Drug
Lenacapavir clinical trials
Also written GS-6207, Yeztugo® and Sunlenca®.
- studies test it
- 22
- open now
- 9
- in phase 3
- 8
- first study started
- 2018
Keep track of what changes. Save the lenacapavir studies recruiting or about to start, and get an email each week — studies that open, close, add sites or post results.
Watch these studiesHow studies write it
Studies that test it under each name
Combined with it in one product
Studies by the year they started
22 studies that test it; most in 2026 (8)
| Year | Studies |
|---|---|
| 2018 | 1 |
| 2019 | 1 |
| 2021 | 4 |
| 2022 | 1 |
| 2023 | 3 |
| 2024 | 2 |
| 2025 | 2 |
| 2026 | 8 |
By phase
A phase 1/2 study counts in both.
- Phase 1
- 3
- Phase 2
- 12
- Phase 3
- 8
- Phase 4
- 1
- No phase
- 1
What it is tested for
Each study’s main condition, where its own words name it.
Who runs them
Industry 19 · Other 3
Gilead Sciences (19) · Duke University (1) · National Institute of Allergy and Infectious Diseases (NIAID) (1) · Oswaldo Cruz Foundation (1)
Often tested with
Tested in the same studies.
Bictegravir (6) · Tenofovir alafenamide (6) · Emtricitabine (5) · Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination (5) · Teropavimab (4) · Zinlirvimab (4) · GS-3242 (3) · Emtricitabine tenofovir alafenamide (1)
Studies
Open first, then newest update. How each study uses lenacapavir is read from its arms, and is right about nine times in ten.
Testing it · 22
- Substudy-01: A Study of Long-Acting HIV-1 Treatments Taken by Mouth in People With HIV-1 With Undetectable Virus LevelsRecruitingPhase 2Gilead SciencesNCT07841990Written as Lenacapavir
- Enhancing PrEP Uptake and Retention Among Latine TGW and GBM in the South Using Long-Acting Injectable PrEPRecruitingPhase 4Duke UniversityNCT07218211Written as Lenacapavir long-acting
- Lenacapavir Intensification to Disrupt HIV Reservoirs in Virologically Suppressed People With HIV Receiving Antiretroviral TherapyRecruitingPhase 1National Institute of Allergy and Infectious Diseases (NIAID)NCT06819176Written as Lenacapavir
- A Study of GS-3242 in Combination With Lenacapavir Versus Biktarvy in Virologically Suppressed People With HIV-1RecruitingPhase 2Gilead SciencesNCT07645287Written as Lenacapavir Tablet
- Study of an Injectable Regimen of GS-3242 With Lenacapavir Compared to Biktarvy in People New to HIV-1 TreatmentRecruitingPhase 2/3Gilead SciencesNCT07708727Written as Lenacapavir Tablet
- Study of Lenacapavir, Teropavimab, and Zinlirvimab Versus Cabotegravir and Rilpivirine in Virologically Suppressed Adults With HIV-1 on Oral Daily Antiretroviral TherapyRecruitingPhase 3Gilead SciencesNCT07682961Written as Lenacapavir
- Study of Lenacapavir, Teropavimab, and Zinlirvimab in Virologically Suppressed Adults With HIV-1 on Stable Oral Treatment RegimensRecruitingPhase 3Gilead SciencesNCT07683000Written as Lenacapavir
- Evaluation of Long-Acting Lenacapavir for the Treatment of HIV-1 in Treatment-experienced Adolescents and ChildrenRecruitingPhase 2Gilead SciencesNCT06749054Written as Oral Lenacapavir
- ImPrEP LEN Brasil: Twice-Yearly Lenacapavir for HIV PreventionRecruitingNot applicableOswaldo Cruz FoundationNCT07497594Written as Lenacapavir long-acting
- Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With a Complicated Regimen (ARTISTRY-1)Active, not recruitingPhase 2/3Gilead SciencesNCT05502341Written as Lenacapavir
- Pre-Exposure Prophylaxis Study of Lenacapavir and Emtricitabine/Tenofovir Alafenamide in Adolescent Girls and Young Women at Risk of HIV InfectionActive, not recruitingPhase 3Gilead SciencesNCT04994509Written as Oral Lenacapavir (LEN)
- Pre-Exposure Prophylaxis Study of Lenacapavir in Cisgender Men, Transgender Women, Transgender Men, and Gender Nonbinary People at Risk for HIV InfectionActive, not recruitingPhase 3Gilead SciencesNCT04925752Written as Oral Lenacapavir (LEN)
- Study of Bictegravir/Lenacapavir in Children and Adolescents With HIV-1Active, not recruitingPhase 2/3Gilead SciencesNCT06532656Written as Lenacapavir
- Study of Lenacapavir as a Once-Yearly Injection for HIV Pre-exposure Prophylaxis (PrEP)Active, not recruitingPhase 3Gilead SciencesNCT07047716Written as Lenacapavir Injection
- Study of Lenacapavir and Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF) in Prevention of HIV in Cisgender Women in the United States (HPTN 102)Active, not recruitingPhase 2Gilead SciencesNCT06101329Written as Lenacapavir Tablet
- Study of Lenacapavir and Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF) for Prevention of HIV in People Who Inject Drugs (HPTN 103)Active, not recruitingPhase 2Gilead SciencesNCT06101342Written as Lenacapavir Injection
- Study of Lenacapavir Taken Twice a Year for HIV Pre-Exposure Prophylaxis (PrEP)Active, not recruitingPhase 2Gilead SciencesNCT06513312Written as Lenacapavir Injection
- A Study of Teropavimab and Zinlirvimab in Combination With Capsid Inhibitor Lenacapavir in Virologically Suppressed Adults With HIV-1 InfectionActive, not recruitingPhase 2Gilead SciencesNCT05729568Written as Lenacapavir Tablet
- Study Evaluating the Safety and Efficacy of Islatravir in Combination With Lenacapavir in Virologically Suppressed People With HIVActive, not recruitingPhase 2Gilead SciencesNCT05052996Written as LEN
- Study to Evaluate the Safety and Efficacy of Teropavimab and Zinlirvimab in Combination With Lenacapavir in Virologically Suppressed Adults With HIV-1 InfectionCompletedPhase 1Gilead SciencesNCT04811040Written as Oral Lenacapavir
See all 22 studies that test lenacapavir →
Given in every arm · 4 — lenacapavir is usual care beside what is tested
- Study to Evaluate the Safety and Efficacy of Lenacapavir (GS-6207) in Combination With an Optimized Background Regimen (OBR) in Heavily Treatment Experienced Participants Living With HIV-1 Infection With Multidrug ResistanceActive, not recruitingPhase 2/3Gilead SciencesNCT04150068Written as Oral Lenacapavir
- Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With BiktarvyActive, not recruitingPhase 3Gilead SciencesNCT06333808Written as Lenacapavir
- Implementation and Deliver of Lenacapavir for PrEP in a Community Pharmacy SettingActive, not recruitingPhase 4Kelley-Ross & Associates, Inc.NCT07210125Written as Lenacapavir long-acting
- A Study to Investigate if Long Acting Cabotegravir (CAB) and Lenacapavir (LEN) Injections Are Tolerable and Acceptable When Administered to Healthy Adults Without HIVActive, not recruitingPhase 1ViiV HealthcareNCT06970223Written as Lenacapavir long-acting
Codes
What other systems call lenacapavir · ClinicalTrials.gg INT002095
- MeSH (NLM) C000730993lenacapavirConfirmed ClinicalTrials.gov, NLM
- UNII (FDA) A9A0O6FB4HLENACAPAVIRConfirmed FDA, NLM, Wikidata
- Wikidata Q105981469lenacapavirConfirmed FDA, NLM, Wikidata
- NCI Thesaurus C174616LenacapavirOne source FDA
- DrugBank DB15673One source Wikidata
| System | Code | Name there | Checked by |
|---|---|---|---|
| MeSH (NLM) | C000730993 | lenacapavir | Confirmed ClinicalTrials.gov, NLM |
| UNII (FDA) | A9A0O6FB4H | LENACAPAVIR | Confirmed FDA, NLM, Wikidata |
| Wikidata | Q105981469 | lenacapavir | Confirmed FDA, NLM, Wikidata |
| NCI Thesaurus | C174616 | Lenacapavir | One source FDA |
| DrugBank | DB15673 | — | One source Wikidata |
Also registered as lenacapavir sodium (UNII BDT58WJ9WE).
“Confirmed” means two independent publishers link the code to this drug; “one source”, one does and its name agrees.