A PHASE 1, OPEN-LABEL, RANDOMIZED, SINGLE DOSE, CROSSOVER STUDY TO DETERMINE THE BE OF NIRMATRELVIR FOLLOWING ORAL ADMINISTRATION OF FDC TABLETS RELATIVE TO THE PAXLOVID® COMMERCIAL TABLETS IN HEALTHY ADULT PARTICIPANTS UNDER FASTED CONDITIONS

Medicines that may have different names or be made in different ways but have the same effect on the body are called bioequivalent.
The purpose of this study is to learn about the bioequivalence of nirmatrelvir plus ritonavir after taking 2 different combination tablet forms by mouth. These combination tablets are compared to the tablet formulation that is already in the market. This study will be done under fasted conditions in healthy adult participants.
This study is seeking participants who are:
Male and non-pregnant female participants aged 18 years and above.
with a body weight of more than 50 kilograms and Body Mass Index (BMI) between 16 to 32 kilograms per meter squared.
are healthy as confirmed by medical history, physical examination, laboratory tests.
The study will also look at the safety and tolerability of nirmatrelvir plus ritonavir combination tablet and marketed tablet formulations in healthy adult participants.
The study will consist of 4 treatments:
Treatment A: Single oral dose of nirmatrelvir plus ritonavir 150 (1 × 150)/100 milligrams marketed tablets under fasted conditions (Reference 1) Treatment B (low dose strength): Single oral dose of nirmatrelvir plus ritonavir 150/100 milligrams (2 × [75/50 milligrams]) combination tablets under fasted conditions (Test 1) Treatment C: Single oral dose of nirmatrelvir/ritonavir 300 (2 × 150)/100 milligrams marketed tablets under fasted conditions (Reference 2) Treatment D (high dose strength): Single oral dose of nirmatrelvir/ritonavir 300/100 milligrams (2 × [150/50 milligrams]) combination tablets under fasted conditions (Test 2)
All treatments will be given under fasted conditions. Fasted condition means the participants would not have had anything to eat before taking the medicines.
Around 28 participants will be enrolled in the study. Healthy participants will be tested to see if they can be in the study within 28 days before receiving the study medicine. Selected participants will be admitted to the clinical research unit (CRU) one day before receiving the study medicine and will remain in the CRU until discharge after completing all the treatment periods.
On Day 1 of each period, participants will be given a single dose of study medicine nirmatrelvir/ritonavir 300/100 mg or 150/100 mg by mouth by chance. Study medicine will be given with approximately 240 milliliters of room temperature water under fasted conditions (overnight fast of at least 10 hours and no food until 4 hours after receiving the study medicine). Blood samples will be collected at different times of the day up to 48 hours after taking the study medicine. Participants will be discharged from the CRU on Day 3 of Period 4, after all the study related procedures have been completed.
A follow-up call will be made to participants around 28 to 35 days from receiving the final dose of the study medicine. The study will look at the experiences of participants receiving the study medicine. This will help to understand if the study medicine is safe and effective.

开始日期2025-02-14

申办/合作机构

Pfizer Inc.

NCT06792214

/ Recruiting临床4期IIT

Antiviral Strategies in the Prevention of Long-term Cardiovascular Outcomes Following COVID-19: The paxloviD/Remdesivir Effectiveness For the prEvention of loNg coviD (DEFEND) Clinical Trial

The DEFEND trial will be the world's first clinical trial to study the effectiveness of Paxlovid or Veklury in the prevention of cardiovascular post-acute sequelae of SARS-CoV-2 among hospitalized adults. Additionally, this pilot study will inform the design and conduct of a future full-scale multi-centre trial by testing the feasibility and accuracy of this study design.

开始日期2025-01-03

申办/合作机构

Mount Sinai Hospital (Canada)

[+3]

NCT05997485

/ WithdrawnN/A

A Retrospective Observational Non-Interventional Study (NIS) to Assess Patient Characteristics Among COVID-19 Patients Receiving Treatment With Nirmatrelvir/Ritonavir (PAXLOVIDTM) in Morocco.

The purpose of this study is to collect information on the:
general information of a group of people such as their age, sex, and other facts.
clinical information of the patients such as any other illness before having COVID 19.
In adult patients with COVID-19 who have been prescribed nirmatrelvir and ritonavir treatment.
This study will be conducted in Morocco. The study will capture information of the adult COVID-19 outpatients and inpatients who have been prescribed nirmatrelvir, ritonavir treatment. The inpatients will be admitted in the hospital for other reasons than COVID-19.
This study will have about 150 patients. The study will involve collection of patient information from medical records. The information collected can be either from papers or from computers.
The study will include patient information of those who:
are confirmed to have COVID-19 infection during the study period from 01 June 2022 to 30 June 2023.
are 18 years of age or older.
are prescribed Nirmatrelvir and ritonavir. This study will help to inform decision-making on use of Paxlovid at the national level.

开始日期2024-03-30

申办/合作机构

Pfizer Inc.

100 项与奈玛特韦/利托那韦相关的临床结果

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100 项与奈玛特韦/利托那韦相关的转化医学

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100 项与奈玛特韦/利托那韦相关的专利（医药）

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489

项与奈玛特韦/利托那韦相关的文献（医药）

2025-09-01·Medicina de Familia-SEMERGEN

Article

作者: García-Ortiz, A ; Hernández-Arroyo, M J ; González-Rodríguez, V M ; Rodríguez-Barrueco, C ; Romero-Sanabria, M ; Corredera-Blanco, S

OBJECTIVE:

To analyze the effectiveness and potential safety concerns of Nirmatrelvir + ritonavir (NMV-r) (Paxlovid®) in adults with mild-moderate COVID-19 disease at high risk of progression.

DESIGN:

Descriptive cross-sectional observational study.

SETTING:

Castilla y León, Spain.

PARTICIPANTS:

134 patients ≥18 years old with COVID-19 at high risk of progression to severe disease, who were treated between June and September 2022 with NMV-r.

MAIN MEASUREMENTS:

The most relevant drug interactions with concomitant medication were obtained from pharmaceutical validation records. From the monitoring of hospital admissions and deaths in the 28 days following the start of treatment, information regarding the effectiveness of the treatment was obtained.

RESULTS:

57.5% were women, the average age±SD was 69.7±17.1, 68.0% received NMV-r in the first two days of the start of symptoms, 74.6% were at home, and 95.7% were vaccinated. The main risk condition for disease progression was being immunocompromised (74.5%), followed by being >65 years old, vaccinated, but with risk factors (21.2%). A total of 62.9% had relevant interactions, with an average±SD of 1.7±1.0 per patient. 2.2% required hospital admission and 3.0% died.

CONCLUSIONS:

NMV-r has been effective in preventing severe forms of COVID-19 and hospital admissions in at-risk populations with a high vaccination rate. The prevalence of potential interactions is high, however, collaboration between family physicians and pharmacists allows NMV-r to be used safely.

2025-04-01·International Journal of Clinical Pharmacy

Frequency, type and severity of drug-related problems and pharmacist interventions in Paxlovid® prescribing: a descriptive analysis

Article

作者: Stoiber, Alina ; Sailer, Gudrun ; Huf, Wolfgang ; Tonna, Antonella ; Gray, Gwen

BACKGROUND:

Paxlovid® (nirmatrelvir and ritonavir) is the only licensed oral antiviral for COVID-19. Ritonavir is a potent inhibitor of cytochrome P450 enzymes causing numerous drug-drug interactions (DDIs).

AIM:

To describe the frequency, type, and severity of detected drug related problems (DRPs) associated with Paxlovid®.

METHOD:

This study involved a retrospective quantitative analysis including all patients prescribed Paxlovid® at a public hospital in Vienna, Austria. Data were collected from the patients' records by a clinical pharmacist. A customised, piloted data collection form was used. A sample of data was checked for consistency by an independent clinical pharmacist. Any DDI and severity classification was recorded using an established interaction checker tool. Dosage adjustments due to renal impairment were recorded.

RESULTS:

One hundred twenty-two of 140 patients (87.1%) required interventions to prevent DRPs. Pharmacists' intervention at dispensing was needed in 63.6% (n = 89) of cases. In 3 (2.1%) patients, Paxlovid® was prescribed despite being contraindicated due to severe renal impairment. The most common were DDIs (n = 80; 57.1%). Renal impairment and DDIs were noted in 24.3% (n = 34) of cases. A total of 313 DDIs were recorded in 114 (81.4%) patients, with severe interactions in 24 (17%) patients.

CONCLUSION:

Pharmacists' involvement in prescribing highly interacting drugs such as Paxlovid® is essential to enhance patient safety.

2025-04-01·THERAPEUTIC DRUG MONITORING

Therapeutic Drug Monitoring of Nirmatrelvir/Ritonavir (Paxlovid) in Patients Treated for COVID-19: Results From a Prospective Multicenter Observational Study

Article

作者: Brod, Torben ; Martens-Lobenhoffer, Jens ; Böger, Corinna R. ; Stichtenoth, Dirk O. ; Worthmann, Hans

Background::

Paxlovid is a combination of the antiviral agents nirmatrelvir and ritonavir indicated for the oral treatment of high-risk, symptomatic patients with coronavirus disease 2019 (COVID-19). As real-world data on the plasma concentrations of nirmatrelvir/ritonavir (Paxlovid) are limited, the aim of this study was to investigate nirmatrelvir/ritonavir plasma trough levels in a clinical setting using therapeutic drug monitoring.

Methods::

A prospective, noninterventional, multicenter, observational clinical study was conducted in which the plasma trough levels of nirmatrelvir/ritonavir were simultaneously determined by using liquid chromatography tandem mass spectrometry in patients with symptomatic COVID-19. The blood samples were collected on days 1, 3, and 5 after the first full-dose day (day 0), and patient data such as sex, height, weight, renal function, liver enzymes, and concomitant (co-) medications were obtained to describe the plasma levels with respect to potential influencing factors.

Results::

A total of 46 blood samples from 21 patients were analyzed. The geometric mean Cmin was 4997 ng/mL for nirmatrelvir and 529.4 ng/mL for ritonavir. The plasma concentrations covered a wide range, the highest being observed in patients with advanced age and renally excreted comedications. Patients older than 65 years had a significantly higher risk of achieving excessive plasma trough concentrations above 8840 ng/mL for nirmatrelvir and 1440 ng/mL for ritonavir compared with younger patients (odds ratio 11.2, 95% confidence interval 1.04–120.4).

Conclusions::

The plasma trough concentrations of nirmatrelvir and ritonavir in patients treated for symptomatic COVID-19 were higher than the reference values of 2210 ng/mL for nirmatrelvir and 360 ng/mL for ritonavir stated in the product characteristics. Advanced age and renally eliminated comedication were identified as possible influencing factors that warrant further investigation.

1,433

项与奈玛特韦/利托那韦相关的新闻（医药）

2025-03-25

·辉瑞制药

辉瑞抗病毒药物瑞派乐® (奈玛特韦片/利托那韦片组合包装)获常规批准，用于新冠重症高风险人群抗感染治疗

近日，辉瑞抗病毒药物瑞派乐® (英文商品名称：PAXLOVID®，药品通用名称：奈玛特韦片/利托那韦片组合包装)获国家药品监督管理局常规批准，用于治疗成人伴有进展为重症高风险因素的轻至中度新型冠状病毒感染（COVID-19）患者1。瑞派乐®于2022年2月由国家药品监督管理局按照药品特别审批程序，应急审评审批，获得附条件批准。辉瑞按照国家药品监督管理局要求，继续开展相关研究工作，完成了附条件要求后，基于研究结果获得常规批准。瑞派乐®是由奈玛特韦和利托那韦组成，其中奈玛特韦是一种新冠病毒3CL蛋白酶抑制剂，能通过阻断新冠病毒3CL蛋白酶的活性，破坏新冠病毒的后续RNA复制过程。另一种成分利托那韦通过抑制CYP3A介导的奈玛特韦代谢，从而升高奈玛特韦血药浓度，增强抗病毒效果。辉瑞中国区总裁、RDPAC执行委员会主席Jean-Christophe Pointeau 此次瑞派乐®的常规批准进一步表明该药物的疗效和安全性获得了国家监管机构的认可，凸显了该药物为临床救治及患者带来的价值。秉持‘为患者带来改变其生活的突破创新’的使命，辉瑞将加速创新以应对不断变化的感染性疾病带来的挑战。依据《新型冠状病毒感染诊疗方案（试行第十版）》，具有以下特征或基础疾病的人群，发生新冠感染时住院和死亡风险更高，是新冠重型/危重型高危人群，包括：大于 65 岁，尤其是未全程接种新冠病毒疫苗者；有心脑血管疾病（含高血压）、慢性肺部疾病、糖尿病、慢性肝脏、肾脏疾病、肿瘤等基础疾病以及维持性透析患者；免疫功能缺陷；肥胖（体质指数≥30）；晚期妊娠和围产期女性；重度吸烟者。首都医科大学附属北京地坛医院主任医师张福杰教授对于新冠重症的高风险人群，在病程早期接受抗新冠病毒药物治疗能加快病毒清除，降低病毒载量和重症风险，同时还能降低长新冠发生风险。如果合并基础疾病，是新冠重症高风险人群，一旦出现咳嗽、咽痛、肌肉疼痛、发热等症状，应及时筛查新冠，确定感染新冠病毒后要第一时间就医。瑞派乐®于2023年5月获美国食品药品管理局（FDA）常规批准，成为首个获FDA正式批准的新冠口服治疗药物2。针对新冠重症高风险人群的EPIC-HR研究证实3，与安慰剂相比，在首次出现新冠症状后5天内接受奈玛特韦/利托那韦药物治疗的成年人中，住院或死亡风险显著降低87.8%；在出现症状3天内接受治疗的成年人中，住院或死亡风险显著降低88.9%。真实世界研究表明，奈玛特韦/利托那韦可以缩短老年患者4以及免疫受损患者5的病毒清除时间，能够显著降低合并糖尿病6、心血管疾病7、肿瘤8等慢性病患者的住院和死亡风险。新冠病毒的变异主要集中在病毒表面的刺突蛋白。新冠病毒刺突蛋白参与病毒进入人体和变异逃逸的关键环节，很多新变异株的改变主要归因于新冠病毒的刺突蛋白变异9。而新冠抗病毒药物是通过针对病毒复制过程中不同的靶点起效10，3CL蛋白酶特异性抑制剂针对的是新冠病毒靶点3CL蛋白酶，该靶点为新冠病毒复制的关键，因此感染后使用该类药物可有效保护患者11。2021年底至今，主要是Omicron变异株主导。2024年发表的一篇Meta分析评估了奈玛特韦/利托那韦对Omicron变异株的疗效，结果显示奈玛特韦/利托那韦治疗组与较低的死亡风险和较低的住院风险相关12。面对仍处在不断变异下的新冠病毒的威胁，张福杰教授指出，新冠重症高风险人群首要治疗目标是降低重症和死亡风险。在传染病多发、呼吸道疾病高发季节，高风险人群要做好日常防护，及时进行新冠抗原和核酸检测。如出现结果阳性，要及时在医生指导下进行抗病毒治疗，以预防疾病进展为危重症。关于辉瑞：为患者带来改变其生活的突破创新滑动阅览在辉瑞，我们通过科学和全球资源为人们提供治疗方案，以延长其生命，显著改善其生活。在医疗卫生产品的探索、研发和生产过程中，辉瑞始终致力于奉行严格的质量、安全和价值标准。我们在全球的产品组合包括创新药品和疫苗。每天，辉瑞在发达和新兴市场的员工都在推进人类健康，推动疾病的预防、治疗和治愈，以应对挑战我们这个时代的顽疾。辉瑞还与医疗卫生服务方、政府和社区合作，支持并促进世界各地的人们能够获得更为可靠和可承付的医疗卫生服务。这与辉瑞作为一家全球卓越的创新生物制药公司的责任是一致的。175年来，辉瑞一直致力于为所有依赖我们的人带来改变。如需了解更多信息，请登录www.pfizer.com.cn。免责声明滑动阅览本新闻稿仅在于传递科学前沿信息，不构成且在任何情况下均不应被视为对任何药物或治疗方案的推荐或推广。本新闻稿中所含信息仅截至发布日期。本新闻稿中的所有行动和声明均应遵守不时修订的适用法律法规。没有任何迹象表明与所述内容有关的所有信息均包含在本新闻稿中。不管是由于新信息、未来事件还是进展，辉瑞一概不承担对前瞻性声明进行更新的义务。对于因使用、依赖本新闻稿中包含的任何信息或任何信息遗漏而直接或间接产生的任何损失，辉瑞不承担任何责任。如果分发或使用其中的信息违反了适用的法律或法规，任何司法管辖区或国家的任何个人或实体均不得分发或使用这些信息。建议在使用本新闻稿或进行相关行动之前，向有关部门进行独立咨询/建议，并进行必要的尽职调查和调研等。如您有药物或治疗方面的问题，请咨询医疗卫生专业人士。滑动查看 1 奈玛特韦片/利托那韦片组合包装说明书(2025年3月6日版). 2 https://www.fda.gov/news-events/press-announcements/fda-approves-first-oral-antiviral-treatment-covid-19-adults 3 N Engl Med.2022 Apr 14;386(15):1397-1408 4 Weng C, Xie R, Han G, et al. Safety and Efficacy of Paxlovid Against Omicron Variants of Coronavirus Disease 2019 in Elderly Patients. Infect Dis Ther. 2023 Feb;12(2):649-662. 5 Sun F, Lin Y, Wang X, et al. Paxlovid in patients who are immunocompromised and hospitalised with SARS-CoV-2 infection. Lancet Infect Dis. 2022 Sep;22(9):1279. 6 Wan EYF, Wong ZCT, Yan VKC, et al. Comparing the effectiveness of molnupiravir and nirmatrelvir-ritonavir in non-hospitalized and hospitalized COVID-19 patients with type 2 diabetes: A target trial emulation study. Diabetes Obes Metab. 2024 Oct;26(10):4653-4664. 7 Liu TH, Wu JY, Huang PY, Hsu WH, Chuang MH, Tsai YW, Lai CC, Huang CY. Clinical efficacy of nirmatrelvir plus ritonavir in patients with COVID-19 and preexisting cardiovascular diseases. Expert Rev Anti Infect Ther. 2024 Jan-Jun;22(1-3):121-128. 8 Hsu WH, Shiau BW, Tsai YW, Wu JY, Huang PY, Chuang MH, Liu TH, Lai CC, Weng TC. The effect of oral antiviral therapy for COVID-19 in managing non-hospitalized patients with lung cancer. J Infect Public Health. 2024 Aug;17(8):102465. 9 Viruses.2022;14(3):640 10 王鲁文,范慧,陈国忠.新型冠状病毒的小分子抗病毒药物的研究进展[J].武汉大学学报(医学版),2023,44(09):1068-1077. 11 尹德航,黄婧彤,李佳乐,等.临床阶段及已批准上市新型冠状病毒3CL蛋白酶抑制剂的研究进展[J].中国药物化学杂志, 2023. 12 Lau KTK, Xiong X, Wong CKH, et al. Comparative Effectiveness of Antivirals and Monoclonal Antibodies for Treating COVID-19 Patients Infected with Omicron Variant: A Systematic Review and Network Meta-Analysis. Influenza Other Respir Viruses. 2024 Dec;18(12):e70065. 往期 · 推荐遏制耐药，拯救生命，我们在行动！生命的韧性：与多发性骨髓瘤共处辉瑞靶向免疫疗法易瑞欧®（埃纳妥单抗）在华获批，用于治疗复发或难治性多发性骨髓瘤【一键通达】药品问询不再难，医学信息解忧烦!

疫苗申请上市

2025-03-07

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肽类药物：现状、进展与未来展望

本文将概述肽类治疗药物、递送平台和疫苗的当前市场和临床试验进展。通过文献分析，探讨肽类药物开发的关键研究领域，并着重介绍肽类药物的结构修饰原则，以及筛选、设计和递送技术的最新进展。新型肽类治疗药物，包括肽 - 药物复合物、新型肽类疫苗和创新的肽类诊断试剂的加速发展，有望推动疾病治疗方案迈向精准定制的新时代。一、肽类药物的发展历程与市场现状自 1922 年胰岛素用于治疗糖尿病，肽类药物正式登上医学舞台。发展至今，全球已有近 100 种肽类药物获批，广泛应用于糖尿病、肥胖症、心血管疾病等诸多领域。从市场数据来看（图 8a展示了部分 GLP-1 激动剂的销售情况），肽类药物市场呈现出持续增长的趋势。以司美格鲁肽为例，其不同剂型在 2024 年的销售额相当可观，这充分反映出市场对肽类治疗药物的强劲需求。通过对 2005 - 2024 年文献的分析（图 3），可以发现该领域的研究热度不断攀升，美国和中国在肽类药物研究方面成果突出。其中，癌症研究逐渐成为肽类药物开发的关键领域（图 3b），这也为攻克癌症难题带来了新的希望。二、肽类药物的特性与优势肽类药物具有诸多独特优势。它的特异性极高，能够精准地作用于目标，极大地减少了对正常细胞的不良影响；免疫原性低，引发人体免疫反应的概率较低；生产成本相对较低，在大规模生产上具有一定的经济优势。然而，肽类药物也存在一些局限性，比如在体内稳定性差，容易被快速降解，导致生物利用度较低，这使得许多肽类药物目前只能通过皮下注射给药，给患者带来了不便。三、肽类药物的递送平台创新为了解决肽类药物的局限性，科研人员在递送平台方面进行了大量创新研究。1.肽 - 药物偶联物（PDCs） PDCs 是一种极具潜力的递送平台，它由细胞靶向肽、连接子和细胞毒性有效载荷组成。形象地说，细胞靶向肽就像是 “导航仪”，能引导药物精准地找到肿瘤细胞；连接子起着连接和控制药物释放的作用；细胞毒性有效载荷则是 “战斗武器”，负责对肿瘤细胞进行攻击。目前，已有一些 PDCs 进入临床试验阶段（表 5展示了处于临床试验阶段的多种 PDCs），例如 Lutathera 用于治疗神经内分泌肿瘤，Pepaxto 用于治疗多发性骨髓瘤，不过 Pepaxto 因疗效问题退出了美国市场。此外，像 SNG1005 和 AEZS - 108 等在研的 PDCs，分别在治疗脑转移癌和前列腺癌方面展现出了良好的前景。 2.CPPs - 工程化纳米载体 CPPs（细胞穿透肽）可以帮助药物顺利穿过细胞膜，进入细胞内部发挥作用。虽然目前相关产品尚未获批上市，但科研人员通过将其与靶向肽结合等方式，不断提高药物递送的精准性。在针对心脏疾病和跨越血脑屏障的药物递送研究方面，已经取得了一些令人欣喜的进展。四、肽类药物在各治疗领域的应用进展1.糖尿病治疗在糖尿病治疗领域，肽类药物不断推陈出新。从最初的胰岛素，到如今的 GLP - 1 受体激动剂，治疗效果得到了显著提升。例如司美格鲁肽，经过结构修饰后，不仅实现了口服给药，而且只需每周服用一次，大大提高了患者的用药依从性。还有替尔泊肽，作为双靶点激动剂，在控制血糖和体重方面表现优异（图 8b对部分 GLP - 1 激动剂的相关信息进行了展示）。2.癌症治疗肽类药物在癌症治疗中发挥着重要作用。抗癌肽（ACPs）可以直接杀死肿瘤细胞，还能作为疫苗激活人体的抗肿瘤免疫反应。像天然抗癌肽 Apicidin，能够抑制肿瘤血管生成；合成或修饰的抗癌肽，如 Octreotide、Bortezomib 和 Motixafortide 等，已获批用于癌症治疗，并在临床实践中取得了一定的成效。此外，肽类在肿瘤诊断方面也有重要应用，例如$[^{68}Ga]Ga - DOTA - TOC$和 Illuccix® 等放射性药物，能够帮助医生更精准地定位和诊断肿瘤。3.心血管疾病治疗在心血管疾病治疗方面，肽类药物作用于多个靶点。例如作用于 G 蛋白偶联受体的 GLP - 1 受体激动剂，不仅能有效控制血糖，还对心血管疾病具有一定的预防作用；作用于利钠肽受体的 Nesiritide 和 Carperitide 等药物，可用于治疗心力衰竭；作用于血管紧张素转化酶（ACE）的抑制肽，则有助于降低血压。4.抗感染治疗由于抗生素耐药问题日益严峻，抗菌肽（AMPs）成为了研究热点。AMPs 具有抗菌活性高、抗菌谱广、不易产生耐药性等优点。像 Daptomycin、Dalbavancin 和 Rezafungin 等，都是已获批用于治疗细菌感染的抗菌肽药物，还有一些处于研究阶段的药物，也展现出了巨大的潜力。5.抗新冠病毒治疗针对新冠病毒，肽类药物的研发也在积极推进。例如 Paxlovid®，它由 3CL 蛋白酶抑制剂和低剂量 Ritonavir 组成，能够有效降低患者的住院和死亡风险。此外，还有一些针对新冠病毒 S 蛋白和 3CL 蛋白酶的肽类抑制剂正在研究中，有望成为抗击新冠病毒的新利器。6.其他领域治疗肽类药物在消化系统疾病、阿尔茨海默病、罕见病、骨科代谢疾病和偏头痛等领域也有应用和研究进展。比如在消化系统疾病中，部分肽类药物可用于控制胃肠道出血和治疗肠道疾病；在阿尔茨海默病治疗中，科研人员尝试利用肽类干预 β - 淀粉样蛋白的聚集；在罕见病治疗方面，Trofinetide 用于治疗 Rett 综合征，Zilucoplan 用于治疗重症肌无力，Teduglutide 用于治疗短肠综合征，为患者带来了新的希望；在骨科代谢疾病中，一些肽类药物有助于促进骨形成，治疗骨质疏松；在偏头痛治疗中，针对降钙素基因相关肽（CGRP）的药物，如 Ubrogepant 和 Rimegepant 等，能够有效缓解症状。五、肽类疫苗的研究进展在疫苗领域，肽类疫苗具有独特的优势。与传统疫苗相比，它安全性更高，质量更易于控制，还能根据实际需求进行定制。虽然目前尚无肽类疫苗获批上市，但在肿瘤免疫治疗方面的研究进展迅速，许多针对肿瘤特异性抗原的肽类疫苗正在进行临床试验（表 7展示了相关临床试验信息）。六、推动肽类药物发展的关键技术1.展示文库技术展示文库技术是发现新肽类药物的重要手段，包括噬菌体展示技术、细菌展示技术、酵母展示技术、哺乳动物细胞展示技术和无细胞展示技术等。这些技术各自具有优缺点，相互补充，能够快速筛选出与特定靶点结合的肽，为肽类药物的研发提供了有力支持。2.深度学习深度学习在肽类药物研发中也发挥着重要作用。通过对大量数据的分析，它能够辅助设计和优化肽类药物，显著提高研发效率，加速新型肽类药物的发现。七、口服肽类药物的挑战与突破口服肽类药物一直是研究的难点，因为肽类药物在胃肠道中容易被降解，且吸收效果不佳。不过，科研人员通过结构修饰，如采用 D - 氨基酸取代、脂质化、PEG 化和环化等方法，以及改进制药配方，如使用渗透增强剂、开发新型载体等，在口服肽类药物的研究上取得了一定的突破（表 8列举了部分已获批的口服肽类药物及其递送策略）。八、肽类药物面临的挑战与未来展望尽管肽类药物发展前景广阔，但目前仍面临一些挑战，如药物的稳定性、生物利用度、免疫原性等问题有待进一步解决，生产成本也需要降低。不过，随着技术的不断进步，多学科的深度交叉融合，我坚信肽类药物在未来将会取得更大的发展，为更多患者带来更安全、更有效的治疗方案。识别微信二维码，添加生物制品圈小编，符合条件者即可加入生物制品微信群！请注明：姓名+研究方向！版权声明本公众号所有转载文章系出于传递更多信息之目的，且明确注明来源和作者，不希望被转载的媒体或个人可与我们联系(cbplib@163.com)，我们将立即进行删除处理。所有文章仅代表作者观不本站。

疫苗核酸药物

2025-03-06

·drugs

Paxlovid May Offer Little Benefit for Vaccinated Older Adults

THURSDAY, March 6, 2025 -- The antiviral drug Paxlovid may not offer much protection against COVID-related hospitalizations or deaths for vaccinated older adults after all. Research published recently in JAMA Network Open looked at data from more than 1.6 million adults ages 65 to 74 in Ontario, Canada, during 2022. Most participants (nearly 88%) had received at least two doses of the COVID vaccine, and only certain high-risk groups or adults 70 and older were eligible for Paxlovid at the time. The study found that Paxlovid did not significantly reduce the risk of hospitalization or death from COVID in this mostly vaccinated population. “We were surprised and disappointed,” lead study author John Mafi , an associate professor of medicine at the David Geffen School of Medicine at UCLA, told The Washington Post . “We concluded that it’s because it’s a highly vaccinated group with 88 percent fully vaccinated,” he added. The findings could help older adults weigh the benefits and costs of taking Paxlovid. “The cost is part of the calculus because it’s $1,650 per treatment course,” Mafi said. “I think that needs to be part of the conversation.” A spokesperson for Pfizer, which makes Paxlovid, said the company stands by its effectiveness for patients at high risk for severe illness. What's more, Paxlovid may still be helpful for certain high-risk groups, Mafi said. “If you’re immunosuppressed, if you have cancer , chemotherapy , if you are frail, if you’re living in a nursing home, if you have end-stage kidney disease, if you’re an organ transplant recipient, those are very high-risk conditions,” he told The Post . “I would be more cautious in those groups.” Paxlovid, a combination of nirmatrelvir and ritonavir, has been shown to reduce hospitalizations and deaths in unvaccinated, high-risk adults. But prior research found it didn’t significantly shorten COVID symptoms in vaccinated adults. At best, the drug lowered hospitalization risk by 1.3 percentage points in this new study. “If you are vaccinated without additional risk factors, I wouldn’t prescribe Paxlovid, and I probably wouldn’t take it if I was a patient,” study co-author Dr. Peter Wu , associate professor of medicine at the University of Toronto, told The Post . Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

疫苗临床结果信使RNA

100 项与奈玛特韦/利托那韦相关的药物交易

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研发状态

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适应症	国家/地区	公司	日期
新型冠状病毒感染	韩国	Pfizer Inc.	2021-12-27

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适应症	最高研发状态	国家/地区	公司	日期
新冠肺炎后遗症	临床2期	瑞典	Pfizer Inc.	2023-05-01

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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


NCT05898672 (CTgov)	临床1期	新型冠状病毒感染	12	Rosuvastatin (Period 1: Rosuvastatin 10 mg)	醖遞壓鹹艱觸鏇顧鏇築(觸齋糧淵鬱鑰築鏇繭遞) = 膚選鑰築襯鏇簾築夢艱鑰築膚齋壓製鬱衊築築 (襯觸夢構範顧願壓衊網, 46) 更多	-	2024-10-28
				Rosuvastatin+Nirmatrelvir+Ritonavir (Period 2: Rosuvastatin 10 mg + Nirmatrelvir 300 mg/ Ritonavir 100 mg)	醖遞壓鹹艱觸鏇顧鏇築(觸齋糧淵鬱鑰築鏇繭遞) = 糧繭構窪觸鹹築選選衊鑰築膚齋壓製鬱衊築築 (襯觸夢構範顧願壓衊網, 48) 更多
NCT05339334 (CTgov)	临床1期	-	14	PF-07321332+Ritonavir	衊糧鹽鹹淵願衊範廠艱(範鬱廠鑰簾簾壓夢鬱築) = 鏇餘遞廠簾襯鑰憲積選憲鹹艱製襯鏇憲鹹獵糧 (淵夢壓繭襯鬱顧獵鑰構, 29) 更多	-	2024-10-08
NCT05525910 (CTgov)	临床1期	-	15	Nirmatrelvir+Ritonavir (Nirmatrelvir/Ritonavir 300(2*150)/100 mg)	糧繭淵網夢醖築觸範獵(鏇構窪廠鹽鹹鏇夢壓齋) = 餘鹹網遞淵憲遞鹹壓糧簾鏇選襯蓋蓋膚齋壓範 (鏇製廠鏇淵選鏇廠齋衊, 36) 更多	-	2024-09-19
				Nirmatrelvir+Ritonavir (Nirmatrelvir/Ritonavir 2*(150/50 mg) Low Disintegrant)	糧繭淵網夢醖築觸範獵(鏇構窪廠鹽鹹鏇夢壓齋) = 壓窪醖鑰壓襯築製簾襯簾鏇選襯蓋蓋膚齋壓範 (鏇製廠鏇淵選鏇廠齋衊, 28) 更多
ASCO2024 人工标引	N/A	新型冠状病毒感染	182	Nirmatrelvir/ritonavir	齋齋選壓遞夢鹹遞網夢(構網襯製鏇積簾範鑰遞) = 廠廠積廠構窪製蓋網簾鹽壓觸衊鬱淵繭網範醖 (廠鏇願夢鏇築觸積範夢 ) 更多	积极	2024-05-24
NCT04962230 (CTgov)	临床1期	-	12	PF-07321332+Ritonavir (Period1: PF-07321332 300 mg/Ritonavir 100 mg)	鹽醖廠願衊獵積遞齋窪(鏇鹽壓夢衊網觸鏇糧遞) = 淵憲繭襯鹹簾糧膚繭遞鑰積顧網鹽襯憲鹹製淵 (觸蓋壓廠積齋餘遞積範, 33) 更多	-	2023-10-10
				PF-07321332+Carbamazepine+Ritonavir (Period2: Carbamazepine + PF-07321332 300 mg/Ritonavir 100 mg)	鹽醖廠願衊獵積遞齋窪(鏇鹽壓夢衊網觸鏇糧遞) = 觸鏇夢醖壓願築膚鹹鑰鑰積顧網鹽襯憲鹹製淵 (觸蓋壓廠積齋餘遞積範, 43) 更多
NCT05129475 (CTgov)	临床1期	-	12	PF-07321332+Ritonavir (PF-07321332 300 mg/Ritonavir 100 mg Fed)	選醖鏇壓襯廠糧構顧廠(憲選膚糧網繭鏇遞築餘) = 繭糧夢獵築齋鹹齋憲鹽襯顧憲選窪網膚壓範廠 (範窪窪網選餘範鏇衊製, 31) 更多	-	2023-10-05
				PF-07321332+Ritonavir (PF-07321332 300 mg/Ritonavir 100 mg Fasted)	選醖鏇壓襯廠糧構顧廠(憲選膚糧網繭鏇遞築餘) = 願蓋醖鏇廠築壓淵齋網襯顧憲選窪網膚壓範廠 (範窪窪網選餘範鏇衊製, 35) 更多
NCT04909853 (CTgov)	临床1期	肾功能不全 \| 慢性肾病	35	PF-07321332+ritonavir (Part 1: Normal Renal Function)	製憲夢遞鏇膚憲鬱齋獵(網夢願齋範醖鹽觸鑰膚) = 壓襯艱艱醖鹽齋餘觸窪窪構醖淵製遞網繭醖廠 (願醖醖襯襯積鬱觸簾糧, 31) 更多	-	2023-08-02
				PF-07321332+ritonavir (Part 1: Mild Renal Impairment)	製憲夢遞鏇膚憲鬱齋獵(網夢願齋範醖鹽觸鑰膚) = 艱鏇壓選範築糧簾繭夢窪構醖淵製遞網繭醖廠 (願醖醖襯襯積鬱觸簾糧, 29) 更多
NCT04962022 (CTgov)	临床1期	新型冠状病毒感染	12	PF-07321332+Ritonavir (PF-07321332 (Suspension)/Ritonavir 300/100 mg BID, Fasted)	願膚鑰膚選襯蓋壓選鏇(繭齋鹽衊鏇齋衊製選簾) = 顧憲淵構遞衊齋鬱餘醖艱齋壓築築窪襯窪餘觸 (鑰構憲簾獵壓餘繭鏇觸, 17) 更多	-	2023-07-13
				Itraconazole+PF-07321332+Ritonavir (Itraconazole 200 mg QD + PF-07321332(Suspension)/Ritonavir 300/100 mg BID, Fasted)	願膚鑰膚選襯蓋壓選鏇(繭齋鹽衊鏇齋衊製選簾) = 簾網觸鹹鹹鬱窪衊鑰鬱艱齋壓築築窪襯窪餘觸 (鑰構憲簾獵壓餘繭鏇觸, 15) 更多
ISTH2023	N/A	新型冠状病毒感染 D-Dimer \| ferritin \| C-reactive protein	20	Paxlovid	遞艱壓窪積構餘獵窪鑰(蓋鹽願構繭窪廠鏇壓製) = 鏇顧鏇窪構積鹽壓製蓋鹹襯範壓淵壓顧窪顧餘 (鬱繭願夢憲繭窪選餘選 ) 更多	积极	2023-06-24
EPICOVIDEHA (EHA2023)	N/A	血液肿瘤	108	Molnupiravir	鹹鬱蓋簾遞夢齋築壓鑰(壓選廠衊淵醖憲獵鏇壓) = 餘衊鬱餘願憲鏇願遞廠壓憲廠壓衊窪獵夢簾簾 (顧觸壓鬱餘醖淵艱觸鹹 ) 更多	-	2023-06-08
				Nirmatrelvir/Ritonavir	鹹鬱蓋簾遞夢齋築壓鑰(壓選廠衊淵醖憲獵鏇壓) = 淵艱鏇範製繭廠願糧鹹壓憲廠壓衊窪獵夢簾簾 (顧觸壓鬱餘醖淵艱觸鹹 ) 更多