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Compound · clinical trials

Lenacapavir clinical trials

Source: ClinicalTrials.gov, U.S. National Library of Medicine — the 16 trials in our USA and UK registers that name Lenacapavir as an intervention. Synced 25 Sep 2026
16Current trials
6Recruiting now
1Lead sponsor
2Country registers
Maintained by Sreepriya Prasannan
MSc Digital Transformation of Life Sciences (Innopharma Education / Griffith College); MSc & BSc Botany HSE Spark Ignite 2026 โ€” Top 14 finalist
Compiled from ClinicalTrials.gov registry records ยท Last verified ยท Editorial standards
At a glance

Lenacapavir is named as an intervention in 16 current clinical trials in our USA and UK registers. 6 are recruiting patients now. The most common phase is Phase 2. The lead sponsor is Gilead Sciences. The most-studied condition is HIV-1-infection.

Trials by status

  • Recruiting638%
  • Active, closed1063%

Trials by phase

  • Phase 2638%
  • Phase 3531%
  • Phase 2/3425%
  • Observational16%
01

Clinical trials of Lenacapavir

16 trials
StudyPhaseStatusLead sponsorRegisters
Study of Lenacapavir, Teropavimab, and Zinlirvimab Versus Cabotegravir and Rilpivirine in Virologically Suppressed Adults With HIV-1 on Oral Daily Antiretroviral Therapy
NCT07682961 · ClinicalTrials.gov ↗ · HIV Infections
Phase 3 Recruiting Gilead Sciences USA
Study of Lenacapavir, Teropavimab, and Zinlirvimab in Virologically Suppressed Adults With HIV-1 on Stable Oral Treatment Regimens
NCT07683000 · ClinicalTrials.gov ↗ · HIV-1-infection
Phase 3 Recruiting Gilead Sciences USA
Study of an Injectable Regimen of GS-3242 With Lenacapavir Compared to Biktarvy in People New to HIV-1 Treatment
NCT07708727 · ClinicalTrials.gov ↗ · HIV-1-infection
Phase 2/3 Recruiting Gilead Sciences USA
Evaluation of Long-Acting Lenacapavir for the Treatment of HIV-1 in Treatment-experienced Adolescents and Children
NCT06749054 · ClinicalTrials.gov ↗ · HIV-1-infection
Phase 2 Recruiting Gilead Sciences USA
A Study of GS-3242 in Combination With Lenacapavir Versus Biktarvy in Virologically Suppressed People With HIV-1
NCT07645287 · HIV-1-infection
Phase 2 Recruiting Gilead Sciences USA
Implementation Study of Lenacapavir Pre-exposure Prophylaxis for HIV Prevention
NCT07473778 · HIV Infections
Observational Recruiting Gilead Sciences USA
Study of Lenacapavir for HIV Pre-Exposure Prophylaxis in People Who Are at Risk for HIV Infection
NCT04925752 · ClinicalTrials.gov ↗ · Pre-Exposure Prophylaxis of HIV Infection
Phase 3 Active, closed Gilead Sciences USA
Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With Biktarvy
NCT06333808 · HIV-1-infection
Phase 3 Active, closed Gilead Sciences UK, USA
Study of Lenacapavir as a Once-Yearly Injection for HIV Pre-exposure Prophylaxis (PrEP)
NCT07047716 · ClinicalTrials.gov ↗ · HIV Pre-exposure Prophylaxis
Phase 3 Active, closed Gilead Sciences USA
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 Resistance
NCT04150068 · ClinicalTrials.gov ↗ · HIV-1-infection
Phase 2/3 Active, closed Gilead Sciences USA
Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With a Complicated Regimen
NCT05502341 · ClinicalTrials.gov ↗ · HIV-1-infection
Phase 2/3 Active, closed Gilead Sciences UK, USA
Study of Bictegravir/Lenacapavir in Children and Adolescents With HIV-1
NCT06532656 · ClinicalTrials.gov ↗ · HIV-1-infection
Phase 2/3 Active, closed Gilead Sciences USA
A Study of Teropavimab and Zinlirvimab in Combination With Capsid Inhibitor Lenacapavir in Virologically Suppressed Adults With HIV-1 Infection
NCT05729568 · ClinicalTrials.gov ↗ · HIV-1 Infection
Phase 2 Active, closed Gilead Sciences USA
Study of Lenacapavir and Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF) in Prevention of HIV in Cisgender Women in the United States (HPTN 102)
NCT06101329 · ClinicalTrials.gov ↗ · Pre-Exposure Prophylaxis of HIV Infection
Phase 2 Active, closed Gilead Sciences USA
Study of Lenacapavir and Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF) for Prevention of HIV in People Who Inject Drugs (HPTN 103)
NCT06101342 · Pre-Exposure Prophylaxis of HIV Infection
Phase 2 Active, closed Gilead Sciences USA
Study of Lenacapavir Taken Twice a Year for HIV Pre-Exposure Prophylaxis (PrEP)
NCT06513312 · Pre-Exposure Prophylaxis of HIV Infection
Phase 2 Active, closed Gilead Sciences UK

Registers list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.

02

Conditions studied with Lenacapavir

5 conditions
HIV-1-infection8Pre-Exposure Prophylaxis of HIV Infection4HIV Infections2HIV-1 Infection1HIV Pre-exposure Prophylaxis1
03

Sponsors

lead sponsor per trial
Lead sponsorTrials
Gilead Sciences16
04

By country register

RegisterTrialsRecruiting
Clinical trials in USA156
Clinical trials in UK30

A trial with sites in more than one country appears in each of those registers.

05

Related compounds

06

Questions about Lenacapavir trials

How many clinical trials are testing Lenacapavir?

16 current trials in our USA and UK registers name Lenacapavir as a drug or biological intervention, as of the registry sync on 25 September 2026. Completed and withdrawn studies are not counted.

Are Lenacapavir trials recruiting patients?

Yes. 6 of the 16 trials are recruiting: 6 with sites in USA. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.

Who sponsors Lenacapavir clinical trials?

The lead sponsor is Gilead Sciences. The number in brackets is how many trials each organisation leads.

Where does this information come from?

Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Lenacapavir works or whether it is effective, and it is not medical advice.

How this page is built

Everything on this page is copied from public ClinicalTrials.gov registry records โ€” it is not written from memory, and nothing here describes how Lenacapavir works or whether it is effective. Each trial links to its own record so you can check it yourself.

This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Lenacapavir (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 25 Sep 2026.

Please verify before you rely on this. This page is general information for life-science and pharmaceutical professionals. It is not medical advice, and it has not been reviewed by a clinician โ€” our editorial team holds life-science qualifications, not clinical ones. It is not exhaustive and may not reflect the most recent label change. Always check the official prescribing information (US Prescribing Information or EU SmPC) and speak to your doctor or pharmacist before acting on anything here. Drugs in the same class are not automatically interchangeable, and approvals, brand names and indications differ between the US, the EU/Ireland (EMA/HPRA) and other regions. Spotted an error? Tell us โ€” we correct promptly and log it.