A Randomized, Open-label Study Evaluating the Antiviral Activity and Safety of 3 Month Fuzeon Induction With an Optimized Background Antiretroviral Regimen Versus OB Alone, in Fuzeon-naive HIV-1 Infected Patients With Virological Failure.

This 2 arm study will assess the efficacy and safety of a new regimen of Fuzeon
+ optimized background antiretroviral treatment, in Fuzeon-naive HIV-1 infected patients with virological failure. Eligible patients will be randomized to recei ve either new optimized treatment alone, or optimized treatment + Fuzeon 90mg s.
c. twice daily, to determine the effect of 3 month induction with Fuzeon.It will be possible for a patient to receive several additional 3 month periods with F uzeon, in the case of new virological failure. The anticipated time on study tre atment is 3-12 months, and the target sample size is <100 individuals.

开始日期2008-01-01

申办/合作机构

Hoffmann-La Roche, Inc.

NCT00537394

/ Completed临床3期IIT

The Optimized Treatment That Includes or Omits NRTIs Trial: A Randomized Strategy Study for HIV-1-Infected Treatment-Experienced Subjects Using the cPSS to Select an Effective Regimen

The goal of anti-HIV therapy is to prevent HIV from replicating. Long-term control of HIV requires at least two anti-HIV drugs that are active against the virus. Drug resistance is a problem for many treatment-experienced, HIV-infected people. The purpose of this study was to determine the benefit of adding a nucleoside reverse transcriptase inhibitor (NRTI) to a new anti-HIV drug regimen for the suppression of HIV.

开始日期2008-01-01

申办/合作机构

National Institute of Allergy & Infectious Diseases

100 项与恩夫韦肽相关的临床结果

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100 项与恩夫韦肽相关的转化医学

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100 项与恩夫韦肽相关的专利（医药）

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950

项与恩夫韦肽相关的文献（医药）

2025-08-01·Current medicinal chemistry

Structural Basis of HIV-1 gp41 N-trimer for Designing Bifunctional Peptide-based Fusion Inhibitors

Article

作者: Liang, Guodong ; Wang, Jinlin ; Li, Peiying ; Ma, Yuheng ; Li, Ruijuan ; Na, Heiya

Background::

Pathogenic viruses that cause large-scale global or regional outbreaks almost always contain class I fusion proteins. Although the viruses differ in morphology, they all require fusion protein-mediated virus-host cell membranes during the early stages of host cell invasion.

Methods::

The CHR region and NHR region of fusion proteins can form the 6-HB structure to drive the fusion pore formation between viruses and host cells through metastable interactions. Here, we obtained bifunctional N-peptides with inhibitory activities against two viruses, HIV-1 and MERS-CoV, based on the sequences in the HIV-1 NHR region by constructing N-trimer conformation interacting with the CHR region.

Results::

This study demonstrates that N-peptides with the coiled triple helix structure obtained from the NHR region in 6-HB are able to target the CHR region and exhibit inhibitory activity against a variety of viruses.

Conclusion::

Moreover, this strategy can be used to investigate antivirals against unknown viruses for future outbreaks.

2025-07-01·ANTIVIRAL RESEARCH

Structural characterization of HIV fusion inhibitor LP-98: Insights into antiviral and resistance mechanisms

Article

作者: Zhu, Yuanmei ; Cui, Sheng ; He, Yuxian ; Chong, Huihui ; Liu, Nian

LP-98 is a lipopeptide-based HIV fusion inhibitor with exceptional potency and long-acting antiviral activity, currently in phase II clinical trials. In this study, we elucidated the structural basis of LP-98's antiviral activity and resistance mechanisms. Using AlphaFold3, we first predicted the six-helical bundle (6-HB) structure formed by LP-98 and the gp41-derived NHR peptide N44, identifying key residues mediating interhelical interactions. Subsequent crystallographic analysis of the LP-98/N44 complex confirmed these binding features, revealing that a cluster of hydrophobic residues in LP-98, along with a network of 15 hydrogen bonds, two electrostatic interactions and a salt bridge, critically stabilizes the 6-HB structure. Superposition analyses of the LP-98/N44 crystal structure with either the predicted 6-HB model or the LP-40/N44 crystal structure provided further mechanistic insights into LP-98's binding mode. Additionally, structural and functional characterization of the N-terminal Tyr-127 residue using a truncated variant (LP-98-Y) demonstrated its essential role in inhibitor binding and antiviral activity. Notably, LP-98 exhibited significantly reduced efficacy against T20-resistant HIV strains harboring single or double mutations in NHR. Our structural models shed light on the molecular basis of this resistance, offering critical insights for drug optimization. Collectively, these findings provide a detailed structural understanding of LP-98's antiviral mechanism, supporting its continued development as a promising next-generation HIV fusion inhibitor.

2025-06-16·JOURNAL OF CONTROLLED RELEASE

Transdermal delivery of enfuvirtide using dissolving microneedles integrated with novel insertion and removal indicator.

Article

作者: Nevot, Maria ; Li, Yaocun ; Li, Huanhuan ; Pandya, Anjali Kiran ; Abraham, Abraham M ; Riveira, Eva ; Vora, Lalitkumar ; Ballana, Ester ; McCarthy, Helen O ; Wang, Jiawen ; Houghton, Joseph ; Luo, Yidan ; Donnelly, Ryan F

Enfuvirtide, the first HIV fusion inhibitor, exhibits remarkable antiviral efficacy and a favourable safety profile compared with antiretroviral therapy alone. However, its clinical application is constrained by the necessity for subcutaneous administration and the high incidence of injection site reactions (ISRs) in 98 % of patients. This study seeks to overcome these limitations by developing dissolving microneedle array patches (DMAPs), offering a painless and efficient alternative for enfuvirtide delivery. Two bilayer DMAP designs featuring poly(vinyl pyrrolidone) (PVP) based-hydrophilic and poly(lactic acid) (PLA)-based hydrophobic baseplates were engineered, incorporating a novel PLA-silica baseplate as a colorimetric dissolution indicator for visual feedback on successful patch insertion and timely removal. The DMAPs with embedded indicators exhibited a rapid color change from yellow to green within 3 min of insertion into the rats' dorsal skin. This change was triggered by hydration of the dye crystal violet encapsulated in silica, as interstitial fluid migrated from the needle shafts to the baseplate. A subsequent transition to purple occurred within 2 h due to further dye hydration, indicating complete needle dissolution and successful delivery of enfuvirtide. In vivo studies on Sprague Dawley rats demonstrated that enfuvirtide achieved a C_max of 1864 ± 480 ng/mL at 0.5 h with the PLA-silica DMAP, compared to 973 ± 200 ng/mL at 1 h with the PVP-baseplate DMAP. Both formulations exhibited biocompatibility and safety in vivo, with the PLA-silica DMAP supporting rapid drug release suitable for short-term applications, while the PVP-based DMAP offered potential for long-term use without irritation. These findings underscore DMAPs as a promising alternative to subcutaneous injection of enfuvirtide, capable of reducing ISRs and potentially enhancing patient adherence. Notably, this work introduced an innovative solution for prompt patch removal upon complete drug delivery, effectively addressing dosing inconsistencies and enabling individualised administration, which is crucial for ensuring the reliability and patient acceptability for widespread adoption of this technology.

项与恩夫韦肽相关的新闻（医药）

2025-07-27

·同写意

与百家医药企业共话：以长期主义视角，算好空间账

AHA会议

2025-04-03

·Illumina因美纳

八分钟掌握单细胞捕获 “黑科技”

传统的细胞研究多为观察细胞群体的平均行为，然而，细胞间的差异性往往隐藏着关键的生物学信息。单细胞捕获技术能够精准分离单个细胞，深入分析细胞异质性，在肿瘤细胞多样性研究、神经细胞精细分类等众多领域具有重要价值。因美纳单细胞解决方案 ISCP 的涡旋法单细胞捕获技术具有显著特点。它利用涡旋原理，温和高效地分散细胞，在确保细胞活性的同时，实现通量灵活、低多胞率的单细胞捕获，提高实验成功率和重复性，为后续测序和分析奠定基础。我们准备了两段操作视频，让您在八分钟内全面掌握 ISCP 捕获单细胞的核心流程。视频涵盖涡旋法捕获的关键技巧和样本处理的规范操作，清晰呈现每个环节。您将看到细胞在涡旋力作用下被有序分离、捕获，深入了解操作细节和背后原理，助力实际操作更加熟练。点击观看操作视频，开启单细胞捕获之旅！T2试剂盒单细胞捕获操作流程T20试剂盒单细胞捕获操作流程.

诊断试剂细胞疗法

2025-02-07

·循因缉药

“置换”Illumina：me better！

环球视野，深度视角各位亲爱的股东，大家早上好中午好晚上好。 2025年2月4日，中国商务部发布公告将美国PVH集团和因美纳（Illumina）公司列入《不可靠实体清单》。重磅“炸弹”落下，Illumina作为测序仪龙头的存在引发了广泛的关注。除了可能到来的惩罚性措施，也有不少人关注存量Illumina测序仪的客户怎么办？美对华禁售部分质谱仪、流式细胞仪，咋办？但是，大家并没有当时禁售部分质谱仪和流式细胞仪那么紧张，甚至，还有点小兴奋。为什么？很简单，我们有底气。一时间华大智造、赛陆、真迈纷纷拍案而起，一场“置换”Illumina的大戏拉开了帷幕。那么，我们不妨借这个机会聊几个话题，这也可能是面临选择的终端用户关心的问题：第一，选择路线的问题，是“平替”还是“me better” 第二，选择宽度与选择深度问题；第三，从整个事件来聊聊产业发展问题。 #01 “我有3个方案” 我们先来聊聊如何选择“置换”Illumina的方案上来，首先有3个方向。第一，第三方“通用试剂”；优点是价格可控，机器、流程无需做任何变动，只是相当于你的打印机换了第三方墨盒。但是，也有风险。比如，机器坏了，你用第三方试剂Illumina不给保修的风险。还有，知识产权风险。也别问我这个第三方是谁，我也不知道，嘿嘿。第二，“平替”；国内平替方案有两个：真迈和赛陆。优点是价格也可控，流程基本没有变化。但是，要更换测序仪和试剂，相当于选择更换一个国产的平替版Illumina。缺点是这两家覆盖的产品线、获证情况都各有千秋，尚有待补足之处。比如，真迈和赛陆分别只有Genolab M/Salus Pro一张三类医疗器械证，略显单薄（MGI有23张）。（并非说这两家或其他任何一家不行，钱是自己的，要综合评估，仅表达观点）第三，“me better”。我们不妨跳出“如何造一辆跑的最快的马车”这一思想禁锢，想一想我们最根本的需求是什么？ “置换”Illumina的根本是寻找一个供应更稳定、性价比更高、产品线更齐全、更能满足下游应用的一个供应商，那么我找的可能不是Illumina的“平替”而是一个更好的测序解决方案。所以，我们认为，“置换”Illumina的最优解就是选择一个“me better”。所谓“me better”要置换的不是单单一个Illumina的测序仪，还要考虑3个层面的问题。其一，产品线是否齐全，也就是产品线的宽度；宽度，意味着选择多寡和搭配的灵活程度，虽然可能大多数客户目前只有或低或高不同通量的需求，然而，世界总是在发展。总有现有选择不再满足需求的时候，这时候如果当初选择考虑不充分就容易形成“技术债”。其二，考虑后续发展的需求，也就是产品线的深度；深度，意味着上下游纵深打通的可能性以及“后劲”。买测序仪，不仅是买来做个测序，对吧？我们要不要考虑自动化？要不要考虑单细胞测序？那么空间生物学、蛋白组学要不要考虑呢？其三，考虑置换后产品的持续性，也就是供应商的健壮性。选择的方案是否有专利风险？供应商能否持续供货？这都是选择“me better”的理由，也是一个合格“me better”应有的特质。 #02 “me better”的修养 Illumina产品线涵盖低、中低、中、高、超高通量五个产品系列，从产品线宽度上，上表中可以看出，目前能与Illumina旗鼓相当的国产解决方案提供商只有华大智造了。 DNBSEQ-T20更是独一档的存在，我想着要用T20替代的好像没出生，就没放进去。华大智造也拥有目前中国最全面的高通量测序解决方案，包括“不发光”技术路线的CycloneSeq纳米孔测序仪、“自发光”技术路线DNBSEQ E25、“激发光”路线的DNBSEQ G99/200/2000/T7等。这足以支撑起客户当下的需求，以及未来的战略搭配。而技术路线上，DNBSEQ低duplication这个特点您要是不知道都不好意思跟大家打招呼。 index hopping更是在华大平台上没啥存在感，且，华大智造更是将测序准确度提升到了Q40的水平。从产品深度上来看，华大智造还有单细胞解决方案、MGISEQ-2000RS FluoXpert多重免疫荧光方案和STOmics空间组学方案。且，已经适配了Olink蛋白组学解决方案，多组学研究不仅国内最全面，且已经走在了Illumina的前头。华大智造产品线涵盖整个测序上下游，从前处理、自动化平台到后续的存储、分析平台应有尽有。甚至，可以从样本采集（微针）、样本存储、样本前处理自动化平台、测序、数据存储打通，直接端出一个智能实验室。这，就是可供选择的产品线深度。至于健壮性，意味着供应方要知识产权护城河稳固、供应稳定。纵观中国测序仪的发展脉络，基本上可以分为华大前和华大后。这一点，我们在此前文章已多次提及，不再赘述。随着华大智造赢得与Illumina的专利官司，扫清了专利障碍，华大智造更是逐步走向世界。其扎根的国内，测序行业的格局已经悄然生变。我们此前引用了灼识咨询的梳理，中国国内的新增测序仪已经从Illumina占据绝对地位转变成华大智造、Illumina双雄竞争的格局，并逐渐由华大智造后来居上。这个趋势不可逆，这一点从Illumina的财报也能看出来。从2022年到2024年间，Illumina大中华区销售额一路下滑，从销售占比10%下降至7%。华大智造也从最开始的“me too”成长为测序仪界的“me better”，坐上国内测序仪领域的头把交椅。果然，中国产品更适合中国宝宝的体质。华大智造成立于2016年4月13日，9年时间也是其积累的厚度。且不说作为上市公司相较于初创公司，华大智造的供应具有更高的稳定性。至于从SBS到DNBSEQ的迁移障碍存在吗？有，但不多。在原来的文库上加一个MGI的APP转化，然后...DNBSEQ上机测序..没了... #03 “夺回选择权” 当然，客户最终选择哪种置换方案都是根据自身和选择综合考量的结果。也要看各国产厂商能够拿出来的“诚意”。让人生出最大的感慨就是，中国生命科学智造在测序领域的进步就是再一次把选择权交还给了客户。要说这跟华大智造的崛起一点关系没有，我相信绝大多数人是不认可的。而我们也一直在呼吁，希望中国能够产生一个类似Thermo Fisher一样的生命科学领域强者。它可以是华大智造，也可以是真迈、赛陆或者任何一个领域内正儿八经深耕不辍的坚守者。一个华大智造的人才、技术外溢就推动了整个测序行业的选择权易主。如果诞生了中国的Thermo Fisher，那么，面对咄咄逼人的高性能质谱、流式细胞仪禁运，我们看到的也会是欢天喜地、摩拳擦掌的兴奋，而不是，沉默。这两天华大智造的股价也涨疯了，是不是拿出点“诚意”？ #04 最后-诚意最后，根据产业链的消息：只要有Illumina仪器的地方，MGI华大智造都可以零门槛提供免费试用。这当然不算啥诚意，关键是后面：后续根据开机频率及旧设备使用年限给予相应的旧机器抵扣政策，不仅限于长短读长测序设备/试剂，还有自动化及多组学产品。也就是说，华大智造所有的产品你都能够用Illumina产品享受“置换补贴”... 当然具体折扣（诚意）是多少，我肯定不知道。反正，把Illumina玩成“国补”这一局面估计这个巨头是怎么也没想到的。嗨，有这好事必须上“me better”了。 END 找小编，扫这里！至此，各位股东星标了么？点赞了么？转发了么？在看了么？谢谢！所有内容均不作为投资建议，信息均来自公开资料。近期文章： Illumina因美纳被列入不可靠实体清单 Illumina：转型之年，中国遇险 Twist 2025Q1：强劲！ 10x Genomics单细胞专利再现缺口丹纳赫2024Q4：稳定、强劲但不完美赛默飞全面转正

100 项与恩夫韦肽相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D02499	恩夫韦肽	J05AX07	DB00109

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
HIV感染	美国	Hoffmann-La Roche, Inc.	2003-03-13

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
获得性免疫缺陷综合征	临床3期	法国	Hoffmann-La Roche, Inc.	2006-04-01
进行性多病灶脑白质病	临床2期	法国	Hoffmann-La Roche, Inc.	2005-04-01
HIV血清阳性	临床1期	美国	Trimeris, Inc.	2004-07-13
HIV血清阳性	临床1期	美国	Hoffmann-La Roche, Inc.	2004-07-13

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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


NCT00326963 (CTgov)	临床4期	HIV感染	142	PI+enfuvirtide [Fuzeon]	鬱構衊網選鬱積憲膚衊 = 餘願齋鏇齋顧鹹襯鏇鑰憲窪鑰憲製夢蓋範鏇廠 (蓋憲鏇願顧夢鬱製簾蓋, 鏇構蓋蓋憲淵膚選願繭 ~ 蓋衊膚遞壓鏇鹽醖壓觸) 更多	-	2016-08-16
NCT02582983 (CTgov)	临床4期	HIV感染	23	Enfuvirtide	鬱鬱膚餘淵觸構衊淵醖 = 顧鹽憲構鬱鬱鹽選夢鹹網觸膚積膚顧膚範餘顧 (範鹽鑰窪艱蓋鬱憲糧壓, 餘淵壓選夢築淵網壓憲 ~ 構襯顧膚構憲夢窪艱膚) 更多	-	2016-07-06
INNOVE study (IAS2010)	N/A	多器官功能衰竭	29	ENF+OBR	鑰餘鏇選範簾範夢憲製(顧襯蓋願糧憲簾襯顧積) = 醖糧獵範壓製網齋願鏇廠遞鏇積壓獵願製鏇膚 (鑰窪廠襯積艱廠鹽夢鹹 )	-	2010-01-01
INNOVE study (IAS2010)	N/A	多器官功能衰竭	29	OBR	鑰餘鏇選範簾範夢憲製(顧襯蓋願糧憲簾襯顧積) = 築淵製簾構網醖衊齋艱廠遞鏇積壓獵願製鏇膚 (鑰窪廠襯積艱廠鹽夢鹹 )	-	2010-01-01
NCT00487188 (INTENSE, Pubmed \| J Antimicrob Chemother)	临床4期	维持	47	Enfuvirtide+HAART	鹹壓餘齋製遞衊憲鬱鑰(網願鹽餘積蓋製蓋窪憲) = 糧鬱淵蓋糧夢願積觸膚蓋構衊夢膚壓憲餘築壓 (窪襯憲築鏇淵繭鑰窪醖 )	-	2008-12-01
NCT00487188 (INTENSE, Pubmed \| J Antimicrob Chemother)	临床4期	维持	47	HAART alone	鹹壓餘齋製遞衊憲鬱鑰(網願鹽餘積蓋製蓋窪憲) = 顧鹽網遞選製鹹淵鏇網蓋構衊夢膚壓憲餘築壓 (窪襯憲築鏇淵繭鑰窪醖 )	-	2008-12-01
NCT00089492 (T20-401, Pubmed)	临床2期	HIV感染	64	Enfuvirtide 180 mg qd	餘糧蓋襯顧鹹鑰壓簾選(網觸夢壓顧網蓋製窪鏇) = 繭蓋觸夢艱糧選鑰簾壓淵繭艱鹽艱顧積鏇餘夢 (廠鏇艱簾蓋艱糧夢餘遞 ) 更多	积极	2008-04-01
NCT00089492 (T20-401, Pubmed)	临床2期	HIV感染	64	Enfuvirtide 90 mg bid	餘糧蓋襯顧鹹鑰壓簾選(網觸夢壓顧網蓋製窪鏇) = 鹹鬱範窪鑰糧廠鹽製積淵繭艱鹽艱顧積鏇餘夢 (廠鏇艱簾蓋艱糧夢餘遞 ) 更多	积极	2008-04-01
IAS2007	N/A	HIV感染	-	Enfuvirtide (ENF)	衊窪齋餘鹽鏇蓋夢蓋積(壓範壓鑰網夢壓衊壓鹹) = 鬱簾醖繭鏇鏇鑰憲蓋壓製築衊壓壓鬱醖醖範夢 (夢鏇憲顧鹹網獵廠繭窪 ) 更多	-	2007-01-01
Telan study (IAS2007)	N/A	-	28	ENF (enfuvirtide)	遞淵網鏇鑰鹽構艱艱鬱(壓範蓋獵網構襯選餘衊) = 積顧壓膚觸製齋網淵艱鏇範繭構網廠顧鹹糧獵 (餘簾繭顧製簾構齋鏇餘 )	-	2007-01-01
NCT00031044 (AACTG A5118, Pubmed \| Antivir Ther)	临床1/2期	HIV感染	18	Amdoxovir	衊獵築構齋鹹網膚鬱獵(憲膚膚選齋鑰繭淵齋糧) = 範醖製蓋遞構鹽顧繭範製醖鹽窪簾觸憲蓋鹽積 (壓蓋窪繭製廠膚窪鹽蓋, 1 ~ 115)	-	2006-01-01
NCT00031044 (AACTG A5118, Pubmed \| Antivir Ther)	临床1/2期	HIV感染	18	Placebo	衊獵築構齋鹹網膚鬱獵(憲膚膚選齋鑰繭淵齋糧) = 願鬱顧觸壓齋膚鹹夢鏇製醖鹽窪簾觸憲蓋鹽積 (壓蓋窪繭製廠膚窪鹽蓋, 1 ~ 101)	-	2006-01-01
RADATA-Fuzeon cohort (IAS2006)	N/A	-	228	Enfuvirtide	醖築鬱顧鏇繭選獵餘積(鬱夢願繭築鹽獵襯顧夢) = 壓鑰選繭壓鑰淵夢範築膚夢觸鬱憲壓壓鬱簾襯 (遞選壓鹽願鑰構廠遞鬱 ) 更多	积极	2006-01-01