Overview
Rosiglitazone is an anti-diabetic drug in the thiazolidinedione class of drugs. It is marketed by the pharmaceutical company GlaxoSmithKline as a stand-alone drug (Avandia) and in combination with metformin (Avandamet) or with glimepiride (Avandaryl). Like other thiazolidinediones, the mechanism of action of rosiglitazone is by activation of the intracellular receptor class of the peroxisome proliferator-activated receptors (PPARs), specifically PPARγ. Rosiglitazone is a selective ligand of PPARγ, and has no PPARα-binding action. Apart from its effect on insulin resistance, it appears to have an anti-inflammatory effect: nuclear factor kappa-B (NFκB) levels fall and inhibitor (IκB) levels increase in patients on rosiglitazone. Recent research has suggested that rosiglitazone may also be of benefit to a subset of patients with Alzheimer's disease not expressing the ApoE4 allele. This is the subject of a clinical trial currently underway.
Background
Rosiglitazone is an anti-diabetic drug in the thiazolidinedione class of drugs. It is marketed by the pharmaceutical company GlaxoSmithKline as a stand-alone drug (Avandia) and in combination with metformin (Avandamet) or with glimepiride (Avandaryl). Like other thiazolidinediones, the mechanism of action of rosiglitazone is by activation of the intracellular receptor class of the peroxisome proliferator-activated receptors (PPARs), specifically PPARγ. Rosiglitazone is a selective ligand of PPARγ, and has no PPARα-binding action. Apart from its effect on insulin resistance, it appears to have an anti-inflammatory effect: nuclear factor kappa-B (NFκB) levels fall and inhibitor (IκB) levels increase in patients on rosiglitazone. Recent research has suggested that rosiglitazone may also be of benefit to a subset of patients with Alzheimer's disease not expressing the ApoE4 allele. This is the subject of a clinical trial currently underway.
Indication
Rosiglitazone is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Associated Conditions
- Type 2 Diabetes Mellitus
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2019/11/01 | Phase 2 | Completed | J JESUS VENEGAS, MD | ||
2019/10/03 | Phase 2 | Recruiting | Dan Zandberg | ||
2017/10/13 | Not Applicable | UNKNOWN | Zhaoyun Zhang | ||
2016/03/01 | Not Applicable | Completed | Centro de Investigacao em Saude de Manhica | ||
2015/08/18 | Phase 4 | Completed | |||
2013/06/07 | Phase 1 | Completed | |||
2012/10/15 | Phase 3 | Completed | |||
2012/04/10 | Phase 3 | Completed | |||
2011/08/11 | Phase 1 | Completed | |||
2011/08/01 | Phase 4 | Terminated |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Physicians Total Care, Inc. | 54868-5262 | ORAL | 4 mg in 1 1 | 8/30/2012 | |
| Physicians Total Care, Inc. | 54868-5376 | ORAL | 2 mg in 1 1 | 8/30/2012 | |
| Physicians Total Care, Inc. | 54868-5157 | ORAL | 4 mg in 1 1 | 8/30/2012 | |
| Physicians Total Care, Inc. | 54868-4965 | ORAL | 2 mg in 1 1 | 8/30/2012 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Rosiglitazone Sodium Tablets | 国药准字H20074065 | 化学药品 | 片剂 | 8/30/2020 | |
| Rosiglitazone Sodium Tablets | 国药准字H20041399 | 化学药品 | 片剂 | 4/17/2020 | |
| Rosiglitazone Tartrate Tablets | 国药准字H20080406 | 化学药品 | 片剂 | 4/20/2023 | |
| Rosiglitazone Tartrate Tablets | 国药准字H20090196 | 化学药品 | 片剂 | 11/23/2023 | |
| Rosiglitazone Tartrate Capsules | 国药准字H20090107 | 化学药品 | 胶囊剂 | 5/8/2023 | |
| Rosiglitazone Hydrochloride Tablets | 国药准字H20041537 | 化学药品 | 片剂(薄膜衣) | 2/26/2020 | |
| Rosiglitazone Hydrochloride Tablets | 国药准字H20041536 | 化学药品 | 片剂(薄膜衣) | 2/26/2020 | |
| Rosiglitazone Hydrochloride Tablets | 国药准字H20080258 | 化学药品 | 片剂 | 11/14/2022 | |
| Rosiglitazone Hydrochloride Tablets | 国药准字H20080256 | 化学药品 | 片剂 | 11/14/2022 | |
| Rosiglitazone Hydrochloride Tablets | 国药准字H20041408 | 化学药品 | 片剂 | 9/5/2024 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||