Drug

Nateglinide

As of the edition of 20 October 2026, Nateglinide is a small molecule: marketed, first approved in 2000 (US); acts on ABCC8 and KCNJ11; no US protection is listed.

Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.

The drug

Status
Marketed; latest approval 2000
Kind
Small molecule
Brand name
Starlix
First approved
22 December 2000 (US)
Approvals on record
4 in 2 regions
Holder of the most recent approval
Novartis; 3 holders in all
Withdrawn from market
20 November 2008 (in some regions)
Registered trials
15, 0 stopped early
Disease areas
Nutrition and metabolism; Hormones

US protection

No US protection is listed.

The FDA registers list no drug-substance patent or exclusivity that counts for this drug.

This is the US only.

Companies that need a new molecule because of this drug

2 company-target rows on route B because of this drug.

Companies on route B for this drug

In the product

2 company-target rows are on route B because of Nateglinide.

Targets

GeneProteinUniProt
ABCC8ATP-binding cassette sub-family C member 8Q09428
KCNJ11ATP-sensitive inward rectifier potassium channel 11Q14654

Registered trials

PhaseTrialsCompletedActiveStopped early
Phase 13300
Phase 33300
Phase 49900
All trials15

Who has held its approvals

CompanyRoleYears
NovartisOriginator and Lead sponsor of trials2000 to now
AstellasLater holder and Lead sponsor of trials2011 to now
AjinomotoApplicant