15 October 2024
GS-4182 is an investigational lenacapavir prodrug with improved bioavailability and potential for oral weekly administration. GS-4182 is studied in combination with GS-1720, a new oral INSTI. If successful, a weekly oral HIV treatment could provide a valuable alternative for PLHIV.
In June 2025, The U.S. FDA has placed a clinical hold on Gilead’s HIV treatment trials of GS-1720 and/or GS-4182. The clinical hold is due to the identification of a safety signal of decreases in CD4+T-cell (CD4) and absolute lymphocyte counts in a subset of participants receiving the combination of GS-1720 and GS-4182. We are closely monitoring updates in relation to this.
In December 2022, Gilead filed three international patent applications covering lenacapavir pro-drugs, which may include GS-4182. Confirmation will be possible once the chemical structure of GS-4182 is available in the public domain. The expected expiry of the compound patents is 2042, and additional secondary patent filings are anticipated.