排名前五的靶点	数量

CFTR(囊性纤维化跨膜传导调节因子)	2
NK1R(神经激肽-1-受体)	1
S1PR1(鞘氨醇-1-磷酸受体-Edg-1)	1
Melatonin receptor(褪黑激素受体家族)	1
HDACs(组蛋白去乙酰化酶家族)	1

关联

项与 Vanda Pharmaceuticals, Inc. 相关的药物

Ponesimod

靶点

S1PR1

作用机制

S1PR1调节剂

在研机构

Actelion Pharmaceuticals US, Inc. [+7]

原研机构

Actelion Pharmaceuticals Ltd.

在研适应症

复发性多发性硬化 [+1]

非在研适应症

慢性移植物抗宿主病 [+1]

最高研发阶段批准上市

首次获批国家/地区

美国

首次获批日期2021-03-18

Tasimelteon

他司美琼

靶点

Melatonin receptor

作用机制

褪黑激素受体家族激动剂

在研机构

Vanda Pharmaceuticals Netherlands BV [+1]

原研机构

Vanda Pharmaceuticals, Inc.

在研适应症

入睡和睡眠障碍 [+5]

非在研适应症

重度抑郁症 [+6]

最高研发阶段批准上市

首次获批国家/地区

美国

首次获批日期2014-01-31

Iloperidone

伊潘立酮

靶点

5-HT2A receptor x D2 receptor

作用机制

5-HT2A receptor拮抗剂 [+1]

在研机构

原研机构

在研适应症

非在研适应症

最高研发阶段批准上市

首次获批国家/地区

美国

首次获批日期2009-05-06

项与 Vanda Pharmaceuticals, Inc. 相关的临床试验

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.

NCT06296966 / Recruiting临床2期

A Four-Week, Double-Masked, Randomized, Placebo-Controlled, Phase 2, Evaluation of the Safety and Efficacy of VSJ-110 Ophthalmic Solution in the Treatment of Dry Eye

The purpose of this study is to determine the safety and efficacy of VSJ-110 compared to placebo in the treatment of dry eye.

开始日期2024-02-29

申办/合作机构

Vanda Pharmaceuticals, Inc.

NCT05922995 / Not yet recruiting早期临床1期IIT

A Single Center, Open Label Prospective Observational Pilot Study to Evaluate the Effects of Tasimelteon in Participants With REM Behavior Disorder (RBD)

To assess the effects of a daily single oral dose of 20 mg tasimelteon compared to baseline on events of dream enactment on patients with REM Behavior Disorder, as measured by a daily log.
To assess the effects of 20 mg tasimelteon compared to baseline on insomnia= symptoms, as measured by validated questionnaires (Insomnia Severity Index [ISI], Pittsburgh Sleep Quality Inventory [PSQI], Epworth Sleepiness Scale [ESS], Clinical Global Impression of Change Scale (CGI-C), Patient Global Impression of Change Scale (PGI-C)) as well as rest/activity pattern from actigraphy.
To assess the effects of 20 mg tasimelteon on patients who have a reduced or aberrant melatonin secretion compared to normal secretion by measuring salivary DLMO at baseline and correlating with the degree of change in RBD symptoms by end of the study.
To assess for any role a patient's unique genome may play in their response to tasimelteon; obtained via whole genome sequencing.
To assess the safety and tolerability of a daily single oral dose of 20 mg tasimelteon.

开始日期2023-09-30

申办/合作机构

The Brigham & Women's Hospital, Inc.

[+1]

100 项与 Vanda Pharmaceuticals, Inc. 相关的临床结果

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0 项与 Vanda Pharmaceuticals, Inc. 相关的专利（医药）

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项与 Vanda Pharmaceuticals, Inc. 相关的文献（医药）

2024-10-01·Cornea

Pharmacogenomic Analysis of Response to Topical Tumor Necrosis Factor α Antagonist Licaminlimab (OCS-02) in Dry Eye Disease [RETRACTED]

Article

作者: Baudouin, Christophe ; Galor, Anat ; He, Yunsheng ; Weissgerber, Georges ; Perez, Victor L. ; Donnenfeld, Eric

Purpose::

The purpose of this study was to evaluate the pharmacogenomics of response to topical ocular tumor necrosis factor α (TNFα) inhibitor licaminlimab in patients with DED.

Methods::

Three single-nucleotide polymorphisms (SNPs) associated with Sjögren syndrome, 3 in the TNFα gene and 1 in the TNF receptor 1 (TNFR1) gene, were assessed for association with response to licaminlimab in participants from a randomized, vehicle-controlled, Phase 2 study in which adults with DED and severe ocular discomfort persisting despite treatment with artificial tears received licaminlimab or vehicle for 6 weeks. Response was assessed for change from baseline in Global Ocular Discomfort score at Day 29 of treatment. The pharmacogenomic analysis was a prospectively specified exploratory objective of the study. mRNA expression for TNFα, interleukin (IL) 1β, and IL8 in conjunctival epithelium cells was determined. The relationship between SNPs and response to licaminlimab was assessed using a mixed model repeated measures analysis.

Results::

SNP rs1800693 in the TNFR1 gene showed a significant effect on response to licaminlimab (P < 0.0001, initial association test); no effect was seen for any of the other SNPs tested. The CC genotype of rs1800693 was associated with much greater response to licaminlimab than the CT or TT genotypes: LS mean changes from baseline to Day 29 in Global Ocular Discomfort score were −29.5, −0.09, and −3.90, in patients with the CC, CT, and TT genotypes, respectively (P < 0.0001). No significant effect was observed in vehicle-treated patients. Improvements from baseline were seen in 3/4 licaminlimab-treated participants with the CC genotype. Conjunctival epithelium cell levels of mRNA for TNFα, IL1β, and IL8 decreased from baseline in participants with the CC genotype, but not with the CT or TT genotypes. Between-genotype differences in mRNA levels were not observed in participants receiving vehicle.

Conclusions::

The CC genotype of rs1800693, relatively common in patients with DED, was strongly associated with response to licaminlimab and decreased inflammatory cytokine gene expression in ocular surface cells during treatment. This study is one of the first to our knowledge to investigate pharmacogenomics in the treatment of DED.

2024-03-01·La Revue du praticien

[Pharmacotherapies for insomnia].

Article

作者: Vecchierini, Marie-Françoise ; Léger, Damien

PHARMACOTHERAPIES FOR INSOMNIA. The first line of treatment in adult chronic insomnia is cognitive behavioral therapy (CBT). However, its difficult accessibility limited its use and medications are still often prescribed. Considering the drugs with marketing authorization, Z-drugs (zolpidem and zopiclone) if taken at the right hour and dosage promote sleep initiation and have less deleterious effects than benzodiazepines, especially the long-acting ones which should be avoided. This class of drugs cannot be prescribed longer than 28 days. Some antihistaminic licensed drugs are authorized as hypnotics, with a low proof of efficacy and a risk of adverse event as sedation and somnolence the next day. Their prescription should be avoided in old subjects. Some clinicians used antidepressant sedative medications, at low dosage, as hypnotic drugs but "off label", outside authorization. Now melatonin, an endogenous synchronizer of biologic rhythms, has obtained the authorization for the treatment of insomniac troubles, in subjects of at least 55 years old, in its slow- release formula, replacing the physiological decline of this hormone with aging. Melatonin is not a hypnotic, but has soporific properties, inducing sleep, improving sleep efficacy, sometimes sleep duration and morning alertness. When discontinued, it induced no withdrawal syndrome. It has shown no risk of abuse potential and no deleterious side-effects, if used at the right dose and in the absence of hepatic interaction with other compounds. Finally, a new class of hypnotics, "the orexin antagonists" has its first representative on the French market: daridorexant. The place of these molecules in the therapeutic strategy for chronic insomnia needs to be clarified.

2024-01-01·Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association

The Efficacy of Tradipitant in Patients With Diabetic and Idiopathic Gastroparesis in a Phase 3 Randomized Placebo-Controlled Clinical Trial

Article

作者: Fisher, Michaela ; Polymeropoulos, Mihael H ; Moszczynski, Paula ; Polymeropoulos, Christos ; Birznieks, Gunther ; Madonick, Darby ; Kupersmith, Caleigh ; Carlin, Jesse L ; Camilleri, Michael ; Xiao, Changfu ; Smieszek, Sandra ; Lembo, Anthony

BACKGROUND:

Neurokinin receptor 1 antagonists are effective in reducing nausea and vomiting in chemotherapy-induced emesis. We investigated the safety and efficacy of tradipitant, a neurokinin receptor 1 antagonist, in patients with idiopathic and diabetic gastroparesis.

METHODS:

A total of 201 adults with gastroparesis were randomly assigned to oral tradipitant 85 mg (n = 102) or placebo (n = 99) twice daily for 12 weeks. Symptoms were assessed by a daily symptom dairy, Gastroparesis Cardinal Symptom Index scores, and other patient-reported questionnaires. Blood levels were monitored for an exposure-response analysis. The primary outcome was change from baseline to week 12 in average nausea severity, measured by daily symptom diary.

RESULTS:

The intention-to-treat (ITT) population did not meet the prespecified primary endpoint at week 12 (difference in nausea severity change drug vs placebo; P = .741) or prespecified secondary endpoints. Post hoc analyses were performed to control for drug exposure, rescue medications, and baseline severity inflation. Subjects with high blood levels of tradipitant significantly improved average nausea severity beginning at early time points (weeks 2-4). In post hoc sensitivity analyses, tradipitant treatment demonstrated strengthened effects, with statistically significant improvements in nausea at week 12.

CONCLUSIONS:

Although tradipitant did not reach significance in the ITT population, a pharmacokinetic exposure-response analysis demonstrated significant effects with adequate tradipitant exposure. When accounting for confounding factors such as baseline severity inflation and rescue medication, a statistically significant effect was also observed. These findings suggest that tradipitant has potential as a treatment for the symptom of nausea in gastroparesis. (ClincialTrials.gov, Number: NCT04028492).

183

项与 Vanda Pharmaceuticals, Inc. 相关的新闻（医药）

2024-10-30

·PRNewswire

Vanda Pharmaceuticals to Announce Third Quarter 2024 Financial Results on November 6, 2024

Conference Call and Webcast to Follow WASHINGTON, Oct. 30, 2024 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced it will release results for the third quarter 2024 on Wednesday, November 6, 2024, after the market closes. Vanda will host a conference call at 4:30 PM ET on Wednesday, November 6, 2024, during which management will discuss the third quarter 2024 financial results and other corporate activities. To participate in the conference call, please dial 1-800-715-9871 (domestic) or 1-646-307-1963 (international) and use passcode 2555000. The conference call will be broadcast simultaneously and archived on Vanda's website, . Investors should go to the website at least 15 minutes early to register, download, and install any necessary audio software. A replay of the call will be available on Wednesday, November 6, 2024, beginning at 8:30 PM ET and will be accessible until Wednesday, November 13, 2024, 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 2555000. 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. 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] 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

财报

2024-10-18

·生物制药小编

万达制药三拒收购

近日，Vanda Pharmaceuticals再次拒绝了Cycle Pharmaceuticals收购要约。相比第一次，Cycle的报价不变，仍然是每股8美元，总计合计4.88亿美元。 2024年6月，Cycle首次对Vanda 提出了收购邀约，当时公司股价还上涨了24%。在Cycle这两次报价中，发生的一件重大事件就是Vanda的胃轻瘫药物tradipitant的新药上市申请遭到FDA拒绝批准。 tradipitant被拒后，Vanda并没有因此觉得自己掉价了，仍然坚持认为Cycle第二次提出的报价严重低估了公司的价值，不符合公司及其股东的最佳利益。Vanda甚至还将Cycle的收购邀约描述为“投机主义”，试图以折让的价格收购公司股票。在被Vanda拒绝的邀邀约收购的名单上，并非只有Cycle一家。在此之前（2024年5月），Vanda董事会还拒绝了CDMO公司Future Pak提出的每股7.25—7.75美元的收购邀约。董事会认为，Future Pak的收购会给公司带来巨大的风险和不确定性，不符合股东的最佳利益。为了避免公司被恶意收购，Vanda还因此启动了一项“毒丸计划”。多次硬刚FDA 如果要描述Vanda的一个突出特点的话，那就是“刚”。一般的药企在新药上市申请遭到监管拒绝后，都是老老实实补充相关数据，以达到FDA的监管要求，但大多数情况下，这家公司在遇到与FDA意见分歧的时候都选择了硬刚。早在2018年，FDA部分暂停了tradipitant的两项临床研究后，Vanda就将FDA告上法庭。因为FDA要求Vanda提供动物的临床前毒理数据，而Vanda认为动物研究并非必要的（之后提交新药上市申请的时候，Vanda还是坚持己见，选择了基于微生理系统的非动物临床前毒理学数据，不难理解，FDA最终向公司发出了一封CRL）。同年，FDA拒绝批准Hetlioz治疗时差障碍的新适应症后，Vanda再度选择与FDA当庭对峙。这次，tradipitant治疗胃轻瘫的上市申请被拒后，Vanda也同样对FDA的批准决定进行了指责。相关阅读：药物被拒，反而指责FDA违宪营收下滑挑战不论是Future Pak，还是Cycle，对Vanda都是提出的溢价收购——目前Vanda的股价为4.8美元/股。对于Vanda而言，需要应对的是营收出现显著下滑的情况，2023年公司营收较2022年（约2.544亿美元）下降了约24%，为1.926亿美元。公司收入主要来自两款上市产品Hetlioz和Fanapt。 Hetlioz是一款褪黑素受体激动剂，2014年获得FDA批准用以治疗非24小时睡醒周期障碍，此后又被批准用于治疗史密斯-马吉利综合征。作为公司的一大营收支柱，Hetlioz贡献了超一半的收入。然而Hetlioz在2023年销售业绩出现显著下滑，同比2022年（1.597亿美元）下降了37%，至1.002亿美元。2024年上半年销售额同样较2023年上半年下降了37%，至3880万美元。除了销售下滑之外，Hetlioz今年也是流年不利，3月的时候，用于失眠适应症的新药补充上市申请遭到了FDA的拒绝，在4月，Hetlioz还输掉了与仿制药厂家的诉讼，未来Hetlioz想要扭转销售下跌势头将更具挑战。 Fanapt算是有个好消息，今年在4月成功获批了I型双相情感障碍的新适应症批准。Fanapt在2009年首次获得FDA批准，用于急性成人精神分裂症。今年上半年，Fanapt已经成为公司销售额第一的的产品，不过相比2023年（4700万美元），销售额还是下滑了7%，为4370万美元。事实上，Vanda应该也是对这种情况有所预料，在去年底，Vanda花了1亿美元从强生那收购了一款自免新药Ponvory的美国以及加拿大权益。2024年上半年，Ponvory贡献了1540万美元的销售收入。参考出处 https://www.fiercepharma.com/pharma/vanda-swats-down-another-buyout-bid-cycle https://www.biospace.com/business/vanda-rejects-another-acquisition-offer-from-cycle-affirms-confidence-in-business药品上市被拒，Vanda再次破防

并购

2024-10-15

·Endpoints

Cycle makes another offer for Vanda; Ocean Biomedical, Molecure ink new deal

Plus, news about Gilead Sciences and Yuhan: Vanda gets second unsolicited offer: Cycle Group Holdings again submitted a proposal to buy Vanda for $8 per share in cash. Vanda, which is currently trading at about $4.87 $VNDA per share, rejected Cycle’s offer of the same size in May. It later received an FDA rejection for a gastrointestinal treatment in September. — Kyle LaHucik Ocean Biomedical, Molecure ink deal: The Rhode Island-based company will pay up to $32 million for access to Molecure’s preclinical YKL-40 inhibitor, called OAT-3912, and other inhibitors in that class. Molecure gets $600,000 in cash and stock to start. — Kyle LaHucik Gilead Sciences, Yuhan terminate deal : The companies “mutually agreed” to end an agreement first inked in 2019 to develop a pair of MASH therapies, according to a Gilead spokesperson. At the time, Gilead had paid $15 million upfront and promised up to $770 million in milestones. — Jaimy Lee

并购

100 项与 Vanda Pharmaceuticals, Inc. 相关的药物交易

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100 项与 Vanda Pharmaceuticals, Inc. 相关的转化医学

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当前项目

药物(靶点)	适应症	全球最高研发状态

他司美琼 ( Melatonin receptor )	睡眠-觉醒节律障碍更多	批准上市
伊潘立酮 ( 5-HT2A receptor x D2 receptor )	精神分裂症更多	批准上市
Ponesimod ( S1PR1 )	复发性多发性硬化更多	批准上市
VHX-896	躁郁症1型更多	临床3期
VSJ-110 ( CFTR )	干眼综合征更多	临床2期