Fanapt sales and 35% growth in prescriptions. HETLIOZ continues to deliver stable performance with $18.0 million in Q3 sales," said Mihael H. Polymeropoulos, M.D., Vanda's President, CEO and Chairman of the Board. "We are particularly encouraged by our advancing pipeline, with multiple near-term regulatory milestones: the tradipitant NDA for motion sickness under FDA review with a PDUFA target action date of December 30, 2025; the Bysanti NDA for bipolar I disorder and schizophrenia also under FDA review with a PDUFA target action date of February 21, 2026; and the anticipated Q4 submission of the imsidolimab BLA for generalized pustular psoriasis. We are also investing strategically in our commercial infrastructure, including increased brand visibility through targeted sponsorships, with the goal of supporting long-term market leadership and future commercial launches. We believe that these milestones, combined with our collaborative framework with the FDA, will position Vanda for sustained growth and expanded therapeutic impact in 2026 and beyond." Financial Highlights Third Quarter of 2025 Total net product sales from Fanapt®, HETLIOZ® and PONVORY® were $56.3 million in the third quarter of 2025, an 18% increase compared to $47.7 million in the third quarter of 2024. Fanapt® net product sales were $31.2 million in the third quarter of 2025, a 31% increase compared to $23.9 million in the third quarter of 2024. HETLIOZ® net product sales were $18.0 million in the third quarter of 2025, a 1% increase compared to $17.9 million in the third quarter of 2024. PONVORY® net product sales were $7.0 million in the third quarter of 2025, a 20% increase compared to $5.9 million in the third quarter of 2024. Net loss was $22.6 million in the third quarter of 2025 compared to net loss of $5.3 million in the third quarter of 2024. Cash, cash equivalents and marketable securities (Cash) was $293.8 million as of September 30, 2025, representing a decrease to Cash of $31.8 million compared to June 30, 2025. First Nine Months of 2025 Total net product sales from Fanapt®, HETLIOZ® and PONVORY® were $158.9 million in the first nine months of 2025, a 9% increase compared to $145.6 million in the first nine months of 2024. Fanapt® net product sales were $84.1 million in the first nine months of 2025, a 24% increase compared to $67.6 million in the first nine months of 2024. HETLIOZ® net product sales were $55.0 million in the first nine months of 2025, a 3% decrease compared to $56.6 million in the first nine months of 2024. PONVORY® net product sales were $19.8 million in the first nine months of 2025, a 7% decrease compared to $21.3 million in the first nine months of 2024. Net loss was $79.3 million in the first nine months of 2025 compared to net loss of $14.0 million in the first nine months of 2024. Cash was $293.8 million as of September 30, 2025, representing a decrease to Cash of $80.9 million compared to December 31, 2024. Key Operational Highlights – Commercial Fanapt® experienced significant growth, with total prescriptions (TRx)1 increasing by 35% and Fanapt® net product sales increasing by 31% in the third quarter of 2025 as compared to the third quarter of 2024. During the first nine months of 2025, Vanda's direct-to-consumer campaign, launched in the first quarter, continued to drive meaningful gains in brand awareness for the company and its products, Fanapt® and PONVORY®. The Company maintained strategic investments in its commercial infrastructure, including increased brand visibility through targeted sponsorships, with the goal of supporting long-term market leadership and future commercial launches. Key Operational Highlights – Regulatory & Clinical Development A clinical study of tradipitant in the prevention of vomiting induced by a GLP-1 analog, Wegovy® (semaglutide), is now complete. Results are expected in the fourth quarter of 2025. On October 1, 2025, Vanda announced that it had agreed on a collaborative framework with the U.S. Food and Drug Administration (FDA) for the resolution of certain disputes regarding HETLIOZ® (tasimelteon) and tradipitant. Pursuant to the agreement: The FDA will conduct an expedited re-review of the partial clinical hold preventing long term clinical studies of tradipitant for the treatment of motion sickness by November 26, 2025. The FDA will continue its review of Vanda's New Drug Application (NDA) for this indication, with the existing Prescription Drug User Fee Act (PDUFA) target action date of December 30, 2025. The FDA will conduct an expedited re-review of Vanda's supplemental New Drug Application (sNDA) for HETLIOZ® for the treatment of jet lag disorder by January 7, 2026, including consideration of alternative or narrowed indications focusing on the sleep-related aspects of jet lag disorder. Bysanti™ NDA for bipolar I disorder and schizophrenia is under review by the FDA with a PDUFA target action date of February 21, 2026. Tradipitant NDA for motion sickness is under review by the FDA with a PDUFA target action date of December 30, 2025. A Bysanti™ Phase III clinical study for use as a once-daily adjunctive treatment for major depressive disorder (MDD) is enrolling patients and results are expected in 2026. Imsidolimab Biologics License Application (BLA) in generalized pustular psoriasis (GPP) expected to be submitted to the FDA in the fourth quarter of 2025. The Phase III study of the long acting injectable formulation of iloperidone in the treatment of schizophrenia in relapse-prevention is enrolling patients. A clinical study of the long acting injectable formulation of iloperidone in people with treatment-resistant hypertension is ongoing and Vanda plans to begin enrolling patients soon. GAAP Financial Results Net loss was $22.6 million in the third quarter of 2025 compared to net loss of $5.3 million in the third quarter of 2024. Diluted net loss per share was $0.38 in the third quarter of 2025 compared to diluted net loss per share of $0.09 in the third quarter of 2024. Net loss was $79.3 million in the first nine months of 2025 compared to net loss of $14.0 million in the first nine months of 2024. Diluted net loss per share was $1.35 in the first nine months of 2025 compared to diluted net loss per share of $0.24 in the first nine months of 2024. 2025 Financial Guidance Vanda is updating its 2025 financial guidance and expects to achieve the following financial objectives in 2025: Conference Call Vanda has scheduled a conference call for today, Wednesday, October 29, 2025, at 4:30 PM ET. During the call, Vanda's management will discuss the third quarter 2025 financial results and other corporate activities. Investors can call 1-888-596-4144 (domestic) or 1-646-968-2525 (international) and use passcode number 8728050. A replay of the call will be available on Wednesday, October 29, 2025, beginning at 7:00 PM ET and will be accessible until Wednesday, November 5, 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 8728050. 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 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 Vanda's plans for pursuit of FDA approval of BysantiTM 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 and prospects for approval; the goals and expected results of Vanda's commercial infrastructure investment strategy; Vanda's expectations with respect to the strength of its business; Vanda's clinical development plans and expected timelines for tradipitant in the prevention of vomiting induced by Wegovy®, BysantiTM for the treatment of MDD and the long acting injectable formulation of iloperidone in the treatments of schizophrenia in relapse-prevention and hypertension; and the actions that the FDA is expected to take, and the timing thereof, with respect to the NDA for tradipitant for the treatment of motion sickness and the sNDA for HETLIOZ® for the treatment of jet lag disorder 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; 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 the fourth quarter of 2025; Vanda's ability to achieve long-term market leadership and execute new commercial launches through its commercial infrastructure investments; Vanda's ability to complete the clinical studies for tradipitant in the prevention of vomiting induced by Wegovy® and BysantiTM for the treatment of MDD and receive results in the expected timeframes; Vanda's ability to complete enrollment of patients in the clinical study for the long acting injectable formulation of iloperidone in the treatment of schizophrenia in relapse-prevention and to begin enrolling patients in the study of the long acting injectable formulation of iloperidone for the treatment of hypertension in the expected timeframe; and the FDA's ability to conduct expedited re-reviews of the partial clinical hold on tradipitant for the treatment of motion sickness by November 26, 2025 and the sNDA for HETLIOZ® for the treatment of jet lag disorder by January 7, 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 Kelleher / Dan Moore Collected Strategies [email protected] Follow us on X @vandapharma SOURCE Vanda Pharmaceuticals Inc. 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财报临床3期申请上市

2025-09-28

·米内网

石药集团加速蜕变

精彩内容今年以来，石药集团喜讯不断：10个品种获批上市，10款1类新药首次获批临床，达成4项重磅BD交易等。石药集团以创新研发为发展引擎，2025年上半年研发费用达26.83亿元，占成药收入比重26.2%。目前公司有78款1类新药、19款2.2类改良新药/生物类似药在国内处于申请临床及以上阶段，其中有19款已步入NDA或III期临床，上市在即；35个新分类申报品种在审，10余个暂无首仿（含剂型首仿）获批。首仿、1类新药获批！独家新药销售大涨 9月18日，石药集团发布2025年中期报告，报告期内公司实现收入总额132.73亿元，归母净利润25.48亿元。从分业务收入看，成药收入102.48亿元，原料产品收入20.75亿元，功能食品及其他收入9.5亿元。作为石药集团的主营业务，成药业务受集采影响显著，2025年上半年神经系统、抗肿瘤、抗感染、心血管、呼吸系统、消化代谢六大领域收入均有不同程度的下滑；但授权费收入达10.75亿元，成为成药业务新增长动力。 2025H1石药集团成药板块分治疗领域销售情况（单位：亿元）来源：公司公告，米内网整理在传统业务承压之下，石药集团将目光投向了创新转型。近年来，公司持续加大研发投入，研发费用由2021年的约34亿元增长至2024年的近52亿元，2025上半年以约27亿元再创新高，研发费用占成药收入比重也由2021年的约15%持续提升至2025年上半年的超26%。近年来石药集团研发费用情况（单位：亿元）来源：公司公告，米内网整理在持续且高强度的研发投入下，石药集团创新药管线逐渐步入兑现期，2022年拿下2.2类新药盐酸米托蒽醌脂质体注射液，2023年喜提1类新药纳鲁索拜单抗注射液（RANKL单抗）、新型冠状病毒mRNA疫苗，2024年收获1类新药恩朗苏拜单抗注射液（PD-1单抗）、甲磺酸瑞泽替尼胶囊（三代EGFR抑制剂）及生物类似药注射用奥马珠单抗，2025年以来斩获1类新药普卢格列汀片（DPP4抑制剂）等。此外，早前石药集团获批的新药在商业化方面也有亮眼的表现。米内网数据显示，在2025年上半年中国三大终端六大市场（统计范围详见本文末），丁苯酞氯化钠注射液销售额超20亿元，丁苯酞软胶囊销售额超10亿元，聚乙二醇化重组人粒细胞刺激因子注射液销售额超8亿元，注射用重组人TNK组织型纤溶酶原激活剂销售额超4亿元且同比大涨约238%。今年以来，石药集团持续推动1类创新药、2类改良型新药、生物类似药及化药仿制药的研发。 1类创新药方面，DPP4抑制剂普卢格列汀片获批上市；HER2双抗药物安尼妥单抗注射液提交NDA申请获受理；SYHX1901片（JAK/SyK双靶点抑制剂）、SYS6010（EGFR ADC）等首次启动III期临床；21款1类新药获批临床，其中有10款为首次获批，且均已启动临床，包括3款ADC药物SYS6045、SYS6041、SYS6040，PDE4B抑制剂SYH2059片、PD-1/IL-15双功能融合蛋白JMT108注射液、口服GLP-1激动剂SYH2067胶囊、siRNA药物SYH2068注射液等。 2025年以来石药集团国内首次获批临床的1类新药来源：米内网中国申报进度（MED）数据库 2类化药新药方面，司美格鲁肽注射液提交NDA，该药目前在国内暂无国产批文获批，原研产品2024年在中国三大终端六大市场的销售额超过60亿元；SYH9016注射液（亮丙瑞林缓释注射液）、普卢格列汀二甲双胍缓释片(Ⅰ、Ⅱ)等首次获批临床且已启动临床；生物类似药方面，度普利尤单抗注射液、SYS6036注射液、仑卡奈单抗注射液等获批临床。仿制药方面，9个品种获批生产并视同过评，包括艾普拉唑肠溶片、美洛昔康注射液(Ⅲ)两款重磅首仿；20余个品种以新注册分类报产，其中布瑞哌唑片、利那洛肽胶囊、布地奈德肠溶胶囊、乌帕替尼缓释片等暂无国产仿制药获批。今年以来石药集团获批上市的仿制药注：标*为首仿来源：米内网中国申报进度（MED）数据库创新驱动！78款1类新药亮眼含合作引进的产品在内，目前石药集团有78款1类新药（不含已有批文品种、疫苗等）在国内处于申请临床及以上阶段，集中在抗肿瘤药领域，自身免疫、消化代谢、心脑血管、呼吸、神经等也有所涉及。石药集团国内在研的1类创新药来源：米内网综合数据库从药品类型看，41款为小分子化学药，既布局了BTK、FGFR、CDK9、PTK、GLP-1等热门靶点，也有全新结构的first in class药物，此外在小核酸药物方面也有布局；36款为大分子生物药，涵盖单抗、双抗、ADC、CAR-T、融合蛋白等药物形式。从研发进展看，FcRn抑制剂巴托利单抗注射液、HER2双抗安尼妥单抗注射液分别于2024年7月、2025年9月提交NDA，有望于今年及明年获批上市，为全身性重症肌无力（MG）患者、胃/胃-食管结合部腺癌患者带来新的治疗选择。 10款1类新药处于III期临床（不含Ib/III期、II/III期），上市可期。其中，M701为双抗药物，目前公司已有10款双抗药物/双特异性融合蛋白在国内处于获批临床及以上阶段，涉及EpCAM、CD3、PD-L1、TGF-β、HER2、CD38、VEGF、CLDN6等靶点；DP303c、JSKN003、SYS6010均为ADC药物，目前公司已有11款ADC药物在国内处于I期临床及以上阶段，涉及HER2、Claudin18.2、Nectin-4、HER3、ROR1等靶点。除了1类新药，石药集团还有12个2.2类改良新药、7个生物类似药在国内处于申请临床及以上阶段。石药集团国内在研的制剂改良新药/生物类似药来源：米内网综合数据库乌司奴单抗注射液、SYHX2011、司美格鲁肽注射液分别于2024年11月、2024年12月、2025年8月提交NDA，有望于今年或明年迎来好消息。其中，SYHX2011是以注射用紫杉醇（白蛋白结合型）为基础，采用专利技术开发的创新型纳米制剂，具有更显著的疗效获益。注射用西罗莫司(白蛋白结合型)、注射用多西他赛(白蛋白结合型)2款2.2类新药处于III期临床，目前均暂无企业拥有上述品种的生产批文；帕妥珠单抗注射液、司库奇尤单抗注射液2款生物类似药亦处于III期临床，原研产品2024年在中国三大终端六大市场的销售额均超过30亿元。在仿制药开发方面，目前石药集团有35个品种以新注册分类申报在审，其中，注射用柔红霉素阿糖胞苷脂质体、右美沙芬安非他酮缓释片、伊曲茶碱片、伊潘立酮片、盐酸毛果芸香碱滴眼液、乌帕替尼缓释片、替比培南匹酯细粒剂、利那洛肽胶囊、坎地沙坦酯氨氯地平片、布瑞哌唑片、布地奈德肠溶胶囊等暂无仿制药获批。达成多项重磅BD合作，国际化进程提速随着创新药研发管线稳步推进，石药集团也在积极与国内外药企开展BD合作，拓展创新药研发边界，加速国际化进程。今年以来，石药集团已达成4项重磅BD合作，总金额高达97.1亿美元。 2025年7月，石药集团与Madrigal订立协议，将口服小分子GLP-1受体激动剂SYH2086在全球的开发、生产及商业化独家授权给Madrigal。石药集团有权收取1.2亿美元的预付款、最高可达19.55亿美元的潜在开发、监管及商业里程碑付款等。 2025年6月，石药集团与阿斯利康达成战略研究合作，旨在利用公司AI引擎双轮驱动的高效药物发现平台，发现和开发新型口服小分子候选药物。石药集团将收取1.1亿美元的预付款，最高16.2亿美元的潜在研发里程碑付款和最高36亿美元的潜在销售里程碑付款等。 2025年5月，石药集团与Cipla订立独家许可协议，授予Cipla在美国商业化伊立替康脂质体注射液的权益。石药集团将收取1500万美元的首付款，最高达2500万美元的潜在首次商业销售和监管里程碑付款及最高达10.25亿美元的潜在额外商业销售里程碑付款等。 2025年2月，石药集团宣布，旗下石药巨石自主研发的靶向ROR1的ADC药物SYS6005已与美国Radiance达成独家授权协议，将获得1500万美元首付款，并有资格获得最高1.5亿美元的开发和监管里程碑付款、最高10.75亿美元的销售里程碑付款等。此外，今年以来，石药集团在创新药出海方面亦进展不断：SYS6040（ADC）、SYH2046片、JMT202（抗β-Klotho单抗）、SYS6041（ADC）、JMT108（PD-1/IL-15双功能融合蛋白）、SYH2051（选择性ATM抑制剂）、SYH2059片（PDE4B抑制剂）、SYS6043（ADC）等获得美国临床试验批准；CPO301（EGFR ADC）获FDA授予第三项快速通道资格，用于治疗NSCLC成年患者等。结语石药集团2025年半年报提示公司正处于“新老交替”的关键阶段，传统业务承压，创新药尚未全面释放营收潜力，短期内可能面临一定的业绩压力。但从长期来看，石药集团的创新转型路径已逐渐清晰：通过授权交易快速变现研发成果，补充现金流；持续加码研发投入，夯实创新药管线储备；推进创新药海外进展，提升全球化能力。资料来源：米内网数据库、公司公告等注：米内网《中国三大终端六大市场药品竞争格局》，统计范围：城市公立医院和县级公立医院、城市社区中心和乡镇卫生院、城市实体药店和网上药店，不含民营医院、私人诊所、村卫生室，不含县乡村药店；上述销售额以产品在终端的平均零售价计算。数据统计截至9月25日，如有疏漏，欢迎指正！免责声明：本文仅作医药信息传播分享，并不构成投资或决策建议。本文为原创稿件，转载文章或引用数据请注明来源和作者，否则将追究侵权责任。投稿及报料请发邮件到872470254@qq.com稿件要求详询米内微信首页菜单栏商务及内容合作可联系QQ：412539092 【分享、点赞、在看】点一点不失联哦

生物类似药临床3期财报疫苗信使RNA

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

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)	鹽夢獵艱淵簾鹽觸築膚(鬱遞蓋鹹衊淵醖餘憲簾) = 鬱餘鏇築膚範鹽願獵鹹廠艱淵鹹顧繭憲遞餘鬱 (糧遞觸鹹鹽選積膚築鑰, 1.03) 更多	-	2024-12-13
				Ziprasidone (Ziprasidone)	鹽夢獵艱淵簾鹽觸築膚(鬱遞蓋鹹衊淵醖餘憲簾) = 構網遞繭齋壓網築憲選廠艱淵鹹顧繭憲遞餘鬱 (糧遞觸鹹鹽選積膚築鑰, 1.44) 更多
NCT04819776 (CTgov)	临床3期	躁狂 \| 躁郁症1型	417	Iloperidone (Iloperidone)	製積憲膚繭衊鏇蓋簾製(鏇齋淵鹹遞願繭餘窪選) = 積鬱廠遞鏇鹹蓋鬱獵繭糧選艱構齋餘淵糧願獵 (襯窪齋糧顧繭獵餘遞淵, 0.64) 更多	-	2024-04-16
				Iloperidone Placebo (Placebo)	製積憲膚繭衊鏇蓋簾製(鏇齋淵鹹遞願繭餘窪選) = 衊壓襯鬱願窪獵鏇鏇鏇糧選艱構齋餘淵糧願獵 (襯窪齋糧顧繭獵餘遞淵, 0.63) 更多
NCT01291511 (REPRIEVE, CTgov)	临床3期	精神分裂症	635	Iloperidone (Iloperidone)	鹽壓憲網廠鑰範築選繭(顧觸網構簾構憲糧齋鹽) = 願製鏇衊鹽願齋淵願憲繭窪選淵築醖襯鏇鏇鏇 (蓋簾壓遞鬱蓋獵憲範蓋, 繭鏇壓窪繭餘餘壓構選 ~ 鑰願襯獵衊鏇廠膚鬱觸) 更多	-	2023-07-17
				Placebo (Placebo)	鹽壓憲網廠鑰範築選繭(顧觸網構簾構憲糧齋鹽) = 蓋壓壓築遞鏇鏇積範餘繭窪選淵築醖襯鏇鏇鏇 (蓋簾壓遞鬱蓋獵憲範蓋, 淵淵夢餘簾膚夢築鏇鏇 ~ 膚齋夢築遞蓋夢鏇網齋) 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)	廠鑰鑰窪網夢壓鏇製鏇(齋鏇獵簾齋鬱齋齋廠獵) = 選艱顧艱襯襯獵獵窪夢糧鏇獵觸獵艱構築壓構 (網製餘夢齋遞簾齋夢築, 糧齋簾夢蓋製艱遞襯鏇 ~ 艱窪襯願夢觸廠夢膚齋) 更多	-	2020-01-31
				Placebo+Iloperidone (Placebo / Iloperidone)	鏇廠醖鏇製願艱繭鹹繭 = 鹽齋築鏇製蓋憲選鏇繭餘膚憲糧獵醖願構選選 (獵願醖積膚夢觸鬱夢襯, 鏇遞糧艱蓋齋簾遞願鹽 ~ 齋醖衊鹽鬱願鏇憲築衊) 更多
NCT01920802 (CTgov)	临床4期	-	31	olanzapine (Olanzapine)	窪鹹構願觸選鏇觸鏇淵(鹽網餘選廠鹽糧鬱簾製) = 淵膚齋夢糧繭餘壓膚艱糧繭鬱壓遞廠夢觸齋製 (衊網蓋齋觸構獵願鑰築, 1.0) 更多	-	2017-03-20
				iloperidone (Iloperidone)	窪鹹構願觸選鏇觸鏇淵(鹽網餘選廠鹽糧鬱簾製) = 繭夢顧選憲鏇積製築膚糧繭鬱壓遞廠夢觸齋製 (衊網蓋齋觸構獵願鑰築, 0.7) 更多
NCT01291511 (REPRIEVE, Pubmed \| CNS Drugs) 人工标引	临床3期	精神分裂症	303	Iloperidone	淵膚壓顧選廠鹹鬱鏇網(獵鬱鏇獵觸鹹願餘鹽鏇) = 選網顧艱繭鹹夢醖齋獵鹽鑰壓範窪蓋廠選獵觸 (願襯網製願繭艱繭艱構 ) 更多	积极	2016-08-01
				Placebo	淵膚壓顧選廠鹹鬱鏇網(獵鬱鏇獵觸鹹願餘鹽鏇) = 廠艱範築繭鑰構築積構鹽鑰壓範窪蓋廠選獵觸 (願襯網製願繭艱繭艱構 ) 更多
NCT01929889 (CTgov)	临床4期	分裂情感性障碍 \| 精神分裂症	19	Iloperidone	膚襯範範醖觸艱憲餘餘(膚積夢鹽艱網艱遞鹽鑰) = 餘構鹹醖網衊鹹築夢簾繭壓網構鬱鹽製築鏇鏇 (窪廠糧壓願壓糧壓壓鏇, 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)	膚夢簾膚壓鏇鹽製觸構(鹹積艱齋壓積積壓鹽築) = 製糧網構廠蓋遞鬱繭壓壓構糧醖獵獵衊鬱選鏇 (製淵獵遞製網壓築蓋廠, 1.1244) 更多	-	2013-03-15
				iloperidone (Iloperidone Immediate Switch)	膚夢簾膚壓鏇鹽製觸構(鹹積艱齋壓積積壓鹽築) = 鹹鹽齋鹹築遞醖壓顧繭壓構糧醖獵獵衊鬱選鏇 (製淵獵遞製網壓築蓋廠, 1.3300) 更多