The most common side effects include reactions at the injection site and nausea.[11][14]
Lenacapavir was approved for medical treatment in the European Union in August 2022,[11][15] in Canada in November 2022,[5][6] and in the United States in December 2022.[16][17] It is the first of a class of drugs calledcapsid inhibitors to be approved by the USFood and Drug Administration for treating HIV/AIDS.[14][18] In June 2025, lenacapavir, as Yeztugo, received approval in the US for HIV prevention.[10][19][20][21]
Lenacapavir, as Sunlenca, in combination with other antiretrovirals, isindicated for the treatment of HIV/AIDS.[9] It is used in heavily treatment-experienced adults withmultiple drug resistance in whom current antiretroviral therapy is ineffective due to resistance, intolerance or safety considerations.[9][14]
Lenacapavir, (as Yeztugo or Yeytuo), is indicated forpre-exposure prophylaxis for HIV prevention to reduce the risk of sexually acquired HIV-1 in adults and adolescents weighing more than 35 kilograms (77 lb) who are at risk for HIV-1 acquisition.[10][12]
Lenacapavir works by binding directly to the interface betweenHIV-1 viralcapsid protein (p24) subunits in capsidhexamers,[22] interfering with essential steps ofviral replication, including capsid-mediated nuclear uptake of HIV-1 proviral DNA (it over-stabilizes the capsid, preventing it from properly releasing its contents),[23] virus assembly and release, production of capsid protein subunits, and capsid core formation.[9][14] The USFood and Drug Administration considers it to be afirst-in-class medication.[18][24]
Because lenacapavir is the first medication that targets the p24 capsid, mutations that confer resistance to other antiretrovirals have no effect on lenacapavir. However, mutations of the capsid can still confer resistance, especially when the drug is used without anoptimized background therapy.[25]
The safety and efficacy of lenacapavir were established through a multi-center clinical trial with 72 participants whose HIV infections were resistant to multiple classes of HIV medications.[14] These participants had to have high levels of virus in their blood despite being on antiretroviral drugs.[14] Participants were enrolled into one of two study groups.[14] One group was randomized to receive either lenacapavir or placebo in a double-blind fashion, and the other group received open-label lenacapavir.[14] 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.[14]
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".[27]
In June 2022, theCommittee for Medicinal Products for Human Use (CHMP) of theEuropean Medicines Agency 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.[28] The applicant for this medicinal product is Gilead Sciences Ireland UC.[28]
Lenacapavir was authorized for medical use in the European Union in August 2022,[11][29] in Canada in November 2022,[5][6] and in the United States in December 2022.[14][30]
In February 2025, the USFood and Drug Administration (FDA) accepted Gilead Sciences's drug application for twice-yearly lenacapavir under priority review.[31] The FDA approved lenacapavir (as Yeztugo) for HIV prevention in June 2025.[20][21]
In July 2025, the CHMP adopted a positive opinion recommending the granting of a marketing authorization for the medicinal product Yeytuo (lenacapavir) intended for the prophylaxis against sexually acquired human immunodeficiency virus type 1 (HIV-1) infection.[12][32] Yeytuo was authorized for medical use in the European Union in September 2025.[12][13]
As of 2024[update] the medication, produced by Gilead Sciences, costsUS$42,250 for the first year. A study presented in July 2024[33] found thatmass production of ageneric 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 drugpreventatively.[34]
Gilead Sciences set the list price for Yeztugo at $28,218 in 2025.[20]
In September 2025, partnerships led by theClinton Health Access Initiative,Unitaid, and theGates Foundation secured agreements withIndian manufacturers to provide lenacapavir for HIV prevention at US$40 per patient annually in 120 low- and middle-income countries.[35] The first doses of the drug arrived in Zambia and Eswatini later in 2025 with US and Gilead support,[36] though some advocacy groups criticized the Trump administration for trying to take credit after it "decimated" U.S. global AIDS programs.[37]
Studies have been conducted for the use of lenacapavir in treatment-naive individuals.[38] For virally suppressed individuals switching treatment, early studies have tested lenacapavir injections in combination with infusions of the broadly neutralizing antibodies teropavimab and zinlirvimab[39] as well as lenacapavir withislatravir.[40]
Aphase III clinical trial study examined efficacy forpre-exposure HIV prevention (PrEP).[41][42][43][44] 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.[45] 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.[46]
^abcdef"Sunlenca EPAR".European Medicines Agency (EMA). 22 June 2022.Archived from the original on 26 August 2022. Retrieved25 August 2022. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
^abcd"Yeytuo EPAR".European Medicines Agency (EMA). 25 July 2025. Retrieved27 July 2025. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
^ab"Yeytuo PI".Union Register of medicinal products. 25 August 2025. Retrieved30 September 2025.
^Margot NA, Jogiraju V, Pennetzdorfer N, Naik V, VanderVeen LA, Ling J, et al. (June 2025). "Resistance Analyses in Heavily Treatment-Experienced People With HIV Treated With the Novel HIV Capsid Inhibitor Lenacapavir After 2 Years".The Journal of Infectious Diseases.231 (5):1239–1245.doi:10.1093/infdis/jiaf050.PMID39873394.
^Cohen J (December 2024). "Science's 2024 Breakthrough of the Year: Opening the door to a new era of HIV prevention".Science.386 (6727):1208–1209.doi:10.1126/science.adv2100.PMID39666802.
^ab"Sunlenca: Pending EC decision".European Medicines Agency (EMA). 23 June 2022.Archived from the original on 26 June 2022. Retrieved26 June 2022. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
^Bekker LG, Das M, Abdool Karim Q, Ahmed K, Batting J, Brumskine W, et al. (October 2024). "Twice-Yearly Lenacapavir or Daily F/TAF for HIV Prevention in Cisgender Women".The New England Journal of Medicine.391 (13):1179–1192.doi:10.1056/NEJMoa2407001.PMID39046157.
^Kelley CF, Acevedo-Quiñones M, Agwu AL, Avihingsanon A, Benson P, Blumenthal J, et al. (November 2024). "Twice-Yearly Lenacapavir for HIV Prevention in Men and Gender-Diverse Persons".The New England Journal of Medicine.392 (13):1261–1276.doi:10.1056/NEJMoa2411858.PMID39602624.
^Bekker LG, Das M, Abdool Karim Q, Ahmed K, Batting J, Brumskine W, et al. (July 2024). "Twice-Yearly Lenacapavir or Daily F/TAF for HIV Prevention in Cisgender Women".The New England Journal of Medicine.391 (13):1179–1192.doi:10.1056/NEJMoa2407001.PMID39046157.
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