TGA approves registration of lenacapavir for pre-exposure prophylaxis (PreP) for HIV (YEYTUO)

On 17 December 2025, the TGA made the decision to approve the registration of lenacapavir (YEYTUO).

What is YEYTUO approved for 

YEYTUO is indicated for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults and adolescents 16 years and older weighing at least 35 kg.

This approval covers the following dosage forms and strengths:

• YEYTUO lenacapavir 463.5 mg/1.5 mL, solution for injection, AUST R 489330 and
• YEYTUO lenacapavir 300 mg, film-coated tablet, AUST R 489331. 

Summary

Lenacapavir (LEN; GS-6207) is a novel, first-in-class, multistage, human immunodeficiency virus type 1 (HIV-1) capsid inhibitor. 

Lenacapavir was first registered in Australia for HIV treatment in 2023, with the approval of SUNLENCA. 

Sunlenca, in combination with other antiretrovirals, is indicated for the treatment of adults with multidrug resistant HIV-1 infection for whom it is otherwise not possible to construct a suppressive anti-viral regimen. 

Gilead Sciences Pty Ltd then sought registration of lenacapavir for pre-exposure prophylaxis (PrEP) for HIV under the trade name YEYTUO.  

Related content 

Details relating to the approved use of the medicine, including the approved indication are available in the Product Information. 

PI/CMI search facility | Therapeutic Goods Administration (TGA)

More information 

Questions relating to supply of YEYTUO should be directed to the sponsor of the medicine, Gilead Sciences Pty Ltd. 

The TGA encourages affected patients to speak to their doctor if they have questions or concerns about this medicine.