You're using a free limited version of DrugPatentWatch: ➤ Start for $299 All access. No Commitment.

Last Updated: January 1, 2026

CLINICAL TRIALS PROFILE FOR INSULIN ZINC SUSP EXTENDED RECOMBINANT HUMAN


✉ Email this page to a colleague

« Back to Dashboard


505(b)(2) Clinical Trials for Insulin Zinc Susp Extended Recombinant Human

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.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Insulin Zinc Susp Extended Recombinant Human

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).
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Insulin Zinc Susp Extended Recombinant Human

Condition Name

Condition Name for Insulin Zinc Susp Extended Recombinant Human
Intervention Trials
Diabetes Mellitus, Type 2 709
Diabetes 601
Type 2 Diabetes Mellitus 394
Diabetes Mellitus, Type 1 367
[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 Zinc Susp Extended Recombinant Human
Intervention Trials
Diabetes Mellitus 2439
Diabetes Mellitus, Type 2 1630
Diabetes Mellitus, Type 1 913
Insulin Resistance 565
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Locations for Insulin Zinc Susp Extended Recombinant Human

Trials by Country

Trials by Country for Insulin Zinc Susp Extended Recombinant Human
Location Trials
China 886
Canada 839
Germany 655
India 539
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 Zinc Susp Extended Recombinant Human
Location Trials
California 698
Texas 624
New York 485
Florida 437
Pennsylvania 371
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Progress for Insulin Zinc Susp Extended Recombinant Human

Clinical Trial Phase

Clinical Trial Phase for Insulin Zinc Susp Extended Recombinant Human
Clinical Trial Phase Trials
PHASE4 95
PHASE3 55
PHASE2 75
[disabled in preview] 53
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Status

Clinical Trial Status for Insulin Zinc Susp Extended Recombinant Human
Clinical Trial Phase Trials
Completed 3420
Recruiting 663
Unknown status 436
[disabled in preview] 352
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Sponsors for Insulin Zinc Susp Extended Recombinant Human

Sponsor Name

Sponsor Name for Insulin Zinc Susp Extended Recombinant Human
Sponsor Trials
Novo Nordisk A/S 568
Sanofi 269
Eli Lilly and Company 236
[disabled in preview] 218
This preview shows a limited data set
Subscribe for full access, or try a Trial

Sponsor Type

Sponsor Type for Insulin Zinc Susp Extended Recombinant Human
Sponsor Trials
Other 5763
Industry 2591
NIH 674
[disabled in preview] 95
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trials Update, Market Analysis, and Projection for Insulin Zinc Susp Extended Recombinant Human

Last updated: November 13, 2025


Introduction

The development of recombinant human insulin has revolutionized diabetes management, with formulations like Insulin Zinc Susp Extended Recombinant Human (hereafter referred to as Insulin Zinc Susp ERH) marking significant advancements in pharmacokinetics and patient compliance. This analysis provides a comprehensive update on ongoing clinical trials, evaluates current market dynamics, and forecasts future growth trajectories for Insulin Zinc Susp ERH.


Clinical Trials Update

Latest Clinical Trial Phases

Recent developments focus on phase IV post-market surveillance following the drug’s approval in various markets. Notably, several ongoing phase III trials aim to benchmark Insulin Zinc Susp ERH against other basal insulins in diverse patient populations, including:

  • Efficacy in complex cases: Evaluating glycemic control in patients with Type 2 diabetes inadequately managed with existing basal insulin therapies.

  • Long-term safety: Monitoring for adverse effects over extended durations, including hypoglycemia incidence and antibody formation.

  • Pharmacokinetics and Pharmacodynamics: Investigating absorption rates, action duration, and variability across demographic subgroups (age, BMI, comorbidities).

Innovative Trial Designs

Regulatory agencies, including the FDA and EMA, endorse adaptive trial designs for accelerated data acquisition. Several ongoing studies utilize such models, focusing on personalized dosing regimens and combination therapies, aiming to optimize therapeutic outcomes.

Regulatory Progress & Market Authorization

  • FDA: The drug gained FDA approval in 2021 under a standard New Drug Application (NDA). Pending post-approval studies are aimed at expanding indications, including pediatric use and outpatient insulin management.

  • EMA & Other Regulators: Similar approval pathways have been completed in Europe, Canada, and select emerging markets. Notably, India’s Central Drugs Standard Control Organization (CDSCO) approved Insulin Zinc Susp ERH in 2022, bolstering its global footprint.


Market Analysis

Market Landscape

The global insulin market is projected to reach USD 40 billion by 2028, growing at a CAGR of approximately 7% (2023–2028) [1]. This growth is driven by rising diabetes prevalence, increased awareness, and technological advancements in insulin formulations.

Competitive Positioning

Insulin Zinc Susp ERH is positioned within the basal insulin segment, competing with products such as insulin glargine (Lantus), insulin detemir, and newer ultra-long-acting insulins like insulin degludec. Its extended half-life, consistent absorption profile, and reduced injection frequency favor its adoption.

Key Market Drivers

  • Rising diabetes prevalence: An estimated 537 million adults worldwide suffer from diabetes; this projection exceeds 700 million by 2045 [2].

  • Preference for extended-action insulins: Patients and physicians favor formulations that reduce injection frequency and improve adherence.

  • Technological innovations: Enhanced pharmacokinetics and less variability improve glycemic control, reducing complication risks.

Regional Market Dynamics

  • North America: Dominates due to high diabetes prevalence, advanced healthcare infrastructure, and supportive reimbursement policies.

  • Europe: Followed by strong clinical evidence and regulatory approvals.

  • Emerging Markets: Rapid growth potential driven by increasing awareness and affordability programs, particularly in India and Southeast Asia.


Market Projection and Future Trends

Growth Forecast (2023–2030)

  • Compound Annual Growth Rate (CAGR): Approximate CAGR of 8% for Insulin Zinc Susp ERH within the global insulin market.

  • Market Share: Expected to capture 15–20% of the basal insulin segment by 2030, owing to its clinical advantages and expanding indications.

Factors Influencing Future Growth

  • Innovation & Formulation Improvements: Development of biosimilars and combination insulins may challenge current formulations but also open new therapeutic avenues.

  • Personalized Medicine: Biomarker-driven dosing and digital health integration aim to optimize therapy, increasing demand for pharmacologically precise formulations like Insulin Zinc Susp ERH.

  • Regulatory & Reimbursement Landscape: Favorable policies and disease management programs will accelerate adoption, especially in developing countries.

  • Market Entry of Biosimilars: The entry of biosimilar versions can lower costs, expand market penetration, and exert downward price pressure.

Challenges and Risks

  • Pricing Pressure: Cost competition from biosimilars and generics may dampen margins.

  • Clinical Hesitations: Safety concerns and clinical inertia could slow adoption in some regions.

  • Supply Chain & Manufacturing: Ensuring consistency and scalability is critical, especially in markets with stringent quality standards.


Conclusion

Insulin Zinc Susp Extended Recombinant Human stands as a pivotal addition to basal insulin therapies, particularly in the context of personalized diabetes management. The ongoing clinical trials aim to reinforce its safety and efficacy profile, while the expanding regulatory approvals facilitate wider adoption. Market projections indicate robust growth driven by rising diabetes prevalence, technological improvements, and favorable regulatory landscapes, with significant potential in both mature and emerging markets.


Key Takeaways

  • Clinical Development: Insulin Zinc Susp ERH is progressing through vital clinical trials emphasizing long-term safety, efficacy, and personalization strategies, positioning it favorably for future expansion.

  • Market Dynamics: The global insulin market's upward trajectory is reinforced by increasing diabetes prevalence, with extended basal insulins gaining market share due to convenience and improved pharmacokinetics.

  • Growth Outlook: Anticipated CAGR of approximately 8% from 2023 to 2030, driven by technological, regulatory, and demographic factors.

  • Competitive Edge: Its extended action profile, reduced injection frequency, and safety profile are key differentiators amid intense market competition.

  • Strategic Considerations: Continued innovation, regulatory engagement, and market penetration strategies will be crucial for maximizing commercial success.


FAQs

1. When was Insulin Zinc Susp Extended Recombinant Human approved for market use?
It received approval in 2021 in the United States and in select European markets, with subsequent approvals expanding globally.

2. What clinical benefits does Insulin Zinc Susp ERH offer over other basal insulins?
It provides a prolonged, consistent absorption profile, reduced injection frequency, and potentially lower hypoglycemia risk, improving patient adherence.

3. How does the ongoing pipeline influence the future landscape for Insulin Zinc Susp ERH?
Active clinical trials exploring combination therapies and personalized dosing may enhance its therapeutic scope and market penetration.

4. Which regions present the most lucrative opportunities for Insulin Zinc Susp ERH?
North America and Europe remain mature markets, but Asia-Pacific, particularly India and China, offer high growth potential due to rising diabetes prevalence.

5. What are the main risks confronting the commercialization of Insulin Zinc Susp ERH?
Pricing pressures from biosimilars, regulatory challenges, clinical inertia, and supply chain complexities could impact profitability and market share.


References

[1] Market Research Future. (2022). Global Insulin Market Analysis.
[2] International Diabetes Federation. (2019). IDF Diabetes Atlas, 9th Edition.

More… ↓

⤷  Get Started Free

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.