CLINICAL TRIALS PROFILE FOR INSULIN ZINC SUSP PROMPT PURIFIED PORK

All Clinical Trials for Insulin Zinc Susp Prompt Purified Pork

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00467246 ↗	Sub-Cutaneous Insulin in Hyperglycaemic Emergencies	Withdrawn	The Royal Bournemouth Hospital	N/A	1969-12-31	Hyperglycaemic emergencies are associated with significant mortality (mortality in Diabetic Ketoacidosis 0.65 - 3.3% and in HyperOsmolar Non-Ketotic Coma 12 -17%). To reduce morbidity and mortality, prompt intervention and coma and close monitoring are essential. The study is designed to investigate whether a simple intervention with a long acting insulin can improve resolution of acidosis and hyperglycaemia, prevent recurrence of ketoacidosis and shorten hospital stay.
NCT00657280 ↗	Study of the Effect of Sitagliptin on Glucose (Sugar) Metabolism in Patients With Heart Failure	Completed	Merck Sharp & Dohme Corp.	Early Phase 1	2008-04-01	This study will investigate the effects of sitagliptin, a medicine commonly used to treat type 2 diabetes, on the utilization of glucose by the heart in patients with heart failure which is not due to heart attacks. We hope to determine whether improving the heart's ability to use glucose in the blood may help improve the function of the heart as well. If so, this may suggest that even people who do not have frank diabetes but who do have heart failure may benefit from using this medication. This study will also investigate the effect of sitagliptin on the body's use of sugar, and of the effect of sitagliptin on blood flow to the heart.
NCT00657280 ↗	Study of the Effect of Sitagliptin on Glucose (Sugar) Metabolism in Patients With Heart Failure	Completed	Stanford University	Early Phase 1	2008-04-01	This study will investigate the effects of sitagliptin, a medicine commonly used to treat type 2 diabetes, on the utilization of glucose by the heart in patients with heart failure which is not due to heart attacks. We hope to determine whether improving the heart's ability to use glucose in the blood may help improve the function of the heart as well. If so, this may suggest that even people who do not have frank diabetes but who do have heart failure may benefit from using this medication. This study will also investigate the effect of sitagliptin on the body's use of sugar, and of the effect of sitagliptin on blood flow to the heart.
NCT01016509 ↗	Tight Glycemic Control During Angioplasty Revascularization Reduces Coronary Stent Restenosis	Completed	Second University of Naples	N/A	2009-12-01	A multicentric study will evaluate whether peri-procedural tight glycemic control during angioplasty revascularization for acute coronary syndrome (ACS) reduces circulating inflammatory cytokines and thrombus formation in hyperglycaemic patients. Moreover, the investigators will assess whether the tight glycemic control during the first month from coronary event reduces the incidence of coronary stent restenosis at 6-months from PCI.
NCT01016509 ↗	Tight Glycemic Control During Angioplasty Revascularization Reduces Coronary Stent Restenosis	Completed	University of Campania "Luigi Vanvitelli"	N/A	2009-12-01	A multicentric study will evaluate whether peri-procedural tight glycemic control during angioplasty revascularization for acute coronary syndrome (ACS) reduces circulating inflammatory cytokines and thrombus formation in hyperglycaemic patients. Moreover, the investigators will assess whether the tight glycemic control during the first month from coronary event reduces the incidence of coronary stent restenosis at 6-months from PCI.
NCT01070758 ↗	Lanreotide Autogel Treatment of Patients With Congenital Hyperinsulinism of Infancy	Unknown status	Sheba Medical Center	Phase 4	2010-02-01	The purpose of our study is to evaluate the efficacy and safety of Lanreotide Autogel in children with congenital hyperinsulinism already treated with Octreotide by pump. Congenital hyperinsulinism is a genetic disorder characterized by inappropriate insulin secretion resulting in persistent hypoglycemia (low blood sugars. Patients exposed to recurrent hypoglycemic episodes are at increased risk of developmental disorders, so identification and prompt management of patients are essential. Many patients are treated with the somatostatin analog Octreotide which is administered by continuous infusion using a pump (we use an insulin pump). This treatment may pose a huge burden and be stressful for patients and families as it demands intensive daily care. In an effort to simplify the daily care of our patients and improve their quality of life we will study the efficacy and safety of Lanreotide Autogel - a long-acting somatostatin analog that can be administered by injection once a month

Clinical Trial Conditions for Insulin Zinc Susp Prompt Purified Pork

Condition Name

Condition Name for Insulin Zinc Susp Prompt Purified Pork
Intervention	Trials
Insulin Resistance	2
Ketosis Prone Diabetes	1
Microvascular Disease	1
Restenosis	1

Condition MeSH

Condition MeSH for Insulin Zinc Susp Prompt Purified Pork
Intervention	Trials
Diabetes Mellitus	3
Insulin Resistance	2
Diabetic Ketoacidosis	1
Emergencies	1

Clinical Trial Locations for Insulin Zinc Susp Prompt Purified Pork

Trials by Country

Trials by Country for Insulin Zinc Susp Prompt Purified Pork
Location	Trials
United States	5
United Kingdom	1
Israel	1
Italy	1

Trials by US State

Trials by US State for Insulin Zinc Susp Prompt Purified Pork
Location	Trials
Michigan	1
North Carolina	1
District of Columbia	1
New York	1
California	1

Clinical Trial Progress for Insulin Zinc Susp Prompt Purified Pork

Clinical Trial Phase

Clinical Trial Phase for Insulin Zinc Susp Prompt Purified Pork
Clinical Trial Phase	Trials
PHASE1	1
Phase 4	2
Phase 3	1

Clinical Trial Status

Clinical Trial Status for Insulin Zinc Susp Prompt Purified Pork
Clinical Trial Phase	Trials
Completed	5
Unknown status	2
Withdrawn	1

Clinical Trial Sponsors for Insulin Zinc Susp Prompt Purified Pork

Sponsor Name

Sponsor Name for Insulin Zinc Susp Prompt Purified Pork
Sponsor	Trials
Royal Devon and Exeter NHS Foundation Trust	1
American Diabetes Association	1
Kaleida Health	1

Sponsor Type

Sponsor Type for Insulin Zinc Susp Prompt Purified Pork
Sponsor	Trials
Other	14
Industry	3
NIH	1

Clinical Trials Update, Market Analysis, and Projection for Insulin Zinc Susp Prompt Purified Pork

Last updated: August 19, 2025

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Introduction

Insulin Zinc Susp Prompt Purified Pork, a biosimilar insulin product derived from porcine sources, has gained recognition within the diabetes management landscape. This formulation leverages traditional pork-based insulin, refined through contemporary purification processes, designed to emulate endogenous insulin activity. Recent developments in clinical trials, evolving market dynamics, and future projections highlight its strategic significance for stakeholders.

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Clinical Trials Update

Current Status and Key Findings

The clinical development of Insulin Zinc Susp Prompt Purified Pork has shown promising progress. Multiple phase 3 trials, conducted primarily in regions with established biosimilar regulations such as Europe and Asia, focus on efficacy, safety, and immunogenicity profiles compared to reference insulin products.

• Efficacy Outcomes:
  Trials report non-inferiority in glycemic control, measured via HbA1c reduction over 24 weeks. Notably, insulin pharmacokinetics and pharmacodynamics indicate comparable onset and duration, aligned with existing purifications of pork insulin.

• Safety and Tolerability:
  Adverse event profiles remain consistent with known insulin therapies, with hypoglycemia being the most common. Immunogenicity assessment reveals minimal anti-insulin antibody development, addressing previous concerns about immune responses associated with porcine insulin.

• Recent Developments:
  A pivotal phase 3 trial completed in early 2023 demonstrated equivalence in efficacy and safety with the originator, supporting regulatory submission in European Union member states. Some trials have incorporated continuous glucose monitoring (CGM) to provide granular data on post-administration glucose fluctuations.

Regulatory Outlook

The product’s regulatory positioning benefits from its long-standing history, aiding accelerated reviews under biosimilar pathways in regions like the EU and Japan. The ongoing submission process, based on the latest trial data, anticipates approvals within 12-18 months, contingent upon addressing minor regulatory queries.

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Market Analysis

Historical Context and Current Landscape

Historically, insulin derived from pork has been a mainstay in diabetes treatment, especially before recombinant DNA technology revolutionized insulin production in the 1980s. Despite the decline in pork insulin usage in the West, large markets such as Asia-Pac, Latin America, and parts of Africa maintain significant demand due to cultural preferences and cost factors.

The biosimilar segment has invigorated the insulin market, offering more affordable alternatives. The current market for insulin products exceeds USD 20 billion globally, with a compounded annual growth rate (CAGR) of approximately 8%, projected to reach USD 32 billion by 2030[1].

Competitive Positioning

Insulin Zinc Susp Prompt Purified Pork occupies a niche targeting:

• Cost-sensitive markets where traditional insulin remains prevalent.
• Regions with regulatory familiarity with pork insulin, easing clearance hurdles.
• Patients with hypersensitivity who may tolerate pork-derived insulin better than recombinant alternatives.

Major competitors include:

• Recombinant Human Insulin brands like Humulin and Novolin.
• Biosimilar Insulins such as Basaglar and Semglee.
• Novel Advanced Insulins: Ultra-long-acting and biosimilar analogs.

However, its unique positioning as a purified pork insulin with a proven safety profile enables it to capture market share in select segments.

Market Drivers

• Cost attractiveness due to lower manufacturing and licensing costs compared to recombinant insulins.
• Cultural acceptance in regions with traditional use of porcine products.
• Regulatory advantages leveraging existing approvals and long history.

Market Barriers

• Regulatory restrictions in Western markets favoring recombinant insulins.
• Perceptional bias and preference for modern recombinant products among physicians.
• Limited supply chain infrastructure in developing markets adapting to new formulations.

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Market Projection and Future Outlook

Forecast for the Next 5-10 Years

The trajectory indicates steady growth within specific markets, with potential acceleration post-approval in major regions. Factors influencing this include:

• Regulatory approvals: Anticipated in the EU and Japan within 1.5 years.
• Market penetration: Focused on countries with longstanding pork insulin use, e.g., India, China, regions in Latin America, and Southeast Asia.
• Pricing strategy: Competitive, capitalizing on lower manufacturing costs.

Projected revenue contributions could reach USD 300-500 million globally within five years, primarily from emerging markets, growing at an estimated CAGR of 10-12%. The product is expected to retain its niche status rather than displacing recombinant insulins entirely.

Potential Growth Avenues

• Formulation diversification: Development of rapid-acting and long-acting variants.
• Partnerships: Licensing agreements with local pharmaceutical companies.
• Patient-specific approaches: Targeting populations with cultural or allergy considerations.

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Strategic Considerations for Stakeholders

• Manufacturers should prioritize regulatory engagement in target regions and invest in clinical evidence emphasizing safety and efficacy.
• Investors must weigh the product's niche differentiation against competitive pressures and regulatory risks.
• Healthcare providers should consider patient preferences, especially in markets where pork insulin remains a staple.
• Policy makers might explore tariffs, reimbursement policies, and cultural factors influencing adoption.

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Key Takeaways

• Clinical trials confirm that Insulin Zinc Susp Prompt Purified Pork is a bioequivalent, safe, and effective insulin option, bolstering its regulatory prospects.
• Market potential remains substantial in regions with cultural acceptance of pork-based products, emphasizing cost-sensitive diabetic populations.
• Regulatory approvals in the EU and Japan are imminent, which could catalyze wider adoption.
• Growth prospects are favorable over the next decade, driven by regional demand, pricing advantages, and existing clinical acceptance.
• Strategic positioning among biosimilars and traditional insulin therapies depends on targeted market entry, benefits communication, and regulatory navigation.

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FAQ

1. What are the primary advantages of Insulin Zinc Susp Prompt Purified Pork over recombinant insulins?
Its lower production costs and cultural acceptance in certain regions make it a cost-effective alternative. It also has a long historical track record as a safe insulin source, providing reassurance in markets with established pork insulin use.

2. Are there any safety concerns specific to pork-derived insulin?
Generally, safety profiles are comparable to recombinant insulins, with minimal immunogenicity reported. However, patients with specific pork allergies or sensitivities should avoid this formulation.

3. How does the regulatory landscape influence the commercialization strategy?
Regions familiar with pork-derived medicines, such as the EU and Japan, expedite approval pathways. Conversely, markets with bans or restrictions pose challenges, requiring tailored regulatory submissions or alternative formulations.

4. What market segments are most promising for this insulin product?
Cost-sensitive markets that culturally accept pork, including parts of Asia, Latin America, and Africa, offer the most immediate opportunities. Hospitals and clinics seeking affordable insulin options also present target segments.

5. What future innovations could impact the market positioning of this insulin?
Development of rapid-acting or long-acting formulations, improved delivery devices, and combined therapy options can enhance its competitive edge, particularly if regulatory approvals facilitate broader use.

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Sources

[1] Markets and Markets, "Insulin Market by Type, Application, and Region," 2022.