BLAINTRAVENOUS, SUBCUTANEOUSINJECTABLE1 Generic Approved
Approved
Apr 2004
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
221
Data completeness
5/8 — Partial
APIDRA (insulin glulisine) by Sanofi. Approved for insulin analog [epc]. First approved in 2004.
Drug data last refreshed 20h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
APIDRA (insulin glulisine) is a rapid-acting insulin analog indicated for type 1 and type 2 diabetes mellitus, gestational diabetes, and hyperglycemia. It works by binding to insulin receptors to facilitate glucose uptake and utilization in peripheral tissues. Administered via subcutaneous or intravenous injection, it mimics the body's natural insulin response to meals.
$3MPart D
LOE ApproachingDeclining
Approaching loss of exclusivity with minimal Part D spending signals a mature, commoditized product with limited team expansion opportunities.
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 (221)
Efficacy and Safety of iGlarLixi Versus Standard of Care in a Real-world Adult China Population With Uncontrolled Type 2 Diabetes on Oral Agents
Started Dec 2025
1,316 enrolled
Type 2 Diabetes
A Study to Investigate Safety and Efficacy of iGlarLixi in Adult Patients With Type 2 Diabetes Mellitus
Started Jan 2025
105 enrolled
Type 2 Diabetes
iGlarLixi CGM Study in Chinese T2D Individuals After OADs
Started Dec 2024
678 enrolled
Type 2 Diabetes (T2D)
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
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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.