{"id":"liraglutide","brandName":"Victoza","genericName":"liraglutide","companyId":"novo-nordisk","companyName":"Novo Nordisk","phase":"marketed","status":"active","modality":"","aliases":[],"developmentCodes":[],"firstApprovalDate":null,"firstApprovalCountry":null,"aiSummary":"","enrichmentLevel":3,"visitCount":1,"mechanism":{"target":"Glucagon-like peptide 1 receptor","drugClass":"GLP-1 Receptor Agonist [EPC]"},"administration":{"route":"Subcutaneous"},"safety":{"boxedWarnings":["WARNING: RISK OF THYROID C-CELL TUMORS WARNING: RISK OF THYROID C-CELL TUMORS Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice. It is unknown whether liraglutide injection causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as the human relevance of liraglutide-induced rodent thyroid C-cell tumors has not been determined [ see Warnings and Precautions ( 5.1 ), Nonclinical Toxicology ( 13.1 ) ]. Liraglutide injection is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk for MTC with the use of liraglutide injection and inform them of symptoms of thyroid tumors (e.g., a mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with liraglutide injection [ see Contraindications ( 4 ), Warnings and Precautions ( 5.1 ) ]. WARNING: RISK OF THYROID C-CELL TUMORS See full prescribing information for complete boxed warning. • Liraglutide causes thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice. It is unknown whether liraglutide injection causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as the human relevance of liraglutide-induced rodent thyroid C-cell tumors has not been determined ( 5.1 , 13.1 ) . • Liraglutide injection is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk of MTC and the symptoms of thyroid tumors ( 4 , 5.1 )."],"safetySignals":[{"date":"","signal":"NAUSEA","source":"FDA FAERS","actionTaken":"7119 reports"},{"date":"","signal":"BLOOD GLUCOSE INCREASED","source":"FDA FAERS","actionTaken":"4052 reports"},{"date":"","signal":"VOMITING","source":"FDA FAERS","actionTaken":"3446 reports"},{"date":"","signal":"DIARRHOEA","source":"FDA FAERS","actionTaken":"3345 reports"},{"date":"","signal":"PANCREATITIS","source":"FDA FAERS","actionTaken":"2341 reports"},{"date":"","signal":"WEIGHT DECREASED","source":"FDA FAERS","actionTaken":"2115 reports"},{"date":"","signal":"DECREASED APPETITE","source":"FDA FAERS","actionTaken":"2113 reports"},{"date":"","signal":"HEADACHE","source":"FDA FAERS","actionTaken":"2018 reports"},{"date":"","signal":"OFF LABEL USE","source":"FDA FAERS","actionTaken":"1761 reports"},{"date":"","signal":"FATIGUE","source":"FDA FAERS","actionTaken":"1657 reports"}],"drugInteractions":[],"commonSideEffects":[{"effect":"Nausea","drugRate":"2.9%","severity":"common","organSystem":""},{"effect":"Vomiting","drugRate":"1.7%","severity":"common","organSystem":""},{"effect":"Diarrhea","drugRate":"1.4%","severity":"common","organSystem":""},{"effect":"Erythema at injection site","drugRate":"2.5%","severity":"common","organSystem":""},{"effect":"Pruritus at injection site","drugRate":"2.5%","severity":"common","organSystem":""},{"effect":"Rash at injection site","drugRate":"2.5%","severity":"common","organSystem":""}],"contraindications":["Breastfeeding (mother)","C-cell hyperplasia of thyroid","Disorder of thyroid gland","Hypoglycemic disorder","Medullary thyroid carcinoma","Multiple endocrine neoplasia, type 2","Pancreatitis","Pregnancy, function"],"specialPopulations":{},"discontinuationRates":[],"seriousAdverseEvents":[{"effect":"Severe hypoglycemia (requiring assistance)","drugRate":"0.7%","severity":"serious"}]},"trials":["NCT01744236","NCT01234649","NCT02611232","NCT03856632","NCT03182426","NCT01473953","NCT07374445","NCT02535299","NCT02584582","NCT01836523","NCT05390892","NCT05705388","NCT05479591","NCT05925959","NCT07029009","NCT01615978","NCT06836284","NCT04666987","NCT05390307","NCT02973321","NCT00620282","NCT04881110","NCT04952779","NCT02638805","NCT01226966","NCT01558271","NCT03038620","NCT03426085","NCT02089256","NCT05492305","NCT03233178","NCT01890993","NCT02607306","NCT00993304","NCT01270789","NCT04417582","NCT00518882","NCT03632759","NCT06742710","NCT03737240","NCT01612468","NCT01954147","NCT01550653","NCT03371862","NCT01845259","NCT03151005","NCT07304141","NCT03191396","NCT02503943","NCT06449235"],"indications":{"approved":[{"name":"Diabetes mellitus type 2","diseaseId":"diabetes-mellitus-type-2","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Weight loss","diseaseId":"weight-loss","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"}],"offLabel":[],"pipeline":[]},"commercial":{"revenueYear":2024,"annualRevenue":3200,"revenueSource":"Novo AR 2024 (Victoza/Saxenda)","revenueCurrency":"USD","revenueConfidence":"verified"},"patents":[{"type":"Method of Use","number":"9968659","applicant":"NOVO NORDISK INC","territory":"US","tradeName":"SAXENDA","expiryDate":"2037-01-09"},{"type":"Formulation","number":"8114833","applicant":"NOVO NORDISK INC","territory":"US","tradeName":"SAXENDA","expiryDate":"2025-08-13"},{"type":"Compound","number":"8114833*PED","applicant":"NOVO NORDISK INC","territory":"US","tradeName":"VICTOZA","expiryDate":"2026-02-13"},{"type":"Compound","number":"9968659*PED","applicant":"NOVO NORDISK INC","territory":"US","tradeName":"VICTOZA","expiryDate":"2037-07-09"}],"timeline":[],"rwe":[],"competitors":[],"ownershipHistory":[],"trialDetails":[{"nctId":"NCT01744236","phase":"Phase 4","title":"A Phase IV, 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of ITCA 650 in Patients With Type 2 Diabetes Receiving Stab","status":"COMPLETED","sponsor":"Intarcia Therapeutics","isPivotal":true,"enrollment":136,"indication":"Diabetes Mellitus, Type 2","completionDate":"2017-10"},{"nctId":"NCT01226966","phase":"N/A","title":"Conditions for Prescribing Liraglutide in Medical Practice and Assessment of Maintenance Level, Tolerability, and Efficacy of Victoza® (Liraglutide) in Subjects With Type 2 Diabetes","status":"COMPLETED","sponsor":"Novo Nordisk A/S","isPivotal":false,"enrollment":3152,"indication":"Diabetes, Diabetes Mellitus, Type 2","completionDate":"2013-11"},{"nctId":"NCT01558271","phase":"Phase 3","title":"A Phase 3 Study of LY2189265 Monotherapy Compared to Placebo and Liraglutide in Patients With Type 2 Diabetes Mellitus","status":"COMPLETED","sponsor":"Eli Lilly and Company","isPivotal":true,"enrollment":492,"indication":"Type 2 Diabetes Mellitus","completionDate":"2014-05"},{"nctId":"NCT03038620","phase":"Phase 4","title":"Impact of 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