CLINICAL TRIALS PROFILE FOR ACETOHEXAMIDE

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All Clinical Trials for ACETOHEXAMIDE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01068860 ↗	To Compare the Effect of a Subcutaneous Canakinumab Administration to Placebo in Patients With Impaired Glucose Tolerance or Patients With Type 2 Diabetes With Differing Baseline Diabetes Therapies	Completed	Novartis	Phase 2	2010-02-01	This was a 10-week, placebo-controlled, randomized study to investigate the effect of injectable IL-1B antagonist, Canakinumab , in participants with impaired glucose tolerance or Type 2 Diabetes Mellitus (T2DM) already treated on different background diabetes therapies.
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.

Clinical Trial Conditions for ACETOHEXAMIDE

Condition Name

Condition Name for ACETOHEXAMIDE
Intervention	Trials
Diabetes Mellitus, Type 2	2
Type 2 Diabetes Mellitus	2
Impaired Glucose Tolerance	1

Condition MeSH

Condition MeSH for ACETOHEXAMIDE
Intervention	Trials
Diabetes Mellitus, Type 2	4
Diabetes Mellitus	4
Pancreatitis	1
Pancreatic Neoplasms	1

Clinical Trial Locations for ACETOHEXAMIDE

Trials by Country

Trials by Country for ACETOHEXAMIDE
Location	Trials
India	7
Italy	7
United States	7
Canada	5
Australia	1

Trials by US State

Trials by US State for ACETOHEXAMIDE
Location	Trials
Utah	1
Texas	1
Pennsylvania	1
North Dakota	1
Nebraska	1

Clinical Trial Progress for ACETOHEXAMIDE

Clinical Trial Phase

Clinical Trial Phase for ACETOHEXAMIDE
Clinical Trial Phase	Trials
Phase 2	1

Clinical Trial Status

Clinical Trial Status for ACETOHEXAMIDE
Clinical Trial Phase	Trials
Completed	4

Clinical Trial Sponsors for ACETOHEXAMIDE

Sponsor Name

Sponsor Name for ACETOHEXAMIDE
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 ACETOHEXAMIDE
Sponsor	Trials
Other	9
Industry	1

Last updated: July 28, 2026

Acetohexamide clinical trials update, market analysis, and commercialization projection

What is acetohexamide and what drug class does it belong to?

Acetohexamide is an oral second-generation sulfonylurea (SUs) used for type 2 diabetes mellitus (T2DM). It is used as a glucose-lowering agent via pancreatic insulin secretion stimulation. As a classic older SU, its commercial profile is typically dominated by legacy brands, local market availability, and competition from newer classes (DPP-4 inhibitors, GLP-1 receptor agonists, SGLT2 inhibitors) and other SUs.

Current marketed products and key geographies

Acetohexamide’s market presence is highly geography- and brand-dependent. Many countries moved away from older SUs and toward newer agents; availability can be sporadic and manufacturer-specific.

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What clinical trials involving acetohexamide are active, recruiting, or completed?

No complete, current clinical-trials status dataset is available in the provided information to support an accurate active/recruiting/completed breakdown by NCT number, sponsor, phase, indication, and dates. Without verified listings, a clinical-trials update cannot be produced.

What trial types are most relevant for acetohexamide?

For older sulfonylureas, the most commercially meaningful trial categories usually include:

• Bioequivalence (BE) studies for generic entry
• Pharmacokinetic (PK) and formulation optimization studies
• Comparative effectiveness studies versus other oral antidiabetics (less common today)
• Safety and tolerability studies tied to new formulations or local regulatory requirements

A trial update needs registry-confirmed details to map to market timing and regulatory pathways.

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Is acetohexamide undergoing any label expansion or new regulatory submissions?

No verified, source-backed regulatory submission timeline or label-change activity is available in the provided information. A label-expansion update would require specific FDA/EMA/MHRA/NMPA submission records or registry-linked evidence.

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What is the Orange Book status of acetohexamide in the US?

No Orange Book listing or patent-code/expiration record for acetohexamide is available in the provided information. A status answer requires the precise listed drug (RLD) name and strength/formulation, then mapping to patent expiration dates and exclusivities.

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What patents protect acetohexamide (composition, formulation, method-of-use) and when do they expire?

No patent estate data for acetohexamide is available in the provided information. A patent-protection analysis requires:

• Identifying the RLD and dosage forms
• Pulling composition-of-matter, formulation, and method patents
• Mapping each to USPTO family members and jurisdictional coverage
• Computing theoretical expiration and any term adjustments

Without that, litigation risk, generics launch timing, and licensing leverage cannot be quantified.

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When does acetohexamide lose exclusivity, and what generic entry risks exist?

No verified exclusivity or patent-expiration timeline is available in the provided information. A generic-entry risk assessment depends on:

• Remaining exclusivity (if any) and patent term end dates
• Whether Paragraph IV certifications are plausible
• Likelihood of settlements or authorized generics
• Practical barriers (manufacturing, impurity controls, BE requirements in specific jurisdictions)

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How much market does acetohexamide have, and what is current demand trend?

No quantified market size, sales volume, or revenue data for acetohexamide is available in the provided information. A market model also requires:

• Country-level sales split
• Mix by brand vs generic
• Dose-strength distribution
• Pricing trends (wholesale acquisition cost proxies, reimbursement rules, and tenders)

Without these inputs, any market figures or demand trends would be non-actionable.

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What competitive landscape does acetohexamide face versus other sulfonylureas and newer antidiabetics?

A strategic, execution-grade comparison requires current prescribing patterns and brand/generic availability by country. High-level competitive dynamics for acetohexamide typically include:

• Competing sulfonylureas (e.g., glipizide, glyburide, gliclazide) that often have stronger tolerability or availability
• Second-line oral agents with better durability and lower hypoglycemia risk in practice
• Newer injectables and oral agents that have displaced older SUs in many formularies

However, a quantified competitor share and pricing comparison cannot be produced without source-backed market data.

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What is the most likely commercialization trajectory for acetohexamide (next 3 to 7 years)?

No verified sales baseline, payer policy position, or manufacturing pipeline data is available in the provided information. A projection requires at minimum:

• Starting revenue and volume by geography
• Expected generic launches and BE/approval timelines
• Antidiabetic class displacement assumptions by country/formulary
• Sensitivity around hypoglycemia-linked utilization and guideline shifts

A projection without those anchored facts would not meet high-stakes analysis standards.

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What regulatory pathways would govern new acetohexamide products in key markets?

For legacy small molecules, new entrants generally rely on:

• Generic Abbreviated New Drug Application (ANDA) routes where applicable (US)
• Generic authorization routes (EU national procedures, mutual recognition, or abridged/abridged national pathways)
• Bioequivalence package submission for oral solid formulations
• Pharmacovigilance updates tied to product lifecycle

A market-timing answer needs explicit country actions and product-level status.

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What manufacturing and formulation/IP barriers could slow generic or reintroduction efforts?

Generic acetohexamide entry barriers often center on:

• Ability to meet impurity specifications and stability requirements for sulfonylureas
• Consistent particle size and dissolution behavior tied to bioequivalence
• Supply-chain and quality systems for bulk API and finished product
• Any remaining process patents or regulatory data protections in specific jurisdictions

A barrier assessment requires known patent/process facts and product compliance history.

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Key Takeaways

• Acetohexamide is a second-generation sulfonylurea used for type 2 diabetes.
• A clinical trials update, Orange Book/patent status, exclusivity timeline, and quantified market projection cannot be produced from the provided information.
• For commercialization modeling, the analysis requires verified registry/patent listings and current sales or market-share baselines by jurisdiction.

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FAQs

1. What phase of clinical development is typical for acetohexamide generics in 2026?
2. How do sulfonylurea hypoglycemia risks affect formulary inclusion for acetohexamide by country?
3. What bioequivalence study designs are commonly accepted for older sulfonylurea tablets?
4. Do any ongoing patent estates or process patents commonly block reintroduction of legacy antidiabetics like acetohexamide?
5. Which antidiabetic classes most strongly displace sulfonylureas in tiered formularies?

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References

1. No sources were provided in the prompt, and no external source-backed citations are included.