CLINICAL TRIALS PROFILE FOR INSULIN PURIFIED PORK

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

All Clinical Trials for Insulin 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.

Clinical Trial Conditions for Insulin Purified Pork

Condition Name

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

Clinical Trial Locations for Insulin Purified Pork

Trials by Country

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

Trials by US State

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

Clinical Trial Progress for Insulin Purified Pork

Clinical Trial Phase

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

Clinical Trial Status

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

Clinical Trial Sponsors for Insulin Purified Pork

Sponsor Name

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

Sponsor Type

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

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

Last updated: October 30, 2025

---

Introduction

Insulin derived from animal sources, particularly pork, has historically played a vital role in diabetes management post its discovery in the early 20th century. Despite advances in recombinant DNA technology enabling human insulin synthesis, purified pork insulin remains relevant in specific markets due to regulatory, economic, and supply chain factors. This article provides a comprehensive update on clinical trials, market dynamics, and future projection for purified pork insulin, informing stakeholders' strategic decisions within this niche segment.

---

Clinical Trials and Efficacy Evaluations

Current Status of Clinical Trials

While recombinant human insulin and analogs dominate global markets, purified pork insulin still undergoes clinical evaluation, mainly to confirm its safety, efficacy, and immunogenicity in specific patient populations. The latest data indicates limited ongoing clinical trials focused specifically on pork insulin, primarily aimed at:

• Bioequivalence Studies: Confirming comparable pharmacokinetics to recombinant human insulin to satisfy regulatory requirements, especially in countries with established approval pathways for animal-derived insulins.
• Immunogenicity Assessments: Due to non-human protein presence, ongoing studies analyze immune responses, with most showing acceptable safety profiles—though with a slightly increased risk of antibody formation compared to human insulin.
• Niche Population Studies: Some trials target alternative or underserved patient populations, including those with allergies to recombinant insulin or where supply constraints limit access to synthetic insulins.

Notably, these trials tend to be small-scale and localized, reflecting the limited global therapeutic reliance on pork insulin today.

Regulatory Landscape and Approval Status

In regions like Europe, purified pork insulin remains approved (e.g., by the European Medicines Agency—EMA); however, uptake has plateaued due to the advent of modern insulin analogs. The FDA's approval of pork insulin largely ceased by the early 2000s, replaced by recombinant variants, although regulatory bodies in some countries continue to permit its use under specific circumstances.

The regulatory trajectory suggests a stable but declining clinical trial pipeline, primarily focused on confirming existing safety profiles rather than novel indications or formulations.

---

Market Analysis

Historical Context and Current Market Share

Historically, pork insulin constituted a significant segment of insulin sales, particularly before recombinant technologies emerged in the 1980s. In 2020, according to IQVIA data, animal-derived insulins accounted for fewer than 2% of the global insulin market, predominantly used in specific geographical regions such as India, Latin America, and parts of Asia.

California-based companies like Biocon and Indian manufacturers such as Wockhardt produce pork insulin, catering to cost-sensitive markets. Notably:

• India: Pork insulin remains an affordable alternative, particularly among rural and low-income populations where recombinant insulin costs are prohibitive.
• Latin America: Countries with established regulatory frameworks still prescribe pork insulin, especially where supply chain constraints exist for synthetic insulins.

Market Drivers and Constraints

Drivers:

• Cost-Effectiveness: Pork insulin production utilizes established biotechnological processes; thus, it remains cheaper compared to recombinant analogs, influencing market share in price-sensitive regions.
• Regulatory Approvals: Existing regulatory approvals facilitate continued use where newer insulin formulations are unavailable or delayed.
• Supply Chain Resilience: Animal-sourced insulin benefits from an established manufacturing infrastructure, resilient against some global supply chain disruptions.

Constraints:

• Preferential Shift to Recombinant Insulin: Globally, the trend favors human insulin and analogs due to improved pharmacokinetics, reduced immunogenicity, and patient convenience.
• Limited Innovation: Clinical developments predominantly target recombinant insulin improvements, marginalizing pig-insulin innovations.
• Patient Allergy and Immunogenicity: Slightly higher immunogenicity rates limit widespread adoption.
• Market Perception: Growing preference for 'biotech' products influences physicians and patients toward recombinant variants.

Future Market Trends

The future of purified pork insulin hinges on regional specific factors:

• Emerging Markets: In developing countries, cost considerations may sustain pork insulin's niche role, especially where regulatory and manufacturing infrastructure favor traditional methods.
• Reimbursement Policies: Payers increasingly favor newer insulin analogs, further diminishing pork insulin's market share.
• Regulatory Changes: Stricter safety and immunogenicity standards globally may accelerate phase-out, although some regional markets may sustain or even revive pork insulin markets due to its affordability.

---

Market Projection and Strategic Outlook

Short-Term Outlook (Next 3-5 Years)

Market demand for purified pork insulin is expected to decline gradually, driven by the proliferation of recombinant insulin and analogs. However, in regions with weak regulatory oversight or limited access to advanced pharmaceuticals, pork insulin will sustain modest demand. Manufacturers focusing on these markets should prioritize:

• Cost-competitive production: Enhancing efficiency and reducing prices to maintain relevance.
• Regulatory compliance: Securing streamlined approvals in emerging markets.
• Education: Engaging healthcare providers about the safety profile to sustain trust.

Long-Term Outlook (Beyond 5 Years)

Global trends predict further erosion of pork insulin's market share, potentially leading to its phase-out in favor of recombinant preparations. Nonetheless:

• Regional Variances: Some regions may continue to depend on low-cost animal insulins for decades.
• Niche Applications: Limited specialized applications or formulations—such as insulin formulations with specific pharmacodynamics—could sustain minimal markets.
• Generic and Biosimilar Development: The entry of biosimilar human insulins will overshadow animal-based options, further constraining pork insulin’s market potential.

---

Implications for Stakeholders

Manufacturers: Should evaluate regional demand, regulatory pathways, and cost competitiveness when deciding on investment in pork insulin production or alternatives.

Regulators: Must balance historical safety data with the benefits of innovation, ensuring patient safety while accommodating regional needs.

Healthcare Providers: Need awareness of the evolving landscape, understanding the safety, efficacy, and supply considerations for various insulin sources.

Investors: Might consider pork insulin as a declining but steady niche asset, amplifying focus on more dynamic segments like recombinant and biosimilar insulins.

---

Key Takeaways

• Declining Relevance: Purified pork insulin’s market relevance diminishes globally, supplanted by recombinant and analog insulins designed for improved efficacy and patient comfort.
• Regional Significance: Its survival hinges on regulatory approval, cost considerations, and infrastructural resilience, mainly in developing nations.
• Clinical and Regulatory Stability: Existing clinical safety profiles remain adequate, but innovation is limited, and new clinical trials are infrequent.
• Market Dynamics: Cost and supply chain robustness favor pork insulin in niche settings, but modern trends favor advanced biologics.
• Strategic Focus: Industry stakeholders should tailor strategies to regional realities, emphasizing cost-effective manufacturing, regulatory compliance, and educational initiatives where pork insulin remains relevant.

---

FAQs

1. Is purified pork insulin still approved for clinical use worldwide?
Yes, it remains approved in regions like Europe and some Asian countries, but many markets have shifted focus to recombinant insulins, resulting in limited clinical use.

2. What are the main advantages of pork insulin compared to recombinant insulin?
Cost-effectiveness and established manufacturing processes are its primary advantages, especially in low-income settings. However, it has slightly higher immunogenicity and less favorable pharmacokinetics.

3. Are there any ongoing clinical trials for pork insulin?
Current trials are limited mainly to regional efficacy, safety, and bioequivalence studies. No major new clinical trials are underway, reflecting its declining global prominence.

4. Will pork insulin dominate in specific markets in the future?
It may persist in niche markets where economic factors outweigh the benefits of newer insulins, primarily in developing countries with constrained healthcare budgets.

5. How does the safety profile of pork insulin compare with recombinant insulin?
Extensive historical data confirm its safety, though immunogenicity risks are slightly higher. Modern processing reduces impurities, maintaining acceptable safety standards where it remains in use.

---

References

1. IQVIA. Global Insulin Market Data 2020.
2. European Medicines Agency. Summary of Product Characteristics: Insulin Pork.
3. Wockhardt. Product Portfolio Update on Animal Insulins, 2022.
4. WHO. Access to affordable insulin in low-income countries, 2021.
5. American Diabetes Association. Standards of Medical Care in Diabetes—2022.