Lenacapavir, sold under the brand name Sunlenca, is an

antiretroviral medication The management of HIV/AIDS normally includes the use of multiple antiretroviral drugs as a strategy to control HIV infection. There are several classes of antiretroviral agents that act on different stages of the HIV life-cycle. The use of mul ...

used to treat and prevent

HIV/AIDS The HIV, human immunodeficiency virus (HIV) is a retrovirus that attacks the immune system. Without treatment, it can lead to a spectrum of conditions including acquired immunodeficiency syndrome (AIDS). It is a Preventive healthcare, pr ...

. It is taken

by mouth Oral administration is a route of administration whereby a substance is taken through the Human mouth, mouth, swallowed, and then processed via the digestive system. This is a common route of administration for many medications. Oral administ ...

or by

subcutaneous injection Subcutaneous administration is the insertion of medications beneath the skin either by injection or infusion. A subcutaneous injection is administered as a bolus (medicine), bolus into the subcutis, the layer of skin directly below the dermis and ...

. Lenacapavir is a human immunodeficiency virus type 1 (HIV-1) capsid inhibitor. The most common side effects include reactions at the injection site and nausea. Lenacapavir was approved for medical treatment in the European Union in August 2022, in Canada in November 2022, and in the United States in December 2022. It is the first of a class of drugs called capsid inhibitors to be approved by the US

Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respo ...

(FDA) for treating HIV/AIDS. In June 2025, it received approval in the US for HIV prevention.

Medical uses

Lenacapavir, as Sunlenca, in combination with other antiretrovirals, is

indicated In medicine, an indication is a valid reason to use a certain test, medication, procedure, or surgery. There can be multiple indications to use a procedure or medication. An indication can commonly be confused with the term diagnosis. A diagnosis ...

for the treatment of HIV/AIDS. It is used in heavily treatment-experienced adults with

multiple drug resistance Multiple drug resistance (MDR), multidrug resistance or multiresistance is antimicrobial resistance shown by a species of microorganism to at least one antimicrobial drug in three or more antimicrobial categories. Antimicrobial categories are ...

in whom current antiretroviral therapy is ineffective due to resistance, intolerance or safety considerations. Lenacapavir, as Yeztugo, is indicated for pre‑exposure prophylaxis to reduce the risk of sexually acquired HIV-1 in adults and adolescents weighing more than who are at risk for HIV-1 acquisition.https://www.gilead.com/-/media/files/pdfs/medicines/hiv/yeztugo/yeztugo_pi.pdf

Mechanism of action

Lenacapavir works by binding directly to the interface between

HIV-1 The subtypes of HIV include two main subtypes, known as HIV type 1 (HIV-1) and HIV type 2 (HIV-2). These subtypes have distinct genetic differences and are associated with different epidemiological patterns and clinical characteristics. HIV-1 e ...

viral

capsid A capsid is the protein shell of a virus, enclosing its genetic material. It consists of several oligomeric (repeating) structural subunits made of protein called protomers. The observable 3-dimensional morphological subunits, which may or m ...

protein ( p24) subunits in capsid

hexamer In chemistry and biochemistry, an oligomer () is a molecule that consists of a few repeating units which could be derived, actually or conceptually, from smaller molecules, monomer, monomers.Quote: ''Oligomer molecule: A molecule of intermediate ...

s, interfering with essential steps of

viral replication Viral replication is the formation of biological viruses during the infection process in the target host cells. Viruses must first get into the cell before viral replication can occur. Through the generation of abundant copies of its genome ...

, including capsid-mediated nuclear uptake of HIV-1 proviral DNA, virus assembly and release, production of capsid protein subunits, and capsid core formation. The US

considers it to be a

first-in-class medication A first-in-class medication is a prototype drug that uses a "new and unique mechanism of action" to treat a particular medical condition. While the Food and Drug Administration's Center for Drug Evaluation and Research tracks first-in-class medic ...

History

Lenacapavir was developed by

Gilead Sciences Gilead Sciences, Inc. () is an American biopharmaceutical company headquartered in Foster City, California, that focuses on researching and developing antiviral drugs used in the treatment of HIV/AIDS, hepatitis B, hepatitis C, influenza, and CO ...

. The safety and efficacy of lenacapavir were established through a multicenter clinical trial with 72 participants whose HIV infections were resistant to multiple classes of HIV medications. These participants had to have high levels of virus in their blood despite being on antiretroviral drugs. Participants were enrolled into one of two study groups. One group was randomized to receive either lenacapavir or placebo in a double-blind fashion, and the other group received open-label lenacapavir. The primary measure of efficacy was the proportion of participants in the randomized study group who achieved a certain level of reduction in virus during the initial 14 days compared to baseline. The US

granted the application for lenacapavir

priority review Priority review is a program of the United States Food and Drug Administration (FDA) to expedite the review process for drugs that are expected to have a particularly great impact on the treatment of a disease. The priority review voucher program ...

, fast track, and

breakthrough therapy Breakthrough therapy is a United States Food and Drug Administration designation that expedites drug development that was created by Congress under Section 902 of the 9 July 2012 Food and Drug Administration Safety and Innovation Act. The FDA's "b ...

designations. In 2024, lenacapavir was named the "2024 Breakthrough of the Year", citing its "astonishing 100% efficacy" in one large efficacy trial in women to prevent HIV and "99.9% efficacy in gender diverse people who have sex with men," while highlighting that research providing a "new understanding of the structure and function of HIV's capsid protein" led to the drug's "off-the-charts success".

Society and culture

Legal status

In June 2022, the

Committee for Medicinal Products for Human Use The Committee for Medicinal Products for Human Use (CHMP), formerly known as the Committee for Proprietary Medicinal Products (CPMP), is the European Medicines Agency's committee responsible for elaborating the agency's opinions on all issues regar ...

of the

European Medicines Agency The European Medicines Agency (EMA) is an agency of the European Union (EU) in charge of the evaluation and supervision of pharmaceutical products. Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products ...

adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Sunlenca, intended for the treatment of adults with multidrug‑resistant human immunodeficiency virus type 1 (HIV‑1) infection. The applicant for this medicinal product is Gilead Sciences Ireland UC. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged. Lenacapavir was approved for medical use in the European Union in August 2022, in Canada in November 2022, and in the United States in December 2022. In February 2025, the FDA accepted Gilead Sciences's drug application for twice-yearly lenacapavir under priority review. The FDA approved lenacapavir for HIV prevention in June 2025. It will be sold under the brand name Yeztugo for this application.

Economics

the drug, produced by Gilead Sciences, costs for the first year. A study presented in July 2024 found that

mass production Mass production, also known as mass production, series production, series manufacture, or continuous production, is the production of substantial amounts of standardized products in a constant flow, including and especially on assembly lines ...

of a generic version would allow a profit margin of 30% on an annual price of $40 if used by 10 million people. The authors said that lowering world HIV levels significantly would probably require 60 million people to take the drug preventatively. Gilead Sciences set the list price for Yeztugo at $28,218 in 2025.

Research

Studies have been conducted for the use of lenacapavir in treatment-naive individuals. For virally suppressed individuals switching treatment, early studies have tested lenacapavir injections in combination with infusions of the broadly neutralizing antibodies teropavimab and zinlirvimab as well as lenacapavir with

islatravir Islatravir (4′-ethynyl-2-fluoro-2′-deoxyadenosine, EFdA, or MK-8591) is an investigational drug for the treatment of HIV infection. It is classified as a nucleoside reverse transcriptase translocation inhibitor (NRTTI). Merck is developing ...

. A

phase III clinical trial The phases of clinical research are the stages in which scientists conduct experiments with a health intervention to obtain sufficient evidence for a process considered effective as a medical treatment. For drug development, the clinical phase ...

study examined efficacy for pre-exposure HIV prevention (PrEP). It found an incidence rate ratio of 0.00 (as no cases occurred in the lenacapavir group) with a 95% confidence interval of 0.00-0.04 with p<.001. Injection site reactions led to discontinuation by 0.2% of lenacapavir patients Another lenacapavir phase III study, examined the incidence compared to the background rate for men persons. It found an incidence rate ratio of 0.04 with a 95% confidence interval of 0.01 to 0.18, at p<.001. Injection site reactions led to discontinuation by 1.2% of patients. Lenacapavir has been found to be effective as HIV pre-exposure prophylaxis (PrEP) in heterosexual cisgender women in Africa.

References

External links

* * {{Authority control Amides Antiretroviral drugs Chloroarenes Cyclopropanes Fluoroarenes Gilead Sciences Indazoles Orphan drugs Pyridines Sulfonamides Trifluoromethyl compounds