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Human Regular U-500 Insulin
Human Regular U-500 Insulin is a Insulin (short-acting/regular) Small molecule drug developed by Eli Lilly and Company. It is currently FDA-approved for Type 1 diabetes mellitus, Type 2 diabetes mellitus (particularly in insulin-resistant patients requiring high doses). Also known as: LY041001, Humulin R, U-500R.
Human Regular U-500 Insulin is a concentrated insulin formulation that binds to insulin receptors on cells to promote glucose uptake and utilization, lowering blood glucose levels.
Human Regular U-500 Insulin is a concentrated insulin formulation that binds to insulin receptors on cells to promote glucose uptake and utilization, lowering blood glucose levels. Used for Type 1 diabetes mellitus, Type 2 diabetes mellitus (particularly in insulin-resistant patients requiring high doses).
At a glance
| Generic name | Human Regular U-500 Insulin |
|---|---|
| Also known as | LY041001, Humulin R, U-500R |
| Sponsor | Eli Lilly and Company |
| Drug class | Insulin (short-acting/regular) |
| Target | Insulin receptor |
| Modality | Small molecule |
| Therapeutic area | Diabetes |
| Phase | FDA-approved |
Mechanism of action
This is a five-fold concentrated form of human regular (short-acting) insulin, allowing patients to inject smaller volumes while receiving higher doses. It works by binding to insulin receptors on muscle, fat, and liver cells, facilitating glucose transport into cells and promoting glycogen synthesis while inhibiting gluconeogenesis. The U-500 concentration is particularly useful for insulin-resistant patients requiring large daily doses.
Approved indications
- Type 1 diabetes mellitus
- Type 2 diabetes mellitus (particularly in insulin-resistant patients requiring high doses)
Common side effects
- Hypoglycemia
- Injection site reactions
- Lipodystrophy
- Weight gain
- Allergic reactions
Key clinical trials
- AT278, NovoRapid® and Humulin® R (U500) in Glucose Clamp Study (PHASE1)
- A Study of U-500 Insulin (LY041001) in Participants With Type 2 Diabetes (PHASE1)
- An Administration Method Study of Human Regular U-500 Insulin (LY041001) in Participants With Type 2 Diabetes Mellitus (PHASE3)
- Study of Human Regular U-500 Insulin in Adult Participants With Type 2 Diabetes (PHASE4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Human Regular U-500 Insulin CI brief — competitive landscape report
- Human Regular U-500 Insulin updates RSS · CI watch RSS
- Eli Lilly and Company portfolio CI
Frequently asked questions about Human Regular U-500 Insulin
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Related
- Drug class: All Insulin (short-acting/regular) drugs
- Target: All drugs targeting Insulin receptor
- Manufacturer: Eli Lilly and Company — full pipeline
- Therapeutic area: All drugs in Diabetes
- Indication: Drugs for Type 1 diabetes mellitus
- Indication: Drugs for Type 2 diabetes mellitus (particularly in insulin-resistant patients requiring high doses)
- Also known as: LY041001, Humulin R, U-500R
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing