Drug information

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Lenacapavir
Other Names
lenacapavir sodium, LEN, GS-6207, GS-CA2
Drug Class
Capsid Inhibitors
Molecular Formula

C39 H31 Cl F10 N7 Na O5 S2

Registry Number
2283356-12-5 (CAS)
Chemical Name

sodium;[4-chloro-7-[2-[(1S)-2-(3,5-difluorophenyl)-1-[[2-[(2S,4R)-5,5-difluoro-9-(trifluoromethyl)-7,8-diazatricyclo[4.3.0.02,4]nona-1(6),8-dien-7-yl]acetyl]amino]ethyl]-6-(3-methyl-3-methylsulfonylbut-1-ynyl)pyridin-3-yl]-1-(2,2,2-trifluoroethyl)indazol-3-yl]-methylsulfonylazanide

Organization
Gilead Sciences, Inc.
Phase of Development

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 PubChem,1 ClinicalTrials.gov,2,3 and Gilead press release4)

What is lenacapavir (HIV prevention)?What is lenacapavir (HIV prevention)?

What is lenacapavir (HIV prevention)?

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.4 Lenacapavir is also being studied as an investigational drug to prevent HIV infection.2,3

Lenacapavir belongs to a group of HIV drugs called capsid inhibitors.4 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.5-8 

Lenacapavir may work against HIV strains that are resistant to other HIV drugs.6

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 (HIV prevention)Select clinical trials of lenacapavir (HIV prevention)

Select clinical trials of lenacapavir (HIV prevention)

Study Names: PURPOSE 1; GS-US-412-5624; NCT04994509

Phase: 3
Status: This study is ongoing, but not recruiting participants.
Locations: South Africa and Uganda
Purpose: The purpose of this study is to evaluate the safety and 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.2

Study Names: PURPOSE 2; GS-US-528-9023; NCT04925752

Phase: 3
Status: This study is ongoing, but not recruiting participants.
Locations: United States, Brazil, Puerto Rico, and South Africa
Purpose: The purpose of this study is to evaluate the safety and efficacy of twice-yearly subcutaneous lenacapavir and daily oral emtricitabine/tenofovir DF (brand name: Truvada) for PrEP in cisgender men, transgender women, transgender men, and gender nonbinary people who have sex with partners assigned male at birth and are at risk of acquiring HIV infection.3

Study Names: PURPOSE 3; HPTN-102; GS-US-528-6020; NCT06101329

Phase: 2
Status: This study is currently recruiting participants.
Locations: United States
Purpose: The purpose of this study is to evaluate the pharmacokinetics of twice-yearly subcutaneous lenacapavir and to assess the safety and acceptability of twice-yearly SC lenacapavir and daily oral Truvada for PrEP in cisgender women in the United States.9

Study Names: PURPOSE 4; HPTN-103; GS-US-528-6363; NCT06101342

Phase: 2
Status: This study is currently recruiting participants.
Locations: United States
Purpose: The purpose of this study is to evaluate the pharmacokinetics of twice-yearly SC lenacapavir and to assess the safety of twice-yearly SC lenacapavir and daily oral Truvada for PrEP in people who inject drugs in the United States.10

For more details on the studies listed above, see the Health Professional version of this drug summary.

Additionally, a Phase 2 trial (PURPOSE 5) will be evaluating the consistent and continuous use of twice-yearly subcutaneous lenacapavir for PrEP compared with Truvada in people who are disproportionately affected by HIV in France and the United Kingdom.11

What side effects might lenacapavir (HIV prevention) cause?What side effects might lenacapavir (HIV prevention) cause?

What side effects might lenacapavir (HIV prevention) cause?

Study results for the Phase 2 and Phase 3 PURPOSE prevention trials 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 for PrEP continues, additional information on possible side effects will be gathered.

Side effects known to be associated with lenacapavir for HIV treatment are described in the FDA-approved Full Prescribing Information for Sunlenca.6

Where can I get more information about clinical trials studying lenacapavir (HIV prevention)?Where can I get more information about clinical trials studying lenacapavir (HIV prevention)?

Where can I get more information about clinical trials studying lenacapavir (HIV prevention)?

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.)

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. 

References

  1. National Center for Biotechnology Information. PubChem compound summary for CID 153435888, lenacapavir sodium. Accessed April 30, 2024
  2. 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 April 30, 2024
  3. 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 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 April 30, 2024
  4. 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 April 30, 2024
  5. 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 April 30, 2024
  6. Gilead Sciences, Inc. Sunlenca: full prescribing information, October 2, 2023. DailyMed. Accessed April 30, 2024
  7. 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 April 30, 2024
  8. 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 April 30, 2024
  9. Gilead Sciences. A Phase 2, open-label, multicenter, randomized study to evaluate the pharmacokinetics, safety, and acceptability of twice yearly long-acting subcutaneous lenacapavir for pre-exposure prophylaxis in cisgender women in the United States. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on October 20, 2023. NLM Identifier: NCT06101329. Accessed April 30, 2024
  10. Gilead Sciences. A Phase 2, open-label, multicenter, randomized study to evaluate the pharmacokinetics and safety of twice yearly long-acting subcutaneous lenacapavir for pre-exposure prophylaxis in people who inject drugs. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on October 20, 2023. NLM Identifier: NCT06101342. Accessed April 30, 2024
  11. Gilead Sciences: Press release, dated October 18, 2023. Gilead Sciences announces new clinical trial in Europe to assess lenacapavir for HIV prevention as part of landmark purpose program. Accessed April 30, 2024

 

Last Reviewed: April 30, 2024