|Lenacapavir Voice Recording.m4a|
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Lenacapavir is in Phase 3 development for HIV prevention.
FDA-Approved Products for HIV Treatment: Lenacapavir (brand name: Sunlenca), in combination with other antiretrovirals, is approved by the U.S. Food and Drug Administration (FDA) for the treatment of HIV in heavily treatment-experienced adults with multidrug-resistant HIV.
(Compound details obtained from NIAID Therapeutics Database,1 American Medical Association website,2ClinicalTrials.gov,3,4 and Gilead press release5)
What is lenacapavir?
Lenacapavir is a drug that has been approved by the U.S. Food and Drug Administration (FDA) under the brand name Sunlenca for the treatment of HIV. Lenacapavir is also being studied as an investigational drug to prevent HIV infection.3-5
Lenacapavir belongs to a group of HIV drugs called capsid inhibitors.1 Capsid inhibitors interfere with HIV capsid, a protein shell that protects HIV’s genetic material and enzymes needed for replication. Capsid inhibitors can disrupt HIV capsid during multiple stages of the viral life cycle. This prevents HIV from multiplying and can reduce the amount of HIV in the body.6-9
Lenacapavir may work against HIV strains that are resistant to other HIV drugs.7
To learn about how investigational drugs are tested during clinical trials, read the HIVinfo What is an Investigational HIV Drug? and HIV and AIDS Clinical Trials fact sheets.
Select clinical trials of lenacapavir
Lenacapavir for HIV prevention
Study Names: PURPOSE 1; GS-US-412-5624; NCT04994509
Status: This study is currently recruiting participants.
Locations: South Africa and Uganda
Purpose: The purpose of this two-part study is to 1) estimate the background HIV incidence rate, and 2) evaluate the efficacy of twice yearly subcutaneous lenacapavir and daily oral emtricitabine/tenofovir alafenamide (brand name: Descovy) for pre-exposure prophylaxis (PrEP) in adolescent girls and young women who are at risk of acquiring HIV infection.3
Study Names: PURPOSE 2; GS-US-528-9023; NCT04925752
Status: This study is currently recruiting participants.
Locations: United States, Brazil, Puerto Rico, and South Africa
Purpose: The purpose of this two-part study is to 1) estimate the background HIV incidence rate, and 2) evaluate the efficacy of twice yearly subcutaneous lenacapavir for PrEP in cisgender men, transgender women, transgender men, and gender nonbinary people who have sex with partners assigned male at brith and are at risk of acquiring HIV infection.4
For more details on the studies listed above, see the Health Professional version of this drug summary.
What side effects might lenacapavir cause?What side effects might lenacapavir cause?
What side effects might lenacapavir cause?
Study results for the Phase 3 prevention trials (PURPOSE 1; NCT04994509 and PURPOSE 2; NCT04925752) evaluating lenacapavir for HIV PrEP are not yet available.
Because lenacapavir for prevention is still being studied, information on possible side effects of the drug is not complete. As testing of lenacapavir continues, additional information on possible side effects will be gathered.
Side effects known to be associated with lenacapavir treatment are described in the FDA-approved Full Prescribing Information for Sunlenca.7
Where can I get more information about clinical trials studying lenacapavir?
More information about lenacapavir-related research studies is available from ClinicalTrials.gov. (The ClinicalTrials.gov search can be modified so that you can get results that better match your interests. To learn more about the ClinicalTrials.gov search features, please see How to Search).
Some clinical trials may be looking for volunteer participants. Your health care provider can help you decide whether participating in a clinical trial is right for you. For more information, visit NIH Clinical Research Trials and You.
- National Institute of Allergy and Infectious Diseases (NIAID). NIAID ChemDB, HIV Drugs in Development. Accessed January 9, 2023
- American Medical Association (AMA) website. Statement on a nonproprietary name adopted by the USAN council: lenacapavir. Accessed January 9, 2023
- Gilead Sciences. A Phase 3, double-blinded, multicenter, randomized study to evaluate safety and efficacy of twice yearly long-acting subcutaneous lenacapavir, and daily oral emtricitabine/tenofovir alafenamide for pre-exposure prophylaxis in adolescent girls and young women at risk of HIV infection. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on August 2, 2021. NLM Identifier: NCT04994509. Accessed January 9, 2023
- Gilead Sciences. A Phase 3, double-blind, multicenter, randomized study to evaluate the efficacy and safety of subcutaneous twice yearly long-acting lenacapavir for HIV pre-exposure prophylaxis in cisgender men, transgender women, transgender men, and gender non-binary people ≥ 16 years of age who have sex with partners assigned male at birth and are at risk for HIV infection. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on May 28, 2021. NLM Identifier: NCT04925752. Accessed January 9, 2023
- Gilead Sciences: Press release, dated December 22, 2022. Sunlenca® (lenacapavir) receives FDA approval as a first-in-class, twice-yearly treatment option for people living with multi-drug resistant HIV. Accessed January 9, 2023
- Ogbuagu O, Segal-Maurer S, Brinson C, et al. Long-acting lenacapavir in people with multidrug resistant HIV-1: Week 52 results. Poster presented at: Conference on Retroviruses and Opportunistic Infections (CROI); February 12-16, 2022; Virtual. Accessed January 9, 2023
- Gilead Sciences, Inc. Sunlenca: full prescribing information, December 21, 2022. DailyMed. Accessed January 9, 2023
- Link JO, Rhee MS, Tse WC, et al. Clinical targeting of HIV capsid protein with a long-acting small molecule. Nature. 2020;584(7822):614-618. doi:10.1038/s41586-020-2443-1. Accessed January 9, 2023
- Bester SM, Wei G, Zhao H, et al. Structural and mechanistic bases for a potent HIV-1 capsid inhibitor. Science. 2020;370(6514):360-364. doi:10.1126/science.abb4808. Accessed January 9, 2023
Last Reviewed: January 9, 2023