Doravirine/Islatravir: First Approval.

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.