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Novolog (INSULIN ASPART)
Novolog works by binding to the insulin receptor, triggering a cascade of cellular responses that lower blood glucose levels.
Novolog (INSULIN ASPART) is a recombinant human insulin analog developed by Novo Nordisk Inc, targeting the insulin receptor to treat diabetes mellitus. It is a small molecule insulin drug, FDA-approved in 2000. Novolog is a patented product, and its commercial status is not off-patent. Key safety considerations include the risk of hypoglycemia and allergic reactions. As a medication, Novolog helps regulate blood sugar levels by mimicking the body's natural insulin production.
At a glance
| Generic name | INSULIN ASPART |
|---|---|
| Sponsor | Novo Nordisk |
| Drug class | Insulin Analog [EPC] |
| Target | Insulin receptor |
| Modality | Recombinant protein |
| Therapeutic area | Metabolic |
| Phase | FDA-approved |
| First approval | 2000 |
| Annual revenue | 2800 |
Mechanism of action
The primary activity of insulin, including insulin aspart is the regulation of glucose metabolism. Insulin and its analogs lower blood glucose by stimulating peripheral glucose uptake, especially by skeletal muscle and fat, and by inhibiting hepatic glucose production. Insulin inhibits lipolysis and proteolysis, and enhances protein synthesis.
Approved indications
- Diabetes mellitus
Common side effects
- Severe hypoglycemia
- Allergic Reactions
- Lipodystrophy
- Weight gain
- Peripheral Edema
- Anti-insulin antibodies (AIA)
- Anti-drug antibodies (ADA)
- Ophthalmologic refraction disorder
- Worsening of diabetic retinopathy
- Acute painful peripheral neuropathy
- Localized cutaneous amyloidosis
- Hyperglycemia
Key clinical trials
- Impact on Birth Weight of Two Therapeutic Strategies (Insulin Therapy From the Beginning of Pregnancy vs. Insulin Therapy Initiated According to Fetal Growth Evaluated by Ultrasonography Measurements) in Pregnant Women With Monogenic Diabetes (NA)
- Testing a Conversion Factor for a More Rapidly Acting Insulin in an Automated Insulin Delivery System Among Adolescents With T1D (NA)
- Glycemic Control After Antenatal Corticosteroids in Women With Pregestational and Gestational Diabetes (PHASE2)
- Fiasp® Versus NovoRapid® in Children With Type 1 Diabetes on MiniMed 640G Pump With Sensor
- Two Way Crossover Closed Loop MPC vs Control IQ (NA)
- Comparison of the Pharmacokinetics (PK) and Pharmacodynamics (PD) Biosimilarity of Proposed Biosimilar Rapid-Acting Insulin Aspart (I004) and NovoLog After Single-Dose Subcutaneous Administration to Healthy Volunteers (PHASE2,PHASE3)
- Oral Anti Diabetic Agents in the Hospital (PHASE4)
- Regimen Transition After Short-Term Intensive Insulin Therapy in 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 |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| SEC EDGAR | Revenue + earnings |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Novolog CI brief — competitive landscape report
- Novolog updates RSS · CI watch RSS
- Novo Nordisk portfolio CI