TheraRadar

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Data updated: Mar 10, 2026

NOVOLOG

INSULIN ASPART RECOMBINANT
Metabolic Approved 2000-06-07

NOVOLOG is a rapid-acting human insulin analog indicated to improve glycemic control. It is approved for use in both adult and pediatric patients with diabetes mellitus. This medication serves as a therapeutic option for managing blood sugar levels in patients with these metabolic conditions.

Source: FDA Label • Novo Nordisk • Insulin Analog

How NOVOLOG Works

The primary activity of NOVOLOG is the regulation of glucose metabolism. It lowers blood glucose by stimulating peripheral glucose uptake in skeletal muscle and fat while inhibiting hepatic glucose production. Furthermore, it inhibits lipolysis and proteolysis and enhances protein synthesis.

Source: FDA Label
8
Indications
--
Phase 3 Trials
1
Priority Reviews
25
Years on Market

Details

Status
Prescription
First Approved
2000-06-07
Routes
SUBCUTANEOUS
Dosage Forms
INJECTABLE

Companies

Active Ingredient: INSULIN ASPART RECOMBINANT

NOVOLOG Approval History

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What NOVOLOG Treats

1 indications

NOVOLOG is approved for 1 conditions since its original approval in 2000. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Diabetes
Source: FDA Label

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Active Pipeline

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

Full development history with FDA approval milestones

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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.

NOVOLOG FDA Label Details

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Indications & Usage

FDA Label (PDF)

NOVOLOG is indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus. NOVOLOG is rapid acting human insulin analog indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus .

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Data Sources

Data sourced from official FDA and NIH databases. Click links to verify on original sources.