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Last Updated: January 1, 2026

CLINICAL TRIALS PROFILE FOR INSULIN ZINC SUSP PURIFIED PORK


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505(b)(2) Clinical Trials for Insulin Zinc Susp Purified Pork

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Combination NCT00151697 ↗ LANN-study: Lantus, Amaryl, Novorapid, Novomix Study Completed Rijnstate Hospital Phase 3 2005-05-01 Many diabetics gain weight while on insulin therapy. In this study, we evaluate the efficacy of the combination of glimepiride and short-acting insulin on weight control and glucose control. In this study, 150 diabetics whose diabetic control is inadequate while on maximal oral treatment will be randomized to either the new combination treatment or twice daily injections with a mixture of short- and longacting insulin or once-daily injection with a basal insulin analog. The study will compare glucose control and weight gain during a year after randomisation between the three treatments.
OTC NCT00169299 ↗ Herbal Alternatives for Menopause Symptoms (HALT Study) Unknown status National Center for Complementary and Integrative Health (NCCIH) Phase 4 2001-06-01 Surveys indicate that 25 to 33% of women have moderate to severe menopausal symptoms including hot flashes, night sweats, and disturbed sleep. The treatment of choice in the medical community for these symptoms is hormone replacement therapy, which is estrogen and sometimes progestin. Many women also use over-the-counter herbal remedies. However, less is known about how well these products work, or their safety. Few have undergone the kind of rigorous testing required of prescription drugs and little is known about their long-term effectiveness in relieving symptoms. The purpose of this study is to compare several over-the-counter herbal remedies to hormone replacement therapy. Our primary aim is to look at the effects of these remedies on your self-reported menopausal symptoms. We will also be measuring their effects on other factors known to be affected by hormone replacement therapy: cholesterol, blood sugar, bone density, vaginal cell structure, and blood clotting.
OTC NCT00169299 ↗ Herbal Alternatives for Menopause Symptoms (HALT Study) Unknown status National Institute on Aging (NIA) Phase 4 2001-06-01 Surveys indicate that 25 to 33% of women have moderate to severe menopausal symptoms including hot flashes, night sweats, and disturbed sleep. The treatment of choice in the medical community for these symptoms is hormone replacement therapy, which is estrogen and sometimes progestin. Many women also use over-the-counter herbal remedies. However, less is known about how well these products work, or their safety. Few have undergone the kind of rigorous testing required of prescription drugs and little is known about their long-term effectiveness in relieving symptoms. The purpose of this study is to compare several over-the-counter herbal remedies to hormone replacement therapy. Our primary aim is to look at the effects of these remedies on your self-reported menopausal symptoms. We will also be measuring their effects on other factors known to be affected by hormone replacement therapy: cholesterol, blood sugar, bone density, vaginal cell structure, and blood clotting.
OTC NCT00169299 ↗ Herbal Alternatives for Menopause Symptoms (HALT Study) Unknown status Group Health Cooperative Phase 4 2001-06-01 Surveys indicate that 25 to 33% of women have moderate to severe menopausal symptoms including hot flashes, night sweats, and disturbed sleep. The treatment of choice in the medical community for these symptoms is hormone replacement therapy, which is estrogen and sometimes progestin. Many women also use over-the-counter herbal remedies. However, less is known about how well these products work, or their safety. Few have undergone the kind of rigorous testing required of prescription drugs and little is known about their long-term effectiveness in relieving symptoms. The purpose of this study is to compare several over-the-counter herbal remedies to hormone replacement therapy. Our primary aim is to look at the effects of these remedies on your self-reported menopausal symptoms. We will also be measuring their effects on other factors known to be affected by hormone replacement therapy: cholesterol, blood sugar, bone density, vaginal cell structure, and blood clotting.
OTC NCT00169299 ↗ Herbal Alternatives for Menopause Symptoms (HALT Study) Unknown status Kaiser Permanente Phase 4 2001-06-01 Surveys indicate that 25 to 33% of women have moderate to severe menopausal symptoms including hot flashes, night sweats, and disturbed sleep. The treatment of choice in the medical community for these symptoms is hormone replacement therapy, which is estrogen and sometimes progestin. Many women also use over-the-counter herbal remedies. However, less is known about how well these products work, or their safety. Few have undergone the kind of rigorous testing required of prescription drugs and little is known about their long-term effectiveness in relieving symptoms. The purpose of this study is to compare several over-the-counter herbal remedies to hormone replacement therapy. Our primary aim is to look at the effects of these remedies on your self-reported menopausal symptoms. We will also be measuring their effects on other factors known to be affected by hormone replacement therapy: cholesterol, blood sugar, bone density, vaginal cell structure, and blood clotting.
New Combination NCT00501709 ↗ Prevention of Autoimmune Destruction and Rejection of Human Pancreatic Islets Following Transplantation for Insulin Dependent Diabetes Mellitus Completed Juvenile Diabetes Research Foundation Phase 1/Phase 2 2007-02-01 Pancreatic islets are the part of the pancreas that produce insulin and help control the blood sugar. This study aims to improve islet transplantation as a treatment for Type 1 Diabetes by using a new combination of immunosuppressive drugs that have been successful in treating other autoimmune diseases and in preventing kidney transplant rejection.
New Combination NCT00501709 ↗ Prevention of Autoimmune Destruction and Rejection of Human Pancreatic Islets Following Transplantation for Insulin Dependent Diabetes Mellitus Completed University of California, San Francisco Phase 1/Phase 2 2007-02-01 Pancreatic islets are the part of the pancreas that produce insulin and help control the blood sugar. This study aims to improve islet transplantation as a treatment for Type 1 Diabetes by using a new combination of immunosuppressive drugs that have been successful in treating other autoimmune diseases and in preventing kidney transplant rejection.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Insulin Zinc Susp Purified Pork

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00000110 ↗ Influence of Diet and Endurance Running on Intramuscular Lipids Measured at 4.1 TESLA Completed National Center for Research Resources (NCRR) N/A 1969-12-31 The purpose of this pilot investigation is to use 1 H Magnetic Resonance Spectroscopy (MRS) to 1) document the change in intra-muscular lipid stores (IML) before and after a prolonged bout of endurance running and, 2) determine the pattern (time course) of IML replenishment following an extremely low-fat diet (10% of energy from fat) and a moderate-fat diet (35% of energy from fat). Specifically, the study will evaluate the change in IML following a 2-hour training run and the recovery of IML in response to the post-exercise low-fat or moderate-fat diet in 10 endurance trained athletes who will consume both diets in a randomly assigned cross-over fashion. We hypothesize that IML will be depleted with prolonged endurance exercise, and that replenishment of IML will be impaired by an extremely low-fat diet compared to a moderate-fat diet. Results of this pilot study will be used to apply for extramural grant support from NIH or the US Armed Forces to investigate the effect of dietary fat on the health and performance of individuals performing heavy physical training. It is anticipated that this methodology could also be employed in obesity research to delineate, longitudinally, the reported cross-sectional relationships among IML stores, insulin resistance and obesity.
NCT00000159 ↗ Sorbinil Retinopathy Trial (SRT) Completed National Eye Institute (NEI) Phase 3 1983-08-01 To evaluate the safety and efficacy of the investigational drug sorbinil, an aldose reductase inhibitor, in preventing the development of diabetic retinopathy and neuropathy in persons with insulin-dependent diabetes.
NCT00000380 ↗ Growth Hormone Releasing Hormone (GHRH) Treatment for Age-Related Sleep Disturbances Completed National Institute of Mental Health (NIMH) N/A 1996-06-01 The purpose of this study is to examine the effects of giving growth hormone releasing hormone (GHRH) to treat sleep disorders in older men and in older women who are on estrogen replacement therapy (ERT). Many older men and women complain of sleep disturbances. GHRH has been used successfully to treat sleep disorders in young men and may help older men and women. 40 healthy older men and 40 healthy older women on ERT will receive either GHRH or an inactive placebo. An individual may be eligible for this study if he/she is a healthy older man or woman with sleep disturbances, and is on estrogen replacement therapy (women).
NCT00000380 ↗ Growth Hormone Releasing Hormone (GHRH) Treatment for Age-Related Sleep Disturbances Completed University of Washington N/A 1996-06-01 The purpose of this study is to examine the effects of giving growth hormone releasing hormone (GHRH) to treat sleep disorders in older men and in older women who are on estrogen replacement therapy (ERT). Many older men and women complain of sleep disturbances. GHRH has been used successfully to treat sleep disorders in young men and may help older men and women. 40 healthy older men and 40 healthy older women on ERT will receive either GHRH or an inactive placebo. An individual may be eligible for this study if he/she is a healthy older man or woman with sleep disturbances, and is on estrogen replacement therapy (women).
NCT00000466 ↗ Postmenopausal Estrogen/Progestin Interventions (PEPI) Completed Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Phase 3 1987-09-01 To assess the effects of various postmenopausal estrogen replacement therapies on selected cardiovascular risk factors, including high density lipoprotein cholesterol, systolic blood pressure, fibrinogen, and insulin and on osteoporosis risk factors. Conducted in collaboration with the National Institute of Child Health and Human Development, the National Institute of Arthritis and Musculoskeletal and Skin Diseases, The National Institute of Diabetes and Digestive and Kidney Diseases, and the National Institute on Aging. The extended follow-up is for 3 years focusing on endometrium and breast evaluation.
NCT00000466 ↗ Postmenopausal Estrogen/Progestin Interventions (PEPI) Completed National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) Phase 3 1987-09-01 To assess the effects of various postmenopausal estrogen replacement therapies on selected cardiovascular risk factors, including high density lipoprotein cholesterol, systolic blood pressure, fibrinogen, and insulin and on osteoporosis risk factors. Conducted in collaboration with the National Institute of Child Health and Human Development, the National Institute of Arthritis and Musculoskeletal and Skin Diseases, The National Institute of Diabetes and Digestive and Kidney Diseases, and the National Institute on Aging. The extended follow-up is for 3 years focusing on endometrium and breast evaluation.
NCT00000466 ↗ Postmenopausal Estrogen/Progestin Interventions (PEPI) Completed National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Phase 3 1987-09-01 To assess the effects of various postmenopausal estrogen replacement therapies on selected cardiovascular risk factors, including high density lipoprotein cholesterol, systolic blood pressure, fibrinogen, and insulin and on osteoporosis risk factors. Conducted in collaboration with the National Institute of Child Health and Human Development, the National Institute of Arthritis and Musculoskeletal and Skin Diseases, The National Institute of Diabetes and Digestive and Kidney Diseases, and the National Institute on Aging. The extended follow-up is for 3 years focusing on endometrium and breast evaluation.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Insulin Zinc Susp Purified Pork

Condition Name

Condition Name for Insulin Zinc Susp Purified Pork
Intervention Trials
Diabetes Mellitus, Type 2 709
Diabetes 601
Type 2 Diabetes Mellitus 394
Diabetes Mellitus, Type 1 367
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Condition MeSH

Condition MeSH for Insulin Zinc Susp Purified Pork
Intervention Trials
Diabetes Mellitus 2438
Diabetes Mellitus, Type 2 1630
Diabetes Mellitus, Type 1 913
Insulin Resistance 563
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Clinical Trial Locations for Insulin Zinc Susp Purified Pork

Trials by Country

Trials by Country for Insulin Zinc Susp Purified Pork
Location Trials
China 886
Canada 839
Germany 655
India 539
United Kingdom 477
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Trials by US State

Trials by US State for Insulin Zinc Susp Purified Pork
Location Trials
California 698
Texas 624
New York 485
Florida 437
Pennsylvania 371
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Clinical Trial Progress for Insulin Zinc Susp Purified Pork

Clinical Trial Phase

Clinical Trial Phase for Insulin Zinc Susp Purified Pork
Clinical Trial Phase Trials
PHASE4 95
PHASE3 53
PHASE2 75
[disabled in preview] 2423
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Clinical Trial Status

Clinical Trial Status for Insulin Zinc Susp Purified Pork
Clinical Trial Phase Trials
Completed 3419
Recruiting 662
Unknown status 436
[disabled in preview] 949
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Clinical Trial Sponsors for Insulin Zinc Susp Purified Pork

Sponsor Name

Sponsor Name for Insulin Zinc Susp Purified Pork
Sponsor Trials
Novo Nordisk A/S 568
Sanofi 269
Eli Lilly and Company 236
[disabled in preview] 498
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Sponsor Type

Sponsor Type for Insulin Zinc Susp Purified Pork
Sponsor Trials
Other 5759
Industry 2591
NIH 673
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Clinical Trials Update, Market Analysis and Projection for Insulin Zinc Suspension Purified Pork

Last updated: October 30, 2025


Introduction

Insulin Zinc Susp Purified Pork, a porcine-derived insulin formulation stabilized with zinc salts, remains a relevant therapeutic agent in diabetes management. With ongoing advancements in biotechnology and market shifts favoring recombinant human insulin, understanding the clinical, commercial, and future growth landscape of this biotechnology product is critical for stakeholders.


Clinical Trials Update

Historical Context and Current Status

Traditionally, insulin products derived from porcine pancreas have served as vital alternatives for patients allergic to bovine insulin or recombinant formulations. However, with the advent of recombinant DNA technology, animal-derived insulin usage declined sharply since the late 20th century [1].

Recent Clinical Research and Trials

While most clinical trials for Insulin Zinc Susp Purified Pork date back to the 1980s and 1990s, recent updates, albeit sparse, indicate continued interest in optimizing formulation stability and immunogenicity profiles.

  • Immunogenicity and Safety Studies: Recent retrospective analyses compare the immunogenicity of porcine insulin versus recombinant human insulin, citing lower cross-reactivity and allergic reactions with certain formulations, including zinc-stabilized suspensions [2].

  • Bioequivalence and Pharmacokinetic Studies: Limited recent trials evaluate bioequivalence of zinc-stabilized pork insulin with biosimilars, emphasizing sustained-release profiles owing to zinc’s stabilizing effects [3].

Emerging Perspectives

Despite limited ongoing trials specific to Insulin Zinc Susp Purified Pork, some research explores combining porcine proteins with novel delivery systems to extend duration of action and reduce injection frequency, indicating incremental innovation rather than fundamental clinical shifts.


Market Analysis

Historical Market Landscape

The global insulin market has experienced dynamic growth driven by rising diabetes prevalence, technological innovations, and strategic societal health initiatives.

  • Market Share of Animal Insulins: Historically, porcine insulin held approximately 45-50% of the insulin segment in certain regions during the 1990s, primarily in Asia and parts of Europe. Presently, but the trend has shifted heavily toward recombinant human insulin and analogs, which now account for over 90% of the global market [4].

Current Market Dynamics

  • Decline in Animal Insulin Usage: The decreasing utilization of porcine insulin is driven by manufacturing complexities, patient safety concerns, and regulatory preferences favoring recombinant technologies. Nevertheless, specific markets continue to use porcine insulin due to infrastructure and economic factors.

  • Regional Market Concentration: In countries like China and some Southeast Asian nations, where recombinant technology penetration remains lower, animal-derived insulin retains a niche role—contributing to approximately 10-15% share in these regions.

  • Regulatory Environment: Major regulatory bodies, including the FDA and EMA, have phased out approvals for new animal insulin applications; existing products are still marketed, but future approvals are scarce.

Market Opportunities and Challenges

  • Opportunities:

    • Market retention in low-income regions and markets with limited access to recombinant technology.
    • Development of combined formulations for improved stability and administration ease.
  • Challenges:

    • Stringent regulatory policies.
    • Growing preference for recombinant and analog insulins due to safety, efficacy, and manufacturing efficiency.
    • Patient perceptions favoring modern formulations.

Future Market Projection

Short-term Outlook (Next 5 Years)

  • A continued decline in new market entries for Insulin Zinc Susp Purified Pork.
  • Existing products will sustain niche markets with incremental growth driven by regional healthcare infrastructures.
  • Limited innovation activity, focusing on formulation improvements, stability, and delivery methods.

Long-term Outlook (Beyond 10 Years)

  • The global market share is expected to contract further, possibly stabilizing at a small fraction (<5%) primarily in legacy markets.
  • Potential resurgence in specific scenarios where traditional insulins are preferred due to cost or manufacturing benefits, especially in developing regions.

Market Value Estimation

  • Overall, due to the decline in demand, the global valuation of porcine insulin products is projected to decline from a peak of approximately USD 500 million in the early 2000s to below USD 50 million by 2030, assuming current trends persist [4].

Impact of Biotechnological Advances

  • Development of oral insulin candidates and novel delivery systems may further accelerate the obsolescence of traditional animal insulins, including Zinc Susp Purified Pork.

Concluding Insights

While Insulin Zinc Susp Purified Pork has historically played a significant role in diabetes care, its current clinical relevance and market presence are diminishing rapidly. The primary driver remains regional usage, usually in markets less penetrated by recombinant products. Future growth hinges on targeted regional strategies and niche applications, with mainstream markets expected to phase out use in favor of safer, more effective recombinant formulations.


Key Takeaways

  • Clinical Trials: No recent significant trials, with existing data supporting safety and bioequivalence; innovation remains limited.
  • Market Trends: Dominated by recombinant human insulin and analogs, leading to a steep decline in animal insulin market share globally.
  • Regional Niche: Persistent usage in developing markets where infrastructure and regulation favor older formulations.
  • Future Outlook: Further market contraction anticipated; marginal growth possible in underserved regions.
  • Strategic Focus: Stakeholders should prioritize niche market sustainability and explore formulation innovations to prolong product viability.

FAQs

  1. Why has the use of porcine insulin declined globally?
    The advent of recombinant human insulin and analogs offers improved safety, efficacy, and manufacturing efficiency, replacing animal-derived insulins in most markets.

  2. Are there any ongoing clinical trials for Insulin Zinc Susp Purified Pork?
    Current clinical trials are scarce; most data are retrospective or historical. Focus has shifted to recombinant formulations.

  3. What regional markets still utilize porcine insulin significantly?
    Countries in Southeast Asia, China, and some Eastern European regions continue to use porcine insulin, primarily due to economic and infrastructural factors.

  4. What are the main regulatory challenges faced by animal insulin products?
    Stringent safety and efficacy standards have phased out new approvals, making existing products difficult to market without robust data supporting equivalence and safety.

  5. Is there potential for resurgence of animal insulins in the future?
    It is unlikely at the global scale unless significant breakthroughs emerge in cost-effective manufacturing or regulatory environments favor such products for specific indications or populations.


References

[1] Diabetes Technology & Therapeutics, 2010;12(1):47-55.
[2] Journal of Diabetes Research, 2015;2015:1-10.
[3] PharmacoEconomics, 2018;36(7):817-829.
[4] Global Market Insights, 2022 Report on Insulin Market.

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