{"id":"fluticasone-furoate-umeclidinium-vilanterol-fuv","rwe":[],"tags":[],"safety":{"boxedWarnings":[],"drugInteractions":[],"commonSideEffects":[{"effect":"Nasopharyngitis","drugRate":"10%","severity":"Mild"},{"effect":"Upper respiratory tract infection","drugRate":"8%","severity":"Mild"},{"effect":"Headache","drugRate":"7%","severity":"Mild"}],"contraindications":[],"specialPopulations":{}},"trials":[],"_chembl":null,"aliases":["Trelegy"],"patents":[{"type":"Formulation","number":"8347879","applicant":"HALEON US HOLDINGS LLC","territory":"US","tradeName":"FLONASE SENSIMIST ALLERGY RELIEF","expiryDate":"2028-07-15"},{"type":"Formulation","number":"8062264","applicant":"HALEON US HOLDINGS LLC","territory":"US","tradeName":"FLONASE SENSIMIST ALLERGY RELIEF","expiryDate":"2026-04-05"},{"type":"Formulation","number":"8147461","applicant":"HALEON US HOLDINGS LLC","territory":"US","tradeName":"FLONASE SENSIMIST ALLERGY RELIEF","expiryDate":"2028-10-15"}],"pricing":[],"offLabel":[],"timeline":[{"date":"2023-01-01","type":"Clinical","milestone":"Phase 3 trial initiation","regulator":"FDA"}],"_dailymed":null,"aiSummary":"Fluticasone Furoate/Umeclidinium/Vilanterol (FUV) is a combination inhaler developed by Thammasat University for the maintenance treatment of chronic obstructive pulmonary disease (COPD). The drug combines a corticosteroid, a long-acting muscarinic antagonist, and a long-acting beta2-adrenergic agonist to provide comprehensive bronchodilation and anti-inflammatory effects. Despite its potential benefits, FUV has not yet received FDA approval, and its development status remains in the pipeline. Common side effects include nasopharyngitis, upper respiratory tract infection, and headache. The drug's safety profile and efficacy are currently being evaluated in clinical trials.","ecosystem":[],"mechanism":{"target":"Airway inflammation and bronchoconstriction","novelty":"Triple-combination therapy for COPD","modality":"Inhalation","drugClass":"Combination inhaler (ICS/LAMA/LABA)","explanation":"The combination of these three components targets multiple pathways involved in COPD pathophysiology, reducing airway inflammation and bronchoconstriction.","oneSentence":"FUV is a triple-combination inhaler that integrates a corticosteroid (fluticasone furoate), a long-acting muscarinic antagonist (umeclidinium), and a long-acting beta2-adrenergic agonist (vilanterol) to provide synergistic bronchodilation and anti-inflammatory effects.","technicalDetail":"Fluticasone furoate reduces inflammation by inhibiting the production of inflammatory cytokines and chemokines, umeclidinium blocks muscarinic receptors to prevent bronchoconstriction, and vilanterol stimulates beta2-adrenergic receptors to relax smooth muscle in the airways."},"_scrapedAt":"2026-03-27T23:46:44.735Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"commercial":{"yoyGrowth":null,"launchDate":null,"annualCostUS":null,"currentRevenue":null,"patientPopulation":null,"peakSalesEstimate":null},"references":[],"biosimilars":[],"competitors":[],"indications":{"approved":[],"offLabel":[],"pipeline":["Chronic Obstructive Pulmonary Disease (COPD)"]},"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT06905483","phase":"PHASE4","title":"Comparative Effects of Triple Inhaled Therapy With Budesonide/Glycopyrronium/Formoterol Versus Fluticasone Furoate/Umeclidinium/Vilanterol on Small Airway Disease in COPD Patients: A Randomized Crossover Study","status":"COMPLETED","sponsor":"Thammasat University","startDate":"2025-04-01","conditions":"COPD, Chronic Obstructive Pulmonary Disease (COPD), Small Airway Disease","enrollment":22}],"_emaApprovals":[],"_faersSignals":[],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"formularyStatus":[],"_approvalHistory":[],"developmentCodes":[],"ownershipHistory":[],"publicationCount":1,"therapeuticAreas":["Respiratory"],"biosimilarFilings":[],"companionDiagnostics":[],"genericManufacturerList":[],"phase":"marketed","status":"active","brandName":"Fluticasone Furoate/Umeclidinium/Vilanterol (FUV)","genericName":"Fluticasone Furoate/Umeclidinium/Vilanterol (FUV)","companyName":"Thammasat University","companyId":"thammasat-university","modality":"Small molecule","firstApprovalDate":"","enrichmentLevel":3,"visitCount":0,"regulatoryByCountry":[{"country_code":"US","regulator":"FDA","status":"approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"patentsNormalised":[{"patent_number":"8062264","territory":"US","patent_type":"Formulation","expiry_date":"2026-04-05T00:00:00.000Z","status":"active","paragraph_iv_filed":false},{"patent_number":"8347879","territory":"US","patent_type":"Formulation","expiry_date":"2028-07-15T00:00:00.000Z","status":"active","paragraph_iv_filed":false},{"patent_number":"8147461","territory":"US","patent_type":"Formulation","expiry_date":"2028-10-15T00:00:00.000Z","status":"active","paragraph_iv_filed":false}],"trialStats":{"total":2,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":false,"safety":true,"trials":true,"score":3}}