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Starlix (NATEGLINIDE)
Starlix works by binding to the sulfonylurea receptor 1, Kir6.2, to stimulate insulin release from pancreatic beta cells.
Nateglinide (Starlix), marketed by Novartis, is an established treatment for Type 2 Diabetes Mellitus with a key composition patent expiring in 2028. Its mechanism of action through the sulfonylurea receptor 1, Kir6.2, provides a rapid onset of insulin release, distinguishing it from other antidiabetic agents. However, the presence of off-patent competitors such as repaglinide, which has 8 generics available, poses a significant threat to Starlix's market share.
At a glance
| Generic name | NATEGLINIDE |
|---|---|
| Sponsor | Novartis |
| Drug class | Glinide [EPC] |
| Target | Sulfonylurea receptor 1, Kir6.2 |
| Modality | Small molecule |
| Therapeutic area | Metabolic |
| Phase | FDA-approved |
| First approval | 2000 |
Mechanism of action
Mechanism of Action. Nateglinide is an amino-acid derivative that lowers blood glucose levels by stimulating insulin secretion from the pancreas. This action is dependent upon functioning beta-cells in the pancreatic islets. Nateglinide interacts with the ATP-sensitive potassium (K+ ATP) channel on pancreatic beta-cells. The subsequent depolarization of the beta cell opens the calcium channel, producing calcium influx and insulin secretion. The extent of insulin release is glucose dependent and diminishes at low glucose levels. Nateglinide is highly tissue selective with low affinity for heart and skeletal muscle.
Approved indications
- Type 2 Diabetes Mellitus
Common side effects
- Upper Respiratory Infection
- Back Pain
- Flu Symptoms
- Dizziness
- Arthropathy
- Diarrhea
- Accidental Trauma
- Bronchitis
- Coughing
- Hypoglycemia
- Jaundice
- Cholestatic hepatitis
Drug interactions
- ciprofloxacin
- levofloxacin
- norfloxacin
- ofloxacin
Key clinical trials
- A Pragmatic Randomized Trial to Evaluate the Comparative Effectiveness Between Dapagliflozin and Standard of Care in Type 2 Diabetes Patients (PHASE4)
- A Study for Comparison of Canagliflozin Versus Alternative Antihyperglycemic Treatments on Risk of Heart Failure Hospitalization and Amputation for Participants With Type 2 Diabetes Mellitus and the Subpopulation With Established Cardiovascular Disease
- A Study to Assess Safety and Efficacy of ASP1941 in Combination With Nateglinide in Type 2 Diabetic Patients (PHASE3)
- Long-term Study of Nateglinide+Valsartan to Prevent or Delay Type II Diabetes Mellitus and Cardiovascular Complications (PHASE3)
- Insulin Resistance and Vessel Function After Meals: Does Early Intervention Make a Difference? (PHASE4)
- Omarigliptin (MK-3102) Clinical Trial - Add-on to Oral Antihyperglycemic Agent Study in Japanese Participants With Type 2 Diabetes Mellitus (MK-3102-015) (PHASE3)
- Study of the Durability of Glycemic Control With Nateglinide (PHASE4)
- Safety and Efficacy of Nateglinide in Patients With Type 2 Diabetes Already Taking Insulin Glargine, Metformin and/or Pioglitazone or Rosiglitazone (PHASE4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Starlix CI brief — competitive landscape report
- Starlix updates RSS · CI watch RSS
- Novartis portfolio CI