RegulationBreakthrough Therapy (United States), Orphan Drug (Japan), Orphan Drug (Australia), Accelerated assessment (European Union), Priority Review (United States)

Structure/Sequence

Molecular FormulaC39H32ClF10N7NaO5S2

InChIKeyQXFAXPSMLXKBJU-PZNXWHLTSA-N

CAS Registry2283356-12-5

Clinical Trials associated with Lenacapavir Sodium

NCT07218211

/ Not yet recruitingPhase 4IIT

INCLUSION - Enhancing PrEP Uptake and Retention Among Latine Transgender Women and Gay, Bisexual, and Other Men Who Have Sex With Men in the South Using Long-Acting Injectable PrEP

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 With HIV Receiving Antiretroviral Therapy

Background:
Antiretroviral viral therapy (ART) allows people 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 Date24 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

100 Translational Medicine associated with Lenacapavir Sodium

100 Patents (Medical) associated with Lenacapavir Sodium

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.

327

News (Medical) associated with Lenacapavir Sodium

19 Dec 2025

·www.gilead.com

Gilead and U.S. Government Enter Agreement to Lower Costs of Medicines for Americans

Agreement addresses all requests by President Trump to reduce drug costs in the U.S., encourage global investment and protect American biopharma leadership Company reinforces commitment to U.S. manufacturing and American jobs FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced an agreement with the U.S. government designed to reduce drug costs for Americans, reinforcing the company’s long-standing commitment to U.S.-based innovation, affordability, and global health leadership. “This agreement reflects a foundational commitment to both affordability and future innovation, a commitment that we have long seen as essential to shaping the future of healthcare,” said Daniel O’Day, Chairman and Chief Executive Officer, Gilead Sciences. “The progress toward expanding access and increasing investment in U.S. innovation will meaningfully contribute to America’s health and economic priorities. Gilead Sciences will continue to work with the Administration in service of these priorities for the benefit of generations to come.” As part of the three-year agreement, Gilead addresses all requests by President Trump to implement a new pricing strategy that prioritizes American patients, ensuring the U.S. no longer bears a disproportionate share of global healthcare costs. This includes: Discounts on certain existing medicines within the U.S. Medicaid program, similar to what is paid in comparably developed nations, including select medications to treat HIV, hepatitis C, hepatitis B and COVID-19. Pricing future medicines at parity with other key developed nations. Launching a Direct-to-Patient Program where individuals with a prescription can obtain Gilead’s hepatitis C treatment and cure, Epclusa ®, at a discounted cash price. Gilead will make Epclusa available via TrumpRx.gov where American patients can be connected directly with Gilead’s Direct-to-Patient Program. An agreement with the U.S. Department of Commerce to be exempt from Section 232 pharmaceutical tariffs for three years, provided Gilead further invests in manufacturing in the United States. Based on these terms, the company expects the financial impact to be manageable in 2026 and beyond. Additional terms of the agreement with the U.S. government remain confidential. This agreement reinforces America’s leadership in global health and biomedical innovation and builds upon Gilead’s recently announced landmark partnership with the U.S. Department of State to provide its breakthrough HIV prevention medicine, lenacapavir, at no profit to up to two million individuals in the most severely affected countries around the world over the next three years. Gilead also recently announced it will invest $32 billion in U.S.-based manufacturing, R&D, and infrastructure over the next five years. This investment is projected to generate $43 billion in national economic value and create more than 3,000 direct and indirect jobs. About Gilead Sciences Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID-19, cancer, and inflammation. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, Calif. Forward-Looking Statements This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the impact of the agreement with the U.S. government and the Direct-to-Patient Program on Gilead’s business, operations and financial condition and results; risks related to the ability to realize the anticipated benefits of the agreement with the U.S. government and the Direct-to-Patient Program, including that patient access and other expected benefits will not be realized or will not be realized within the expected time periods; the uncertainties inherent in research and development; the uncertainties inherent in business and financial planning, including, without limitation, risks related to Gilead’s business and prospects, manufacturing expansion and capabilities, adverse developments in Gilead’s markets or adverse developments in the U.S. or global capital markets, credit markets, regulatory environment or economies generally; risks and uncertainties related to issued or future executive orders or other new, or changes in, laws or regulations; and competitive developments; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and factors are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2025, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation and disclaims any intent to update any such forward-looking statements. Epclusa® is a trademark of Gilead Sciences, Inc. or its related companies and the full prescribing information is available at https://www.gilead.com/medicines. Gilead and the Gilead logo are trademarks of Gilead Sciences, Inc., or its related companies. For more information about Gilead, please visit the company’s website at www.gilead.com, follow Gilead on X/Twitter (@Gilead Sciences) and LinkedIn (@Gilead-Sciences). Ashleigh Koss, Media public_affairs@gilead.com Jacquie Ross, Investors investor_relations@gilead.com

16 Dec 2025

·www.fiercepharma.com

Gilead's single-tablet HIV combo of bictegravir, lenacapavir passes another late-stage test on way to filings

The Artistry-2 win comes a month after Gilead reported a separate positive trial result for the investigational regimen. With a second late-stage trial win for its investigational HIV combo in the books, Gilead Sciences is moving full steam ahead toward regulatory filings for the novel HIV regimen.In Gilead's Artistry-2 study, the company's single-tablet regimen of bictegravir and lenacapavir matched up to Gilead's own megablockbuster HIV medicine Biktarvy when assessing patients' treatment responses, Gilead said in a Dec. 15 release. The trial enrolled adults with HIV who had achieved virologic suppression on Biktarvy and randomized them 2-1 to either switch to the novel regimen or continue receiving Biktarvy.In top-line results shared Monday, Gilead said the bictegravir 75-mg/lenacapavir 50-mg regimen was noninferior to Biktarvy, meeting the trial's primary endpoint. The primary endpoint looked at the percentage of participants with HIV-1 RNA levels ≥50 copies/mL at Week 48. The investigational combo was generally well tolerated, Gilead added.“These data support the potential of BIC/LEN as a meaningful additional treatment option for adults with HIV who are virologically suppressed," Gilead's Jared Baeten, M.D., Ph.D., senior vice president of clinical development and virology therapeutic area head, said in a statement. "We look forward to sharing the full Phase 3 data from the ARTISTRY-1 and ARTISTRY-2 trials next year and submitting these data for regulatory approval.”The news comes about a month after Gilead reported a top-line win in the Artistry-1 study. The trials were similar in design, but Artistry-1 enrolled patients who were on complex multi-tablet regimens at baseline. Bictegravir, an integrase strand transfer inhibitor, is one of the three active ingredients in Biktarvy, alongside the antivirals emtricitabine and tenofovir alafenamide. Lenacapavir is a capsid inhibitor used in the company's long-acting HIV treatment Sunlenca and its twice-yearly PrEP drug Yeztugo.When Gilead reported the Artistry-1 win, Citi analyst Geoffrey Meacham, Ph.D., wrote that the novel regimen "targets a key unmet need within the HIV market (~6-8%), who are not candidates for the standard-of-care" drug Biktarvy. Thus, the combo could allow Gilead to expand its reach in HIV without "cannibalizing its flagship product," Meacham wrote.In the wake of the Artistry-2 readout, Meacham explained in a note to clients that the novel offering could find use in the "Biktarvy switch market." "Indeed, today's positive results will enable Gilead to position the combo strategically and retain patients who might otherwise switch to other 2 drug regimen," Meacham wrote. "Overall the positive results across both ARTISTRY (1&2) trials will allow Gilead to provide a simplified 2-drug regimen and provide an alternative for the specific market segments that prefer fewer medications."Meacham's team is projecting 2030 sales of $630 million for the combo product. After planned filings next year, Gilead could launch the drug in 2027, the analyst wrote.

Clinical ResultPhase 3

16 Dec 2025

·www.biopharmadive.com

FDA ‘proactively’ hands J&J a voucher; Pfizer issues 2026 forecasts

Today, a brief rundown of news from Johnson & Johnson and Pfizer, as well as updates from Gilead Sciences, Link Cell Therapies and Sanofi that you may have missed.The Food and Drug Administration on Monday said it proactively awarded one of its new regulatory fast passes to a multiple myeloma drug regimen from Johnson & Johnson. Last week, J&J presented results at the American Society of Hematology meeting suggesting that the regimen, a combination of its medicines Tecvayli and Darzalex, could be curative when used early in patients disease course. The FDA read those results, consulted with in-house experts and reached out to J&J the following day to discuss a national priority review voucher, Commissioner Marty Makary said in the agencys statement. That voucher, the 16th granted so far, could shorten an evaluation of that combination to as little as one to two months. Ben FidlerPfizer issued financial forecasts for 2026 on Tuesday, predicting revenue next year of $59.5 billion to $62.5 billion and earnings per share of $2.80 to $3 apiece. Those numbers reflect an expected $1.5 billion decline in COVID-19 products between 2025 and 2026 and a $1.5 billion hit due to the loss of exclusivity of certain products. Pfizers earnings per share guidance comes in about 5% lower than consensus estimates, but isnt necessarily a surprise given the acquisition-related dilution from the Metsera and 3SBio deals, wrote Leerink Partners David Risinger. The company also narrowed its 2025 revenue projections to $62 billion, from between $61 billion to $64 billion previously. Ben FidlerGilead Sciences said Monday that a single-tablet combination of two of its HIV drugs succeeded in the second of two late-stage trials, paving the way for a potential approval filing. In the ARTISTRY-2 trial, study volunteers with suppressed levels of HIV and already on Gileads Biktarvywere randomized to either continue on therapy or switch to a single-tablet form of Gileads bictegravirand lenacapavir. Gilead said the new pill was non-inferior to Biktarvy at keeping viral levels down after 48 weeks, and that those findings, combined with positive results from another late-stage trial,will form the basis of regulatory submissions. Delilah Alvarado Link Cell Therapies, a cancer cell therapy startup, emerged from stealth Monday with $60 million in a Series A funding led by Johnson & Johnsons venture arm. The South San Francisco, California-based biotechnology company is developing precise CAR-T therapies that only activate when a combination of specific protein targets are present on tumor cells. It plans to bring its lead program for kidney cancer into human testing in 2026, with a second prospect for colorectal tumors reaching clinical trials the following year. To date, Link has raised $92 million in private funding from J&J, Samsara BioCapital, Wing Venture Capital and Bristol Myers Squibb, among others. Gwendolyn WuSanofi is expanding an autoimmune disease-focused alliance with startup Dren Bio, agreeing on Monday to add another drug to their existing deal. Sanofi, in March,paid Dren $600 million to acquire a so-called myeloid cell engager for multiple inflammatory conditions. That therapy, DR-0201, is in two Phase 1 studies and so far has shown the potential to induce sustained treatment-free remission in people with autoimmune diseases, Dren said. The new deal will see the companies collaborate on a second therapy thats also a next-generation drug able to lower levels of malfunctioning B cells. Dren will receive $100 million in guaranteed cash and is eligible for another $1.7 billion in future payouts. It can also opt into splitting development costs and future U.S. profits. Ben FidlerSanofi also licensed a potential Alzheimers disease treatment from Korean biotech ADEL. Per deal terms, Sanofi is paying ADEL $80 million up front, and possibly $1.04 billion overall, for a prospect called ADEL-Y01. That drug targets a type of tau protein and is currently in Phase 1 testing in the U.S. Sanofi is also getting rights to certain related backup compoundsin the alliance. Ben Fidler '

Cell TherapyClinical ResultPhase 1ASHPhase 3

100 Deals associated with Lenacapavir Sodium

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB15673

R&D Status

10 top approved records.

to view more data

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

Clinical Result

Indication

Phase

Evaluation

View All Results

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	ydbibswowx(pbthtspcdf) = komozqvzrv sqctbhoixz (owwknswytr, 214 - 337) View more	Positive	07 Oct 2025
				Lenacapavir+emtricitabine/tenofovir alafenamide	ydbibswowx(pbthtspcdf) = phkhbuqaia sqctbhoixz (owwknswytr, 203 - 320) View more
NCT04994509 \| NCT04925752 (PURPOSE 2, NEWS) Manual	Phase 3	HIV Infections	-	lenacapavir (每年两次)	yufjdswvqj(pzycdastzp) = 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。 hiddeozyzm (ykihrdcwnl ) View more	Positive	16 Jul 2025
NCT05729568 (CTgov)	Phase 2	HIV Infections	83	Antiretroviral Therapy	nhjfvuxjpk = ilqskqdykq kehbwceuhd (kciwgdztpz, bwlghnbore - ufgfchzjxk) View more	-	15 Jul 2025
NCT04994509 \| NCT04925752 (PURPOSE 2, FDA_CDER) Manual	Phase 3	HIV Infections	-	YEZTUGO (PURPOSE 1)	ynftsyugdj(ruppjsjepb) = melorgmhix etihcaoplp (esjouyrfgx )	Positive	18 Jun 2025
				TRUVADA (PURPOSE 1)	ynftsyugdj(ruppjsjepb) = ikoeslqvuh etihcaoplp (esjouyrfgx )
NCT04150068 (Phase 2/3 Trial, Pubmed \| Clin Infect Dis)	Phase 2/3	HIV Infections multidrug-resistant HIV-1	72	Lenacapavir + OBR	fjwujuyrfx(knwgmemxju) = There were no Grade 4 or serious treatment-related adverse events igmuvvccpm (mpsxhefkxa ) 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	tvefsottdh(avkkfxyggo) = gosskdvdwl csrprolsrt (evhjicryea, 56.1 - 112.0) View more	Positive	12 Mar 2025
				ventrogluteal intramuscular injection lenacapavir with 10% w/w ethanollenacapavir with 10% w/w ethanol	tvefsottdh(avkkfxyggo) = vqwvbtpehs csrprolsrt (evhjicryea, 55.3 - 105.5) View more
NCT04811040 (CTgov)	Phase 1	HIV Infections	32	LEN+Zinlirvimab+Teropavimab (Primary Cohort: LEN+Teropavimab+Zinlirvimab 10 mg/kg)	rklsxtltfx = kadbictmud carklcizoi (nqcpmsnatz, ovwqospuyn - lnbcqepljk) View more	-	27 Jan 2025
				LEN+Zinlirvimab+Teropavimab (Primary Cohort: LEN+Teropavimab+Zinlirvimab 30 mg/kg)	rklsxtltfx = lqbriomyff carklcizoi (nqcpmsnatz, nmkyushdgh - shyiyhisyv) View more
NCT05052996 (CTgov)	Phase 2	HIV Infections	142	LEN+ISL (Cohort 1- Group 1 (ISL+LEN))	rmhdbwgznm(ddeykrfciw) = lilmawrbzq hxjfyjxhdt (dtzflacwcd, 265.0) View more	-	14 Jan 2025
				LEN+ISL (Cohort 1- Group 2 (B/F/TAF to ISL+LEN))	rmhdbwgznm(ddeykrfciw) = txdscpismi hxjfyjxhdt (dtzflacwcd, 304.8) View more
NCT04925752 (PURPOSE 2, Pubmed \| N Engl J Med) Manual	Phase 3	HIV Infections	3,265	Lenacapavir	svyddfvyaz(wjfvkfzhxu) = fnccdlauln vgzkwutrmf (apxvzoswtl, 0.01 - 0.37) View more	Positive	27 Nov 2024
				Emtricitabine-tenofovir disoproxil fumarate (F/TDF)	svyddfvyaz(wjfvkfzhxu) = zrhbuxxysc vgzkwutrmf (apxvzoswtl, 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	fnpglhftzb(ihwctavrvh) = xmxjaoajwi evlqiszfmj (zzsytujbvr ) View more	Positive	26 Nov 2024
				Bictegravir 75 mg + Lenacapavir 50 mgLenacapavir 50 mg	fnpglhftzb(ihwctavrvh) = tspiomnrci evlqiszfmj (zzsytujbvr ) View more

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

AI Agents Built for Biopharma Breakthroughs

Accelerate discovery. Empower decisions. Transform outcomes.

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis