Yeztugo FDA Approval History

FDA Approved: Yes (First approved June 18, 2025)
Brand name: Yeztugo
Generic name: lenacapavir
Dosage form: Tablets and Injection
Company: Gilead Sciences, Inc.
Treatment for: Pre-Exposure Prophylaxis of HIV

Yeztugo (lenacapavir) is a human immunodeficiency virus type 1 (HIV-1) capsid inhibitor for pre‑exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1.

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 treatment.

Development timeline for Yeztugo

Date	Article
Jun 18, 2025	Approval FDA Approves Yeztugo (lenacapavir) as the First and Only HIV Prevention Option Offering 6 Months of Protection
Feb 18, 2025	U.S. FDA Accepts Gilead’s New Drug Applications for Twice-Yearly Lenacapavir for HIV Prevention Under Priority Review

Further information

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