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# FDA Clinical Hold on Gilead HIV Trials
- URL: https://www.fdaweb.com/fda-clinical-hold-on-gilead-hiv-trials/
- Published: 2022-01-03T12:00:00.000Z
- Updated: 2026-09-14T17:27:03.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150816

FDA has placed a clinical hold on 10 Gilead trials studying injectable versions of its experimental HIV treatment lenacapavir. *Endpoints News* [reports](https://endpts.com/fda-slaps-a-hold-on-gileads-injectable-hiv-treatment-over-concerns-about-potential-glass-contaminants/?utm%5Fmedium=email&utm%5Fcampaign=1377%20-%20Takeda%20loses%20its%20shot%20at%20a%20key%20approval%20as%20FDA%20hits%20reject%20Trial%20failures%20blitz%20Allakos%20market%20cap%20Basic&utm%5Fcontent=1377%20-%20Takeda%20loses%20its%20shot%20at%20a%20key%20approval%20as%20FDA%20hits%20reject%20Trial%20failures%20blitz%20Allakos%20market%20cap%20Basic+CID%5Fa6ebae05bc7ef77061b95ec1553eaeb3&utm%5Fsource=ENDPOINTS%20emails&utm%5Fterm=FDA%20slaps%20a%20hold%20on%20Gileads%20injectable%20HIV%20treatment%20over%20concerns%20about%20potential%20glass%20contaminants) that the agency expressed concerns that vials made of borosilicate glass could lead to the formation of sub-visible glass particles in the solution.

Gilead CEO **Merdad Parsey** said the company is committed to working diligently with FDA to resolve the glass vial compatibility quality issue and resume injectable lenacapavir dosing in the affected studies in a timely fashion.