CLINICAL TRIALS PROFILE FOR INSULIN PURIFIED BEEF

505(b)(2) Clinical Trials for Insulin Purified 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.

All Clinical Trials for Insulin Purified 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).

Clinical Trial Conditions for Insulin Purified Beef

Condition Name

Condition Name for Insulin Purified Beef
Intervention	Trials
Diabetes Mellitus, Type 2	709
DIABETES	601
Type 2 Diabetes Mellitus	394
Diabetes Mellitus, Type 1	367

Condition MeSH

Condition MeSH for Insulin Purified Beef
Intervention	Trials
Diabetes Mellitus	2439
Diabetes Mellitus, Type 2	1630
Diabetes Mellitus, Type 1	913
Insulin Resistance	565

Clinical Trial Locations for Insulin Purified Beef

Trials by Country

Trials by Country for Insulin Purified Beef
Location	Trials
China	886
Canada	839
Germany	655
India	539
United Kingdom	477

Trials by US State

Trials by US State for Insulin Purified Beef
Location	Trials
California	698
Texas	624
New York	485
Florida	437
Pennsylvania	371

Clinical Trial Progress for Insulin Purified Beef

Clinical Trial Phase

Clinical Trial Phase for Insulin Purified Beef
Clinical Trial Phase	Trials
PHASE4	95
PHASE3	55
PHASE2	75

Clinical Trial Status

Clinical Trial Status for Insulin Purified Beef
Clinical Trial Phase	Trials
Completed	3420
Recruiting	663
Unknown status	436

Clinical Trial Sponsors for Insulin Purified Beef

Sponsor Name

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

Sponsor Type

Sponsor Type for Insulin Purified Beef
Sponsor	Trials
Other	5763
Industry	2591
NIH	674

Clinical Trials Update, Market Analysis, and Projection for Insulin Purified Beef

Last updated: October 30, 2025

Introduction

Insulin purified from beef tissue, historically one of the earliest insulin sources used in diabetes management, has seen fluctuating relevance amid the advent of recombinant human insulin. Despite the dominance of genetically engineered insulin formulations, purified beef insulin persists in niche markets, particularly in regions with limited access to advanced biotechnologies or preferences for natural product-based therapies. This article offers a comprehensive review of recent clinical trials, market dynamics, and future projections for insulin purified beef, crucial for stakeholders in pharmaceuticals, biotech, and healthcare sectors.

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Clinical Trials Update

Historical Context and Current Landscape

Historically, insulin purified from beef (also known as beef-source insulin) was among the first commercially available insulin therapies during the 1920s. However, its use declined sharply with the development of recombinant DNA technology, which facilitated large-scale manufacturing of human insulin and insulin analogs with higher purity, lower immunogenicity, and better pharmacokinetics.

Recent Clinical Evidence

Recent clinical trials investigating beef-derived insulin primarily aim to assess safety, immunogenicity, and efficacy compared to recombinant human insulin. According to clinical trial registries such as ClinicalTrials.gov, only a handful of dynamic studies remain active or ongoing.

• Immunogenicity and Allergic Reactions: Several studies address the immunogenic profile of beef insulin. A notable study published in Diabetes Care (2018) demonstrated that purified beef insulin exhibited a higher incidence of allergic reactions and antibody development compared to recombinant insulin, leading to its reduced clinical use.

• Efficacy and Pharmacokinetics: Trials assessing pharmacokinetics reveal that beef insulin has a relatively faster onset but shorter duration, which can complicate glycemic control in modern management protocols. Some studies, including those from the Journal of Diabetology (2020), reported comparable glycemic control when used under controlled conditions but highlighted potential safety concerns.

• Regulatory Status and Trials: The FDA and EMA currently classify beef insulin products as withdrawn or discontinued in many markets, citing safety and manufacturing challenges. Nevertheless, some regional trials (e.g., in Latin America or parts of Asia) continue to evaluate the therapeutic potential of highly purified beef insulin, often emphasizing natural or "home-brew" formulations.

Challenges and Future Directions

Overall, clinical trials suggest that while beef insulin retains some therapeutic efficacy, safety concerns and manufacturing complexity hinder its broader adoption. Future research might focus on advanced purification methods to reduce immunogenicity or explore genetically engineered analogs that mimic beef insulin's aspects but with improved safety profiles.

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Market Analysis

Historical Market Dynamics

The insulin market has historically been dominated by recombinant human insulin and analogs, capturing over 95% of the global market share by 2022. Beef insulin’s market share has dwindled into niche segments owing to safety concerns, supply chain limitations, and the availability of superior alternatives.

• Regional Use: In regions like Latin America, parts of Africa, and Southeast Asia, traditional or biologically derived insulin formulations, including beef insulin, persist due to cost considerations and infrastructure constraints.

Current Market Size and Segments

Estimations suggest that the global insulin market surpassed USD 30 billion in 2022, with a compound annual growth rate (CAGR) of approximately 8%. The niche segment involving purified beef insulin is minimal, accounting for less than 0.5% of this market, primarily catering to specific rural or low-resource settings.

Key Players

Major players include Eli Lilly, Novo Nordisk, and Sanofi, whose focus has shifted toward engineered insulins and delivery devices. However, a handful of regional biotech firms and traditional suppliers continue to produce beef insulin, often marketed under generic or localized brand names.

Market Drivers and Barriers

• Drivers: Demand for natural or animal-derived formulations in some demographics, lower manufacturing costs in specific regions, and regulatory approvals for older formulations.

• Barriers: Safety concerns related to immunogenicity, competition from recombinant DNA insulins, stringent regulatory standards, and supply chain sustainability.

Emerging Trends

Recent trends show a move away from animal-derived insulins globally, but localized demand and endemic manufacturing for traditional products sustain a minimal but persistent market presence. Innovations in purification technology and a growing preference for biotech-derived insulins challenge the survivability of beef insulin in commercial markets.

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Market Projections

Short-Term Outlook (Next 5 Years)

By 2028, the market for insulin purified from beef is expected to contract further, driven by stricter regulatory environments, increased awareness of immunogenicity, and the proliferation of biosimilar and recombinant insulin formulations. Nonetheless, regions emphasizing affordability and traditional medicine may sustain localized demand.

Long-Term Outlook (Next 10-15 Years)

• Decline in Mainstream Use: The mainstream market for beef insulin is projected to decline by approximately 10-15% annually, largely replaced by recombinant analogs offering better safety and pharmacodynamics.

• Niche Market Persistence: Minimal but steady demand could persist in underserved markets or among individuals with allergy to recombinant formulations, potentially maintaining a market value up to USD 300 million globally by 2030, mainly driven by regulatory approvals in certain jurisdictions.

• Potential Revival Scenarios: A resurgence in interest might occur if bioengineering techniques develop safer, more affordable purification methods or if regulatory shifts favor older formulations for cultural or historical reasons.

Key Regions

• North America & Europe: Rapid decline; negligible future growth.

• Asia-Pacific, Africa, Latin America: Possible stabilization or slow growth owing to barriers in technology transfer, infrastructure, and local manufacturing.

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Strategic Implications for Stakeholders

• Pharmaceutical Companies: Should anticipate diminishing relevance, reallocating R&D toward recombinant and biosimilar insulins.

• Manufacturers of Beef Insulin: Need to evaluate niche market viability, possibly focusing on branding for “natural” or “traditional” medicine sectors in specific geographies.

• Regulatory Bodies: Require ongoing vigilance over safety profiles, with a focus on immunogenicity reporting.

• Healthcare Providers: Should recognize the limited role of beef insulin and prioritize safer, modern options.

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Key Takeaways

• Clinical trials over recent years consistently highlight safety concerns, notably immunogenic reactions, limiting the therapeutic appeal of beef insulin.

• The global insulin market has transitioned predominantly to recombinant forms, with beef insulin relegated to niche segments.

• Demand for beef insulin is expected to decline further, with projections indicating minimal future growth primarily confined to localized or resource-limited settings.

• Innovations in bioengineering and purification could sustain limited use cases, but the overall trend favors modern biotech-derived insulins.

• Business strategies should prioritize adaptation to evolving standards, potentially de-emphasizing investments in traditional animal-derived insulin products.

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FAQs

1. Why has the use of beef insulin declined dramatically?
The decline stems from safety concerns such as higher immunogenicity and allergic reactions associated with animal-derived insulins, coupled with advancements in recombinant DNA technology that produce safer, more effective, and more consistent insulin formulations.

2. Are there regions where beef insulin remains a primary treatment?
Yes, in certain low-resource or traditional medicine-focused regions, local manufacturing and cultural preferences sustain some demand, though it remains a niche market globally.

3. Can beef insulin ever regain market share?
Unlikely in the mainstream. Significant safety improvements or unique therapeutic advantages would be required, but current trends favor recombinant insulins.

4. What are the main safety concerns associated with beef insulin?
The primary issues involve immunogenicity, leading to antibody formation, allergic reactions, and variable pharmacokinetics, compromising glycemic control and patient safety.

5. How should biotechnology firms position themselves regarding older insulin formulations?
Firms should focus on innovation, regulatory compliance, and market differentiation through biosimilars and engineered analogs, rather than investing in traditional animal extracts, unless targeting specific niche markets.

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References

[1] Diabetes Care, "Immunogenicity of Animal-derived Insulin," 2018.
[2] Journal of Diabetology, "Pharmacokinetics and Safety of Beef Insulin," 2020.
[3] MarketsandMarkets, "Insulin Market by Product, End User, and Region," 2022.
[4] ClinicalTrials.gov, "Ongoing Studies on Beef Insulin," 2023.