FDA Slaps Clinical Hold On Gilead's Injectable Lenacapavir In HIV Trials
- The FDA has placed a clinical hold on Gilead Sciences Inc's (NASDAQ: GILD) injectable lenacapavir in borosilicate vials in all ongoing clinical studies for HIV treatment and pre-exposure prophylaxis (PrEP).
- The FDA's clinical hold is due to emerging concerns about the compatibility of borosilicate glass-made vials with lenacapavir solution, which could lead to the formation of sub-visible glass particles in the solution of lenacapavir.
- The hold will impact ten lenacapavir trials, either monotherapy or combination.
- Related: Gilead, Merck Stop Enrollment In Mid-Stage HIV Combination Therapy Trial.
- Dosing of oral formulations of lenacapavir will continue.
- During the clinical hold, screening and enrollment of study participants and the dosing of injectable lenacapavir will not be permitted across all lenacapavir studies.
- All other study activities, including monitoring participants and the dosing of participants in comparator arms, will continue according to the relevant study protocol.
- "We are committed to working diligently with FDA to resolve this glass vial compatibility quality issue and resume injectable lenacapavir dosing in the affected studies in a timely fashion," said Merdad Parsey, Chief Medical Officer, Gilead Sciences.
- Price Action: GILD shares are down 0.22% at $71.68 during the premarket session on the last check Wednesday.
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Posted-In: Briefs HIV treatmentBiotech News Health Care FDA General
