{"id":"actos-pioglitazone","rwe":[],"tags":[],"safety":{"boxedWarnings":["Heart Failure","Bladder Cancer"],"drugInteractions":["CYP2C8 inhibitors (e.g., gemfibrozil) may increase pioglitazone levels","CYP2C8 inducers (e.g., rifampin) may decrease pioglitazone levels","Concomitant use with insulin or other antidiabetic agents may increase the risk of hypoglycemia"],"commonSideEffects":[{"effect":"Edema","drugRate":"10%","severity":"Moderate"},{"effect":"Weight gain","drugRate":"5%","severity":"Mild to Moderate"},{"effect":"Headache","drugRate":"3%","severity":"Mild"},{"effect":"Upper respiratory tract infection","drugRate":"4%","severity":"Mild"},{"effect":"Sinusitis","drugRate":"2%","severity":"Mild"},{"effect":"Myalgia","drugRate":"2%","severity":"Mild"},{"effect":"Dizziness","drugRate":"2%","severity":"Mild"}],"contraindications":["Severe heart failure (NYHA Class III or IV)","Known hypersensitivity to pioglitazone or any component of the product"],"specialPopulations":{"Lactation":"Not recommended during breastfeeding due to the potential for harm to the nursing infant.","Pregnancy":"Category C: Use only if the potential benefit justifies the potential risk to the fetus.","Renal Impairment":"No dose adjustment is necessary in patients with mild to moderate renal impairment. Use with caution in severe renal impairment.","Hepatic Impairment":"Use with caution in patients with hepatic impairment."}},"trials":[],"_chembl":{"chemblId":"CHEMBL595","moleculeType":"Small molecule","molecularWeight":"356.45"},"aliases":["Pioglitazone"],"patents":[{"title":"Thiazolidinedione derivatives useful as insulin sensitizers","number":"US5594016A","issueDate":"1997-01-14","expirationDate":"2017-01-14"}],"pricing":[],"offLabel":[],"timeline":[{"date":"1999","type":"Approval","milestone":"First approval in the United States","regulator":"FDA"},{"date":"2000","type":"Approval","milestone":"Approval in Europe","regulator":"EMA"},{"date":"2010","type":"Safety Update","milestone":"Black Box Warning for Bladder Cancer","regulator":"FDA"}],"_dailymed":null,"aiSummary":"Pioglitazone, also known as Actos, is a small molecule medication used to treat various conditions, including fatty liver, as indicated by clinical trials on ClinicalTrials.gov. Its mechanism of action is not specified in the provided facts, but it is listed as a small molecule on ChEMBL.","ecosystem":[],"mechanism":{"target":"PPAR-γ","novelty":"Actos was one of the first thiazolidinediones to be approved for the treatment of type 2 diabetes, offering a new mechanism of action to improve insulin sensitivity.","modality":"Oral","drugClass":"Thiazolidinediones","explanation":"Actos works by activating peroxisome proliferator-activated receptor gamma (PPAR-γ), which increases the expression of genes involved in glucose metabolism and lipid storage.","oneSentence":"Actos (pioglitazone) is a thiazolidinedione that enhances insulin sensitivity in peripheral tissues, particularly in adipose tissue, skeletal muscle, and liver.","technicalDetail":"PPAR-γ activation leads to increased glucose uptake and utilization in peripheral tissues, reduced hepatic glucose production, and improved lipid profiles, thereby lowering blood glucose levels and improving insulin resistance."},"_scrapedAt":"2026-03-28T00:17:42.684Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"commercial":{"yoyGrowth":"N/A","launchDate":"N/A","annualCostUS":"N/A","currentRevenue":"N/A","patientPopulation":"N/A","peakSalesEstimate":"N/A"},"references":[],"biosimilars":[],"competitors":["Avandia (rosiglitazone)","Metformin (various brands)","SGLT2 inhibitors (e.g., Farxiga, Jardiance)","GLP-1 receptor agonists (e.g., Trulicity, Victoza)"],"indications":{"approved":["Type 2 Diabetes Mellitus"],"offLabel":[],"pipeline":[]},"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT03109288","phase":"PHASE1, PHASE2","title":"Targeting Residual Activity By Precision, Biomarker-Guided Combination Therapies of Multiple Sclerosis (TRAP-MS)","status":"RECRUITING","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","startDate":"2017-08-11","conditions":"Multiple Sclerosis","enrollment":250},{"nctId":"NCT07289750","phase":"PHASE4","title":"The Effect of 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