Lenacapavir is a long-acting HIV-1 capsid inhibitor marketed as Sunlenca for multidrug-resistant HIV-1 treatment in heavily treatment-experienced patients in combination regimens. It can be initiated with oral and injectable loading and then maintained with subcutaneous dosing every six months. The FDA first approved Sunlenca on December 22, 2022.
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.
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.
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.
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.
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.
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.
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.
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.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07467018 |
Mobile Vehicle-Based Delivery of Lenacapavir Pre-Exposure Prophylaxis in Los Angeles County |
RECRUITING | |
| NCT06819176 |
Lenacapavir Intensification to Disrupt HIV Reservoirs in Virologically Suppressed People With HIV Receiving Antiretroviral Therapy |
RECRUITING | PHASE1 |
| NCT06532656 |
Study of Bictegravir/Lenacapavir in Children and Adolescents With HIV-1 |
RECRUITING | PHASE2/PHASE3 |
| NCT06333808 |
Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With Biktarvy |
ACTIVE_NOT_RECRUITING | PHASE3 |
| NCT05502341 |
Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With a Complicated Regimen |
ACTIVE_NOT_RECRUITING | PHASE2/PHASE3 |
| NCT03739866 |
Study to Evaluate Safety, Pharmacokinetics, and Antiviral Activity of Lenacapavir Administered Subcutaneously in Human Immunodeficiency Virus (HIV) -1 Infected Adults |
COMPLETED | PHASE1 |
