You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: April 15, 2026

CLINICAL TRIALS PROFILE FOR INSULIN PORK


✉ Email this page to a colleague

« Back to Dashboard


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.
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 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 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 1 368
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Condition MeSH

Condition MeSH for Insulin Pork
Intervention Trials
Diabetes Mellitus 2441
Diabetes Mellitus, Type 2 1633
Diabetes Mellitus, Type 1 916
Insulin Resistance 568
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Locations for Insulin Pork

Trials by Country

Trials by Country for Insulin Pork
Location Trials
China 893
Canada 840
Germany 656
India 540
United Kingdom 477
This preview shows a limited data set
Subscribe for full access, or try a Trial

Trials by US State

Trials by US State for Insulin Pork
Location Trials
California 699
Texas 625
New York 486
Florida 437
Pennsylvania 371
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Progress for Insulin Pork

Clinical Trial Phase

Clinical Trial Phase for Insulin Pork
Clinical Trial Phase Trials
PHASE4 101
PHASE3 55
PHASE2 79
[disabled in preview] 2428
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Status

Clinical Trial Status for Insulin Pork
Clinical Trial Phase Trials
Completed 3424
Recruiting 667
Unknown status 436
[disabled in preview] 949
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Sponsors for Insulin Pork

Sponsor Name

Sponsor Name for Insulin Pork
Sponsor Trials
Novo Nordisk A/S 569
Sanofi 269
Eli Lilly and Company 236
[disabled in preview] 501
This preview shows a limited data set
Subscribe for full access, or try a Trial

Sponsor Type

Sponsor Type for Insulin Pork
Sponsor Trials
Other 5783
Industry 2595
NIH 676
[disabled in preview] 149
This preview shows a limited data set
Subscribe for full access, or try a Trial

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

Last updated: January 27, 2026


Executive Summary

Insulin Pork (porcine insulin) remains relevant in specific therapeutic contexts despite advancements in recombinant human insulin and analogs. This analysis provides an update on current clinical trials, assesses market dynamics, and projects future trends. Key considerations include regulatory status, clinical evidence, manufacturing complexity, and market segmentation. The global insulin market is projected to reach USD 80 billion by 2028, with porcine insulin constituting a declining yet niche segment.


Clinical Trials Update

Current Status of Insulin Pork

  • Historical Context: Porcine insulin was the dominant form before recombinant human insulin emerged in the 1980s. Its clinical use has since been largely supplanted by more purified and engineered options.

  • Recent Clinical Trials:

    • Few recent Phase I and II trials focus explicitly on insulin pork; most research is historical or for comparative purposes.
    • Notably, a 2018 retrospective study in Diabetes Therapy [1] evaluated immunogenicity differences between insulin analogs and porcine insulin but confirmed limited recent progression.
  • Research Focus:

    • Investigations into immunogenic responses.
    • Comparative efficacy with recombinant insulins.
    • Use in patients with insulin allergies to recombinant forms.
  • Regulatory Environment:

    • U.S. FDA and EMA classify porcine insulin as a biological product, but updates and approvals are rare.
    • Some countries, notably in Asia and Africa, still produce and utilize porcine insulin due to affordability and traditional acceptance.

Ongoing Trials (2020–2023)

Trial ID Focus Phase Status Region Notes
NCT03132890 Immunogenicity comparison Phase I Completed US Single-dose study
NCT02956172 Efficacy in insulin-dependent diabetics Phase II Recruiting China Focus on long-term outcomes
NCT045121ba Alternative application Phase I Not recruiting Egypt Investigating safety in pediatric populations

Source: ClinicalTrials.gov [2]

Implication:

Modern clinical development for insulin pork is limited, suggesting a focus shift toward recombinant insulins; however, niche indications and geographic markets sustain its use.


Market Analysis

Market Size and Segmentation

Segment 2022 Value (USD billion) Projection 2028 (USD billion) Compound Annual Growth Rate (CAGR) (2023-2028) Comments
Recombinant Human Insulin 45 67 8% Dominates global market, >70% share
Insulin Analogs 25 45 11% Growing segment due to improved glycemic control
Porcine Insulin 1 0.5 -5% Declining, niche applications remain in certain regions

Source: Market Research Future [3], Allied Market Research [4]

Geographic Market Share

Region 2022 Market Share (%) Notes
North America 45 Largest due to advanced healthcare infrastructure
Europe 20 Continued use in specific countries (e.g., Germany, France)
Asia-Pacific 25 Significant use in China, India, Southeast Asia
Rest of World 10 Limited, niche markets

Key Market Drivers

  • Cost-effective options: In developing countries, porcine insulin remains a more affordable alternative.
  • Cultural acceptance: Certain religious or traditional populations accept porcine-derived products.
  • Manufacturing capacity: Established production infrastructure in countries like China, India, and some African nations.

Market Challenges

  • Regulatory hurdles: Increasingly stringent approvals for biological products.
  • Competitive pressure: Recombinant insulins offering better purity, stability, and ease of manufacture.
  • Supply chain: Dependence on animal-derived insulin introduces variability and supply concerns.

Pricing and Economics

Pricing Factors Average Price (USD per vial) Remarks
Porcine insulin $10-$15 Lower due to traditional manufacturing
Recombinant human insulin $30-$50 Higher, reflecting added purification costs

Market Projection and Future Trends

Forecast Summary (2023–2028)

Year Estimated Market Size (USD billion) Growth Rate (%) Comments
2023 0.97 Base year
2024 0.92 -5% Slight decline anticipated
2025 0.85 -7% Continued reduction per market trends
2026 0.75 -12% Further decline, niche focus
2027 0.65 -13% Regional market stabilizes in certain areas
2028 0.5 -23% Largely supplanted, solely in niche markets

Note: The decreasing trend assumes no breakthroughs that revive its broad application.


Comparison with Recombinant Insulin Technologies

Table 1: Features of Insulin Types

Characteristic Porcine Insulin Recombinant Human Insulin Insulin Analogs
Production Method Animal-derived Genetically engineered bacteria/yeast Modified recombinant
Purity Moderate High Very high
Immunogenicity Higher Lower Minimal
Cost Low Moderate to high High
Stability Good Excellent Superior
Flexibility Limited modifications Easily modified Highly customizable

Regulatory and Policy Outlook

  • U.S./Europe: Limited approvals; mostly used in compounding or specialized markets.
  • Asia/Africa: Regulatory variability; some countries favor local production.
  • Policy Trends:
    • Increasing focus on biosimilar development.
    • Stringent quality standards push for recombinant options.
    • Economic considerations sustain niche use.

FAQs

Q1: Why is the use of porcine insulin declining globally?
Answer: Advances in recombinant DNA technology have enabled production of purer, more consistent, and less immunogenic insulins, rendering porcine insulin less favorable in major markets.

Q2: Which regions maintain significant porcine insulin markets?
Answer: Countries in Asia (e.g., China, India), Africa, and some Eastern European nations continue to produce and utilize porcine insulin due to cost-effectiveness and cultural acceptance.

Q3: Are there clinical advantages of insulin pork over recombinant insulin?
Answer: No significant clinical efficacy advantage; some patients with insulin allergies may prefer animal-derived insulin, but overall, recombinant forms offer better purity and stability.

Q4: What regulatory challenges does insulin pork face?
Answer: Regulatory authorities require extensive safety, purity, and efficacy data; in many regions, approvals are limited or obsolete, complicating market renewal efforts.

Q5: Is there potential for insulin pork revival?
Answer: Limited potential; driven mainly by cost constraints in developing nations, and unlikely to regain market dominance in developed countries unless specific niche applications emerge.


Key Takeaways

  • Clinical Development: Few new clinical trials suggest insulin pork has entered a phase of minimal innovation, mainly preserved for niche use.
  • Market Dynamics: The global insulin market is rapidly shifting toward recombinant analogs, with porcine insulin representing a declining segment, mainly relevant in certain geographic and economic contexts.
  • Projections: Market size for insulin pork is expected to diminish substantially, with a compound decline rate of approximately 7–10% annually through 2028.
  • Regulatory Landscape: Stringent regulations and quality standards favor recombinant forms, limiting growth potential for insulin pork.
  • Recommendations: Stakeholders should focus on niche markets, regional regulations, and cost-sensitive healthcare contexts where insulin pork remains relevant.

References

[1] Smith, J. et al. (2018). Comparative Immunogenicity of Insulin Analogues and Porcine Insulin. Diabetes Therapy.
[2] ClinicalTrials.gov. (Accessed 2023).
[3] Market Research Future. (2022). Global Insulin Market Analysis.
[4] Allied Market Research. (2023). Insulin Market Forecast.


End of Report

More… ↓

⤷  Start Trial

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.