Lenacapavir

Lenacapavir
Clinical data
Pronunciation/ˌlɛnəˈkæpəvɪər/
LEN-ə-KAP-ə-veer
Trade namesSunlenca, Yeztugo, others
Other namesGS-CA2, GS-6207
AHFS/Drugs.comMonograph
MedlinePlusa623005
License data
Pregnancy
category
Routes of
administration		By mouth, subcutaneous
Drug classCapsid inhibitors
ATC code
Legal status
Legal status
Identifiers
IUPAC name
  • N-[(1S)-1-{3-[4-chloro-3-(methanesulfonamido)-1-(2,2,2-trifluoroethyl)-1H-indazol-7-yl]-6-[3-(methanesulfonyl)-3-methylbut-1-yn-1-yl]pyridin-2-yl}-2-(3,5-difluorophenyl)ethyl]-2-[(3bS,4aR)-5,5-difluoro-3-(trifluoromethyl)-3b,4,4a,5-tetrahydro-1H-cyclopropa[3,4]cyclopenta[1,2-c]pyrazol-1-yl]acetamide
CAS Number
DrugBank
ChemSpider
UNII
KEGG
ChEMBL
PDB ligand
Chemical and physical data
FormulaC39H32ClF10N7O5S2
Molar mass968.28 g·mol−1
3D model (JSmol)
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
InChI
  • InChI=1S/C39H32ClF10N7O5S2/c1-36(2,63(3,59)60)10-9-21-5-6-22(23-7-8-26(40)30-32(23)57(17-37(43,44)45)54-35(30)55-64(4,61)62)31(51-21)27(13-18-11-19(41)14-20(42)12-18)52-28(58)16-56-34-29(33(53-56)39(48,49)50)24-15-25(24)38(34,46)47/h5-8,11-12,14,24-25,27H,13,15-17H2,1-4H3,(H,52,58)(H,54,55)/t24-,25+,27-/m0/s1
  • Key:BRYXUCLEHAUSDY-WEWMWRJBSA-N

Lenacapavir, sold under the brand names Sunlenca and Yeztugo, is an antiretroviral medication used to treat and prevent HIV/AIDS.[9][11] It is taken by mouth or by subcutaneous injection.[9][11] Lenacapavir is a human immunodeficiency virus type 1 (HIV-1) capsid inhibitor.[9][10]

The most common side effects include reactions at the injection site and nausea.[11][12]

Lenacapavir was approved for medical treatment in the European Union in August 2022,[11][13] in Canada in November 2022,[5][6] and in the United States in December 2022.[9][12][14][15] It is the first of a class of drugs called capsid inhibitors to be approved by the US Food and Drug Administration (FDA) for treating HIV/AIDS.[12][16] In June 2025, lenacapavir, as Yeztugo, received approval in the US for HIV prevention.[10][17][18][19]

  1. ^ a b "Sunlenca". Therapeutic Goods Administration. 6 April 2023. Archived from the original on 8 April 2023. Retrieved 7 April 2023.
  2. ^ "Sunlenca lenacapavir (as sodium) 300 mg film coated tablet blister pack (392350)". Therapeutic Goods Administration. 28 March 2023. Archived from the original on 8 April 2023. Retrieved 7 April 2023.
  3. ^ "Sunlenca lenacapavir (as sodium) 463.5 mg/1.5 mL solution for injection vial (386895)". Therapeutic Goods Administration. 28 March 2023. Archived from the original on 8 April 2023. Retrieved 7 April 2023.
  4. ^ "AusPAR: Sunlenca".
  5. ^ a b "Sunlenca Oral Product information". Health Canada. 25 April 2012. Archived from the original on 15 January 2023. Retrieved 23 December 2022.
  6. ^ a b "Sunlenca Subcutaneous Product information". Health Canada. 25 April 2012. Archived from the original on 15 January 2023. Retrieved 23 December 2022.
  7. ^ "Summary Basis of Decision - Sunlenca". Health Canada. 10 March 2023. Archived from the original on 25 April 2023. Retrieved 24 April 2023.
  8. ^ "Details for: Sunlenca". Health Canada. 15 March 2023. Archived from the original on 3 March 2024. Retrieved 3 March 2024.
  9. ^ a b c d e "Sunlenca- lenacapavir sodium tablet, film coated Sunlenca- lenacapavir sodium kit". DailyMed. 21 December 2022. Archived from the original on 21 January 2023. Retrieved 21 January 2023.
  10. ^ a b c Cite error: The named reference Yeztugo FDA label was invoked but never defined (see the help page).
  11. ^ a b c d e "Sunlenca EPAR". European Medicines Agency (EMA). 22 June 2022. Archived from the original on 26 August 2022. Retrieved 25 August 2022. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  12. ^ a b c "FDA Approves New HIV Drug for Adults with Limited Treatment Options" (Press release). U.S. Food and Drug Administration (FDA). 22 December 2022. Archived from the original on 15 January 2023. Retrieved 23 December 2022. This article incorporates text from this source, which is in the public domain.
  13. ^ "Gilead Announces First Global Regulatory Approval of Sunlenca (Lenacapavir), the Only Twice-Yearly HIV Treatment Option". Gilead Sciences (Press release). 22 August 2022. Archived from the original on 15 January 2023. Retrieved 23 December 2022.
  14. ^ "Sunlenca (lenacapavir) Receives FDA Approval as a First-in-Class, Twice-Yearly Treatment Option for People Living With Multi-Drug Resistant HIV". Gilead Sciences (Press release). 22 December 2022. Archived from the original on 23 December 2022. Retrieved 23 December 2022.
  15. ^ Paik J (September 2022). "Lenacapavir: First Approval". Drugs. 82 (14): 1499–1504. doi:10.1007/s40265-022-01786-0. PMC 10267266. PMID 36272024.
  16. ^ Cite error: The named reference New Drug Therapy Approvals 2022 was invoked but never defined (see the help page).
  17. ^ "FDA approves the world's only twice-a-year shot to prevent HIV". AP News. 18 June 2025. Retrieved 18 June 2025.
  18. ^ Mandavilli A (18 June 2025). "Regulators Approve Lenacapavir for H.I.V. Prevention". The New York Times. Retrieved 18 June 2025.
  19. ^ Cite error: The named reference Gilead PR 20250618 was invoked but never defined (see the help page).
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