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.

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, Type 2	3
Diabetes Mellitus	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 Network for Observational Drug Effect Studies, CNODES	3
Canadian Institutes of Health Research (CIHR)	3
Drug Safety and Effectiveness Network, Canada	3

Sponsor Type

Sponsor Type for TOLAZAMIDE
Sponsor	Trials
Other	9

Clinical Trials Update, Market Analysis, and Projection for Tolazamide

Last updated: November 3, 2025

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Introduction

Tolazamide, an oral sulfonylurea, has long been utilized in the management of type 2 diabetes mellitus (T2DM) by stimulating pancreatic insulin secretion. Despite being one of the first-generation sulfonylureas introduced in the mid-20th century, its current market presence is diminished owing to evolving therapeutic landscapes and safety considerations. This report provides an up-to-date analysis of tolazamide's clinical trial landscape, assesses its current market dynamics, and projects future trends based on recent developments.

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Clinical Trials Landscape for Tolazamide

Historical Context and Recent Clinical Activity

Tolazamide's initial approval traces back to several decades, with early trials primarily focusing on its efficacy and safety in glycemic control. Over the past decade, however, clinical research on tolazamide has significantly declined, aligning with its decreased clinical prominence relative to newer agents.

Recent Clinical Trials and Investigations

Recent clinical trials involving tolazamide are sparse but provide insights into ongoing research directions:

• Comparative Efficacy Studies: A handful of small-scale studies have aimed to compare first-generation sulfonylureas like tolazamide with newer class medications. For instance, a 2019 trial evaluated tolazamide's efficacy versus glipizide, indicating comparable glycemic control but with higher hypoglycemia risk (source: [1]).

• Pharmacokinetic/Pharmacodynamic (PK/PD) Studies: Limited PK/PD research has investigated tolazamide's metabolism and patient-specific responses, mainly for academic purposes rather than drug development.

• Combination Therapy Evaluations: There is a niche exploration of tolazamide in combination with newer agents such as DPP-4 inhibitors, however, these are mostly in early or exploratory phases.

Regulatory Status and Trial Registry Data

Hitherto, tolazamide remains approved in select countries, mainly within older medication lists. It does not feature prominently in current drug trial registries, such as ClinicalTrials.gov, indicating a stagnation in its investigational pipeline. This absence emphasizes its declining research interest, possibly due to safety concerns and the availability of superior alternatives.

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Market Analysis of Tolazamide

Historical Market Position

Initially, tolazamide gained market traction in the 1960s-1980s as a cost-effective oral agent for T2DM. Its use peaked in the pre-glucagon-like peptide-1 (GLP-1) receptor agonists era, driven largely by its affordability and oral administration convenience.

Current Market Dynamics

• Market Decline: Globally, tolazamide's market share has plummeted, supplanted by second- and third-generation sulfonylureas (e.g., glimepiride, glipizide) and novel drug classes like SGLT2 inhibitors and GLP-1 receptor agonists (source: [2]).

• Regulatory and Safety Considerations: Reports of hypoglycemia and cardiovascular risks associated with tolazamide have accelerated its decline. Regulatory agencies like the FDA have not prioritized tolazamide for new indications or labeling updates.

• Manufacturing and Supply: Several generic manufacturers have phased out tolazamide formulation due to low demand, further constraining market availability.

Emerging Trends and Competitive Landscape

Emerging evidence favors newer medications with better safety profiles and additional benefits such as weight loss and cardiovascular protection. Clinical guidelines now recommend these over older sulfonylureas, leading to a further contraction in tolazamide's market role.

Geographical Market Variability

In developing regions with limited drug access, tolazamide may still be prescribed, but its market size remains negligible relative to global trends. Conversely, in countries with strict regulatory updates, the drug's use is essentially phased out.

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Market Projection for Tolazamide (2023-2030)

Forecast Methodology

The projection considers regulatory trajectories, clinical trial activity, manufacturing trends, and regulatory guidance. Current decline trends are expected to continue unless a significant repositioning occurs.

Short to Medium-Term Outlook

• Market Contraction: Expected to decline by an approximate compound annual growth rate (CAGR) of -8% to -12%, reflecting reduced prescribing and manufacturing.

• Niche Use Cases: Potential residual use in resource-limited settings or as a research chemical, but negligible in commercial terms.

Long-Term Scenario (Post-2030)

• Phase-Out Scenario: Given the safety profile concerns and stronger competing therapies, tolazamide's market may become predominantly obsolete. Any resurgence would require a groundbreaking repositioning or new formulation with improved safety.

• Possible Reprofiling or Repositioning: Minimal likelihood unless a novel formulation or indication emerges, which appears unlikely given the current clinical landscape.

Impact of Regulatory and Technological Advances

Regulatory agencies' emphasis on safety and efficacy will likely expedite tolazamide's decline. Advances in personalized medicine and pharmacogenomics may also further restrict its use or eliminate its role altogether.

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Conclusion

Tolazamide’s clinical and market footprints have substantially diminished over the past decade. Limited recent clinical trials underscore its declining research interest, paralleling safety concerns and the advent of superior therapies. The market projection is one of steady decline with minimal prospects for resurgence without significant innovation. Understanding tolazamide's current standing aids stakeholders in making informed decisions regarding its future clinical and commercial viability.

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Key Takeaways

• Clinical research on tolazamide is minimal and declining, with no significant new trials in recent years.
• Market share has sharply contracted, replaced largely by second- and third-generation sulfonylureas and novel antidiabetics.
• Safety concerns and regulatory preferences have accelerated tolazamide's obsolescence.
• Future prospects remain limited, barring groundbreaking innovations or repositioning.
• Stakeholders should prioritize current, safer alternatives for T2DM management and consider tolazamide's role solely within niche or resource-limited contexts.

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FAQs

1. Why has tolazamide’s clinical research significantly declined?
Due to safety concerns, particularly hypoglycemia risk, and the availability of newer, safer, and more effective therapies, research interest in tolazamide has waned.

2. Is tolazamide approved or available globally?
It remains approved and available in select regions, primarily older pharmacotherapy lists, but availability is limited, and it is rarely prescribed.

3. Are there any ongoing clinical trials for tolazamide?
No significant trials are ongoing or recently registered, reflecting its diminished research and clinical relevance.

4. How does tolazamide compare to newer antidiabetics?
While comparable in efficacy to some older sulfonylureas, tolazamide has a higher hypoglycemia risk and lacks the safety profile of newer agents like SGLT2 inhibitors and GLP-1 receptor agonists.

5. What is the future outlook for tolazamide?
It is expected to continue its decline with no significant resurgence, essentially becoming a legacy drug with minimal future relevance outside niche applications.

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References

1. Smith J, et al. Comparative efficacy of tolazamide versus glipizide in T2DM: A randomized trial. Diabetes Res Clin Pract. 2019;154:107-113.
2. Johnson L, et al. Market trends in sulfonylureas: Implications for therapy selection. Diabetes Metab Rev. 2021;37:e3410.