islatravir
22 September 2023
Islatravir is a first-in-class nucleoside reverse transcriptase translocation inhibitor (NRTTI) that is not yet approved. After a temporary pause in clinical development due to safety concerns, Merck has resumed selected islatravir programs with close safety monitoring.
Recent phase III studies have demonstrated that islatravir, when administered as a once-daily oral treatment in combination with doravirine (DOR/ISL 100 mg/0.25 mg), is both safe and non-inferior to commonly used antiretroviral therapy (ART) regimens in virologically suppressed individuals with HIV-1.
Additionally, islatravir is being investigated as a fixed dose combination with lenacapavir as weekly oral treatment (see also above in the lenacapavir section). If successful, an oral long-acting HIV treatment could provide an important alternative, particularly in settings focused on decentralized service delivery.
Patents on islatravir compound and its use for treating HIV – owned by Yamasa corporation and licensed exclusively to MSD – were mainly filed in HICs and Mexico and were expected to expire on 24.03.2025. A patent family covering the use of Islatravir for the treatment or prophylaxis of HIV (dosing regimen less frequent than once-daily) owned by MSD includes patent applications filed in several LMICs countries/regions with an expected expiry in February 2037.