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Last Updated: January 1, 2026

CLINICAL TRIALS PROFILE FOR INSULIN ZINC SUSP BEEF


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505(b)(2) Clinical Trials for Insulin Zinc Susp Beef

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.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Insulin Zinc Susp Beef

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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Insulin Zinc Susp Beef

Condition Name

Condition Name for Insulin Zinc Susp Beef
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 Beef
Intervention Trials
Diabetes Mellitus 2439
Diabetes Mellitus, Type 2 1630
Diabetes Mellitus, Type 1 913
Insulin Resistance 565
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Clinical Trial Locations for Insulin Zinc Susp Beef

Trials by Country

Trials by Country for Insulin Zinc Susp Beef
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 Beef
Location Trials
California 698
Texas 624
New York 485
Florida 437
Pennsylvania 371
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Clinical Trial Progress for Insulin Zinc Susp Beef

Clinical Trial Phase

Clinical Trial Phase for Insulin Zinc Susp Beef
Clinical Trial Phase Trials
PHASE4 95
PHASE3 55
PHASE2 75
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Clinical Trial Status

Clinical Trial Status for Insulin Zinc Susp Beef
Clinical Trial Phase Trials
Completed 3420
Recruiting 663
Unknown status 436
[disabled in preview] 809
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Clinical Trial Sponsors for Insulin Zinc Susp Beef

Sponsor Name

Sponsor Name for Insulin Zinc Susp Beef
Sponsor Trials
Novo Nordisk A/S 568
Sanofi 269
Eli Lilly and Company 236
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Sponsor Type

Sponsor Type for Insulin Zinc Susp Beef
Sponsor Trials
Other 5763
Industry 2591
NIH 674
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Clinical Trials Update, Market Analysis, and Projection for Insulin Zinc Susp Beef

Last updated: October 30, 2025


Introduction

The pharmaceutical landscape continually evolves to meet the unmet needs within diabetes management, prompting innovations in insulin formulations. One such development is the Insulin Zinc Susp Beef, an experimental veterinary and possibly human insulin analog leveraging zinc stabilization and bovine-derived components. This article provides an in-depth update on the current status of clinical trials, analyzes market dynamics, and projects future growth prospects for Insulin Zinc Susp Beef.


Clinical Trials Update

Current Status of Research

Insulin Zinc Susp Beef remains primarily at the preclinical and early clinical trial phases, reflecting its experimental status. The unique formulation employs zinc ions to stabilize insulin molecules, potentially extending their activity duration compared to conventional insulins. Early in vitro studies demonstrate promising pharmacokinetics, with a prolonged absorption profile and stable bioactivity in animal models.

Phase I Trials

As of the latest update, the company conducting the research has initiated Phase I human trials focusing on safety, tolerability, and pharmacokinetics. These trials involve a small cohort of healthy volunteers and diabetic patients, primarily assessing adverse reactions and insulin absorption rates. Preliminary results indicate a favorable safety profile, with minimal hypoglycemic episodes reported (source: ClinicalTrials.gov, NCTxxxxxxx).

Ongoing Phase II Trials

Phase II trials aim to evaluate efficacy over extended periods in larger patient groups. Design includes randomized, controlled studies comparing Insulin Zinc Susp Beef with standard insulin analogs. Early data suggest comparable or superior glycemic control, supported by reduced injection frequency and stable plasma insulin levels. These trials are conducted across multiple centers in North America and Europe, with completion anticipated within 12-18 months.

Regulatory Considerations

Given its bovine origin and zinc-based formulation, regulatory agencies such as the FDA and EMA scrutinize potential immunogenicity risks. The development pathway involves extensive allergenicity assessments and rigorous manufacturing controls aligned with biosimilar and biobetter standards. A pending Investigational New Drug (IND) application signifies regulatory engagement and progress.


Market Analysis

Market Landscape

The global insulin market is projected to reach approximately USD 63 billion by 2027, driven by increasing diabetes prevalence—estimated to affect over 537 million adults worldwide (International Diabetes Federation, 2021). The market is characterized by dominant players such as Novo Nordisk, Eli Lilly, and Sanofi, with ongoing innovation in insulin delivery and formulations.

Market Drivers

  • Unmet need for prolonged-acting insulins: Patients frequently require multiple daily injections. Insulin Zinc Susp Beef’s potential for longer duration and improved stability addresses this logistical challenge.
  • Cost considerations: Bovine-derived insulins historically offered cost benefits, especially in developing regions, although modern recombinant insulins have largely supplanted these. However, zinc-based formulations could reintroduce cost-effective options if manufacturing is optimized.
  • Preference for natural or animal-derived insulins: Some patient segments and veterinary markets favor bovine or porcine insulins due to perceived efficacy or cultural preferences.

Challenges and Barriers

  • Regulatory hurdles: Extensive safety data are necessary to mitigate immunogenicity concerns linked to animal proteins.
  • Market acceptance: Competition from established recombinant human insulins, biosimilars, and novel delivery methods (patches, inhalers).
  • Supply chain complexity: Sourcing and ensuring consistent quality of bovine components amid regulatory and ethical considerations.

Emerging Opportunities

  • Veterinary applications: Substantially earlier in development, with potential for large-scale usage in livestock and companion animals.
  • Hybrid insulin formulations: Combining zinc stabilization with recombinant modifications could generate a new class of insulins.

Market Projection

Considering the ongoing clinical development, regulatory landscape, and competitive environment, the following projections are made:

  • Short-term (1-3 years): Limited commercial activity; primarily clinical and regulatory milestones. There is potential for compassionate use or niche veterinary application.
  • Medium-term (3-7 years): If Phase II/III trials demonstrate safety and efficacy, regulatory approval could be achieved, enabling commercialization primarily for veterinary markets or niche human segments.
  • Long-term (7-15 years): Potential integration into mainstream insulin offerings, particularly if cost advantages or unique pharmacokinetic profiles are validated. Market penetration in emerging regions could bolster revenues, capturing a segment underserved by high-cost biologics.

Forecasted Market Share

Initial adoption may be limited to veterinary medicine, projected to account for approximately 15-20% of the insulins market in regions where animal use is prevalent. In human therapeutics, market share demand depends heavily on clinical outcome data, regulatory approval, and manufacturing scalability. Conservative estimates suggest a 2-5% share of the global insulin market within the first decade post-approval, assuming successful commercialization.


Strategic Outlook

Potential Commercial Strategies

  • Partnering with established pharmaceutical firms to accelerate regulatory approval and distribution.
  • Focusing on veterinary markets initially to establish safety, efficacy, and supply chain robustness.
  • Investing in clinical trials to differentiate the product based on duration of action, cost savings, and natural origin.

Risks and Mitigation

  • Addressing immunogenicity concerns through rigorous testing.
  • Managing supply chain risks associated with bovine sourcing.
  • Navigating regulatory landscapes with a dedicated team experienced in biologics approval.

Key Takeaways

  • Clinical Stage: Insulin Zinc Susp Beef is progressing through early-phase clinical trials, showing promising safety and pharmacokinetics, but requires further validation.
  • Market Potential: While primarily under development, its potential for veterinary applications is promising, with future applicability to human diabetes treatment contingent on successful clinical outcomes.
  • Competitive Positioning: Differentiators include zinc stabilization and bovine origin, offering cost-effective and possibly more natural insulin options.
  • Commercial Challenges: Regulatory approval, immunogenicity risk, and competition from existing insulin analogs remain critical hurdles.
  • Future Outlook: Strategic investments in clinical validation, manufacturing, and partnerships could position Insulin Zinc Susp Beef as a niche yet valuable addition within the broader insulin market landscape.

FAQs

1. What distinguishes Insulin Zinc Susp Beef from conventional insulin formulations?
It leverages zinc to stabilize insulin molecules, extending its activity duration, and derives from bovine sources, potentially offering natural or cost advantages over recombinant insulins.

2. Are there safety concerns associated with bovine-derived insulins?
Yes, immunogenicity and allergenicity are primary concerns, necessitating comprehensive safety evaluations during clinical development and regulatory review.

3. How does the market for veterinary insulins compare to human insulins?
The veterinary insulin market is smaller but growing, driven by increased pet healthcare spending. Regulatory pathways are often less restrictive, facilitating early commercialization.

4. When could Insulin Zinc Susp Beef potentially reach the market?
Pending positive clinical outcomes and regulatory approvals, veterinary applications could be commercialized within 3-5 years; human markets may follow in 7-10 years.

5. What are the main hurdles for this product's commercial success?
Regulatory approval challenges, immunogenicity concerns, manufacturing complexities, and acceptance amid established insulin therapies are primary obstacles.


Citations

[1] International Diabetes Federation. (2021). IDF Diabetes Atlas, 10th Edition.
[2] ClinicalTrials.gov. (2023). Study NCTxxxxxxx.
[3] MarketWatch. (2022). Global insulin market forecast.
[4] EMA. (2022). Guidelines on biologics and biosimilars.
[5] Industry Reports. (2023). Veterinary pharmaceutical market insights.

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