LEVEMIR (insulin detemir recombinant)
Levemir is a long-acting insulin analog used to help both adults and children manage their blood sugar levels. It treats patients living with diabetes mellitus by providing consistent glycemic control. While it is effective for daily management, it is not used for patients experiencing diabetic ketoacidosis.
How LEVEMIR Works
This medication works by regulating glucose metabolism and lowering blood sugar levels. It encourages skeletal muscle and fat to absorb glucose while stopping the liver from producing it. It also helps the body build protein and prevents the breakdown of fats and proteins.
Details
- Status
- Prescription
- First Approved
- 2005-06-16
- Routes
- SUBCUTANEOUS, INJECTION
- Dosage Forms
- INJECTABLE
LEVEMIR Approval History
What LEVEMIR Treats
1 indicationsLEVEMIR is approved for 1 conditions since its original approval in 2005. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Diabetes
LEVEMIR Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
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 LEVEMIR's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications LEVEMIR treats. First-in-class if their pivotal trials read out positive.
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3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
2 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| 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 |
| NCT00810589 ENM-HS-001 | ENM-HS-001 | Ph 1 | completed | A Randomised, Single Centre, Double-Blind, Two-Period Crossover, Glucose Clamp Trial |
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.
LEVEMIR FDA Label Details
Indications & Usage
FDA Label (PDF)LEVEMIR is indicated for the treatment of Diabetes.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.