BLASUBCUTANEOUSINJECTABLE1 Generic Approved
Approved
Apr 2004
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
5/8 — Partial
APIDRA SOLOSTAR (insulin glulisine) by Sanofi. Approved for insulin analog [epc]. First approved in 2004.
Drug data last refreshed 23h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
APIDRA SOLOSTAR is a rapid-acting insulin analog (insulin glulisine) administered via subcutaneous injection in a pre-filled SoloStar pen device. Approved by the FDA in April 2004, it is indicated for blood glucose control in patients with diabetes mellitus. The product works by mimicking the body's natural insulin response, with a faster onset and shorter duration of action compared to human insulin, making it suitable for mealtime insulin therapy in both type 1 and type 2 diabetes.
$0.0BPart D
Mechanism of Action
Pharmacologic Class:
Insulin Analog
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Evaluation of Insulin Glulisine (GP40321) Compared to Insulin Glulisine (Apidra® SoloStar®) in Type 1 Diabetes Mellitus Patients
Started Apr 2023
224 enrolled
Type 1 Diabetes Mellitis
A Study to Demonstrate Bioequivalence Between Insulin Glulisine U300 and Insulin Glulisine U100 After a Single Subcutaneous Dose Using the Euglycemic Clamp Technique, in Patients With Type 1 Diabetes Mellitus
Started Feb 2017
44 enrolled
Type1 Diabetes Mellitus
Beneficial Effect of Insulin Glulisine by Lipoatrophy and Type 1 Diabetes (LAS)
Started Sep 2016
14 enrolled
Type 1 DiabetesLipoatrophy
Comparator Trial Using Insulin Glulisine vs. Insulin Lispro for Treatment of Gestational Diabetes
Started Apr 2013
17 enrolled
Diabetes During Pregnancy
Efficacy and Safety of Lixisenatide Versus Insulin Glulisine on Top of Insulin Glargine With or Without Metformin in Type 2 Diabetic Patients
Started Jan 2013
894 enrolled
Type 2 Diabetes
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.