APIDRA (insulin glulisine recombinant)
APIDRA (insulin glulisine recombinant) is a rapid-acting human insulin analog. It is indicated to improve glycemic control in both adult and pediatric patients with diabetes mellitus. The medication serves as a therapeutic intervention for managing blood sugar levels in these patient populations.
How APIDRA Works
APIDRA regulates glucose metabolism by lowering blood glucose levels through multiple pathways. It stimulates peripheral glucose uptake in skeletal muscle and fat while simultaneously inhibiting hepatic glucose production. Additionally, the drug inhibits the processes of lipolysis and proteolysis and enhances protein synthesis.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2004-04-16
- Revenue
- $91M (Q4-2020)
- Routes
- INTRAVENOUS, SUBCUTANEOUS
- Dosage Forms
- INJECTABLE
APIDRA Approval History
What APIDRA Treats
1 indicationsAPIDRA is approved for 1 conditions since its original approval in 2004. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Diabetes
APIDRA Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in APIDRA's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications APIDRA treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to APIDRA
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
3 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02914886 LAS | IIT-14652 | Ph 4 | completed | Beneficial Effect of Insulin Glulisine by Lipoatrophy and Type 1 Diabetes (LAS) |
| NCT02048189 TRICIDIA | RUDONI PARI 2011 | Ph 4 | terminated | Treatment With Continuous Sub-cutaneous Insulin Infusion Via a Portable Pump Versus Discontinuous Insulin Infusion Via Multiple-injections in Type 2 Diabetes |
| NCT03328845 INEOX | FIM-EOX-2016-01 | Ph 4 | completed | Impact on the Oxidative Stress of the Different Analogues of Insulin in People With Type 1 Diabetes. (Ineox Study) |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
APIDRA FDA Label Details
Indications & Usage
FDA Label (PDF)APIDRA is indicated for the treatment of Diabetes.
Pro Intelligence Preview
Deep insights for APIDRA
Revenue Insights
- • Q4-2020: $91M
- • Historical trend analysis
Patent Timeline
- • Patent expiration dates
- • Generic/biosimilar risk
Trial Analysis
- • 3 total trials
- • Stage: Mature
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment