NATEGLINIDE
Nateglinide is a glinide medication used for adults with type 2 diabetes to help manage their blood sugar levels alongside diet and exercise. It helps patients with glycemic control by lowering blood glucose, though it is not used to manage type 1 diabetes or diabetic ketoacidosis. This medication is prescribed to improve blood glucose management in the type 2 diabetes population.
How NATEGLINIDE Works
This drug works by stimulating the pancreas to release insulin, a process that requires functioning beta-cells. It interacts with ATP-sensitive potassium channels on these cells, causing a depolarization that opens calcium channels and triggers insulin secretion. This effect is glucose-dependent, meaning the amount of insulin released decreases as blood sugar levels drop.
Details
- Status
- Discontinued
- First Approved
- 2009-09-09
- Routes
- ORAL
- Dosage Forms
- TABLET
NATEGLINIDE Approval History
What NATEGLINIDE Treats
3 indicationsNATEGLINIDE is approved for 3 conditions since its original approval in 2009. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Type 2 Diabetes
- Diabetic Ketoacidosis
- Type 1 Diabetes
NATEGLINIDE 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 NATEGLINIDE's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications NATEGLINIDE treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to NATEGLINIDE
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
4 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT01316107 | 1941-CL-0111 | Ph 3 | completed | A Study to Assess Safety and Efficacy of ASP1941 in Combination With Nateglinide in Type 2 Diabetic Patients |
| NCT00858013 results posted | AJIRB-CRO-08-197 | Ph 4 | completed | Study of the Durability of Glycemic Control With Nateglinide |
| NCT02088918 | ID_Fasticmet_1201 | Ph 1 | completed | A Open-label, Single-dose, 2-Sequence, 2-Period, Crossover Study to Assess Safety and Pharmacokinetics of a Nateglinide/Metformin HCl Combined Tablet Compared With a Nateglinide 120 mg Tablet and Metformin HCl 500 mg Tablet Under Fasting Conditions in Healthy Male Subjects |
| NCT01030952 results posted | CDJN608ACN07 | Ph 4 | completed | Effects of Nateglinide on Postprandial Glucose Excursion by Restoring Early Phase Insulin Secretion |
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.
NATEGLINIDE FDA Label Details
Indications & Usage
FDA Label (PDF)NATEGLINIDE is indicated for the treatment of Type 2 Diabetes; Diabetic Ketoacidosis; Type 1 Diabetes.
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STARLIX
Full clinical data, patents, trials, and competitive landscape for nateglinide.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.