Drugs / Lenacapavir
Lenacapavir
Regulatory milestones approvals, filings & regulatory actions · 14 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed HIV infectious disease 5 milestones | |||||
| Filed | US (FDA) | — | HIV infectious disease | 2026-04-29 | “accepted its New Drug Application (NDA) submission for bictegravir 75 mg/lenacapavir 50 mg (BIC/LEN)” gilead.com ↗ |
| Filed | US (FDA) | — | HIV infectious disease | 2022-06-27 | “today announced the resubmission of the New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for lenacapavir” gilead.com ↗ |
| Rejected (CRL) | US (FDA) | — | HIV infectious disease | 2022-03-01 | “today announced the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) for the New Drug Application (NDA) for lenacapavir” gilead.com ↗ “Received a Complete Response Letter from FDA related to vial compatibility issues for the New Drug Application of investigational lenacapavir” gilead.com ↗ |
| Filed | EU (EMA) | — | HIV infectious disease | 2021-08-19 | “Marketing Authorization Application (MAA) for lenacapavir, an investigational, long-acting HIV-1 capsid inhibitor, has been fully validated and is now under evaluation with the...” gilead.com ↗ “Gilead also submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for lenacapavir as a potential treatment for HIV-1 infection” gilead.com ↗ |
| Filed | US (FDA) | — | HIV infectious disease | 2021-06-28 | “Gilead filed a New Drug Application to FDA seeking approval of lenacapavir for the treatment of HIV-1 infection” gilead.com ↗ |
| Approved Indication not stated 9 milestones | |||||
| Filed | US (FDA) | Yeztugo | HIV pre-exposure prophylaxis | 2026-08-04 | “FDA accepted a supplemental New Drug Application submission for Yeztugo® (lenacapavir) 300-mg tablets as a potential once-weekly oral formulation for HIV pre-exposure...” gilead.com ↗ |
| Filed | US (FDA) | Yeztugo | HIV prevention | 2026-06-15 | “accepted its supplemental New Drug Application (sNDA) for Yeztugo ® (lenacapavir) 300-mg tablet” gilead.com ↗ |
| Filed | Other | — | HIV prevention | 2025-06-18 | “Gilead has also filed for regulatory approval for twice-yearly lenacapavir for PrEP with authorities in Australia, Brazil , Canada, South Africa and Switzerland.” gilead.com ↗ “Gilead has also filed for regulatory approval for twice-yearly lenacapavir for PrEP with authorities in Australia, Brazil , Canada and South Africa” gilead.com ↗ “Gilead has also filed for regulatory approval for twice-yearly lenacapavir for PrEP with authorities in Australia, Brazil , Canada” gilead.com ↗ “Gilead has also filed for regulatory approval for twice-yearly lenacapavir for PrEP with authorities in Australia, Brazil” gilead.com ↗ “Gilead has also filed for regulatory approval for twice-yearly lenacapavir for PrEP with authorities in Australia” gilead.com ↗ |
| Filed | EU (EMA) | — | HIV prevention | 2025-02-11 | “a marketing authorization application and an EU-Medicines for All application to the European Medicines Agency (“EMA”)” gilead.com ↗ |
| Filed | US (FDA) | — | HIV prevention | 2025-02-11 | “today announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) submissions for lenacapavir” gilead.com ↗ “Completed the New Drug Application submissions to U.S. Food and Drug Administration (“FDA”)” gilead.com ↗ |
| 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 ↗ |
| Clinical hold | US (FDA) | — | HIV treatment, HIV pre-exposure prophylaxis | 2021-12-21 | “the U.S. Food and Drug Administration (FDA) has placed a clinical hold on the use of injectable lenacapavir in borosilicate vials” gilead.com ↗ “the FDA had placed a clinical hold on the use of injectable lenacapavir in borosilicate vials due to a vial compatibility issue.” gilead.com ↗ |
Trials 29
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 14 trials · 1 met primary | ||||||
| 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 | Met primary |
| Phase 210 trials · 1 missed | ||||||
| Phase 2 | NCT07841990 | Sep 2026 → Aug 2027 expected | HIV infectious disease | Gilead Sciences | Not yet recruiting | No outcome recorded |
| 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 | Missed primary |
| Phase 2/34 trials · 2 met primary | ||||||
| Phase 2/3 | NCT07708727 | Jul 2026 → Oct 2030 expected | HIV infectious disease | Gilead Sciences | 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 | Met primary |
| Phase 2/3 | NCT04150068 | Nov 2019 → Oct 2020 overdue | HIV infectious disease | Gilead Sciences | Active not recruiting | Met primary |
| Phase 38 trials · 4 met primary | ||||||
| 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 | Met primary |
| Phase 3 | NCT06630299 | Oct 2024 → Apr 2026 overdue | HIV infectious disease | Gilead Sciences | Active not recruiting | Met primary |
| Phase 3 | NCT06333808 | Mar 2024 → Oct 2025 overdue | HIV infectious disease | Gilead Sciences | Active not recruiting | Met primary |
| 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 | Met primary |
| 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 |
News releases announcing trial results or a regulatory action · 51
| Date | Issuer | Release |
|---|---|---|
| 2026-08-27 | Gilead Sciences | Regulatory U.S. FDA Approves Gilead’s Bixlenvo™, a New Once-Daily Single Tablet Option for Virologically Suppressed Adults With HIV, Including Those on Complex Regimens gilead.com ↗ |
| 2026-08-05 | MSD R&D (China) Co., Ltd. | Results 週1回経口投与のHIV治療薬として開発中のイスラトラビル／レナカパビル配合剤、抗レトロウイルス療法から切り替えた成人HIV陽性者においてウイルス学的抑制を維持 msd.co.jp ↗
主要評価項目である48週時点の結果では、週1回経口投与のHIV治療薬として開発中のイスラトラビル2 mg／レナカパビル300 mg（ISL/LEN）配合錠は、世界の主要なガイドラインで推奨されるBIKTARVY®（ビクテグラビル50 mg／エムトリシタビン200 mg／テノホビルアラフェナミド25 mg配合錠、B/F/TAF）（ISLEND-1試験）またはその他の標準治療で毎日経口投与する抗レトロウイルス療法（ISLEND-2試験）から切り替えたウイルス学的抑制が得られている成人HIV陽性者において、有効性が示されました。 |
| 2026-08-04 | Merck Sharp & Dohme LLC | Results Merck & Co., Inc., Rahway, N.J., USA Announces Second-Quarter 2026 Financial Results; Highlights Key Regulatory and Clinical Milestones Across Broad, Diverse Pipeline merck.com ↗
In collaboration with Gilead, presented first Phase 3 results for islatravir/lenacapavir (ISL/LEN), an investigational oral once-weekly single-tablet HIV treatment regimen, which maintained virological suppression in adults with HIV who switched antiretroviral therapy. |
| 2026-07-29 | ViiV Healthcare | Results CABENUVA DEMONSTRATES SUPERIORITY TO DAILY ORAL THERAPY IN ADOLESCENTS LIVING WITH HIV, AS ViiV HEALTHCARE HIGHLIGHTS NEW LONG-ACTING INJECTABLE DATA AT AIDS 2026 viivhealthcare.com ↗
Six-month follow-up CLARITY data further reinforce a more favourable injection experience with long-acting cabotegravir compared with lenacapavir after a single dose; |
| 2026-07-21 | Gilead Sciences | Results Investigational Once-Weekly Oral HIV Treatment Regimen of Islatravir and Lenacapavir Maintained Virological Suppression in Adults With HIV Who Switched Antiretroviral Therapy gilead.com ↗
High Rates of Virologic Suppression Sustained at Week 48 Across ISL/LEN Treatment Groups in Both Phase 3 ISLEND Trials |
| 2026-06-15 | Gilead Sciences | Regulatory U.S. FDA Accepts Gilead’s Application for Investigational Once-Weekly Oral Yeztugo, Potentially the First Long-Acting Pill for HIV Prevention gilead.com ↗
Gilead Sciences, Inc. (Nasdaq: GILD) today announced the U.S. Food and Drug Administration (FDA) accepted its supplemental New Drug Application (sNDA) for Yeztugo ® (lenacapavir) 300-mg tablet as a potential once-weekly (QW) oral formulation for the prevention of HIV as pre-exposure prophylaxis (PrEP). |
| 2026-04-29 | Gilead Sciences | Regulatory U.S. FDA Grants Priority Review of New Drug Application for Gilead’s Once-Daily HIV Treatment of Bictegravir Plus Lenacapavir gilead.com ↗
The FDA has granted priority review of the application and assigned a Prescription Drug User Fee Act (PDUFA) action date of August 27, 2026. |
| 2025-10-19 | Gilead Sciences | Results Gilead to Spotlight New Virology Data Across HIV, Viral Hepatitis and Respiratory Diseases at IDWeek 2025 gilead.com ↗
In a 12-week interim analysis of the Phase 4 EMPOWER study ( NCT06104306 ), individuals who switched from IM CAB+RPV to once-daily Biktarvy maintained viral suppression with no treatment-related serious adverse events and reported an increase in treatment satisfaction scores, citing higher satisfaction with side effects of their treatment. |
| 2025-10-15 | Gilead Sciences | Results Gilead Presents New HIV Research Data at EACS 2025 – Driving Scientific Innovation in Treatment and Prevention gilead.com ↗
In the group of BICSTaR study participants with 5 years of real-world follow-up, Biktarvy continued to demonstrate sustained viral suppression, a favorable safety and tolerability profile, and a high barrier to resistance. |
| 2025-10-15 | ViiV Healthcare | Results ViiV HEALTHCARE’S CLARITY STUDY SHOWS LONG-ACTING CABOTEGRAVIR MORE ACCEPTABLE THAN LENACAPAVIR INJECTIONS AFTER A SINGLE DOSE, WITH 90% PREFERRING CABOTEGRAVIR viivhealthcare.com ↗ |
| 2025-08-26 | Gilead Sciences | Regulatory European Commission Authorizes Twice-Yearly Yeytuo® (Lenacapavir) for HIV Prevention gilead.com ↗
Yeytuo is the first and only twice-yearly PrEP option to be approved for use in the European Union’s 27 member states, as well as Norway, Iceland and Liechtenstein. |
| 2025-07-25 | Gilead Sciences | Regulatory Gilead Receives Positive CHMP Opinions Under Accelerated Review From European Medicines Agency for Twice-Yearly Lenacapavir for HIV Prevention gilead.com ↗
The CHMP also adopted a positive EU-Medicines for all (EU-M4all) opinion, which enables a streamlined assessment for World Health Organization (WHO) prequalification and will facilitate national regulatory evaluations in low- and lower-middle-income countries (LLMICs). |
| 2025-07-14 | Gilead Sciences | Results Gilead Presents New Data on Twice-Yearly Lenacapavir (Yeztugo®) for HIV Prevention at IAS 2025 gilead.com ↗
Yeztugo was efficacious in people aged 16-25 years, with zero reported HIV infections in young people receiving Yeztugo in PURPOSE 1 and two HIV infections among young people in PURPOSE 2. |
| 2025-06-18 | Gilead Sciences | Regulatory Yeztugo® (Lenacapavir) Is Now the First and Only FDA-Approved HIV Prevention Option Offering 6 Months of Protection gilead.com ↗
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has approved Yeztugo ® (lenacapavir)—the company’s injectable HIV-1 capsid inhibitor—as pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV in adults and adolescents weighing at least 35kg, making it the first and only twice-yearly option available in the United States for people who need or want PrEP. |
| 2025-03-12 | Gilead Sciences | Results Gilead Presents New HIV Treatment and Cure Research Data at CROI 2025, Including an Investigational Long-Acting, Twice-Yearly Therapy Option gilead.com ↗
At CROI 2025, the primary results of a Phase 2 study evaluating the investigational combination of LTZ were presented during an oral session and featured in the press program; those data announced at CROI confirm previously presented Phase 1b results. |
| 2025-03-11 | Gilead Sciences | Results First Clinical Data for Gilead’s Investigational Once-Yearly Lenacapavir for HIV Prevention Presented at CROI 2025 and Published in The Lancet gilead.com ↗
Gilead Sciences, Inc. (Nasdaq: GILD) today presented the first data from its ongoing Phase 1 study investigating two novel, once-yearly formulations of lenacapavir, the company’s injectable HIV-1 capsid inhibitor, for the investigational use of HIV prevention as pre-exposure prophylaxis (PrEP). |
| 2025-02-24 | Gilead Sciences | Regulatory European Medicines Agency Validates Gilead’s Marketing Authorization Application and EU-Medicines for All Application for Twice-Yearly Lenacapavir for HIV Prevention gilead.com ↗
The EU MAA will be reviewed by the CHMP under the centralized licensing procedure for all 27 Member States of the European Union, as well as Norway, Iceland and Liechtenstein. |
| 2025-02-18 | Gilead Sciences | Regulatory U.S. FDA Accepts Gilead’s New Drug Applications for Twice-Yearly Lenacapavir for HIV Prevention Under Priority Review gilead.com ↗
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) submissions for lenacapavir—the company’s twice-yearly injectable HIV-1 capsid inhibitor—for the prevention of HIV as pre-exposure prophylaxis (PrEP). |
| 2024-11-27 | Gilead Sciences | Results Gilead Announces New England Journal of Medicine Publication of PURPOSE 2 Results gilead.com ↗
The study found that twice-yearly lenacapavir for pre-exposure prophylaxis (PrEP) was highly efficacious at reducing HIV infections, reducing them by 96% compared to background HIV incidence. |
| 2024-11-13 | Gilead Sciences | Results Gilead Presents Full PURPOSE 2 Data Results for Twice-Yearly Lenacapavir for HIV Prevention at HIV Glasgow gilead.com ↗
Gilead Sciences, Inc. (Nasdaq: GILD) today presented the first in-depth look at full results from its pivotal Phase 3 PURPOSE 2 trial ( NCT04925752 ), which is studying twice-yearly lenacapavir, the company’s injectable HIV-1 capsid inhibitor, for the investigational use of HIV prevention among a broad and geographically diverse range of cisgender men and gender-diverse people. |
| 2024-11-12 | Gilead Sciences | Results Scientific Leadership Spotlighted as Gilead Presents Research Data Across Its Broad and Innovative HIV Treatment Portfolio and Pipeline gilead.com ↗
At Week 26, 21% (n=3) of participants who received LEN + TAB and the low dose of ZAB and 0% (n=0) participants who received LEN +TAB and the high dose of ZAB had an HIV viral load ≥50 copies/mL (per FDA Snapshot). |
| 2024-10-19 | Merck Sharp & Dohme LLC | Results 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 merck.com ↗
At 48 weeks, the novel investigational combination maintained a high rate (n=49; 94.2%) of viral suppression (HIV-1 RNA <50 copies/mL) in virologically suppressed adults, a secondary endpoint of the study. |
| 2024-10-19 | Gilead Sciences | Results 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 ↗
At 48 weeks, the novel investigational combination maintained a high rate (n=49; 94.2%) of viral suppression (HIV-1 RNA <50 copies/mL) in virologically suppressed adults, a secondary endpoint of the study. |
| 2024-10-07 | Gilead Sciences | Results Gilead Presents Additional Efficacy, Safety and Demographic Data From PURPOSE 2 Trial at 5th HIV Research for Prevention Conference gilead.com ↗
Efficacy and Safety Data Demonstrated 96% Reduction in HIV Infections with Lenacapavir Compared to Background HIV Incidence Among a Geographically Diverse Population of Cisgender Men and Gender-Diverse People |
| 2024-09-12 | Gilead Sciences | Results 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 ↗
Gilead Sciences, Inc. (Nasdaq: GILD) today announced the results of an interim analysis from a second pivotal Phase 3 clinical trial investigating the use of the company’s twice-yearly injectable HIV-1 capsid inhibitor, lenacapavir. |
| 2024-07-25 | Gilead Sciences | Results Gilead Presents Research Data Across Its Broad and Innovative HIV Treatment Portfolio and Pipeline gilead.com ↗
These data support the ongoing clinical development of GS-1720 and GS-4182 as the components of an investigational, first-in-class, once-weekly oral capsid-inhibitor/INSTI combination regimen for HIV treatment. |
| 2024-07-24 | Gilead Sciences | Results Full Efficacy and Safety Results for Gilead Investigational Twice-Yearly Lenacapavir for HIV Prevention Presented at AIDS 2024 gilead.com ↗
Detailed data from the trial’s interim analysis announced in June showed that lenacapavir, the company’s twice-yearly injectable HIV-1 capsid inhibitor, demonstrated zero infections, 100% efficacy and superiority to background HIV incidence for the investigational use of HIV prevention in cisgender women (women assigned female at birth). |
| 2024-06-20 | Gilead Sciences | Results Gilead’s Twice-Yearly Lenacapavir Demonstrated 100% Efficacy and Superiority to Daily Truvada® for HIV Prevention gilead.com ↗
Gilead Sciences, Inc. (Nasdaq: GILD) today announced topline results from an interim analysis of its pivotal, Phase 3 PURPOSE 1 trial indicating that the company’s twice-yearly injectable HIV-1 capsid inhibitor, lenacapavir, demonstrated 100% efficacy for the investigational use of HIV prevention in cisgender women. |
| 2024-03-06 | Merck Sharp & Dohme LLC | Results 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 merck.com ↗
At 24 weeks, the novel investigational combination maintained a high rate (94.2%) of viral suppression (HIV-1 RNA <50 copies/mL), which is a secondary endpoint of the study. |
| 2024-03-06 | Gilead Sciences | Results 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 ↗
At 24 weeks, the novel investigational combination maintained a high rate (94.2%) of viral suppression (HIV-1 RNA <50 copies/mL), which is a secondary endpoint of the study. |
| 2024-03-05 | Gilead Sciences | Results Gilead’s Innovative HIV Treatment Research Pipeline Aims to Address Unmet Needs and Advance Public Health gilead.com ↗
The findings help support the efficacy and safety profile of switching individuals with HIV on complex regimens to a potentially less complex combination of bictegravir and lenacapavir. |
| 2023-10-20 | Gilead Sciences | Results New Data Presented at EACS 2023 Further Demonstrate Strong Clinical Profile of Twice-Yearly Sunlenca® for Adults With Multi-Drug Resistant HIV gilead.com ↗
Gilead Sciences, Inc. (Nasdaq: GILD) presented new data today supporting Sunlenca ® (lenacapavir) as an important treatment option for adults with multi-drug resistant (MDR) HIV who have extensive treatment history. |
| 2023-10-03 | Gilead Sciences | Results Gilead to Present Latest Innovative Virology Data on Current and Potentially Transformative Therapies Across HIV and COVID-19 at IDWeek 2023 gilead.com ↗
Latest HIV Treatment Research Reinforces Biktarvy Efficacy Data in a Broad Range of People with HIV |
| 2023-07-24 | Gilead Sciences | Results Twice-Yearly Lenacapavir Demonstrates Sustained Impact on Health-Related Quality of Life in People With HIV gilead.com ↗
Using five validated scoring instruments measuring health-related quality of life components including physical and mental health, CAPELLA participants (n=64/72) reported favorable scores at Week 52 and with relative consistency over the time period. |
| 2023-02-22 | Gilead Sciences | Results 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 ↗
Results fromthe Phase 1b clinical trial demonstrated the investigational combination was generally well tolerated with high efficacy in select virologically suppressed participants living with HIV. |
| 2022-12-22 | Gilead Sciences | Regulatory Sunlenca® (lenacapavir) Receives FDA Approval as a First-in-Class, Twice-Yearly Treatment Option for People Living With Multi-Drug Resistant HIV gilead.com ↗
today announced that Sunlenca® (lenacapavir), in combination with other antiretroviral(s) (ARV), has been granted approval by the U.S. Food and Drug Administration (FDA) for the treatment of HIV-1 infection in heavily treatment-experienced (HTE) adults with multi-drug resistant (MDR) HIV-1 infection. |
| 2022-08-22 | Gilead Sciences | Regulatory Gilead Announces First Global Regulatory Approval of Sunlenca® (Lenacapavir), the Only Twice-Yearly HIV Treatment Option gilead.com ↗
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the European Commission (EC) has granted Marketing Authorization for Sunlenca ® (lenacapavir) injection and tablets for the treatment of HIV infection, in combination with other antiretroviral(s), in adults with multi-drug resistant HIV infection for whom it is otherwise not possible to construct a suppressive anti-viral regimen. |
| 2022-06-27 | Gilead Sciences | Regulatory 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 | Regulatory Investigational Lenacapavir Receives Positive CHMP Opinion for People With Multi-Drug Resistant HIV gilead.com ↗
The CHMP positive opinion is a scientific recommendation to the European Commission (EC) to grant marketing authorization in Europe and will be reviewed by the EC, which has the authority to authorize medicines in the 27 Member States of the European Union, as well as Norway, Iceland and Liechtenstein. |
| 2022-05-16 | Gilead Sciences | Regulatory FDA Lifts Clinical Hold on Investigational Lenacapavir for the Treatment and Prevention of HIV gilead.com ↗
Gilead Sciences, Inc. (Nasdaq: GILD) today announced the U.S. Food and Drug Administration (FDA) has lifted the clinical hold placed on the company’s Investigational New Drug Application (IND) to evaluate injectable lenacapavir for HIV treatment and HIV pre-exposure prophylaxis (PrEP). |
| 2022-03-01 | Gilead Sciences | Regulatory Gilead Receives Complete Response Letter From U.S. FDA for Investigational Lenacapavir Due to Vial Compatibility Issues gilead.com ↗
In the CRL, the FDA has cited Chemistry Manufacturing and Controls (CMC) issues relating to the compatibility of lenacapavir with the proposed container vial as the reason for their action. |
| 2022-02-08 | Gilead Sciences | Results Gilead to Present Latest Antiviral Research and Development Data at CROI 2022 Addressing Urgent Global Needs gilead.com ↗
These results demonstrate Biktarvy’s long-term safety and tolerability profile, and sustained efficacy with a high barrier to resistance in participants who initiated treatment with the guidelines-recommended, once-daily, single-tablet regimen. |
| 2021-12-21 | Gilead Sciences | Regulatory Gilead Announces Clinical Hold on Studies Evaluating Injectable Lenacapavir for HIV Treatment and Prevention Due to Vial Quality Concerns gilead.com ↗
During the clinical hold, screening and enrollment of study participants and the dosing of injectable lenacapavir will not be permitted across all lenacapavir studies. |
| 2021-08-19 | Gilead Sciences | Regulatory 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 ↗
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the company’s Marketing Authorization Application (MAA) for lenacapavir, an investigational, long-acting HIV-1 capsid inhibitor, has been fully validated and is now under evaluation with the European Medicines Agency (EMA). |
| 2021-06-28 | Gilead Sciences | Regulatory 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 ↗ |
| 2021-03-09 | Gilead Sciences | Results Gilead’s Investigational Lenacapavir Demonstrates Sustained Long-Acting Efficacy Through Week 26 in Data Presented at CROI gilead.com ↗
The new interim efficacy results demonstrate that lenacapavir administered subcutaneously every six months maintained high rates of virologic suppression through 26 weeks in a difficult-to-treat patient population with limited therapy options and high unmet medical need. |
| 2020-11-18 | Gilead Sciences | Results 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 ↗
Gilead Sciences, Inc. (Nasdaq: GILD) today announced topline results from the Phase 2/3 CAPELLA trial evaluating the company’s investigational, long-acting HIV-1 capsid inhibitor, lenacapavir, in heavily treatment-experienced people with multidrug resistant HIV-1 infection. |
| 2020-07-04 | Gilead Sciences | Results Gilead Sciences Presents Data Supporting a Potential Six-Month Dosing Interval for Investigational HIV-1 Capsid Inhibitor Lenacapavir (GS-6207) gilead.com ↗
In the study, lenacapavir was generally well-tolerated, and no serious adverse events were reported. |
| 2020-03-11 | Gilead Sciences | Results New Clinical Study Data for Gilead’s Investigational HIV-1 Capsid Inhibitor GS-6207 Presented at CROI 2020 gilead.com ↗
Phase 1 data in healthy volunteers evaluating an oral tablet formulation found GS-6207 to be generally safe and well-tolerated with a pharmacokinetic profile supporting once a week administration without regard to food. |
| 2019-11-08 | Gilead Sciences | Results Gilead Presents Data on Investigational HIV-1 Capsid Inhibitor GS-6207 as a Potential Component of Long-Acting HIV Therapy gilead.com ↗
New data from two Phase 1 studies demonstrate that GS-6207 has potent antiviral activity and a potential dosing interval of up to every six months. |
| 2019-07-22 | Gilead Sciences | Results Gilead Presents Proof-of-Concept Data for GS-6207, a First-in-Class Capsid Inhibitor, in People Living With HIV gilead.com ↗ |
All press releases naming this drug 77 releases
Evidence & citations 15 cited values
Every value below carries the sentence it was read from. 31 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 ↗28“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 | “Once-weekly oral islatravir plus lenacapavir (ISL+LEN) has the potential to address adherence challenges with daily HIV-1 treatment.” PMID 41429026 ↗ Dec 20259“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 ↗ “bictegravir (BIC)/lenacapavir (LEN)” NCT06532656 ↗ “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 ↗ |