Jun 16, 2026
The U.S. FDA has accepted Gilead's application for an investigational once-weekly oral lenacapavir for HIV prevention, with a review date set for February 2027. Concurrently, PEPFAR and The Global Fund are expanding access to the twice-yearly injectable version to a total of 3 million people by 2028. Gilead will present new data on both lenacapavir and a novel bictegravir/lenacapavir combination at CROI 2026.
May 14, 2026
South Africa will begin providing lenacapavir on June 5 after delays tied to postimportation testing, while Uganda has launched rollout of the twice-yearly HIV prevention injection in Lira.
May 01, 2026
FDA grants Priority Review for Gilead's bictegravir/lenacapavir single-tablet HIV regimen. The NDA is supported by ARTISTRY-1 and ARTISTRY-2 trials showing noninferiority. A PDUFA target date of August 27, 2026 has been set.
Apr 15, 2026
Lenacapavir was launched in Zimbabwe in February 2026 as Kenya became the fourth African country to start administering the twice-yearly HIV prevention injection. The rollout follows launches in Eswatini and Zambia in December 2025, five months after US FDA approval.
Mar 06, 2026
South Africa is working to identify local manufacturers for lenacapavir, a twice-yearly injectable HIV prevention drug that showed near-perfect efficacy in clinical trials. Kenya has already received 21,000 doses of the medication.
Feb 27, 2026
Zimbabwe began rolling out lenacapavir, a twice-yearly injectable HIV prevention drug, on February 19 in Epworth. The program will initially target more than 46,000 people at high risk across 24 sites nationwide.
Feb 26, 2026
A once-daily single-tablet combination of bictegravir and lenacapavir demonstrated non-inferiority to existing HIV treatments in Phase 3 trials, offering simplified treatment for people living with HIV who are virologically suppressed.
Feb 22, 2026
Zimbabwe rolled out lenacapavir, a twice-yearly HIV prevention injection, on Thursday for high-risk populations including sex workers and adolescent girls. The donor-supported program will initially reach 46,000 people across 24 sites.
Feb 28, 2025
Drug Hunter has opened nominations for the 2025 Molecules of the Year following the announcement of the final Molecules of the Month for 2025. Eligible molecules must have been first disclosed or had a major update in 2025.
