Starlix

(Nateglinide)

ApprovedSmall molecule

Novartis

Starlix is one of 93 small molecule programs targeting Insulin resistance. It is currently in Approved.

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Insulin ResistanceActive, not recruiting

Insulin SecretionActive, not recruiting

Type 2 DiabetesActive, not recruiting

Insulin ResistanceApproved

Active, not recruiting

Insulin SecretionApproved

Active, not recruiting

Type 2 DiabetesApproved

Active, not recruiting

Competition

Competitive Landscape

885 competitors in Type 2 Diabetes

#DrugCompanyPhaseTrials

Starlix

Novartis

Approved

1 2

Cysteine Hydrochloride

Novartis

Preclinical

1 3

Inderal

WWyeth-Lederle Vaccines

Preclinical

1 4

Cecon

MMcGuff Pharmaceuticals, Inc.

Preclinical

1 5

Forxiga

AstraZeneca

Preclinical

3 6

Sulfonylureas

Eli Lilly

Preclinical

1 7

Acipimox

Boehringer Ingelheim

Preclinical

2 8

GLP-1

RRigshospitalet, Denmark

Preclinical

1 9

Blank Control

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Preclinical

1 10

Henagliflozin

TThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Clinical

Trials by Indication[1]

Type 2 Diabetic Patients3 trials

The Effects of Nateglinide and Acarbose on the Post-Prandial Glucose Control in Type 2 Diabetic Patients

Completed·IInje University·Phase 4·NCT00437918·85 enrolled

A Study to Assess Safety and Efficacy of ASP1941 in Combination With Nateglinide in Type 2 Diabetic Patients

Completed· Astellas logo

Astellas·Phase 3·NCT01316107·122 enrolled

Nateglinide: a Double Blind Add-on Study With Pioglitazone for Type 2 Diabetic Patients

Completed· Astellas logo

Astellas·Phase 2/3·NCT00189774

Labor2 trials

Bioequivalence Study of Nateglinide Tablets 120 mg of Dr. Reddy's Laboratories Limited Under Fasting Condition

Completed·—·Phase 1·NCT01159158·68 enrolled

Bioequivalence Study of Nateglinide Tablets 120 mg of Dr. Reddy's Laboratories Limited Under Fed Condition

Completed·—·Phase 1·NCT01160029·58 enrolled

Insulin resistance2 trials

Insulin Resistance and Vessel Function After Meals: Does Early Intervention Make a Difference?

Completed·AAtheline Major-Pedersen·Phase 4·NCT00259168·70 enrolled

Insulin Resistance and Central Nervous System (CNS) Function in Type 2 Diabetes

Completed·NNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)·Phase 4·NCT00212290·140 enrolled

Fasting Conditions1 trial

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

Completed· IlDong Pharmaceutical Co Ltd logo

IlDong Pharmaceutical Co Ltd·Phase 1·NCT02088918·40 enrolled

Type 2 Diabetes1 trial

Safety and Efficacy of Nateglinide in Patients With Type 2 Diabetes Already Taking Insulin Glargine, Metformin and/or Pioglitazone or Rosiglitazone

Completed· Novartis logo

Novartis·Phase 4·NCT00402909·28 enrolled

5 more indications

Insulin Secretion1 trial

Effects of Nateglinide on Postprandial Glucose Excursion by Restoring Early Phase Insulin Secretion

Completed· Novartis logo

Novartis·Phase 4·NCT01030952·103 enrolled

Renal Transplant Recipients1 trial

Efficacy and Safety of Nateglinide Treatment in Renal Transplant Recipients

Completed·UUniversity of Oslo School of Pharmacy·Phase 4·NCT00319189·15 enrolled

Dyslipidemia1 trial

Effects of Nateglinide vs Acarbose on Postprandial Glucose Fluctuation, Dyslipidemia, and Inflammatory Factors

Completed· Novartis logo

Novartis·Phase 4·NCT00928889·160 enrolled

Hemodynamic1 trial

A Pilot Study to Evaluate the Effects of Nateglinide vs. Glibenclamide on Renal Hemodynamics and Albumin Excretion

Completed· Novartis logo

Novartis·Phase 4·NCT00238472·24 enrolled

Unspecified1 trial

Study of the Durability of Glycemic Control With Nateglinide

Completed·—·Phase 4·NCT00858013·88 enrolled

Regulatory

FDA Approval Timeline[4]

Dec 22, 2000

STARLIX

NDA NDA021204

Sources

References

[1]
ClinicalTrials.gov — 14 trial records for Nateglinide. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Nateglinide compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Nateglinide. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA021204). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Novartis company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: Novartis

Starlix

Status by Indication[3][1]

Competitive Landscape

Trials by Indication[1]

Type 2 Diabetic Patients3 trials

Labor2 trials

Insulin resistance2 trials

Fasting Conditions1 trial

Type 2 Diabetes1 trial

Insulin Secretion1 trial

Renal Transplant Recipients1 trial

Dyslipidemia1 trial

Hemodynamic1 trial

Unspecified1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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