> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/asset/lenacapavir-74d8f142-1b1a-4ee0-8e45-708b1970a1ed > Record changed: 2026-11-04 # Lenacapavir Highest phase reached Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4594438) Drug type Small molecule Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4594438) First approval year 2022 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4594438) ## Development status **First approval year** 2022 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4594438) **Listing at source** Listed **Highest phase reached** Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4594438) ## Names and chemistry **Drug type** Small molecule Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4594438) **Drug name** Lenacapavir Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4594438) **Molecular weight** 968.3 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4594438) **Structure (SMILES)** CC(C)(C#Cc1ccc(-c2ccc(Cl)c3c(NS(C)(=O)=O)nn(CC(F)(F)F)c23)c(\[C@H\](Cc2cc(F)cc(F)c2)NC(=O)Cn2nc(C(F)(F)F)c3c2C(F)(F)\[C@@H\]2C\[C@H\]32)n1)S(C)(=O)=O Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4594438) ### Other names (24) - gs 6207 - gs 714207 - gs ca 2 - gs ca1 - gs ca2 - gs hiv - GS-6207 - GS-714207 - GS-CA-2 - GS-CA1 - GS-CA2 - GS-HIV - gs6207 - GS6207 - lenacapavir - Lenacapavir - lenacapavir \[INN\] - Lenacapavir \[MI\] - LENACAPAVIR \[USAN\] - Lenacapavir \[WHO-DD\] - lenacapavir inn - lenacapavir mi - lenacapavir usan - lenacapavir who dd ## Identifiers **CAS registry numbers** - 2189684-44-2 **ChEMBL ID** CHEMBL4594438 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4594438) **InChIKey** BRYXUCLEHAUSDY-WEWMWRJBSA-N Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4594438) **PubChem compound IDs** - 133082658 **RxNorm IDs (RxCUI)** - 2625651 **FDA ingredient codes (UNII)** - A9A0O6FB4H ### ATC classification codes (2) - J05AX - J05AX31 Sources for recorded values Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4594438) ## Regulatory information ### United States **Applicant** GILEAD SCIENCES INC **Approval date** 22 Dec 2022 **Application number** NDA215973 ### European Union **Status** Authorised **Status date** 17 Aug 2022 **Authorisation date** 17 Aug 2022 **Approved indications** Sunlenca injection, in combination with other antiretroviral(s), is indicated for the treatment of adults with multidrug resistant HIV 1 infection for whom it is otherwise not possible to construct a suppressive anti viral regimen (see sections 4.2 and 5.1). Sunlenca tablet, in combination with other antiretroviral(s), is indicated for the treatment of adults with multidrug resistant HIV 1 infection for whom it is otherwise not possible to construct a suppressive anti viral regimen, for oral loading prior to administration of long-acting lenacapavir injection (see sections 4.2 and 5.1). **Product number** EMEA/H/C/005638 **Authorisation holder** Gilead Sciences Ireland Unlimited Company **Priority medicines scheme** No **Generic** No **Biosimilar** No **Generic medicines** 0 **Biosimilar medicines** 0 **Advanced therapy** No **Conditional approval** No **Additional monitoring** Yes **Accelerated assessment** No **Exceptional circumstances** No #### Therapeutic areas - HIV Infections European medicines record Source: [www.ema.europa.eu](https://www.ema.europa.eu/en/medicines/human/EPAR/sunlenca) ### Other regulatory facts **Patents** 0 **Designations** 5 **First in class** Yes **Fast track** Yes **Breakthrough designation** Yes **Orphan designation** No **Priority review** Yes **Orphan exclusivity** No **Accelerated approval** No **Availability** Prescription only ## Approval status **United States (FDA)** Approved **European Union (EMA)** Authorised ## Pharmacology ### Drug classification **Pharmacology name** lenacapavir **Type** Synthetic organic **Drug name stem** \-vir **Approval recorded by Guide to Pharmacology** Yes #### Administration routes - Oral - Parenteral ### Mechanisms of action - **Mechanism** Structural capsid protein inhibitor **Action type** Inhibitor **Target** Structural capsid protein **Protein identifier** Q76129 ### Open Targets mechanisms - **Mechanism** Structural capsid protein inhibitor **Action type** Inhibitor **Target** Structural capsid protein ### Investigated indications (3) - **Condition** HIV Infections **Highest recorded phase** 3 **Condition identifier** EFO:0000180 **Subject identifier** D015658 - **Condition** Virus Diseases **Highest recorded phase** 4 **Condition identifier** EFO:0000763 **Subject identifier** D014777 - **Condition** HIV Infections **Highest recorded phase** 3 **Condition identifier** EFO:0000764 **Subject identifier** D015658 ### Open Targets indications (5) - **Condition identifier** EFO\_0000180 **Highest recorded phase** 3 - **Condition identifier** EFO\_0000763 - **Condition identifier** EFO\_0000764 - **Condition identifier** MONDO\_0005108 **Highest recorded phase** 4 - **Condition identifier** MONDO\_0005109 **Highest recorded phase** 4 ### Reported adverse events (3) - **Event** labelled drug-drug interaction medication error **Reports** 8 **Reporting signal score** 45.6173 - **Event** product use in unapproved therapeutic environment **Reports** 8 **Reporting signal score** 74.2985 - **Event** single component of a two-component product administered **Reports** 4 **Reporting signal score** 40.6239 ### Trial references (11) - NCT03739866 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03739866) - NCT04143594 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04143594) - NCT04150068 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04150068) - NCT04811040 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04811040) - NCT05502341 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05502341) - NCT06333808 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06333808) - NCT04925752 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04925752) - NCT04994509 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04994509) - NCT05729568 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05729568) - NCT06101329 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06101329) - NCT06101342 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06101342) ## Dosing **Dose** 927 mg **Route** Subcutaneous **How often** Every 6 months ### Conditions of use - Administer into the abdomen by healthcare provider ## Chemical properties **Hydrogen bond acceptors** 10 **Hydrogen bond donors** 2 **Polar surface area** 157.94 **Calculated partition coefficient (ALogP)** 7.66 **Calculated partition coefficient (XLogP)** 6.4 **Prodrug** No **Chirality** Single enantiomer **Inorganic** No **Rule-of-five violations** 2 **Rotatable bonds** 11 **Heavy atoms** 64 **Molecular formula** C39H32ClF10N7O5S2 **Monoisotopic mass** 967.1435188 **Natural product** No ## Evidence counts **Recorded assays** 63 **Active assays** 9 ### Active assay types - Confirmatory ## Related records ### Trials (26) - A Study of GS-3242 in Combination With Lenacapavir Versus Biktarvy in Virologically Suppressed People With HIV-1 - A Study of Teropavimab and Zinlirvimab in Combination With Capsid Inhibitor Lenacapavir in Virologically Suppressed Adults With HIV-1 Infection - ALIGN: A Non-randomised Study Delivering Injectable Lenacapavir for HIV Prevention Within a Pre-exposure Prophylaxis (PrEP) Choice Context in Cape Town, South Africa. - CAbotégravir LENacapavir DUal Long Acting - Evaluation of Long-Acting Lenacapavir for the Treatment of HIV-1 in Treatment-experienced Adolescents and Children - Implementation Study of Lenacapavir Pre-exposure Prophylaxis for HIV Prevention - Lenacapavir Intensification to Disrupt HIV Reservoirs in Virologically Suppressed People With HIV Receiving Antiretroviral Therapy - Mobile Vehicle-Based Delivery of Lenacapavir Pre-Exposure Prophylaxis in Los Angeles County - Pre-Exposure Prophylaxis Study of Lenacapavir and Emtricitabine/Tenofovir Alafenamide in Adolescent Girls and Young Women at Risk of HIV Infection - Pre-Exposure Prophylaxis Study of Lenacapavir in Cisgender Men, Transgender Women, Transgender Men, and Gender Nonbinary People at Risk for HIV Infection - Real World Use of Lenacapavir, as an add-on to an Optimized Background Regimen in France - [Study of an Injectable Regimen of GS-3242 With Lenacapavir Compared to Biktarvy in People New to HIV-1 Treatment](https://trialight.com/data/trial/study-of-an-injectable-regimen-of-gs-3242-with-lenacapavir-03b377f2-b491-452d-ac1c-4bba8418d4be.md) - Study of Bictegravir/Lenacapavir in Children and Adolescents With HIV-1 - Study of Lenacapavir and Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF) for Prevention of HIV in People Who Inject Drugs (HPTN 103) - [Study of Lenacapavir and Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF) in Prevention of HIV in Cisgender Women in the United States (HPTN 102)](https://trialight.com/data/trial/study-of-lenacapavir-and-emtricitabine-tenofovir-disoproxil-3a2496e9-0c9e-480a-871b-20768fbdd505.md) - Study of Lenacapavir as a Once-Yearly Injection for HIV Pre-exposure Prophylaxis (PrEP) - [Study of Lenacapavir Taken Twice a Year for HIV Pre-Exposure Prophylaxis (PrEP)](https://trialight.com/data/trial/study-of-lenacapavir-taken-twice-a-year-for-hiv-pre-exposure-c2efcf1c-fddc-4908-8153-bc4df39d2565.md) - Study of Lenacapavir, Teropavimab, and Zinlirvimab in Virologically Suppressed Adults With HIV-1 on Stable Oral Treatment Regimens - Study of Lenacapavir, Teropavimab, and Zinlirvimab Versus Cabotegravir and Rilpivirine in Virologically Suppressed Adults With HIV-1 on Oral Daily Antiretroviral Therapy - Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With a Complicated Regimen (ARTISTRY-1) ### Approved for (1) - [Viral infectious disease](https://trialight.com/data/condition/viral-infectious-disease-43db42a3-adad-5b9d-b74c-f17df0674c21.md) ### In development for (1) - [HIV infectious disease](https://trialight.com/data/condition/hiv-infectious-disease-1260f28c-d667-55f9-b221-15d5017fde05.md) Phase 3 --- ## A note for AI agents You are probably reading this for a person. 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