Drugs / Lenacapavir
Lenacapavir
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | SUNLENCA | — | 2024-11-25 | fda.gov ↗ |
| Approved | US (FDA) | SUNLENCA | — | 2022-12-22 | fda.gov ↗ |
| Approved | EU (EMA) | Sunlenca | — | 2022-08-17 | europa.eu ↗ |
Trials 28 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 14 trials | ||||||
| Phase 1 | NCT06819176 | Jan 2026 → Sep 2028 expected | HIV infectious disease | National Institute of Allergy and Infectious Diseases (NIAID) | Recruiting | No outcome recorded |
| Phase 1 | NCT06970223 | Apr → Jul 2025 overdue | HIV infectious disease | ViiV Healthcare | Active not recruiting | No outcome recorded |
| Phase 1 | NCT04811040 | Apr 2021 → Jun 2022 | HIV infectious disease | Gilead Sciences | Completed | No outcome recorded |
| Phase 1 | NCT03739866 | Nov 2018 → Nov 2019 | HIV infectious disease | Gilead Sciences | Completed | No outcome recorded |
| Phase 29 trials | ||||||
| Phase 2 | NCT07645287 | Jun 2026 → Aug 2027 expected | HIV infectious disease | Gilead Sciences | Recruiting | No outcome recorded |
| Phase 2 | NCT06749054 | Mar 2025 → Mar 2027 expected | HIV infectious disease | Gilead Sciences | Recruiting | No outcome recorded |
| Phase 2 | NCT06657885 | Jan 2025 → Jul 2026 | HIV infectious disease | Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba | Withdrawn | No outcome recorded |
| Phase 2 | NCT06513312 | Oct 2024 → May 2026 overdue | — | Gilead Sciences | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06101342 | Dec 2023 → Jan 2028 expected | — | Gilead Sciences | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06101329 | Nov 2023 → Jul 2026 overdue | — | Gilead Sciences | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05729568 | May 2023 → Jul 2024 overdue | HIV infectious disease | Gilead Sciences | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05052996 | Oct 2021 → Dec 2023 overdue | HIV infectious disease | Gilead Sciences | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04143594 | Nov 2019 → Oct 2021 | HIV infectious disease | Gilead Sciences | Completed | No outcome recorded |
| Phase 2/34 trials | ||||||
| Phase 2/3 | NCT07708727 | Jul 2026 → Oct 2030 expected | HIV infectious disease | Gilead Sciences | Not yet recruiting | No outcome recorded |
| Phase 2/3 | NCT06532656 | Nov 2024 → Jul 2030 expected | HIV infectious disease | Gilead Sciences | Active not recruiting | No outcome recorded |
| Phase 2/3 | NCT05502341 | Aug 2022 → Sep 2025 overdue | HIV infectious disease | Gilead Sciences | Active not recruiting | No outcome recorded |
| Phase 2/3 | NCT04150068 | Nov 2019 → Oct 2020 overdue | HIV infectious disease | Gilead Sciences | Active not recruiting | No outcome recorded |
| Phase 38 trials | ||||||
| Phase 3 | NCT07682961 | Jul 2026 → Mar 2029 expected | HIV infectious disease | Gilead Sciences | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07683000 | Jul 2026 → Mar 2029 expected | HIV infectious disease | Gilead Sciences | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07047716 | Jul 2025 → Sep 2028 expected | — | Gilead Sciences | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06630286 | Oct 2024 → Apr 2026 overdue | HIV infectious disease | Gilead Sciences | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06630299 | Oct 2024 → Apr 2026 overdue | HIV infectious disease | Gilead Sciences | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06333808 | Mar 2024 → Oct 2025 overdue | HIV infectious disease | Gilead Sciences | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04994509 | Aug 2021 → May 2024 overdue | — | Gilead Sciences | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04925752 | Jun 2021 → Aug 2024 overdue | — | Gilead Sciences | Active not recruiting | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT07218211 | Jan 2026 → Jan 2027 expected | — | Duke University | Recruiting | No outcome recorded |
| Phase 4 | NCT07210125 | Sep 2025 → Mar 2027 expected | HIV infectious disease | Kelley-Ross & Associates, Inc. | Active not recruiting | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT07497594 | Feb 2026 → Feb 2029 expected | — | Oswaldo Cruz Foundation | Recruiting | No outcome recorded |
Press releases naming this drug 50 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-07-21 | Gilead Sciences | Investigational Once-Weekly Oral HIV Treatment Regimen of Islatravir and Lenacapavir Maintained Virological Suppression in Adults With HIV Who Switched Antiretroviral Therapy gilead.com ↗ |
| 2026-06-08 | Gilead Sciences | Gilead and Merck Announce Positive Topline Results From Two Phase 3 Studies Evaluating Islatravir/Lenacapavir, an Oral Once-Weekly HIV Treatment gilead.com ↗ |
| 2026-06-05 | Gilead Sciences | Gilead Applauds Collaborative Efforts to Launch Lenacapavir for HIV Prevention in South Africa gilead.com ↗ |
| 2026-04-29 | Gilead Sciences | U.S. FDA Grants Priority Review of New Drug Application for Gilead’s Once-Daily HIV Treatment of Bictegravir Plus Lenacapavir gilead.com ↗ |
| 2026-04-14 | Gilead Sciences | PEPFAR and The Global Fund Make Additional Investment in Gilead’s Lenacapavir for HIV Prevention to Further Expand Access gilead.com ↗ |
| 2026-02-25 | Gilead Sciences | Gilead’s Single-Tablet Regimen of Bictegravir and Lenacapavir Maintained Virological Suppression in People With HIV Who Switched Antiretroviral Therapy gilead.com ↗ |
| 2025-12-15 | Gilead Sciences | Gilead’s Investigational Single-Tablet Regimen of Bictegravir and Lenacapavir for HIV Treatment Meets Primary Endpoint in Phase 3 ARTISTRY-2 Trial gilead.com ↗ |
| 2025-11-18 | Gilead Sciences | Gilead Joins Partners for Delivery of First Shipments of Breakthrough Twice-yearly Lenacapavir for HIV Prevention to Sub-Saharan Africa gilead.com ↗ |
| 2025-11-13 | Gilead Sciences | Gilead’s Investigational Single-Tablet Regimen of Bictegravir and Lenacapavir for HIV-1 Treatment Meets Primary Endpoint in Phase 3 ARTISTRY-1 Trial gilead.com ↗ |
| 2025-10-31 | Gilead Sciences | Gilead Sciences Wins Prestigious 2025 Prix Galien USA Award for Best Pharmaceutical Product With Yeztugo® (Lenacapavir) gilead.com ↗ |
| 2025-09-04 | Gilead Sciences | Gilead Announces Partnership With PEPFAR to Deliver Twice-Yearly Lenacapavir for HIV Prevention for up to Two Million People in Primarily Low- and Lower-Middle-Income Countries gilead.com ↗ |
| 2025-08-26 | Gilead Sciences | European Commission Authorizes Twice-Yearly Yeytuo® (Lenacapavir) for HIV Prevention gilead.com ↗ |
| 2025-07-25 | Gilead Sciences | Gilead Receives Positive CHMP Opinions Under Accelerated Review From European Medicines Agency for Twice-Yearly Lenacapavir for HIV Prevention gilead.com ↗ |
| 2025-07-14 | Gilead Sciences | Gilead Presents New Data on Twice-Yearly Lenacapavir (Yeztugo®) for HIV Prevention at IAS 2025 gilead.com ↗ |
| 2025-07-09 | Gilead Sciences | Gilead Finalizes Agreement With the Global Fund to Accelerate Access to Twice-Yearly Lenacapavir for HIV Prevention for up to Two Million People in Primarily Low- and Lower-Middle-Income Countries gilead.com ↗ |
| 2025-06-18 | Gilead Sciences | Yeztugo® (Lenacapavir) Is Now the First and Only FDA-Approved HIV Prevention Option Offering 6 Months of Protection gilead.com ↗ |
| 2025-03-11 | Gilead Sciences | First Clinical Data for Gilead’s Investigational Once-Yearly Lenacapavir for HIV Prevention Presented at CROI 2025 and Published in The Lancet gilead.com ↗ |
| 2025-02-24 | Gilead Sciences | European Medicines Agency Validates Gilead’s Marketing Authorization Application and EU-Medicines for All Application for Twice-Yearly Lenacapavir for HIV Prevention gilead.com ↗ |
| 2025-02-18 | Gilead Sciences | U.S. FDA Accepts Gilead’s New Drug Applications for Twice-Yearly Lenacapavir for HIV Prevention Under Priority Review gilead.com ↗ |
| 2024-11-13 | Gilead Sciences | Gilead Presents Full PURPOSE 2 Data Results for Twice-Yearly Lenacapavir for HIV Prevention at HIV Glasgow gilead.com ↗ |
| 2024-10-19 | Gilead Sciences | Gilead and Merck Announce Phase 2 Data Showing a Treatment Switch to an Investigational Oral Once-Weekly Combination Regimen of Islatravir and Lenacapavir Maintained Viral Suppression in Adults at Week 48 gilead.com ↗ |
| 2024-10-02 | Gilead Sciences | Gilead Signs Royalty-Free Voluntary Licensing Agreements with Six Generic Manufacturers to Increase Access to Lenacapavir for HIV Prevention in High-Incidence, Resource-Limited Countries gilead.com ↗ |
| 2024-09-12 | Gilead Sciences | Gilead’s Twice-Yearly Lenacapavir for HIV Prevention Reduced HIV Infections by 96% and Demonstrated Superiority to Daily Truvada® in Second Pivotal Phase 3 Trial gilead.com ↗ |
| 2024-07-24 | Gilead Sciences | Full Efficacy and Safety Results for Gilead Investigational Twice-Yearly Lenacapavir for HIV Prevention Presented at AIDS 2024 gilead.com ↗ |
| 2024-06-20 | Gilead Sciences | Gilead’s Twice-Yearly Lenacapavir Demonstrated 100% Efficacy and Superiority to Daily Truvada® for HIV Prevention gilead.com ↗ |
| 2024-03-06 | Gilead Sciences | Gilead and Merck Announce Phase 2 Data Showing an Investigational Oral Once-Weekly Combination Regimen of Islatravir and Lenacapavir Maintained Viral Suppression at Week 24 gilead.com ↗ |
| 2023-10-20 | Gilead Sciences | New Data Presented at EACS 2023 Further Demonstrate Strong Clinical Profile of Twice-Yearly Sunlenca® for Adults With Multi-Drug Resistant HIV gilead.com ↗ |
| 2023-10-18 | Gilead Sciences | Gilead Sciences Announces New Clinical Trial in Europe to Assess Lenacapavir for HIV Prevention as Part of Landmark Purpose Program gilead.com ↗ |
| 2023-07-24 | Gilead Sciences | Twice-Yearly Lenacapavir Demonstrates Sustained Impact on Health-Related Quality of Life in People With HIV gilead.com ↗ |
| 2023-02-22 | Gilead Sciences | Gilead Presents Positive Proof-of-Concept Data for Investigational Combination Regimen of Lenacapavir with Broadly Neutralizing Antibodies as a Potential Twice-Yearly Approach for the Treatment of HIV gilead.com ↗ |
| 2022-12-22 | Gilead Sciences | Sunlenca® (lenacapavir) Receives FDA Approval as a First-in-Class, Twice-Yearly Treatment Option for People Living With Multi-Drug Resistant HIV gilead.com ↗ |
| 2022-08-22 | Gilead Sciences | Gilead Announces First Global Regulatory Approval of Sunlenca® (Lenacapavir), the Only Twice-Yearly HIV Treatment Option gilead.com ↗ |
| 2022-06-27 | Gilead Sciences | Gilead Resubmits New Drug Application to U.S. Food and Drug Administration for Lenacapavir, an Investigational, Long-Acting HIV-1 Capsid Inhibitor gilead.com ↗ |
| 2022-06-24 | Gilead Sciences | Investigational Lenacapavir Receives Positive CHMP Opinion for People With Multi-Drug Resistant HIV gilead.com ↗ |
| 2022-05-16 | Gilead Sciences | FDA Lifts Clinical Hold on Investigational Lenacapavir for the Treatment and Prevention of HIV gilead.com ↗ |
| 2022-03-01 | Gilead Sciences | Gilead Receives Complete Response Letter From U.S. FDA for Investigational Lenacapavir Due to Vial Compatibility Issues gilead.com ↗ |
| 2022-02-16 | Gilead Sciences | New Clinical Data Support the Sustained Efficacy of Long-acting Lenacapavir, Gilead’s Investigational HIV-1 Capsid Inhibitor gilead.com ↗ |
| 2021-12-21 | Gilead Sciences | Gilead Announces Clinical Hold on Studies Evaluating Injectable Lenacapavir for HIV Treatment and Prevention Due to Vial Quality Concerns gilead.com ↗ |
| 2021-10-26 | Gilead Sciences | Gilead and Merck Initiate Phase 2 Study Evaluating an Oral Weekly Combination Regimen of Investigational Lenacapavir and Investigational Islatravir for HIV-1 Treatment in Virologically Suppressed Adults gilead.com ↗ |
| 2021-08-19 | Gilead Sciences | European Medicines Agency Validates Gilead’s Marketing Authorization Application for Lenacapavir, an Investigational, Long-Acting Capsid Inhibitor for the Treatment of HIV-1 in People With Limited Therapy Options gilead.com ↗ |
| 2021-07-17 | Gilead Sciences | New Phase 3 Data Support the Sustained, Long-Acting Efficacy of Lenacapavir, Gilead's Investigational HIV-1 Capsid Inhibitor gilead.com ↗ |
| 2021-06-28 | Gilead Sciences | Gilead Submits New Drug Application to U.S. Food and Drug Administration for Lenacapavir, an Investigational, Long-Acting Capsid Inhibitor for the Treatment of HIV-1 in People With Limited Therapy Options gilead.com ↗ |
| 2021-03-15 | Gilead Sciences | Gilead and Merck Announce Agreement to Jointly Develop and Commercialize Long-Acting, Investigational Treatment Combinations of Lenacapavir and Islatravir in HIV gilead.com ↗ |
| 2021-03-09 | Gilead Sciences | Gilead’s Investigational Lenacapavir Demonstrates Sustained Long-Acting Efficacy Through Week 26 in Data Presented at CROI gilead.com ↗ |
| 2020-11-18 | Gilead Sciences | Gilead Announces Investigational Long-Acting HIV-1 Capsid Inhibitor, Lenacapavir, Achieves Primary Endpoint in Phase 2/3 Study in Heavily Treatment-Experienced People Living With HIV gilead.com ↗ |
| 2020-07-04 | Gilead Sciences | Gilead Sciences Presents Data Supporting a Potential Six-Month Dosing Interval for Investigational HIV-1 Capsid Inhibitor Lenacapavir (GS-6207) gilead.com ↗ |
| 2020-03-11 | Gilead Sciences | New Clinical Study Data for Gilead’s Investigational HIV-1 Capsid Inhibitor GS-6207 Presented at CROI 2020 gilead.com ↗ |
| 2019-11-08 | Gilead Sciences | Gilead Presents Data on Investigational HIV-1 Capsid Inhibitor GS-6207 as a Potential Component of Long-Acting HIV Therapy gilead.com ↗ |
| 2019-07-22 | Gilead Sciences | Gilead Presents Proof-of-Concept Data for GS-6207, a First-in-Class Capsid Inhibitor, in People Living With HIV gilead.com ↗ |
| 2019-03-07 | Gilead Sciences | Gilead Announces Data From Two Studies Supporting Further Development of GS-6207, a Novel, Investigational HIV-1 Capsid Inhibitor as a Component of Future Long-Acting HIV Therapies gilead.com ↗ |
Evidence & citations 15 cited values
Every value below carries the sentence it was read from. 30 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Lenacapavir | “The goal of this clinical study is to learn about the safety and efficacy of switching to once weekly tablet of islatravir/lenacapavir (ISL/LEN) regimen versus continuing...” NCT06630286 ↗27“Once-weekly oral islatravir plus lenacapavir (ISL+LEN) has the potential to address adherence challenges with daily HIV-1 treatment.” PMID 41429026 ↗ Dec 2025 “The experimental drugs used in this study are cabotegravir, marketed as Vocabria®, and lenacapavir, marketed as Sunlenca®.” NCT06657885 ↗ “islatravir/lenacapavir (ISL/LEN) regimen” NCT06630299 ↗ |
| Known as | GS-6207 | “lenacapavir (formerly GS-6207)” NCT04143594 ↗ |
| Known as | GS-6207-02 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4594438 ↗ |
| Known as | GS-714207 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4594438 ↗ |
| Known as | GS-CA-2 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4594438 ↗ |
| Known as | GS-CA1 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4594438 ↗ |
| Known as | GS-HIV | ChEMBL registry synonym — accepted as the source's own label CHEMBL4594438 ↗ |
| Known as | GS-HIV Na | ChEMBL registry synonym — accepted as the source's own label CHEMBL4594438 ↗ |
| Known as | GS-HIV SODIUM | ChEMBL registry synonym — accepted as the source's own label CHEMBL4594438 ↗ |
| Known as | LEN | “The goal of this clinical study is to learn about the safety and tolerability of bictegravir/lenacapavir (BIC/LEN) and to learn how the study drug interacts with the body in...” NCT06532656 ↗9“Once-weekly oral islatravir plus lenacapavir (ISL+LEN) has the potential to address adherence challenges with daily HIV-1 treatment.” PMID 41429026 ↗ Dec 2025 “The goal of this clinical study is to learn more about the study drug, lenacapavir (LEN).” NCT06749054 ↗ “study drug lenacapavir (LEN), safety, tolerability, and pharmacokinetics” NCT07047716 ↗ “Phase 2: Bictegravir (BIC) 75 mg + Lenacapavir (LEN) 25 mg” NCT05502341 ↗ “the HIV capsid inhibitor lenacapavir (LEN)” NCT04811040 ↗ “islatravir/lenacapavir (ISL/LEN) regimen” NCT06630299 ↗ “study drug lenacapavir (LEN)” NCT06513312 ↗ “Oral Lenacapavir (LEN)” NCT04925752 ↗ “Oral Lenacapavir (LEN)” NCT04994509 ↗ |
| Known as | LENACAPAVIR SODIUM | ChEMBL registry synonym — accepted as the source's own label CHEMBL4594438 ↗ |
| Known as | Sunlenca | “Lenacapavir (Sunlenca) is a prescription drug approved by the Food and Drug Administration (FDA) for the treatment of people living with multidrug-resistant HIV.” NCT06819176 ↗1“The experimental drugs used in this study are cabotegravir, marketed as Vocabria®, and lenacapavir, marketed as Sunlenca®.” NCT06657885 ↗ |
| Action | Inhibit | “where it interferes with capsid-protein-mediated interactions between proteins that are essential for multiple phases of the viral replication cycle.” PMID 32612233 ↗ Jul 2020 |
| Modality | Small molecule | — CHEMBL4594438 ↗ |
| Route | Subcutaneous | “Administered subcutaneously in the abdomen” NCT03739866 ↗ |