CLINICAL TRIALS PROFILE FOR ROSIGLITAZONE MALEATE

All Clinical Trials for Rosiglitazone Maleate

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00004180 ↗	Rosiglitazone in Treating Patients With Liposarcoma	Completed	National Cancer Institute (NCI)	Phase 2	1999-10-01	RATIONALE: Rosiglitazone may help liposarcoma cells develop into normal fat cells. PURPOSE: Phase II trial to study the effectiveness of rosiglitazone in treating patients who have liposarcoma.
NCT00004180 ↗	Rosiglitazone in Treating Patients With Liposarcoma	Completed	Dana-Farber Cancer Institute	Phase 2	1999-10-01	RATIONALE: Rosiglitazone may help liposarcoma cells develop into normal fat cells. PURPOSE: Phase II trial to study the effectiveness of rosiglitazone in treating patients who have liposarcoma.
NCT00015691 ↗	Metformin and Rosiglitazone, Alone or in Combination, in HIV-Infected Patients With Insulin and Fat Abnormalities	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	N/A	1969-12-31	The purpose of this study is to see whether metformin alone, rosiglitazone alone, or metformin and rosiglitazone together will lower insulin levels in the blood and decrease fat in the abdomen or other parts of the body. Studies have shown that certain anti-HIV medications can cause a number of side effects, including high blood sugar (resulting from the body's failure to use insulin), high insulin, and excess fat build-up in the abdominal area. These side effects are known to increase the risk of heart disease. Metformin and rosiglitazone are 2 drugs that have been shown to lower insulin resistance and lessen abdominal fat in patients who are not HIV-infected. This study will investigate the use of these drugs in HIV-infected patients.
NCT00084578 ↗	Celecoxib and Rosiglitazone in Treating Patients Who Are Undergoing Cystoscopic Surveillance for Early-Stage Noninvasive Carcinoma of the Bladder or Radical Cystectomy for Muscle-Invasive Carcinoma of the Bladder	Withdrawn	National Cancer Institute (NCI)	N/A	2004-03-01	RATIONALE: Celecoxib may stop the growth of tumor cells by blocking the enzymes necessary for their growth and by stopping blood flow to the tumor. Rosiglitazone may help tumor cells develop into normal bladder cells. PURPOSE: This randomized clinical trial is studying how well giving celecoxib together with rosiglitazone works in treating patients who are undergoing cystoscopic surveillance (screening) for early-stage noninvasive (carcinoma in situ) carcinoma (cancer) of the bladder or radical cystectomy for muscle-invasive carcinoma (cancer has spread into the muscle layer of bladder tissue) of the bladder.
NCT00084578 ↗	Celecoxib and Rosiglitazone in Treating Patients Who Are Undergoing Cystoscopic Surveillance for Early-Stage Noninvasive Carcinoma of the Bladder or Radical Cystectomy for Muscle-Invasive Carcinoma of the Bladder	Withdrawn	Fox Chase Cancer Center	N/A	2004-03-01	RATIONALE: Celecoxib may stop the growth of tumor cells by blocking the enzymes necessary for their growth and by stopping blood flow to the tumor. Rosiglitazone may help tumor cells develop into normal bladder cells. PURPOSE: This randomized clinical trial is studying how well giving celecoxib together with rosiglitazone works in treating patients who are undergoing cystoscopic surveillance (screening) for early-stage noninvasive (carcinoma in situ) carcinoma (cancer) of the bladder or radical cystectomy for muscle-invasive carcinoma (cancer has spread into the muscle layer of bladder tissue) of the bladder.
NCT00098852 ↗	Rosiglitazone in Treating Patients With Locoregionally Extensive or Metastatic Thyroid Cancer	Unknown status	National Cancer Institute (NCI)	Phase 2	2004-10-01	RATIONALE: Drugs such as rosiglitazone may make tumor cells more sensitive to radioactive iodine. PURPOSE: This phase II trial is studying how well rosiglitazone works in treating patients with locoregionally extensive or metastatic thyroid cancer.
NCT00098852 ↗	Rosiglitazone in Treating Patients With Locoregionally Extensive or Metastatic Thyroid Cancer	Unknown status	University of California, San Francisco	Phase 2	2004-10-01	RATIONALE: Drugs such as rosiglitazone may make tumor cells more sensitive to radioactive iodine. PURPOSE: This phase II trial is studying how well rosiglitazone works in treating patients with locoregionally extensive or metastatic thyroid cancer.

Clinical Trial Conditions for Rosiglitazone Maleate

Condition Name

Condition Name for Rosiglitazone Maleate
Intervention	Trials
Diabetes Mellitus, Type 2	5
HIV Infections	3
Atherosclerosis	2
Diabetes Mellitus	2

Condition MeSH

Condition MeSH for Rosiglitazone Maleate
Intervention	Trials
Diabetes Mellitus	10
Diabetes Mellitus, Type 2	9
HIV Infections	3
Atherosclerosis	2

Clinical Trial Locations for Rosiglitazone Maleate

Trials by Country

Trials by Country for Rosiglitazone Maleate
Location	Trials
United States	129
Germany	16
Mexico	12
Canada	8
Italy	6

Trials by US State

Trials by US State for Rosiglitazone Maleate
Location	Trials
California	9
New York	6
Massachusetts	5
Tennessee	5
Pennsylvania	5

Clinical Trial Progress for Rosiglitazone Maleate

Clinical Trial Phase

Clinical Trial Phase for Rosiglitazone Maleate
Clinical Trial Phase	Trials
Phase 3	9
Phase 2	5
Phase 1	5

Clinical Trial Status

Clinical Trial Status for Rosiglitazone Maleate
Clinical Trial Phase	Trials
Completed	17
Terminated	2
Withdrawn	2

Clinical Trial Sponsors for Rosiglitazone Maleate

Sponsor Name

Sponsor Name for Rosiglitazone Maleate
Sponsor	Trials
GlaxoSmithKline	9
National Cancer Institute (NCI)	6
National Institutes of Health (NIH)	2

Sponsor Type

Sponsor Type for Rosiglitazone Maleate
Sponsor	Trials
Industry	17
NIH	9
Other	8

Rosiglitazone Maleate: Clinical Trials, Market Analysis, and Projections

Introduction

Rosiglitazone maleate, marketed under the brand name Avandia, is a medication used to treat type 2 diabetes. It belongs to the class of thiazolidinediones, which work by enhancing insulin sensitivity. Here, we will delve into the clinical trials, market analysis, and future projections for this drug.

Clinical Trials and Safety Profile

Cardiovascular Risks

Clinical trials and meta-analyses have extensively evaluated the safety profile of rosiglitazone, particularly focusing on its cardiovascular risks. A meta-analysis published in 2010 pooled data from 56 randomized clinical trials involving 35,531 patients. The results indicated an increased risk for myocardial infarction (MI) associated with rosiglitazone, although there was no significant increase in cardiovascular or all-cause mortality[1].

Ophthalmic Benefits

In addition to its primary use in diabetes management, rosiglitazone has shown potential benefits in delaying the onset of proliferative diabetic retinopathy (PDR). A study conducted at the Joslin Diabetes Center found that patients treated with rosiglitazone had a 59% relative risk reduction in progression to PDR compared to the control group[4].

Regulatory Actions

Despite the cardiovascular concerns, a joint FDA advisory committee voted to allow Avandia to remain on the market in 2010, with recommendations for additional warnings and restrictions on its label. GlaxoSmithKline (GSK), the manufacturer, emphasized the importance of controlled clinical trials in assessing the benefits and risks of the drug[3].

Market Analysis

Current Market Size and Growth

The rosiglitazone maleate market is anticipated to grow significantly due to the increasing prevalence of type 2 diabetes globally. As of 2024, the market is valued at USD 2.85 billion and is expected to reach USD 4.73 billion by 2031, with a compound annual growth rate (CAGR) of 7.51%[2].

Key Drivers

Several factors are driving the growth of the rosiglitazone maleate market:

• Increasing Prevalence of Diabetes: The rising global incidence of type 2 diabetes creates a growing demand for effective treatments that enhance insulin sensitivity and glycemic management.
• Urbanization and Economic Growth: Urbanization, particularly in regions like Asia-Pacific, and increasing disposable income are boosting the demand for rosiglitazone maleate.
• Strategic Alliances and Innovations: Pharmaceutical companies are forming strategic alliances and investing in research and development to improve drug formulations and delivery systems, further driving market growth[2].

Regional Market Dynamics

The market for rosiglitazone maleate is diverse and spread across various regions:

• Asia-Pacific: This region is experiencing rapid growth due to a large population, rising disposable income, and increasing urbanization.
• Europe: Characterized by a mature market with well-established infrastructure and consumer preferences.
• Latin America: Presents opportunities and challenges, with economic fluctuations and political instability affecting market dynamics.
• Middle East and Africa: Emerging markets with promising growth potential driven by economic diversification, urbanization, and a young population[2].

Market Projections

Future Growth Prospects

The rosiglitazone maleate market is expected to continue its upward trajectory driven by several factors:

• Expanding Patient Base: The increasing prevalence of type 2 diabetes and other metabolic conditions will continue to drive demand.
• Innovations in Drug Formulations: Ongoing research into new formulations and delivery systems will enhance the market appeal of rosiglitazone maleate.
• Strategic Consolidations: Mergers and acquisitions among pharmaceutical companies will help in consolidating market positions and expanding product portfolios[2].

Off-Label Uses

The potential for off-label use, such as treating polycystic ovarian syndrome (PCOS) and other metabolic conditions, further enhances the market prospects of rosiglitazone maleate[2].

Key Players

The market for rosiglitazone maleate is dominated by several key players:

• GlaxoSmithKline (GSK): The original manufacturer of Avandia.
• Hengrui Pharma: A significant player in the generic market.
• Taiji Group: Known for its contributions to the pharmaceutical industry.
• Shengjitang Pharma: Another major player in the rosiglitazone maleate market.
• Huanghe Pharma: Contributing to the market through various formulations and distribution channels[2].

Conclusion

Rosiglitazone maleate remains a crucial medication in the management of type 2 diabetes, despite its complex safety profile. The market for this drug is expected to grow significantly, driven by the increasing prevalence of diabetes, innovations in drug formulations, and strategic alliances among pharmaceutical companies.

Key Takeaways

• Rosiglitazone maleate is associated with an increased risk of myocardial infarction but may offer benefits in delaying proliferative diabetic retinopathy.
• The market is valued at USD 2.85 billion in 2024 and is projected to reach USD 4.73 billion by 2031.
• Key drivers include the growing prevalence of type 2 diabetes, urbanization, and innovations in drug formulations.
• The market is dominated by players like GSK, Hengrui Pharma, and others.

FAQs

1. What are the primary risks associated with rosiglitazone maleate?

   • The primary risk associated with rosiglitazone maleate is an increased risk of myocardial infarction (MI), although it does not significantly increase cardiovascular or all-cause mortality[1].

2. What is the current market size of rosiglitazone maleate, and what are its future projections?

   • The market is currently valued at USD 2.85 billion and is expected to reach USD 4.73 billion by 2031, with a CAGR of 7.51%[2].

3. Who are the key players in the rosiglitazone maleate market?

   • Key players include GlaxoSmithKline (GSK), Hengrui Pharma, Taiji Group, Shengjitang Pharma, and Huanghe Pharma[2].

4. What are the potential off-label uses of rosiglitazone maleate?

   • Rosiglitazone maleate is being explored for off-label use in treating conditions such as polycystic ovarian syndrome (PCOS) and other metabolic disorders[2].

5. How does rosiglitazone maleate impact diabetic retinopathy?

   • Rosiglitazone may delay the onset of proliferative diabetic retinopathy (PDR) due to its antiangiogenic activity[4].

Sources

1. Nissen, S. E., & Wolski, K. (2010). Rosiglitazone Revisited: An Updated Meta-analysis of Risk for Myocardial Infarction and Cardiovascular Mortality. Archives of Internal Medicine, 170(14), 1191-1201.
2. OpenPR. (n.d.). Rosiglitazone Maleate Market Size, Share and Forecast By Key Players-Hengrui Pharma, GSK, Taiji Group, Shengjitang Pharma, Huanghe Pharma.
3. GlaxoSmithKline. (2010). GlaxoSmithKline statement in response to FDA Advisory Committees’ vote on safety of Avandia® (rosiglitazone).
4. Cunningham, S., & Jenkins, A. J. (2008). Rosiglitazone and delayed onset of proliferative diabetic retinopathy. Archives of Ophthalmology, 126(7), 935-942.
5. Market Research Reports. (2024). Global Rosiglitazone Maleate Market 2024 by Manufacturers, Regions, Type and Application, Forecast to 2030.

Last updated: 2025-01-07