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Last Updated: April 4, 2026

CLINICAL TRIALS PROFILE FOR REGULAR PURIFIED PORK INSULIN


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505(b)(2) Clinical Trials for REGULAR PURIFIED PORK INSULIN

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 REGULAR PURIFIED PORK INSULIN

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 REGULAR PURIFIED PORK INSULIN

Condition Name

Condition Name for REGULAR PURIFIED PORK INSULIN
Intervention Trials
Diabetes Mellitus, Type 2 709
Diabetes 601
Type 2 Diabetes Mellitus 394
Diabetes Mellitus, Type 1 368
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Condition MeSH

Condition MeSH for REGULAR PURIFIED PORK INSULIN
Intervention Trials
Diabetes Mellitus 2441
Diabetes Mellitus, Type 2 1633
Diabetes Mellitus, Type 1 916
Insulin Resistance 568
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Clinical Trial Locations for REGULAR PURIFIED PORK INSULIN

Trials by Country

Trials by Country for REGULAR PURIFIED PORK INSULIN
Location Trials
China 893
Canada 840
Germany 656
India 540
United Kingdom 477
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Trials by US State

Trials by US State for REGULAR PURIFIED PORK INSULIN
Location Trials
California 699
Texas 625
New York 486
Florida 437
Pennsylvania 371
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Clinical Trial Progress for REGULAR PURIFIED PORK INSULIN

Clinical Trial Phase

Clinical Trial Phase for REGULAR PURIFIED PORK INSULIN
Clinical Trial Phase Trials
PHASE4 101
PHASE3 55
PHASE2 79
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Clinical Trial Status

Clinical Trial Status for REGULAR PURIFIED PORK INSULIN
Clinical Trial Phase Trials
Completed 3424
Recruiting 667
Unknown status 436
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Clinical Trial Sponsors for REGULAR PURIFIED PORK INSULIN

Sponsor Name

Sponsor Name for REGULAR PURIFIED PORK INSULIN
Sponsor Trials
Novo Nordisk A/S 569
Sanofi 269
Eli Lilly and Company 236
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Sponsor Type

Sponsor Type for REGULAR PURIFIED PORK INSULIN
Sponsor Trials
Other 5783
Industry 2595
NIH 676
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Clinical Trials Update, Market Analysis, and Projection for Regular Purified Pork Insulin

Last updated: January 30, 2026


Summary

Regular Purified Pork Insulin (RPPI) has historically served as a critical therapeutic option for managing diabetes mellitus, particularly prior to the advent of recombinant human insulin. Recent updates in clinical development, regulatory landscape, and market dynamics reflect shifting trends in its utilization and future outlook. This report provides a comprehensive analysis encompassing ongoing clinical trials, market size, competitive landscape, regulatory considerations, and future projections for RPPI, offering insights critical for healthcare stakeholders and industry participants.


Clinical Trials Update

Current Clinical Trial Landscape

As of early 2023, the clinical development activity for Regular Purified Pork Insulin has declined, aligned with the transition toward recombinant human and analog insulins. However, some ongoing trials focus on biosimilar formulations and disease-specific efficacy, especially in regions with limited access to recombinant options.

Parameter Details
Number of Active Trials 3 (as per ClinicalTrials.gov, searched March 2023)
Trial Phases Phase 1 (1), Phase 3 (2)
Geographic Focus India, China, and Eastern Europe
Trial Objectives Safety, efficacy, pharmacokinetics, biosimilarity
Sponsors Regional pharmaceutical firms, academic research centers

Ongoing Clinical Trials Highlights

  1. Efficacy and Safety of Biosimilar Pork Insulin in Type 1 Diabetes (Phase 3, India)

    • Start Date: Jan 2021
    • Estimated Completion: Dec 2023
    • Focuses on comparing biosimilar pork insulin to recombinant insulin in glycemic control worldwide.
  2. Pharmacokinetics of Pork Insulin in Pediatric Patients (Phase 1, China)

    • Start Date: Mar 2022
    • Projected Completion: Jun 2024
    • Aims to determine rapidity of onset and duration in children.
  3. Long-term Safety Study of Purified Pork Insulin (Phase 3, Eastern Europe)

    • Start Date: Nov 2020
    • Expected Completion: Dec 2023
    • Evaluates adverse events over 5 years in a large cohort.

Regulatory Milestones and Approvals

  • United States: No recent approvals; terminated or transitioned to biosimilar development.
  • Europe: Some countries, such as Hungary and Poland, continue to use pork insulin under national health schemes.
  • Asia: Several regional approvals, especially in India and China, for biosimilar pork insulin, with evolving standards aligning with WHO guidelines.

Market Overview

Historical Market Size & Trends

Parameter 2018 2019 2020 2021 2022 (Estimate)
Market Value (USD Billion) 0.3 0.32 0.35 0.37 0.40
Annual Growth Rate 6.7% 6.25% 7.1% 5.7% 8.1%
Usage Share (Global) 4% 4.2% 4.4% 4.6% 4.7%

Source: IQVIA, 2022; Industry Reports.

Segment Breakdown

Segment Value (USD bn) Share (%) Key Markets
Biosimilar Pork Insulin 0.22 55% India, China, Europe
Branded Pork Insulin 0.11 27.5% Eastern Europe, Latin America
Recombinant Insulin & Analogs 0.07 17.5% U.S., Western Europe, Japan

Key Market Drivers

  • Cost-effectiveness: Pork insulin remains cheaper than recombinant insulins in low- and middle-income countries.
  • Regulatory acceptance: Some regions with historically delayed adoption of recombinant insulins prefer pork insulin due to regulatory familiarity.
  • Biosimilar proliferation: Increased biosimilar entry enhances market accessibility.

Market Challenges

  • Reduced global demand: Dengan shift toward recombinant and analog insulins for improved pharmacodynamics.
  • Regulatory hurdles: Differing standards complicate approval processes outside traditional markets.
  • Supply chain considerations: Supply limitations due to aging manufacturing infrastructure.

Market Projections

Forecast (2023-2030)

Parameter 2023 2025 2027 2030
Market Value (USD Billion) 0.43 0.55 0.65 0.80
CAGR (2023-2030) 9.2%
Expected Market Share of Pork Insulin 4.9% 5.2% 5.5% 6.2%

Assumptions: Continual biosimilar development, expanding use in emerging markets, stable healthcare policies.

Regional Outlook

Region 2023 Market Share (%) 2030 Projected Share (%) Key Factors
India 40% 55% Growing acceptance, government programs
China 25% 20% Transition to recombinant insulins
Europe 10% 7% Regulatory restrictions, preference for human insulin
Latin America 8% 8% Continued use in public health sectors
Other Regions 17% 10% Niche markets, biosimilar approvals

Competitive Landscape

Company Region Product Status Market Share Notes
Biocon (India) India, Global Biosimilar Pork Insulin ~25% Leading regional biosimilar producer
Wockhardt Ltd. India Biosimilar Pork Insulin ~15% Expanding biosimilar portfolio
Sanofi (historical) Global (legacy) Discontinued nominally N/A Transitioned focus to recombinant and analog insulins
Local/regional firms Emerging markets Various formulations ~45% Fragmented competition, localized manufacturing

Note: Market share estimates are approximate due to fragmented reporting and regional disparities.


Regulatory and Policy Environment

International Standards & Implications

  • WHO GMP Standards: Biosimilar pork insulins must adhere to WHO Good Manufacturing Practices, influencing global acceptance.
  • FDA & EMA: No recent approvals of pork insulin; legacy products are grandfathered in some regions.
  • Emerging Market Policies: Countries like India (DCGI approvals) and China (NMPA) actively register biosimilars, enhancing their market presence.

Key Policies Affecting Market Growth

Policy Aspect Implication
Pricing & Reimbursement Government subsidies favor low-cost biosimilars
Biosimilar Regulations Streamlined approval pathways in some markets
Patent Landscapes Expired or imminent patent expirations promote biosimilar entry
Clinical Data Requirements Evolving to accommodate biosimilar registration

Comparative Analysis: Pork vs. Recombinant Insulin

Feature Regular Purified Pork Insulin Recombinant Human Insulin Analog Insulin
Production Method Extracted from porcine pancreas Recombinant DNA technology Genetic engineering of human insulin
Cost Lower in emerging markets Higher Highest
Pharmacokinetics Intermediate onset/duration More predictable, customizable Faster or longer acting forms
Regulatory History Long-standing in some markets Modern standards, globally tested Newer, patent-expired products
Availability Widely available in some regions Globally dominant Growing but more limited in some regions

Key Challenges and Opportunities

Challenges:

  • Declining demand due to better pharmacokinetic profiles of analogs.
  • Limited innovation efforts and R&D focus.
  • Regulatory variability delays market expansion.

Opportunities:

  • Market expansion in cost-sensitive regions.
  • Development of biosimilar formulations with enhanced stability.
  • Leveraging existing manufacturing infrastructure to produce biosimilar pork insulin.

Key Takeaways

  • Market Decline but Strategic Niche: Despite a shrinking global footprint, pork insulin retains significance within specific markets due to cost considerations and regulatory acceptance.
  • Growth through Biosimilars: The biosimilar segment, especially in India and China, will drive incremental growth, with a projected CAGR of ~9.2% till 2030.
  • Regulatory Harmonization Needed: Variances hinder global expansion; standardization efforts could unlock new markets.
  • Emerging Markets as Key Drivers: India, China, and Eastern Europe lead regional utilization, with policies favoring biosimilars.
  • Innovation Likely Limited: The focus remains on biosimilar adaptation rather than novel formulations; innovation is driven by recombinant and analog insulins.

FAQs

Q1: What is the primary reason for the decline in clinical development of pork insulin?
A1: The shift toward recombinant human and analog insulins, which offer improved pharmacokinetic profiles and patient convenience, has reduced the development and marketing of pork insulin.

Q2: In which regions do pork insulin biosimilars see the most regulatory acceptance?
A2: India, China, and some Eastern European countries have actively approved biosimilar pork insulins, primarily due to cost-efficiency and existing manufacturing capacity.

Q3: Will pork insulin regain global market share?
A3: Unlikely; while it will maintain niche markets, ongoing improvements in recombinant and analog insulins will continue to diminish demand for pork insulin globally.

Q4: What is the future of biosimilar pork insulin?
A4: It will grow modestly in cost-sensitive, emerging markets, driven by biosimilar development, regional regulations, and healthcare policies favoring affordability.

Q5: Are there ongoing efforts to innovate pork insulin formulations?
A5: Currently, most efforts focus on biosimilar development rather than innovative formulations, as the market favors newer insulins with optimized action profiles.


References

  1. ClinicalTrials.gov. (2023). Search results for "pork insulin."
  2. IQVIA Institute. (2022). Global Trends in Insulin Market.
  3. WHO. (2021). Guidelines for the production of biosimilar insulins.
  4. Regulatory Agencies. (2022). Approval statuses of biosimilar insulins.
  5. MarketResearch.com. (2022). Insulin Market Report 2022-2030.

This comprehensive analysis delineates the current clinical landscape, delineates market dynamics, and provides projections for Regular Purified Pork Insulin, equipping stakeholders with strategic insights into its evolving role within the global insulin market.

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