{"id":"cabotegravir-oli","safety":{"commonSideEffects":[{"rate":null,"effect":"Diarrhea"},{"rate":null,"effect":"Nausea"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Insomnia"},{"rate":null,"effect":"Hypersensitivity reactions"}]},"_chembl":{"chemblId":"CHEMBL2403238","moleculeType":"Small molecule","molecularWeight":"405.36"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Cabotegravir inhibits HIV integrase, an enzyme essential for viral replication. By blocking integrase activity, the drug prevents integration of viral DNA into the host genome, thereby halting HIV replication. The OLI (once-daily integrase inhibitor) formulation is designed for convenient daily oral dosing in HIV treatment and prevention regimens.","oneSentence":"Cabotegravir is an integrase strand transfer inhibitor (INSTI) that blocks HIV integrase, preventing the virus from inserting its genetic material into human host cell DNA.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T00:16:57.595Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"HIV-1 infection in treatment-experienced adults"},{"name":"HIV-1 prevention (PrEP) in at-risk individuals"}]},"trialDetails":[{"nctId":"NCT05514509","phase":"PHASE4","title":"A Study Evaluating Implementation Strategies for the Delivery of APRETUDE for Black cis-and Transgender Women in United States EHE Territories","status":"COMPLETED","sponsor":"ViiV Healthcare","startDate":"2022-10-28","conditions":"HIV Infections","enrollment":370},{"nctId":"NCT05374525","phase":"PHASE4","title":"A Study Evaluating Implementation Strategies for the Delivery of Cabotegravir in Low and High-Volume PrEP Site in the United States","status":"COMPLETED","sponsor":"ViiV Healthcare","startDate":"2022-05-18","conditions":"HIV Infections","enrollment":287},{"nctId":"NCT05546242","phase":"PHASE3","title":"Improving HIV-1 Control in Africa with Long Acting Antiretrovirals","status":"ACTIVE_NOT_RECRUITING","sponsor":"MRC/UVRI and LSHTM Uganda Research Unit","startDate":"2022-12-08","conditions":"HIV-1-infection","enrollment":540},{"nctId":"NCT04542070","phase":"PHASE3","title":"A Study to Evaluate Efficacy and Safety of Cabotegravir (CAB) Long Acting (LA) Plus (+) Rilpivirine (RPV) LA Versus BIKTARVY® (BIK) in Participants With Human Immunodeficiency Virus (HIV)-1 Who Are Virologically Suppressed","status":"COMPLETED","sponsor":"ViiV Healthcare","startDate":"2020-11-09","conditions":"HIV Infections","enrollment":687},{"nctId":"NCT04371380","phase":"PHASE1","title":"Pharmacokinetic Study of Cabotegravir and Rilpivirine Long-acting Intramuscular Injections in Healthy Adult Participants","status":"COMPLETED","sponsor":"ViiV Healthcare","startDate":"2020-09-16","conditions":"HIV Infections","enrollment":15},{"nctId":"NCT04399551","phase":"PHASE3","title":"A Study Evaluating Implementation Strategies for Cabotegravir (CAB)+ Rilpivirine (RPV) Long-acting (LA) Injectables for Human Immunodeficiency Virus (HIV)-1 Treatment in European Countries","status":"COMPLETED","sponsor":"ViiV Healthcare","startDate":"2020-09-28","conditions":"HIV Infections","enrollment":437}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":7,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"marketed","status":"active","brandName":"Cabotegravir OLI","genericName":"Cabotegravir OLI","companyName":"ViiV Healthcare","companyId":"viiv-healthcare","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Cabotegravir is an integrase strand transfer inhibitor (INSTI) that blocks HIV integrase, preventing the virus from inserting its genetic material into human host cell DNA. Used for HIV-1 infection in treatment-experienced adults, HIV-1 prevention (PrEP) in at-risk individuals.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}