Drug

Rosiglitazone

Regulatory activity · MHRA

ClassPeroxisome proliferator-activated receptor gamma agonistEmerging researchLate-stage developmentSteady momentum

Also known as Avandamet, Avandaryl, Avandia, Rosiglitazon+2 more

Avandamet, Avandaryl, Avandia, Rosiglitazon, Rosiglitazona, Rosiglitazonum.

RxNorm84108 ChEMBLCHEMBL121 ATCA10BG02UNII05V02F2KDG

Research papers

Active clinical trials

PPARG

Primary target

Regulatory events

Latest activity

beta

Recent clinical, regulatory, research and industry developments relating to this drug.

A Phase II Clinical Trial of Anti-PD-1 mAb Therapy Alone or With Metabolic Modulators to Reverse Tumor Hypoxia and Immune Dysfunction in Solid Tumor Malignancies

Clinical trial2026-06-23Results expected Q2 2032 · ClinicalTrials.gov

Risk of Pancreatitis With Incretin Therapies Versus Thiazolidinediones in the Veterans Health Administration.

Research2023-10-26The Annals of pharmacotherapy

Clinical Evaluation of Rosiglitazone Maleate (BRL49653C) in Patients With Type 2 Diabetes Mellitus (Combination Therapy With Sulfonyl Urea) - A Placebo-Controlled Double-Blind Study -

Clinical trial2022-12-12Results posted · ClinicalTrials.gov

Rosiglitazone Adjunctive Therapy for Severe Malaria in Children

Clinical trial2021-12-01Completed · ClinicalTrials.gov

Studies to Treat Or Prevent Pediatric Type 2 Diabetes (STOPP-T2D) Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) Clinical Trial

Clinical trial2021-07-30Results posted · ClinicalTrials.gov

Role of Insulin Action and Free Fatty Acids in Hyperandrogenism and Role of Metabolism of Inositols in Insulin Resistance of Women With Polycystic Ovary Syndrome

Clinical trial2021-07-01Completed · ClinicalTrials.gov

Effects of Avandia on Cognition and Cerebral Glucose Utilisation in Subjects With Mild to Moderate Alzheimer's Disease (AD).

Clinical trial2020-11-18Results posted · ClinicalTrials.gov

A Pilot Study of Rosiglitazone in the Treatment of GH Secreting Pituitary Adenomas

Clinical trial2018-12-31Primary completion · ClinicalTrials.gov

Drug Safety Update: Rosiglitazone: recommended withdrawal from clinical use

Regulatory2014-12-11MHRA

Recombinant human growth hormone and rosiglitazone for abdominal fat accumulation in HIV-infected patients with insulin resistance: a randomized, double-blind, placebo-controlled, factorial trial.

Research2013-04-12PloS one

Drospirenone/ethinyl estradiol versus rosiglitazone treatment in overweight adolescents with polycystic ovary syndrome: comparison of metabolic, hormonal, and cardiovascular risk factors.

Research2011-02-16The Journal of clinical endocrinology and metabolism

Randomized comparison of the effects of rosiglitazone vs. placebo on peak integrated cardiovascular performance, cardiac structure, and function.

Research2010-07-02European heart journal

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name

Rosiglitazone

Aliases & brands

AvandametAvandarylAvandiaRosiglitazonRosiglitazonaRosiglitazonum

RxNorm CUI

84108

ChEMBL ID

CHEMBL121

ATC codes

A10BG02

UNII

05V02F2KDG

Primary mechanism

Peroxisome proliferator-activated receptor gamma agonist

Regulatory jurisdictions

mhra

Pharmacology & targets

1 target

Known molecular targets and mechanisms supported by curated pharmacology databases.

Peroxisome proliferator-activated receptor gamma

PPARG · P37231

AGONISTPeroxisome proliferator-activated receptor gamma agonist

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Authorities

MHRA

Total events

mhraMedicines and Healthcare products Regulatory Agency· 1 event

2014-12-11Safety communicationSafety

Drug Safety Update: Rosiglitazone: recommended withdrawal from clinical use

Evidence ↗

Contains public sector information from the Medicines and Healthcare products Regulatory Agency (MHRA) licensed under the Open Government Licence (OGL v3).

Clinical trials

126 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme

CLINICALTRIALS.GOV · LIVE REGISTRY

126

registered trials across all phases

LATEST COMPLETION 2021

Active studies

Recruiting

Late-stage (III+)

Completed

Discontinued

PHASE DISTRIBUTIONn = 126

Phase 114Phase 1 / 23Phase 218Phase 2 / 35Phase 332Phase 434Phase N / A20

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Obesity, Insulin Resistance, and Bone Metabolism in Adolescents With PCOS: Effects of Insulin Sensitizers Versus Oral Contraceptives

CompletedPH IVSilva Arslaniann=652015

Effects of Rosiglitazone and Alpha-lipoic Acid on the Patients With Pathologically Proved NASH (Non-alcoholic Steato-hepatitis)

TerminatedPH IVSeoul St. Mary's Hospitaln=262013

Influence of Glitazones on the Vasodilatory Effect of HDL Lipoproteins and on Phospholipase A2

CompletedPH IVCentre Hospitalier Universitaire Dijonn=402012

A Double-Blind, Placebo-Controlled Trial of Rosiglitazone for Clozapine Induced Glucose Metabolism Impairment: Bergman's Minimal Model Analysis

CompletedPH IVMassachusetts General Hospitaln=202011

AVANDIA CV Outcomes Study: Thiazolidinedione Intervention With Vitamin D Evaluation (TIDE) A Multicenter Randomized Double-Blind Placebo-Controlled Trial of a Thiazolidinedione or Placebo and of Vitamin D or Placebo In People With Type 2 Diabetes at Risk For Cardiovascular Disease

TerminatedPH IVKey trialGlaxoSmithKlinen=1,3322010

Recent completions

Trials that read out recently, adding to the completed evidence base.

Rosiglitazone Adjunctive Therapy for Severe Malaria in Children

CompletedN/ACentro de Investigacao em Saude de Manhican=2102021

Role of Insulin Action and Free Fatty Acids in Hyperandrogenism and Role of Metabolism of Inositols in Insulin Resistance of Women With Polycystic Ovary Syndrome

CompletedN/AJean-Patrice Baillargeonn=522021

A Phase I, Non-randomized Open-label Study to Evaluate the Effect of BAY73-4506 (Regorafenib) on Probe Substrates of CYP 2C9 (Warfarin), 2C19 (Omeprazole) and 3A4 (Midazolam) in a Cocktail Approach (Group A) and on a Probe Substrate of CYP 2C8 (Rosiglitazone, Group B) in Patients With Advanced Solid Tumors

CompletedPH IBayern=412018

Obesity, Insulin Resistance, and Bone Metabolism in Adolescents With PCOS: Effects of Insulin Sensitizers Versus Oral Contraceptives

CompletedPH IVSilva Arslaniann=652015

Studies to Treat Or Prevent Pediatric Type 2 Diabetes (STOPP-T2D) Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) Clinical Trial

CompletedPH IIINational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)n=6992014

Cyclotron Produced Isotopes in Biology and Medicine, Project 3: Specific Aim 1A and 1B Effects of Fatty Acid Delivery on Myocardial Metabolism and Function in Type 2 Diabetes (T2DM)

CompletedN/AWashington University School of Medicinen=782012

Research activity

6 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time

20032024

Most influential

Chronic inflammation in fat plays a crucial role in the development of obesity-related insulin resistance.

The Journal of clinical investigation · 2003 · 4,951 cites

Rosiglitazone for active ulcerative colitis: a randomized placebo-controlled trial.

Gastroenterology · 2008 · 184 cites

Drospirenone/ethinyl estradiol versus rosiglitazone treatment in overweight adolescents with polycystic ovary syndrome: comparison of metabolic, hormonal, and cardiovascular risk factors.

The Journal of clinical endocrinology and metabolism · 2011 · 32 cites

Randomized comparison of the effects of rosiglitazone vs. placebo on peak integrated cardiovascular performance, cardiac structure, and function.

European heart journal · 2010 · 22 cites

Recombinant human growth hormone and rosiglitazone for abdominal fat accumulation in HIV-infected patients with insulin resistance: a randomized, double-blind, placebo-controlled, factorial trial.

PloS one · 2013 · 10 cites

Risk of Pancreatitis With Incretin Therapies Versus Thiazolidinediones in the Veterans Health Administration.

The Annals of pharmacotherapy · 2024 · 8 cites

Related drugs

1 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

Pioglitazone

Studied across 2 of the same disease areas as Rosiglitazone in the shared literature.

2 shared diseases1 shared paper

References & data sources

RxNorm (U.S. National Library of Medicine) — drug identity
ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
Europe PMC — research literature
ClinicalTrials.gov — clinical trials
Regulatory event sources are credited in the Regulatory Timeline above.