PMID- 36272024 OWN - NLM STAT- MEDLINE DCOM- 20221103 LR - 20230616 IS - 1179-1950 (Electronic) IS - 0012-6667 (Print) IS - 0012-6667 (Linking) VI - 82 IP - 14 DP - 2022 Sep TI - Lenacapavir: First Approval. PG - 1499-1504 LID - 10.1007/s40265-022-01786-0 [doi] AB - Lenacapavir (Sunlenca((R))) is a long-acting capsid inhibitor of human immunodeficiency virus type 1 (HIV-1) being developed by Gilead Sciences Inc. It is available as an oral tablet and injectable solution, with the latter being a slow-release formulation to allow bi-annual subcutaneous administration. In August 2022, lenacapavir received its first approval in the EU for use in combination with other antiretroviral(s) in adults with multi-drug resistant HIV infection, for whom it is otherwise not possible to construct a suppressive anti-viral regimen. This article summarizes the milestones in the development of lenacapavir leading to this first approval for the treatment of HIV-1 infection. CI - (c) 2022. The Author(s), under exclusive licence to Springer Nature Switzerland AG. FAU - Paik, Julia AU - Paik J AD - Springer Nature, Mairangi Bay, Private Bag 65901, Auckland, 0754, New Zealand. dru@adis.com. LA - eng PT - Journal Article PT - Review PL - New Zealand TA - Drugs JT - Drugs JID - 7600076 RN - 0 (Anti-HIV Agents) RN - 0 (Anti-Retroviral Agents) SB - IM EIN - Drugs. 2023 Jul;83(11):1061. PMID: 37314634 MH - Adult MH - Humans MH - *HIV Infections/drug therapy MH - *Anti-HIV Agents/pharmacology MH - *HIV-1 MH - Anti-Retroviral Agents/therapeutic use PMC - PMC10267266 COIS- During the peer review process the manufacturer of the agent under review was offered an opportunity to comment on the article. Changes resulting from any comments received were made by the authors on the basis of scientific completeness and accuracy. Julia Paik is a salaried employee of Adis International Ltd/Springer Nature, and declares no relevant conflicts of interest. All authors contributed to the review and are responsible for the article content. EDAT- 2022/10/23 06:00 MHDA- 2022/11/04 06:00 PMCR- 2022/10/22 CRDT- 2022/10/22 11:18 PHST- 2022/10/23 06:00 [pubmed] PHST- 2022/11/04 06:00 [medline] PHST- 2022/10/22 11:18 [entrez] PHST- 2022/10/22 00:00 [pmc-release] AID - 10.1007/s40265-022-01786-0 [pii] AID - 1786 [pii] AID - 10.1007/s40265-022-01786-0 [doi] PST - ppublish SO - Drugs. 2022 Sep;82(14):1499-1504. doi: 10.1007/s40265-022-01786-0.