Lowers the risk of sexually acquired HIV-1. NDA 220018, held by Gilead Sciences Inc. Lenacapavir Sodium, Lenacapavir.
As of Nov 13, 2026, NDA 220018 (Yeztugo), held by Gilead Sciences Inc, was first approved by FDA on Jun 18, 2025, with 0 approved supplements and 0 published complete response letters.
YEZTUGO is indicated for pre‑exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults and adolescents weighing at least 35 kg who are at risk for HIV-1 acquisition. Individuals must have a negative HIV-1 test prior to initiating YEZTUGO.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 18, 2025 | Original applicationNew indication · Priority review | Approved |
| YeztugoEQ 463.5MG BASE/1.5ML (EQ 309MG BASE/ML) · solution;subcutaneous | Lenacapavir Sodium | RxReference drug |
| Yeztugo463.5MG/1.5ML(309MG/ML) · solution;subcutaneous | Lenacapavir | Rx |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
