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 6h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
APIDRA SOLOSTAR (insulin glulisine) is a rapid-acting insulin analog administered by subcutaneous injection in a prefilled pen device. It is indicated for glycemic control in patients with diabetes mellitus. The drug works by binding to insulin receptors to facilitate glucose uptake and utilization in target tissues.
$9MPart D
LOE ApproachingDeclining
Minimal commercial momentum with only $9M in Part D spending and 8,200 claims in 2023; brand team is likely small and focused on retention rather than expansion.
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.