Drugs / COLESTILAN CHLORIDE
COLESTILAN CHLORIDE
also known as
MCI-196 · Colestilan · CHOLEBINE · Colestimide · Bindren · Cholebine (japan) · colestilan(INN) · Colestimide(JAN)
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Withdrawn | EU (EMA) | BindRen | — | 2015-05-26 | europa.eu ↗ |
| Approved | EU (EMA) | BindRen | — | 2013-01-21 | europa.eu ↗ |
Trials 11
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| Phase 2 | NCT00497198 | Oct 2005 → Sep 2007 | type 2 diabetes mellitus | Tanabe Pharma Corporation | Completed | No outcome recorded |
| Phase 310 trials · 1 met primary | ||||||
| Phase 3 | NCT01814904 | Apr 2014 → Jan 2015 | chronic kidney disease, hyperphosphatemia | Tanabe Pharma Corporation | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT01818687 | Aug 2013 → Dec 2014 | chronic kidney disease, hyperphosphatemia | Tanabe Pharma Corporation | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT01814917 | Aug 2013 → Dec 2014 | chronic kidney disease, hyperphosphatemia | Tanabe Pharma Corporation | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT00858637 | Mar 2009 → Mar 2010 | chronic kidney disease | Tanabe Pharma Corporation | Completed | No outcome recorded |
| Phase 3 | NCT00772382 | Dec 2008 → Aug 2010 | chronic kidney disease, hyperphosphatemia | Tanabe Pharma Corporation | Completed | No outcome recorded |
| Phase 3 | NCT00542386 | Dec 2007 → Nov 2009 | chronic kidney disease, hyperlipidemia, hyperphosphatemia | Tanabe Pharma Corporation | Completed | No outcome recorded |
| Phase 3 | NCT00542815 | Nov 2007 → Aug 2010 | chronic kidney disease, hyperphosphatemia | Tanabe Pharma Corporation | Completed | No outcome recorded |
| Phase 3 | NCT00506441 | Sep 2007 → Sep 2009 | chronic kidney disease, hyperphosphatemia | Tanabe Pharma Corporation | Completed | Met primary |
| Phase 3 | NCT00416520 | Jun 2007 → Nov 2009 | chronic kidney disease, hyperphosphatemia | Tanabe Pharma Corporation | Completed | No outcome recorded |
| Phase 3 | NCT00451295 | May 2007 → Jan 2011 | chronic kidney disease, hyperphosphatemia | Tanabe Pharma Corporation | Terminated | No outcome recorded Stop: Enrollment |
| Comparator or background therapy2 trials | ||||||
| Phase 1 | NCT01976572 Comparator | Oct 2013 → Jan 2014 | chronic kidney disease, hyperphosphatemia | Tanabe Pharma Corporation | Completed | No outcome recorded |
| — | NCT00548145 Comparator | Nov 2007 → Oct 2011 | Alzheimer disease, hyperlipidemia | Osaka University | Terminated | No outcome recorded |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2013-01-29 | Tanabe Pharma Corporation | Regulatory BindRen® Granted Marketing Authorization in Europe for Treatment of Hyperphosphatemia tanabe-pharma.com ↗
BindRen® Granted Marketing Authorization in Europe for Treatment of Hyperphosphatemia |
All press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2013-01-29 | Tanabe Pharma Corporation | BindRen® Granted Marketing Authorization in Europe for Treatment of Hyperphosphatemia tanabe-pharma.com ↗ |
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 15 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | COLESTILAN CHLORIDE | ChEMBL registry synonym — accepted as the source's own label CHEMBL2103800 ↗ |
| Known as | Bindren | ChEMBL registry synonym — accepted as the source's own label CHEMBL2103800 ↗ |
| Known as | CHOLEBINE | “MCI-196 (Colestilan(INN), Colestimide(JAN), CHOLEBINE®)” NCT00416520 ↗1“MCI-196(colestilan(INN), Colestimide(JAN), CHOLEBINE®)” NCT00451295 ↗ |
| Known as | Cholebine (japan) | ChEMBL registry synonym — accepted as the source's own label CHEMBL2103800 ↗ |
| Known as | Colestilan | “MCI-196 (Colestilan(INN), Colestimide(JAN), CHOLEBINE®)” NCT00416520 ↗ |
| Known as | colestilan(INN) | “MCI-196(colestilan(INN), Colestimide(JAN), CHOLEBINE®)” NCT00451295 ↗ |
| Known as | Colestimide | “MCI-196 (Colestilan(INN), Colestimide(JAN), CHOLEBINE®)” NCT00416520 ↗ |
| Known as | Colestimide(JAN) | “MCI-196(colestilan(INN), Colestimide(JAN), CHOLEBINE®)” NCT00451295 ↗ |
| Known as | MCI-196 | “The objective of this study is to assess the safety and tolerability of colestilan (MCI-196) in paediatric subjects (aged 2 years to \<18 years) with CKD stages 3b to 5,...” NCT01818687 ↗9“treatment with colestilan (MCI-196)” NCT01814917 ↗ |
| Modality | Other / unclassified | “a bile acid sequestrant” PMID 20047620 ↗ Sep 2009 |
| Route | Oral | “Colestilan was administered orally 5 g t.i.d” NCT01976572 ↗ |