Gilead’s Bixlenvo gains US approval

28 August 2026

The US Food and Drug Administration (FDA) has approved Bixlenvo (bictegravir 75mg/lenacapavir 50mg), the smallest once-daily single tablet regimen (STR) for the treatment of HIV in adults who are virologically suppressed.

Developed by US antivirals specialist Gilead Sciences (Nasdaq: GILD), Bixlenvo is now the first and only STR option for virologically suppressed people with HIV who are on complex regimens and unable to take currently available STRs, the company noted.

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