HUMULIN R KWIKPEN (insulin human) · Eli Lilly
AFREZZA is a rapid-acting inhaled human insulin indicated to improve glycemic control in adult patients with diabetes mellitus. As an inhaled formulation, it provides a method for managing blood sugar levels without the need for traditional injection. The medication is not recommended for the treatment of diabetic ketoacidosis or for use in patients who currently smoke or have recently stopped smoking.
How HUMULIN R KWIKPEN Works
This medication lowers blood glucose levels by stimulating peripheral glucose uptake in skeletal muscle and fat tissues. It further regulates blood sugar by inhibiting the liver's production of glucose. Additionally, the drug inhibits the breakdown of fats and proteins while simultaneously enhancing protein synthesis within the body.
Development Insights
Details
- Status
- Prescription
- First Approved
- 1982-10-28
- Routes
- SUBCUTANEOUS
- Dosage Forms
- SOLUTION
HUMULIN R KWIKPEN Approval History
What HUMULIN R KWIKPEN Treats
1 indicationsHUMULIN R KWIKPEN is approved for 1 conditions since its original approval in 1982. These indications span multiple therapeutic areas including oncology, immunology, and more.
HUMULIN R KWIKPEN 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 HUMULIN R KWIKPEN's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications HUMULIN R KWIKPEN treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to HUMULIN R KWIKPEN
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Eli Lilly's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
Clinical Trial Registry
6 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06558422 | AAAU9702 P30DK063608, K12DK133995 | Ph 1 | not yet recruiting | Human Models of Selective Insulin Resistance: Pancreatic Clamp |
| NCT05724134 | AAAU3014 3P30DK063608 | Ph 1 | completed | Pancreatic Clamp in NAFLD |
| NCT06939959 results posted | 579/DME/KMC | Ph 4 | completed | Topical Insulin for Ocular Surface Interface in Dry Eye Disease |
| NCT06126354 | AAAU7680 3P30DK063608 | Ph 1 | withdrawn | Dexamethasone/Pancreatic Clamp P&F |
| NCT02028078 PILOT_EGP | PILOT_EGP | Ph 2 | completed | Pilot Study Investigating the Feasibility of Determining the Endogenous Glucose Production During a Hypoglycaemia |
| NCT01269606 | ANA-3877 U1111-1117-1353, JapicCTI-111383 | Ph 1 | completed | Comparing Insulin Aspart With Fast-acting Insulin Human in Subjects With Type 1 Diabetes |
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.
HUMULIN R KWIKPEN FDA Label Details
Indications & Usage
FDA Label (PDF)HUMULIN R U-500 is a concentrated human insulin indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus requiring more than 200 units of insulin per day. HUMULIN ® R U-500 is a concentrated human insulin indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus requiring more than 200 units of insulin per day. Limitation of Use: The safety and efficacy of HUMULIN R U-500 used in combination with other insulins has not been determined. The safety and efficacy of HUMULIN R U-500 delivered by continuous subcutaneous infusion...
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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