{"title":"Doravirine/Islatravir: First Approval.","authors":"Sheridan M Hoy","doi":"10.1007/s40265-026-02367-1","DOIUrl":null,"url":null,"abstract":"<p><p>Doravirine/islatravir is an oral two-drug fixed-dose combination of doravirine [a non-nucleoside reverse transcriptase inhibitor (NNRTI)] and islatravir [a nucleoside reverse transcriptase translocation inhibitor (NRTTI)]. Developed by Merck & Co., Inc., Rahway, NJ, USA, doravirine/islatravir [IDVYNSO<sup>®</sup> イドビンソ<sup>®</sup> (Japan); IDVYNSO™ (USA); IDVYNSO<sup>®</sup> (Canada)] was first approved on 6 March 2026 in Japan and subsequently approved on 21 April 2026 in the USA and 3 June 2026 in Canada for the treatment of HIV-1 infection in adults who are virologically suppressed (HIV-1 RNA < 50 copies/mL). Clinical development is underway in several other countries worldwide. This article summarizes the milestones in the development of doravirine/islatravir leading to these first approvals.</p>","PeriodicalId":11482,"journal":{"name":"Drugs","volume":" ","pages":"1941-1952"},"PeriodicalIF":14.7000,"publicationDate":"2026-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Drugs","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s40265-026-02367-1","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2026/9/12 0:00:00","PubModel":"Epub","JCR":"Q1","JCRName":"PHARMACOLOGY & PHARMACY","Score":null,"Total":0}
引用次数: 0
Abstract
Doravirine/islatravir is an oral two-drug fixed-dose combination of doravirine [a non-nucleoside reverse transcriptase inhibitor (NNRTI)] and islatravir [a nucleoside reverse transcriptase translocation inhibitor (NRTTI)]. Developed by Merck & Co., Inc., Rahway, NJ, USA, doravirine/islatravir [IDVYNSO® イドビンソ® (Japan); IDVYNSO™ (USA); IDVYNSO® (Canada)] was first approved on 6 March 2026 in Japan and subsequently approved on 21 April 2026 in the USA and 3 June 2026 in Canada for the treatment of HIV-1 infection in adults who are virologically suppressed (HIV-1 RNA < 50 copies/mL). Clinical development is underway in several other countries worldwide. This article summarizes the milestones in the development of doravirine/islatravir leading to these first approvals.
期刊介绍：
Drugs is a journal that aims to enhance pharmacotherapy by publishing review and original research articles on key aspects of clinical pharmacology and therapeutics. The journal includes:
Leading/current opinion articles providing an overview of contentious or emerging issues.
Definitive reviews of drugs and drug classes, and their place in disease management.
Therapy in Practice articles including recommendations for specific clinical situations.
High-quality, well designed, original clinical research.
Adis Drug Evaluations reviewing the properties and place in therapy of both newer and established drugs.
AdisInsight Reports summarising development at first global approval.
Moreover, the journal offers additional digital features such as animated abstracts, video abstracts, instructional videos, and podcasts to increase visibility and educational value. Plain language summaries accompany articles to assist readers with some knowledge of the field in understanding important medical advances.
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