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Lenacapavir

Sunlenca

Small molecule

Capsid inhibitor

Lenacapavir (LEN), also known as GS-6207, is a first in-class HIV-1 capsid inhibitor used in combination with other antiretrovirals for the treatment of multi-drug resistant HIV-1 infection, and has potential application as HIV pre-exposure prophylaxis. LEN is utilised combinatorially for HIV-1 treatment, as it displays excellent synergy and no known cross-resistance with any other currently approved class of antiretroviral, in addition to possessing antiviral activity at picomolar levels.

For Treatment: Lenacapavir (SUNLENCA) 463.5mg/3ml subcutaneous injection with 300mg oral lead-in tablets are approved for use by 11 regualtory authorities (all for high income countries) for HIV-1 treatment under certain conditions. For PrEP: US FDA and South Africa has approved lenacapavir (Yeztugo) for HIV-1 prevention. It is also under review in Brazil, EU (+EEA), Australia, and Canada. Gilead has disclosed that it is preparing additional filings in countries that rely on FDA approval for regulatory submission, including Argentina, Mexico and Peru.

US FDA granted Breakthrough Therapy Designation for SUNLENCA in combination with other antiretroviral drugs for heavily treatment-experienced patients (HTE) adults with multi-drug resistant (MDR) HIV-1 infection failing their current antiretroviral regimen due to resistance, intolerance, or safety considerations. A European Marketing Authorization was issued for the use of SUNLENCA and it has also been classified as ‘Fast-Track Reimbursement’ by the Ministry of Health, Labour and Welfare, Japan, and ‘Part 1- Schedule 1 & Schedule 3 Poison’ by the Department of Health, Hong Kong. WHO guidelines released in July 2025 recommend offering six-monthly injectable lenacapavir as an additional PrEP option.