Drugs / Azilsartan medoxomil
Azilsartan medoxomil
also known as
AZL-M · AR-14 · Azilsartan kamedoxomil component of edarbyclor · Azilsartan medoxomil potassium · Azilsartan medoxomilo · Edarbi · Ipreziv · TAK-491
Other / unclassified targets AGTR1 via inhibition
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
| 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 Stop: Business |
| Phase 21 trial · 1 met primary | ||||||
| Phase 2 | NCT00362115 | May → Dec 2006 | hypertensive disorder | Takeda | Completed | Met primary |
| Phase 318 trials · 14 met primary | ||||||
| Phase 3 | NCT02480764 | Aug 2015 → Sep 2017 | essential hypertension | Takeda | Completed | Met primary |
| 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 | Met primary |
| Phase 3 | NCT01496430 | Jan 2012 → May 2013 | hypertensive disorder, type 2 diabetes mellitus | Takeda | Terminated | Met primary Stop: Business |
| Phase 3 | NCT01309828 | Mar 2011 → Oct 2012 | — | Takeda | Completed | No outcome recorded |
| Phase 3 | NCT01033071 | Jan → Oct 2010 | essential hypertension | Takeda | Completed | Met primary |
| 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 | Met primary |
| Phase 3 | NCT00847626 | Jan 2009 → May 2010 | hypertensive disorder | Takeda | Completed | Met primary |
| Phase 3 | NCT00696436 | Apr 2008 → Aug 2009 | essential hypertension | Takeda | Completed | Met primary |
| Phase 3 | NCT00760214 | Jan 2008 → Apr 2009 | hypertensive disorder | Takeda | Completed | Met primary |
| Phase 3 | NCT00591578 | Dec 2007 → Sep 2009 | hypertensive disorder | Takeda | Completed | Met primary |
| Phase 3 | NCT00591253 | Oct 2007 → Apr 2009 | essential hypertension | Takeda | Completed | Met primary |
| Phase 3 | NCT00591266 | Oct 2007 → Mar 2009 | essential hypertension | Takeda | Completed | Met primary |
| Phase 3 | NCT00591773 | Sep 2007 → Mar 2009 | essential hypertension | Takeda | Completed | Met primary |
| Phase 3 | NCT00696384 | Jun 2007 → Apr 2009 | essential hypertension | Takeda | Completed | Met primary |
| 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 | Met primary |
| Phase 41 trial | ||||||
| Phase 4 | NCT02517866 | Jul 2015 → Nov 2016 | essential hypertension, type 2 diabetes mellitus | Takeda | Completed | No outcome recorded |
| Comparator or background therapy3 trials | ||||||
| Phase 3 | NCT01456169 Comparator | Oct 2011 → Dec 2012 | essential hypertension | Takeda | Completed | Met primary |
| Phase 3 | NCT00818883 Background | Feb → Nov 2009 | essential hypertension | Takeda | Completed | Met primary |
| 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 |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2024-07-04 | Zydus Lifesciences Limited | Regulatory Zydus receives tentative approval from USFDA for Azilsartan Medoxomil Tablets, 40 mg and 80 mg zyduslife.com ↗
Zydus Lifesciences Limited (including its subsidiaries/ affiliates, hereafter referred to as “Zydus”) has received tentative approval from the United States Food and Drug Administration (USFDA) to market Azilsartan Medoxomil Tablets, 40 mg and 80 mg (USRLD: Edarbi® tablets). |
| 2022-07-25 | Lupin Limited | Regulatory Lupin Receives Approval from U.S. FDA for Azilsartan Medoxomil Tablets lupin.com ↗
Mumbai, Baltimore, July 25, 2022: Global pharma major Lupin Limited (Lupin) today announced that it has received approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA), Azilsartan Medoxomil Tablets, 40 mg and 80 mg, to market a generic equivalent of Edarbi® Tablets, 40 mg and 80 mg, of Azurity Pharmaceuticals, Inc. |
| 2021-12-23 | Lupin Limited | Regulatory Lupin Receives Tentative Approval from U.S. FDA for Azilsartan Medoxomil Tablets lupin.com ↗
today announced that it has received tentative approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) Azilsartan Medoxomil Tablets, 40 mg, and 80 mg |
All press releases naming this drug 6 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-06-17 | Lupin Limited | Lupin Launches Azilsartan Medoxomil Tablets in the United States lupin.com ↗ |
| 2024-07-04 | Zydus Lifesciences Limited | Zydus receives tentative approval from USFDA for Azilsartan Medoxomil Tablets, 40 mg and 80 mg zyduslife.com ↗ |
| 2022-07-25 | Lupin Limited | Lupin Receives Approval from U.S. FDA for Azilsartan Medoxomil Tablets lupin.com ↗ |
| 2021-12-23 | Lupin Limited | Lupin Receives Tentative Approval from U.S. FDA for Azilsartan Medoxomil Tablets lupin.com ↗ |
| 2018-02-23 | Dong-A ST Co., Ltd. | Dong-A ST and Takeda Pharmaceuticals Korea host launch symposium for ‘Edarbi’, a hypertension treatm donga-st.com ↗ |
| 2017-12-21 | Dong-A ST Co., Ltd. | Dong-A ST hosts series of launch symposiums for Edarbi, a hypertension treatment donga-st.com ↗ |
Evidence & citations 13 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 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00760214 ↗ |
| Known as | AR-14 | ChEMBL registry synonym — accepted as the source's own label CHEMBL2028661 ↗ |
| Known as | Azilsartan kamedoxomil component of edarbyclor | ChEMBL registry synonym — accepted as the source's own label CHEMBL2028661 ↗ |
| Known as | Azilsartan medoxomil potassium | ChEMBL registry synonym — accepted as the source's own label CHEMBL2028661 ↗ |
| Known as | Azilsartan medoxomilo | ChEMBL registry synonym — accepted as the source's own label CHEMBL2028661 ↗ |
| 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 | Ipreziv | ChEMBL registry synonym — accepted as the source's own label CHEMBL2028661 ↗ |
| Known as | TAK-491 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02541669 ↗ |
| Action | Inhibit | “Type-1 angiotensin II receptor antagonist” CHEMBL2028661 ↗1“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 ↗ |
| Target | AGTR1 | “Type-1 angiotensin II receptor antagonist” CHEMBL2028661 ↗ |