Drugs / Nateglinide
Nateglinide
also known as
A-4166 · AY-4166 · D-nateglinide · DJN 608 · Nateglinida · NSC-758695 · SDZ DJN 608 · Senaglinide · +3 more
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Withdrawn | EU (EMA) | Trazec | — | 2008-11-20 | europa.eu ↗ |
| Label expansion | US (FDA) | STARLIX | — | 2003-10-20 | fda.gov ↗ |
| Approved | EU (EMA) | Starlix | — | 2001-04-03 | europa.eu ↗ |
| Approved | US (FDA) | STARLIX | — | 2000-12-22 | fda.gov ↗ |
Trials 11
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT00189774 | — | type 2 diabetes mellitus | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT00097786 | Jan 2002 → Oct 2009 | type 2 diabetes mellitus | Novartis Pharmaceuticals | Completed | Mixed |
| Phase 49 trials | ||||||
| Phase 4 | NCT01030952 | Dec 2009 → Feb 2011 | type 2 diabetes mellitus | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 4 | NCT00928889 | Jul 2009 → Jun 2010 | type 2 diabetes mellitus | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 4 | NCT00437918 | Jan 2007 → Mar 2008 | type 2 diabetes mellitus | Inje University | Completed | No outcome recorded |
| Phase 4 | NCT00402909 | Nov 2006 → Aug 2007 | type 2 diabetes mellitus | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 4 | NCT00369148 | Jul 2004 → Mar 2006 | type 2 diabetes mellitus | Keio University | Completed | No outcome recorded |
| Phase 4 | NCT00259168 | Jun 2003 → Mar 2006 | prediabetes syndrome | Atheline Major-Pedersen | Completed | No outcome recorded |
| Phase 4 | NCT00238472 | May 2003 → Jun 2005 | type 2 diabetes mellitus | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 4 | NCT00212290 | Nov 2002 → Dec 2006 | type 2 diabetes mellitus | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Completed | No outcome recorded |
| Phase 4 | NCT00319189 | Nov 2002 → Nov 2003 | diabetes mellitus, glucose intolerance | University of Oslo School of Pharmacy | Completed | No outcome recorded |
| Comparator or background therapy6 trials | ||||||
| Phase 1 | NCT02088918 Comparator | Oct → Dec 2012 | — | IlDong Pharmaceutical Co Ltd | Completed | No outcome recorded |
| Phase 3 | NCT01456130 Background | Nov 2011 → Mar 2013 | diabetes mellitus | Takeda | Completed | No outcome recorded |
| Phase 3 | NCT01316107 Background | Jan 2011 → Oct 2012 | type 2 diabetes mellitus | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 4 | NCT02616666 Comparator | Aug 2016 → Dec 2025 | type 2 diabetes mellitus | University of Liverpool | Completed | No outcome recorded |
| Phase 4 | NCT01919489 Comparator | Mar 2014 → Aug 2020 | type 2 diabetes mellitus | Emory University | Completed | No outcome recorded |
| Phase 4 | NCT00858013 Comparator | Apr 2009 → Jun 2014 | type 2 diabetes mellitus | Ajou University School of Medicine | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2008-12-24 | Astellas Pharma Inc | Regulatory NEW INDICATION FOR FAST-ACTING POSTPRANDIAL HYPOGLICEMIC AGENT FASTIC®TABLET / STARSIS®TABLET WAS APPROVED FOR COMBINATION THERAPY WITH THIAZOLIDINES astellas.com ↗
The two companies conducted clinical trials in Japanese patients for the combination therapy with thiazolidines and obtained the approval for the indication. |
All press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2008-12-24 | Astellas Pharma Inc | NEW INDICATION FOR FAST-ACTING POSTPRANDIAL HYPOGLICEMIC AGENT FASTIC®TABLET / STARSIS®TABLET WAS APPROVED FOR COMBINATION THERAPY WITH THIAZOLIDINES astellas.com ↗ |
Evidence & citations 14 cited values
Every value below carries the sentence it was read from. 18 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Nateglinide | “SU treatments will include any SU and the related insulin secretagogues repaglinide or nateglinide, each of them in combination with metformin.” NCT02616666 ↗16“oral anti-diabetic agents (OADs: metformin, sulfonylureas, nateglinide, repaglinide or pioglitazone)” NCT01919489 ↗ “Nateglinide: Dose: 30 mg tablet or 90 mg tablet” NCT01456130 ↗ |
| Known as | A-4166 | ChEMBL registry synonym — accepted as the source's own label CHEMBL783 ↗ |
| Known as | AY-4166 | ChEMBL registry synonym — accepted as the source's own label CHEMBL783 ↗ |
| Known as | D-nateglinide | ChEMBL registry synonym — accepted as the source's own label CHEMBL783 ↗ |
| Known as | DJN 608 | ChEMBL registry synonym — accepted as the source's own label CHEMBL783 ↗ |
| Known as | Nateglinida | ChEMBL registry synonym — accepted as the source's own label CHEMBL783 ↗ |
| Known as | NSC-758695 | ChEMBL registry synonym — accepted as the source's own label CHEMBL783 ↗ |
| Known as | SDZ DJN 608 | ChEMBL registry synonym — accepted as the source's own label CHEMBL783 ↗ |
| Known as | Senaglinide | ChEMBL registry synonym — accepted as the source's own label CHEMBL783 ↗ |
| Known as | Starlix | ChEMBL registry synonym — accepted as the source's own label CHEMBL783 ↗ |
| Known as | Starsis | ChEMBL registry synonym — accepted as the source's own label CHEMBL783 ↗ |
| Known as | Trazec | ChEMBL registry synonym — accepted as the source's own label CHEMBL783 ↗ |
| Modality | Small molecule | — CHEMBL783 ↗ |
| Route | Oral | “nateglinide 30 mg tablets (3 times daily” NCT00097786 ↗ |