Gilead and Merck Advance Once-Weekly Oral Lenacapavir Regimens for HIV Treatment and Prevention
The landscape of HIV treatment and prevention is shifting rapidly toward long-acting oral regimens, anchored by Gilead Sciences' first-in-class capsid inhibitor lenacapavir.1 On June 15, 2026, Gilead announced a major regulatory milestone: the U.S. Food and Drug Administration (FDA) has accepted its supplemental New Drug Application (sNDA) for Yeztugo (lenacapavir) 300-mg tablets as a potential once-weekly oral pre-exposure prophylaxis (PrEP) formulation. The FDA has set a Prescription Drug User Fee Act (PDUFA) action date of February 2, 2027.
If approved, once-weekly oral Yeztugo could become the world's first long-acting oral PrEP option, complementing Gilead's development of twice-yearly injectable lenacapavir. The submission is backed by robust data from the pivotal Phase 3 PURPOSE 1 and PURPOSE 2 trials, which demonstrated stellar efficacy across diverse global cohorts including cisgender women, cisgender men, and gender-diverse individuals. Lenacapavir oral tablets are currently approved only as an initial loading dose and a temporary bridging therapy for patients whose twice-yearly injections are delayed.
Meanwhile, Gilead is also collaborating with Merck on a long-acting oral treatment regimen combining lenacapavir and Merck’s nucleoside reverse transcriptase translocation inhibitor islatravir. Positive 48-week data from the Phase 3 ISLEND-1 and ISLEND-2 trials recently demonstrated that this once-weekly oral single-tablet combination achieved high rates of virologic suppression comparable to daily Biktarvy, paving the way for a separate regulatory filing in 2027.
"Gilead Sciences, Inc. today announced the U.S. Food and Drug Administration (FDA) accepted its supplemental New Drug Application (sNDA) for Yeztugo ® (lenacapavir) 300-mg tablet as a potential once-weekly (QW) oral formulation for the prevention of HIV as pre-exposure prophylaxis (PrEP). The FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of February 2, 2027." — EATG Press Release / Gilead Sciences
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An instance of Chronic disease markets belong to therapies that convert daily maintenance into highly convenient, discrete interventions. — The massive HIV field is rapidly transferring focus to long-acting, once-weekly oral regimens to displace daily adherence burdens. ↩︎