Yeztugo FDA Approval History
Last updated by Judith Stewart, BPharm on July 2, 2025.
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.
- Yeztugo contains lenacapavir, a HIV-1 capsid inhibitor first approved for the treatment of HIV-1 infection under the brand name Sunlenca in 2022.
- FDA approval of Yeztugo was supported by data from the Phase 3 PURPOSE 1 (NCT04994509) and PURPOSE 2 (NCT04925752) studies that showed that ≥99.9% of participants remained HIV negative on twice-yearly injectable Yeztugo.
- In PURPOSE 1, data at the primary analysis showed twice-yearly subcutaneous Yeztugo demonstrated zero HIV infections among 2,134 participants in the Yeztugo group, 100% reduction in HIV infections and superiority of prevention of HIV infections when compared with once-daily oral Truvada (emtricitabine 200mg and tenofovir disoproxil fumarate 300mg) in cisgender women in sub-Saharan Africa.
- In PURPOSE 2, there were two HIV infections among 2,179 participants in the twice-yearly subcutaneous Yeztugo group, demonstrating 99.9% of participants in the Yeztugo group did not acquire HIV infection and superiority of prevention of HIV infections when compared with once-daily oral Truvada among a broad and geographically diverse range of cisgender men and gender-diverse people.
- In both trials, Yeztugo also demonstrated superiority of prevention of HIV infections when compared with background HIV incidence (bHIV) and was generally well-tolerated, with no significant or new safety concerns identified. Data from both trials were published in The New England Journal of Medicine. - Yeztugo tablets are administered orally, and the Yeztugo injection is administered subcutaneously by a healthcare provider into the abdomen or thigh. Dosing is Initiated with 927 mg by subcutaneous injection (2 x 1.5 mL injections) and 600 mg orally (2 x 300 mg tablets) on Day 1, followed by 600 mg orally on Day 2, and continued with 927 mg by subcutaneous injection every 6-months.
- Yeztugo carries a Boxed Warning for the risk of drug resistance with use in undiagnosed HIV-1 infection. Individuals must be tested for HIV-1 infection prior to initiating Yeztugo, and with each subsequent injection of Yeztugo. Warnings and precautions associated with Yeztugo include risk of developing resistance to lenacapavir (if an individual acquires HIV-1 either before, during or after treatment) and serious injection site reactions due to improper administration (intradermal injection).
- Common adverse reactions (incidence greater than or equal to 5%, all grades) include injection site reactions, headache, and nausea.
Development timeline for Yeztugo
Further information
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