NOVOLOG (insulin aspart recombinant)
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.
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.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2000-06-07
- Routes
- SUBCUTANEOUS
- Dosage Forms
- INJECTABLE
NOVOLOG Approval History
What NOVOLOG Treats
1 indicationsNOVOLOG is approved for 1 conditions since its original approval in 2000. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Diabetes
NOVOLOG 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 NOVOLOG's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications NOVOLOG 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
7 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07560150 | API-I004-CL-C | Ph 2, Ph 3 | recruiting | Comparison of the Pharmacokinetics (PK) and Pharmacodynamics (PD) Biosimilarity of Proposed Biosimilar/Interchangeable Rapid-Acting Insulin Aspart (I004) and NovoLog® After Single-Dose Subcutaneous Administration to Healthy Volunteers |
| NCT05539872 results posted | API-I004-CL-B | Ph 2, Ph 3 | completed | Comparison of the Pharmacokinetics (PK) and Pharmacodynamics (PD) Biosimilarity of Proposed Biosimilar Rapid-Acting Insulin Aspart (I004) and NovoLog After Single-Dose Subcutaneous Administration to Healthy Volunteers |
| NCT04460326 In-FI results posted | H-39600 | Ph 3 | completed | Novolog vs. Fiasp Insulin in Non-critically Ill Hospitalized Patients With Type 2 Diabetes Mellitus |
| NCT03262116 results posted | 2017P001778 | Ph 2, Ph 3 | terminated | Individualizing Automated Closed Loop Glucose Control Through Pharmacokinetic Profiling in an Insulin-Only Bionic Pancreas |
| NCT05184868 | ARE-247-103 | Ph 1 | completed | AT247, NovoLog® and Fiasp® Administered Via Continuous Subcutaneous Infusion in Glucose Clamp Study |
| NCT03554486 results posted | 46202 | Ph 4 | completed | Evaluation of Fiasp® (Fast Acting Insulin Aspart) in 670G Hybrid Closed-Loop Therapy |
| NCT00624767 | C08-002 | Ph 2 | completed | A Study to Evaluate the Effect of Nasal Insulin on Postprandial Glycemic Control in Type 2 Diabetic Patients |
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.
NOVOLOG FDA Label Details
Indications & Usage
FDA Label (PDF)NOVOLOG 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.
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