[10][11] Lenacapavir was approved for medical treatment in the European Union in August 2022,[10][12] in Canada in November 2022,[5][6] and in the United States in December 2022.

[11] The primary measure of efficacy was the proportion of participants in the randomized study group who achieved a certain level of reduction in virus during the initial 14 days compared to baseline.

[11] The US Food and Drug Administration granted the application for lenacapavir priority review, fast track, and breakthrough therapy designations.

[19] Lenacapavir was approved for medical use in the European Union in August 2022,[10][20] in Canada in November 2022,[5][6] and in the United States in December 2022.

A study presented in July 2024[22] found that mass production of a generic version would allow a profit margin of 30% on an annual price of $40 if used by 10 million people.

[24] It is being investigated as a treatment for HIV patients infected with multidrug-resistant virus and as a twice-yearly injectable for pre-exposure prophylaxis.

[28] A phase III clinical trial study examined efficacy for pre-exposure HIV prevention (PrEP).