Drugs / darexaban
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | Japan (PMDA) | — | venous thromboembolism | 2010-09-29 | “submitted a market authorization application for darexaban maleate (“darexaban”; generic name; development code name: YM150) to the Ministry of Health, Labour and Welfare today...” astellas.com ↗ |
Trials 25
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 112 trials · 1 met primary | ||||||
| Phase 1 | NCT01125657 | Feb → Mar 2010 | — | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 1 | NCT01125670 | Feb → Apr 2010 | — | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 1 | NCT01409603 | Jan → May 2010 | — | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 1 | NCT01405989 | Jan → Mar 2010 | — | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 1 | NCT01406002 | Jan → Mar 2010 | — | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 1 | NCT01118559 | Nov 2009 → Jan 2010 | — | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 1 | NCT01409616 | Apr → Sep 2009 | — | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 1 | NCT01424332 | Dec 2007 → Mar 2008 | — | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 1 | NCT01657981 | Feb → Mar 2007 | — | Astellas Pharma Europe B.V. | Completed | No outcome recorded |
| Phase 1 | NCT01514825 | Nov 2006 → Feb 2007 | — | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 1 | NCT01655056 | Jun → Nov 2006 | — | Astellas Pharma Europe B.V. | Completed | No outcome recorded |
| Phase 1 | NCT01514812 | Feb → Apr 2006 | — | Astellas Pharma Inc | Completed | Met primary |
| Phase 26 trials · 1 missed | ||||||
| Phase 2 | NCT00994292 | Sep 2009 → Feb 2011 | acute coronary syndrome | Astellas Pharma Europe B.V. | Completed | Missed primary |
| Phase 2 | NCT00938730 | Jun 2009 → Sep 2010 | atrial fibrillation | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 2 | NCT00595426 | May 2008 → May 2009 | osteoarthritis, knee | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 2 | NCT00448214 | Mar 2007 → Oct 2008 | atrial fibrillation | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 2 | NCT00408239 | Dec 2006 → Mar 2009 | venous thromboembolism | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 2 | NCT00353678 | Jun 2006 → Aug 2007 | thrombotic disease | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 2/33 trials | ||||||
| Phase 2/3 | NCT00913120 | May 2009 → Mar 2010 | venous thromboembolism | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 2/3 | NCT00917254 | May 2009 → Jan 2010 | venous thromboembolism | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 2/3 | NCT00902928 | Apr 2009 → Jun 2010 | venous thromboembolism | Astellas Pharma Europe B.V. | Completed | No outcome recorded |
| Phase 34 trials | ||||||
| Phase 3 | NCT00937911 | Jun 2009 → Apr 2010 | venous thromboembolism | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 3 | NCT00942435 | Jun 2009 → Apr 2010 | venous thromboembolism | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 3 | NCT00937820 | Jun 2009 → Dec 2010 | venous thromboembolism | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 3 | NCT01028950 | May 2009 → Apr 2010 | venous thromboembolism | Astellas Pharma Inc | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2011-02-15 | Astellas Pharma Inc | Regulatory Astellas Pharma Inc.: Withdraws Application for Marketing Approval of Darexaban (YM150), an Oral Direct Factor Xa Inhibitor, in Japan astellas.com ↗
Following that discussion with PMDA, Astellas decided to withdraw the application today. |
| 2010-09-29 | Astellas Pharma Inc | Regulatory Astellas Pharma Inc.: Submits Application for Marketing Approval of Darexaban (YM150), an Oral Direct Factor Xa Inhibitor, in Japan astellas.com ↗
Astellas Pharma Inc. (“Astellas”; headquarters: Tokyo; President and CEO: Masafumi Nogimori) announced that it submitted a market authorization application for darexaban maleate (“darexaban”; generic name; development code name: YM150) to the Ministry of Health, Labour and Welfare today in Japan. |
All press releases naming this drug 3 releases
| Date | Issuer | Release |
|---|---|---|
| 2011-09-28 | Astellas Pharma Inc | Astellas Pharma Inc. Discontinues Development of Darexaban (YM150),an Oral Direct Factor Xa Inhibitor astellas.com ↗ |
| 2011-02-15 | Astellas Pharma Inc | Astellas Pharma Inc.: Withdraws Application for Marketing Approval of Darexaban (YM150), an Oral Direct Factor Xa Inhibitor, in Japan astellas.com ↗ |
| 2010-09-29 | Astellas Pharma Inc | Astellas Pharma Inc.: Submits Application for Marketing Approval of Darexaban (YM150), an Oral Direct Factor Xa Inhibitor, in Japan astellas.com ↗ |
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 27 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Darexaban | “RUBY-1: a randomized, double-blind, placebo-controlled trial of the safety and tolerability of the novel oral factor Xa inhibitor darexaban (YM150) following acute coronary syndrome.” PMID 21878434 ↗ Aug 20117“Darexaban (YM150) prevents venous thromboembolism in Japanese patients undergoing major abdominal surgery: Phase III randomized, mechanical prophylaxis-controlled, open-label study.” PMID 22762942 ↗ Jul 2012 “Darexaban (YM150) versus enoxaparin for the prevention of venous thromboembolism” PMID 24136153 ↗ Oct 2013 |
| Known as | Tanexaban | ChEMBL registry synonym — accepted as the source's own label CHEMBL1922235 ↗ |
| Known as | YM150 | “RUBY-1: a randomized, double-blind, placebo-controlled trial of the safety and tolerability of the novel oral factor Xa inhibitor darexaban (YM150) following acute coronary syndrome.” PMID 21878434 ↗ Aug 201119“Darexaban (YM150) is an oral direct factor Xa inhibitor in clinical development for prophylaxis of venous thromboembolism (VTE) after major orthopaedic surgery.” PMID 22762942 ↗ Jul 2012 |
| Action | Inhibit | “Direct Factor Xa Inhibitor YM150” NCT00353678 ↗1“Coagulation factor X inhibitor” CHEMBL1922235 ↗ |
| Modality | Small molecule | — CHEMBL1922235 ↗ |
| Route | Oral | “Oral” NCT00408239 ↗ |
| Target | F10 | “Coagulation factor X inhibitor” CHEMBL1922235 ↗ |