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for Early-Stage Noninvasive Carcinoma of the Bladder or Radical Cystectomy for Muscle-Invasive Carcinoma of the Bladder	Withdrawn	National Cancer Institute (NCI)	N/A	2004-03-01	RATIONALE: Celecoxib may stop the growth of tumor cells by blocking the enzymes necessary for their growth and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.

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
Tennessee	5
Pennsylvania	5
Ohio	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 Update, Market Analysis, and Projections

Last updated: February 20, 2026

What is the current status of clinical development for rosiglitazone maleate?

Rosiglitazone maleate, a thiazolidinedione (TZD) class drug, was historically used for type 2 diabetes management. Its development has largely been discontinued due to safety concerns, but there are ongoing efforts in repurposing or reformulation.

Clinical Trials Overview

• Current Trials: As of 2023, no active phase 3 or phase 4 clinical trials are registered for rosiglitazone maleate. Most trials under the original patent expired without recent ongoing studies.

• Historical Data: Multiple trials from 2000-2010 focused on efficacy in blood glucose control and cardiovascular outcomes. Safety issues, notably increased risk of cardiovascular events, led regulators to restrict its use.

• Repurposing Efforts: A limited number of trials are exploring derivatives or combination therapies with rosiglitazone for conditions like non-alcoholic steatohepatitis (NASH) and diabetic complications. These are primarily early-phase (phase 1 or phase 2) studies initiated between 2018-2022, mostly small-scale or investigator-initiated.

Regulatory Status

• Approved in the early 2000s in several markets for type 2 diabetes. US FDA revoked approval for new patients in 2010 due to safety risks. Europe and other jurisdictions imposed restrictions or withdrew approval.

How does the market for rosiglitazone and its alternatives look?

Market Size (Pre-2010)

• Global Diabetes Drugs Market: Valued at approximately $54 billion in 2021, with significant contributions from oral hypoglycemics, including TZDs.

• Rosiglitazone’s Share: Estimated to be 5–7% of TZD sales at peak (2005–2008), roughly $1.5-$3 billion annually.

Market Decline

• Sales Decline: Post-2010, sales dropped sharply following safety warnings. Patent expiration in 2013 led to generic availability, further reducing price and market share.

• Market Exit: Several pharmaceutical companies (e.g., GlaxoSmithKline, Takeda) exited the market. No major players currently pursue rosiglitazone commercialization.

Alternative Treatments

• Drugs like pioglitazone (another TZD) dominate, representing about 10% of the diabetes drug market, with a more favorable safety profile.

• The combined market for TZDs was estimated at $4–5 billion globally in 2022, dominated by pioglitazone and newer agents like SGLT2 inhibitors and GLP-1 receptor agonists.

What are future projections for rosiglitazone-related therapies?

Market Revival Potential

• High Safety Concerns: The legacy safety issues restrict reintroduction without significant reformulation or risk mitigation strategies.

• Repurposing and Reformulation: Early-phase trials for combination therapies or targeted delivery could create niche markets, particularly for NASH or resistant diabetic patients.

Forecast (Next 5–10 Years)

Scenario	Likelihood	Key Factors	Market Size Projection
No revival	High	Safety issues, regulatory barriers	Market remains negligible
Niche reformulation	Moderate	Success of reformulated formulations with safety improvements	Up to $200 million annually by 2027
New indications	Low	Requires substantial investment, uncertain efficacy	<$50 million annually

Key Drivers and Barriers

Drivers

• Growing prevalence of type 2 diabetes, projected to reach 700 million globally by 2045 (IDF).[1]

• Increasing interest in combination therapies targeting multiple metabolic pathways.

Barriers

• Safety profile deters widespread use and investment.

• Competition from newer, safer drug classes (SGLT2 inhibitors, GLP-1 receptor agonists).

• Regulatory hurdles around safety enhancements.

What are the strategic considerations for stakeholders?

• Pharmaceutical companies should weigh the costs of reformulation against potential niche benefits.

• Investors should consider the minimal upside unless new indications demonstrate safety and efficacy.

• Researchers can explore targeted delivery systems or combinations that mitigate risks associated with rosiglitazone.

Key Takeaways

• Clinical development for rosiglitazone maleate is dormant, with ongoing investigations limited to early-phase repurposing efforts.

• The market for rosiglitazone has effectively collapsed since 2010 due to safety concerns, with no significant sales in recent years.

• Future projections suggest limited growth potential without substantial innovation or safety improvements; niche opportunities may emerge with successful reformulation.

• The global diabetes market continues to expand, favoring newer, safer agents over TZDs like rosiglitazone.

• Regulatory and safety issues pose significant barriers to re-entering the broader market.

FAQs

1. Why was rosiglitazone withdrawn from the market?
Safety concerns, specifically an increased risk of cardiovascular events, led to regulatory restrictions and withdrawal in several markets.

2. Are there any current clinical trials for rosiglitazone?
Most registered trials are small, early-phase studies focusing on reformulation or combination therapy, not on new indications.

3. Can rosiglitazone be used for any conditions today?
Its use is limited to research settings or off-label in some regions, but it is not approved for new prescriptions in major markets.

4. Is there potential for rosiglitazone in treating non-diabetic conditions?
Some early-stage studies explore its use for NASH and metabolic syndrome, but these are unlikely to influence mainstream markets soon.

5. What are safer alternatives to rosiglitazone?
Pioglitazone offers similar benefits with fewer cardiovascular risks; newer classes like SGLT2 inhibitors and GLP-1 receptor agonists dominate current therapy options.

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References

[1] International Diabetes Federation. (2022). IDF Diabetes Atlas, 10th edition.