Drugs / Rosiglitazone
Rosiglitazone
also known as
Avandia · Rosiglitazone maleate · RSG · BRL49653C · RSG XR · Rosiglitazone Malate · Rosiglitazone XR · rosiglitazone: AVANDIA · +4 more
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| Withdrawn | EU (EMA) | Avandia | — | 2015-07-11 | europa.eu ↗ |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
today
US approved 1999
EU approved 2000
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 120 trials · 1 met primary | ||||||
| Phase 1 | NCT01287598 | Aug 2011 → Jul 2018 | neoplasm | Bayer | Completed | No outcome recorded |
| Phase 1 | NCT01402076 | Aug 2011 | — | Vanda Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT01209143 | Nov 2010 → Mar 2012 | — | Genentech, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01100619 | Apr 2010 → Aug 2012 | renal cell carcinoma, thyroid Hurthle cell carcinoma, thyroid gland papillary carcinoma | Exelixis | Completed | No outcome recorded |
| Phase 1 | NCT01376063 | Mar → May 2010 | — | Kyntra Bio | Completed | No outcome recorded |
| Phase 1 | NCT01088594 | Feb → Mar 2010 | type 2 diabetes mellitus | Solvay Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT00964106 | Aug 2009 → Aug 2011 | — | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT00933309 | Jul 2009 → Aug 2012 | female breast carcinoma | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 1 | NCT00884533 | Jun → Aug 2009 | Alzheimer disease | GlaxoSmithKline | Withdrawn | No outcome recorded |
| Phase 1 | NCT00811356 | Dec 2008 → Mar 2009 | malaria | GlaxoSmithKline | Terminated | No outcome recorded |
| Phase 1 | NCT00785213 | Sep → Oct 2008 | — | Mutual Pharmaceutical Company, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00733785 | Aug → Nov 2008 | Alzheimer disease | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT00688207 | Apr → Sep 2008 | Alzheimer disease | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT00615212 | Jan → Feb 2008 | type 2 diabetes mellitus | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT00551564 | Jul 2007 → Sep 2008 | type 2 diabetes mellitus | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT00511823 | Jul → Sep 2007 | chemotherapy-induced toxicity | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT00443170 | Nov 2006 → ? | anemia | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT00318630 | Jul 2005 → Jun 2006 | asthma | GlaxoSmithKline | Completed | Met primary |
| Phase 1 | NCT00039663 | May 2002 → Oct 2005 | HIV infectious disease | National Institutes of Health Clinical Center (CC) | Completed | No outcome recorded |
| Phase 1 | NCT00006185 | Sep 1999 → Aug 2003 | HIV infectious disease, lipodystrophy | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Completed | No outcome recorded |
| Phase 1/23 trials · 1 met primary | ||||||
| Phase 1/2 | NCT00309660 | Nov 2005 → Jun 2007 | ulcerative colitis | Herlev Hospital | Unknown | No outcome recorded |
| Phase 1/2 | NCT00130286 | Mar 2005 → Aug 2010 | HIV infectious disease, lipodystrophy, metabolic syndrome X | Weill Medical College of Cornell University | Completed | No outcome recorded |
| Phase 1/2 | NCT00149383 | Dec 2004 → Nov 2005 | Plasmodium falciparum malaria | Mahidol University | Completed | Met primary |
| Phase 225 trials · 2 met primary · 1 missed | ||||||
| Phase 2 | NCT04114136 | Sep 2020 → Apr 2032 expected | esophageal adenocarcinoma, gastric adenocarcinoma, head and neck squamous cell carcinoma, hepatocellular carcinoma +3 | Dan Zandberg | Recruiting | No outcome recorded |
| Phase 2 | NCT00614874 | Dec 2008 → Feb 2010 | asthma | Creighton University | Completed | Met primary |
| Phase 2 | NCT00405015 | Apr 2007 → Jul 2008 | abdominal obesity-metabolic syndrome, ischemic disease | Radboud University Medical Center | Completed | No outcome recorded |
| Phase 2 | NCT00699036 | Apr 2007 → Jul 2009 | NAFLD1, metabolic dysfunction-associated steatohepatitis | Brooke Army Medical Center | Unknown | No outcome recorded |
| Phase 2 | NCT00612066 | Apr 2007 → Nov 2010 | ACTH-dependent Cushing syndrome | Jonsson Comprehensive Cancer Center | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT01150981 | Nov 2006 → Apr 2010 | metabolic syndrome X | University of Massachusetts, Worcester | Completed | No outcome recorded |
| Phase 2 | NCT00616642 | Oct 2006 → Nov 2010 | central nervous system neoplasm | Jonsson Comprehensive Cancer Center | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT00381238 | Jun 2006 → Feb 2009 | Alzheimer disease | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT00242593 | Jun 2006 → Dec 2011 | cognitive impairment with or without cerebellar ataxia | University of Washington | Unknown | No outcome recorded |
| Phase 2 | NCT00369174 | Jun 2006 → Aug 2007 | oral mucosa leukoplakia | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 2 | NCT00115661 | Jul 2005 → May 2006 | endometriosis | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Terminated | No outcome recorded |
| Phase 2 | NCT00178841 | Jun 2005 → Mar 2007 | Sezary syndrome, mycosis fungoides | Vanderbilt University | Completed | No outcome recorded |
| Phase 2 | NCT00309309 | Apr 2005 → Jul 2007 | — | Mario Negri Institute for Pharmacological Research | Completed | No outcome recorded |
| Phase 2 | NCT00334568 | Dec 2004 → Jul 2007 | Alzheimer disease | GlaxoSmithKline | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT00379600 | Nov 2004 → Dec 2006 | rheumatoid arthritis | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT00098852 | Oct 2004 → Jun 2010 | head and neck cancer | University of California, San Francisco | Unknown | No outcome recorded |
| Phase 2 | NCT00265148 | May 2004 → Jul 2008 | Alzheimer disease | GlaxoSmithKline | Completed | Missed primary |
| Phase 2 | NCT00370305 | May 2004 → Oct 2008 | glucose intolerance, metabolic syndrome X | Charite University, Berlin, Germany | Completed | No outcome recorded |
| Phase 2 | NCT00064727 | Jul 2003 → Apr 2007 | congestive heart failure | National Heart, Lung, and Blood Institute (NHLBI) | Completed | No outcome recorded |
| Phase 2 | NCT00492700 | Jan 2003 → ? | metabolic dysfunction-associated steatohepatitis | Association pour la Recherche sur les Maladies Hépatiques Virales | Completed | No outcome recorded |
| Phase 2 | NCT00065065 | Sep 2002 → Jan 2008 | ulcerative colitis | James Lewis | Completed | Met primary |
| Phase 2 | NCT00018382 | Oct 1999 → Mar 2003 | Alzheimer disease | US Department of Veterans Affairs | Completed | No outcome recorded |
| Phase 2 | NCT00004180 | Oct 1999 → Mar 2006 | sarcoma | Dana-Farber Cancer Institute | Completed | No outcome recorded |
| Phase 2 | NCT00015626 | — | diabetes mellitus | National Center for Research Resources (NCRR) | Completed | No outcome recorded |
| Phase 2 | NCT00006493 | — | HIV infectious disease, hyperlipidemia | National Center for Research Resources (NCRR) | Completed | No outcome recorded |
| Phase 2/33 trials | ||||||
| Phase 2/3 | NCT00169923 | Apr 2007 → May 2009 | chronic kidney disease | Leiden University Medical Center | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 2/3 | NCT00121953 | Jul 2005 → May 2008 | endometriosis | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Withdrawn | No outcome recorded |
| Phase 2/3 | NCT04148183 | Jan 2004 → Jan 2005 | — | J JESUS VENEGAS, MD | Completed | No outcome recorded |
| Phase 335 trials · 5 met primary · 7 missed | ||||||
| Phase 3 | NCT01453049 | Apr → Oct 2010 | type 2 diabetes mellitus | GlaxoSmithKline | Terminated | No outcome recorded |
| Phase 3 | NCT00550420 | Oct 2007 → Feb 2009 | Alzheimer disease | GlaxoSmithKline | Terminated | No outcome recorded |
| Phase 3 | NCT00490568 | Aug 2007 → Jun 2009 | Alzheimer disease | GlaxoSmithKline | Terminated | No outcome recorded |
| Phase 3 | NCT00452166 | Apr 2007 → Mar 2008 | chronic kidney disease | Leiden University Medical Center | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT00428090 | Feb 2007 → Sep 2008 | Alzheimer disease | GlaxoSmithKline | Completed | Missed primary |
| Phase 3 | NCT01574820 | Nov 2006 → Aug 2010 | coronary artery disorder, glucose intolerance, prediabetes syndrome | National Cheng-Kung University Hospital | Completed | No outcome recorded |
| Phase 3 | NCT00399711 | Nov 2006 → Nov 2007 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | Met primary |
| Phase 3 | NCT00348140 | Jul 2006 → Mar 2009 | Alzheimer disease | GlaxoSmithKline | Completed | Missed primary |
| Phase 3 | NCT00432679 | May 2006 → Mar 2007 | type 2 diabetes mellitus | GlaxoSmithKline | Completed | Met primary |
| Phase 3 | NCT00318422 | May 2006 → May 2007 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | Met primary |
| Phase 3 | NCT00409097 | Apr 2006 → Dec 2007 | critical illness polyneuropathy, multiple organ dysfunction syndrome | Amsterdam UMC, location VUmc | Unknown | No outcome recorded |
| Phase 3 | NCT00297063 | Jan 2006 → May 2007 | type 2 diabetes mellitus | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00465296 | Jan 2006 → Jul 2007 | metabolic syndrome X | Medstar Health Research Institute | Terminated | No outcome recorded Stop: Business |
| Phase 3 | NCT00523913 | Nov 2005 → Apr 2007 | type 2 diabetes mellitus | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00135330 | Oct 2005 → Jul 2008 | type 2 diabetes mellitus | AstraZeneca | Completed | Missed primary |
| Phase 3 | NCT00349427 | Oct 2005 → ? | type 2 diabetes mellitus | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00240604 | Apr 2005 → Dec 2013 | glucose intolerance | Hadassah Medical Organization | Unknown | No outcome recorded |
| Phase 3 | NCT00116831 | Jan 2005 → Aug 2008 | atherosclerosis | GlaxoSmithKline | Completed | Missed primary |
| Phase 3 | NCT00081328 | May 2004 → Feb 2011 | type 2 diabetes mellitus | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Completed | Met primary |
| Phase 3 | NCT00359112 | Feb 2004 → ? | type 2 diabetes mellitus | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00422955 | Nov 2003 → Oct 2005 | diabetic neuropathy | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00499707 | Oct 2003 → Dec 2004 | type 2 diabetes mellitus | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00203632 | Sep 2003 → Oct 2007 | diabetes mellitus | University of Calgary | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT00169832 | Jun 2003 → Jul 2007 | diabetes mellitus | Laval University | Completed | Missed primary |
| Phase 3 | NCT00197132 | Oct 2002 → Aug 2003 | — | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00123227 | Oct 2002 → May 2005 | hypertensive disorder, type 2 diabetes mellitus | Royal Brompton & Harefield NHS Foundation Trust | Unknown | No outcome recorded |
| Phase 3 | NCT00489229 | Oct 2002 → Dec 2005 | diabetes mellitus, glucose intolerance | Universiti Sains Malaysia | Completed | Missed primary |
| Phase 3 | NCT00231387 | Sep 2002 → May 2005 | type 2 diabetes mellitus | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00140647 | Jul 2001 → Jul 2006 | atherosclerosis, glucose intolerance | Gerstein, Hertzel, MD | Completed | Missed primary |
| Phase 3 | NCT00095654 | Jul 2001 → Oct 2006 | cardiovascular disorder, glucose intolerance | Gerstein, Hertzel, MD | Completed | Mixed |
| Phase 3 | NCT00379769 | Apr 2001 → Dec 2008 | type 2 diabetes mellitus | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00032487 | Dec 2000 → May 2008 | type 2 diabetes mellitus | VA Office of Research and Development | Completed | No outcome recorded |
| Phase 3 | NCT00500955 | Apr 2000 → Jun 2004 | type 2 diabetes mellitus | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00279045 | Jan 2000 → Jun 2006 | type 2 diabetes mellitus | GlaxoSmithKline | Completed | Met primary |
| Phase 3 | NCT01706211 | Oct 1998 → Apr 2000 | type 2 diabetes mellitus | National Taiwan University Hospital | Completed | No outcome recorded |
| Phase 431 trials · 1 met primary · 3 missed | ||||||
| Phase 4 | NCT00819910 | Sep 2008 → May 2010 | hypertriglyceridemia | Ahmad Slim | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT00567593 | Oct 2007 → Mar 2008 | inflammatory bowel disease | James Lewis | Completed | No outcome recorded |
| Phase 4 | NCT00343395 | Jun 2006 → Nov 2007 | coronary artery disorder | Intermountain Health Care, Inc. | Terminated | No outcome recorded |
| Phase 4 | NCT00314561 | May → Dec 2006 | metabolic syndrome X | Korea University Anam Hospital | Completed | No outcome recorded |
| Phase 4 | NCT00225355 | Feb → Nov 2006 | metabolic syndrome X | University of Glasgow | Terminated | No outcome recorded |
| Phase 4 | NCT00274495 | Jan 2006 → Oct 2007 | chronic hepatitis C virus infection, fatty liver disease | Beth Israel Medical Center | Terminated | No outcome recorded |
| Phase 4 | NCT00300911 | Dec 2005 → ? | type 2 diabetes mellitus | Baskent University | Completed | No outcome recorded |
| Phase 4 | NCT00318656 | Nov 2005 → Oct 2007 | type 2 diabetes mellitus | GlaxoSmithKline | Completed | Missed primary |
| Phase 4 | NCT00440375 | Jun 2005 → Mar 2006 | obesity disorder, type 2 diabetes mellitus | Baskent University | Completed | No outcome recorded |
| Phase 4 | NCT00424762 | Feb 2005 → Apr 2007 | type 2 diabetes mellitus | University of Texas Southwestern Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT00306176 | Jan 2005 → Oct 2006 | type 2 diabetes mellitus | Aristotle University Of Thessaloniki | Completed | No outcome recorded |
| Phase 4 | NCT00364221 | Nov 2004 → Jul 2006 | metabolic syndrome X | University of Colorado, Denver | Completed | No outcome recorded |
| Phase 4 | NCT00367055 | Oct 2004 → Oct 2008 | type 2 diabetes mellitus | GlaxoSmithKline | Completed | Missed primary |
| Phase 4 | NCT00571506 | May 2004 → Aug 2007 | type 2 diabetes mellitus, vascular disorder | University of Arkansas | Completed | No outcome recorded |
| Phase 4 | NCT00290394 | Mar → Aug 2004 | type 2 diabetes mellitus | Baskent University | Completed | No outcome recorded |
| Phase 4 | NCT00733174 | Mar 2004 → Jan 2009 | glucose intolerance | Denver Research Institute | Unknown | No outcome recorded |
| Phase 4 | NCT01406704 | Jan 2004 → Dec 2010 | metabolic dysfunction-associated steatohepatitis | Seoul St. Mary's Hospital | Terminated | No outcome recorded |
| Phase 4 | NCT00675740 | Jan 2004 → Feb 2007 | glucose intolerance | University of Leipzig | Completed | No outcome recorded |
| Phase 4 | NCT00372086 | Aug 2003 → Sep 2005 | type 1 diabetes mellitus | The University of New South Wales | Completed | No outcome recorded |
| Phase 4 | NCT00123643 | May 2003 → Dec 2005 | type 2 diabetes mellitus | St. Paul Heart Clinic | Completed | No outcome recorded |
| Phase 4 | NCT00121966 | Jan 2003 → Jul 2007 | type 2 diabetes mellitus | Odense University Hospital | Completed | No outcome recorded |
| Phase 4 | NCT00306696 | Oct 2002 → Jan 2004 | diabetes mellitus | GlaxoSmithKline | Completed | Met primary |
| Phase 4 | NCT00329225 | Sep 2002 → Apr 2004 | type 2 diabetes mellitus | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 4 | NCT00044460 | May 2002 → Apr 2003 | type 2 diabetes mellitus | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 4 | NCT00306644 | May 2002 → Nov 2004 | type 2 diabetes mellitus | GlaxoSmithKline | Completed | Missed primary |
| Phase 4 | NCT00501020 | Jun 2001 → Feb 2003 | type 2 diabetes mellitus | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 4 | NCT00304993 | Jan 2001 → Feb 2005 | metabolic syndrome X | Foundation Research, Florida | Completed | No outcome recorded |
| Phase 4 | NCT00358124 | Jan 2001 → Jun 2002 | type 2 diabetes mellitus | Sanofi | Completed | No outcome recorded |
| Phase 4 | NCT00333723 | Jul 2000 → Jan 2003 | type 2 diabetes mellitus | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 4 | NCT00225342 | — | intermediate coronary syndrome, type 2 diabetes mellitus | University of Glasgow | Withdrawn | No outcome recorded |
| Phase 4 | NCT00522470 | — | obesity disorder, type 2 diabetes mellitus | Baskent University | Completed | No outcome recorded |
| Phase not applicable23 trials · 1 missed | ||||||
| — | NCT03309319 | Oct 2016 → Dec 2018 | pituitary tumor | Zhaoyun Zhang | Unknown | No outcome recorded |
| — | NCT02694874 | Feb 2016 → Mar 2020 | malaria | Manhiça Health Research Centre | Completed | Missed primary |
| — | NCT00242619 | Jul 2007 → Dec 2009 | bipolar disorder, depressive disorder | Stanford University | Completed | No outcome recorded |
| — | NCT00466713 | Mar → Dec 2007 | dilated cardiomyopathy | Stanford University | Terminated | No outcome recorded |
| — | NCT01019356 | Aug 2006 → Jul 2021 | polycystic ovary syndrome | Jean-Patrice Baillargeon | Completed | No outcome recorded |
| — | NCT00348309 | Jul 2006 → Jan 2009 | Alzheimer disease | GlaxoSmithKline | Completed | Mixed |
| — | NCT00486187 | Apr 2006 → Jun 2009 | type 2 diabetes mellitus | Dr. Milan Gupta | Completed | No outcome recorded |
| — | NCT00516880 | Mar 2006 → Nov 2008 | cardiovascular disorder, kidney disorder | Hospital Authority, Hong Kong | Unknown | No outcome recorded |
| — | NCT00285805 | Feb → Oct 2006 | — | Radboud University Medical Center | Completed | No outcome recorded |
| — | NCT00282945 | Jan 2006 → Oct 2007 | type 2 diabetes mellitus | Pfizer | Terminated | No outcome recorded |
| — | NCT00252499 | Oct 2005 → Aug 2010 | fatty liver disease | US Department of Veterans Affairs | Terminated | No outcome recorded |
| — | NCT00154011 | Sep 2005 → Jun 2006 | — | Technical University Dresden | Completed | No outcome recorded |
| — | NCT00636766 | Sep 2005 → Dec 2007 | atherosclerosis, metabolic syndrome X, stroke disorder, type 2 diabetes mellitus | Aristotle University Of Thessaloniki | Completed | No outcome recorded |
| — | NCT00264251 | Jul 2005 → Aug 2007 | HIV infectious disease, obesity disorder | St. Luke's-Roosevelt Hospital Center | Completed | No outcome recorded |
| — | NCT00166803 | Jun 2005 → Nov 2008 | diabetes mellitus | National Taiwan University Hospital | Suspended | No outcome recorded Stop: Business |
| — | NCT00285142 | Jun → Nov 2004 | — | University Hospital, Montpellier | Completed | No outcome recorded |
| — | NCT00084578 | Mar 2004 → Apr 2006 | urinary bladder cancer | Fox Chase Cancer Center | Withdrawn | No outcome recorded |
| — | NCT00577590 | Oct 2003 → Aug 2012 | type 2 diabetes mellitus | Washington University School of Medicine | Completed | No outcome recorded |
| — | NCT00143624 | Jun 2003 → Dec 2009 | HIV infectious disease, atherosclerosis | University of British Columbia | Completed | No outcome recorded |
| — | NCT00549874 | Feb 2002 → Nov 2006 | type 2 diabetes mellitus | University of Michigan | Completed | No outcome recorded |
| — | NCT00025753 | — | HIV infectious disease | National Center for Research Resources (NCRR) | Completed | No outcome recorded |
| — | NCT00483392 | — | — | University Medical Centre Ljubljana | Completed | No outcome recorded |
| — | NCT00015691 | ? → Jan 2006 | HIV infectious disease, hyperinsulinism, lipodystrophy | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Comparator or background therapy53 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 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 2/3 | 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 3 | NCT00975286 Background | Oct 2009 → Aug 2011 | type 2 diabetes mellitus | Sanofi | Completed | Met primary |
| Phase 3 | NCT00680745 Background | Apr 2008 → Nov 2009 | type 2 diabetes mellitus | AstraZeneca | Completed | Met primary |
| 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 | Met primary |
| Phase 3 | NCT00350779 Background | Jun 2006 → Sep 2007 | type 2 diabetes mellitus | Merck Sharp & Dohme LLC | Completed | Met primary |
| Phase 3 | NCT00541775 Comparator | Jun 2006 → Mar 2007 | type 2 diabetes mellitus | Merck Sharp & Dohme LLC | Completed | Met primary |
| Phase 3 | NCT00361868 Comparator | Jun 2006 → Dec 2007 | glucose metabolism disease, hyperlipidemia | Solvay Pharmaceuticals | Terminated | No outcome recorded |
| Phase 3 | NCT00333151 Background | May 2006 → Aug 2007 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | Met primary |
| Phase 3 | NCT00295633 Background | Mar 2006 → Oct 2007 | type 2 diabetes mellitus | AstraZeneca | Completed | Met primary |
| 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 | 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 | NCT00182052 Comparator | Sep 2000 → Aug 2003 | prostate adenocarcinoma | Massachusetts General Hospital | 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 | Missed primary |
| 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 |
| — | 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 |
News releases announcing trial results or a regulatory action · 11
| Date | Issuer | Release |
|---|---|---|
| 2013-11-25 | GlaxoSmithKline | Regulatory GSK Responds to FDA Decision on Avandia (rosiglitazone) gsk.com ↗
Issued: London UK GSK plc [LSE/NYSE: GSK] announced today that the U.S. Food and Drug Administration (FDA) has eased restrictions on patient access to Avandia (rosiglitazone), following an FDA Advisory Committee review in June 2013. |
| 2013-06-06 | GlaxoSmithKline | Regulatory GSK statement in response to FDA Advisory Committee’s vote on availability of Avandia (rosiglitazone) gsk.com ↗
GlaxoSmithKline [NYSE: GSK] confirmed today that a joint advisory committee to the U.S. Food and Drug Administration (FDA) voted to continue to make Avandia (rosiglitazone) available to appropriate patients with the majority of the members voting to either modify (13) or remove (7) the Risk Evaluation and Mitigation Strategy (REMS) program in place. |
| 2011-02-07 | GlaxoSmithKline | Regulatory GSK revises US Avandia label to include new restrictions on use gsk.com ↗
GlaxoSmithKline (GSK) today announced revised US prescribing information and medication guides for all rosiglitazone-containing medicines (Avandia®, Avandamet® and Avandaryl®) to include additional safety information and restrictions on the use of these medicines. |
| 2010-09-22 | GlaxoSmithKline | Regulatory GSK regulatory update on Avandia following EMA and FDA reviews gsk.com ↗
In the European Union*, the EMA has suspended the marketing authorisation for all rosiglitazone-containing medicines (Avandia, Avandamet® and Avaglim®). |
| 2010-07-20 | GlaxoSmithKline | Regulatory GlaxoSmithKline statement in response to FDA announcement on TIDE trial gsk.com ↗
“This pause in enrollment will give clinical trial investigators and patients time to learn about the data presented to the FDA Advisory Committee and the Committee’s recommendations,” said Dr. Ellen Strahlman, GSK’s Chief Medical Officer. |
| 2010-07-13 | GlaxoSmithKline | Regulatory GlaxoSmithKline statement in response to FDA Advisory Committees’ vote on safety of Avandia® (rosiglitazone) gsk.com ↗
Committee members voted for recommendations ranging from making no changes to the current label, to revising the label with additional warnings and restrictions (20) to withdrawal from the U.S. market (12). |
| 2010-07-08 | GlaxoSmithKline | Regulatory GSK EU regulatory update on Avandia (rosiglitazone) gsk.com ↗ |
| 2010-07-08 | GlaxoSmithKline | Results Data support Avandia (rosiglitazone maleate) cardiovascular safety profile gsk.com ↗
GSK’s review supports the overall positive benefit-risk profile of rosiglitazone as an important medicine for patients with type 2 diabetes. |
| 2009-06-04 | GlaxoSmithKline | Results Large, long-term study shows Avandia has no increased overall cardiovascular risk compared to other commonly used diabetes medicines gsk.com ↗
Clinical trial results presented today at the American Diabetes Association annual meeting show that overall rates of cardiovascular hospitalization and cardiovascular death are similar in patients taking Avandia (rosiglitazone) compared to those receiving metformin and sulfonylurea. |
| 2007-08-20 | Novo Nordisk A/S | Results Liraglutide improves glucose control and lowers body weight in two phase 3 studies comprising more than 2,000 patients novonordisk.com ↗
In the LEAD® 1 study, liraglutide provided statistically significantly better glucose control than rosiglitazone. |
| 2004-12-21 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces Tentative Approval Of Rosiglitazone Maleate Tablets tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration has granted tentative approval for the company's ANDA for Rosiglitazone Maleate Tablets, 2 mg, 4 mg and 8 mg. |
All press releases naming this drug 18 releases
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 ↗ |
| 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 ↗ “Avandia (Rosiglitazone)” NCT00064727 ↗ “rosiglitazone (Avandia)” NCT00025753 ↗ |
| 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 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” NCT00369174 ↗ “Drug: rosiglitazone maleate” NCT00484419 ↗ “rosiglitazone maleate” NCT00084578 ↗ |
| Known as | Rosiglitazone XR | “Rosiglitazone XR (extended release) oral tablets” NCT00334568 ↗1“Drug: Rosiglitazone XR” NCT00490568 ↗ |
| Known as | rosiglitazone: AVANDIA | “rosiglitazone (Avandia)” NCT00000620 ↗1“rosiglitazone: AVANDIA” NCT00953498 ↗ |
| 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“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 ↗ “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 ↗ “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 ↗ |