AVANDIA

LOE Approaching

rosiglitazone maleate

NDAORALTABLETPriority Review

Approved

May 1999

Lifecycle

LOE Approaching

Competitive Pressure

30/100

Clinical Trials

7

Mechanism of Action

12.1 Mechanism of Action Rosiglitazone, a member of the thiazolidinedione class of antidiabetic agents, improves glycemic control by improving insulin sensitivity. Rosiglitazone is a highly selective and potent agonist for the peroxisome proliferator-activated receptor-gamma (PPARγ). In humans,…

Indications (2)

type 2 diabetes mellitus type 1 diabetes mellitus

Clinical Trials (5)

NCT00551564Phase 1Completed

Study to Determine the Utility of Novel Technologies and Biomarkers to Measure Human Response to Rosiglitazone Maleate

Started Jul 2007

36 enrolled

Diabetes Mellitus, Type 2

NCT00131664Phase 3Completed

Avandia™ + Amaryl™ or Avandamet™ Compared With Metformin (AVALANCHE™ Study)

Started Sep 2005

391 enrolled

Type 2 Diabetes Mellitus

NCT00318630Phase 1Completed

The Effect Of AVANDIA On The Late Asthmatic Response

Started Jul 2005

26 enrolled

Asthma

NCT00186537N/ACompleted

Comparing Tricor, Avandia, or Weight Loss to Lower Cardiovascular Risk Factors in People With High Triglycerides.

Started Sep 2003

47 enrolled

Insulin ResistanceHypertriglyceridemia

NCT00150410Phase 3Completed

Demonstrate Exubera Works As Well As Avandia When Added To Sulfonylurea + Metformin In Controlling Glucose

Started Jan 2003

626 enrolled

Diabetes Mellitus

External Resources

Full prescribing information

FDA approval history

Drug nomenclature & identifiers