Rosiglitazone
Small molecule targets PPARG via activation
Regulatory milestones approvals, filings & regulatory actions · 9 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Withdrawn | EU (EMA) | Avandia | — | 2015-07-11 | europa.eu ↗ |
| Label expansions (6) | US (FDA) | AVANDIA | — | 2000-04-03 – 2008-07-10 | fda.gov ↗ |
| Approved | EU (EMA) | Avandia | — | 2000-07-11 | europa.eu ↗ |
| Approved | US (FDA) | AVANDIA | — | 1999-05-25 | fda.gov ↗ |
Trials 140 · started per year
Also used as a comparator or background therapy in 53 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 16 trials | ||||||
| Phase 1 | NCT01415128 Comparator | Apr → May 2010 | erectile dysfunction | VIVUS LLC | Completed | No outcome recorded |
| Phase 1 | NCT01872780 Comparator | Aug 2008 → Feb 2009 | — | Inje University | Completed | No outcome recorded |
| Phase 1 | NCT00607945 Background | Jan 2008 → May 2012 | type 2 diabetes mellitus | Ohio State University | Completed | No outcome recorded |
| Phase 1 | NCT00692510 Background | Nov 2007 → Sep 2008 | Alzheimer disease | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT00362726 Comparator | Sep → Nov 2006 | HIV infectious disease | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1 | NCT00193648 Comparator | Jul 2005 → Oct 2007 | focal segmental glomerulosclerosis | Northwell Health | Completed | No outcome recorded |
| Phase 26 trials | ||||||
| Phase 2 | NCT00618072 Comparator | Jan 2008 → Jan 2011 | hyperinsulinism, obesity disorder | New York Medical College | Completed | No outcome recorded |
| Phase 2 | NCT00609362 Comparator | Jan 2008 → Nov 2009 | osteoporosis | University of Aarhus | Completed | No outcome recorded |
| Phase 2 | NCT00367744 Comparator | Jul 2006 → Dec 2008 | HIV infectious disease | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 2 | NCT01577095 Comparator | Apr 2006 → May 2007 | type 2 diabetes mellitus | China Medical University Hospital | Completed | No outcome recorded |
| Phase 2 | NCT00110851 Background | Apr 2005 → Aug 2007 | type 2 diabetes mellitus | Wellstat Therapeutics | Completed | No outcome recorded |
| Phase 2 | NCT00481663 Background | Aug 2003 → Jul 2004 | type 2 diabetes mellitus | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT00831129 Comparator | Sep 2006 → Mar 2011 | prediabetes syndrome | University of Chicago | Completed | No outcome recorded |
| Phase 2/3 | NCT00119496 Comparator | Jul 2005 → Jun 2007 | asthma | University of Glasgow | Completed | No outcome recorded |
| Phase 319 trials | ||||||
| Phase 3 | NCT00975286 Background | Oct 2009 → Aug 2011 | type 2 diabetes mellitus | Sanofi | Completed | No outcome recorded |
| Phase 3 | NCT00680745 Background | Apr 2008 → Nov 2009 | type 2 diabetes mellitus | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT00484419 Comparator | May 2007 → Apr 2008 | hyperlipidemia, type 2 diabetes mellitus | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 3 | NCT00427154 Comparator | Jan 2007 → Mar 2008 | type 2 diabetes mellitus | Novo Nordisk A/S | Terminated | No outcome recorded |
| Phase 3 | NCT00348712 Comparator | Oct 2006 → Mar 2008 | type 2 diabetes mellitus | Novo Nordisk A/S | Terminated | No outcome recorded |
| Phase 3 | NCT00343980 Comparator | Oct 2006 → Mar 2008 | type 2 diabetes mellitus | Novo Nordisk A/S | Terminated | No outcome recorded |
| Phase 3 | NCT00396227 Comparator | Oct 2006 → Oct 2007 | type 2 diabetes mellitus | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT00350779 Background | Jun 2006 → Sep 2007 | type 2 diabetes mellitus | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT00361868 Comparator | Jun 2006 → Dec 2007 | glucose metabolism disease, hyperlipidemia | Solvay Pharmaceuticals | Terminated | No outcome recorded |
| Phase 3 | NCT00541775 Comparator | Jun 2006 → Mar 2007 | type 2 diabetes mellitus | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT00333151 Background | May 2006 → Aug 2007 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 3 | NCT00295633 Background | Mar 2006 → Oct 2007 | type 2 diabetes mellitus | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT00131664 Comparator | Sep 2005 → Jan 2008 | type 2 diabetes mellitus | Canadian Heart Research Centre | Completed | No outcome recorded |
| Phase 3 | NCT00116922 Comparator | Jun 2004 → Jan 2010 | diabetes mellitus, glucose intolerance | Samuel Lunenfeld Research Institute, Mount Sinai Hospital | Completed | No outcome recorded |
| Phase 3 | NCT00324350 Comparator | Oct 2003 → Jun 2009 | atherosclerosis, coronary artery disorder, hyperlipoproteinemia, hypertensive disorder +1 | University of California, San Francisco | Completed | No outcome recorded |
| Phase 3 | NCT00182052 Comparator | Sep 2000 → Aug 2003 | prostate adenocarcinoma | Massachusetts General Hospital | Completed | No outcome recorded |
| Phase 3 | NCT00331487 Comparator | Sep 2000 → Mar 2004 | type 2 diabetes mellitus | Takeda | Completed | No outcome recorded |
| Phase 3 | NCT00006305 Comparator | Sep 2000 → Nov 2008 | coronary artery disorder, type 2 diabetes mellitus | University of Pittsburgh | Completed | No outcome recorded |
| Phase 3 | NCT00000620 Background | Sep 1999 → Jun 2009 | atherosclerosis, coronary artery disorder, hyperlipoproteinemia, hypertensive disorder +1 | National Heart, Lung, and Blood Institute (NHLBI) | Completed | No outcome recorded |
| Phase 414 trials | ||||||
| Phase 4 | NCT06449235 Comparator | Sep 2024 → Apr 2025 overdue | type 2 diabetes mellitus | Bangladesh Institute of Research and Rehabilitation in Diabetes, Endocrine and Metabolic Disorders | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT00879970 Comparator | May 2009 → Nov 2010 | type 2 diabetes mellitus | GlaxoSmithKline | Terminated | No outcome recorded |
| Phase 4 | NCT00948324 Comparator | Jun 2008 → May 2019 | type 2 diabetes mellitus | Sun Yat-sen University | Suspended | No outcome recorded |
| Phase 4 | NCT00679939 Comparator | Apr 2008 → Sep 2010 | type 2 diabetes mellitus | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 4 | NCT00953498 Comparator | Oct 2007 → Mar 2012 | type 2 diabetes mellitus | Centre Hospitalier Universitaire Dijon | Completed | No outcome recorded |
| Phase 4 | NCT00386100 Comparator | Oct 2006 → Sep 2009 | type 2 diabetes mellitus | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 4 | NCT00207402 Comparator | Oct 2005 → Jan 2010 | hepatitis C virus infection | Brooke Army Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT00640224 Comparator | Mar 2005 → Jul 2015 | polycystic ovary syndrome | Silva Arslanian | Completed | No outcome recorded |
| Phase 4 | NCT00373178 Comparator | Jan 2005 → Jan 2007 | type 2 diabetes mellitus | Aristotle University Of Thessaloniki | Completed | No outcome recorded |
| Phase 4 | NCT00738023 Comparator | Mar 2004 → Dec 2009 | hypertensive disorder, type 2 diabetes mellitus | Emory University | Completed | No outcome recorded |
| Phase 4 | NCT00746174 Comparator | Feb 2004 → Mar 2007 | — | University of Texas Southwestern Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT01045590 Comparator | Dec 2003 → Feb 2006 | type 2 diabetes mellitus | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 4 | NCT00337350 Comparator | Sep 2003 → Jan 2011 | schizophrenia | Massachusetts General Hospital | Completed | No outcome recorded |
| Phase 4 | NCT02526615 Comparator | Oct 2000 → Dec 2001 | type 2 diabetes mellitus | Turku University Hospital | Completed | No outcome recorded |
| Phase not applicable6 trials | ||||||
| — | NCT00776607 Comparator | Apr 2007 → Apr 2011 | latent autoimmune diabetes in adults | Abertawe Bro Morgannwg University NHS Trust | Unknown | No outcome recorded |
| — | NCT00324675 Comparator | Aug 2006 → Dec 2008 | diabetic kidney disease, type 2 diabetes mellitus | Technical University Dresden | Completed | No outcome recorded |
| — | NCT00413335 Comparator | Nov 2005 → Sep 2008 | glucose intolerance, obesity disorder, type 2 diabetes mellitus | Yale University | Completed | No outcome recorded |
| — | NCT00186537 Comparator | Sep 2003 → Sep 2008 | hypertriglyceridemia | Stanford University | Completed | No outcome recorded |
| — | NCT00225225 Comparator | Oct 2002 → Sep 2005 | type 2 diabetes mellitus | Stanford University | Terminated | No outcome recorded |
| — | NCT00194896 Comparator | Feb 2000 → Sep 2008 | type 2 diabetes mellitus | University of Washington | Completed | No outcome recorded |
Press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2007-09-27 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Announces Settlement Of Generic Avandia®, Avandamet®, And Avandaryl® Litigation With Glaxosmithkline tevapharm.com ↗ |
| 2004-12-21 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Announces Tentative Approval Of Rosiglitazone Maleate Tablets tevapharm.com ↗ |
Evidence & citations 17 cited values
Every value below carries the sentence it was read from. 197 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | rosiglitazone | “An extended release (XR) formulation of rosiglitazone maleate (RSG), a new formulation of rosiglitazone, is being investigated as a treatment for patients with mild to moderate...” NCT00884533 ↗188“Patients in the glibenclamide + rosiglitazone treatment group who have FPG \< 270mg/dL after the glibenclamide 5mg om run-in will receive glibenclamide 5mg om + rosiglitazone 4mg om.” NCT01045590 ↗ “Rosiglitazone improves glycemic control for patients with type 2 diabetes mellitus, but there remains controversy regarding an observed association with cardiovascular hazard.” PMID 23857320 ↗ Jul 2013 “This study compares the effects of Avandamet (rosiglitazone maleate/metformin) treatment and metformin plus sulphonylurea treatment in overweight people with type 2 diabetes.” NCT00359112 ↗ “combined rosiglitazone/metformin (Avandametä) to placebo in subjects with normal or intermediate fasting glucose (IFG) and stable coronary artery disease.” NCT00343395 ↗ “Patients will progress from lifestyle modification to metformin, to metformin with Rosiglitazone and finally insulin depending on HbA1c levels.” NCT00776607 ↗ “Rosiglitazone Versus Rosiglitazone and Metformin Versus Rosiglitazone and Avandia in the Treatment of Nonalcoholic Steatohepatitis (NASH)” NCT00699036 ↗ “Avandamet contains two drugs commonly used to control blood sugar levels in patients with diabetes (metformin and rosiglitazone).” NCT00933309 ↗ “Chemical Name: Thiazolidinediones (e.g., Pioglitazone, Rosiglitazone) Class: Thiazolidinediones (TZDs)” NCT06449235 ↗ “TZD (either rosiglitazone or pioglitazone) if given, to be continued at stable dose up to Week 24.” NCT00975286 ↗ “pioglitazone 30 mg (or rosiglitazone in countries where pioglitazone was not licensed)” NCT00481663 ↗ “Rosiglitazone was used by 74% and pioglitazone by 13% of participants.” PMID 26305617 ↗ Aug 2015 “RSG:CSII combined with three months rosiglitazoneor 4mg QD.” NCT00948324 ↗ “Avandamet (Rosiglitazone maleate/metformin hydrochloride)” NCT00386100 ↗ “Actos (pioglitazone), Avandia (rosiglitazone)” NCT00396227 ↗ “Rosiglitazone maleate on days 1 and 9” NCT01376063 ↗ “Rosiglitazone 8 mg single dose” NCT01577095 ↗ “Avandia (rosiglitazone)” NCT00207402 ↗ “rosiglitazone (Avandia)” NCT00000620 ↗ |
| Known as | Avandia | “Effect of Rosiglitazone Maleate (Avandia®) on Carotid Intima Media Thickness, Brachial Artery Reactivity, Glucose Metabolism, Blood Lipid Concentrations, Body Fat Distribution,...” NCT00143624 ↗12“This study was designed to evaluate the safety and efficacy of AVANDIA (rosiglitazone) (8mg once daily) in African American and Hispanic patients with type 2 diabetes mellitus.” NCT00333723 ↗ “This study utilizes the drug rosiglitazone (Avandia)to treat the effects of airway inflammation in patients with asthma.” NCT00614874 ↗ “Rosiglitazone (also called "Avandia") is used to treat insulin resistance in people who have diabetes” NCT00130286 ↗ “AvandiaTM and AmarylTM combine two antidiabetic agents, rosiglitazone maleate and glimepiride.” NCT00131664 ↗ “receive either placebo (control) or rosiglitazone, Avandia®, 4 mg daily for 2 weeks.” NCT00121953 ↗ “Rosiglitazone (Avandia) vs. Placebo for Androgen Dependent Prostate Cancer” NCT00182052 ↗ “Rosiglitazone (Avandia®): PPARgamma agonist IND69,782:” NCT00193648 ↗ “Avandia® (Rosiglitazone Maleate)” NCT00484419 ↗ “rosiglitazone (Avandia)” NCT00025753 ↗ “Avandia (Rosiglitazone)” NCT00064727 ↗ |
| Known as | Avandia (GlaxoSmithKline) | “Avandia (GlaxoSmithKline)” NCT00675740 ↗ |
| Known as | Avandia (rosiglitazone) | “Avandia (rosiglitazone)” NCT00207402 ↗ |
| Known as | BRL-049653 | “A Study to Evaluate the Efficacy of Rosiglitazone (BRL-049653) on Reduction of Microalbuminuria in Subjects With Type 2 Diabetes Mellitus” NCT00500955 ↗ |
| Known as | BRL49653C | “Clinical Evaluation of Rosiglitazone Malate (BRL49653C) in Patients With Type 2 Diabetes Mellitus -Long-term Study of Rosiglitazone Maleate-” NCT00523913 ↗3“Clinical Evaluation of Rosiglitazone Malate (BRL49653C) in Patients With Type 2 Diabetes Mellitus” NCT00297063 ↗ “Rosiglitazone (BRL49653C)” NCT00432679 ↗ |
| Known as | rosiglitazone (Avandia) | “rosiglitazone (Avandia)” NCT00000620 ↗1“rosiglitazone: AVANDIA” NCT00953498 ↗ |
| Known as | Rosiglitazone Malate | “Clinical Evaluation of Rosiglitazone Malate (BRL49653C) in Patients With Type 2 Diabetes Mellitus -Long-term Study of Rosiglitazone Maleate-” NCT00523913 ↗1“Clinical Evaluation of Rosiglitazone Malate (BRL49653C) in Patients With Type 2 Diabetes Mellitus” NCT00297063 ↗ |
| Known as | rosiglitazone maleate | “Effect of Rosiglitazone Maleate (Avandia®) on Carotid Intima Media Thickness, Brachial Artery Reactivity, Glucose Metabolism, Blood Lipid Concentrations, Body Fat Distribution,...” NCT00143624 ↗8“An extended release (XR) formulation of rosiglitazone maleate (RSG), a new formulation of rosiglitazone, is being investigated as a treatment for patients with mild to moderate...” NCT00884533 ↗ “Clinical Evaluation of Rosiglitazone Malate (BRL49653C) in Patients With Type 2 Diabetes Mellitus -Long-term Study of Rosiglitazone Maleate-” NCT00523913 ↗ “Patients receive 4 mg oral rosiglitazone maleate once daily in week 1 and then 8 mg once daily beginning in week 2” NCT00616642 ↗ “Participants in this arm receive 4 mg of study drug (rosiglitazone maleate) twice daily by mouth.” NCT00004180 ↗ “Drug: rosiglitazone maleate” NCT00551564 ↗ “Drug: rosiglitazone maleate” NCT00484419 ↗ “Drug: rosiglitazone maleate” NCT00369174 ↗ “rosiglitazone maleate” NCT00084578 ↗ |
| Known as | Rosiglitazone XR | “Rosiglitazone XR (extended release) oral tablets” NCT00334568 ↗1“Drug: Rosiglitazone XR” NCT00490568 ↗ |
| Known as | RSG | “This was a randomized, double-blind, double dummy, multicenter study to assess the safety, efficacy and tolerability of the addition of RSG (rosiglitazone) to sub-maximal MET...” NCT00501020 ↗7“Rosiglitazone (RSG) has been tested in clinical studies and is approved by the FDA as a treatment for type II diabetes mellitus, a disease that occurs when the body is unable...” NCT00348309 ↗ “An extended release (XR) formulation of rosiglitazone maleate (RSG), a new formulation of rosiglitazone, is being investigated as a treatment for patients with mild to moderate...” NCT00884533 ↗ “Rosiglitazone (RSG) has been tested in clinical studies and is approved by the FDA as a treatment for type II diabetes mellitus, a disease that occurs when the body is unable...” NCT00348140 ↗ “After a 1-year randomized trial, 53 patients underwent a control liver biopsy and were enrolled in an open-label extension trial of rosiglitazone (RSG), 8 mg/day for 2 additional years.” PMID 19877169 ↗ Feb 2010 “Subjects were randomized to rosiglitazone (RSG) or metformin (MET) for 52 wk followed by 24 wk of open-label MET.” PMID 27052635 ↗ Mar 2016 “The efficacy of diuretics in the management of rosiglitazone (RSG)-induced fluid retention was evaluated” PMID 17093067 ↗ Nov 2006 “either rosiglitazone (RSG) 4 mg b.i.d or matching placebo (PLC) for 52 weeks” PMID 22723267 ↗ Jun 2012 |
| Known as | RSG XR | “All subjects will receive rosiglitazone extended-release (RSG XR) 4mg once daily for the first 4 weeks of the study followed by 8mg RSG XR as adjunctive therapy to their...” NCT00490568 ↗2“All subjects will receive rosiglitazone extended-release (RSG XR) 4mg once daily for the first 4 weeks of the study followed by 8mg RSG XR.” NCT00550420 ↗ “Extended Release Formulation of Rosiglitazone (RSG XR)” NCT00688207 ↗ |
| Known as | TZD | “rosiglitazone (TZD) and electroacupuncture (EA) combined therapy” NCT01577095 ↗ |
| Action | Activate | “Rosiglitazone, a Full-Agonist Ligand for the Peroxisome Proliferator-Activated Receptor Gamma (PPAR)” NCT00004180 ↗ |
| Modality | Small molecule | “insulin-sensitizing compounds” NCT00018382 ↗ |
| Route | Oral | “Patients receive oral rosiglitazone twice daily.” NCT00004180 ↗ |
| Target | PPARG | “Rosiglitazone works by stimulating the PPAR gamma system.” NCT00006493 ↗ |