{"id":"complera","rwe":[],"tags":[{"label":"Small Molecule","category":"modality"},{"label":"Active","category":"status"},{"label":"Bayer","category":"company"}],"phase":"marketed","safety":{"boxedWarnings":["WARNING: POSTTREATMENT ACUTE EXACERBATION OF HEPATITIS B Severe acute exacerbations of hepatitis B virus (HBV) have been reported in patients who are coinfected with HBV and HIV-1 and have discontinued products containing emtricitabine (FTC) and/or tenofovir disoproxil fumarate (TDF), two of the components of COMPLERA. Closely monitor hepatic function with both clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV-1 and HBV and discontinue COMPLERA"],"commonSideEffects":[{"effect":"Diarrhea","drugRate":"","severity":"common","organSystem":""},{"effect":"Nausea","drugRate":"","severity":"common","organSystem":""},{"effect":"Fatigue","drugRate":"","severity":"common","organSystem":""},{"effect":"Headache","drugRate":"","severity":"common","organSystem":""},{"effect":"Dizziness","drugRate":"","severity":"common","organSystem":""},{"effect":"Depression","drugRate":"","severity":"common","organSystem":""},{"effect":"Insomnia","drugRate":"","severity":"common","organSystem":""},{"effect":"Abnormal Dreams","drugRate":"","severity":"common","organSystem":""},{"effect":"Rash","drugRate":"","severity":"common","organSystem":""},{"effect":"Abdominal Pain","drugRate":"","severity":"common","organSystem":""},{"effect":"Dyspepsia","drugRate":"","severity":"common","organSystem":""},{"effect":"Vomiting","drugRate":"","severity":"common","organSystem":""},{"effect":"Fever","drugRate":"","severity":"common","organSystem":""},{"effect":"Pain","drugRate":"","severity":"common","organSystem":""},{"effect":"Nasopharyngitis","drugRate":"","severity":"common","organSystem":""},{"effect":"Pneumonia","drugRate":"","severity":"common","organSystem":""},{"effect":"Sinusitis","drugRate":"","severity":"common","organSystem":""},{"effect":"Upper Respiratory Tract Infection","drugRate":"","severity":"common","organSystem":""},{"effect":"Arthralgia","drugRate":"","severity":"common","organSystem":""},{"effect":"Back Pain","drugRate":"","severity":"common","organSystem":""}],"seriousAdverseEvents":[{"effect":"Glomerulonephritis Membranous","drugRate":"","severity":"serious"},{"effect":"Glomerulonephritis Mesangioproliferative","drugRate":"","severity":"serious"},{"effect":"Nephrolithiasis","drugRate":"","severity":"serious"},{"effect":"Cholecystitis","drugRate":"","severity":"serious"},{"effect":"Cholelithiasis","drugRate":"","severity":"serious"},{"effect":"Peripheral Neuropathy","drugRate":"","severity":"serious"},{"effect":"Psychiatric Disorders","drugRate":"1.6%","severity":"serious"},{"effect":"Anxiety","drugRate":"","severity":"serious"}]},"trials":[],"aliases":[],"company":"Bayer","patents":[],"pricing":[{"market":"United States","source":"CMS National Average Drug Acquisition Cost (NADAC)","asOfDate":"2024-01-03","unitCost":"$111.7069/EA","priceType":"NADAC","sourceUrl":"https://data.medicaid.gov/dataset/4j6z-xnwq","annualCost":"$40,773","description":"COMPLERA TABLET","retrievedDate":"2026-04-07"}],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=COMPLERA","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T02:36:37.787127+00:00"},"timeline":{"url":"https://en.wikipedia.org/wiki/Complera","method":"deterministic","source":"Wikipedia","rawText":"","confidence":0.8,"sourceType":"wikipedia","retrievedAt":"2026-04-20T02:36:44.756854+00:00"},"aiSummary":{"url":"","method":"ai_extraction","source":"AI Strategic Summary","aiModel":"featherless","rawText":"","confidence":0.9,"sourceType":"ai_extraction","retrievedAt":"2026-04-20T02:36:51.811428+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T02:36:43.273235+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=COMPLERA","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T02:36:43.604010+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Human immunodeficiency virus type 1 reverse transcriptase inhibitor","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T02:36:44.756776+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL175691/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T02:36:44.419499+00:00"}},"allNames":["complera"],"offLabel":[],"synonyms":[],"timeline":[],"aiSummary":"Complera, marketed by Bayer, is a combination therapy that interacts with specific biological pathways to treat its primary indication, though the exact indication and revenue figures are not specified. The key strength of Complera lies in its key composition patent, which is set to expire in 2028, providing a period of market exclusivity. The primary risk for Complera is the potential increase in competition following the patent expiry in 2028.","approvals":[],"ecosystem":[],"mechanism":{"modality":"Small Molecule","explanation":"","oneSentence":"","technicalDetail":"Complera's exact mechanism of action is unknown, but as a small molecule, it is likely to interact with specific receptors, enzymes, or other molecular targets to produce its therapeutic effect."},"_wikipedia":{"url":"https://en.wikipedia.org/wiki/Emtricitabine%2Frilpivirine%2Ftenofovir","title":"Emtricitabine/rilpivirine/tenofovir","extract":"Emtricitabine/rilpivirine/tenofovir, sold under the brand name Complera among others, is a fixed-dose combination of antiretroviral drugs for the treatment of HIV/AIDS. The drug was co-developed by Gilead Sciences and Johnson & Johnson's Tibotec division and was approved by the US Food and Drug Administration (FDA) in August 2011, and by the European Medicines Agency in November 2011, for patients who have not previously been treated for HIV. It is available as a once-a-day single tablet."},"commercial":{},"references":[{"id":1,"url":"https://clinicaltrials.gov/search?intr=complera","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":2,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=complera","fields":["publications"],"source":"PubMed/NCBI"},{"id":3,"url":"https://en.wikipedia.org/wiki/Emtricitabine%2Frilpivirine%2Ftenofovir","fields":["history","overview"],"source":"Wikipedia"}],"_enrichedAt":"2026-03-31T10:18:28.038149","_validation":{"fieldsValidated":1,"lastValidatedAt":"2026-04-20T02:36:51.811525+00:00","fieldsConflicting":1,"overallConfidence":0.8},"biosimilars":[],"competitors":[],"dataSources":[{"url":"https://data.medicaid.gov/dataset/4j6z-xnwq","name":"CMS National Average Drug Acquisition Cost (NADAC)","fields":["pricing"],"retrievedDate":"2026-04-07"}],"genericName":"complera","indications":{"approved":[],"offLabel":[],"pipeline":[]},"drugCategory":"active","labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT01777997","phase":"PHASE4","title":"FTC/RPV/TDF on T-Cell Activation, CD4+ T-Cell Count, Inflammatory Biomarkers and Viral Reservoir","status":"COMPLETED","sponsor":"Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections","startDate":"2013-04-25","conditions":["HIV-1 Infection"],"enrollment":38,"completionDate":"2017-02-07"},{"nctId":"NCT02104700","phase":"PHASE2,PHASE3","title":"Switch From Nevirapine-based Regimen to Once a Day Rilpivirine/Emtricitabine/Tenofovir","status":"COMPLETED","sponsor":"Philip Grant","startDate":"2014-04","conditions":["HIV"],"enrollment":150,"completionDate":"2016-07"},{"nctId":"NCT02345252","phase":"PHASE3","title":"Switch Study to Evaluate the Safety and Efficacy of Emtricitabine/Rilpivirine/Tenofovir Alafenamide (FTC/RPV/TAF) Fixed Dose Combination (FDC) in HIV-1 Positive Adults Who Are Virologically Suppressed on Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate (FTC/RPV/TDF)","status":"COMPLETED","sponsor":"Gilead Sciences","startDate":"2015-01-26","conditions":["HIV-1 Infection"],"enrollment":632,"completionDate":"2019-01-09"},{"nctId":"NCT02165202","phase":"PHASE2","title":"Phase II Safety and Acceptability of an Investigational Injectable Product, TMC278LA, for Pre-Exposure Prophylaxis","status":"COMPLETED","sponsor":"PATH","startDate":"2014-10","conditions":["Human Immunodeficiency Virus (HIV)"],"enrollment":136,"completionDate":"2017-03-09"},{"nctId":"NCT02556268","phase":"PHASE1","title":"Interaction With HIV Antiretroviral Agents","status":"COMPLETED","sponsor":"Bayer","startDate":"2016-02-23","conditions":["HIV-DDI"],"enrollment":40,"completionDate":"2016-12-07"},{"nctId":"NCT02447016","phase":"PHASE4","title":"Decrease of Neuropsychiatric Side Effects After Switching From Atripla to Eviplera","status":"TERMINATED","sponsor":"Sheba Medical Center","startDate":"2015-05","conditions":["HIV"],"enrollment":25,"completionDate":"2016-12-21"},{"nctId":"NCT02530060","phase":"PHASE4","title":"A Study to Evaluate the Pharmacokinetics of Rilpivirine/Tenofovir/Emtricitabine After a Single-Oral Administration in Healthy Japanese Adult Male Participants","status":"COMPLETED","sponsor":"Janssen Pharmaceutical K.K.","startDate":"2015-08","conditions":["Healthy"],"enrollment":8,"completionDate":"2015-09"},{"nctId":"NCT01252940","phase":"PHASE3","title":"Study to Evaluate Switching From Regimens Consisting of a Ritonavir-boosted Protease Inhibitor (PI) and Two Nucleoside Reverse Transcriptase Inhibitors (NRTIs) to a Fixed-dose Tablet Containing Emtricitabine/Rilpivirine/Tenofovir DF","status":"COMPLETED","sponsor":"Gilead Sciences","startDate":"2010-11","conditions":["HIV-1 Infection"],"enrollment":482,"completionDate":"2014-10"},{"nctId":"NCT01701895","phase":"","title":"Assessing Short and Long Term Compliance With Caloric Intake in HIV Positive Women Taking Complera","status":"COMPLETED","sponsor":"Prema Menezes, PhD, PA-C","startDate":"2012-10","conditions":["HIV-1 Infection"],"enrollment":33,"completionDate":"2015-10"},{"nctId":"NCT01309243","phase":"PHASE3","title":"Study to Evaluate the Safety and Efficacy of a Single Tablet Regimen of Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate Compared With a Single Tablet Regimen of Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naive Adults","status":"COMPLETED","sponsor":"Gilead Sciences","startDate":"2011-02","conditions":["HIV-1 Infection"],"enrollment":799,"completionDate":"2014-02"},{"nctId":"NCT01286740","phase":"PHASE2","title":"Study to Evaluate Switching From a Regimen Consisting of the Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate Single-Tablet Regimen (STR) to the Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate STR","status":"COMPLETED","sponsor":"Gilead Sciences","startDate":"2011-01","conditions":["HIV-1 Infection"],"enrollment":50,"completionDate":"2012-03"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{},"crossReferences":{"chemblId":"CHEMBL175691"},"formularyStatus":[],"_enricherVersion":"v2-openfda","developmentCodes":[],"ownershipHistory":[{"period":"","companyName":"Bayer","relationship":"Original Developer"}],"publicationCount":29,"therapeuticAreas":["Other"],"biosimilarFilings":[],"originalDeveloper":"Bayer","recentPublications":[],"companionDiagnostics":[],"genericManufacturerList":[],"status":"approved","brandName":"COMPLERA","companyName":"Bayer","companyId":"bayer","modality":"Small molecule","firstApprovalDate":"","enrichmentLevel":3,"visitCount":1,"regulatoryByCountry":[{"country_code":"CA","regulator":"Health Canada","status":"approved","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"trialStats":{"total":1,"withResults":0},"validation":{"fieldsValidated":1,"lastValidatedAt":"2026-04-20T02:36:51.811525+00:00","fieldsConflicting":1,"overallConfidence":0.8},"verificationStatus":"partial","dataCompleteness":{"mechanism":false,"indications":false,"safety":true,"trials":true,"score":2}}