Randomized Multicentric Proof-of-Concept Phase 2 Trial Doravirine in the Early Outpatient Management of West Nile Virus Infection in Patients at Risk of Progression - DORICO Trial

开始日期2025-11-01

申办/合作机构

ASST degli Spedali Civili di Brescia

CTIS2023-504952-87-00

/ Recruiting临床4期IIT

Impact of Doravirine in Liver Steatosis and Fibrosis in PLWH. A pilot, proof of concept study (DORALI Study)

开始日期2025-01-13

申办/合作机构-

NCT06602622

/ Recruiting临床4期IIT

Change in Body Weight and BMI in PWH Virologically Suppressed Who Maintain a Second-generation INSTI Regimen Compared to Those Who Switch to DOR/3TC/TDF At 48 Weeks

Patients who developed metabolic syndrome after initiation of HIV treatment or with antiretroviral therapy (ART) for at least 36 months, treated with second generation integrase inhibitors (BIC/TAF/FTC, DTG/ABC/3Tc or DTG+TDF/FTC) who have gained at least 10% of their total body weight after starting ART, with a body mass index ≥25 kg/m2 and body fat greater than 20% will be eligible to participate in this clinical trial. If they decide to participate, they will sign an informed consent. After this, a mobile application will randomly decide whether the participant will continue with their ART regimen or switch to another ART (listed in the guidelines as one of the main lines of treatment) containing doravirine/lamivudine/disoproxil fumarate tenofovir. Medical visits will be at 1 month, 3 months, 6 months, 9 months, and 12 months after get in to this protocol, with laboratory studies that evaluate fats, blood sugar, liver function, kidney function, and test for HIV control; in addition, each visit will be given self-fillable scales to evaluate neuropsychiatric disorders such as depression, anxiety, insomnia, satisfaction with treatment or symptoms associated with it.The aim of the study is to observe whether there is weight loss with the change in HIV treatment.

开始日期2024-08-14

申办/合作机构

Instituto Mexicano del Seguro Social

100 项与多拉韦林相关的临床结果

登录后查看更多信息

100 项与多拉韦林相关的转化医学

登录后查看更多信息

100 项与多拉韦林相关的专利（医药）

登录后查看更多信息

568

项与多拉韦林相关的文献（医药）

2026-02-01·JOURNAL OF ETHNOPHARMACOLOGY

Yulinzhu activates ESR1-mediated germline stem cell regeneration to improve diminished ovarian reserve

Article

作者: Sun, Liwei ; Ma, Rui ; Jin, Wenqi ; Fu, Baoyu ; Liu, Fangbing ; Yang, Dan ; Yang, Ling ; Yang, Pengdi

ETHNOPHARMACOLOGICAL RELEVANCE:

Diminished ovarian reserve (DOR), characterized by reduced quantity and diminished quality of oocytes, significantly impairs female fertility. Research indicates that germline stem cells (GSCs) possess the potential to fundamentally replenish the oocyte pool through self-renewal. Clinical studies have confirmed that Yulinzhu (YLZ) can effectively regulate menstrual disorders and hormonal levels, and improve DOR. However, whether YLZ can ameliorate ovarian reserve function by regulating the proliferation of GSCs, as well as its molecular mechanisms of action, remain to be fully elucidated.

AIM OF THE STUDY:

This study aimed to determine whether YLZ can improve ovarian reserve function by promoting the regeneration of GSCs and to explore the underlying mechanisms involved.

METHODS AND MATERIALS:

The therapeutic efficacy of YLZ against DOR was evaluated in both rat and Drosophila models. This included assessing hormone levels via enzyme-linked immunosorbent assay (ELISA), analyzing ovarian morphology through hematoxylin and eosin (H&E) staining, calculating the ovarian index, examining follicular development, and quantifying GSCs. The LC-MS/MS was then employed to identify the principal constituents of YLZ, and network pharmacology was utilized to predict potential therapeutic targets and signaling pathways relevant to DOR. Component-target interactions were further examined using molecular docking and surface plasmon resonance (SPR). Finally, the predicted targets and signaling pathways were validated through immunofluorescence, reverse transcription-quantitative PCR (RT-qPCR), and western blotting.

RESULTS:

In vivo experiments showed that YLZ alleviated ovarian atrophy, elevated hormone levels, and promoted follicular development in DOR rats. Furthermore, YLZ increased the expression of Oct4 and MVH markers of ovarian GSCs in DOR rats and raised GSC numbers in aged Drosophila ovaries, supporting GSC regeneration and enhancing ovarian reserve. A total of 93 active components were identified in YLZ, with network analysis highlighting the estrogen signaling pathway and the stem cell pluripotency pathway as central to its therapeutic effect on DOR. ESR1 was identified as the core therapeutic target through component-target network construction and affinity kinetic analysis. Moreover, it was found that kaempferol and quercetin, both belonging to flavonoids, have highly similar parent structures that enable them to recognize and bind to the same binding domains on the ESR1 protein. Further verification indicates that the kaempferol and quercetin in YLZ can promote the self-renewal of GSCs and enhance ovarian reserve capacity by up-regulating ESR1-mediated estrogen signaling and stem cell pluripotency pathways. Kaempferol and quercetin were identified as the core material basis for regulating the core pathway and producing the main pharmacological effects.

CONCLUSION:

The results suggest that YLZ regulates estrogen signaling and stem cell pluripotency pathway by targeting ESR1, thereby promoting GSC regeneration to enhance ovarian reserve function. Kaempferol and quercetin were identified as the principal active constituents, underscoring the therapeutic potential of YLZ in the treatment of DOR.

2025-12-31·ANNALS OF MEDICINE

The efficacy and safety of doravirine/lamivudine/tenofovir disoproxil fumarate in treatment-naïve and treatment-experienced patients with HIV

Article

作者: Yuan, Jing ; Zeng, Qin ; Li, Mei ; Yang, Honghong ; Liu, Qian

BACKGROUND:

Doravirine (DOR) has demonstrated good efficacy for the treatment of people with HIV (PWH); however, there is limited real-world research in developing countries.

METHODS:

We retrospectively assessed the efficacy and safety of DOR/lamivudine (3TC)/tenofovir disoproxil fumarate (TDF) at 24 and 48 weeks in treatment-naïve and treatment-experienced PWH.

RESULTS:

A total of 83 PWH were included from January 1, 2022, to December 31, 2023. The median age was 40 years (32-54). Twenty-seven patients (32.5%) were treatment-naïve PWH, and 56 patients (67.5%) were treatment-experienced PWH, the most common switch was from integrase inhibitors (37/56) to DOR, followed by efavirenz (18/56) and nevirapine (1/56). In treatment-naïve PWH, the median CD4+ T-cell count was 222.9 ± 144.2 cells/mL at baseline, which increased to 337.8 ± 189.6 cells/μL at week 24 (p < 0.001) and to 431.6 ± 259.9 cells/μL at week 48 (p < 0.001). The overall VS rate was 76.9% (20/26) at week 24 and 93.3% (14/15) at week 48. Creatinine (Cr) significantly increased from baseline to week 48 (p = 0.013) but remained normal. There were no significant differences observed in BMI, glucose, estimated glomerular filtration rate (eGFR), liver enzymes, or plasma lipid levels between the baseline and follow-up data. In treatment-experienced PWH, there were no significant changes in the VS rate, CD4+ T-cell count, Cr, eGFR or liver enzymes between the baseline and follow-up data. However, compared to baseline, statistically significant reductions in plasma lipids were observed at week 24 and at week 48. There was also a significant decrease observed in BMI at week 48 compared with baseline. In addition, anxiety, depression and sleep disorders improved in those patients who switched regimens from efavirenz to DOR.

CONCLUSIONS:

We provide a short-term observational report of the efficacy and safety of DOR/3TC/TDF in routine clinical practice, further supporting its use in PWH.

2025-12-01·JOURNAL OF CHROMATOGRAPHY B-ANALYTICAL TECHNOLOGIES IN THE BIOMEDICAL AND LIFE SCIENCES

Development, validation and clinical implementation of a HPLC-MS/MS method for the simultaneous quantification of bictegravir, emtricitabine, doravirine, cabotegravir, lenacapavir, fostemsavir, tenofovir alafenamide and the corresponding metabolites temsavir and tenofovir, in human plasma

Article

作者: Spagnuolo, Vincenzo ; Nozza, Silvia ; Ripa, Marco ; Castagna, Antonella ; Muccini, Camilla ; Ferrari, Davide ; Locatelli, Massimo ; Mattino, Alessia ; Sabetta, Eleonora

A highly sensitive and specific liquid chromatography-tandem mass spectrometry method was developed, fully validated, and successfully implemented for routine analysis to simultaneously quantify Bictegravir, Emtricitabine, Doravirine, Cabotegravir, Lenacapavir, Fostemsavir, Tenofovir alafenamide, and their metabolites, Temsavir and Tenofovir, in human plasma. The sample preparation employed a commercial liquid-liquid extraction kit optimized for low plasma volumes (50 μL), which also included the Internal Standard. The method demonstrated excellent precision, accuracy, and robustness, making it suitable for pharmacokinetic and therapeutic drug monitoring applications. Analyte separation was carried out using a gradient elution program over a total run time of seven minutes, with a flow rate of 0.35 mL/min. The mobile phase consisted of solvent A (water containing 0.1 % formic acid) and solvent B (acetonitrile containing 0.1 % formic acid). Detection was performed using a QTRAP® 5500 triple quadrupole mass spectrometer (SCIEX) equipped with an electrospray ionization source operating in positive ion mode. Ion monitoring was performed in multiple reaction monitoring (MRM) mode for all analytes. The method was validated in accordance with European Medicines Agency (EMA) guidelines across clinically relevant concentration ranges. The proposed method was successfully implemented in routine analysis. Following the initial months of application, biological samples from 165 patients were analyzed primarily to assess therapy adherence and confirm that drug blood concentrations reached the minimum threshold. Additionally, data on drug pharmacokinetics were obtained. Our findings indicate that the proposed method is a reliable and accurate tool for high-throughput screening that could be readily used by the clinicians to optimize therapeutic treatments, verify patients' adherence and reduce drug-related toxicities.

项与多拉韦林相关的新闻（医药）

2025-12-01

·医药观澜

2025年，每月或每半年一次用药的HIV预防新药研发取得进展，为患者带来新曙光

编者按：今日（12月1日）正值世界艾滋病日。随着抗逆转录病毒药物的广泛应用，艾滋病已从致命性疾病转变为可控的慢性疾病。然而，艾滋病病毒（HIV）感染者仍面临诸多未被满足的临床需求，尤其对于已产生耐药性或难以长期坚持复杂治疗方案的患者而言。为应对这些挑战，全球范围内有上百个新药研发项目正在持续推进，旨在进一步拓展HIV感染治疗的临床边界与可能性。作为全球医药及生命科学行业值得信赖的合作伙伴和重要贡献者，药明康德始终致力于提供一体化、端到端的新药研发和生产服务，助力全球合作伙伴加速包括HIV感染在内的各类感染性疾病创新疗法的研发进程、造福病患。今日（12月1日）是世界艾滋病日。根据世界卫生组织（WHO）官网数据，截至2024年底，估计有4080万艾滋病毒感染者。2024年，估计有63万人死于艾滋病毒相关原因，另有约130万人感染艾滋病毒。艾滋病曾经被认为是无药可治的致命疾病。随着高效抗逆转录病毒疗法——即俗称的“鸡尾酒疗法”的应用，艾滋病已经成为可控的慢性疾病。然而，HIV病毒感染者仍面临着未被满足需求，特别是那些经历过大量治疗、选择有限，并因耐药性或难以坚持复杂方案而处境艰难的感染者。由于抗逆转录病毒疗法服药种类多、剂量大、频次多等，而艾滋病患者又往往需要终身服药以实现长期病毒抑制，用药依从性成为患者的一大挑战。 2025年以来，针对HIV感染的在研管线取得多项新进展，尤其以小分子管线进展较为显著，这些在研新药针对HIV暴露前预防、降低服药频次等方面取得积极成果。图片来源：123RF 2025年艾滋病新药研发取得多项进展 11月，默沙东（MSD）宣布，其在研的一日一次口服双药单片方案doravirine/islatravir（DOR/ISL；100 mg/0.25 mg）在关键3期临床试验中达到主要终点。该试验纳入既往未接受过抗病毒治疗的HIV-1成人初治患者。结果显示，DOR/ISL在病毒学抑制率方面不劣于一日一次口服三药方案bictegravir/emtricitabine/tenofovir alafenamide（BIC/FTC/TAF；50 mg/200 mg/25 mg），成功达成预设主要疗效目标。默沙东计划进一步向全球监管机构递交相关申报资料。 Doravirine是一种每日一次的口服创新非核苷逆转录酶抑制剂，Islatravir（MK-8591）是一种核苷类逆转录酶易位抑制剂。值得一提的是，今年7月，美国FDA已受理DOR/ISL用于HIV-1感染成人患者的新药申请，拟用于将目前在抗病毒方案下已获得稳定病毒学抑制的成人患者转换至DOR/ISL方案治疗。同样在7月，默沙东宣布启动EXPrESSIVE临床3期项目，评估其在研口服每月一次小分子疗法MK-8527，用于HIV暴露前预防（PrEP）的安全性和有效性。MK-8527是一款核苷类逆转录酶易位抑制剂，可通过多种作用机制抑制逆转录酶活性，包括易位抑制和延迟链终止。在PrEP方面，2025年另一款新药也取得重要进展。由吉利德科学（Gilead Sciences）研发的Yeztugo（lenacapavir）于今年6月和8月分别获美国FDA和欧盟委员会批准，作为每半年注射一次的PrEP疗法。在Purpose 1和Purpose 2临床试验中，该疗法分别实现了100%和99.9%的HIV感染预防效果。Yeztugo是一种“first-in-class”长效艾滋病毒衣壳抑制剂，可以干扰艾滋病毒衣壳蛋白的组装和拆卸，在病毒生命周期的多个阶段发挥作用。今年10月底，Yeztugo还获得了盖伦奖“Best Pharmaceutical Product”。 10月，艾迪药业在研的HIV整合酶抑制剂复方制剂ADC118片在中国获批临床，适用于作为完整方案治疗HIV-1感染的成人。ADC118片是以创新化学结构的HIV整合酶抑制剂Asuptegravir（ASU，项目代号：ACC017）为核心，联合恩曲他滨、丙酚替诺福韦组成的三联复方制剂（ACC017/FTC/TAF），其可通过抑制HIV整合酶活性，有效阻断HIV基因组整合进入宿主基因组DNA。ACC017已经启动3期临床，拟与其他抗逆转录药物联合治疗成人HIV-1感染。根据此前公布的1b/2a期数据，ACC017片40mg单药治疗10天，病毒载量就可平均下降2.34log₁₀拷贝/mL；联合FTC/TAF治疗18天，超过90%的受试者实现了病毒学完全抑制。 2025年其他分子类型治疗HIV感染领域也迎来新进展，比如：Immunocore公司于3月公布了其在研T细胞受体（TCR）疗法IMC-M113V治疗HIV感染者的1/2期临床试验的初步数据。该产品利用一种T细胞受体与HIV感染免疫细胞上的HLA-A*02:01-Gag复合物结合，抗CD3效应臂随后招募T细胞摧毁含有整合HIV DNA的CD4阳性细胞，消灭所谓的病毒储存库。数据显示，IMC-M113V耐受性良好，并在中断抗逆转录病毒治疗后呈现剂量依赖性控制病毒的迹象。除了上述进展，2025年针对HIV感染的新药研发领域还迎来多项其他进展，此处不再一一列举。一体化CRDMO平台，助力全球抗感染性新药研发当前，全球范围内还有百余项新药管线正在临床研究阶段探索治疗HIV感染的潜力，分子类型涵盖小分子、抗体、疫苗、核酸、多肽、细胞疗法等等。从作用机制来看，这些在研产品涵盖核苷类逆转录酶抑制剂、非核苷类逆转录酶抑制剂、整合酶抑制剂、IL-7融合蛋白、IL-21融合蛋白、α4β7整合素单克隆抗体、抗PD-L1联合疗法、治疗性核酸疫苗、靶向CD19的CAR-T疗法、JAK抑制剂等各类机制药物。2025年艾滋病新药研发领域取得的进展，标志着该领域又向前迈出了坚实一步。长期以来，药明康德都在支持全球合作伙伴从药物研究（R）、开发（D）到商业化生产（M）各个阶段的需求，通过独特的一体化、端到端CRDMO模式，助力突破性疗法加速研发进程。期待在创新生态圈的共同合作和努力下，一个没有艾滋病的未来能够早日成为现实。在全球产业同仁协力攻克艾滋病的征程中，药明康德也以其一体化、端到端的新药研发生产赋能平台，助力全球合作伙伴将更多好药新药更快带给全球病患。免责声明：本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「医药观澜」微信公众号回复“转载”，获取转载须知。

临床3期

2025-11-20

·创药邦

创药邦 | 生物医药每日信息汇总20251120

文章来源创药邦团队，转载请注明出处 NEWS 新闻早知道创药速递「鲲石生物」获5000万人民币A轮融资，加速巨噬细胞药物创新「尧唐生物」获FDA批准，启动全球首个PH1体内基因编辑疗法关键性临床试验四川迈锐迪医疗完成数千万元天使轮融资，加速微流控智造赋能核药产业转化 4200万美元！「赛诺菲」投资一家ADC公司 5000万美元首付款！GSK押注泽安生物MCE平台 AI Proteins完成4250万美元A轮融资，开发微蛋白新药 23.7亿美元！Alkermes提高报价收购Avadel 「同立海源」与「邦耀生物」达成战略合作，共推 CAR-T 疗法新纪元欧盟批准皮下注射Keytruda上市！ FDA加速批准拜耳突破性抗癌小分子上市！默沙东HIV口服疗法有望明年上市！突破性Celcuity小分子疗法完成FDA上市申请递交刘如谦博士团队创新基因编辑策略登《自然》从长度到拓扑：韩国团队将二级loop结构引入poly(A)尾，显著提升表达与稳定性「鲲石生物」获5000万人民币A轮融资，加速巨噬细胞药物创新近日，鲲石生物完成5000万元人民币A轮融资，用于深入推进其全球领先的巨噬细胞药物研发及临床转化。本轮融资将重点用于公司全球领先的巨噬细胞药物平台建设，加速推进自主研发的第三代CAR-M靶向HER2管线的IND申报、一期临床进程以及胰腺癌，肺癌等管线临床前研究和IIT探索。此次融资的顺利完成，不仅体现了资本市场对公司在巨噬细胞药物领域创新能力和研发进展的高度认可，也为后续临床转化奠定了坚实基础。「尧唐生物」获FDA批准，启动全球首个PH1体内基因编辑疗法关键性临床试验 2025年11月19日，尧唐生物（YolTech Therapeutics）宣布，公司自主研发的体内基因编辑药物YOLT-203 注射液已获得FDA临床试验（IND）批准，将正式启动全球多中心、双盲、随机对照确证性临床研究，用于治疗原发性高草酸尿症1型（PH1）。YOLT-203是一款创新型体内基因编辑药物，采用尧唐生物自主研发的CRISPR/Cas基因编辑工具YolCas12HF，并通过自主开发的脂质纳米颗粒（LNP）系统精准递送至肝细胞，靶向编辑HAO1基因，抑制乙醇酸氧化酶（GO）表达，从源头减少草酸生成，有望实现“一次治疗、终身治愈”，为原发性高草酸尿症1型（PH1）患者提供全新的治愈希望。四川迈锐迪医疗完成数千万元天使轮融资，加速微流控智造赋能核药产业转化近日，四川迈锐迪医疗科技有限公司宣布完成数千万元天使轮融资。本轮融资主要由省科创投院士基金、西部成果转化中心、咸阳财金、国生创新、迈锐可联合投资。本轮融资资金将主要用于精准可控高负载核药项目开发及放射性药物中试平台建设，依托微流控技术赋能核药产业转化。 4200万美元！「赛诺菲」投资一家ADC公司 2025年11月19日，致力于开发用于治疗自身免疫性和炎症性疾病的抗体-药物偶联物（ADC）的生物技术公司 Lifordi Immunotherapeutics, Inc. ，宣布获得赛诺菲旗下的风险投资部门 Sanofi Ventures 的战略投资，以及现有投资者 ARCH Ventures、5AM Ventures 和 Atlas Venture 的追加融资。这家总部位于马萨诸塞州伯灵顿的初创公司去年由 ARCH Venture Partners、Atlas Venture 和 5AM Ventures 领投，完成了 7000 万美元的 A 轮融资。该公司透露，目前已从上述三家投资机构以及新投资者赛诺菲风险投资再筹集了约 4200 万美元。 5000万美元首付款！GSK押注泽安生物MCE平台 11月19日，泽安生物医药（LTZ Therapeutics）宣布继今年7月与礼来强强联手，公司又与国际医药巨头葛兰素史克达成一项具有里程碑意义的战略合作。基于LTZ全球首创的“髓系细胞衔接器”（Myeloid Cell Engager）平台，双方将在肿瘤领域共同开发最多4款First-in-Class候选药物，聚焦血液瘤与实体瘤的重大未满足临床需求。此次合作标志着LTZ的核心技术平台获得世界顶级药企的持续权威背书，并将显著加速其创新免疫疗法的全球临床转化。根据协议条款，LTZ将获得5000万美元首付款，并有资格基于研发进展获得潜在里程碑付款。此外，待相关合作产品成功商业化后，LTZ还将享有基于全球净销售额的分级特许权使用费。 AI Proteins完成4250万美元A轮融资，开发微蛋白新药 11月19日，波士顿，AI Proteins是一家开创了一类使用人工智能从头开始构建的新药物的生物技术公司，宣布完成4150万美元的A轮融资。本轮融资由Mission BioCapital和Santé Ventures领投，现有投资者包括Lightchain Capital、Cobro Ventures等也参与其中。这笔融资将加速AI Proteins的使命，即解锁由从头微小蛋白质（miniproteins）构建的下一代变革性新药。生成式人工智能、合成生物学和机器人技术的融合为该公司的发现平台提供了动力，并使这种新型疗法的创造成为可能。AI Proteins的模块化微小蛋白完全基于第一性原理创建，不受进化或人类偏见的约束，以实现对功能、稳定性、溶液行为和药理学的完全控制。它们可以针对复杂和多样化的作用机制进行定制，包括靶向递送或多特异性药物。 23.7亿美元！Alkermes提高报价收购Avadel 11月19日，都柏林，Alkermes（NASDAQ：ALKS）和Avadel Pharmaceuticals（NASDAQ：AVDL）宣布两家公司已就增加推荐报价的条款达成协议，根据该报价Alkermes将以每股高达22.50美元的总交易对价收购Avadel，其中包括21.00美元的现金和一（1）项不可转让的或有价值权（“CVR”），持有人有权获得每股1.50美元的潜在额外现金支付，具体取决于美国FDA对LUMRYZ™的最终批准。（如Alkermes和权利代理人签订的CVR协议中所定义），用于在2028年底前治疗成人特发性嗜睡（“增加报价”）。关于增加要约，Alkermes和Avadel已于2025年11月18日对双方之前于2025年10月22日签订并宣布的最终交易协议进行了修订。「同立海源」与「邦耀生物」达成战略合作，共推 CAR-T 疗法新纪元近日，北京同立海源生物科技有限公司与上海邦耀生物科技有限公司正式宣布，双方于 2025 年 11 月 18 日签署战略合作协议。双方将围绕邦耀生物全球领先的非病毒 PD1 定点整合 CAR-T 产品（BRL-201）开展深度合作，共同加速该疗法在复发难治性 B 细胞非霍奇金淋巴瘤（R/R B-NHL）领域的临床转化与商业化进程，为肿瘤患者提供更可及、更安全的细胞治疗解决方案。欧盟批准皮下注射Keytruda上市！默沙东（MSD）今日宣布，欧盟委员会（EC）已批准旗下Keytruda SC（pembrolizumab与berahyaluronidase alfa）皮下注射疗法，用于Keytruda在欧洲所获批的全部33项成人适应症。欧盟这次的批准主要基于临床试验MK-3475A-D77的结果。该研究为一项随机、多中心、开放标签、活性对照试验，入组未经治疗的转移性非小细胞肺癌（NSCLC）患者，这些患者未检测到EGFR、ALK或ROS1基因变异。试验随机分配377例患者（2：1），分别接受每6周皮下注射Keytruda联合含铂双药化疗，或每6周静脉输注Keytruda联合含铂双药化疗。 FDA加速批准拜耳突破性抗癌小分子上市！ 11月20日，美国FDA宣布加速批准拜耳（Bayer）旗下小分子疗法Hyrnuo（sevabertinib），用于治疗经FDA批准的检测方法确认存在HER2（ERBB2）酪氨酸激酶结构域（TKD）激活突变、且已接受过至少一种全身治疗的成人局部晚期或转移性非鳞状非小细胞肺癌（NSCLC）患者。这次批准的疗效评估主要基于SOHO-01研究，这是一项开放标签、单臂、多中心、多队列的临床试验，入组对象为不可切除或转移性非鳞状NSCLC患者，这些患者存在HER2 TKD激活突变，且已接受过至少一种全身治疗，并在试验中接受sevabertinib治疗。默沙东HIV口服疗法有望明年上市！ 11月19日，默沙东（MSD）宣布，其在研的一日一次口服双药单片方案doravirine/islatravir（DOR/ISL；100 mg/0.25 mg）在关键性、双盲3期临床试验MK-8591A-053中达到主要终点。该试验纳入既往未接受过抗病毒治疗的HIV-1成人初治患者，以第48周时HIV-1 RNA<50拷贝/毫升的患者比例为主要疗效评估指标。结果显示，DOR/ISL在病毒学抑制率方面不劣于一日一次口服三药方案bictegravir/emtricitabine/tenofovir alafenamide（BIC/FTC/TAF；50 mg/200 mg/25 mg），成功达成预设主要疗效目标。安全性方面，DOR/ISL的总体安全性特征与BIC/FTC/TAF相当，同样满足试验预定的主要安全性终点。 Celcuity突破性小分子疗法完成FDA上市申请递交近日，Celcuity宣布已完成向美国FDA递交在研广谱PI3K/mTORC1/2抑制剂gedatolisib的NDA，拟用于治疗激素受体阳性（HR+）、HER2阴性（HER2-）的晚期乳腺癌（ABC）患者。本次NDA是通过FDA的实时肿瘤学审评（RTOR）项目递交，旨在缩短监管审评周期。Gedatolisib此前已基于积极的早期临床数据获得突破性疗法认定和快速通道资格。刘如谦博士团队创新基因编辑策略登《自然》 11月19日，基因编辑领域先驱刘如谦（David Liu）博士在《自然》期刊发布一项最新研究，提出了一种有望跨多种遗传病通用的新型基因编辑策略。现有的单碱基编辑（base editing）和先导编辑（prime editing）技术虽然理论上能够矫正大多数致病突变，但往往需要为每一种突变单独开发治疗方案，限制了其广泛应用。对于由早现终止密码子导致的遗传病，抑制性tRNA（sup-tRNA）提供了一条更通用的思路，但此前的策略受到效力有限，或需要患者接受终身给药等限制。刘博士团队提出了“先导编辑介导的早现终止密码子读通”（PERT）策略，通过先导编辑将内源、非必需的tRNA永久改造成优化的sup-tRNA，实现对无义突变的长期纠正。从长度到拓扑：韩国团队将二级loop结构引入poly(A)尾，显著提升表达与稳定性 2025年11月17日，韩国天主教大学团队在期刊NPJ Vaccines发表论文“Loop structure in poly(A) tail of mRNA vaccine enhances antigen translation efficiency and mRNA stability”，首次将“二级结构”概念系统引入poly(A)尾设计，通过在原本线性的腺苷串里“嵌入”一段能够自身回折、形成局部双链“小发夹”的序列，表达水平和稳定性显著提升，且并未因高水平抗原而放大免疫毒性，为mRNA平台提供了新的可翻译工程化维度。识别微信二维码，添加细创药邦小编，符合条件者即可加入微信群！请注明：姓名+研究方向！ END 作者 | Field 审核 | Sunbor 转载及其他广告合作请联系：13735420749（微信） // 免责声明 * 创药邦内容团队专注于介绍生物创新药领域研究进展，本文仅作信息交流之目的，不代表平台立场； * 本文仅供医疗健康专业人士学习参考之用，个人需向医疗健康专业人士进行咨询，以获得个人医疗建议； * 本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及），不构成任何投资意见和建议，请以官方/公司公告为准； * 如有涉及版权问题，请及时与我们联系，我们将给予删除或下线处理。创药邦是面向生物创新药领域的专业平台，以「助力产业&资本」为己任。在创药邦，可以和同行分享最新的生物创新药前沿技术进展、行业政策和趋势，为创新药企提供融资、重组和并购等金融服务，帮助技术转化、项目转移和产品许可等产业服务，在创药邦找可靠的创新药项目，优化资源配置。

细胞疗法临床申请抗体药物偶联物免疫疗法基因疗法

2025-11-20

·ETPharma

Merck's oral HIV treatment non-inferior to Gilead's Biktarvy in late-stage trial

Bengaluru: Merck said on Wednesday its experimental oral HIV medicine was found to be non-inferior to Gilead Sciences' top-selling drug Biktarvy in a late-stage study involving previously untreated adult patients. The data showed that an oral combination regimen of doravirine and islatravir showed suppression of the HIV-1 virus at similar levels as Biktarvy at week 48, Merck said. Its safety profile was also comparable to Gilead's drug, which has become the standard of care for HIV-1 treatment . Biktarvy and Merck's drug are antiretroviral treatments , combinations of medicines used to stop reproduction of the virus. HIV-1 is the most common strain of the retrovirus that causes Acquired Immunodeficiency Syndrome, commonly known as AIDS. "Despite these positive findings, we do not anticipate today's readout to create a near-term shift in the HIV treatment paradigm," BMO Capital Markets analyst Evan Seigerman said, adding that there needs to be more "granular data" to be confident about the safety of Merck's drug. The company plans to present detailed findings from the trial at a future medical meeting and submit applications including these data to health authorities. The U.S. Food and Drug Administration is set to make its decision on approval for Merck's oral drug by April 28. While islatravir is an experimental treatment, Merck's doravirine is already approved and sold in the U.S. under the brand Pifeltro for HIV-1 treatment in combination with other antiretrovirals, and as a single-tablet regimen, Delstrigo. Islatravir is currently being tested in multiple trials in combination with other antiretrovirals for potential daily and once-weekly treatments for HIV-1. Last year, the doravirine and islatravir combination was shown to be non-inferior to Biktarvy in suppressing the replication of HIV-1 in patients who were already on antiretroviral therapy. (Reporting by Sneha S K in Bengaluru; Editing by Tasim Zahid and Leroy Leo)

临床研究临床结果上市批准

100 项与多拉韦林相关的药物交易

登录后查看更多信息

外链

KEGG	Wiki	ATC	Drug Bank
D10624	多拉韦林	J05AG06	DB12301

研发状态

批准上市

10 条最早获批的记录,

后查看更多信息

适应症	国家/地区	公司	日期
HIV感染	美国	Merck Sharp & Dohme Corp.	2018-08-30

未上市

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
禁食	临床3期	美国	Merck Sharp & Dohme Corp.	2022-08-01
代谢综合征	临床3期	美国	Merck Sharp & Dohme Corp.	2022-08-01
肥胖	临床3期	美国	Merck Sharp & Dohme Corp.	2022-08-01
动脉粥样硬化	临床1期	美国	Merck Sharp & Dohme Corp.	2024-03-01
血脂障碍	临床1期	美国	Merck Sharp & Dohme Corp.	2024-03-01
脂质代谢紊乱	临床1期	美国	Merck Sharp & Dohme Corp.	2024-03-01
获得性免疫缺陷综合征	临床1期	美国	Merck Sharp & Dohme Corp.	2022-06-09
潜伏性结核	临床1期	美国	Merck Sharp & Dohme Corp.	2019-04-22
肾功能不全	临床1期	-	Merck Sharp & Dohme Corp.	2016-01-26

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04233216 (Pubmed \| AIDS)	临床3期	HIV感染	100	DOR/ISL 100 mg/0.75 mg	築簾壓積獵夢醖廠齋觸(餘網鏇獵鏇鏇淵願築獵) = 選遞夢網淵築積餘糧繭艱餘蓋餘糧齋鏇築築壓 (繭壓網餘醖遞範憲襯鹹 ) 更多	积极	2025-10-02
NCT02275780 \| NCT02403674 (DRIVE-AHEAD and DRIVE-FORWARD, Pubmed \| J Acquir Immune Defic Syndr)	临床3期	药物不良反应一线	-	Doravirine/lamivudine/TDF	憲鬱壓廠鬱鏇製構積構(憲廠範選襯廠鏇獵範顧) = 26 and 15 participants randomized to EFV/FTC/TDF and DRV/r + 2 NRTIs, respectively, had ongoing NPAEs, resolving by week 192 in 73% (19/26) and 40% (6/15) of participants switching to a DOR-based regimen 積襯糧鏇膚夢築醖繭壓 (廠鹹窪夢繭憲鬱構鹹廠 ) 更多	积极	2025-05-01
				EFV/FTC/TDF
NCT03894124 (CTgov)	临床1期	HIV感染	24	Doravirine	衊願廠獵鹹襯鑰積鹽憲(鹹積鬱衊鑰夢憲艱製網) = 範艱製築艱築鑰繭範淵蓋壓壓鏇鏇夢壓築淵鑰 (襯艱齋獵壓夢構鑰鹹醖, 襯醖網願築憲夢顧簾築 ~ 構繭鹽範築願鏇選蓋壓) 更多	-	2024-09-19
NCT04689737 (CTgov)	临床4期	终末期肾脏病 \| HIV感染	8	Doravirine	夢襯鏇憲網醖願鹽膚齋(選蓋餘觸鑰糧餘範齋醖) = 蓋艱餘鬱鹹淵蓋範鹹製蓋獵積憲鑰構網獵衊製 (鏇壓繭膚淵憲鹹膚願糧, 糧齋膚鏇窪糧鑰選鹽廠 ~ 積夢願夢網膚構鏇觸顧) 更多	-	2024-08-27
NCT04538040 (CTgov)	临床4期	HIV感染	20	Doravirine+Bictegravir/emtricitabine/tenofovir alafenamide	鬱膚廠製鬱構選鹽餘衊 = 壓顧廠製構蓋遞鏇糧憲夢壓齋艱獵淵鬱遞憲壓 (膚願遞夢窪繭顧構醖齋, 憲醖壓襯繭構積獵願鹽 ~ 範糧壓選糧齋餘鹹範網) 更多	-	2024-03-05
NCT02275780 \| NCT02403674 (DRIVE-AHEAD \| DRIVE-FORWARD, Pubmed)	临床3期	HIV感染一线	1,494	Doravirine	範繭鹹鹹範選鹽鏇餘膚(襯願壓襯鏇獵願選鑰簾) = 窪簾夢獵夢願壓築蓋壓願遞憲鹽範襯觸膚糧獵 (襯鹽鏇鬱窪淵獵襯夢憲 )	积极	2024-02-01
				Ritonavir-boosted darunavir	範繭鹹鹹範選鹽鏇餘膚(襯願壓襯鏇獵願選鑰簾) = 網觸夢鬱鏇壓壓網夢壓願遞憲鹽範襯觸膚糧獵 (襯鹽鏇鬱窪淵獵襯夢憲 )
NCT04233216 (CTgov)	临床3期	HIV感染	35	DOR/ISL+ISL (ISL + ART)	繭網艱構鏇鹽鏇艱鑰淵 = 觸憲觸餘選蓋艱獵簾襯壓鑰艱醖膚蓋膚顧選糧 (鹽繭糧獵衊糧製繭壓膚, 艱遞網簾簾衊壓鹽鏇遞 ~ 鏇憲廠鹽構鬱憲廠顧獵) 更多	-	2023-12-08
				DOR/ISL+DOR (DOR + ART)	繭網艱構鏇鹽鏇艱鑰淵 = 壓構餘蓋窪構範糧繭觸壓鑰艱醖膚蓋膚顧選糧 (鹽繭糧獵衊糧製繭壓膚, 網衊蓋網觸顧構壓壓繭 ~ 襯遞簾膚網鬱簾簾壓壓) 更多
NCT04097925 (CTgov)	临床2期	HIV感染	30	Descovy+Doravirine	觸膚構網餘顧憲構鑰選(繭襯鹹憲憲餘願膚淵範) = 淵獵選衊鑰獵遞糧糧鏇鏇築廠鹹鏇糧淵製顧遞 (艱襯窪蓋醖積醖鹹壓觸, 壓製淵壓積鏇窪襯範壓 ~ 淵繭襯餘壓鬱襯艱壓淵) 更多	-	2022-05-25
NCT04079452 (CTgov)	临床3期	HIV感染	15	FTC+Doravirine+TAF (Doravirine+TAF/FTC Arm (Single Arm))	窪範鹽鑰衊鬱壓鏇艱淵(願築鏇觸壓糧夢襯膚衊) = 餘鹹壓蓋膚糧壓鏇繭築衊鏇繭構衊夢衊淵構艱 (鹹鑰艱顧簾鬱簾鹹淵憲, 網鬱膚蓋淵繭壓觸蓋觸 ~ 獵鬱觸廠網齋選遞夢鹽) 更多	-	2022-04-28
				FTC+TAF+Doravirie (Doravirie+TAF/FTC Arm (Single Arm))	積願範糧衊膚醖鹽築艱(餘繭顧簾網餘鹹觸選範) = 蓋壓選鏇窪鏇鹽鏇獵築網夢觸蓋簾窪壓鏇壓繭 (衊壓願網鏇觸蓋襯構鏇, 築獵襯廠積願築衊醖齋 ~ 鏇壓繭選簾醖夢廠構淵) 更多
NCT03272347 (phase 2b trial \| 8591-011, CTgov)	临床2期	HIV感染	123	Placebo to Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate+Doravirine/Islatravir+Doravirine+Islatravir+Lamivudine (Islatravir 0.25 mg)	糧餘鏇遞襯獵顧淵壓糧 = 蓋網範餘廠膚蓋築憲繭壓築齋簾窪鏇艱壓糧遞 (願觸觸窪餘網淵鹽襯衊, 製鬱糧繭範鹽遞範網糧 ~ 壓醖觸壓獵夢觸構繭願) 更多	-	2022-04-27
				Placebo to Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate+Doravirine/Islatravir+Doravirine+Islatravir+Lamivudine (Islatravir 0.75 mg)	糧餘鏇遞襯獵顧淵壓糧 = 範醖鬱製願顧憲繭鹹憲壓築齋簾窪鏇艱壓糧遞 (願觸觸窪餘網淵鹽襯衊, 膚鬱繭觸廠衊製鏇鬱齋 ~ 鏇積構鑰鹽窪襯鬱構範) 更多