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recombinant human insulin
recombinant human insulin is a Insulin Small molecule drug developed by Biodel. It is currently FDA-approved for Type 1 diabetes mellitus, Type 2 diabetes mellitus.
Recombinant human insulin binds to insulin receptors on cells to promote glucose uptake and utilization, lowering blood glucose levels.
Recombinant human insulin is a protein-based insulin receptor agonist used to treat various conditions, including insulin resistance and metabolic syndrome X. It is classified as an agonist and is used to activate the insulin receptor, which helps regulate blood sugar levels.
At a glance
| Generic name | recombinant human insulin |
|---|---|
| Sponsor | Biodel |
| Drug class | Insulin |
| Target | Insulin receptor |
| Modality | Small molecule |
| Therapeutic area | Diabetes |
| Phase | FDA-approved |
Mechanism of action
Recombinant human insulin is a synthetic form of the naturally occurring hormone insulin, produced via recombinant DNA technology. It mimics endogenous insulin by binding to insulin receptors on target tissues, facilitating cellular glucose uptake and promoting anabolic metabolism. This restores glucose homeostasis in patients with insulin deficiency or resistance.
Approved indications
- Type 1 diabetes mellitus
- Type 2 diabetes mellitus
Common side effects
- Hypoglycemia
- Weight gain
- Injection site reactions
- Lipodystrophy
Key clinical trials
- A Phase III Study to Investigate if the Study Drug Diamyd Can Preserve Insulin Production and Improve Glycemic Control in Patients Newly Diagnosed With Type 1 Diabetes (PHASE3)
- Empagliflozin and Anakinra for the Treatment of Postprandial Hypoglycemia in Patients With Prediabetes (PHASE2)
- Human Models of Selective Insulin Resistance: Pancreatic Clamp (PHASE1)
- Pharmacokinetic and Pharmacodynamic Effects of Insulex® R in Comparison to Humulin® R in Healthy Subjects (PHASE1)
- Pancreatic Clamp in NAFLD (PHASE1)
- Comparative Effectiveness and Safety of Four Second Line Pharmacological Strategies in Type 2 Diabetes Study
- Physical Activity and Insulin Sensitivity Dynamics (NA)
- Injections of Glutamic Acid Decarboxylase (GAD) for LADA Type of Diabetes (PHASE2)
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:
- recombinant human insulin CI brief — competitive landscape report
- recombinant human insulin updates RSS · CI watch RSS
- Biodel portfolio CI
Frequently asked questions about recombinant human insulin
What is recombinant human insulin?
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Who makes recombinant human insulin?
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Related
- Drug class: All Insulin drugs
- Target: All drugs targeting Insulin receptor
- Manufacturer: Biodel — full pipeline
- Therapeutic area: All drugs in Diabetes
- Indication: Drugs for Type 1 diabetes mellitus
- Indication: Drugs for Type 2 diabetes mellitus
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing