Drugs / Azilsartan medoxomil
Azilsartan medoxomil
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Edarbi | — | 2011-12-07 | europa.eu ↗ |
| Approved | US (FDA) | EDARBI | — | 2011-02-25 | fda.gov ↗ |
Trials 22 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT02541669 | Nov 2015 → Mar 2017 | — | Takeda | Completed | No outcome recorded |
| Phase 1 | NCT01078376 | May 2010 → Jul 2013 | hypertensive disorder | Takeda | Terminated | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT00362115 | May → Dec 2006 | hypertensive disorder | Takeda | Completed | No outcome recorded |
| Phase 318 trials | ||||||
| Phase 3 | NCT02480764 | Aug 2015 → Sep 2017 | essential hypertension | Takeda | Completed | No outcome recorded |
| Phase 3 | NCT02235909 | Mar 2015 → Nov 2019 | hypertensive disorder | Arbor Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT02203916 | Jul 2014 → Jan 2016 | essential hypertension | Takeda | Completed | No outcome recorded |
| Phase 3 | NCT01496430 | Jan 2012 → May 2013 | hypertensive disorder, type 2 diabetes mellitus | Takeda | Terminated | No outcome recorded |
| Phase 3 | NCT01309828 | Mar 2011 → Oct 2012 | — | Takeda | Completed | No outcome recorded |
| Phase 3 | NCT01033071 | Jan → Oct 2010 | essential hypertension | Takeda | Completed | No outcome recorded |
| Phase 3 | NCT00996281 | Oct 2009 → Nov 2011 | essential hypertension | Takeda | Completed | No outcome recorded |
| Phase 3 | NCT00846365 | Mar 2009 → Jun 2010 | essential hypertension | Takeda | Completed | No outcome recorded |
| Phase 3 | NCT00847626 | Jan 2009 → May 2010 | hypertensive disorder | Takeda | Completed | No outcome recorded |
| Phase 3 | NCT00696436 | Apr 2008 → Aug 2009 | essential hypertension | Takeda | Completed | No outcome recorded |
| Phase 3 | NCT00760214 | Jan 2008 → Apr 2009 | hypertensive disorder | Takeda | Completed | No outcome recorded |
| Phase 3 | NCT00591578 | Dec 2007 → Sep 2009 | hypertensive disorder | Takeda | Completed | No outcome recorded |
| Phase 3 | NCT00591253 | Oct 2007 → Apr 2009 | essential hypertension | Takeda | Completed | No outcome recorded |
| Phase 3 | NCT00591266 | Oct 2007 → Mar 2009 | essential hypertension | Takeda | Completed | No outcome recorded |
| Phase 3 | NCT00591773 | Sep 2007 → Mar 2009 | essential hypertension | Takeda | Completed | No outcome recorded |
| Phase 3 | NCT00696384 | Jun 2007 → Apr 2009 | essential hypertension | Takeda | Completed | No outcome recorded |
| Phase 3 | NCT00695955 | Jun 2007 → May 2010 | essential hypertension | Takeda | Completed | No outcome recorded |
| Phase 3 | NCT00696241 | Jun 2007 → Oct 2008 | essential hypertension | Takeda | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT02517866 | Jul 2015 → Nov 2016 | essential hypertension, type 2 diabetes mellitus | Takeda | Completed | No outcome recorded |
Also used as a comparator or background therapy in 4 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 32 trials | ||||||
| Phase 3 | NCT01456169 Comparator | Oct 2011 → Dec 2012 | essential hypertension | Takeda | Completed | No outcome recorded |
| Phase 3 | NCT00818883 Background | Feb → Nov 2009 | essential hypertension | Takeda | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT07547878 Comparator | Apr 2026 → Mar 2029 expected | chronic kidney disease, type 2 diabetes mellitus | Baylor Research Institute | Not yet recruiting | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT01774591 Comparator | Jan 2013 → Nov 2015 | hypertensive disorder | University of Chicago | Completed | No outcome recorded |
Press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2014-06-18 | Takeda | Zacras ® Combination Tablets LD and Zacras ® Combination Tablets HD, Fixed-Dose Combination of Azilsartan and Amlodipine, and Azilva ® Tablets 10mg, Treatment for Hypertension, are Now Available in Japan takeda.com ↗ |
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 30 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | azilsartan medoxomil | “All subjects were randomized to 80mg azilsartan medoxomil (azilsartan) daily or placebo and followed for six months.” NCT01774591 ↗23 |
| Known as | azilsartan | “All subjects were randomized to 80mg azilsartan medoxomil (azilsartan) daily or placebo and followed for six months.” NCT01774591 ↗ |
| Known as | Azilsartan medoximil | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01774591 ↗ |
| Known as | AZL-M | “A phase 3, 26-week, open-label, titrate-to-target study (n=418) assessed the safety of azilsartan medoxomil (AZL-M) alone and with chlorthalidone (CLD), followed by a 6-week,...” PMID 25619410 ↗ Jan 20153“Azilsartan medoxomil (AZL-M) is a unique angiotensin II receptor blocker (ARB) under development for the treatment of hypertension.” PMID 21762358 ↗ Jun 2011 “Azilsartan medoxomil (AZL-M), an angiotensin II receptor blocker” PMID 32769878 ↗ Aug 2020 “azilsartan medoxomil (AZL-M) 40 mg” PMID 29445520 ↗ Feb 2018 |
| Known as | Edarbi | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07547878 ↗ |
| Known as | TAK-491 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02541669 ↗ |
| Action | Inhibit | “angiotensin II type 1 receptor antagonist” NCT00362115 ↗ |
| Modality | Other / unclassified | “TAK-491 (azilsartan medoxomil) is an angiotensin II receptor blocker” NCT00591773 ↗ |
| Route | Oral | “orally” NCT00362115 ↗ |