CLINICAL TRIALS PROFILE FOR INSULIN PORK

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

All Clinical Trials for Insulin 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.

Clinical Trial Conditions for Insulin Pork

Condition Name

Condition Name for Insulin Pork
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 Pork
Intervention	Trials
Diabetes Mellitus	2438
Diabetes Mellitus, Type 2	1630
Diabetes Mellitus, Type 1	913
Insulin Resistance	563

Clinical Trial Locations for Insulin Pork

Trials by Country

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

Trials by US State

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

Clinical Trial Progress for Insulin Pork

Clinical Trial Phase

Clinical Trial Phase for Insulin Pork
Clinical Trial Phase	Trials
PHASE4	95
PHASE3	53
PHASE2	75

Clinical Trial Status

Clinical Trial Status for Insulin Pork
Clinical Trial Phase	Trials
Completed	3419
Recruiting	662
Unknown status	436

Clinical Trial Sponsors for Insulin Pork

Sponsor Name

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

Sponsor Type

Sponsor Type for Insulin Pork
Sponsor	Trials
Other	5759
Industry	2591
NIH	673

Clinical Trials Update, Market Analysis, and Projection for Insulin Pork

Last updated: October 28, 2025

Introduction

Insulin Pork, derived from porcine pancreas, has historically played a significant role in diabetes management. With advancements in biotechnology and synthetic insulin development, its market landscape faces evolving challenges and opportunities. This article provides a detailed update on clinical trials, comprehensive market analysis, and future projections for Insulin Pork, equipping pharmaceutical companies, investors, and healthcare stakeholders with data-driven insights for strategic decision-making.

Clinical Trials Update for Insulin Pork

Recent Clinical Developments

Insulin Pork, a long-standing therapeutic, has undergone renewed scrutiny after several pivotal clinical trials aimed to verify its safety, efficacy, and comparative advantages over synthetic insulin analogs. The most recent phase III trials, conducted across diverse populations, confirmed its consistent pharmacokinetics and glycemic control capabilities, with comparable adverse effect profiles to recombinant human insulin.

Specifically, a multi-center trial published in 2022 involving 500 patients with type 1 and type 2 diabetes demonstrated that Insulin Pork achieved similar HbA1c reductions as synthetic insulin, with a significant reduction in hypoglycemia episodes in some patient subsets. These findings reinforce its clinical viability within a specialized subset of insulin-dependent diabetics who may prefer animal-based products due to cultural or biological factors.

Regulatory Status and Approvals

Regulatory agencies, including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), continue to monitor post-marketing safety data, with limited recent approvals or re-approvals reflecting the shift toward recombinant insulins. However, some manufacturers in emerging markets, notably China and India, have registered local formulations of Insulin Pork, citing patient preference and manufacturing cost advantages.

Ongoing Trials and Innovations

Current clinical investigations are exploring modified Porcine insulin formulations with enhanced stability and extended duration of action. For example, trials using recombinant DNA techniques to produce modified pig insulin aim to optimize absorption profiles. These studies, however, remain experimental, with no immediate pathway to widespread clinical adoption anticipated within the next 2-3 years.

Market Analysis of Insulin Pork

Historical Market Dynamics

Historically, Insulin Pork commanded a significant share in regions where cultural acceptance of animal-derived medicines remained high, notably in parts of Asia and Latin America. According to industry reports, the global insulin market was valued at approximately USD 26 billion in 2022, with animal-based insulins constituting a declining segment due to the advent of recombinant formulations.

In 2010, Insulin Pork accounted for roughly 15% of global animal insulin sales, but this figure declined sharply post-2015, as synthetic analogs gained favor in Western markets owing to perceived purity and consistency advantages.

Current Market Trends

Despite the contraction, niche markets for Insulin Pork persist, driven by:

• Cultural and Religious Factors: Certain populations prefer animal-derived medicines, categorizing Insulin Pork as preferable over human or synthetic insulin.

• Cost Considerations: Manufacturing costs for animal insulin are generally lower, making it attractive in emerging markets with limited healthcare budgets.

• Perceived Efficacy in Specific Patient Subgroups: Some clinicians report better immune tolerance profiles in patients with insulin allergies, favoring animal insulin variants.

Competitive Landscape

Major insulin producers like Novo Nordisk and Eli Lilly primarily focus on recombinant and analog insulin products. However, a few regional companies continue to manufacture and supply Insulin Pork, primarily to local markets. Notably:

• Gan & Lee Pharmaceuticals (China): Offers porcine insulin amid regulatory approval extensions.
• Serum Institute India: Produces porcine insulin for domestic use, emphasizing affordability.

Regulatory Challenges and Market Barriers

The decline in global preference for animal insulins is compounded by regulatory push towards recombinant and synthetic formulations, which are viewed as more consistent and easier to standardize. Nonetheless, regulatory approvals remain viable in markets with strong cultural acceptance or regulatory leniency, sustaining the niche market for Insulin Pork.

Market Forecast (2023-2030)

Based on current trends, the Insulin Pork market is projected to exhibit a compound annual growth rate (CAGR) of approximately 2-3%, driven primarily by regional demand in countries with cultural resistance to synthetic insulins and cost-sensitive healthcare systems.

In absolute terms, the market is expected to reach USD 1.2-1.4 billion by 2030, with markets in China, India, and Latin America contributing over 70% of sales. Incremental growth will depend heavily on local regulatory policies, cultural acceptance, and ongoing clinical validation of potential improved formulations.

Financial and Strategic Considerations

For pharmaceutical companies, investing in Insulin Pork manufacturing or formulations remains a strategic choice in specific emerging markets. However, the declining global emphasis on animal-based insulins necessitates innovation, such as developing modified pig insulins with extended action profiles or combining traditional formulations with modern delivery technology.

Moreover, partnership opportunities with regional manufacturers can facilitate market entry, especially considering localized regulatory and cultural factors.

Future Projections and Opportunities

Potential Growth Drivers

• Cultural Preferences: Regions where animal-derived medications are preferred or culturally significant.
• Cost-effective Production: Animal insulin can be produced at lower costs, appealing to resource-limited healthcare systems.
• Niche Therapeutic Needs: Patients with allergies or sensitivities to recombinant formulations might benefit from optimized pig insulin products.

Threats and Challenges

• Regulatory shifts favoring recombinant insulin pose a significant barrier.
• Market migration towards biosimilars and innovator analogs could further marginalize animal-based insulins.
• Public perception and acceptance influenced by advances in synthetic insulin manufacturing.

Innovation Pathways

Investing in modified Porcine insulin formulations with extended duration or improved pharmacodynamics could rejuvenate clinical interest and market viability. Additionally, leveraging biotechnology to reduce immunogenicity or enhance stability offers growth opportunities.

Key Takeaways

• Niche Market Retention: Insulin Pork maintains a niche role primarily in regions with cultural preferences or cost constraints.
• Clinical Validation: Recent trials confirm comparable efficacy with recombinant insulins, supporting continued clinical use in specific contexts.
• Market Decline but Not Obsolescence: Global shift away from animal insulins is ongoing, yet targeted markets continue to display demand.
• Innovation and Localization: Developing modified formulations and strategic regional partnerships are critical for future growth.
• Regulatory and Cultural Sensitivity: Success depends on navigating diverse regulatory landscapes and cultural attitudes effectively.

FAQs

1. Is Insulin Pork still widely used globally?
   No; its use has declined sharply in developed markets but persists in select regions due to cultural or cost factors.

2. What advantages does Insulin Pork offer over synthetic insulins?
   It may be preferred in certain patient populations due to cultural acceptance and potential immunogenicity profiles, plus lower manufacturing costs in some regions.

3. Are there ongoing clinical trials to improve Insulin Pork formulations?
   Yes, current research focuses on modified pig insulins with enhanced pharmacokinetics, although these are still in experimental stages.

4. What regulatory challenges does Insulin Pork face?
   Increasing preference for recombinant insulins and stringent safety standards hinder approvals, especially in Western markets.

5. What is the future outlook for Insulin Pork?
   While declining globally, niche markets and innovation in formulation provide ongoing opportunities, particularly in developing countries and culturally specific populations.

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Sources:

[1] Marketwatch. Global Insulin Market Analysis 2022.
[2] European Medicines Agency. Regulatory Updates on Animal Insulins.
[3] ClinicalTrials.gov. Recent Clinical Trials on Porcine Insulin.
[4] Industry Reports. Emerging Markets in Diabetes Care.
[5] Pharmaceutical Biotechnology Journal. Innovations in Animal-Derived Biopharmaceuticals.

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This comprehensive overview equips healthcare and pharmaceutical stakeholders to formulate strategic responses, innovate product offerings, and identify high-potential markets amid evolving regulatory and cultural landscapes concerning Insulin Pork.