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Nateglinide

Phase 4FDA approved

Undisclosed | Small molecule | Other |Dr. Reddy's Laboratories Ltd|Trials Updated: Jul 13, 2010

Nateglinide development status

FDA approval on record Dec 22, 2000 as Starlix
Approval holderNovartis
ApplicationNDA021204
Highest phase Phase 4 run by Atheline Major-Pedersen (NCT00259168)
Phase scored for RDYPhase 1
Registered trials 7 across 4 sponsors since Oct 2005

Nateglinide target and mechanism

Molecular targetKCNJ11, ABCC8
Target classBlocker
ModalitySmall molecule
ChEMBLCHEMBL783

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials2
Total Enrollment126

FDA Designations

No designations recorded

Nateglinide clinical trials

Nateglinide · 2 trials · 1 indication

Phase 1 2
NCT01159158Bioequivalence Study of Nateglinide Tablets 120 mg of Dr. Reddy's Laboratories Limited Under Fasting ConditionHealthy
COMPLETED68 Analytics
NCT01160029Bioequivalence Study of Nateglinide Tablets 120 mg of Dr. Reddy's Laboratories Limited Under Fed ConditionHealthy
COMPLETED58 Analytics
PHASE1COMPLETED
Bioequivalence Study of Nateglinide Tablets 120 mg of Dr. Reddy's Laboratories Limited Under Fasting Condition
HealthyUnlock trial analytics
PHASE1COMPLETED
Bioequivalence Study of Nateglinide Tablets 120 mg of Dr. Reddy's Laboratories Limited Under Fed Condition
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Bioequivalence on Cmax and AUC parameters
3 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
NateglinideEXPERIMENTALNateglinide Tablets 120 mg of Dr. Reddys Laboratories Limited
StarlixACTIVE_COMPARATORStarlix Tablets 120 mg of Novartis

Interventions

NameTypeDescription
NateglinideDRUGNateglinide Tablets 120 mg
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersYes

Inclusion Criteria: * Male or female, smoker or non-smoker, 18 years of age and older. * Capable of consent Exclusion Criteria: Subjects to whom any of the following applies will be excluded from the study: * Clinically significant illnesses within 4 weeks prior to the administration of the stud...

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Frequently asked questions about Nateglinide

What is Nateglinide?

Nateglinide is a small molecule drug developed by Dr. Reddy's Laboratories Ltd. It is being studied in Phase 1 clinical development. The specific medical conditions it is intended to treat have not been disclosed. It is not described as an approved product in the available development information.

What does Nateglinide target?

Nateglinide targets KCNJ11 and ABCC8. It acts as a blocker of these targets. KCNJ11 and ABCC8 are components of ATP-sensitive potassium channels. By blocking these channels, the drug is designed to influence channel activity, which is the basis of its pharmacological action.

Who makes Nateglinide?

Nateglinide is developed by Dr. Reddy's Laboratories Ltd, which trades under the ticker RDY. The company is responsible for the clinical development of this small molecule drug candidate.

What phase is Nateglinide in?

Nateglinide is in Phase 1 clinical development. Two Phase 1 trials have been completed, and no active trials are currently listed. The drug is investigational and has not been approved for any indication based on the available development information.

What clinical trials is Nateglinide in?

Nateglinide has been evaluated in two completed Phase 1 trials: NCT01160029, a bioequivalence study under fed conditions with 58 healthy volunteers, and NCT01159158, a bioequivalence study under fasting conditions with 68 healthy volunteers. Both trials were active-controlled and randomized, with a total enrollment of 126 participants.