A Phase 1, Single Dose Study to Evaluate the Safety and Pharmacokinetics of GB-hMG (Menotropins) for Subcutaneous Injection in Healthy Premenopausal Women

开始日期2024-10-25

申办/合作机构-

CTRI/2024/10/075239

/ Not yet recruiting临床4期

Comparing treatment efficacy between recombinant FSH LH and recombinant FSH Highly purifiedhuman menopausal gonadotropins(HMG) A Prospective randomized controlled study. - NIL

开始日期2024-10-15

申办/合作机构-

CTRI/2024/09/073446

/ Not yet recruitingN/AIIT

Comparison of Clomiphene Citrate vs Human Menopausal Gonadotropin for controlled ovarian stimulation in infertile women with decreased ovarian reserve (DOR) - A randomised controlled trial - NIL

开始日期2024-09-15

申办/合作机构-

100 项与高纯度尿促性素相关的临床结果

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100 项与高纯度尿促性素相关的转化医学

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100 项与高纯度尿促性素相关的专利（医药）

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2,434

项与高纯度尿促性素相关的文献（医药）

2025-06-01·OPHTHALMOLOGY

Longitudinal Changes of Retinal Nerve Fiber Layer and Ganglion Cell–Inner Plexiform Layer in Highly Myopic Glaucoma

Article

作者: Jonas, Jost B ; Lin, Fengbin ; Weinreb, Robert N ; Lam, Dennis S C ; Chen, Meiling ; Sun, Xiaodong ; Xiaokaiti, Dilimulati ; Fang, Zige ; Jiang, Jingwen ; Zhou, Fengqi ; Song, Yunhe ; Jin, Ling ; Liu, Xiaoyi ; Kong, Kangjie ; Zangwill, Linda M ; Li, Fei ; Zhang, Xiulan

PURPOSE:

To describe the longitudinal changes in peripapillary retinal nerve fiber layer (pRNFL) and macular ganglion cell-inner plexiform layer (mGC-IPL) thicknesses in highly myopic eyes with and without glaucoma and to investigate the effects of high myopia (HM) on the sectoral patterns of pRNFL and mGC-IPL thinning.

DESIGN:

Longitudinal cohort study.

PARTICIPANTS:

A total of 243 eyes from 243 individuals with 3-year follow-up were included in this study: 109 eyes in the HM group, 64 eyes in the open-angle glaucoma (OAG) group, and 70 eyes in the highly myopic glaucoma (HMG) group. Based on visual field assessment, 19 OAG eyes and 21 HMG eyes were determined to show progressive disease.

METHODS:

Mean and sectoral pRNFL and mGC-IPL thicknesses were obtained using swept-source OCT. A linear mixed-effects model was used to compare the thinning rates and percentages among groups.

MAIN OUTCOME MEASURES:

Mean and sectoral thinning rates and percentages of pRNFL and mGC-IPL in HM, OAG, and HMG eyes.

RESULTS:

The mean age of the participants was 37.2 ± 11.2 years, and the mean follow-up duration was 3.2 ± 0.3 years. The mean pRNFL thickness changed at rates of -0.44 μm/year, -0.63 μm/year, and -1.17 μm/year in the HM, OAG, and HMG group, respectively (P < 0.001), whereas the mean mGC-IPL thickness changed at rates of -0.10 μm/year, -0.32 μm/year, and -0.41 μm/year in the 3 groups, respectively (P < 0.001). Temporal pRNFL thinning was faster in HMG compared with OAG (-1.24 μm/year vs. -0.45 μm/year; P = 0.002). The mGC-IPL thinning rate in each sector was not significantly different between the HMG and OAG groups (P > 0.05 for all). In contrast to OAG, HMG eyes showed greater percentage thinning rates of pRNFL in the inferior and temporal sectors, with a greater mGC-IPL thinning in the inferonasal sector.

CONCLUSIONS:

The patterns of pRNFL and mGC-IPL thinning differ between HMG and OAG. In particular, faster temporal pRNFL thinning may be a distinguishing feature for identifying glaucoma in HM eyes. These findings also may enhance the understanding of the mechanisms of damage in HMG.

FINANCIAL DISCLOSURE(S):

Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

2025-05-01·F&S science

Chemotherapy-induced diminished murine ovarian reserve model and impact of low-dose chemotherapy on fertility

Article

作者: Donnez, Jacques ; Wen, Jen-Yu ; Maurel, Marie-Christine ; Dolmans, Marie-Madeleine ; Cacciottola, Luciana ; Houeis, Lara ; van der Plancke, Graziella ; Dupuy, Laurence ; Kara, Elodie

OBJECTIVE:

To establish a murine model of chemotherapy-induced diminished ovarian reserve (DOR) and investigate residual fertility after chemotherapy exposure.

DESIGN:

Two different chemotherapy protocols were tested to establish a valid DOR model by comparing follicle densities in mice given either protocol or physiological solution. An ovarian stimulation protocol was then selected from among different gonadotropins by counting the number of day 2 embryos obtained from normal mice. Finally, DOR mice were stimulated 5 and 8 weeks after chemotherapy with the chosen gonadotropin protocols, and day 2 embryos were recovered after mating, as was ovarian tissue for further immunohistologic analyses.

SUBJECTS:

Seventy-two Naval Medical Research Institute mice.

EXPOSURE:

Two different chemotherapy protocols.

MAIN OUTCOME MEASURES:

This study compared day 2 embryo counts in both normal and chemotherapy-induced DOR mice. Ovarian histology and morphology were also investigated by follicle counting and classification, as was immunostaining for apoptosis (cleaved caspase-3), activation (phospho-Akt), and proliferation (Ki67).

RESULTS:

A dose of 12 mg/kg of busulfan (Bu) + 120 mg/kg of cyclophosphamide (Cy) was chosen to establish the DOR model as it significantly reduced the ovarian reserve compared to both control mice (physiological solution) and the 1.2 mg/kg of Bu + 12 mg/kg of Cy protocol, without depleting it completely. When stimulated with 3.75 IU of Menopur, normal mice produced significantly more embryos than DOR mice given 12 mg/kg of Bu + 120 mg/kg of Cy (41.40 ± 14.74 vs. 23.67 ± 15.55 day 2 embryos). Although the follicle count was statistically diminished after single-dose chemotherapy administration, the remaining follicles did not display any difference in terms of apoptosis, activation, or proliferation rates.

CONCLUSION:

We successfully established a chemotherapy-induced DOR model using 12 mg/kg of Bu + 120 mg/kg of Cy, as evidenced by lower, but not completely depleted, follicle numbers and fewer retrieved embryos. Histologic study of ovarian tissue exposed to DOR-inducing chemotherapy revealed that surviving follicles were of the similar quality as tissue not exposed to chemotherapy.

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

Race and ethnicity, not just insurance, is associated with biologics initiation in asthma and related conditions

Article

作者: Akenroye, Ayobami ; Louisias, Margee ; Hvisdas, Christopher ; Stern, Jessica ; Jackson, John W

BACKGROUND:

There are pre-existing inequities in asthma care.

OBJECTIVES:

We sought to evaluate effect modification by race of the effect of insurance on biologic therapy use in patients with asthma and related diseases.

METHODS:

We conducted inverse probability weighted analyses using electronic health records data from 2011 to 2020 from a large health care system in Boston, Mass. We evaluated the odds of not initiating omalizumab or mepolizumab therapy within 1 year of prescription for an approved indication.

RESULTS:

We identified 1132 individuals who met study criteria. Twenty-seven percent of these patients had public insurance and 12% belonged to a historically marginalized group (HMG). One-quarter of patients did not initiate the prescribed biologic. Among patients with asthma, individuals belonging to HMG had higher exacerbation rates in the period before initiation compared to non-HMG individuals, regardless of insurance type. Among HMG patients with asthma, those with private insurance were less likely to not initiate therapy compared to those with public insurance (odds ratio [OR]: 0.67, and 95% CI: 0.56-0.79). Among non-HMG with asthma, privately insured and publicly insured individuals had similar rates of not initiating the prescribed biologic (OR: 1.02; 95% CI: 0.95-1.09). Among those publicly insured with asthma, HMGs had higher odds of not initiating therapy compared to non-HMGs (OR: 1.16; 95% CI: 1.03-1.31), but privately insured HMG and non-HMG did not differ significantly (OR: 0.99; 95% CI: 0.91-1.07).

CONCLUSIONS:

Publicly insured individuals belonging to HMG are less likely to initiate biologics when prescribed despite having more severe asthma, while there are no inequities by insurance in individuals belonging to other groups.

项与高纯度尿促性素相关的新闻（医药）

2024-06-20

·FiercePharma

Ferring launches online assessment tool, educational platform around male fertility

The overall goal of the initiative is to make the entire fertility journey more equitable for both women and men, which, according to Ferring, may ultimately help “improve drop-out rates, decrease stress, address stigma, reduce unnecessary medical costs and accelerate the path to pregnancy.” Ferring Pharmaceuticals is setting the record straight on fertility issues. Because infertility is often branded largely as a women’s issue, many men may be unaware of their own possible role in the matter and may not undergo testing in a timely manner—even though research has shown that men “substantially” contribute to about half of all cases of infertility. The issue is further compounded by stigma that may make men feel emasculated or embarrassed to be struggling with their fertility. A new initiative from Ferring, however, is aiming to boost awareness and education around male fertility and break down that stigma. According to a company announcement Thursday, the program was launched in partnership with Posterity Health, a virtual care service focused on male reproductive health and is hosted on Ferring’s existing Fertility Out Loud platform, which launched in 2021 to provide support for aspiring parents. The platform’s new addition will specifically target men, to “activate them to learn about their fertility health and how it may impact the couple’s path to parenthood,” according to Ali Castro, senior director of marketing and strategic engagement for Ferring’s reproductive medicine division. To do so, it’ll offer both educational resources and a confidential digital assessment that male partners can use to gain a better idea of their personal reproductive health. The overall goal of the initiative is to make the entire fertility journey more equitable for both women and men, which, according to Ferring, may ultimately help “improve drop-out rates, decrease stress, address stigma, reduce unnecessary medical costs and accelerate the path to pregnancy.” “When a couple is having trouble conceiving, the male partner typically waits 22 months before seeking an evaluation—during this period the female is often receiving unnecessary, and in some cases, invasive care,” Pam Pure, co-founder and CEO of Posterity, said in the announcement. “Working together with Ferring, we have made it easier to complete a male fertility assessment from home. Identifying and addressing male factor issues early in the fertility journey will empower couples to take control of their reproductive health.” Both the new initiative and larger Fertility Out Loud platform are unbranded, hosted on a standalone site with the only mention of Ferring at the bottom of each page. That said, Ferring does offer several fertility-related products, including Menopur and Novarel, both of which are used to induce ovulation in women struggling with infertility, and Endometrin, which provides extra progesterone to women who are undergoing fertility treatments.

2024-01-14

·行舟Drug

最全美、日、欧盟等28国上市药品检索方法汇总

点击上方的行舟Drug ▲ 添加关注二、欧盟28国英文、简称及加入时间奥地利（AUT、 Austria）比利时（BEL、 Belgium ）保加利亚（BUL、 Bulgaria）克罗地亚（CRO、 Croatia）塞浦路斯（CYP、 Cyprus）捷克（CZE、Czech Republic）丹麦（DEN、 Denmark）爱沙尼亚（EST、 Estonia）芬兰（FIN、 Finland）法国（FRA、 France）德国（GER、Germany）英国（GBR、Great Britain）希腊（GRE、Greece）匈牙利（HUN、 Hungary）爱尔兰（IRL、 Ireland ）意大利（ITA、 Italy ）拉脱维亚（LAT、 Latvia）立陶宛（LTU、 Lithuania）卢森堡（LUX、 Luxembourg）马耳他（ MLT、 Malta）荷兰（NED、 Netherlands）波兰（POL、 Poland）葡萄牙（POR、 Portugal）罗马尼亚（ROM、 Romania）斯洛伐克（SVK、 Slovakia）斯洛文尼亚（SLO、 Slovenia）西班牙（ ESP、 Spain）瑞典（SWE、 Sweden ）冰岛（ISL、Iceland EEA）挪威（NOR、Norway EEA）1965年4月8日，法国、联邦德国、意大利、荷兰、比利时和卢森堡6国在比利时首都布鲁塞尔又签署《布鲁塞尔条约》，1967年7月1日，《布鲁塞尔条约》生效，欧共体正式诞生；1973年英国、丹麦和爱尔兰加入欧共体；1981年希腊加入欧共体；1986年葡萄牙和西班牙加入欧共体；1993年11月1日，根据内外发展的需要，欧共体正式易名为欧洲联盟；1995年奥地利、瑞典和芬兰加入欧盟；2004年5月1日，马耳他、塞浦路斯、波兰、匈牙利、捷克、斯洛伐克、斯洛文尼亚、爱沙尼亚、拉脱维亚、立陶宛10国加入欧盟；2007年1月1日，罗马尼亚、保加利亚加入欧盟；2013年7月1日，克罗地亚正式加入欧洲联盟成为第28个成员国。三、检索药品检索首先要获得药品的商品名和活性成分名，其中商品名一般是英文即可，而活性成分名一般为各国相应语言的名称，差别一般较大，有的即使是英文，不同国家可能也会存在微小差异，所以检索时应灵活运用，综合运用检索信息。另外，在品种相应国家的企业官网也有许多信息可供参考。下面先提供三个获得不同国家药品商品名的途径：1、马丁代尔大典（Proprietary Preparations部分）；2、GENERIC DRUGS（http://www.ndrugs.com/）；3、西班牙官网（前提是要在西班牙上市，主要是在欧盟上市国的商品名）；4、Drugs.com（https://www.drugs.com/）；5、进入KEGG DRUG网址http://www.genome.jp/kegg/drug/，输入英文名，也可查询到其它英文名（用的少些，如尿促性素英文为Menotropins，该名在日本就检索不到，输入该网站检索后知在日本名为Human menopausal gonadotrophin）。另外也可在drugfuture上初步了解品种在各国药典的收载情况，没有通用的信息获得方法，应将各种所得信息取并集了解。下面为具体检索方法：（一）美国FDA官网上信息量很大，有Drugs@FDA、橙皮书、BE一致性指南、非活性成分数据库、溶出数据库等等。药品查询常用Drugs@FDA、橙皮书两个数据库。由于美国药品查询网上已有大量分享，在此不再过多赘述。不过注意名称问题，如绒促性素我国数据库翻译是:Chorionic Gonadotrophin，而FDA的则是CHORIONICGONADOTROPIN，所以检索前面的则是无结果，可检索Chorionic获得信息。美国DAILYMED（https://dailymed-nlm-nih-gov.libproxy1.nus.edu.sg/dailymed/）获得说明书信息，不过这个是非官方的数据，如果与FDA的有出入，以FDA的为准。美国处方药数据库（http://www.rxlist.com/script/main/srchcont_rxlist.asp?src）。（二）日本日本对批准药品各种信息公开的程度是很高的。不过药品检索需要有准确的日文名称，下面先介绍几个准确找到日文名称的方法，不过要综合运用，确保名称准确无误：1、有些老的品种可在我国CDE网站的体外溶出信息库里（日本橙溶出曲线数据库的翻译）找到日文名称：2、通过谷粉搜搜（谷歌）：英文名称+日本。这种可信度没有1、4高；3、进入日本雅虎（http://www.yahoo.co.jp/），检索英文名称。该法同2类似；4、进入国立医药品食品卫生研究所提供的JAN（JapaneseAccepted Names）上市药品名网站（http://moldb.nihs.go.jp/jan/），可查询准确的日文名称。获得日文名后，进入http://www.pmda.go.jp/english/index.html点击红色方框：点击红色处方药方框：在上图设定项全部打钩。输入日文一般名，在最下面点击以ヒト下垂体性性腺刺激ホルモン为例检索，得：点击红色方框：有说明书和IF文件，未见申报资料和报告书。不过日本的说明书里一般不包含毒理研究资料，但是在不良反应方面一般是非常全面的。再以リラナフタート为例检索：点击一般名进入：下面的2个红色方框是申报资料和审评报告，里面信息量极大。进入http://www.info.pmda.go.jp/psearch/html/menu_tenpu_base.html也可直接查询说明书信息。以アモキシシリン水和物为例检索点击检索：点击红色方框：左下角即为PDF版说明书；进入http://generic.createdb.net/，输入日文名也可查询一些药品价格和说明书信息；另用日文名称在厚生劳动省（http://www.mhlw.go.jp/）、日文文献网站（https://www-jstage-jst-go-jp.libproxy1.nus.edu.sg/browse）等查询相关信息。很多时候可以查询到在某次会议上决定停用某药的信息及原因，或相关合成，制剂资料等（引用蒲公英战友的经验，大家可自行试试）。另PMDA网站上还提供了日本最新版药典，网址为http://jpdb.nihs.go.jp/jp17e/；另日本再评价网址：http://www.fpmaj-saihyoka.com/quality/index.html日本橙皮书网址：http://www.jp-orangebook.gr.jp/english/，1995年4月以后申请的口服固体制剂，申请批准时已按要求进行溶出试验的评价，不再进行单独的质量再评价和橙皮书的收录。进入PMDA网站：http://www.pmda.go.jp/english/index.html：点击红色方框：点击红色方框：有部分药品的英文和日文版审评报告，与其他国家相比，披露信息可以说是最多的。三、检索（续-欧盟1）（按加入欧盟时间顺序）欧盟药品一般有集中审评（CP）和非集中审评（DCP）程序（国家和互认程序），集中审评程序的药品一般在EMA官网查询，比较简单，就不在赘述了。另外，http://www.eudrapharm.eu/eudrapharm/welcome.do?selectedStaticLocale.languageCode=en是EMA2006年12月6日建立的数据，供参考。HMA（http://mri.medagencies.org/Human/）官网收载的是互认程序批准的药品，里面有几乎欧盟28国+3国（冰岛、挪威、列支士敦）的药品直接检索链接。下面先对欧盟28国一一介绍：1、法国一、简介1967年7月1日，法国加入欧共体成员国。语言为法语。logo为：二、检索1、进入法国药品安全局http://www.ansm.sante.fr/，点击红色方框：点击上图的“帮助”以了解本站相关的使用信息。以Ovitrelle为例，检索：点击获得详细信息：有些信息，可自行查看。另进入https://www.vidal.fr/，也可查询法国药品处方等信息。2、德国一、简介1967年7月1日，德国加入欧共体成员国。语言为德语。，logo为二、检索 1、进入德国药品局http://www.pei.de/DE/home/de-node.html，选择英文界面：点击红色方框：点击红色方框：点击红色方框：点击红色方框：点击右下角的红色方框：以Targocid为例检索，点击方框的los：点击红色方框：点击获得SPC和说明书信息。另也可通过https://sunset-clause.dimdi.de/Mustertexte/查询，药品信息：点击红色方框：点击：3.意大利一、简介1967年7月1日，意大利成为首批进入欧共体的6国成员之一，语言为意大利语。，logo为二、检索进入意大利官网http://www.agenziafarmaco.gov.it/点击红色方框进入点击红色方框，进入以Simeticone为例，检索活性成分，未检索到，如下：点击红色方框，输入simeticone，得下图。有PIL、SPC等信息，点击进入查看详细信息。下图蓝色方框，为本品意大利语，重复上面的检索。见下图：有不同剂型的商品名，同马丁代尔大典的基本吻合。如下点进去查找先关信息。另外，点击上图绿色方框的公开数据：点击“药物清单数据”：等等，下面还有一些，不一一列举，根据需要自己查看。4.荷兰一、简介1967年7月1日，荷兰成为首批欧共体成员国之一。语言为荷兰语。，logo为二、检索1、进入荷兰药品评价局http://www.cbg-meb.nl/：点击上面的红色方框，再点击Voor mensen（人用），或者点击下面的2个红色方框，再点击胶囊/片剂形状图标进入以Chorionic Gonadotrophin为例（英文商品名、API名均可），本品在荷兰有多个商品名（Choragon; Ovitrelle; Pregnyl; Profasi），一一检索。以Choragon为例，结果如下：点击红色方框进入，得：获得PDF文件。5、比利时一、简介1967年7月1日，比利时成为首批欧共体成员国之一。比利时是西欧的一个联邦国家，首都为布鲁塞尔，欧盟总部所在地。官方语言为法语、荷兰语和德语。全国划分为法语区、荷兰语区、德语区和布鲁塞尔首都法荷语双语区。，logo为二、检索1、进入比利时药品评价局https://www.fagg-afmps.be/en。红色方框选择语言和下载PIL、SPC。主界面：右边有，点击进入点击选择法语（fr），进入在页面最下方的 CBIP.：网址为：http://www.cbip.be/fr/start。点击搜索英文商品名或活性成分名均可。还以Teicoplanin 为例，点击红色方框：蓝色方框为药品分类，红色方框可下载RCP,图片中语言为法语。6、卢森堡一、简介1967年7月1日，卢森堡成为首批欧共体成员国之一。语言为法语、德语、卢森堡语，大小相当于国内的一个县。，logo为二、检索进入官网：http://www.sante.public.lu/fr/politique-sante/ministere-sante/index.html，无英文界面，选择红色方框，进入，是比利时的药品查询地址？共用的？（百度了一下卢森堡与比利时的关系：以前这两块地方都是卢森堡大公管辖的，而卢森堡大公是由尼德兰国王代领的，所以当时的尼德兰包括现在的荷兰比利时和卢森堡。在1830年到1839年比利时革命期间，比利时从尼德兰独立，而亲比利时的卢森堡西部地区就加入了比利时。所以现在比利时有个省叫做卢森堡。而剩下的半个卢森堡就变成了今天的卢森堡大公国。）三、检索（续-欧盟2）7、英国一、简介1973年，英国加入欧共体成员国。语言为英语。，logo为二、检索进入英国药品安全局https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency：点击下面的红色方框：点击红色方框：点击红色方框，以Senokot为例检索：点击获得PAR报告。点击首图的第一个红色方框：点击：红色方框里检索即可。另还可进入英国CMC网站：http://www.medicines.org.uk/emc/search，以Infacol为例，检索：点击获得SPC、PIL信息。8、丹麦一、简介1973年，丹麦加入欧共体成员国。语言为丹麦语，第二官方语言为英语。，logo为二、检索 1、进入丹麦药品局http://laegemiddelstyrelsen.dk/en/。英文界面比较人性化啊。点击红色方框：点击红色方框获得SPC、PIL：点击下面红色方框：进入得：点击得：http://www.medicinpriser.dk/输入英文查询即可查看价格信息。9、爱尔兰一、简介1973年，爱尔兰加入欧共体成员国。语言为爱尔兰、英语。，logo为二、检索 1、进入爱尔兰药品局http://www.hpra.ie/，药品检索一目了然：但是，点进去老是提醒错误，不清楚什么原因，用下面的红色方框检索以Ovitrelle 为例（与输入CHORIONIC GONADOTROPHIN 检索，结果有所不同，所以检索时，可商品名/一般名同时检索获得综合信息）：红色方框获得信息，蓝色方框显示有8个药品。进入上面的仿制药与替代药方框，点击搜索：在下面点击show products或者加法号点击左边红框：信息很多，有的有PAR，里面可能会提到做BE用的参比制剂。10、希腊一、简介1981年，希腊加入欧共体成员国。语言为希腊语。，logo为二、检索1、进入希腊药品国家组织http://www.eof.gr/web/guest;jsessionid=9ce31d9a855371cd79d58e5f05ae：左上角可选择语言，点击国家处方集：点击红色方框，或者点左侧的search点击红色方框，选英文界面还以OVITRELLE为例，点击进去，有PSC、PIL、PAR、价格等很多信息，但是经国家程序批准的药品，其PDF文件为希腊语。另外，还有一些其他信息，根据需要研究。11、葡萄牙一、简介1986年，葡萄牙加入欧共体。语言为葡萄牙语。,logo为二、检索进入官网：http://www.infarmed.pt/portal/page/portal/INFARMED，选择英文版本：点击左下角进入药品检索：点击红色方框（挺人性化的，还有英文翻译），以Sodium Picosulfate为例搜索，未检索到，以其商品名Fructines，检索得：可见活性成分名为Picossulfato de s骴io ，以该名检索：点详细信息：12、西班牙一、简介1986年，西班牙加入欧共体。语言为西班牙语、英语，全球约有5亿人口说西班牙语。，logo为二、检索进入官网：http://www.msc.es/en/home.htm，红色方框可选择英语，该页面右中位置点击红色方框得：选择人用药品，点击蓝色方框：以Targocid为例，查询：点击方框获得详细信息，其中有一条介绍了该品种在欧盟其它国家上市的商品名称，可与马丁代尔大典配合使用：13、奥地利一、简介1995年，奥地利加入欧盟。语言为德语、英语。，logo为二、检索进入奥地利药品器械局官网http://www.basg.gv.at/en/basg-austrian-federal-office-for-safety-in-health-care/：选择英文页面，点击下面的方框选择英文页面，以Targocid为例检索得：14、瑞典一、简介1995年，瑞典加入欧共体成员国。语言为瑞典语。，logo为二、检索 1、进入瑞典药品局https://lakemedelsverket.se/english/，选择英文界面：以Chorionic Gonadotrophin 为例，本品在瑞典有3个商品名：以Ovitrelle为例检索：点击红色方框或详细信息：由于本品为集中审评的品种，在EMA网站上可以查到相关信息。三、检索（续-欧盟3）15、芬兰一、简介1995年，芬兰加入欧共体成员国。语言为芬兰语、瑞典语。，logo为二、检索1、进入芬兰药品局http://www.fimea.fi/，选择英文界面：点击红色方框得：点击红色方框进入：这个检索界面有点不一样。以Lariam为例检索：点击红色方框获得详细信息：点击方法获得相应信息。也有其他下载SPC和PIL的方法，途径差不多，大家研究下官网即可。16、马耳他一、简介2004年5月1日，马耳他加入欧盟。语言为马耳他语、英语。，logo为二、方法 1、进入马耳他药品局http://www.medicinesauthority.gov.mt/home?l=1（英语）点击方框的高级检索，出现如下界面，有国家/集中程序批准的EXCELL版本药品目录：也可点击直接检索，以Choragon 为例：下载详细信息。页面上也有其他信息，可自行了解。17、塞浦路斯一、简介2004年5月1日，塞浦路斯加入欧盟。语言为希腊语、土耳其语。，logo为二、检索进入官网：http://www.moh.gov.cy/moh/moh.nsf/index_en/index_en?OpenDocument，选择英文界面：点击红色方框：点击红色方框：点击红色方框的链接，界面同希腊的基本一样：以PREGNYL为例：点击获得详细信息。18、波兰一、简介2004年5月1日，波兰加入欧盟。语言为波兰语。，logo为二、检索进入波兰药品注册办公室官网：http://www.urpl.gov.pl/pl，选择英文界面：点击红色方框：以Pregnyl为例，检索：点击获得详细信息：当然，也并不是所有的品种都有这些信息，如采用IR、CEN程序进入波兰的产品可能就没有。另外也可以点击首张图片的绿色方框：点击波兰国旗：点击红色方框：再点击红色方框也可进入检索界面。19、匈牙利一、简介2004年5月1日，匈牙利加入欧盟。语言为匈牙利语。，logo为二、检索进入匈牙利国家药品机构官网：https://www.ogyei.gov.hu/nyitooldal/，选择英文界面，很直观简单有数据库连接：点击：以Choragon为例检索，注意是在红色方框、蓝色方框都可以检索：就是蓝色方框网页有点慢：点击查看详细信息：有的品种还会有PAR，RMP（风险管理计划RiskManagement Plan）另，产品上市状态缩写，与常用的缩写稍有不同（以下为谷歌翻译，基本为原文拷贝过来的）：TK：该产品具有有效的销售许可CTK：是由欧洲药品管理局签发,授权是在所有欧盟成员国有效。TT：制剂的上市许可而被删除。该数据库为5年的筹备之内可以删除，因为他们正在删除中找到5年之内仍然处于流通可能（没有安全原因删除）CTT：一个销售授权的产品，欧洲药品管理局已经取消。该数据库为5年的准备中删除，它们可以被发现，因为它们可能仍然在五年内将其删除的可用（它们已被删除非安全原因）ATT：该产品已为行政原因被删除，因为它改变了名称或注册号。随着筹备工作继续进行，或是交易。PI：平行进口20、捷克一、简介2004年5月1日，捷克加入欧盟。语言为捷克语。，logo为二、检索进入捷克国家药品机构官网：http://www.sukl.cz/，选择英文界面：大方框里有些其它信息，点击里面的小方框：以Espumisan为例：点击方框获得详细信息：有PAR、PIL等信息。21、斯洛伐克一、简介2004年5月1日，斯洛伐克加入欧盟，语言为斯洛伐克语，，logo为二、检索进入斯洛伐克国家药品机构官网：http://www.sukl.sk/,最下角选择英文界面：点击红色方框（蓝色方框里的其它信息可根据需要自行了解），以Choriogonadotropin为例检索活性成分：点击MAH下的许可人，可得该许可人在该国上市的所有药品。点击红色方框，获得详细信息：22、斯洛文尼亚斯洛文尼亚网址不知什么原因，一直进不去。药品检索链接为：http://www.jazmp.si/si/zacetna-stran/seznami/。23、爱沙尼亚一、简介2004年5月1日，爱沙尼亚加入欧盟，语言为爱沙尼亚语，国旗为，logo为二、检索进入爱沙尼亚国家药品局官网：http://www.ravimiamet.ee/，选择英文界面：点击红色方框：以Pregnyl为例检索：点击获得详细信息：24、拉脱维亚一、简介2004年5月1日，拉脱维亚加入欧盟，语言为拉脱维亚语，，logo为二、检索进入拉脱维亚国家药品局官网：https://www.zva.gov.lv/，选择英文界面：点击红色方框：点击红色方框：检索即可，以Bronchipret为例检索：另外，不用选择英文界面，在右侧中部如下：点击红色方框，直接有PNZ的PDF版（2010-今）如下：点击图3下边蓝色方框：是API的拉脱维亚语、拉丁语和英语名称，没有详细信息。25、立陶宛一、简介2004年5月1日，立陶宛加入欧盟，语言为立陶宛语，，logo为二、检索进入立陶宛国家药品管控局官网：http://www.vvkt.lt/，选择英文界面：点击红色方框，以Ovitrelle为例，检索：红色方框为详细信息，蓝色方框为说明；再以Pregnyl为例，检索：点击获得详细信息。另也可直接点击下图方框，不过是立陶宛语界面：26、罗马尼亚一、简介2007年1月1日，罗马尼亚加入欧盟，语言为罗马尼亚语，，logo为二、检索进入罗马尼亚国家药品局官网：http://www.anm.ro/anmdm/en/index.html，选择英文界面：点击红色方框得：蓝色方框为其它一些信息，可自行查看。点击红色方框：以上翻译均为谷歌翻译结果，欢迎了解的老师提供准确的翻译结果。以Ovitrelle为例检索：点击获得详细信息：由于是CP程序，所以点击红色方框，直接连接到EMA官网了；再以Pregnyl为例检索：点击就直接可以下载文件了。27、保加利亚一、简介2007年1月1日，保加利亚加入欧盟，语言为保加利亚语，，logo为二、检索进入保加利亚语国家药品局官网：http://www.bda.bg/，选择英文界面：点击红色方框（上面两个一样）：点击红色方框：点击红色方框：点击红色方框:未见药品检索链接，可按字母点进去查看。28、克罗地亚一、简介2013年7月1日，克罗地亚加入欧盟。语言为克罗地亚语。，Logo为二、检索进入克罗地亚国家药械机构官网：http://www.almp.hr/，选择英文界面：点击右边红色数据库方框：以Ovitrelle为例检索：点击获得详细信息：本品为集中程序通过的药品，有相应链接。再以Simvastatin为例检索：点击获得详细信息。另外在下面红色方框里还有申报程序的简单介绍：四、结束语药品信息检索是一个费时费力的过程，也没有放之四海而皆准的方法，不同国家不同品种都有其特殊性，具体检索时要灵活运用现有检索手段。针对有些信息查询困难的品种，也可通过文献专利、向其他同行请教交流等等其他信息获得渠道，力争获取更全面、准确的数据，为项目的顺利研发做好信息支持。文章信息源于公众号药品研发驿站，登载该文章目的为更广泛的传递行业信息，不代表赞同其观点或对其真实性负责。文章版权归原作者及原出处所有，文章内容仅供参考。本网拥有对此声明的最终解释权，若无意侵犯版权，请联系小编删除。学如逆水行舟，不进则退；心似平原走马，易放难收。行舟Drug每日更新欢迎订阅+医药大数据|行业动态|政策解读

医药出海

2023-12-08

·SYNAPSE

What are HMG-CoA reductase inhibitors and how do you quickly get the latest development progress?

HMG-CoA reductase is an enzyme that plays a crucial role in the human body's cholesterol synthesis pathway. It is responsible for catalyzing the conversion of HMG-CoA (3-hydroxy-3-methylglutaryl coenzyme A) to mevalonate, a key precursor in the production of cholesterol. By regulating the activity of HMG-CoA reductase, the body can control the amount of cholesterol synthesized. This enzyme is the target of statin drugs, which inhibit its activity, leading to a reduction in cholesterol levels. Maintaining proper HMG-CoA reductase function is essential for maintaining cholesterol homeostasis and preventing the development of cardiovascular diseases. HMG-CoA reductase inhibitors, also known as statins, are a class of drugs used to lower cholesterol levels in the body. The first statin, lovastatin, was approved by the FDA in 1987. Since then, several other statins have been developed, including atorvastatin, simvastatin, and rosuvastatin. Statins work by inhibiting the enzyme HMG-CoA reductase, which is involved in the production of cholesterol in the liver. By reducing cholesterol levels, statins can help prevent heart attacks, strokes, and other cardiovascular diseases. In addition to their cholesterol-lowering effects, statins have been shown to have other beneficial effects, such as reducing inflammation and improving endothelial function. They have also been investigated for their potential to treat other conditions, such as Alzheimer’s disease, multiple sclerosis, and certain types of cancer. The future of HMG-CoA reductase inhibitors looks promising, with ongoing research into new statins and other cholesterol-lowering drugs. Researchers are also investigating the potential of statins to treat other diseases, such as osteoporosis and autoimmune disorders. However, there are also concerns about the long-term effects of statin use, such as an increased risk of diabetes and liver damage. As such, further research is needed to fully understand the benefits and risks of these drugs. The mechanism of action of HMG-CoA reductase inhibitorsHMG-CoA reductase inhibitors are a class of drugs commonly known as statins. From a biomedical perspective, these drugs are used to lower cholesterol levels in the blood. They work by inhibiting the enzyme HMG-CoA reductase, which plays a crucial role in the production of cholesterol in the liver. By blocking this enzyme, statins reduce the amount of cholesterol synthesized in the body, leading to a decrease in LDL (low-density lipoprotein) cholesterol, often referred to as "bad" cholesterol. Lowering LDL cholesterol levels can help prevent the development of cardiovascular diseases such as heart attacks and strokes. Additionally, statins may have other beneficial effects, such as reducing inflammation and improving the function of blood vessels. HMG-CoA reductase inhibitors are commonly prescribed to individuals with high cholesterol levels or those at risk of cardiovascular diseases. Catalog of HMG-CoA reductase InhibitorsThe currently marketed HMG-CoA reductase inhibitors include: Ezetimibe/Pitavastatin CalciumAtorvastatin/FimasartanFenofibrate/Pitavastatin CalciumAmlodipine Besylate/Fimasartan Potassium Trihydrate/Rosuvastatin CalciumAmlodipine Besylate/Olmesartan Medoxomil/Rosuvastatin CalciumAtorvastatin Calcium Hydrate/Metformin HydrochlorideAtorvastatin/Hydrochlorothiazide/Aspirin/EnalaprilPitavastatin MagnesiumAmlodipine/Losartan Potassium/Rosuvastatin CalciumValsartan/Rosuvastatin CalciumFor more information, please click on the image below. What is the purpose of using HMG-CoA reductase inhibitors?HMG-CoA reductase inhibitors, are used to lower cholesterol levels in the body. They are used adjunctively with diet and exercise to treat and manage hypercholesterolemia (high cholesterol in blood) and for primary and secondary prevention of coronary heart disease. For more information, please click on the image below to log in and search. How can I get the most recent advancements in HMG-CoA reductase inhibitors?In the Synapse database, you can keep abreast of the latest research and development advances of HMG-CoA reductase inhibitors anywhere and anytime, daily or weekly, through the "Set Alert" function. Click on the image below to embark on a brand new journey of drug discovery!

100 项与高纯度尿促性素相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D02692	高纯度尿促性素	G03GA02	DB00032

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
原发性卵巢功能不全	美国	Ferring Pharmaceuticals, Inc.	2014-02-19
女性不育伴无排卵	澳大利亚	Ferring Pharmaceuticals Pty Ltd.	2011-09-13
多囊卵巢综合征	澳大利亚	Ferring Pharmaceuticals Pty Ltd.	2011-09-13
无排卵	美国	Ferring Pharmaceuticals, Inc.	2004-10-29
不孕	美国	Ferring Pharmaceuticals, Inc.	2004-10-29
女性不孕症	美国	Ferring Pharmaceuticals, Inc.	1999-08-27

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适应症	最高研发状态	国家/地区	公司	日期
男性不育症	临床3期	比利时	Ferring Pharmaceuticals A/S	2009-07-01
男性不育症	临床3期	捷克	Ferring Pharmaceuticals A/S	2009-07-01
男性不育症	临床3期	丹麦	Ferring Pharmaceuticals A/S	2009-07-01
男性不育症	临床3期	波兰	Ferring Pharmaceuticals A/S	2009-07-01
男性不育症	临床3期	西班牙	Ferring Pharmaceuticals A/S	2009-07-01
男性不育症	临床3期	瑞典	Ferring Pharmaceuticals A/S	2009-07-01
男性不育症	临床3期	土耳其	Ferring Pharmaceuticals A/S	2009-07-01

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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


NCT05103228 (CTgov)	N/A	不孕 \| 卵巢疾病	190	human menopausal gonadotropin+Follitropin delta+Follitropin Alfa (Lower Gonadotropin Dose Stimulation)	膚齋襯艱鏇襯製鏇簾積 = 築艱鏇衊醖網簾憲衊餘襯範顧獵衊夢鏇齋簾網 (淵糧簾觸窪觸壓襯遞廠, 膚蓋築膚獵積築壓蓋蓋 ~ 築獵簾醖鏇夢鹹蓋鹽壓) 更多	-	2024-12-13
				human menopausal gonadotropin+Follitropin delta+Follitropin Alfa (Higher Gonadotropin Dose Stimulation)	膚齋襯艱鏇襯製鏇簾積 = 膚鹽鑰憲糧網夢襯繭糧襯範顧獵衊夢鏇齋簾網 (淵糧簾觸窪觸壓襯遞廠, 構夢衊鬱鏇選鑰選憲簾 ~ 繭醖鬱壓鏇顧鏇製築願) 更多
NCT04163458 (CLARA, CTgov)	临床3期	不孕 \| 男性不育症	405	Placebo (for MENOPUR powder and solvent for solution for injection)+MENOPUR (MENOPUR Liquid)	壓繭膚壓夢簾襯衊遞衊(鑰襯窪夢鏇鹹壓獵蓋鏇) = 糧製鏇製餘網憲壓製鬱構餘夢構衊遞壓鏇衊醖 (獵鹽鏇簾積繭鏇製選鹹, 5.5) 更多	-	2023-11-07
				Placebo (for MENOPUR solution for injection in pre-filled pen)+MENOPUR powder and solvent for solution for injection, 75 IU (MENOPUR Powder)	壓繭膚壓夢簾襯衊遞衊(鑰襯窪夢鏇鹹壓獵蓋鏇) = 鏇襯願顧簾網鹽鹽構糧構餘夢構衊遞壓鏇衊醖 (獵鹽鏇簾積繭鏇製選鹹, 4.2) 更多
MEGASET-HR (Pubmed \| Pharmacoecon Open)	N/A	-	310	Highly Purified Human Menopausal Gonadotropin (HP-hMG)	構簾獵餘窪願艱憲鏇鏇(襯艱齋製願衊繭壓鬱製) = 觸鬱願鏇鏇艱蓋選製觸餘醖鏇築願襯築築築積 (糧窪壓繭窪築糧糧構鹹 )	积极	2023-09-01
				Recombinant Follicle Stimulating Hormone (rFSH)	構簾獵餘窪願艱憲鏇鏇(襯艱齋製願衊繭壓鬱製) = 膚淵襯簾艱繭窪構觸艱餘醖鏇築願襯築築築積 (糧窪壓繭窪築糧糧構鹹 )
NCT02554279 (MEGASET-HR, Pubmed)	临床4期	-	620	Highly purified human menotropin (HP-hMG)	廠齋窪觸艱鑰襯糧窪鹽(觸鹽夢鹽夢選遞構願網) = 蓋鹹積網鏇憲範衊網製製構齋蓋網壓鑰簾遞鹽 (選願積獵壓淵鹽繭膚遞 )	-	2020-12-01
				Recombinant follicle-stimulating hormone (FSH)	廠齋窪觸艱鑰襯糧窪鹽(觸鹽夢鹽夢選遞構願網) = 廠製襯獵壓夢觸遞觸選製構齋蓋網壓鑰簾遞鹽 (選願積獵壓淵鹽繭膚遞 )
NCT02554279 (MEGASET HR, Pubmed \| Fertil Steril) 人工标引	临床4期	卵巢刺激	619	highly purified human menotropin	蓋網鑰夢壓夢顧顧簾鬱(艱蓋壓蓋夢醖壓憲憲鏇) = 顧糧齋築繭淵遞衊顧顧夢構繭觸遞艱窪醖膚範 (積醖顧繭窪構鏇簾築餘 ) 更多	不佳	2020-08-01
				recombinant follicle-stimulating hormone	蓋網鑰夢壓夢顧顧簾鬱(艱蓋壓蓋夢醖壓憲憲鏇) = 觸築簾選衊製餘願繭壓夢構繭觸遞艱窪醖膚範 (積醖顧繭窪構鏇簾築餘 ) 更多
SUN-092 (ENDO2020)	N/A	无睾症	7	hCG monotherapy	夢構製顧獵衊鬱獵網獵(遞艱選網艱顧積憲糧蓋) = 鏇願鬱齋觸廠選衊鹹獵淵築壓顧襯範蓋壓遞選 (蓋獵積築鏇艱壓糧構蓋, 3.18–10.02) 更多	积极	2020-05-08
				hCG+ therapy	夢構製顧獵衊鬱獵網獵(遞艱選網艱顧積憲糧蓋) = 膚艱積選鹹壓獵積鹽鹹淵築壓顧襯範蓋壓遞選 (蓋獵積築鏇艱壓糧構蓋, 8.30–11.75) 更多
NCT02554279 (MEGASET-HR \| MEGASET HR, CTgov)	临床4期	不孕	620	menotropin (Menotropin)	糧繭餘廠選顧鬱簾衊願 = 顧鹽製遞選網簾淵築壓齋範願鹽鑰餘壓選鹽顧 (艱襯窪壓廠網壓築壓蓋, 醖獵鏇觸選鹽夢獵鑰艱 ~ 衊齋構網膚襯鹽網遞觸) 更多	-	2018-03-02
				recombinant FSH (Recombinant FSH)	糧繭餘廠選顧鬱簾衊願 = 鑰願鹽積繭願鏇餘襯鏇齋範願鹽鑰餘壓選鹽顧 (艱襯窪壓廠網壓築壓蓋, 襯鹽壓衊衊夢窪鹽廠繭 ~ 憲壓膚繭鹽簾膚夢願糧) 更多
NCT01921166 (Diminished Ovarian Reserve, CTgov)	临床4期	不孕	23	Menopur+Clomid+Bravelle+Follistim+Gonal f (Clomiphene Plus Gonadotropins)	獵積夢齋糧廠網獵繭壓 = 遞獵鬱廠廠餘網壓餘夢願繭夢願膚鹽鹽築顧醖 (壓願製襯蓋願製鬱淵衊, 膚醖蓋齋淵顧衊顧選網 ~ 鏇鹽繭獵憲遞積醖選獵) 更多	-	2018-02-23
				Leuprolide flare (Leuprolide Flare)	獵積夢齋糧廠網獵繭壓 = 鹽簾積繭積鬱鏇窪鹽膚願繭夢願膚鹽鹽築顧醖 (壓願製襯蓋願製鬱淵衊, 鑰壓鹽鑰範願淵廠膚艱 ~ 範廠壓願構繭簾糧夢積) 更多
Pubmed \| Gynecol Obstet Fertil Senol	N/A	卵巢过度刺激综合征	421	Highly purified hMG (HP-hMG)	鏇鏇淵顧壓憲餘觸齋衊(願觸齋膚鹽壓襯鹽鬱築) = 選網窪膚鑰醖壓網膚築觸構衊鹹獵鹽鹹窪衊艱 (鹹憲遞壓艱獵窪構壓範, 1.1 ~ 4.3)	-	2017-05-01
NCT02542280 (CTgov)	临床3期	不孕 \| 子宫内膜炎	360	endometrial injury. (Endometrial Injury)	遞網願膚願鹽築選壓願 = 鹹夢醖願鹽淵鹹醖鬱衊製襯選鏇鏇簾窪構製築 (鹹製鬱鹽艱襯齋艱鹹衊, 餘遞衊觸遞遞衊選鹽淵 ~ 繭繭範範艱廠願淵範願) 更多	-	2016-01-08
				ovarian stimulation (no Endometrial Injury)	遞網願膚願鹽築選壓願 = 醖鑰簾壓窪鹽衊鏇築壓製襯選鏇鏇簾窪構製築 (鹹製鬱鹽艱襯齋艱鹹衊, 鹽積繭蓋淵鬱夢獵餘遞 ~ 製壓膚壓獵淵餘遞壓鏇) 更多