默沙东新冠药：莫诺拉韦 molnupiravir
Drug Class
Nucleoside antiviral agent核苷类抗病毒药
Mechanism
Metabolized to a cytidine analog that is incorporated into viral RNA by viral RNA polymerase, causing lethal mutations during viral replication.在体内代谢为胞苷类似物并掺入病毒 RNA 中，通过干扰病毒的 RNA 复制过程导致病毒发生致死性突变，从而抑制病毒复制。
Approved Indication
FDA EUA authorized for the treatment of mild-to-moderate COVID-19 in adults at high risk for progression to severe disease, for whom alternative treatments are not accessible.FDA紧急使用授权（EUA）以及中国NMPA附条件批准，用于治疗伴有进展为重症高风险因素的、轻度至中度新型冠状病毒感染 (COVID-19) 的成人患者。
What This Means For Patients
Molnupiravir (brand name Lagevrio) is an oral antiviral for COVID-19. It holds emergency clearance from the FDA and conditional approval from NMPA, accessible for clinical use in pilot-zone hospitals.莫诺拉韦（商品名 Lagevrio）是默沙东研发的口服新冠抗病毒药。其已获得美国 FDA 的紧急使用授权（EUA）和中国药监局的附条件批准，可在博鳌乐城相关医疗机构使用。
Regulatory Approvals
- FDA — EUA (2021) — source
Pivotal Clinical Evidence
- MOVe-OUT — Jayk Bernal et al., N Engl J Med 2022 (NCT04575597) — DOI
Sources
This page provides regulatory and mechanism-of-action information for reference only. It is not medical advice, a treatment recommendation, or a guarantee of outcome. Availability is subject to individual clinical review.