{"id":"enfuvirtide","rwe":[],"tags":[{"label":"Human Immunodeficiency Virus 1 Fusion Inhibitor","category":"class"},{"label":"Peptide","category":"modality"},{"label":"J05AX07","category":"atc"},{"label":"Off-Patent","category":"patent"},{"label":"Active","category":"status"},{"label":"Human immunodeficiency virus infection","category":"indication"},{"label":"Roche","category":"company"},{"label":"Approved 2000s","category":"decade"},{"label":"Anti-HIV Agents","category":"pharmacology"},{"label":"Anti-Infective Agents","category":"pharmacology"},{"label":"Anti-Retroviral Agents","category":"pharmacology"},{"label":"Antiviral Agents","category":"pharmacology"},{"label":"HIV Fusion Inhibitors","category":"pharmacology"}],"phase":"marketed","safety":{"safetySignals":[{"llr":857.525,"date":"","count":461,"signal":"Depression","source":"DrugCentral FAERS","actionTaken":"Reported 461 times (LLR=858)"},{"llr":752.051,"date":"","count":158,"signal":"Lipodystrophy acquired","source":"DrugCentral FAERS","actionTaken":"Reported 158 times (LLR=752)"},{"llr":723.246,"date":"","count":488,"signal":"Drug interaction","source":"DrugCentral FAERS","actionTaken":"Reported 488 times (LLR=723)"},{"llr":692.692,"date":"","count":136,"signal":"Mitochondrial toxicity","source":"DrugCentral FAERS","actionTaken":"Reported 136 times (LLR=693)"},{"llr":632.859,"date":"","count":223,"signal":"Psychotic disorder","source":"DrugCentral FAERS","actionTaken":"Reported 223 times (LLR=633)"},{"llr":531.519,"date":"","count":116,"signal":"Psychiatric decompensation","source":"DrugCentral FAERS","actionTaken":"Reported 116 times (LLR=532)"},{"llr":496.552,"date":"","count":136,"signal":"Eyelid ptosis","source":"DrugCentral FAERS","actionTaken":"Reported 136 times (LLR=497)"},{"llr":470.02,"date":"","count":105,"signal":"Depression suicidal","source":"DrugCentral FAERS","actionTaken":"Reported 105 times (LLR=470)"},{"llr":434.671,"date":"","count":112,"signal":"Hypomania","source":"DrugCentral FAERS","actionTaken":"Reported 112 times (LLR=435)"},{"llr":417.608,"date":"","count":104,"signal":"Tearfulness","source":"DrugCentral FAERS","actionTaken":"Reported 104 times (LLR=418)"},{"llr":410.86,"date":"","count":77,"signal":"Progressive external ophthalmoplegia","source":"DrugCentral FAERS","actionTaken":"Reported 77 times (LLR=411)"},{"llr":403.798,"date":"","count":113,"signal":"Jaundice cholestatic","source":"DrugCentral FAERS","actionTaken":"Reported 113 times (LLR=404)"},{"llr":381.146,"date":"","count":95,"signal":"Psychomotor skills impaired","source":"DrugCentral FAERS","actionTaken":"Reported 95 times (LLR=381)"},{"llr":360.764,"date":"","count":94,"signal":"Depressive symptom","source":"DrugCentral FAERS","actionTaken":"Reported 94 times (LLR=361)"},{"llr":359.642,"date":"","count":114,"signal":"Schizophrenia","source":"DrugCentral FAERS","actionTaken":"Reported 114 times (LLR=360)"}],"drugInteractions":[{"url":"/drug/maraviroc","drug":"maraviroc","action":"Monitor closely","effect":"May interact with Maraviroc","source":"DrugCentral","drugSlug":"maraviroc"}],"commonSideEffects":[],"contraindications":["Breastfeeding (mother)","Pneumonia","Smokes tobacco daily"]},"trials":[],"aliases":[],"company":"Roche","patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=ENFUVIRTIDE","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T03:48:12.552466+00:00"},"timeline":{"url":"https://en.wikipedia.org/wiki/Enfuvirtide","method":"deterministic","source":"Wikipedia","rawText":"","confidence":0.8,"sourceType":"wikipedia","retrievedAt":"2026-04-20T03:48:25.255689+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T03:48:23.882054+00:00"},"regulatory.eu":{"url":"","method":"api_direct","source":"European Medicines Agency","rawText":"","confidence":1,"sourceType":"ema_api","retrievedAt":"2026-04-20T03:48:12.581998+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=ENFUVIRTIDE","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T03:48:24.637957+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL4085102/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T03:48:25.138996+00:00"}},"allNames":"fuzeon","offLabel":[],"synonyms":["enfuvirtide","fuzeon","pentafuside"],"timeline":[{"date":"2003-01-01","type":"neutral","source":"FDA Orange Book","milestone":"Rights transferred from ROCHE to Roche"},{"date":"2003-03-13","type":"positive","source":"DrugCentral","milestone":"FDA approval (Roche)"},{"date":"2023-05-27","type":"positive","source":"DrugCentral","milestone":"EMA approval (Roche Registration Gmbh)"}],"aiSummary":"Fuzeon (enfuvirtide) is a small molecule human immunodeficiency virus 1 (HIV-1) fusion inhibitor developed by Roche. It was approved by the FDA in 2003 for the treatment of HIV infection. As a fusion inhibitor, Fuzeon works by blocking the fusion of HIV with host cells, preventing the virus from entering and infecting cells. Despite being off-patent, Fuzeon remains a commercial product due to its unique mechanism of action and limited generic competition. Key safety considerations include its short half-life requiring multiple daily injections.","approvals":[{"date":"2003-03-13","orphan":false,"company":"ROCHE","regulator":"FDA"},{"date":"2023-05-27","orphan":false,"company":"ROCHE REGISTRATION GMBH","regulator":"EMA"}],"brandName":"Fuzeon","ecosystem":[{"indication":"Human immunodeficiency virus infection","otherDrugs":[{"name":"abacavir","slug":"abacavir","company":"Viiv Hlthcare"},{"name":"amprenavir","slug":"amprenavir","company":"Glaxosmithkline"},{"name":"atazanavir","slug":"atazanavir","company":"Bristol Myers Squibb"},{"name":"bictegravir","slug":"bictegravir","company":"Gilead Sciences Inc"}],"globalPrevalence":null}],"mechanism":{"novelty":"First-in-class","moaClass":"Fusion Protein Inhibitors","modality":"Peptide","drugClass":"Human Immunodeficiency Virus 1 Fusion Inhibitor","explanation":"","oneSentence":"","technicalDetail":"Fuzeon binds to the gp41 subunit of the HIV envelope glycoprotein, preventing the conformational change necessary for fusion and subsequent viral entry into host cells."},"_wikipedia":{"url":"https://en.wikipedia.org/wiki/Enfuvirtide","title":"Enfuvirtide","extract":"Enfuvirtide (INN), sold under the brand name Fuzeon, is an HIV fusion inhibitor, the first of a class of antiretroviral drugs used in combination therapy for the treatment of AIDS/HIV.","wiki_history":"==History==\nEnfuvirtide originated at Duke University, where researchers formed a pharmaceutical company known as Trimeris.  Trimeris began development on enfuvirtide in 1996 and initially designated it T-20. In 1999, Trimeris entered into partnership with Hoffmann-La Roche to complete the development of the drug. It was approved by the U.S. Food and Drug Administration (FDA) on 13 March 2003 as the first HIV fusion inhibitor, a new class of antiretroviral drugs. It was approved on the basis of two studies which compared the effect of optimized regimens of antiretroviral medication with and without the addition of enfuvirtide on serum viral load."},"commercial":{"launchDate":"2003","_launchSource":"DrugCentral (FDA 2003-03-13, ROCHE)"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/1010","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=ENFUVIRTIDE","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=ENFUVIRTIDE","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://en.wikipedia.org/wiki/Enfuvirtide","fields":["history","overview"],"source":"Wikipedia"},{"id":5,"url":"https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files","fields":["patents","exclusivity","genericManufacturers"],"source":"FDA Orange Book"}],"_emaChecked":true,"_enrichedAt":"2026-03-30T11:00:18.500793","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T03:48:27.030223+00:00","fieldsConflicting":2,"overallConfidence":0.8},"biosimilars":[],"competitors":[{"drugName":"maraviroc","drugSlug":"maraviroc","fdaApproval":"2007-08-06","genericCount":4,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"maribavir","drugSlug":"maribavir","fdaApproval":"2021-11-23","patentExpiry":"Oct 27, 2031","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"letermovir","drugSlug":"letermovir","fdaApproval":"2017-11-08","patentExpiry":"Jan 18, 2029","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"ibalizumab","drugSlug":"ibalizumab","fdaApproval":"2018-03-06","relationship":"same-class"},{"drugName":"tecovirimat","drugSlug":"tecovirimat","fdaApproval":"2018-07-13","patentExpiry":"Sep 4, 2031","patentStatus":"Patent 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patents","relatedDrugs":[{"drugId":"maraviroc","brandName":"maraviroc","genericName":"maraviroc","approvalYear":"2007","relationship":"same-class"},{"drugId":"maribavir","brandName":"maribavir","genericName":"maribavir","approvalYear":"2021","relationship":"same-class"},{"drugId":"letermovir","brandName":"letermovir","genericName":"letermovir","approvalYear":"2017","relationship":"same-class"},{"drugId":"ibalizumab","brandName":"ibalizumab","genericName":"ibalizumab","approvalYear":"2018","relationship":"same-class"},{"drugId":"tecovirimat","brandName":"tecovirimat","genericName":"tecovirimat","approvalYear":"2018","relationship":"same-class"},{"drugId":"baloxavir-marboxil","brandName":"baloxavir marboxil","genericName":"baloxavir 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