Delving into the Latest Updates on Lenacapavir Sodium with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Lenacapavir, 来那帕韦, 莱纳卡帕韦

+ [11]

Target

HIV-1 capsid

Action

inhibitors

Mechanism

HIV-1 capsid inhibitors(HIV-1 capsid inhibitors)

Therapeutic Areas

Immune System DiseasesInfectious DiseasesUrogenital Diseases

Active Indication

HIV Infections

Inactive Indication-

Originator Organization

Gilead Sciences, Inc.

Active Organization

Gilead Sciences, Inc.

Gilead Sciences Shanghai Pharmaceutical Technology Co. Ltd.Gilead Sciences Ireland UC

+ [5]

Inactive Organization-

License Organization

Dr. Reddy's Laboratories Ltd.

EVA Pharma for Pharmaceuticals & Medical Appliances SAE

Gilead Sciences, Inc.

+ [5]

Drug Highest PhaseApproved

First Approval Date

European Union (17 Aug 2022),

HIV Infections

RegulationPriority Review (United States), Breakthrough Therapy (United States), Orphan Drug (Australia), Accelerated assessment (European Union), Orphan Drug (Japan)

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Structure/Sequence

Molecular FormulaC39H32ClF10N7NaO5S2

InChIKeyQXFAXPSMLXKBJU-PZNXWHLTSA-N

CAS Registry2283356-12-5

The purpose of this project is to test a culturally-tailored, community-delivered long-acting injectable PrEP (lenacapavir) program for Latine gay and bisexual men (GBM) and transgender women (TGW). The objective is to evaluate whether this intervention demonstrates greater persistence on lenacapavir for Latine GBM and TGW compared with what has been observed historically at the Duke PrEP Clinic.

Start Date05 Jan 2026

Sponsor / Collaborator

Duke University

[+1]

NCT06819176

/ RecruitingPhase 1IIT

Lenacapavir Intensification to Disrupt HIV Reservoirs in Virologically Suppressed People Living With HIV Receiving Antiretroviral Therapy

Background:
Antiretroviral viral therapy (ART) allows people living with human immunodeficiency (HIV) to live long, healthy lives. But ART is not a cure. HIV can remain in the body, in infected cells called reservoirs. If a person stops taking ART, the HIV can rebound and reach high levels in their blood. Researchers want to find ways to reduce the size of HIV reservoirs in people taking ART.
Objective:
To test a drug (lenacapavir) in people with HIV who are on effective ART. Lenacapavir, also called Sunlenca, is already approved for use in people with HIV who cannot be treated with standard ART.
Eligibility:
People aged 18 to 75 years with HIV that has been suppressed for at least 3 years with ART.
Design:
Participants will have 13 clinic visits over 2 years.
Participants will be screened. They will have a physical exam with blood tests. They will maintain their ART throughout the study.
Participants will undergo leukapheresis up to 6 times. Blood will be drawn via a tube in an arm. The blood will pass through a machine that separates out the white blood cells. The remaining blood will be returned to the body through a second tube.
Two-thirds of participants will take lenacapavir in addition to their regular ART. They will receive the drug as an injection under the skin 3 times at 6-month intervals. They will also take lenacapavir as 2 pills swallowed by mouth on the first 2 days of the study.
...

Start Date01 Dec 2025

Sponsor / Collaborator

National Institute of Allergy & Infectious Diseases

NCT07210125

/ RecruitingPhase 4

Implementation and Delivery of Lenacapavir for PrEP in a Community Pharmacy Setting

This is an open-label, single center study to evaluate implementation of a pharmacist-managed delivery of L4P in a community pharmacy setting and the impact of twice-yearly vs. quarterly PrEP visits on STI rates.

Start Date16 Sep 2025

Sponsor / Collaborator

Kelley-Ross & Associates, Inc.

[+1]

100 Clinical Results associated with Lenacapavir Sodium

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100 Translational Medicine associated with Lenacapavir Sodium

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100 Patents (Medical) associated with Lenacapavir Sodium

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200

Literatures (Medical) associated with Lenacapavir Sodium

01 Jan 2026·JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

Unraveling the bridging region of Lenacapavir atropisomers by two-dimensional liquid chromatography

Article

Author: Carr, Gavin ; Pereira, Alban R ; Adhikari, Sarju ; Foti, Chris ; Shen, Yi

Atropisomers are stereoisomers that arise from restricted bond rotation and undergo dynamic conformational change depending on time and temperature. The interconversion of atropisomers could result in a non-baseline "plateau" or "bridging area" between the isomer peaks in liquid chromatography (LC), which diminishes the chromatographic resolution and reduces the assurance of the analyte's purity. Conventional one-dimensional LC (1D-LC) separation relies on one or two major interactions among the analyte, mobile and stationary phase in an analytical column, which may not be sufficient for deciphering the bridging area. In contrast, two-dimensional LC (2D-LC) leverages orthogonal separation mechanisms in two dimensions, significantly enhancing peak capacity to resolve co-eluting impurities and ensure peak purity. Herein, we present a comprehensive 2D-LC study to investigate the on-column interconversion of Lenacapavir (LEN), which exists as a mixture of two atropisomers. Firstly, different columns, temperature, mobile phase pH, and cation additives were investigated using 1D-LC to assess their potential effects toward on-column interconversion of LEN atropisomers. The bridging area of LEN atropisomers was then unraveled using the heart-cutting mode in 2D-LC, presenting varying ratios for the two atropisomers across the retention time window of LEN. Furthermore, orthogonal conditions for the second dimension were developed to disentangle possible impurities in the bridging area using a regioisomer as surrogate. Lastly, and most importantly, by implementing the developed second-dimension methods, a co-eluting regioisomer of LEN can be separated using 2D-LC. With the aid of high-resolution mass spectrometry (HRMS), we were able to distinguish the co-eluting regioisomer down to 0.05 % (w/w).

31 Dec 2025·Virulence

Lenacapavir’s success: Revitalizing antiviral drug discovery

Author: Miranda, Daniel ; Sanchez, David Jesse

01 Dec 2025·Current HIV/AIDS Reports

Long-Acting Injectable Antiretroviral Drugs for Pregnant and Breastfeeding Women: Current Advances, Challenges, and Future Directions

Review

Author: Hosseinipour, Mina C ; Saidi, Friday ; Chi, Benjamin H

PURPOSE OF REVIEW:

This review explores the promise and challenges of integrating long-acting antiretroviral agents-cabotegravir, lenacapavir, and cabotegravir-rilpivirine-into HIV prevention and treatment programs for pregnant and breastfeeding populations. It aims to examine current evidence, implementation experiences, and barriers to equitable access.

RECENT FINDINGS:

Emerging data support the efficacy and safety of long-acting agents during pregnancy and breastfeeding. Recent clinical trials have begun to include pregnant women by design, and national demonstration projects have successfully introduced injectable PrEP in maternal health settings. These developments signal growing recognition of the need for inclusive research and service delivery models. Long-acting antiretrovirals have the potential to transform maternal HIV prevention and treatment. However, challenges such as delayed inclusion in trials, policy constraints, limited product choice, high costs, and funding limitations persist. Addressing these gaps is critical to ensuring equitable access and informing future research and implementation strategies.

320

News (Medical) associated with Lenacapavir Sodium

28 Nov 2025

·www.pharmaceutical-technology.com

Over half of European HIV patients diagnosed late, ECDC report finds

The ECDC’s 2025 HIV Surveillance Report has found that 54% of patients diagnosed with HIV in 2024 were diagnosed too late to receive fully effective treatment. Image credit: Corona Borealis Studio via Shutterstock.com. A European 2025 HIV/AIDS surveillance report has revealed that countries within the continent are currently failing to test and treat HIV early. The annual report, published by the European Centre for Disease Prevention and Control (ECDC), was released on 27 November 2025 but looks at 2024 data. While the report identified a small downturn in HIV cases between 2023 and 2024, testing gaps were still highly prevalent. This is evidenced by the fact that 54% of patients with HIV across the World Health Organization (WHO) European region in 2024 were unable to receive optimal treatment due to late diagnosis. This is notable as patients with a delayed HIV diagnosis are less likely to gain the full benefits of antiretroviral (ART) therapies. Currently, ART therapies are the mainstay treatment option for patients diagnosed with HIV, as they can suppress viral load and prevent transmission. According to the annual report, 105,922 HIV diagnoses were made across the WHO European region in 2024, which includes 53 countries. Of those receiving late diagnoses, the highest proportion were heterosexual patients – especially men – as well as people that inject drugs. As current testing initiatives across Europe are currently failing to diagnose a majority of patients early, the ECDC noted that the 2030 goal of ending AIDS as a public health threat could be in jeopardy. GlobalData Strategic Intelligence US Tariffs are shifting - will you react or anticipate? Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis. By GlobalData Learn more about Strategic Intelligence To ensure this goal is achieved, the ECDC and the WHO’s European division are calling for the scale-up and routinisation of HIV testing across the continent, with a key focus on self-testing and community-based options. According to Hans Henri P. Kluge, WHO regional director for Europe, tackling the silent HIV crisis will involve “removing the deadly barriers of stigma and discrimination” that currently discourage individuals from seeking out a HIV test. Meanwhile, Pamela Rendi-Wagner, director of the ECDC, stressed the importance of innovating testing strategies, while “ensuring rapid linkage to care” to improve patient outcomes. A major hit to global HIV treatment efforts came this year came when President Donald Trump cut a large amount of funding for foreign aid. This impacted HIV, malaria and tuberculosis treatment services in low-income countries supported by the United States Agency for International Development (USAID). Trump also trimmed financial support for the president’s Emergency Plan for AIDS Relief (PEPFAR). The plan has become a major pillar in fighting the global HIV/AIDS response, providing testing services, antiretroviral treatment and education programmes. HIV treatments advance Currently, HIV remains a major threat to public health, with the WHO estimating that 40.8 million were living with the disease globally at the end of 2024. However, there are a wide range of effective ART options available to patients, meaning that those with access to medications have a similar life expectancy to an individual living without HIV. The most widely prescribed ART is currently Gilead’s Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide), which had a strong financial showing in Q2 2025, with sales jumping 9% to $3.5bn. While the drug’s patent is up for expiry as early as October 2027, GlobalData analysts predict that no other HIV therapy is likely to surpass Biktarvy in terms of commercial success. Alongside Biktarvy, Gilead has found a new key asset in Yeztugo (lenacapavir), which the US Food and Drug Administration (FDA) approved as a biannual pre-exposure prophylaxis (PrEP) for patients at risk of HIV in June 2025. While this treatment is only suitable as a preventive measure, GlobalData analysts note that the therapy is set to revolutionise the HIV landscape. Now, some companies are looking to cure HIV completely. This includes American Gene Technologies, which is currently looking to take its potentially curative cell therapy, AGT103-T, to additional trials after a Phase I study yielded promising results . The International AIDS Vaccine Initiative is also working towards a preventive vaccine for HIV, which has seen an adenovirus vaccine enter Phase I clinical trials in Africa. Currently, the jab is being tested in both HIV-positive and HIV-negative individuals. Pharmaceutical Technology Excellence Awards - The Benefits of Entering Gain the recognition you deserve! The Pharmaceutical Technology Excellence Awards celebrate innovation, leadership, and impact. By entering, you showcase your achievements, elevate your industry profile, and position yourself among top leaders driving pharmaceutical advancements. Don’t miss your chance to stand out—submit your entry today! Nominate Now

VaccinePhase 1Clinical ResultDrug Approval

19 Nov 2025

·endpoints.news

Merck says once-daily HIV drug combo succeeds in another Phase 3

Merck secured another win on Wednesday in its plan to bolster its HIV portfolio. The pharma giant said its two-drug combination was non-inferior to a three-drug package in a Phase 3 trial in adults with HIV-1 who were not previously on antiretroviral treatment. Merck said the study of the single-tablet combination of doravirine and islatravir met the primary efficacy hypothesis at week 48. The safety of DOR/ISL was also “comparable” to the three-drug combination of Gilead’s Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide, or BIC/FTC/TAF). Both are once-daily regimens. DOR/ISL is already under FDA review for a different patient population : people with HIV who are already on an antiretroviral regimen. The regulatory body is slated to decide whether to approve the treatment in that population by April 28 . Merck hopes DOR/ISL will become part of a broader HIV portfolio that could be a $5 billion business . Its existing medicines in the space made $412 million in revenue in the first half of this year, but it’s studying additional combinations and a once-monthly oral PrEP that just entered Phase 3. Merck has been involved in HIV science since the early days of the epidemic, and brought the protease inhibitor Crixivan to market in 1996. Multiple HIV treatment options now exist, and companies like Gilead and GSK’s ViiV make long-acting HIV medicines, but for different patient populations. Merck’s existing HIV work is a small piece of the pharma’s efforts to pad the revenue gap that will come from Keytruda’s patent cliff. Merck has spent more than $19 billion this year on acquisitions, namely for respiratory biotech Verona Pharma and influenza antiviral developer Cidara Therapeutics . The new Phase 3 data will be presented at a future medical conference. Merck said it plans to use the data in applications to health regulators. With the non-inferiority results, Merck hopes to go up against Biktarvy, which brought in $3.7 billion in sales for Gilead in the third quarter of this year. “These data support the potential for this regimen to be a meaningful treatment option for virally suppressed people living with HIV who are looking to switch to a new regimen or people who have not previously been on antiretroviral therapy to start treatment,” Merck Research Laboratories chief medical officer Eliav Barr said in a press release. Merck chief marketing officer Chirfi Guindo said on an investor call in July that the company believes DOR/ISL will be “the preferred switch option for many individuals.” Guindo said the drug combination provides “robust viral control” and a “high barrier to resistance.” Doravirine is an approved HIV medicine known as Pifeltro and part of an HIV pill marketed as Delstrigo. Islatravir, meanwhile, is in multiple clinical trials assessing whether it can be a once-daily or weekly treatment for HIV when paired up with other medicines. The drug is in Phase 3 with Gilead’s lenacapavir as a potential once-weekly oral treatment. Islatravir is also in a Phase 2b in combination with Merck’s ulonivirine, an experimental non-nucleoside reverse transcriptase inhibitor (NNRTI). That pairing is “back on track,” Luisa Stamm, Merck’s associate VP and section head for HIV, said in an interview with Endpoints in July. The drug combo had a safety signal for a prior Phase 2, but Merck is now looking at a lower dosing schedule to assuage concerns.

Phase 3Phase 2AcquisitionClinical Result

19 Nov 2025

·firstwordpharma.com

Merck & Co.'s HIV tablet matches Biktarvy in treatment-naïve patients

The race for a simplified HIV antiretroviral regimen is heating up. Days after Gilead shared data on its experimental two-drug, single-tablet treatment, Merck & Co. has countered with late-stage findings for its own drug duo — though this batch of pivotal results is in treatment-naïve patients. The current standard-of-care HIV viral suppressor is Gilead's Biktarvy, an oral, once-daily tablet that comprises integrase strand transfer inhibitor (INSTI) bictegravir plus emtricitabine and tenofovir alafenamidei. The drug is Gilead's best-seller, bringing in $3.7 billion in revenue for the third quarter (see – Vital Signs: Gilead's fastest growing drugs).Last week, Gilead revealed data from the Phase III ARTISTRY-1 study evaluating a single-tablet combination of bictegravir plus lenacapavir, a long-acting HIV-1 capsid inhibitor marketed as Sunlenca for multidrug-resistant HIV and as Yeztugo for pre-exposure prophylaxis. In the 689 participants — all of whom were virologically suppressed, but were taking anywhere from two to 11 pills daily — bictegravir/lenacapavir was statistically non-inferior to multi-tablet regimens at the 48-week mark. Integrase inhibitor not needed?Merck is comparing its single-tablet, two-drug combo of doravirine/islatravir against Biktarvy in a Phase III study. Unlike Biktarvy or Gilead's experimental duo, Merck's pill does not include an INSTI; islatravir is a nucleoside reverse transcriptase translocation inhibitor designed to block HIV-1 replication via chain termination and induction of structural changes.The MK-8591A-053 trial enrolled 537 patients with HIV-1 infection who've never received an antiretroviral. After 48 weeks, Merck's tablet met its primary endpoint, demonstrating non-inferiority to Biktarvy as measured by the percentage of participants with HIV-1 RNA levels <50 copies/mL. The pharma added that the safety profile of doravirine/islatravir was comparable to Gilead's drug. Doravirine/islatravir "is the first two-drug regimen without an integrase inhibitor showing non-inferior efficacy and safety when compared to the three-drug INSTI-based regimen [Biktarvy] in this population," said Eliav Barr, head of global clinical development and the chief medical officer at Merck Research Laboratories. "These data support the potential for this regimen to be a meaningful treatment option for virally suppressed people living with HIV who are looking to switch to a new regimen or people who have not previously been on antiretroviral therapy to start treatment."Merck's two-drug combo is already under review at the FDA for adults with HIV who are virologically suppressed on antiretroviral therapy. With a PDUFA date of April 28, 2026, it has a head-start on Gilead's bictegravir/lenacapavir in the pre-treated population, where the biopharma is still waiting for results to read out from a second Phase III trial, ARTISTRY-2.Detailed results of doravirine/islatravir in treatment-naïve patients will be presented at a future scientific meeting, and submitted to global regulators.

Phase 3Clinical Result

100 Deals associated with Lenacapavir Sodium

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External Link

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB15673

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
HIV Infections	European Union	Gilead Biopharmaceutics Ireland UC	17 Aug 2022
HIV Infections	Iceland	Gilead Biopharmaceutics Ireland UC	17 Aug 2022
HIV Infections	Liechtenstein	Gilead Biopharmaceutics Ireland UC	17 Aug 2022
HIV Infections	Norway	Gilead Biopharmaceutics Ireland UC	17 Aug 2022

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04143594 (CALIBRATE, Pubmed \| AIDS)	Phase 2	HIV Infections First line	182	Lenacapavir+emtricitabine/tenofovir alafenamide	nyihezmhgr(rpnkfkvtsc) = qmximxgtpd plydxmtwyf (elfwdzhdme, 214 - 337) View more	Positive	07 Oct 2025
				Lenacapavir+emtricitabine/tenofovir alafenamide	nyihezmhgr(rpnkfkvtsc) = virclfxwya plydxmtwyf (elfwdzhdme, 203 - 320) View more
NCT04994509 \| NCT04925752 (PURPOSE 2, NEWS) Manual	Phase 3	HIV Infections	-	lenacapavir (每年两次)	rjdzfpcswk(xqbzgnywwt) = 孕妇与非孕妇安全性相似，按妊娠期或产后状态预测的Yeztugo 暴露无临床显著差异，母乳喂养婴儿暴露量也极小。 mgewpgdrln (vainobapgm ) View more	Positive	16 Jul 2025
NCT05729568 (CTgov)	Phase 2	HIV Infections	83	Antiretroviral Therapy	qvrweeepdm = obokmnwwgh osjwzebaqw (hattfgvrny, kkrmvpumag - upmcvanhwd) View more	-	15 Jul 2025
NCT04994509 \| NCT04925752 (PURPOSE 2, FDA_CDER) Manual	Phase 3	HIV Infections	-	YEZTUGO (PURPOSE 1)	ebbppktgdz(izhrxhfpmq) = badwovntci xzfddcmtcm (tdgipwavox )	Positive	18 Jun 2025
				TRUVADA (PURPOSE 1)	ebbppktgdz(izhrxhfpmq) = udecouxthe xzfddcmtcm (tdgipwavox )
NCT04150068 (Phase 2/3 Trial, Pubmed \| Clin Infect Dis)	Phase 2/3	HIV Infections multidrug-resistant HIV-1	72	Lenacapavir + OBR	mititouulh(bvojgywamb) = There were no Grade 4 or serious treatment-related adverse events anhcwxlvoy (aqlchfyzyg ) View more	Positive	17 Mar 2025
PipelineReview \| Pubmed Manual	Phase 1	HIV Infections	40	ventrogluteal intramuscular injection lenacapavir with 5% w/w ethanollenacapavir with 5% w/w ethanol	lwgbomcshh(owokwvdqke) = ftinkvoabl ginjhbndgo (blclplusbn, 56.1 - 112.0) View more	Positive	12 Mar 2025
				ventrogluteal intramuscular injection lenacapavir with 10% w/w ethanollenacapavir with 10% w/w ethanol	lwgbomcshh(owokwvdqke) = owvfoabyiq ginjhbndgo (blclplusbn, 55.3 - 105.5) View more
NCT04811040 (CTgov)	Phase 1	HIV Infections	32	LEN+Zinlirvimab+Teropavimab (Primary Cohort: LEN+Teropavimab+Zinlirvimab 10 mg/kg)	xyveobcbrm = gyjerxnlki jvyglldjzv (qxncwlyeei, qoeksysejp - kukujiisan) View more	-	27 Jan 2025
				LEN+Zinlirvimab+Teropavimab (Primary Cohort: LEN+Teropavimab+Zinlirvimab 30 mg/kg)	xyveobcbrm = lfnjlslojb jvyglldjzv (qxncwlyeei, atlouodzdn - tlmuimldbf) View more
NCT05052996 (CTgov)	Phase 2	HIV Infections	142	LEN+ISL (Cohort 1- Group 1 (ISL+LEN))	ygfuactdjz(jngumngvzm) = jzcrcliyqd roichadyrl (agztjrcrpr, 265.0) View more	-	14 Jan 2025
				LEN+ISL (Cohort 1- Group 2 (B/F/TAF to ISL+LEN))	ygfuactdjz(jngumngvzm) = jmvjptdctw roichadyrl (agztjrcrpr, 304.8) View more
NCT04925752 (PURPOSE 2, Pubmed \| N Engl J Med) Manual	Phase 3	HIV Infections	3,265	Lenacapavir	vsvepepoec(ycabxqieio) = hlbandqmsv nfhklzsecn (kbqkiairww, 0.01 - 0.37) View more	Positive	27 Nov 2024
				Emtricitabine-tenofovir disoproxil fumarate (F/TDF)	vsvepepoec(ycabxqieio) = ixxocpwvzu nfhklzsecn (kbqkiairww, 0.43 - 1.77) View more
NCT05502341 (ARTISTRY-1, Pubmed) Manual	Phase 2/3	HIV Infections	128	Bictegravir 75 mg + Lenacapavir 25 mgLenacapavir 25 mg	ntnjssomkt(xjdfpnglst) = owpeiblevk meivaxqfua (pieauuckxx ) View more	Positive	26 Nov 2024
				Bictegravir 75 mg + Lenacapavir 50 mgLenacapavir 50 mg	ntnjssomkt(xjdfpnglst) = lcglzkibxo meivaxqfua (pieauuckxx ) View more