TheraRadar
Data updated: May 26, 2026

STARLIX (nateglinide)

Trial Activity: Mature
Metabolic Approved 2000-12-22
Jump to: Indications Approvals Trials Competitors Safety Patents

Development Insights

Astellas Pharma Inc conducting 1 trials (25%)
3 indications explored (Focused)
→ type 2 diabetes mellitus (2 trials)
→ healthy volunteers (1 trials)
→ diabetes mellitus, type 2 (1 trials)
2
Indications
--
Phase 3 Trials
25
Years on Market

Details

Status
Discontinued
First Approved
2000-12-22
Routes
ORAL
Dosage Forms
TABLET

Companies

Novartis
Active Ingredient: NATEGLINIDE

STARLIX Approval History

2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
34 FDA actions from 2000 to 2021 · 1 indication expansions
Oct 2021 SUPPL
Label · Labeling
FDA Letter Label
May 2018 SUPPL
Label · Labeling
FDA Letter Label
Mar 2017 SUPPL
Label · Labeling
FDA Letter Label

What STARLIX Treats

2 FDA approvals

Originally approved for its first indication in 2000 . Covers 2 distinct patient populations.

  • Other (2)
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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
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Active Pipeline

Pro

Ongoing clinical trials by development phase

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Key Completed Trials

Pro

Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

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.

STARLIX FDA Label Details

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Data Sources

FDA Approval: NDA021204 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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