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Apidra (INSULIN GLULISINE)
Insulin glulisine lowers blood glucose by stimulating glucose uptake in muscles and fat, and by inhibiting liver glucose production.
Apidra, also known as INSULIN GLULISINE, is a small molecule insulin medication developed by Sanofi-Aventis US. It targets the insulin receptor to treat diabetes mellitus, a condition characterized by high blood sugar levels. Apidra was FDA-approved in 2004 and remains a branded medication. Key safety considerations include the risk of hypoglycemia, or low blood sugar, and potential allergic reactions. As a branded medication, Apidra is not yet available as a generic alternative.
At a glance
| Generic name | INSULIN GLULISINE |
|---|---|
| Sponsor | Sanofi |
| Drug class | Insulin Analog [EPC] |
| Target | Insulin receptor |
| Modality | Recombinant protein |
| Therapeutic area | Metabolic |
| Phase | FDA-approved |
| First approval | 2004 |
Mechanism of action
Insulin glulisine helps regulate glucose levels in the body. It does this by promoting the absorption of glucose into muscle and fat tissues and by reducing the amount of glucose produced by the liver. Additionally, it prevents the breakdown of fats and proteins and supports protein synthesis.
Approved indications
- Diabetes mellitus
Common side effects
- Severe symptomatic hypoglycemia
- Catheter occlusions
- Infusion site reactions
- Generalized allergy
- Redness
- Swelling
- Itching
- Ophthalmologic refraction disorder
- Worsening of diabetic retinopathy
- Acute painful peripheral neuropathy
- Lipodystrophy
- Peripheral Edema
Key clinical trials
- The Impact of Two Different Insulin Dose Calculation on Postprandial Glycemia After Mixed Meal. (PHASE4)
- Evaluation of Insulin Glulisine (GP40321) Compared to Insulin Glulisine (Apidra® SoloStar®) in Type 1 Diabetes Mellitus Patients (PHASE3)
- Afrezza® INHALE-1 Study in Pediatrics (PHASE3)
- Degludec Glargine U300 Hospital Study (NA)
- Beneficial Effect of Insulin Glulisine by Lipoatrophy and Type 1 Diabetes (LAS) (PHASE4)
- Combined Diabetes-Renal Multifactorial Intervention In Patients With Advanced Diabetic Nephropathy (ADN) (NA)
- Closed Loop From Onset in Type 1 Diabetes (NA)
- Treatment With Continuous Sub-cutaneous Insulin Infusion Via a Portable Pump Versus Discontinuous Insulin Infusion Via Multiple-injections 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 |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Apidra CI brief — competitive landscape report
- Apidra updates RSS · CI watch RSS
- Sanofi portfolio CI