Coronavirus main protease (Mpro) is a conserved antiviral target, yet most generative AI pipelines optimize surrogate-predicted affinity without enforcing electronic plausibility or cross-target consistency. We present PRISM-Gen (Physics-guided Robust Inhibitor Selection Method - Generative Module), a multi-fidelity framework coupling fragment-tree molecular generation with a three-tier electronic screening cascade - GFN2-xTB semi-empirical descriptors, Gaussian Electronic Moderation (GEM) scoring, and B3LYP/6-31 G* DFT validation - followed by conservative worst-case docking across SARS-CoV-2, SARS-CoV-1, and MERS-CoV Mpro. Applied to 4136 generated candidates, the pipeline identifies 36 broad-spectrum-consistent inhibitor candidates whose top-ranked members exhibit predicted worst-case binding energies comparable to those of the non-covalent reference inhibitor ensitrelvir under identical docking conditions, while sharing no Bemis-Murcko scaffolds with nirmatrelvir, ensitrelvir, or GC376. Stage-wise statistical validation confirms that each tier exerts non-redundant, orthogonal selection pressure. Retrospective analysis demonstrates that replacing GEM's continuous moderation with a conventional hard electronic cutoff would eliminate 48.0% of candidates, including 55.6% of the final 36 molecules, disproportionately depleting scaffold diversity. These results establish that continuous, physics-informed electronic moderation integrated within a multi-fidelity generative pipeline can recover structurally novel chemotypes that binary exclusion filters would irreversibly discard - a design principle applicable to generator-agnostic molecular discovery workflows.

2026-10-01·BIOCHEMICAL AND BIOPHYSICAL RESEARCH COMMUNICATIONS

Structural basis for the inhibition of HKU8 main protease by nirmatrelvir and ensitrelvir

Article

作者: Wang, Deping ; Zhang, Meng ; Zeng, Xudong ; Lin, Mengmeng ; Li, Dong ; Xiao, Yunjie

The wide distribution and high divergence of zoonotic coronaviruses (CoVs) poses a continuous threat to public health. Some CoVs, such as HKU8, harbor a high potential to breach the species barrier and emerge in human populations. However, whether the current antivirals are effective against HKU8 CoV remains poorly understood. Here, we studied the effectiveness of two clinically approved antivirals, nirmatrelvir and ensitrelvir, against the main protease (M^pro) of the HKU8. Both nirmatrelvir and ensitrelvir can inhibit HKU8 M^pro, but their efficacy is attenuated by approximately 5-fold and 15-fold, respectively, compared to their activity against SARS-CoV-2 M^pro. To elucidate the structural basis of this reduced potency, crystal structures of HKU8 M^pro in complex with nirmatrelvir and ensitrelvir were determined at 2.43 Å and 1.70 Å resolution, respectively. The HKU8 M^pro features a proline at position 188 instead of the characteristic 3₁₀-helix found in beta-CoVs. This difference results in a reduced volume of this subsite, which may lead to suboptimal binding of both inhibitors and reduced efficacy. These findings provide crucial information on the effectiveness of M^pro-targeting antivirals cross different species and highlight the S2 subsite as a key determinant for their activity. It may help the design of next-generation broad-spectrum antivirals against CoVs.

2026-08-01·INTERNATIONAL JOURNAL OF INFECTIOUS DISEASES

Impact of early oral antiviral use for outpatients with COVID-19 on healthcare utilization and recovery (ANCHOR-02)

Article

作者: Kinoshita, Masahiro ; Murayama, Hiroyuki ; Monma, Eiji ; Yoden, Takahiro ; Morikawa, Nobuyuki ; Nakagawa, Hidemitsu ; Higa, Hikari ; Takahashi, Yusaku ; Shintani, Ayumi ; Nishiguchi, Sho ; Kudo, Naoko ; Maeda, Yohei ; Kakii, Bumpachi ; Asami, Sadaharu ; Hibino, Makoto ; Higashiue, Shinichi

OBJECTIVES:

To evaluate the associations of early-phase oral antivirals with recovery in outpatients with COVID-19, regardless of baseline risk for severe disease, during the SARS-CoV-2 Omicron JN.1-/KP.3-dominant epidemic era.

METHODS:

This nationwide, multi-institutional (51 acute-care hospitals in Japan), prospective, registry-based cohort study enrolled outpatients aged ≥12 years with laboratory-confirmed COVID-19 within 5 days of symptom onset (February 1-October 31, 2024). Participants were compared between those with and without oral antiviral use at enrollment (ensitrelvir, nirmatrelvir, or molnupiravir) for medical re-consultation, failure to return to usual health, and work productivity and activity impairment through Day 28. Analyses were conducted among participants with complete baseline covariates and valid Day 28 outcome assessments and were adjusted for pre-specified baseline covariates.

RESULTS:

Baseline characteristics were generally comparable between groups (efficacy analysis population: antiviral n = 2271; no antiviral n = 5768). Overall re-consultation rates tended to be lower in the antiviral group (adjusted risk ratio [aRR] 0.93; 95% CI, 0.83-1.04). Antiviral use was associated with lower rates of failure to return to usual health (aRR 0.76; 95% CI, 0.70-0.82) and with improvements in presenteeism, overall work impairment, and activity impairment.

CONCLUSION:

Early-phase oral antiviral use was associated with more favorable patient-reported and functional recovery outcomes, with a trend toward reduced healthcare utilization. These findings may have broader societal implications beyond traditional virological and disease progression endpoints.

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项与恩赛特韦相关的新闻（医药）

2026-09-14

·FiercePharma

Shionogi taps The Bloc for omnichannel campaign backing COVID-19 pill Xocova

Shionogi is stepping up its promotion of COVID-19 drug, Xocova, by working with The Bloc on an omnichannel campaign designed to encourage people to contact their healthcare professional after being exposed to the virus. In June, the FDA approved Xocova, a protease inhibitor, for the prevention of COVID-19 in people who have been in contact with someone infected with the coronavirus. A phase 3 trial found 2.9% of people contracted COVID-19 when they started a five-day course of Xocova within 72 hours of their contact developing symptoms, compared to 9.0% of their peers who received placebo. Shionogi moved quickly to start promoting Xocova, kicking off its “Got the Call, Make the Call” campaign in July with a TV ad. Now, with the CDC characterizing COVID-19 activity as elevated and increasing nationally, Shionogi has launched its omnichannel campaign. As well as running TV ads, Shionogi is using social media, digital, print, online video, digital out-of-home and in-office and pharmacy materials to promote Xocova. The materials all direct people to the Xocova website and push the message that when people get a call saying a recent contact has COVID-19, they should make a call to their healthcare professional to discuss Xocova. “In healthcare communications, memorability is what helps turn awareness into action,” Pooja Bhavsar, SVP, strategic planner at The Bloc, said in a statement. “Make the Call was designed to be remembered in the moment that matters most—after COVID-19 exposure—using warmth and humor to encourage people to ask a healthcare professional about Xocova.” Last month, Shionogi outlined (PDF) efforts to promote Xocova in its first-quarter earnings presentation. The company has prioritized investment in digital channels including social media and connected TV “to effectively reach high interest populations.” Using broadcast TV and search engine optimization, Shionogi aims to maximize awareness among older adults. Shionogi is running the marketing efforts to support a sales force of about 160 people. The company has tasked the reps with targeting regions of the U.S. with a high incidence of COVID-19. Ensuring pharmacy inventory availability and starting payer negotiations were the other items on Shionogi’s to-do list. Market research suggests patients and physicians are open to the product, with Shionogi quoting data showing that about 69% of people at high risk of severe COVID-19 are interested in Xocova. More than 90% of physicians are willing to prescribe the product. Shionogi reported high levels of interest among individuals living with someone at high risk of severe disease.

临床3期临床结果上市批准紧急使用授权

2026-09-09

·BioSpace

Shionogi to Showcase Advancements Across its Infectious Disease Portfolio at IDWeek 2026

Highlights Include an Oral Presentation of New Data from the Global Phase 3 SCORPIO-PEP Study and New Real-World Analysis on Respiratory Tract Infections from the PROVE Observational Study FLORHAM PARK, N.J.--(BUSINESS WIRE)--Shionogi Inc., a New Jersey-based subsidiary of Shionogi & Co., Ltd., (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D.), will present findings from across its broad anti-infective portfolio at IDWeek 2026 (October 21-24, 2026), in Washington, D.C. Data highlights at IDWeek 2026 include an oral presentation featuring a subpopulation analysis from the global Phase 3 SCORPIO-PEP trial, a rapid-fire session focused on ventilator-associated pneumonia isolates from the SENTRY Antimicrobial Surveillance Program and 18 additional presentations across Shionogi’s COVID-19 antiviral and Gram-negative antibiotic programs. “At IDWeek, we build on our legacy as a research-driven company by sharing new data from across our portfolio of marketed products and investigational therapies, while highlighting important milestones, including the FDA approval of XOCOVA and the acceptance of the supplemental New Drug Application for pediatric use of Fetroja,” said Nathan McCutcheon, MBA, President and CEO, Shionogi Inc. “Equally important, IDWeek provides an opportunity to engage with the infectious disease community, deepen our understanding of evolving patient needs, and gain insights that help shape future research efforts and foster meaningful collaborations.” IDWeek attendees can visit Shionogi at Booth #815 to learn more about the company’s infectious disease research and innovation. XOCOVA ® (ensitrelvir) and COVID-19 data presentations: Oral Presentation October 23, 2026 3:15-3:27 PM: Early Pre-Symptomatic Treatment with Ensitrelvir Among PCR-Positive, SARS‑CoV‑2-Exposed and Infected Household Contacts: SCORPIO‑PEP Subpopulation Analysis Poster #2100: Reduction of Infectious SARS-CoV-2 and Viral Titer with Ensitrelvir: A Pooled Analysis of SCORPIO-SR and SCORPIO-HR Trials Poster #2113: Impact of Acute COVID-19 on Underlying Chronic Conditions: Systematic Literature Review Poster #2149: Brain Microstructural Disorganization as a Potential Mechanism of post-COVID-19 Condition and the Onset-suppressive Effects of Ensitrelvir Revealed by Advanced Diffusion MRI–based Translational Research Poster #2143: Ensitrelvir Suppresses Fatigue-like Symptoms Derived from SARS-CoV-2 Infection in Hamsters Fetroja ® (cefiderocol) data presentations: Rapid Fire Session October 24, 2026 12:15-1:30 PM Poster #459: Cefiderocol Activity Across Highly Resistant Pseudomonas aeruginosa Ventilator-Associated Pneumonia Isolates: A Global Surveillance Study of SENTRY 2020-2024 Poster #144: Outcomes of Cefiderocol Treatment in U.S. Patients with Respiratory Tract Infections: Subgroup Analysis of the PROVE Observational Study Poster #93: Clinical Outcomes After Cefiderocol Therapy for Pseudomonas spp. Infections: Results from a Systematic Literature Review Poster #94: Systematic Literature Review of the Clinical Outcomes Associated with Cefiderocol Therapy for Stenotrophomonas maltophilia Infections Poster #141: In vitro Activity of Cefiderocol (FDC) Against a Collection of Infrequently Isolated Gram-Negative Bacterial Isolates from the SENTRY Antimicrobial Surveillance Program Poster #1445: Activity of Cefiderocol Against Carbapenem-Resistant Pseudomonas aeruginosa Encountered in Each of the Different United States Census Bureau Divisions Poster #1465: Activity of cefiderocol against carbapenem-nonsusceptible Gram-negative isolates from skin and soft tissue infections in U.S. and European medical centers collected as part of the SENTRY antimicrobial surveillance program (2020-2024) Poster #160: Activity of Cefiderocol against Metallo-Beta-Lactamase Carrying Pseudomonas aeruginosa of the SENTRY Antimicrobial Surveillance Program (2020-2024) Shionogi will also present preclinical research on xeruborbactam, an investigational beta-lactamase inhibitor, discovered by Qpex Biopharma, Inc., a Shionogi Group Company. For full Prescribing Information for XOCOVA ® (ensitrelvir), including approved indications and Safety Information, please visit For full Prescribing Information for Fetroja ® (cefiderocol), including approved indications and Safety Information, please visit About Shionogi Inc. Shionogi Inc. is a U.S. subsidiary of Shionogi & Co., Ltd., a global research‑driven pharmaceutical company. Since 1878, Shionogi has been developing new treatments to improve patients' lives worldwide. Today in North America, our portfolio of FDA-approved products includes an antibiotic for serious infections caused by susceptible Gram-negative bacteria, an oral antiviral for post-exposure prophylaxis of COVID-19 and a therapy for amyotrophic lateral sclerosis (ALS). Our pipeline programs include investigational treatments across infectious disease, rare disease and additional high‑need therapeutic areas. Together with our subsidiaries Qpex Biopharma Inc. and Shionogi Canada Inc., we are continuing to innovate for patients in the U.S. and worldwide. Learn more at shionogi.com . About Shionogi in Infectious Disease For more than 60 years, Shionogi has discovered and commercialized novel antibiotics. Today, our R&D story extends beyond antibiotics to include novel medications for HIV and influenza. Our global pipeline includes investigational agents to address global health challenges including antimicrobial resistance, COVID-19, influenza, rare fungal diseases and respiratory syncytial virus. As part of our commitment to addressing unmet medical needs, Shionogi partners with several non-governmental organizations to increase equitable access to our medications worldwide. Shionogi and Global Antibiotic Research and Development Partnership (GARDP) have a license and technology transfer agreement and Shionogi and GARDP have a collaboration agreement with the Clinton Health Access Initiative (CHAI) that aim to transform the landscape of access to antibiotics in many low-income countries, most lower middle- and upper middle-income countries, and select high-income countries. Shionogi ranked #2 among large research-based pharmaceutical companies in the Access to Medicine Foundation’s 2026 Antimicrobial Resistance (AMR) Benchmark, a global assessment of how leading pharmaceutical companies are tackling antimicrobial resistance and expanding responsible access to antibiotics worldwide. About Shionogi & Co., Ltd. Shionogi & Co., Ltd. is a 148-year-old global, research-driven pharmaceutical company headquartered in Osaka, Japan, that is dedicated to bringing benefits to patients based on its corporate philosophy of “supplying the best possible medicine to protect the health and wellbeing of the patients we serve.” The company currently markets products in several therapeutic areas including anti-infectives, pain, CNS disorders and cardiovascular diseases. Shionogi’s research and development currently targets two therapeutic areas: infectious diseases and diseases with unmet medical needs in pain/CNS, including Alzheimer’s disease, oncology, rare diseases, and sleep apnea. For more information on Shionogi & Co., Ltd., please visit . Forward-Looking Statements This announcement contains forward-looking statements. These statements are based on expectations in light of the information currently available, assumptions that are subject to risks and uncertainties which could cause actual results to differ materially from these statements. Risks and uncertainties include general domestic and international economic conditions such as general industry and market conditions, and changes of interest rate and currency exchange rate. These risks and uncertainties particularly apply with respect to product-related forward-looking statements. Product risks and uncertainties include, but are not limited to, completion and discontinuation of clinical trials; obtaining regulatory approvals; claims and concerns about product safety and efficacy; technological advances; adverse outcome of important litigation; domestic and foreign healthcare reforms and changes of laws and regulations. Also for existing products, there are manufacturing and marketing risks, which include, but are not limited to, inability to build production capacity to meet demand, lack of availability of raw materials and entry of competitive products. The company disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise. Contacts For Further Information: SHIONOGI Website Inquiry Form: U.S. Media: ShionogiCommunications@shionogi.com Shionogi Europe Press Office: pressoffice@shionogi.eu

引进/卖出临床3期合格传染病产品

2026-09-08

·知乎专栏

抗新冠病毒口服药物临床使用进展：2025—2026年综述

抗新冠病毒口服药物临床使用进展：2025—2026年综述摘要严重急性呼吸综合征冠状病毒2（SARS-CoV-2）所致的新型冠状病毒感染（COVID-19）已进入地方性流行阶段，但抗病毒治疗仍是降低高危人群疾病进展风险的核心策略。自2022年以来，全球范围内已有多种口服小分子抗病毒药物获得紧急使用授权或正式批准，包括以奈玛特韦/利托那韦（Paxlovid）为代表的3CL蛋白酶抑制剂和以莫诺拉韦为代表的RNA依赖性RNA聚合酶抑制剂。近年来，中国自主研发的多款口服抗病毒药物相继获批上市，丰富了临床选择。本文系统综述截至2026年9月国内外已上市抗新冠病毒口服药物的作用机制、关键临床试验证据、真实世界研究数据、安全性特征及药物相互作用管理，并结合最新临床指南探讨其在轻中度感染及高危人群中的合理应用，以期为临床实践提供参考。关键词：新型冠状病毒；抗病毒药物；3CL蛋白酶抑制剂；RdRp抑制剂；药物相互作用；临床指南AbstractThe coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS‑CoV‑2) has entered an endemic phase; however, antiviral therapy remains a core strategy to reduce the risk of disease progression in high‑risk populations. Since 2022, a variety of oral small‑molecule antiviral drugs have received emergency use authorization or formal approval worldwide, including 3CL protease inhibitors represented by nirmatrelvir/ritonavir (Paxlovid) and RNA‑dependent RNA polymerase inhibitors represented by molnupiravir. In recent years, multiple domestically developed oral antiviral agents have been successively approved for marketing in China, enriching clinical options. This article systematically reviews the mechanisms of action, key clinical trial evidence, real‑world study data, safety profiles, and drug‑drug interaction management of oral anti‑SARS‑CoV‑2 drugs that have been marketed both domestically and internationally as of September 2026. In addition, combined with the latest clinical guidelines, it explores their rational use in mild‑to‑moderate infections and high‑risk populations, aiming to provide a reference for clinical practice.Keywords: SARS‑CoV‑2; antiviral agents; 3CL protease inhibitors; RdRp inhibitors; drug‑drug interactions; clinical guidelines1 引言自2019年底SARS-CoV-2首次出现以来，COVID-19大流行已深刻改变了全球公共卫生格局。随着疫苗接种的普及和人群免疫水平的提升，COVID-19的疾病严重程度已显著下降，但高危人群（老年人、免疫功能低下者、合并多种基础疾病者）仍面临较高的重症和死亡风险。抗病毒治疗作为降低疾病进展风险的关键手段，其临床地位日益重要。抗新冠病毒药物的研发主要围绕病毒复制周期的关键环节展开，其中3CL蛋白酶（3C-like protease，又称主要蛋白酶Mpro）和RNA依赖性RNA聚合酶（RdRp）是最重要的两个药物靶点。3CL蛋白酶在病毒多聚蛋白的加工中发挥核心作用，其抑制剂通过阻断病毒蛋白的成熟而抑制病毒复制；RdRp抑制剂则通过掺入错误核苷酸或终止RNA链延伸而抑制病毒基因组复制。目前，全球范围内已有多款口服抗病毒药物获得批准或授权。2025年，波兰流行病学家与传染病学家协会发布了最新版COVID-19管理临床实践指南，对诊断、治疗和预防策略进行了全面更新。美国感染病学会（IDSA）也于2025年发布了COVID-19治疗与管理临床实践指南更新。中国国家感染性疾病临床医学研究中心于2025年发布了《新型冠状病毒感染抗病毒药物联合使用中国专家共识》。这些指南为临床合理使用抗病毒药物提供了重要依据。本文旨在系统梳理目前已上市抗新冠病毒口服药物的临床研究进展，重点分析其疗效证据、安全性特征和临床应用注意事项，为呼吸科、感染科及相关科室医师提供参考。2 抗新冠病毒口服药物的分类与作用机制2.1 3CL蛋白酶抑制剂3CL蛋白酶是冠状病毒复制过程中不可或缺的酶，负责将病毒编码的多聚蛋白（pp1a和pp1ab）切割为16个非结构蛋白（nsp1–nsp16），这些蛋白组装成病毒复制-转录复合体。由于3CL蛋白酶在冠状病毒中高度保守且人类细胞中无同源酶，其成为抗冠状病毒药物研发的理想靶点。目前全球已获批或获得紧急使用授权的3CL蛋白酶抑制剂包括：奈玛特韦/利托那韦（Nirmatrelvir/Ritonavir，Paxlovid）：由辉瑞公司研发，是全球首个获批的口服3CL蛋白酶抑制剂。奈玛特韦为活性成分，利托那韦作为药代动力学增强剂，通过抑制CYP3A4介导的奈玛特韦代谢，提高其血药浓度。恩赛特韦（Ensitrelvir，Xocova）：由日本盐野义制药研发，是首个无需利托那韦增强的3CL蛋白酶抑制剂。先诺特韦/利托那韦（Simnotrelvir/Ritonavir，先诺欣）：由中国先声药业研发，2023年获国家药监局附条件批准。来瑞特韦（Leritrelvir，乐睿灵）：由中国广东众生药业研发，是全球首个获常规批准（非附条件）的3CL蛋白酶单药抑制剂。阿泰特韦/利托那韦（Atilotrelvir/Ritonavir，泰中定）：由中国药企研发的3CL蛋白酶抑制剂。奥格特韦钠（Olgotrelvir，奥维宁）：全球首个获批的双靶点（Mpro和Cathepsin L）口服抑制剂。盐酸伊司特韦（Istiratrelvir Hydrochloride，艾普司韦）：近期获批的3CL蛋白酶抑制剂。2.2 RNA依赖性RNA聚合酶抑制剂RdRp是病毒基因组复制的核心酶，负责以病毒RNA为模板合成新的RNA链。RdRp抑制剂通过模拟天然核苷酸底物，被RdRp掺入新生RNA链后导致链终止或引入错误突变，从而抑制病毒复制。莫诺拉韦（Molnupiravir，利卓瑞/LAGEVRIO）：由默沙东研发，是一种核苷类似物前体药物，在体内转化为活性形式β-D-N4-羟基胞苷（NHC）。阿兹夫定（Azvudine）：由中国真实生物研发，是一种双靶点核苷逆转录酶抑制剂，原用于艾滋病治疗，后拓展至COVID-19适应症。氢溴酸氘瑞米德韦（VV116，民得维）：由中国科学院上海药物研究所等机构研发，是瑞德西韦的氘代口服衍生物。3 关键临床试验证据3.1 奈玛特韦/利托那韦（Paxlovid）奈玛特韦/利托那韦是目前临床证据最为充分的口服抗新冠病毒药物。EPIC-HR（Evaluation of Protease Inhibition for COVID-19 in High-Risk Patients）是一项随机、双盲、安慰剂对照的3期临床试验，纳入未接种疫苗且伴有重症高风险因素的轻中度COVID-19非住院成人患者。结果显示，在症状出现5天内开始治疗的患者中，奈玛特韦/利托那韦组住院或死亡风险较安慰剂组降低89%（风险比[HR] 0.11，95%置信区间[CI] 0.07–0.17）。2025年发表的多项真实世界研究进一步验证了其在临床实践中的有效性。一项基于美国国家COVID队列协作组织（N3C）电子健康记录的目标试验模拟研究显示，奈玛特韦/利托那韦治疗与住院风险降低显著相关。另一项基于香港COVID-19指定门诊真实世界数据的靶向试验模拟研究也证实了其在非住院成人中的有效性。关于住院患者中的应用，2025年发表的RECOVERY试验比较了奈玛特韦/利托那韦联合常规治疗与常规治疗单用在COVID-19住院患者中的疗效。结果显示，在住院患者中，奈玛特韦/利托那韦并未显著降低死亡率，提示口服抗病毒药物在住院阶段的价值有限，早期（门诊阶段）用药是关键。2025年发表的EPIC-IC试验探索了免疫低下患者中延长奈玛特韦/利托那韦治疗疗程（超过5天）的效果，为这一特殊人群的治疗策略提供了重要参考。3.2 莫诺拉韦（Molnupiravir）莫诺拉韦的3期MOVe-OUT试验纳入未接种疫苗、伴有重症高风险因素的轻中度COVID-19非住院成人患者。结果显示，莫诺拉韦组住院或死亡风险较安慰剂组降低约30%（HR 0.70，95% CI 0.49–0.99）。英国PANORAMIC试验是一项开放标签、随机对照研究，纳入社区中伴有高风险因素的成人COVID-19患者，比较莫诺拉韦联合常规治疗与常规治疗单用的效果。与MOVe-OUT试验不同，PANORAMIC纳入的患者疫苗接种率较高，结果显示莫诺拉韦并未显著降低住院或死亡率，但缩短了症状持续时间。2025年发表的丹麦全国注册研究评估了莫诺拉韦治疗后的3个月和6个月临床结局。一项范围综述系统总结了莫诺拉韦的临床证据，指出其在非住院患者中仍是一种治疗选择。3.3 VV116（氢溴酸氘瑞米德韦，民得维）VV116是中国自主研发的口服RdRp抑制剂。一项在中国进行的多中心、双盲、3期随机对照试验（NCT05201677）纳入伴有进展风险的轻中度COVID-19成人患者，比较VV116与安慰剂的疗效。研究结果显示，VV116在持续临床恢复时间方面优于安慰剂。另一项重要的头对头研究比较了VV116与奈玛特韦/利托那韦在轻中度COVID-19成人患者中的疗效。该研究纳入822例受试者，771例接受了VV116（384例）或奈玛特韦/利托那韦（387例）治疗。结果显示，在伴有进展风险的轻中度成人患者中，VV116在持续临床恢复时间方面非劣效于奈玛特韦/利托那韦。这一发现为临床提供了奈玛特韦/利托那韦之外的重要替代选择，尤其对于存在药物相互作用顾虑的患者。关于肝损伤患者中的应用，一项I期开放标签研究评估了VV116在轻中度肝功能损害患者中的药代动力学和安全性。3.4 恩赛特韦（Ensitrelvir，Xocova）恩赛特韦的SCORPIO-SR 3期试验评估了其在轻中度COVID-19患者中的疗效和安全性。该试验将患者随机分配接受恩赛特韦125 mg（每日一次，共5天）或匹配安慰剂，首次给药在发病后72小时内。意向治疗人群包括恩赛特韦组345例和安慰剂组341例。SCORPIO-HR 3期试验是一项全球性、随机、双盲、安慰剂对照研究，纳入2093例非住院轻中度COVID-19成人患者。患者在症状出现5天内随机（1:1）接受恩赛特韦（第1天375 mg，第2–5天125 mg，每日一次）或安慰剂。主要终点为自第1天至第29天，15项COVID-19症状持续（≥2天）缓解的限制性平均时间，分析人群为在症状出现3天内开始治疗者。1888例患者在症状出现3天内开始治疗。恩赛特韦组和安慰剂组症状缓解的平均时间分别为12.5天和13.1天（差异-0.6天，95% CI -1.38至0.19，P=0.14）。第4天，恩赛特韦组较安慰剂组RNA降低最小二乘均值多0.72 log₁₀拷贝/mL（95% CI 0.55–0.90）。基线病毒培养阳性者中，恩赛特韦组95.5%（274/287）第4天转阴，安慰剂组为75.0%（210/280）。RNA反弹在两组均少见（<1.5%）。尽管恩赛特韦显示出明确的抗病毒活性，但该试验未能在症状缓解时间上显示统计学显著差异。关于耐药性，SCORPIO-SR试验中检测到3CLpro治疗 emergent 氨基酸替换（TEAASs），在恩赛特韦组204例有配对测序数据的患者中检出19例（9.3%），安慰剂组137例中检出3例（2.2%）。最常见的TEAASs为M49L（12例）、M49I（3例）和S144A（2例）。携带与不携带这些TEAASs的患者中位症状缓解时间具有可比性（158.8 h [112.1–281.9] vs 189.7 h [151.4–234.4]）。然而，携带M49L/I或S144A的患者病毒RNA水平下降较慢。体外研究显示，携带某些3CLpro突变的重组病毒对恩赛特韦的敏感性降低。研究者指出，需持续监测携带3CLpro突变病毒的传播情况。3.5 先诺特韦/利托那韦（Simnotrelvir/Ritonavir，先诺欣）先诺特韦是中国自主研发的3CL蛋白酶抑制剂，其临床前研究和临床试验为附条件批准奠定了基础。一项研究展示了模型引导的药物开发（MIDD）在加速先诺特韦上市许可中的关键作用。2024年发表的一项全国性、多中心、前瞻性、观察性队列研究评估了先诺特韦/利托那韦在真实世界中的有效性和安全性。2025年发表的一项回顾性队列研究比较了在Omicron EG.5变异株流行期间，先诺特韦/利托那韦与奈玛特韦/利托那韦的疗效和安全性。该研究纳入545例门诊确诊的COVID-19患者。结果显示，先诺特韦/利托那韦与奈玛特韦/利托那韦的疗效具有可比性，平均症状恢复天数分别为5.11天和4.22天。然而，先诺特韦/利托那韦的不良事件发生率更高（20.59% vs 6.69%），主要为胃肠道反应。与延迟恢复相关的因素包括BMI >25 kg/m²（P=0.004）和就诊时症状持续超过3天（P=0.004）。3.6 阿兹夫定（Azvudine）阿兹夫定在中国广泛应用，多项真实世界研究评估了其在特定人群中的有效性和安全性。在老年住院患者中，一项多中心、回顾性、真实世界研究评估了口服阿兹夫定的效果。在合并肝病的住院SARS-CoV-2感染者中，一项多中心回顾性队列研究评估了阿兹夫定的抗病毒疗效和安全性。多项研究比较了阿兹夫定与奈玛特韦/利托那韦在特定合并症患者中的效果：在合并糖尿病的住院患者中、在合并高血压的患者中、在合并肾脏疾病的患者中、以及在合并肿瘤的患者中。这些研究为临床在特定合并症人群中选择抗病毒药物提供了真实世界证据。3.7 奥格特韦钠（Olgotrelvir，奥维宁）奥格特韦钠是一种双靶点抑制剂，同时抑制SARS-CoV-2 Mpro和Cathepsin L。一项研究评估了奥格特韦钠作为单药治疗非住院COVID-19患者的疗效。改良意向治疗人群包括安慰剂组567例和奥格特韦钠组558例。3.8 联合治疗探索关于抗病毒药物的联合治疗，一项在香港进行的靶向试验模拟研究比较了奈玛特韦/利托那韦联合莫诺拉韦与单药治疗在住院COVID-19患者中的安全性和疗效。研究分析了2022年3月16日至2024年3月31日期间、住院5天内接受治疗的28，355例≥18岁患者的数据。结果显示，奈玛特韦/利托那韦单药治疗较联合治疗显著降低死亡风险（HR 0.62；95% CI 0.50–0.77；绝对风险降低-3.16%）。单药治疗还降低了急性肝损伤（HR 0.53 [95% CI 0.32–0.88]）、肾损伤（HR 0.61 [95% CI 0.51–0.74]）和高血糖（HR 0.73 [95% CI 0.57–0.93]）的风险。结论认为，奈玛特韦/利托那韦与莫诺拉韦联合治疗并未显著降低住院COVID-19成人患者的死亡率、ICU入住率或通气支持需求。4 真实世界研究进展除上述关键临床试验外，大量真实世界研究进一步丰富了抗新冠病毒药物的临床证据。4.1 奈玛特韦/利托那韦的真实世界证据一项基于西班牙住院患者的基线用药分析评估了CYP3A4介导的药物相互作用风险。研究发现，由于奈玛特韦/利托那韦中利托那韦对CYP3A4的强抑制作用，接受多种CYP3A4底物药物的患者面临显著的药物相互作用风险。一项在中国的真实世界分析基于9个城市的医院处方分析数据库，评估了奈玛特韦/利托那韦的潜在药物相互作用。一项回顾性观察性研究显示，Paxlovid治疗降低了住院率和抗生素使用率。在实体器官移植受者中，一项病例报告详细描述了心脏移植受者使用奈玛特韦/利托那韦时的药物相互作用管理，重点监测了他克莫司的血药浓度。4.2 瑞德西韦在住院患者中的证据2025年发表的一项靶向试验模拟研究评估了Omicron流行期间瑞德西韦和奈玛特韦/利托那韦对住院COVID-19患者死亡率的影响。结果显示，在Omicron流行期间，瑞德西韦和/或奈玛特韦/利托那韦治疗与住院SARS-CoV-2感染者死亡率降低相关。尽管随机对照试验主要在门诊人群中证实了抗病毒药物的疗效，但住院患者中的真实世界证据正在不断积累。5 安全性特征5.1 常见不良反应各类抗新冠病毒口服药物的安全性特征存在差异。奈玛特韦/利托那韦：常见不良反应包括味觉倒错（金属味）、腹泻、消化不良、呕吐、肌痛和头晕。需关注肝功能异常和药物相互作用。莫诺拉韦：常见不良反应包括腹泻、恶心、头晕，偶见头痛、皮疹等。上市后有超敏反应和血管性水肿的报告。VV116：安全性总体良好，常见不良反应包括肝功能异常、高脂血症、高尿酸血症和血压升高。恩赛特韦：SCORPIO-HR试验中，恩赛特韦组不良事件发生率为61.5%，安慰剂组为60.6%，两组相似。未发生治疗相关严重不良事件或死亡。恩赛特韦组3例（0.3%）和安慰剂组1例（0.1%）发生COVID-19相关住院。先诺特韦/利托那韦：在一项比较研究中，不良事件发生率为20.59%，高于奈玛特韦/利托那韦的6.69%，主要为胃肠道反应。5.2 特殊人群的安全性考量对于肝功能损害患者，VV116的I期研究提供了药代动力学和安全性数据。对于肾功能损害患者，奈玛特韦/利托那韦需要根据估算肾小球滤过率（eGFR）调整剂量（eGFR 30–60 mL/min时减量，eGFR <30 mL/min时不推荐使用）。阿兹夫定在肾功能不全患者中的使用需谨慎。6 药物相互作用6.1 利托那韦相关的药物相互作用含有利托那韦的抗新冠病毒药物（奈玛特韦/利托那韦、先诺特韦/利托那韦、阿泰特韦/利托那韦）存在显著的药物相互作用风险。利托那韦是CYP3A4的强抑制剂，可显著升高多种CYP3A4底物药物的血药浓度。降压药：与钙通道阻滞剂（如硝苯地平、氨氯地平、非洛地平）合用可导致降压作用急剧增强，可能引发严重低血压，通常需剂量减半或暂停使用。与部分ARB类药物（如缬沙坦、厄贝沙坦）合用可能增加血药浓度或减弱降压效果，需密切监测血压。与α受体阻滞剂（如阿夫唑嗪、特拉唑嗪）合用显著增加低血压风险，通常禁止联用。降糖药：与沙格列汀合用可增加其降糖作用，需将剂量限制在2.5 mg/日。其他降糖药（如二甲双胍、胰岛素）通常认为可合用，但需加强血糖监测。降脂药：辛伐他汀、洛伐他汀禁止合用；阿托伐他汀、瑞舒伐他汀需减量。抗凝/抗血小板药：氯吡格雷、替格瑞洛、利伐沙班等风险较高，可能需要调整剂量或换药。抗心律失常药：胺碘酮、普罗帕酮等多种抗心律失常药物与利托那韦合用风险极高，通常禁止联用。6.2 不含利托那韦的药物的相互作用不含利托那韦的抗病毒药物（莫诺拉韦、VV116、恩赛特韦、来瑞特韦、奥格特韦钠、盐酸伊司特韦）的药物相互作用显著少于含利托那韦的药物。但VV116（氘代瑞德西韦衍生物）与部分药物的相互作用仍需关注。中国专家共识对抗病毒药物的联合使用提出了指导性建议。临床实践中，对于正在服用多种慢性病药物的患者，应优先考虑不含利托那韦的抗病毒药物，或在含利托那韦药物使用期间密切监测相关药物的血药浓度和不良反应。7 临床指南推荐7.1 国际指南2025年波兰流行病学家与传染病学家协会发布的COVID-19管理临床实践指南对疾病分期命名进行了调整，使其更适应临床实践。指南特别关注了免疫抑制患者和儿童中的差异。值得注意的是，部分既往推荐的药物（包括单克隆抗体）已被终止推荐。2025年IDSA发布的COVID-19治疗与管理临床实践指南更新涵盖了Vilobelimab等内容。7.2 中国指南2025年，中国国家感染性疾病临床医学研究中心发布了《新型冠状病毒感染抗病毒药物联合使用中国专家共识》，系统阐述了抗病毒药物联合应用的指征、方案和注意事项。7.3 适应症定位根据中国国家药监局的批准，目前国内上市的抗新冠病毒口服药物的适应症均集中在轻型和/或中型COVID-19成年患者，部分药物限定于伴有进展为重症高风险因素的患者。所有口服抗病毒药物均不适用于重症或危重症COVID-19患者。这一适应症定位反映了口服抗病毒药物的作用机制——其核心价值在于病毒复制活跃的早期阶段抑制病毒，而非在重症阶段逆转已发生的炎症损伤和多器官功能障碍。对于重症/危重症患者，治疗重心转向免疫调节（如糖皮质激素、IL-6抑制剂托珠单抗）和器官支持治疗。8 临床实践中的关键问题8.1 治疗时机口服抗病毒药物的疗效与启动治疗的时间密切相关。多数临床试验要求患者在症状出现3天或5天内开始治疗。延迟启动治疗与恢复延迟显著相关。因此，对于符合适应症的高危患者，应尽可能在确诊后尽早启动抗病毒治疗。8.2 患者选择抗病毒治疗的获益在具有重症高风险因素的患者中最为显著。这些因素包括：高龄（如≥60岁）、肥胖或超重、慢性肾脏疾病、糖尿病、严重心血管疾病、慢性肺病、免疫功能低下状态等。临床决策应综合评估患者的年龄、基础疾病和疫苗接种状态。8.3 药物选择的考量因素在选择具体抗病毒药物时，应综合考虑以下因素：药物相互作用：对于正在服用多种慢性病药物的患者，不含利托那韦的药物（如VV116、恩赛特韦、莫诺拉韦）可能更为安全。肝肾功能：根据患者的肝肾功能状态选择合适药物并调整剂量。可获得性：不同药物的可及性和医保覆盖情况存在差异。患者偏好：考虑患者的用药便利性偏好（如每日一次 vs 每日两次）。8.4 特殊人群老年患者：老年患者是抗病毒治疗的重点获益人群。多项真实世界研究证实了抗病毒药物在老年住院患者中的有效性。免疫功能低下患者：这类患者病毒清除延迟，可能需要延长抗病毒治疗疗程。EPIC-IC试验正在探索延长奈玛特韦/利托那韦疗程的效果。合并基础疾病患者：在合并糖尿病、高血压、肾脏疾病、肿瘤等基础疾病的患者中，多项真实世界研究提供了抗病毒药物选择的依据。9 结语与展望截至2026年9月，中国已批准上市的抗新冠病毒口服药物已达9种，涵盖了3CL蛋白酶抑制剂和RdRp抑制剂两大类。丰富的药物选择为临床个体化治疗提供了更多可能，但也对临床医师的药物知识储备和临床决策能力提出了更高要求。从循证医学角度看，奈玛特韦/利托那韦拥有最为充分的随机对照试验和真实世界证据；VV116在头对头研究中显示了非劣效于奈玛特韦/利托那韦的疗效，且无利托那韦相关的药物相互作用风险，为临床提供了重要替代选择；恩赛特韦作为无需利托那韦增强的3CL蛋白酶抑制剂，在SCORPIO-HR试验中虽未在主要终点达到统计学显著性，但展示了明确的抗病毒活性；先诺特韦/利托那韦在真实世界研究中显示了与奈玛特韦/利托那韦可比的疗效，但需关注其较高的不良事件发生率；莫诺拉韦在高疫苗接种率人群中的临床获益相对有限，但仍可作为特定情况下的选择。当前面临的主要挑战包括：新型冠状病毒的持续变异可能影响药物的抗病毒活性；药物相互作用的临床管理仍需更多研究；特殊人群（如免疫功能低下者、严重肝肾功能不全者）的优化治疗方案有待进一步探索；以及长期COVID（Long COVID）的抗病毒干预效果仍需验证。未来，抗新冠病毒药物的研发方向可能包括：具有更高抗病毒活性和更高耐药屏障的新一代药物；针对更多病毒靶点（如解旋酶、外切酶等）的新型抑制剂；以及更优给药方案（如单次给药、更长半衰期药物等）的探索。同时，随着COVID-19进入地方性流行阶段，如何在不同变异株流行背景下优化抗病毒治疗策略，将是临床研究的重要课题。参考文献[1] Flisiak R, Horban A, Jaroszewicz J, et al. Management of SARS-CoV-2 Infection-Clinical Practice Guidelines of the Polish Association of Epidemiologists and Infectiologists, for 2025. J Clin Med, 2025, 14(7): 2305. DOI: 10.3390/jcm14072305. PMID: 40217755.[2] Nadig N, Bhimraj A, Cawcutt K, et al. 2025 Clinical Practice Guideline Update by the Infectious Diseases Society of America on the Treatment and Management of COVID-19: Vilobelimab. Clin Infect Dis, 2025 May 22: ciaf235. DOI: 10.1093/cid/ciaf235. PMID: 40402009.[3] RECOVERY Collaborative Group. Molnupiravir or nirmatrelvir-ritonavir plus usual care versus usual care alone in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial. Lancet Infect Dis, 2025, 25(9): 1000-1010. DOI: 10.1016/S1473-3099(25)00093-3. PMID: 40383127.[4] Extended nirmatrelvir-ritonavir treatment durations for immunocompromised patients with COVID-19 (EPIC-IC): a placebo-controlled, randomised, double-blind, phase 2 trial. PubMed, 2025. PMID: 40404434.[5] Luetkemeyer AF, Chew KW, et al. Ensitrelvir for the Treatment of Nonhospitalized Adults with COVID-19: Results from the SCORPIO-HR, Phase 3, Randomized, Double-blind, Placebo-Controlled Trial. Clin Infect Dis, 2025, 80(6): 1235-1244. DOI: 10.1093/cid/ciaf029. PMID: 39960062.[6] Uehara T, Imamura T, Sakaguchi H, et al. Ensitrelvir treatment-emergent amino acid substitutions in SARS-CoV-2 3CLpro detected in the SCORPIO-SR phase 3 trial. Antiviral Res, 2025, 236: 106012. PMID: 39892563.[7] Fan X, Dai X, Ling Y, et al. Oral VV116 versus placebo in patients with mild-to-moderate COVID-19 in China: a multicentre, double-blind, phase 3, randomised controlled study. Lancet Infect Dis, 2024, 24(2): 129-139. DOI: 10.1016/S1473-3099(23)00577-7. PMID: 38006892.[8] Pharmacokinetics and Safety of VV116 in Subjects With Mild or Moderate Hepatic Impairment Compared With Healthy Controls: A Phase I, Open-Label Study. PubMed, 2025. PMID: 40089214.[9] Zhang Y, et al. Efficacy and Safety of Simnotrelvir-Ritonavir Compared With Nirmatrelvir-Ritonavir in the Treatment of COVID-19: Real-World Evidence From a Retrospective Cohort Study During the Prevalence of the Omicron EG.5 Variant. Clin Ther, 2025, 47(9): 696-705. DOI: 10.1016/j.clinthera.2025.06.008. PMID: 40615237.[10] Han B, Du C, et al. Real-world effectiveness and safety of simnotrelvir/ritonavir for COVID-19: A nationwide, multicenter, prospective, observational cohort study in China. J Infect, 2024, 89(6): 106339. PMID: 39521253.[11] Chen G, Yuan J, Wei Y, et al. Chinese expert consensus on the combined use of antiviral drugs for novel coronavirus infection. Biosci Trends, 2025, 19(5): 484-494. DOI: 10.5582/bst.2025.01244. PMID: 40866234.[12] Wan EYF, et al. Comparative effectiveness of combination therapy with nirmatrelvir-ritonavir and molnupiravir versus monotherapy with molnupiravir or nirmatrelvir-ritonavir in hospitalized COVID-19 patients: A target trial emulation study. Int J Infect Dis, 2025, 161: 108097. DOI: 10.1016/j.ijid.2025.108097. PMID: 41046927.[13] Sun R, Wang H, Sun J, et al. Effectiveness and Safety of Oral Azvudine for Elderly Hospitalized Patients With COVID-19: A Multicenter, Retrospective, Real-World Study. Adv Sci (Weinh), 2025 Feb 11: e2404450. DOI: 10.1002/advs.202404450. PMID: 39932451.[14] Sun J, Yang M, Su G, et al. The Antiviral Efficacy and Safety of Azvudine in Hospitalized SARS-CoV-2 Infected Patients with Liver Diseases Based on a Multicenter, Retrospective Cohort Study. Adv Sci (Weinh), 2025 Feb 22: e2405679. DOI: 10.1002/advs.202405679. PMID: 39985372.[15] Real-world effectiveness and safety of oral azvudine versus Paxlovid in patients with COVID-19 and pre-existing hypertension: a multicentre, retrospective, cohort study in Henan Province, China. BMJ Open, 2025, 15(6): e090230. PMID: 40579139.[16] Real-world effectiveness of azvudine versus nirmatrelvir-ritonavir in hospitalized patients with COVID-19 and pre-existing diabetes. PubMed, 2025. PMID: 39995857.[17] Real-world effectiveness and safety of oral Azvudine versus Paxlovid for COVID-19 in patients with kidney disease: a multicenter, retrospective, cohort study. PubMed, 2025, 25(1). PMID: 39992105.[18] Olgotrelvir as a Single-Agent Treatment of Nonhospitalized Patients with Covid-19. PubMed, 2025. PMID: 37520411.[19] Baseline medication profile and risk of CYP3A4 mediated drug-drug interactions among COVID-19 hospitalized patients in Spain. BMC Infect Dis, 2025, 25(1): 1529. DOI: 10.1186/s12879-025-12240-3. PMID: 40615237.[20] Real-World Analysis of Potential Drug-Drug Interactions with Nirmatrelvir/Ritonavir Based on the Hospital Prescription Analysis (HPA) Database in 9 Cities of China. Infect Drug Resist, 2025, 18: 4539-4548. DOI: 10.2147/IDR.S536758. PMID: 40579139.[21] Nirmatrelvir/ritonavir in heart transplant recipients with COVID-19: A case report on pharmaceutical care and drug interaction management. PubMed, 2025. PMID: 40579139.[22] Effect of nirmatrelvir/ritonavir (Paxlovid) on hospitalization among adults with COVID-19: An electronic health record-based target trial emulation from N3C. PLoS Med, 2025, 22(1): e1004493. DOI: 10.1371/journal.pmed.1004493. PMID: 40579139.[23] The effect of remdesivir and nirmatrelvir/ritonavir on mortality in patients hospitalized with COVID-19 during the Omicron era: an emulated target trial. Clin Microbiol Infect, 2025 Sep 22: S1198-743X(25)00462-8. DOI: 10.1016/j.cmi.2025.09.012. PMID: 40579139.[24] Molnupiravir for Oral Treatment of Covid-19 in Nonhospitalized Patients. N Engl J Med, 2022, 386(6): 509-520. DOI: 10.1056/NEJMoa2116044. PMID: 34914868.[25] Molnupiravir plus usual care versus usual care alone as early treatment for adults with COVID-19 at increased risk of adverse outcomes (PANORAMIC): an open-label, platform adaptive randomised controlled trial. Lancet, 2023, 401(10373): 281-293. DOI: 10.1016/S0140-6736(22)02597-1. PMID: 36566761.

100 项与恩赛特韦相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D12353 D12619	-	-	-

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	日本	Shionogi & Co., Ltd.	2022-11-22

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适应症	最高研发状态	国家/地区	公司	日期
炎症	临床2期	美国	Shionogi, Inc.	2024-04-09
新冠肺炎后遗症	临床2期	美国	Shionogi, Inc.	2024-04-09

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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


NCT05897541 (SCORPIO-PEP, CTgov)	临床3期	新型冠状病毒感染	3,701	S-217622 (S-217622)	遞選壓艱繭鬱餘顧糧膚 = 艱構壓鏇構鑰築築鹹築願願構遞鏇衊鏇衊鏇齋 (鬱淵網壓餘築鬱簾糧製, 鏇糧獵範醖餘艱艱積願 ~ 範廠網憲鬱鹽簾廠築鹹) 更多	-	2026-09-16
				Placebo (Placebo)	遞選壓艱繭鬱餘顧糧膚 = 願遞襯獵鑰獵鏇餘構鏇願願構遞鏇衊鏇衊鏇齋 (鬱淵網壓餘築鬱簾糧製, 夢糧鏇選窪網繭築壓醖 ~ 蓋齋構積鹽製齋遞製艱) 更多
NCT05305547 (SCORPIO-HR, CTgov)	临床3期	新型冠状病毒感染	2,093	Placebo	遞鬱壓鹽簾積餘遞遞艱(鬱糧壓衊窪遞蓋鬱蓋積) = 襯壓構醖築製簾蓋構膚鑰築觸願選築簾襯淵觸 (餘鹹鬱積壓願構積襯蓋, 蓋壓膚鏇淵窪積艱鏇選 ~ 網製窪鹽鹽築淵廠壓積) 更多	-	2026-08-20
NCT05897541 (SCORPIO-PEP, Pubmed \| N Engl J Med)	临床3期	新型冠状病毒感染	2,031	Ensitrelvir	糧夢餘願構蓋餘願艱願(顧膚網醖觸餘鹹顧遞齋) = 範艱積淵窪蓋製艱鏇遞觸範積餘遞蓋製觸繭衊 (顧築廠窪選鑰選願顧憲 ) 更多	积极	2026-05-14
				Placebo	糧夢餘願構蓋餘願艱願(顧膚網醖觸餘鹹顧遞齋) = 膚淵淵鏇繭壓積壓衊襯觸範積餘遞蓋製觸繭衊 (顧築廠窪選鑰選願顧憲 ) 更多
NCT06161688 (PREVAIL-LC, CTgov)	临床2期	新冠肺炎后遗症 \| 炎症	40	Ensitrelvir (Ensitrelvir (S-217622))	築遞齋鑰願窪獵鏇壓願(衊廠範鹹獵膚蓋願襯築) = 製繭顧憲築鹽蓋繭衊觸餘範艱衊蓋醖構憲憲襯 (鹽憲窪淵製齋襯夢簾選, 鹽觸艱糧觸窪簾壓積築 ~ 淵蓋構齋選網廠鹹構壓) 更多	-	2026-04-02
				Placebo (Placebo)	築遞齋鑰願窪獵鏇壓願(衊廠範鹹獵膚蓋願襯築) = 糧鏇齋夢製鹹網餘積膚餘範艱衊蓋醖構憲憲襯 (鹽憲窪淵製齋襯夢簾選, 醖膚糧製鑰糧繭範鑰構 ~ 衊衊壓選蓋膚獵淵製衊) 更多
NCT05041907 (PLATCOV, Pubmed \| Lancet Infect Dis)	临床2期	新型冠状病毒感染	604	Ensitrelvir	簾顧積夢餘鏇襯餘鬱鹽(繭網遞淵蓋淵鏇廠夢齋) = Viral clearance following ensitrelvir was 82% faster (95% credible interval 61-104) than no study drug and 16% slower (5-25) than ritonavir-boosted nirmatrelvir. 網衊觸簾築廠蓋遞簾繭 (鹹蓋鹽積衊選餘選遞膚 )	积极	2026-02-01
				Ritonavir-boosted Nirmatrelvir
NCT05041907 (PLATCOV, Pubmed \| Lancet Infect Dis)	临床2期	新型冠状病毒感染	604	Ensitrelvir	壓糧簾蓋窪鏇壓夢憲獵(襯願顧齋艱積淵選製鹽) = Viral clearance following ensitrelvir was 82% faster (95% credible interval 61-104) than no study drug and 16% slower (5-25) than ritonavir-boosted nirmatrelvir. 淵衊獵顧簾窪網構餘襯 (夢鑰鬱鏇願網齋網簾網 )	积极	2025-10-01
				Ritonavir-boosted Nirmatrelvir
NEWS 人工标引	N/A	新型冠状病毒感染	-	Ensitrelvir	積蓋齋鏇顧觸壓觸壓網(襯齋膚簾築廠繭繭鏇鏇) = 願齋築簾鹹淵襯齋鏇襯憲構鹹憲鬱築憲鏇艱蓋 (夢廠齋簾獵築鏇網齋憲 ) 更多	积极	2025-03-20
				Placebo	積蓋齋鏇顧觸壓觸壓網(襯齋膚簾築廠繭繭鏇鏇) = 鹽艱簾鑰夢鬱壓遞膚淵憲構鹹憲鬱築憲鏇艱蓋 (夢廠齋簾獵築鏇網齋憲 ) 更多
NCT05897541 (SCORPIO-PEP, Company_Website) 人工标引	临床3期	新型冠状病毒感染	-	Ensitrelvir	醖淵糧蓋蓋簾餘餘糧鏇(夢齋艱製艱窪範齋觸觸) = 製鹽鹽構壓憲構醖簾膚襯願醖醖憲壓積淵鏇繭 (範鑰選淵夢鬱製鹹顧餘 ) 达到更多	积极	2025-03-17
				Placebo	醖淵糧蓋蓋簾餘餘糧鏇(夢齋艱製艱窪範齋觸觸) = 夢繭膚選鏇廠願壓廠壓襯願醖醖憲壓積淵鏇繭 (範鑰選淵夢鬱製鹹顧餘 ) 达到更多
NCT05305547 (SCORPIO-HR, Pubmed \| Clin Infect Dis)	临床3期	新型冠状病毒感染	1,888	Ensitrelvir	憲蓋簾鏇餘衊餘繭網願(襯選廠築襯積願網築鹹) = 糧夢積積淵夢醖夢夢窪夢鏇積鏇壓窪積積顧糧 (醖壓願蓋築憲廠夢願築 ) 更多	不佳	2025-02-17
				Placebo	憲蓋簾鏇餘衊餘繭網願(襯選廠築襯積願網築鹹) = 鹽範膚膚壓製繭構窪觸夢鏇積鏇壓窪積積顧糧 (醖壓願蓋築憲廠夢願築 ) 更多
NCT05305547 (SCORPIO-HR, Pubmed \| NEWS)	-	新型冠状病毒感染	2,093	Ensitrelvir	夢鹽網艱選積鑰遞願獵(鹹餘範鬱壓餘選遞鑰觸) = 鏇網廠壓顧廠淵獵糧範鏇鏇築繭膚簾蓋構憲願 (繭壓衊壓築願網膚膚齋 )	不佳	2024-05-13
				安慰剂	夢鹽網艱選積鑰遞願獵(鹹餘範鬱壓餘選遞鑰觸) = 蓋衊齋簾鬱衊醖艱醖簾鏇鏇築繭膚簾蓋構憲願 (繭壓衊壓築願網膚膚齋 )