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.

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.

NCT06291831 / CompletedN/A

A Retrospective Observational Non-Interventional Study (NIS) to Assess Patient Characteristics and Healthcare Resource Use (HRU) Among COVID-19 Patients With or Without Nirmatrelvir/Ritonavir (PAXLOVID™) Treatment in the Kingdom of Bahrain.

The purpose of this study is to collect information on the:
general information of a group of people such as their age, sex
clinical information of the patients such as any other illness before having COVID 19.
the number of COVID-19 patients who meet and follow the most up to date World Health Organization (WHO) recommendations for medication to treat COVID-19 (such as version 14, published 10Nov2023) compared to Kingdom of Bahrain national recommendations
adult COVID-19 patients' health care resource use and outcomes within the 28-day period In adult patients with COVID-19 who have been prescribed nirmatrelvir and ritonavir treatment.
This study will be conducted in the Kingdom of Bahrain. The study will capture information of the adult COVID-19 outpatients and inpatients who have been prescribed nirmatrelvir, ritonavir treatment and those not treated with nirmatrelvir, ritonavir.
This study will have about 3000 patients treated with Paxlovid™ therapy and 1000 were not. 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:
had COVID-19 infection during the study period from 16 February 2022 to 30 November 2022.
are 18 years of age or older. This study will help to inform decision-making on use of Paxlovid at the national level.

开始日期2024-03-13

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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397

项与奈玛特韦/利托那韦相关的文献（医药）

2025-02-01·CURRENT OPINION IN STRUCTURAL BIOLOGY

Protein data bank: From two epidemics to the global pandemic to mRNA vaccines and Paxlovid

Review

作者: Burley, Stephen K ; Burley, Stephen K.

Structural biologists and the open-access Protein Data Bank (PDB) played decisive roles in combating the COVID-19 pandemic. Global biostructure data were turned into global knowledge, allowing scientists and engineers to understand the inner workings of coronaviruses and develop effective countermeasures. Two mRNA vaccines, initially designed with guidance from PDB structures of the SARS-CoV-1 and MERS-CoV spike proteins, prevented infections entirely or reduced the likelihood of morbidity and mortality for more than five billion individual recipients worldwide. Structure-guided drug discovery by Pfizer, Inc (facilitated by PDB structures), initiated in the 2000s in response to SARS-CoV-1 and resumed in 2020, yielded nirmatrelvir (the active ingredient of Paxlovid) -- a potent, orally-bioavailable inhibitor of the SARS-CoV-2 main protease. You've got to love the Protein Data Bank!

2025-01-01·Canadian Pharmacists Journal

Opportunities and challenges associated with the launch of nirmatrelvir/ritonavir (Paxlovid) in British Columbia during the COVID-19 pandemic: A qualitative study to explore community pharmacists’ perspectives

Article

作者: Wong, Bryce ; Piszczek, Jolanta ; Sinclair (formerly MacNeil), Kimberley ; Dahri, Karen ; Kuo, I Fan ; Wilbur, Kerry ; Marra, Fawziah

Background::

In February 2022, a novel antiviral for the treatment of COVID-19, nirmatrelvir/ritonavir (Paxlovid), was approved by Health Canada and made available to patients in British Columbia (BC). BC community pharmacists did not prescribe nirmatrelvir/ritonavir, but dispensing involved a detailed assessment with close attention to drug-drug interactions and patient monitoring. As the nirmatrelvir/ritonavir service was unique in BC, and not all pharmacists participated in the program, it is important to evaluate the perspectives of all the pharmacists who were affected so that lessons learned from the program can inform future pandemic planning and government initiatives.

Methods::

A qualitative research study using key informant semistructured interviews was conducted. Community pharmacists with varying degrees of experience with nirmatrelvir/ritonavir were recruited using multiple methods of recruitment through e-mail and fax invitations and social media posts. Open-ended questions explored pharmacists’ experiences with the nirmatrelvir/ritonavir program, including barriers and facilitators to dispensing it, and recommendations for future pharmacy initiatives.

Results::

Forty-three community pharmacists participated in the study. Most participants were between the ages of 30 and 39 years and had practiced for less than 10 years. Thematic analysis yielded 36 codes that were organized into 3 overarching themes related to the following: learning; in-process experiences, supports, difficulties; and perceptions about the expanded scope of practice.

Discussion::

The following strategies may be helpful to consider including in future initiatives: preprinted forms, a hotline for peer support, slower rollouts, a single source for communicating changes, a patient portal, addressing the divisions between dispensary and clinical work, and having specialized positions to support future rollouts.

Conclusion::

Lessons learned from the nirmatrelvir/ritonavir service included a slower approach to program initiation with additional training opportunities and more streamlined prescription options. Pharmacists also wished for better communication support and involvement in the planning of future initiatives.

2025-01-01·MATHEMATICAL BIOSCIENCES

A theory for viral rebound after antiviral treatment: A study case for SARS-CoV-2

Article

作者: Perez, Mara ; Hernandez-Vargas, Esteban A. ; González, Alejandro H ; Sanchez, Ignacio ; Hernandez-Vargas, Esteban A ; González, Alejandro H. ; Actis, Marcelo

A fraction of individuals infected with SARS-CoV-2 experienced rebounds when treated with effective antivirals such as Nirmatrelvir/Ritonavir (Paxlovid). Although this phenomenon has been studied from biological and statistical perspectives, the underlying dynamical mechanism is not yet fully understood. In this work, we characterize the dynamic behavior of a target-cell model to explain post-treatment rebounds from the perspective of set-theoretic stability analysis. Without relying on the effects of the adaptive immune system or the resistance through viral mutations, we develop mathematical conditions for antiviral treatments to avoid viral rebound. Simulation results illustrate the critical role of dosage (i.e., the doses and timing of administration) in taking advantage of highly effective drugs and tailoring therapies.

1,391

项与奈玛特韦/利托那韦相关的新闻（医药）

2024-12-18

·生物谷

Nature：一类新的抗病毒药物可能有助于预防未来的COVID-19流行病

研究人员在BL3安全条件下在小鼠身上测试了其中的一种优化的化合物：TDI-015051，并证实它可以与帕罗韦德一样治疗SARS-CoV-2感染引起的COVID-19。帕罗韦德（Paxlovid）于2021年12月上市。作为一种有效的抗病毒药物，它有效的抗病毒药物。但是与之前的许多抗病毒药物一样，科学家们知道，在某个时候，帕罗韦德可能会因为耐药性而失去一些疗效。如今，致力于应对此类新兴威胁的研究人员在一项新的研究中确定了一种治疗SARS-CoV-2感染的全新方法。他们对一类新型抗病毒药物进行概念验证，这类抗病毒药物不仅靶向SARS，还靶向许多RNA病毒，包括埃博拉病毒和登革热病毒，此外也能靶向在细胞质中复制的DNA病毒，包括痘病毒。这些发现可能为更快、更强有力地应对未来的流行病铺平道路。相关研究结果于2024年12月11日在线发表在Nature期刊上，论文标题为“Small-molecule inhibition of SARS-CoV-2 NSP14 RNA cap methyltransferase”。论文通讯作者、洛克菲勒大学的Thomas Tuschl教授说，“以前没有人找到抑制SARS-CoV-2 RNA加帽甲基转移酶（RNA cap methyltransferase）的方法。我们的研究确立了RNA加帽甲基转移酶作为治疗靶点，并为针对病原体的更多抗病毒药物开发打开了大门，而在此之前，我们只有有限的工具来对抗病原体。” 一条新的前进之路但是包括帕罗韦德在内的大多数抗病毒药物都专注于破坏病毒蛋白酶，即一种分解蛋白的不同类型的病毒酶，主要是因为之前靶向这类酶以防止病毒传播。Tuschl说，“抑制甲基转移酶需要使用非传统的RNA底物，这给药物发现带来了新的挑战。” 作为一位RNA专家，Tuschl之前的研究工作已经导致了治疗遗传性疾病的多种RNA疗法。在COVID-19疫情期间，Tuschl重组了他的实验室，专注于抗病毒药物的发现，他意识到，除蛋白酶抑制剂之外的病毒酶抑制剂有明显的优势。 Tuschl猜测病毒不太可能躲避同时靶向两种无关的病毒酶的联合治疗，例如组合使用蛋白酶抑制剂和甲基转移酶抑制剂。他还意识到，靶向结构上与人类甲基转移酶不同的病毒甲基转移酶的药物将具有高度的选择性，不会损害人类甲基转移酶的功能。为了寻找能够抑制SARS-CoV-2 RNA加帽甲基转移酶NSP14的分子，他的团队在COVID-19疫情早期在洛克菲勒大学的费舍尔药物发现资源中心筛选了430000种化合物，发现了少量抑制NSP14的化合物，其中NSP14是一种具有甲基转移酶活性的多功能酶。然后，这些化合物经过了广泛的化学开发过程，最终获得了优化的候选药物。然后，洛克菲勒大学病毒学与传染病实验室负责人Charles M.Rice及其团队对具有改善的生化抑制作用的化合物进行了基于细胞的测试。 RU-0415529的鉴定和TDI-015051的开发最后，这些作者在BL3安全条件下在小鼠身上测试了其中的一种优化的化合物：TDI-015051，并证实它可以与帕罗韦德一样治疗SARS-CoV-2感染引起的COVID-19。他们还证实，即使SARS-CoV-2发生突变，这种治疗仍然有效，并且与蛋白酶抑制剂联合使用时存在协同作用。 Tuschl说，“即使在单独使用时，SARS-CoV-2也很难逃脱这种化合物。但作为一种与蛋白酶抑制剂联合使用的治疗方法，逃跑几乎是不可能的。” 回到基础这些发现不仅证实了病毒甲基转移酶是有前景的治疗靶点，还表明Tuschl团队开发的特定抑制剂副作用很小。他注意到，“这种化合物的作用机制是独一无二的。” 事实上，这种化合物利用了病毒甲基转移酶的独特结构特征，也需要甲基供体SAM的反应产物的存在，这意味着它选择性地靶向SARS-CoV-2，而不会干扰人类过程。 Tuschl提醒说，“我们还没有准备好在人体中测试这种化合物。”理想的临床候选药物需要改善的稳定性、生物利用度和一系列其他药理学特性，这些特性在长期内仍有待优化。在不久的将来，Tuschl实验室正在扩大这项研究，以探索针对呼吸道合胞病毒（RSV）、黄病毒（如登革热病毒和寨卡病毒）以及猴痘病毒甚至真菌感染的抑制剂，毕竟这些病原体都具有类似的酶敏感性。他说，“这项研究为靶向许多病原体打开了大门。这是为未来流行病做准备的新机会。”（生物谷 Bioon.com）参考资料： Cindy Meyer et al. Small-molecule inhibition of SARS-CoV-2 NSP14 RNA cap methyltransferase. Nature, 2024, doi:10.1038/s41586-024-08320-0.

临床研究基因疗法

2024-12-18

·医药健闻

原百特医疗大中华区总裁加入复星医药；迈瑞联合腾讯发布重症大模型；礼来阿尔茨海默病疗法记能达在中国获批 | 日报

全球医疗行业每日重点资讯文 | 苏丁企业动态原百特医疗大中华区总裁徐润红加入复星医药，担任首席发展官CGO，向CEO汇报工作。在12月13日的CAHA合创营第三期活动上，徐润红以复星医药首席发展官CGO的身份做了开场致辞。徐润红女士曾任百特医疗大中华区总裁，今年5月31日从百特中国离任。徐润红女士自1993年加入百特医疗，历任销售、市场营销等众多职务。辉瑞12月17日发布2025全年业绩预期显示，预计2025年全年收入在610亿美元至640亿美元之间，其中包括在剔除2024年Paxlovid约12亿美元的非经常性收入后，预计2025年新冠产品的收入与2024年基本持平。辉瑞预计2025年全年调整后每股收益介于2.80美元至3.00美元之间，预测到2025年调整后每股经营利润增长10%至18%。辉瑞称，到2024年底，成本调整计划将节省约40亿美元的净运营费用，预计2025年还将节省5亿美元。强生已起诉Cigna旗下部门，指控这家医疗保险公司与药品福利中间商合作，盗用强生的财政援助资金，而这笔资金是专门为服用强生一些高价药的患者提供的。迈瑞医疗在北京发布全球首个临床落地的重症医疗大模型 ——“启元重症大模型”。这款模型是由迈瑞医疗与腾讯携手搭建的一款基于AI大模型的决策辅助系统，借助物联网、云计算、大数据与人工智能技术的深度融合，基于数据还原患者数字画像，再用重症思维去深度分析，然后输入给大模型，进而实现诸多实用功能，例如回溯整合患者病情、预测趋势并提供建议、生成病历文档、提供重症知识查询结果等。厦门大学-东软医疗磁共振联合研发中心签约仪式暨物理智能磁共振技术与产学医合作论坛在厦门大学举行。东软医疗目前已实现1.5T到3T磁共振全部核心技术的自主可控。希望发挥东软医疗的创新能力和厦门大学的科研优势，使联合研发中心成为我国磁共振技术创新发展的重要引擎。太极集团拟受让桐君阁药厂、中药二厂100%股权并对其增资。太极集团公告，拟受让间接控股子公司太极集团重庆桐君阁药厂有限公司100%股权，并对其现金增资32000万元，增资后桐君阁药厂注册资本由8000万元变更为40000万元。同时，公司拟受让间接控股子公司太极集团重庆中药二厂有限公司100%股权，并对其现金增资18500万元，增资后中药二厂注册资本由1500万元变更为20000万元。讯飞医疗科技拟全球发售703.555万股H股，中国香港发售股份70.36万股，国际发售股份633.195万股；2024年12月18日至12月23日招股；发售价将为每股发售股份82.8港元；预期股份将于2024年12月30日开始在联交所买卖。讯飞医疗是一家人工智能赋能的医疗解决方案提供商，提供的产品及解决方案支持从健康风险预警、早筛、辅助诊断及治疗以及治疗效果评估到诊后管理与慢病管理的多种医疗服务。产业动态中国国家药品监督管理局批准礼来公司的阿尔茨海默病疗法，记能达（多奈单抗注射液）用于治疗成人因阿尔茨海默病引起的轻度认知功能障碍和阿尔茨海默病轻度痴呆。多奈单抗是唯一一个有证据支持在清除淀粉样蛋白斑块后可停药的靶向淀粉样蛋白的疗法，这可以通过减少输液次数和治疗成本帮助患者降低治疗负担。继美国、日本、英国之后，中国是批准多奈单抗上市的又一主要市场。中国国家药监局药品审评中心公示，武田制药1类新药mezagitamab注射剂获得一项新的临床试验默示许可，拟开发治疗原发性免疫性血小板减少症(ITP)。Mezagitamab是一种全人源免疫球蛋白IgG1单克隆抗体(mAb)，对表达CD38的细胞(包括浆母细胞、浆细胞和自然杀伤细胞)具有高亲和力，导致它们的耗竭。Mezagitamab治疗旨在提供快速且持续的血小板应答改善，并恢复血小板计数至功能水平。梯瓦制药与赛诺菲表示，一项针对溃疡性结肠炎和克罗恩病药物Duvakitug的研究显示，该药物已达到主要目标。去年，两家公司表示合作开发炎症性肠病(IBD)的治疗药物，希望该药物能够成为重磅炸弹级药物，即年销售额至少达到10亿美元。默沙东宣布终止开发抗TIGIT抗体Vibostolimab和抗LAG-3抗体Favezelimab。Vibostolimab(MK-7684)通过阻断TIGIT受体与其配体(CD112和CD155)结合来恢复T细胞的肿瘤杀伤活性。Favezelimab(MK-4280)通过阻断LAG-3受体与其主要配体、主要组织相容性复合体(MHC)II类分子结合来恢复T细胞效应器功能。默沙东表示，固定剂量组合治疗组发生的免疫相关不良事件比帕博利珠单抗单药治疗组多。先为达生物提交的1类新药伊诺格鲁肽注射液（Ecnoglutide Injection）新适应症上市许可申请获CDE受理，用于在控制饮食和增强体力活动的基础上对成人患者的长期体重管理。伊诺格鲁肽注射液，是先为达生物自主研发的全球首个具有cAMP偏向性的新型长效GLP-1激动剂，其在成人2型糖尿病和肥胖症三项中国Ⅲ期注册临床研究已顺利完成。云顶新耀宣布，中国国家药品监督管理局已正式受理伊曲莫德（VELSIPITY）用于治疗中重度活动性溃疡性结肠炎（UC）患者的新药上市许可申请（NDA）。伊曲莫德是一款每日一次口服的一线先进疗法，于今年上半年陆续在中国澳门、新加坡获得新药上市批准。国家药品监督管理局批准上海畅迪医疗科技有限公司“人工血管”创新产品注册申请。该产品用于动静脉瘘的建立。产品结构为三层复合型结构，可减少术中渗血，具有较好缝合强度，使用过程中不易变形或扭折，预期有助于改善植入后的通畅性。药品监督管理部门将加强该产品上市后监管，保护患者用械安全。贺维斯特医药科技集团 (HiRO)，宣布与韩国首尔的著名医疗机构（CBMC）签署合作备忘录（MOU），建立战略合作伙伴关系。HiRO和CBMC将携手合作，为全球生物技术和制药公司提供从I期到IV期的全面临床试验解决方案。双方将充分发挥各自的专业优势，致力于优化临床试验流程，提升效率，推动创新，共同促进全球医疗研究进程。联系美通社 +86-10-5953 9500 info@prnasia.com

高管变更IPO

2024-12-17

·EndPoints

Pfizer’s message to investors: The ship is steadying in 2025 (even if Washington is turbulent)

Pfizer is targeting a steady 2025, promising pipeline trims, cost cuts and smaller deals as it works to reassure investors about its path forward. What it’s not projecting is much growth. Its revenue next year will be $61 billion to $64 billion, the company said Tuesday — the same range it’s projecting to close out 2024. There are also likely more changes to come to the company’s business, after several rounds of cost-cutting announcements and changes among top executives. As part of the announcement, CEO Albert Bourla said that new CSO Chris Boshoff, who formerly directed all of Pfizer’s oncology work, will team up with chief strategy and innovation officer Andrew Baum “to ensure that we focus our R&D investments on the most impactful opportunities.” He said more would be revealed about the effort “in the coming months.” The company expects to make an additional $500 million in cost cuts in 2025, adding to $4 billion in cuts that went into effect this year. And that does not include $1.5 billion in manufacturing-related cuts that are still ongoing through 2027, with potentially more to come. And the company has no major dealmaking planned for 2025 as it focuses on cutting debt after several major takeovers in recent years. “We have an unwavering commitment to our dividend and remain focused on de-levering while also reinvesting in our company’s future,” Bourla said on a follow-up conference call with investors. Underpinning the projections is confidence in vaccines, including a more regular Covid business. CFO Dave Denton said the company also expects “that there will be no material US policy changes in 2025” that would affect those revenues — even as drugmakers prepare for President-elect Donald Trump’s pick to head health policy, Robert F. Kennedy Jr., to possibly shake up how vaccines are regulated. Pfizer said that excluding one-time revenue associated with Paxlovid in 2024, the 2025 revenue guidance is a slight $1.2 billion increase, and that its earnings will grow as well. Dampening its revenue is an expected $1 billion hit from new Medicare Part D policies set to take effect next year. Pfizer expects adjusted diluted earnings per share to grow 10% to 18% in 2025. The annual guidance glance comes a couple of months after Pfizer first faced an activist campaign from Starboard Value, which took up a $1 billion stake in the business. The firm said that it wanted the board to hold management accountable for what it felt were dismal capital allocation decisions since the Covid pandemic. Bourla has since said there are some points of agreement with the activists, but that the pharma is on the right path forward. Bourla confirmed that he met with the incoming president and Kennedy for dinner . Trump has said that Eli Lilly CEO David Ricks and Mehmet Oz, the Centers for Medicare & Medicaid Services nominee, were also in attendance. Bourla said Tuesday that he has “a very long-lasting relationship with President Trump,” who is proud of Operation Warp Speed, the Trump administration’s effort to swiftly develop Covid vaccines. He said less about Kennedy, a vaccine skeptic and conspiracy theorist who has sown doubt around the public health benefits of vaccination and has magnified unproven risks. Bourla said he couldn’t speak to Kennedy’s beliefs but that “if he’s confirmed, we will work with him to make sure that we advance the right policies.” “We are not interested in politics. We are interested in policies,” Bourla said. “Whoever is in the leading position, we will work with them.” One of Pfizer’s most closely-watched pipeline candidates is its obesity drug danuglipron. Denton said Pfizer does “not have a co-development program baked into our expectations for 2025” — a sign that the company plans to take the asset forward on its own rather than seeking a partner or another asset to pair it with. Pfizer has, however, “contemplated” potential costs of a Phase 3 program and would not need to adjust R&D guidance accordingly. More data on danuglipron are expected in the first quarter of 2025, before a Phase 3 decision is made. Denton said next year’s focus is to protect the dividend and de-lever the balance sheet. But he teased that does not preclude Pfizer from being a buyer next year — but not a major one. “We always have a little flexibility to do [business development] in the near term as we see appropriate assets that would enhance our value long-term,” he said. That’s not expected to include large acquisitions, however, with Denton saying that “large BD” is “largely a ‘26-and-beyond focus for us.” Editor’s note: This story was updated to include additional details about Pfizer’s expected earnings guidance in 2025.

疫苗

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

10 条最早获批的记录,

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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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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


NCT05898672 (CTgov)	临床1期	新型冠状病毒感染	12	Rosuvastatin (Period 1: Rosuvastatin 10 mg)	積餘願膚鹹艱繭鏇構範(鏇獵醖獵衊觸淵願簾齋) = 鹽憲鬱構鬱齋鑰壓餘網窪壓衊遞鹽築遞醖壓觸 (選夢觸餘鏇願選獵築膚, 廠夢繭糧淵觸憲繭鏇齋 ~ 製廠製醖蓋鑰廠鹹艱窪) 更多	-	2024-10-28
				Rosuvastatin+Nirmatrelvir+Ritonavir (Period 2: Rosuvastatin 10 mg + Nirmatrelvir 300 mg/ Ritonavir 100 mg)	積餘願膚鹹艱繭鏇構範(鏇獵醖獵衊觸淵願簾齋) = 鏇築願製築選遞鬱醖鏇窪壓衊遞鹽築遞醖壓觸 (選夢觸餘鏇願選獵築膚, 夢窪餘蓋窪鏇製製鑰鑰 ~ 夢壓襯構襯襯選網艱顧) 更多
NCT05339334 (CTgov)	临床1期	-	14	PF-07321332+Ritonavir	膚範衊淵憲餘選範餘築(衊醖築醖鬱鬱壓醖膚襯) = 網夢繭壓齋糧憲顧鹹齋糧繭廠廠壓觸蓋範廠鏇 (鏇醖窪廠餘廠獵餘壓鏇, 艱糧壓艱窪觸蓋觸蓋鏇 ~ 膚鑰構構糧憲鹽鬱網鬱) 更多	-	2024-10-08
NCT05525910 (CTgov)	临床1期	-	15	Nirmatrelvir+Ritonavir (Nirmatrelvir/Ritonavir 300(2*150)/100 mg)	繭餘範廠憲窪餘選鬱獵(製襯蓋壓壓獵餘遞顧鏇) = 範構觸夢獵鹽襯構糧蓋範淵繭構壓鏇鏇簾獵夢 (製網遞繭衊鏇糧顧壓願, 鬱夢蓋窪艱遞艱繭顧壓 ~ 衊鏇選糧構糧廠夢繭鑰) 更多	-	2024-09-19
				Nirmatrelvir+Ritonavir (Nirmatrelvir/Ritonavir 2*(150/50 mg) Low Disintegrant)	繭餘範廠憲窪餘選鬱獵(製襯蓋壓壓獵餘遞顧鏇) = 鹹窪壓襯鏇齋壓憲鹹淵範淵繭構壓鏇鏇簾獵夢 (製網遞繭衊鏇糧顧壓願, 憲構壓觸網憲膚製構製 ~ 築蓋顧齋夢製構構淵衊) 更多
ASCO2024 人工标引	N/A	新型冠状病毒感染	182	Nirmatrelvir/ritonavir	顧選襯夢構衊壓範顧餘(鏇蓋憲範鬱繭蓋夢網網) = 構蓋淵鏇選範膚衊鹹餘襯網齋簾夢齋齋夢衊願 (鏇繭積廠範製壓衊膚築 ) 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)	簾鹹淵遞鹽壓餘壓願觸(鬱窪網憲簾顧鹽廠鹹鹽) = 網鬱鬱鹽衊簾願選範鑰顧壓憲襯構鏇鑰鏇壓構 (鏇選壓鬱窪鏇憲簾鏇衊, 鑰築蓋夢鑰膚簾鬱膚鹽 ~ 願蓋願襯製憲鹽衊壓觸) 更多	-	2023-10-10
				PF-07321332+Carbamazepine+Ritonavir (Period2: Carbamazepine + PF-07321332 300 mg/Ritonavir 100 mg)	簾鹹淵遞鹽壓餘壓願觸(鬱窪網憲簾顧鹽廠鹹鹽) = 繭壓簾窪窪淵蓋齋衊觸顧壓憲襯構鏇鑰鏇壓構 (鏇選壓鬱窪鏇憲簾鏇衊, 憲範觸構顧遞淵遞夢齋 ~ 齋憲構淵鹽廠觸積鏇壓) 更多
NCT05129475 (CTgov)	临床1期	-	12	PF-07321332+Ritonavir (PF-07321332 300 mg/Ritonavir 100 mg Fed)	憲簾鑰艱齋願範壓築築(壓膚衊壓廠襯築膚顧網) = 窪壓齋衊襯築網鬱膚齋餘築觸淵鏇鏇廠積顧構 (觸齋憲遞衊選鏇襯遞艱, 餘鑰鹹壓築鬱獵網製簾 ~ 簾築製膚蓋廠膚鬱醖願) 更多	-	2023-10-05
				PF-07321332+Ritonavir (PF-07321332 300 mg/Ritonavir 100 mg Fasted)	憲簾鑰艱齋願範壓築築(壓膚衊壓廠襯築膚顧網) = 醖顧憲觸憲鏇鏇獵積鹹餘築觸淵鏇鏇廠積顧構 (觸齋憲遞衊選鏇襯遞艱, 鏇鏇獵夢鹹選鏇網顧齋 ~ 鬱選膚夢顧網壓糧築壓) 更多
NCT04909853 (CTgov)	临床1期	肾功能不全	35	PF-07321332+ritonavir (Part 1: Normal Renal Function)	鑰廠廠範鹹製顧膚選鹹(窪壓艱鬱製遞夢製簾製) = 膚鏇齋願範糧蓋餘積襯憲製鬱積膚顧淵衊顧鹹 (繭淵糧糧夢範遞衊選範, 觸鏇鬱廠夢鬱糧鬱廠醖 ~ 網淵鹽築築憲壓窪艱淵) 更多	-	2023-08-02
				PF-07321332+ritonavir (Part 1: Mild Renal Impairment)	鑰廠廠範鹹製顧膚選鹹(窪壓艱鬱製遞夢製簾製) = 鑰構觸遞積膚憲獵製構憲製鬱積膚顧淵衊顧鹹 (繭淵糧糧夢範遞衊選範, 窪構餘積淵顧襯鑰範積 ~ 衊願艱蓋襯憲鑰襯襯鏇) 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)	網齋鏇窪鹽簾醖壓觸構(醖襯簾餘窪蓋餘製鏇夢) = 襯選夢鏇築鏇構窪顧築鬱願鬱餘蓋糧簾襯鹽願 (願膚壓膚蓋憲鹹觸膚淵, 夢範夢積繭鏇觸膚構壓 ~ 簾膚餘範膚鹹糧夢鑰艱) 更多	-	2023-07-13
				Itraconazole+PF-07321332+Ritonavir (Itraconazole 200 mg QD + PF-07321332(Suspension)/Ritonavir 300/100 mg BID, Fasted)	網齋鏇窪鹽簾醖壓觸構(醖襯簾餘窪蓋餘製鏇夢) = 鬱選鬱繭醖醖艱齋窪襯鬱願鬱餘蓋糧簾襯鹽願 (願膚壓膚蓋憲鹹觸膚淵, 糧廠齋製襯夢製鏇鹽鑰 ~ 鹽鹽衊餘襯獵齋築鏇廠) 更多
ISTH2023	N/A	新型冠状病毒感染 D-Dimer \| ferritin \| C-reactive protein	20	Paxlovid	淵範淵醖壓選鏇顧顧鹹(膚鬱壓鑰蓋憲齋窪醖襯) = 壓簾範淵齋膚繭網鏇襯鏇夢選願廠願顧鹽醖選 (積鹹淵糧艱製齋膚壓夢 ) 更多	积极	2023-06-24
EPICOVIDEHA (EHA2023)	N/A	血液肿瘤	108	Molnupiravir	選醖淵顧衊餘願襯網壓(膚簾網鬱願蓋淵餘鹹觸) = 繭築獵鑰繭糧夢膚觸鏇夢膚襯壓壓鹽繭築顧餘 (餘觸糧鹽積遞憲膚鏇壓 ) 更多	-	2023-06-08
				Nirmatrelvir/Ritonavir	選醖淵顧衊餘願襯網壓(膚簾網鬱願蓋淵餘鹹觸) = 襯襯築網構壓齋範簾窪夢膚襯壓壓鹽繭築顧餘 (餘觸糧鹽積遞憲膚鏇壓 ) 更多