Twice-Yearly : Lenacapavir, a first-in-class, capsid inhibitor approved for both HIV-1 treatment and prevention

On June 18, 2025, Gilead Sciences officially announced via its official website that Yeztugo® (Lenacapavir) has become the first and only FDA-approved HIV prevention drug that provides six months of protective efficacy. Compared with daily oral medication, it features greater convenience and higher medication adherence, especially ideal for people who struggle to stick to daily oral regimens.

Approved Indication(s)：

First approved indication:   On August 2022, lenacapavir received its first approval in the EU for use in combination with other antiretroviral(s) in adults with multi-drug resistant HIV infection, for whom it is otherwise not possible to construct a suppressive anti-viral regimen. 

Newly approved indication:  On June 18, 2025 local time, the U.S. FDA approved lenacapavir  for HIV pre-exposure prophylaxis in adolescents and adults weighing over 35 kg under the brand name Yeztugo.  It is the world’s first PrEP regimen requiring only two injections per year.

In China,

On January 2, 2025, the National Medical Products Administration (NMPA) officially approved lenacapavir tablets and lenacapavir injection for marketing in China.

On July 25, 2025, lenacapavir, an HIV pre-exposure prophylaxis (PrEP) drug requiring only two injections per year, was officially launched at the Boao Lecheng International Medical Tourism Pilot Zone in Hainan.

Lenacapavir

Lenacapavir Starting Materials and Intermediates 

RELYBO is committed to providing global customers with high-purity, high-quality Lenacapavir intermediates with stable supply from kilogram to ton cales, accelerating the innovation and commercialization.