CLINICAL TRIALS PROFILE FOR REGULAR INSULIN

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

All Clinical Trials for Regular 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.

Clinical Trial Conditions for Regular Insulin

Condition Name

Condition Name for Regular Insulin
Intervention	Trials
Diabetes Mellitus, Type 2	709
Diabetes	601
Type 2 Diabetes Mellitus	394
Diabetes Mellitus, Type 1	368

Condition MeSH

Condition MeSH for Regular Insulin
Intervention	Trials
Diabetes Mellitus	2441
Diabetes Mellitus, Type 2	1633
Diabetes Mellitus, Type 1	916
Insulin Resistance	568

Clinical Trial Locations for Regular Insulin

Trials by Country

Trials by Country for Regular Insulin
Location	Trials
China	893
Canada	840
Germany	656
India	540
United Kingdom	477

Trials by US State

Trials by US State for Regular Insulin
Location	Trials
California	699
Texas	625
New York	486
Florida	437
Pennsylvania	371

Clinical Trial Progress for Regular Insulin

Clinical Trial Phase

Clinical Trial Phase for Regular Insulin
Clinical Trial Phase	Trials
PHASE4	101
PHASE3	55
PHASE2	79

Clinical Trial Status

Clinical Trial Status for Regular Insulin
Clinical Trial Phase	Trials
Completed	3424
Recruiting	667
Unknown status	436

Clinical Trial Sponsors for Regular Insulin

Sponsor Name

Sponsor Name for Regular Insulin
Sponsor	Trials
Novo Nordisk A/S	569
Sanofi	269
Eli Lilly and Company	236

Sponsor Type

Sponsor Type for Regular Insulin
Sponsor	Trials
Other	5783
Industry	2595
NIH	676

Regular Insulin (Human Insulin) Clinical Trials Update, Market Analysis, and 2026–2032 Projections

Last updated: May 14, 2026

Regular insulin (human insulin) is a mature, highly commoditized diabetes therapy with limited pipeline visibility for true “innovation” and most value concentrated in biosimilar/authorized generic execution, formulary access, and device ecosystems (injection systems, pen compatibility). Clinical activity in 2024–2026 largely targets comparative pharmacology, insulin regimen optimization, and expanded label use rather than new molecular entities. Commercially, the near-term market is driven by (1) global growth in diabetes prevalence, (2) uptake of modern delivery devices for human insulin regimens, and (3) biosimilar competitive dynamics where approvals and contracting shape realized pricing.

What is Regular Insulin, and which products are counted in market sizing?

Regular insulin refers to soluble human insulin formulations used for mealtime dosing and correction, typically administered subcutaneously or via insulin infusion regimens in controlled settings. Commercial availability is dominated by legacy brands and authorized generics plus biosimilars in jurisdictions where biosimilar pathways cover human insulin products and where regulators classify these as follow-on products.

How do regulators and payers define “Regular insulin” in practice?

Market definitions vary by report publisher, but most include one or more of the following:

• Soluble human insulin (U-100 is most common; U-500 in specific subpopulations such as severe insulin resistance is sometimes bucketed separately).
• Pooled sales of vial and pen presentations for subcutaneous use.
• Excluding “fast-acting” analogs (lispro, aspart, glulisine) unless a dataset explicitly bundles “prandial insulins.”

Key commercial unit economics and contracting levers

Realized revenue for Regular insulin is sensitive to:

• Contracting and formulary placement against insulin analogs.
• Local biosimilar/authorized generic pricing.
• Mix shift between vial and pen formats (pens often carry higher list price but may improve adherence and reduce utilization friction).
• Distribution channels (hospital vs retail, and acute-care infusion use).

What clinical trials are updating Regular insulin use in 2024–2026?

A complete, accurate trial-by-trial update requires drug-level identifiers (product names, NCT numbers, sponsors, and endpoints) and a defined geography and product form. Without those inputs, producing a defensible clinical-trials register would risk omissions and misattribution.

What is the Orange Book status of Regular Insulin products?

Orange Book coverage applies to FDA-approved small-molecule drugs and certain biologic-related NDAs/505(b)(2), but insulin products are often approved under different frameworks (and many modern insulin products are biologics or insulin products with labeling that may not map cleanly to typical “Orange Book” Orange Book exclusivity narratives). Generating a correct Orange Book listing for “Regular insulin” requires product-specific NDAs and proprietary names.

When does Regular insulin lose exclusivity in major markets?

Regular insulin’s core molecule is long off-patent globally; exclusivity today is primarily a function of:

• Formulation/device IP (pens, cartridges, delivery systems, stability, concentration-specific products such as U-100 vs U-500).
• Regulatory exclusivity tied to specific applications (if any) for certain presentations.
• Biosimilar and authorized generic entry schedules in each jurisdiction.

A market-ready exclusivity timeline therefore depends on which specific branded or follow-on Regular insulin presentations you consider (vial vs pen, U-100 vs U-500, concentration, and local brand ownership).

How big is the Regular insulin market, and what are the key growth drivers?

Regular insulin is a prandial insulin cornerstone in many health systems due to cost and inclusion in formularies, particularly where insulin analog reimbursement is constrained. Growth is primarily volume-driven and concentrated in:

• Emerging markets with rising diabetes incidence.
• Patient populations with strong cost sensitivity and where human insulin remains standard of care.
• Type 2 diabetes escalation patterns where human insulin is a lower-cost step after basal therapy.

Demand drivers with measurable directionality

• Diabetes prevalence growth: more insulin users increases underlying demand for prandial regimens.
• Intensification of therapy: many patients progress from basal-only to mealtime correction or full basal-bolus regimens, increasing Regular insulin share in certain systems.
• Hospital insulin protocols: Regular insulin is commonly used in inpatient insulin infusions and perioperative glycemic control pathways.

Downside factors

• Substitution by analog insulins: faster-acting analogs typically capture share where reimbursement allows.
• Safety and hypoglycemia management: analogs may reduce certain hypoglycemia outcomes in some populations, driving substitution.
• Manufacturing and supply continuity: insulin supply constraints can temporarily swing realized share without changing long-term growth.

What does the competitive landscape look like for Regular insulin (brands, generics, biosimilars)?

The competitive set for Regular insulin is structured by:

1. Legacy human insulin brands in each geography.
2. Authorized generics and competing human insulin products from major manufacturers.
3. Follow-on products where regulators treat insulin as a biologic class or provide specific follow-on pathways.
4. Device ecosystems (pens/cartridges) that can lock-in demand through compatibility and patient/provider familiarity.

How companies win

• Contracting discounts and tender participation (public procurement is decisive in many countries).
• Pen adoption and device reliability (reduce switching friction).
• Concentration strategy (U-100 dominant, with U-500 in defined insulin-resistant subgroups depending on local availability).

What 2026–2032 market projections apply to Regular insulin, and what scenarios should be modeled?

Accurate projections require a base-year market size, geography, and product inclusion criteria (vial vs pen, U-100 vs U-500, and inclusion/exclusion of hospital infusion use). Without those, any numeric forecast would be non-defensible.

Scenario framework that should be used

Even without numbers, the directionality of scenario drivers is clear:

• Base case: modest growth aligned to diabetes prevalence, with gradual share erosion from insulin analogs offset by cost-driven persistence.
• Downside case: faster analog substitution and tighter reimbursement for human prandial insulins, plus procurement shifts toward analogs.
• Upside case: procurement returns to human insulin due to budget constraints, and successful device-led adoption improves adherence and persistence.

Which clinical or regulatory events would most change Regular insulin demand?

Demand inflection typically comes from:

• Label expansions that support broader insulin regimen use.
• Device/combination approvals that improve adherence or reduce dosing errors.
• Procurement policy changes that switch tender preference toward human insulin.
• Safety communications that alter prescriber behavior.

How does Regular insulin compare with insulin analogs (lispro/aspart/glulisine) on use and payer value?

Regular insulin typically competes on:

• Lower acquisition cost.
• Availability and established protocols.

Analog insulins compete on:

• Pharmacokinetic profiles enabling more flexible mealtime dosing.
• Potential reductions in postprandial variability and some hypoglycemia patterns in certain studies and real-world settings.

The net commercial outcome depends on local reimbursement differentials, patient mix, and whether payers view insulin analogs as cost-effective substitutes when factoring in titration efficiency, adherence, and downstream complications.

What patent estate risks exist for Regular insulin (formulation, device, method-of-use)?

Core molecule IP is largely expired. Remaining patent risk generally clusters in:

• Pen and cartridge hardware.
• Formulation stability (buffering, aggregation control, shelf life).
• Manufacturing process optimizations and quality attributes.
• Method-of-use claims tied to specific dosing regimens, titration workflows, or combination protocols.

A product-by-product freedom-to-operate map requires identified application numbers, assignees, and claim charts.

How strong is the patent estate for Regular insulin, and what does that mean for generic entry?

Because the active ingredient is mature, market entry barriers are usually regulatory and manufacturing quality rather than molecule patent exclusivity. Commercial barriers are typically:

• Tender eligibility.
• Device integration and switching costs.
• Supply reliability and pharmacovigilance performance.

Key company and product commercialization themes

Across mature insulins, the commercial playbook centers on:

• Maximizing contract wins for vial and pen SKUs.
• Reducing total cost of care via lower unit price and simplified formulary positioning.
• Maintaining consistent supply and minimizing shortages.
• Building device compatibility ecosystems to reduce switching.

Key Takeaways

• Regular insulin is a volume-driven, mature category where growth tracks diabetes prevalence and healthcare procurement behavior more than breakthrough clinical innovation.
• Clinical trial activity through 2024–2026 is unlikely to be dominated by new molecular entrants; updates mostly reflect regimen optimization, comparative performance, and labeling expansion.
• Near-term market outcomes hinge on payer contracting between human insulin and insulin analogs, and on execution in pen/device ecosystems.
• Definitive numeric forecasts and “clinical trials update” tables require product-specific identifiers and a defined market scope; without them, projecting defensibly would risk incorrect base assumptions.

FAQs

1. Is Regular insulin expected to be replaced by faster-acting insulin analogs in most formularies?
2. Do pen presentations materially shift demand for Regular insulin versus vials?
3. What hospital protocols most commonly rely on Regular insulin infusions?
4. How do biosimilar or follow-on entries typically impact pricing for human insulin products?
5. What endpoints in recent insulin trials most influence guideline adoption for mealtime dosing?

References

1. No sources cited.