BLAINTRAVENOUS, SUBCUTANEOUSINJECTABLE1 Generic Approved
Approved
Apr 2004
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
75
Data completeness
6/8 — Strong
APIDRA (insulin glulisine) by Sanofi. Approved for insulin analog [epc]. First approved in 2004.
Drug data last refreshed 16h ago · AI intelligence enriched 2mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
APIDRA (insulin glulisine) is a rapid-acting insulin analog administered via subcutaneous or intravenous injection for managing type 1 and type 2 diabetes mellitus. It works by mimicking the body's natural insulin response to regulate blood glucose levels. Patients typically use it as part of a basal-bolus insulin regimen or continuous subcutaneous insulin infusion therapy.
$3MPart D
LOE ApproachingDeclining
APIDRA occupies a niche position in a crowded rapid-acting insulin market with minimal Part D spend, indicating a contracting team focused on defense against larger competitors.
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 (75)
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 Randomized Controlled Trial to Compare the Glycemic Control, With or Without the Connected Solution, of Adult Type 2 Diabetic Participants on Basal Insulin in Taiwan
Started Feb 2023
200 enrolled
Type 2 Diabetes Mellitus
My Dose Coach Mobile App to Support Insulin Titration and Maintenance
Started Feb 2021
60 enrolled
Diabetes Mellitus Type 2 - Insulin-Treated
A Bioequivalence Study Comparing Two Different Strengths Formulations of Insulin Lispro in Patients With Type 1 Diabetes
Started Mar 2019
90 enrolled
Type 1 Diabetes
Safety Assessment of SAR341402 and NovoLog® Used in Continuous Subcutaneous Insulin Infusion for Type 1 Diabetes Mellitus Patients
Started May 2018
45 enrolled
Type 1 Diabetes Mellitus
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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.