{"id":"rosiglitazone","rwe":[{"pmid":"41895020","year":"2026","title":"Reversing neuroinflammation in ischemic stroke through efferocytotic phenotype reprogramming with polymeric nanoparticles.","finding":"","journal":"Biomaterials","studyType":"Clinical Study"},{"pmid":"41883322","year":"2026","title":"Influence of heat-reinforcing Needling on the PPAR-γ/NF-κB signaling pathway in the synovial membrane of rats with rheumatoid arthritis.","finding":"","journal":"Histology and histopathology","studyType":"Clinical Study"},{"pmid":"41873711","year":"2026","title":"METTL14 inhibits atherogenesis by epigenetically activating PPAR-α/γ transcription and fatty acid oxidation in VSMCs.","finding":"","journal":"Cardiovascular research","studyType":"Clinical Study"},{"pmid":"41867865","year":"2026","title":"FDA-approved drug library screen identifies antidepressants, antimicrobials, anti-COPD, and anti-CVD agents as blockers of NLRP3 inflammasome and sepsis in a sex-dependent manner.","finding":"","journal":"bioRxiv : the preprint server for biology","studyType":"Clinical Study"},{"pmid":"41864062","year":"2026","title":"PPAR-γ suppresses macrophage senescence and allergic airway inflammation through controlling lipid metabolic pathways.","finding":"","journal":"EBioMedicine","studyType":"Clinical Study"}],"tags":[{"label":"Peroxisome Proliferator Receptor gamma Agonist","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"CDGSH iron-sulfur domain-containing protein 1","category":"target"},{"label":"CISD1","category":"gene"},{"label":"PPARA","category":"gene"},{"label":"PPARG","category":"gene"},{"label":"A10BD03","category":"atc"},{"label":"Oral","category":"route"},{"label":"Tablet","category":"form"},{"label":"Off-Patent","category":"patent"},{"label":"Generic Available","category":"availability"},{"label":"Mature","category":"status"},{"label":"Treatment Refractory Type 2 Diabetes Mellitus","category":"indication"},{"label":"Woodward","category":"company"},{"label":"Approved 1990s","category":"decade"},{"label":"Hypoglycemic Agents","category":"pharmacology"}],"phase":"marketed","safety":{"safetySignals":[{"llr":35622.427,"date":"","count":9704,"signal":"Myocardial infarction","source":"DrugCentral FAERS","actionTaken":"Reported 9,704 times (LLR=35622)"},{"llr":34095.743,"date":"","count":8894,"signal":"Cardiac failure congestive","source":"DrugCentral FAERS","actionTaken":"Reported 8,894 times (LLR=34096)"},{"llr":17196.152,"date":"","count":4449,"signal":"Coronary artery disease","source":"DrugCentral FAERS","actionTaken":"Reported 4,449 times (LLR=17196)"},{"llr":11987.389,"date":"","count":4131,"signal":"Cerebrovascular accident","source":"DrugCentral FAERS","actionTaken":"Reported 4,131 times (LLR=11987)"},{"llr":7102.474,"date":"","count":2285,"signal":"Acute myocardial infarction","source":"DrugCentral FAERS","actionTaken":"Reported 2,285 times (LLR=7102)"},{"llr":4925.447,"date":"","count":1030,"signal":"Coronary arterial stent insertion","source":"DrugCentral FAERS","actionTaken":"Reported 1,030 times (LLR=4925)"},{"llr":4544.011,"date":"","count":969,"signal":"Coronary artery bypass","source":"DrugCentral FAERS","actionTaken":"Reported 969 times (LLR=4544)"},{"llr":2435.137,"date":"","count":711,"signal":"Angina unstable","source":"DrugCentral FAERS","actionTaken":"Reported 711 times (LLR=2435)"},{"llr":1887.047,"date":"","count":657,"signal":"Myocardial ischaemia","source":"DrugCentral FAERS","actionTaken":"Reported 657 times (LLR=1887)"},{"llr":1418.838,"date":"","count":308,"signal":"Vascular graft","source":"DrugCentral FAERS","actionTaken":"Reported 308 times (LLR=1419)"},{"llr":1117.134,"date":"","count":328,"signal":"Ischaemic cardiomyopathy","source":"DrugCentral FAERS","actionTaken":"Reported 328 times (LLR=1117)"},{"llr":1099.228,"date":"","count":548,"signal":"Angina pectoris","source":"DrugCentral FAERS","actionTaken":"Reported 548 times (LLR=1099)"},{"llr":1052.81,"date":"","count":540,"signal":"Transient ischaemic attack","source":"DrugCentral FAERS","actionTaken":"Reported 540 times (LLR=1053)"},{"llr":995.254,"date":"","count":385,"signal":"Acute coronary syndrome","source":"DrugCentral FAERS","actionTaken":"Reported 385 times (LLR=995)"},{"llr":976.175,"date":"","count":366,"signal":"Arteriosclerosis coronary artery","source":"DrugCentral FAERS","actionTaken":"Reported 366 times (LLR=976)"}],"drugInteractions":[{"url":"/drug/choline-fenofibrate","drug":"choline fenofibrate","action":"Monitor closely","effect":"May interact with Fenofibric Acid","source":"DrugCentral","drugSlug":"choline-fenofibrate"},{"url":"/drug/ciprofloxacin","drug":"ciprofloxacin","action":"Monitor closely","effect":"May interact with Ciprofloxacin","source":"DrugCentral","drugSlug":"ciprofloxacin"},{"url":"/drug/fenofibrate","drug":"fenofibrate","action":"Monitor closely","effect":"May interact with Fenofibrate","source":"DrugCentral","drugSlug":"fenofibrate"},{"url":"/drug/levofloxacin","drug":"levofloxacin","action":"Monitor closely","effect":"May interact with Levofloxacin","source":"DrugCentral","drugSlug":"levofloxacin"},{"url":"/drug/norfloxacin","drug":"norfloxacin","action":"Monitor closely","effect":"May interact with Norfloxacin","source":"DrugCentral","drugSlug":"norfloxacin"},{"url":"/drug/ofloxacin","drug":"ofloxacin","action":"Monitor closely","effect":"May interact with Ofloxacin","source":"DrugCentral","drugSlug":"ofloxacin"}],"commonSideEffects":[{"effect":"Nausea/Vomiting","drugRate":"","severity":"common","organSystem":""},{"effect":"Anemia","drugRate":"7.1%","severity":"common","organSystem":""},{"effect":"Edema","drugRate":"4.8%","severity":"common","organSystem":""},{"effect":"Diarrhea","drugRate":"","severity":"common","organSystem":""},{"effect":"Headache","drugRate":"","severity":"common","organSystem":""},{"effect":"Dyspepsia","drugRate":"","severity":"common","organSystem":""},{"effect":"Hypoglycemia (rosiglitazone + metformin)","drugRate":"3%","severity":"common","organSystem":""},{"effect":"Hypoglycemia (rosiglitazone + insulin)","drugRate":"14%","severity":"common","organSystem":""},{"effect":"Edema (rosiglitazone + insulin)","drugRate":"14.7%","severity":"common","organSystem":""},{"effect":"Edema (rosiglitazone + metformin)","drugRate":"4.4%","severity":"common","organSystem":""}],"contraindications":["Acute vomiting","Adrenal cortical hypofunction","Alcohol intoxication","Alcoholism","Angina pectoris","Asthenia","Autonomic dysreflexia","Body fluid retention","Breastfeeding (mother)","Cardiogenic shock","Cerebrovascular accident","Chronic heart failure","Cobalamin deficiency","Decompensated cardiac failure","Dehydration","Disease of liver","Disorder of coronary artery","Drug-induced hepatitis","Fever","Fever greater than 100.4 Fahrenheit","Fracture of bone","Glucose-6-phosphate dehydrogenase deficiency anemia","Hemolytic anemia","Hepatic porphyria","Hypoglycemic disorder"],"specialPopulations":{"Pregnancy":"Pregnancy Category C. All pregnancies have background risk of birth defects, loss, or other adverse outcome regardless of drug exposure. This background risk is increased in pregnancies complicated by hyperglycemia and may be decreased with good metabolic control. It is essential for patients with diabetes or history of gestational diabetes to maintain good metabolic control before conception and throughout pregnancy. Careful monitoring of glucose control is essential in such patients. Most experts recommend that insulin monotherapy be used during pregnancy to maintain blood glucose levels as close to normal as possible. Human DataRosiglitazone has been reported to cross the human placenta and be detectable in fetal tissue. The clinical significance of these findings is unknown. There are no adequate and well-controlled studies in pregnant women. AVANDIA should not be used during pregnancy. Animal StudiesThere was no effect on implantation or the embryo with rosiglitazone treatment during early pregnancy in rats, but treatment during mid-late gestation was associated with fetal death and growth retardation in both rats and rabbits. Teratogenicity was not observed at doses up to mg/kg in rats and 100 mg/kg in rabbits (approximately 20 and 75 times human AUC at the maximum recommended human daily dose, respectively). Rosiglitazone caused placental pathology in rats (3 mg/kg/day). Treatment of rats during gestation through lactation reduced the viability of offspring and caused growth retardation. AVANDIA should not be used during pregnancy."},"seriousAdverseEvents":[{"effect":"Congestive Heart Failure","drugRate":"","severity":"serious"},{"effect":"Myocardial Infarction","drugRate":"","severity":"serious"},{"effect":"Myocardial Ischemia","drugRate":"","severity":"serious"},{"effect":"Sudden Death","drugRate":"","severity":"serious"},{"effect":"Fractures (women)","drugRate":"9.3%","severity":"serious"}]},"trials":[],"aliases":[],"company":"Woodward","patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=ROSIGLITAZONE","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T00:38:12.953416+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T00:38:17.841996+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=ROSIGLITAZONE","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T00:38:18.396257+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Peroxisome proliferator-activated receptor gamma agonist","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T00:38:19.510815+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL121/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T00:38:19.162885+00:00"}},"allNames":"avandia","offLabel":[],"synonyms":["rosiglitazone","rosiglitazone maleate","rosiglizole","rosiglitazone hydrochloride","rosiglitazone HCl"],"timeline":[{"date":"1999-01-01","type":"neutral","source":"FDA Orange Book","milestone":"Rights transferred from SB PHARMCO to Woodward"},{"date":"1999-05-25","type":"positive","source":"DrugCentral","milestone":"FDA approval (Sb Pharmco)"},{"date":"2013-01-25","type":"neutral","source":"FDA Orange Book","milestone":"Generic entry — 1 manufacturer approved"}],"aiSummary":"Avandia (Rosiglitazone) is a peroxisome proliferator-activated receptor gamma (PPARγ) agonist, a small molecule modality developed by SB Pharmco and currently owned by Woodward. It targets CDGSH iron-sulfur domain-containing protein 1 and was FDA-approved in 1999 for the treatment of type 2 diabetes mellitus. As an off-patent medication, Avandia is available as a generic. Key safety considerations include its potential to increase the risk of heart failure and fractures. Avandia has a half-life of 3.9 hours and high bioavailability of 99%.","approvals":[{"date":"1999-05-25","orphan":false,"company":"SB PHARMCO","regulator":"FDA"}],"brandName":"Avandia","ecosystem":[{"indication":"Treatment Refractory Type 2 Diabetes Mellitus","otherDrugs":[{"name":"glimepiride","slug":"glimepiride","company":"Sanofi Aventis Us"},{"name":"metformin","slug":"metformin","company":"Bristol Myers Squibb"}],"globalPrevalence":53000000}],"mechanism":{"target":"CDGSH iron-sulfur domain-containing protein 1","novelty":"Follow-on","targets":[{"gene":"CISD1","source":"DrugCentral","target":"CDGSH iron-sulfur domain-containing protein 1","protein":"CDGSH iron-sulfur domain-containing protein 1"},{"gene":"PPARA","source":"DrugCentral","target":"Peroxisome proliferator-activated receptor alpha","protein":"Peroxisome proliferator-activated receptor alpha"},{"gene":"PPARG","source":"DrugCentral","target":"Peroxisome proliferator-activated receptor gamma","protein":"Peroxisome proliferator-activated receptor gamma"},{"gene":"CISD2","source":"DrugCentral","target":"CDGSH iron-sulfur domain-containing protein 2","protein":"CDGSH iron-sulfur domain-containing protein 2"},{"gene":"FFAR1","source":"DrugCentral","target":"Free fatty acid receptor 1","protein":"Free fatty acid receptor 1"},{"gene":"TBXAS1","source":"DrugCentral","target":"Thromboxane-A synthase","protein":"Thromboxane-A synthase"},{"gene":"PPARD","source":"DrugCentral","target":"Peroxisome proliferator-activated receptor delta","protein":"Peroxisome proliferator-activated receptor delta"},{"gene":"CA2","source":"DrugCentral","target":"Carbonic anhydrase 2","protein":"Carbonic anhydrase 2"},{"gene":"MAOB","source":"DrugCentral","target":"Amine oxidase [flavin-containing] B","protein":"Amine oxidase [flavin-containing] B"},{"gene":"SLC10A1","source":"DrugCentral","target":"Sodium/bile acid cotransporter","protein":"Sodium/bile acid cotransporter"}],"moaClass":"Peroxisome Proliferator-activated Receptor Activity","modality":"Small Molecule","drugClass":"Peroxisome Proliferator Receptor gamma Agonist","explanation":"","oneSentence":"","technicalDetail":"Avandia binds to the PPARγ receptor, activating its transcriptional activity and increasing the expression of genes involved in glucose and lipid metabolism, leading to improved insulin sensitivity and glycemic control."},"commercial":{"launchDate":"1999","_launchSource":"DrugCentral (FDA 1999-05-25, SB PHARMCO)"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/2405","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=ROSIGLITAZONE","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=ROSIGLITAZONE","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files","fields":["patents","exclusivity","genericManufacturers"],"source":"FDA Orange Book"}],"_enrichedAt":"2026-03-30T15:36:55.281615","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T00:38:20.801347+00:00","fieldsConflicting":2,"overallConfidence":0.8},"biosimilars":[],"competitors":[{"drugName":"metformin","drugSlug":"metformin","fdaApproval":"1995-03-03","patentExpiry":"May 1, 2035","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"glimepiride","drugSlug":"glimepiride","fdaApproval":"1995-11-30","genericCount":17,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"pioglitazone","drugSlug":"pioglitazone","fdaApproval":"1999-07-15","genericCount":13,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"sitagliptin","drugSlug":"sitagliptin","fdaApproval":"2006-10-16","patentExpiry":"Feb 25, 2035","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"alogliptin","drugSlug":"alogliptin","fdaApproval":"2013-01-25","patentExpiry":"Jun 27, 2028","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"saxagliptin","drugSlug":"saxagliptin","fdaApproval":"2009-07-31","patentExpiry":"Nov 30, 2028","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"linagliptin","drugSlug":"linagliptin","fdaApproval":"2011-05-02","patentExpiry":"Sep 5, 2031","patentStatus":"Patent protected","relationship":"same-class"}],"genericName":"rosiglitazone","indications":{"approved":[{"name":"Treatment Refractory Type 2 Diabetes Mellitus","source":"DrugCentral","snomedId":"","regulator":"FDA","eligibility":"Adults with type 2 diabetes mellitus, in the presence of endogenous insulin, not for type 1 diabetes mellitus or diabetic ketoacidosis","usPrevalence":null,"globalPrevalence":53000000,"prevalenceMethod":"curated","prevalenceSource":"IDF estimate, 2024"}],"offLabel":[],"pipeline":[]},"currentOwner":"Woodward","drugCategory":"mature","labelChanges":[],"patentStatus":"Off-patent — no active Orange Book patents","relatedDrugs":[{"drugId":"metformin","brandName":"metformin","genericName":"metformin","approvalYear":"1995","relationship":"same-class"},{"drugId":"glimepiride","brandName":"glimepiride","genericName":"glimepiride","approvalYear":"1995","relationship":"same-class"},{"drugId":"pioglitazone","brandName":"pioglitazone","genericName":"pioglitazone","approvalYear":"1999","relationship":"same-class"},{"drugId":"sitagliptin","brandName":"sitagliptin","genericName":"sitagliptin","approvalYear":"2006","relationship":"same-class"},{"drugId":"alogliptin","brandName":"alogliptin","genericName":"alogliptin","approvalYear":"2013","relationship":"same-class"},{"drugId":"saxagliptin","brandName":"saxagliptin","genericName":"saxagliptin","approvalYear":"2009","relationship":"same-class"},{"drugId":"linagliptin","brandName":"linagliptin","genericName":"linagliptin","approvalYear":"2011","relationship":"same-class"}],"trialDetails":[{"nctId":"NCT05220917","phase":"","title":"Comparative Effectiveness and Safety of Four Second Line Pharmacological Strategies in Type 2 Diabetes Study","status":"ACTIVE_NOT_RECRUITING","sponsor":"Brigham and Women's Hospital","startDate":"2021-08-01","conditions":["Cardiovascular Events","Type2 Diabetes","Renal Disease"],"enrollment":781430,"completionDate":"2026-07-01"},{"nctId":"NCT03492580","phase":"","title":"A Study for Comparison of Canagliflozin Versus Alternative Antihyperglycemic Treatments on Risk of Heart Failure Hospitalization and Amputation for Participants With Type 2 Diabetes Mellitus and the Subpopulation With Established Cardiovascular Disease","status":"COMPLETED","sponsor":"Janssen Research & Development, LLC","startDate":"2018-02-22","conditions":["Diabetes Mellitus, Type 2","Cardiovascular Diseases"],"enrollment":714582,"completionDate":"2018-06-25"},{"nctId":"NCT04114136","phase":"PHASE2","title":"Anti-PD-1 mAb Plus Metabolic Modulator in Solid Tumor Malignancies","status":"RECRUITING","sponsor":"Dan Zandberg","startDate":"2020-09-14","conditions":["Melanoma","NSCLC","Hepatocellular Carcinoma","Urothelial Cancer","Gastric Adenocarcinoma","HNSCC","Esophageal Adenocarcinoma","Microsatellite Instability-High Solid Malignant Tumor"],"enrollment":72,"completionDate":"2032-04-30"},{"nctId":"NCT00607945","phase":"PHASE1","title":"Dietary Fatty Acids As Complementary Therapy in Type 2 Diabetes Mellitus","status":"COMPLETED","sponsor":"Ohio State University","startDate":"2008-01","conditions":["Type 2 Diabetes Mellitus"],"enrollment":48,"completionDate":"2012-05"},{"nctId":"NCT06449235","phase":"PHASE4","title":"Real-World Evaluation of Omarigliptin for Type 2 Diabetes Meliitus in Bangladesh","status":"NOT_YET_RECRUITING","sponsor":"Bangladesh Institute of Research and Rehabilitation in Diabetes, Endocrine and Metabolic Disorders","startDate":"2024-09","conditions":["Type2diabetes"],"enrollment":938,"completionDate":"2025-06"},{"nctId":"NCT02694874","phase":"NA","title":"Rosiglitazone Adjunctive Therapy for Severe Malaria in Children","status":"COMPLETED","sponsor":"Centro de Investigacao em Saude de Manhica","startDate":"2016-02","conditions":["Malaria"],"enrollment":210,"completionDate":"2021-12"},{"nctId":"NCT01017666","phase":"PHASE1","title":"BIIB014 Effects on the Pharmacokinetics (PK) of Rosiglitazone, Warfarin, and Midazolam","status":"COMPLETED","sponsor":"Biogen","startDate":"2009-11-01","conditions":["Healthy"],"enrollment":28,"completionDate":"2010-06-02"},{"nctId":"NCT00004180","phase":"PHASE2","title":"Rosiglitazone in Treating Patients With Liposarcoma","status":"COMPLETED","sponsor":"Dana-Farber Cancer Institute","startDate":"1999-10","conditions":["Sarcoma"],"enrollment":32,"completionDate":"2015-05"},{"nctId":"NCT00432679","phase":"PHASE3","title":"A Study Of BRL49653C For The Treatment Of Type 2 Diabetes (Combination Therapy With Sulfonyl Urea) -With Placebo 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Kidney Diseases (NIDDK)","startDate":"2004-05","conditions":["Diabetes Mellitus, Type II"],"enrollment":699,"completionDate":"2014-02"},{"nctId":"NCT00265148","phase":"PHASE2","title":"Brain Imaging Study Of Rosiglitazone Efficacy And Safety In Alzheimer's Disease","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2004-05-18","conditions":["Alzheimer's Disease"],"enrollment":80,"completionDate":"2008-07-10"},{"nctId":"NCT00616642","phase":"PHASE2","title":"Rosiglitazone in Treating Patients With Pituitary Tumors","status":"TERMINATED","sponsor":"Jonsson Comprehensive Cancer Center","startDate":"2006-10","conditions":["Brain and Central Nervous System Tumors"],"enrollment":1,"completionDate":"2010-11"},{"nctId":"NCT00612066","phase":"PHASE2","title":"Rosiglitazone in Treating Patients With Newly Diagnosed ACTH-Secreting Pituitary Tumor (Cushing Disease)","status":"TERMINATED","sponsor":"Jonsson Comprehensive Cancer Center","startDate":"2007-04","conditions":["Cushing's 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Montpellier","startDate":"2004-06","conditions":["Healthy"],"enrollment":12,"completionDate":"2004-11"},{"nctId":"NCT00427154","phase":"PHASE3","title":"Effect of Inhaled Pre-prandial Human Insulin on Blood Glucose Control in Type 2 Diabetes","status":"TERMINATED","sponsor":"Novo Nordisk A/S","startDate":"2007-01-10","conditions":["Diabetes","Diabetes Mellitus, Type 2"],"enrollment":227,"completionDate":"2008-03-11"},{"nctId":"NCT00577590","phase":"NA","title":"Effects of Fatty Acid Delivery on Heart Metabolism and Function in Type 2 Diabetes (T2DM","status":"COMPLETED","sponsor":"Washington University School of Medicine","startDate":"2003-10","conditions":["Diabetes Mellitus, Type II"],"enrollment":78,"completionDate":"2012-09"},{"nctId":"NCT00679939","phase":"PHASE4","title":"Study In Postmenopausal Women With Type 2 Diabetes Looking At Approved Diabetes Drugs And How They Affect Bone 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