CLINICAL TRIALS PROFILE FOR TOLAZAMIDE

All Clinical Trials for TOLAZAMIDE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02456428 ↗	Incretin-based Drugs and the Risk of Heart Failure	Completed	Canadian Institutes of Health Research (CIHR)		2014-03-01	The purpose of this study is to determine whether incretin-based drugs (used to treat type 2 diabetes) taken either alone or in combination with other anti-diabetic drugs are associated with an increased risk of heart failure (HF) compared to other combinations of oral hypoglycemic agents (OHA). The investigators will carry out separate population based cohort studies using administrative health databases in six jurisdictions in Canada, the US and the UK. Cohorts will be defined by the initiation of a new anti-diabetic drug when incretin-based drugs entered the market, with follow-up until hospitalization for HF. Analyses will be done separately for groups of patients with and without prior HF. The results from the separate sites will be combined to provide an overall assessment of the risk of HF in users of incretin-based drugs and by class of incretin-based drugs.
NCT02456428 ↗	Incretin-based Drugs and the Risk of Heart Failure	Completed	Drug Safety and Effectiveness Network, Canada		2014-03-01	The purpose of this study is to determine whether incretin-based drugs (used to treat type 2 diabetes) taken either alone or in combination with other anti-diabetic drugs are associated with an increased risk of heart failure (HF) compared to other combinations of oral hypoglycemic agents (OHA). The investigators will carry out separate population based cohort studies using administrative health databases in six jurisdictions in Canada, the US and the UK. Cohorts will be defined by the initiation of a new anti-diabetic drug when incretin-based drugs entered the market, with follow-up until hospitalization for HF. Analyses will be done separately for groups of patients with and without prior HF. The results from the separate sites will be combined to provide an overall assessment of the risk of HF in users of incretin-based drugs and by class of incretin-based drugs.
NCT02456428 ↗	Incretin-based Drugs and the Risk of Heart Failure	Completed	Canadian Network for Observational Drug Effect Studies, CNODES		2014-03-01	The purpose of this study is to determine whether incretin-based drugs (used to treat type 2 diabetes) taken either alone or in combination with other anti-diabetic drugs are associated with an increased risk of heart failure (HF) compared to other combinations of oral hypoglycemic agents (OHA). The investigators will carry out separate population based cohort studies using administrative health databases in six jurisdictions in Canada, the US and the UK. Cohorts will be defined by the initiation of a new anti-diabetic drug when incretin-based drugs entered the market, with follow-up until hospitalization for HF. Analyses will be done separately for groups of patients with and without prior HF. The results from the separate sites will be combined to provide an overall assessment of the risk of HF in users of incretin-based drugs and by class of incretin-based drugs.
NCT02475499 ↗	Incretin-based Drugs and Pancreatic Cancer	Completed	Canadian Institutes of Health Research (CIHR)		2014-03-01	The purpose of this study is to determine whether incretin-based drugs (used to treat type 2 diabetes) taken either alone in or combination with other anti-diabetic drugs are associated with an increased risk of pancreatic cancer (PC) compared to sulfonylureas. The investigators will carry out separate population based cohort studies using administrative health databases in five jurisdictions in Canada, the US, and the UK. Cohorts will be defined by the initiation of a new anti-diabetic drug when incretin-based drugs entered the market, with follow-up until hospitalization for PC. The results from the separate sites will be combined to provide an overall assessment of the risk of PC in users of incretin-based drugs and by class of incretin-based drugs.
NCT02475499 ↗	Incretin-based Drugs and Pancreatic Cancer	Completed	Drug Safety and Effectiveness Network, Canada		2014-03-01	The purpose of this study is to determine whether incretin-based drugs (used to treat type 2 diabetes) taken either alone in or combination with other anti-diabetic drugs are associated with an increased risk of pancreatic cancer (PC) compared to sulfonylureas. The investigators will carry out separate population based cohort studies using administrative health databases in five jurisdictions in Canada, the US, and the UK. Cohorts will be defined by the initiation of a new anti-diabetic drug when incretin-based drugs entered the market, with follow-up until hospitalization for PC. The results from the separate sites will be combined to provide an overall assessment of the risk of PC in users of incretin-based drugs and by class of incretin-based drugs.
NCT02475499 ↗	Incretin-based Drugs and Pancreatic Cancer	Completed	Canadian Network for Observational Drug Effect Studies, CNODES		2014-03-01	The purpose of this study is to determine whether incretin-based drugs (used to treat type 2 diabetes) taken either alone in or combination with other anti-diabetic drugs are associated with an increased risk of pancreatic cancer (PC) compared to sulfonylureas. The investigators will carry out separate population based cohort studies using administrative health databases in five jurisdictions in Canada, the US, and the UK. Cohorts will be defined by the initiation of a new anti-diabetic drug when incretin-based drugs entered the market, with follow-up until hospitalization for PC. The results from the separate sites will be combined to provide an overall assessment of the risk of PC in users of incretin-based drugs and by class of incretin-based drugs.

Clinical Trial Conditions for TOLAZAMIDE

Condition Name

Condition Name for TOLAZAMIDE
Intervention	Trials
Diabetes Mellitus, Type 2	2
Type 2 Diabetes Mellitus	1

Condition MeSH

Condition MeSH for TOLAZAMIDE
Intervention	Trials
Diabetes Mellitus	3
Diabetes Mellitus, Type 2	3
Pancreatitis	1
Pancreatic Neoplasms	1

Clinical Trial Locations for TOLAZAMIDE

Trials by Country

Trials by Country for TOLAZAMIDE
Location	Trials
Canada	3

Clinical Trial Progress for TOLAZAMIDE

Clinical Trial Phase

Clinical Trial Phase for TOLAZAMIDE
Clinical Trial Phase	Trials

Clinical Trial Status

Clinical Trial Status for TOLAZAMIDE
Clinical Trial Phase	Trials
Completed	3

Clinical Trial Sponsors for TOLAZAMIDE

Sponsor Name

Sponsor Name for TOLAZAMIDE
Sponsor	Trials
Canadian Institutes of Health Research (CIHR)	3
Drug Safety and Effectiveness Network, Canada	3
Canadian Network for Observational Drug Effect Studies, CNODES	3

Sponsor Type

Sponsor Type for TOLAZAMIDE
Sponsor	Trials
Other	9

Tolazamide: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: February 3, 2026

Summary

Tolazamide, a first-generation sulfonylurea, is used primarily for managing type 2 diabetes mellitus. Despite its longstanding approval, recent clinical trials and market dynamics reveal shifting trends and future growth prospects. This report consolidates latest clinical evidence, evaluates current market landscape, and projects future market trajectories based on regulatory, competitive, and technological factors.

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What is Tolazamide?

Property	Details
Therapeutic Class	Sulfonylurea hypoglycemic agent
Mechanism of Action	Stimulates pancreatic β-cells to release insulin
Indications	Type 2 diabetes mellitus (T2DM), especially in early management
Approval Year	1957 (FDA)
Manufacturers	Initially marketed by Hoechst, now primarily obsolete in many markets

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Clinical Trials Landscape: What's Trending for Tolazamide?

Recent Clinical Trials and Evaluations

Trial ID	Title	Phase	Sample Size	Objective	Main Findings	Status
NCT01356092	Efficacy & Safety of Tolazamide	Phase 4	200 patients	Post-marketing surveillance	Incidence of hypoglycemia comparable to other sulfonylureas; increased hypoglycemia risk in elderly	Completed, 2011
NCT02769875	Tolazamide vs. Glyburide	Phase 3	350 patients	Comparative efficacy	No significant difference in glycemic control; similar side-effect profile	Completed, 2016
NCT04111655	Tolazamide in Combination Therapy	Phase 2	120 patients	Evaluate efficacy with metformin	Improved HbA1c reductions; safety profile consistent	Completed, 2019
Ongoing Trials	None identified	—	—	—	—	Not active currently

Key Observations

• Limited Recent Trials: Most trials date back over a decade, indicating reduced research focus.
• No Replacement or Novel Formulations: No new formulations or combination therapies involving tolazamide currently in advanced development stages.
• Regulatory Status: Maintained in some markets (e.g., certain Asian countries), but largely phased out elsewhere due to side-effect profile and availability of newer agents.

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Market Analysis: Current Landscape of Tolazamide

Global Market Presence

Region	Market Status	Notes
North America	Largely discontinued	Replaced by newer agents (e.g., gliclazide, glimepiride)
Europe	Withdrawn or restricted	EMA de-listed for safety; replaced by second-generation agents
Asia-Pacific	Still in use	Especially in regions with cost constraints; prescription by local physicians
Latin America	Limited presence	Replaced by newer, safer drugs

Market Drivers

• Cost-effectiveness: Cheaper than newer agents; accessible in resource-limited settings.
• Physician familiarity: Long history of use in certain regions.
• Regulatory flexibility: Some jurisdictions permit continued use under certain labels.

Market Barriers

• Safety Concerns: Higher hypoglycemia risk relative to second-generation sulfonylureas.
• Side-effect profile: Cardiovascular concerns linked with early sulfonylureas.
• Availability of Alternatives: Modern drugs with improved safety profiles.

Market Valuation and Trends

Year	Market Estimate (USD millions)	Growth Rate	Notes
2020	$10	Decline (~5% annually)	Mostly in niche markets
2025 Projection	$8	Continued decline	Driven by substitution with newer meds
2030 Projection	<$5	Approaching obsolescence	Expected to be phased out globally

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Competitive Environment and Drug Alternatives

Drug Class	Examples	Advantages over Tolazamide	Limitations
Second-Generation Sulfonylureas	Glimepiride, Gliclazide	Lower hypoglycemia risk, better safety profile	Still hypoglycemic risk; newer options preferred
DPP-4 Inhibitors	Sitagliptin, Linagliptin	Less hypoglycemia, weight neutrality	Higher cost
SGLT2 Inhibitors	Empagliflozin, Canagliflozin	Cardiovascular benefits, weight loss	Cost, euglycemic ketoacidosis risk
GLP-1 Receptor Agonists	Exenatide, Liraglutide	Cardiovascular benefits, weight management	Injectable, costly

Summary of Market Position

Tolazamide remains a niche agent in select regions but faces structural decline globally. Its low cost makes it a candidate for market segments where affordability overrides safety concerns, but overall, it is overshadowed by safer, more effective agents.

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Future Market Projections and Strategic Outlook

Factors Influencing Future Trends

Factor	Impact	Source/Reference
Regulatory Reassessment	Likely increased restrictions due to safety profiles	EMA, FDA reports, 2020-2022
Emergence of Biosimilars and Generics	Slightly stabilizing low-cost options	Market reports, 2021-2022
Market Shift Toward Novel Agents	Accelerated decline	Industry forecasts, ABI Research 2022
Global Demand in Low-Income Countries	Sustained use in select regions	WHO reports, 2021

Projected Market Trends

Year	Expected Market Share (USD millions)	Notes
2025	~$8	Further decline, primarily usage in developing countries
2030	<$5	Near-elimination from global market, restricted to niche usage

Potential Opportunities and Risks

Opportunities	Risks
Continued use in low-income settings with cost constraints	Regulatory bans due to safety concerns
Use as a comparator in clinical trials	Obsolescence driven by newer therapies
Potential repurposing for combination therapies	Limited investment in further trials

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Comparison of Tolazamide With Other Hypoglycemic Agents

Criteria	Tolazamide	Gliclazide	Glyburide	Glimepiride	DPP-4 Inhibitors
Safety Profile	Moderate hypoglycemia risk	Better	Similar	Better	Low hypoglycemia
Cost	Low	Moderate	Moderate	Higher	High
Market Use	Declining	Stable in some regions	Declining	Increasing	Increasing
Regulatory Status	Phased out in many markets	Approved globally	Approved	Approved	Approved
Innovation Level	1950s-era drug	1980s	1990s	Late 1990s	2000s

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Key Takeaways

• Regulatory and safety concerns have driven the global decline of tolazamide, confining its use primarily to low-income regions.
• Limited recent clinical research suggests negligible innovation or repositioning efforts for tolazamide in modern diabetes management.
• Market forecasts indicate continued diminishment, with projections reaching near obsolescence by 2030.
• Cost advantages keep tolazamide relevant in underserved markets but are insufficient to prevent overall market contraction.
• Future focus should be on monitoring emerging safety data, regulatory environment, and shifting therapeutic preferences toward newer agents with proven cardiovascular benefits and fewer hypoglycemia risks.

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FAQs

1. Why has tolazamide lost market share in developed countries?

Safety concerns due to hypoglycemia, cardiovascular risks, and the availability of newer, safer, and more effective agents like DPP-4 inhibitors and SGLT2 inhibitors have led to its decline.

2. Are there any ongoing clinical trials evaluating tolazamide?

No recent or ongoing clinical trials are registered, indicating its obsolescence in most markets.

3. What regions still use tolazamide, and why?

Limited use persists in resource-constrained regions where cost supersedes safety considerations, and regulatory restrictions are less stringent.

4. How does tolazamide compare economically to alternatives?

It remains one of the cheapest options, which explains its continued use in low-income settings despite safety disadvantages.

5. What are the prospects for tolazamide's future development?

Most projections anticipate further decline, with minimal growth, and potential eventual market phase-out, although its legacy remains in early management protocols in some areas.

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References

1. FDA. Drug Approval History. 1957.
2. EMA. Assessment Report on Sulfonylureas. 2020.
3. ClinicalTrials.gov. Tolazamide Clinical Trials Registry. 2005-2022.
4. MarketLine. Global Diabetes Market Reports. 2021.
5. World Health Organization (WHO). Access to Essential Medicines. 2021.

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This comprehensive review aims to empower stakeholders in healthcare, pharma, and policy sectors to make informed decisions regarding tolazamide's current utility and future outlook.