Drugs / Olmesartan medoxomil
Olmesartan medoxomil
also known as
olmesartan · Olmetec · ATB-1011 · Benicar · Benicar (olmesartan medoxomil) · CS-866 · OLM
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | BENICAR | — | 2010-02-04 | fda.gov ↗ |
| Approved | US (FDA) | BENICAR | — | 2002-04-25 | fda.gov ↗ |
Trials 55 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 19 trials | ||||||
| Phase 1 | NCT07590466 | May → Jul 2026 overdue | hypertensive disorder, type 2 diabetes mellitus | Autotelicbio | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT02058472 | Dec 2013 → May 2014 | — | Dong-A Pharmaceutical Co., Ltd. | Unknown | No outcome recorded |
| Phase 1 | NCT01415466 | Aug → Sep 2011 | — | Daewoong Pharmaceutical Co. LTD. | Completed | No outcome recorded |
| Phase 1 | NCT02962258 | May → Jun 2011 | — | Torrent Pharmaceuticals Limited | Completed | No outcome recorded |
| Phase 1 | NCT01019590 | Nov 2006 | — | Mylan Pharmaceuticals Inc | Completed | No outcome recorded |
| Phase 1 | NCT01020214 | Nov 2006 | — | Mylan Pharmaceuticals Inc | Completed | No outcome recorded |
| Phase 1 | NCT00648219 | Dec 2005 | — | Mylan Pharmaceuticals Inc | Completed | No outcome recorded |
| Phase 1 | NCT00649623 | Dec 2005 | — | Mylan Pharmaceuticals Inc | Completed | No outcome recorded |
| Phase 1 | NCT00151814 | Sep 2005 → Feb 2008 | hypertensive disorder | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT00914524 | Jan 2005 → Apr 2006 | diabetic kidney disease, glomerulonephritis | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT00151775 | May 2005 → Sep 2008 | hypertensive disorder | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 323 trials | ||||||
| Phase 3 | NCT01838850 | Apr 2013 → Aug 2014 | essential hypertension | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 3 | NCT00923091 | Jun 2009 → Jan 2011 | essential hypertension | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 3 | NCT00891267 | Oct 2008 → Apr 2011 | hypertensive disorder, metabolic syndrome X | Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company | Completed | No outcome recorded |
| Phase 3 | NCT00676845 | Aug 2008 → May 2011 | hypertensive disorder, metabolic syndrome X | Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company | Completed | No outcome recorded |
| Phase 3 | NCT00679484 | Jun 2008 → Nov 2009 | symptomatic heart failure | Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company | Terminated | No outcome recorded |
| Phase 3 | NCT00649389 | May 2008 → Apr 2009 | hypertensive disorder | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 3 | NCT00527514 | Sep 2007 → Apr 2008 | hypertensive disorder | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 3 | NCT00430950 | Feb 2007 → May 2008 | essential hypertension | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 3 | NCT00430508 | Feb 2007 → Mar 2008 | essential hypertension | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 3 | NCT00185133 | May 2005 → Jan 2007 | hypertensive disorder | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 3 | NCT00220233 | Apr 2005 → Aug 2007 | essential hypertension | Sankyo Pharma Gmbh | Completed | No outcome recorded |
| Phase 3 | NCT00185159 | Oct 2004 → Jul 2009 | cardiovascular disorder, kidney disorder, type 2 diabetes mellitus | Sankyo Pharma Gmbh | Completed | No outcome recorded |
| Phase 3 | NCT00856271 | Aug 2004 → Feb 2005 | essential hypertension | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 3 | NCT00151827 | Aug 2003 → Jul 2005 | essential hypertension, impaired renal function disease | Sankyo Pharma Gmbh | Completed | No outcome recorded |
| Phase 3 | NCT00751829 | Jul 2003 → Oct 2004 | — | Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company | Completed | No outcome recorded |
| Phase 3 | NCT00751751 | Jun 2003 → Apr 2005 | essential hypertension | Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company | Completed | No outcome recorded |
| Phase 3 | NCT00362960 | May 2003 → Sep 2004 | diabetic kidney disease, proteinuria, type 2 diabetes mellitus | Sankyo Pharma Gmbh | Completed | No outcome recorded |
| Phase 3 | NCT00141453 | Apr 2003 → Aug 2008 | diabetic kidney disease, proteinuria, type 2 diabetes mellitus | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 3 | NCT00857285 | May 2002 → Aug 2003 | essential hypertension | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 3 | NCT00185172 | Jan 2002 → Jun 2005 | essential hypertension | Sankyo Pharma Gmbh | Completed | No outcome recorded |
| Phase 3 | NCT00185185 | Nov 2001 → Feb 2006 | atherosclerotic cardiovascular disease, essential hypertension | Sankyo Pharma Gmbh | Completed | No outcome recorded |
| Phase 3 | NCT00382213 | Jun 2000 → Dec 2004 | atherosclerosis | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 3 | NCT02483936 | ? → Jun 2025 | essential hypertension | EMS | Withdrawn | No outcome recorded |
| Phase 420 trials | ||||||
| Phase 4 | NCT04061824 | May 2016 → Dec 2018 | hyperlipidemia, hypertensive disorder | Yonsei University | Completed | No outcome recorded |
| Phase 4 | NCT02495324 | Jun 2015 → May 2017 | essential hypertension | Boryung Pharmaceutical Co., Ltd | Completed | No outcome recorded |
| Phase 4 | NCT02377661 | Mar 2015 → May 2017 | hypertensive disorder | Wilhelminenspital Vienna | Completed | No outcome recorded |
| Phase 4 | NCT02360956 | Dec 2014 → Jun 2016 | coronary atherosclerosis | Chinese PLA General Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT01611077 | Jan → Dec 2012 | essential hypertension | Institute for Pharmacology and Preventive Medicine | Completed | No outcome recorded |
| Phase 4 | NCT01132768 | May 2010 → Jun 2011 | carotid artery disorder, essential hypertension | Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company | Terminated | No outcome recorded |
| Phase 4 | NCT00949884 | Aug 2009 → Jan 2010 | hypertensive disorder | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 4 | NCT01684748 | Feb 2009 → Aug 2011 | hypertensive disorder, obesity disorder | Virginia Polytechnic Institute and State University | Completed | No outcome recorded |
| Phase 4 | NCT00791258 | Nov 2008 → Aug 2009 | hypertensive disorder | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 4 | NCT00654745 | May 2008 → Apr 2009 | essential hypertension, type 2 diabetes mellitus | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 4 | NCT00412932 | Dec 2006 → Apr 2008 | hypertensive disorder | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 4 | NCT00430638 | Dec 2006 → Oct 2007 | hypertensive disorder | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 4 | NCT00403481 | Nov 2006 → Nov 2007 | hypertensive disorder | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 4 | NCT00890591 | Aug 2006 → Jun 2007 | essential hypertension | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 4 | NCT00311155 | Mar 2006 → Apr 2008 | essential hypertension | Sankyo Pharma Gmbh | Completed | No outcome recorded |
| Phase 4 | NCT00185120 | Sep 2005 → Sep 2006 | hypertensive disorder | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 4 | NCT00185055 | Nov 2004 → Feb 2005 | — | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 4 | NCT00185068 | Mar → Oct 2004 | hypertensive disorder | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 4 | NCT00185094 | Feb 2004 → Jul 2005 | hypertensive disorder, metabolic syndrome X | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 4 | NCT00772499 | Nov 2002 → Jul 2005 | essential hypertension | Daiichi Sankyo | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT07679828 | Jul 2026 → Dec 2029 expected | diabetes mellitus, hyperlipidemia, hypertensive disorder | China Medical University, China | Not yet recruiting | No outcome recorded |
Also used as a comparator or background therapy in 23 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT01493856 Comparator | Jan → Feb 2012 | — | Daewoong Pharmaceutical Co. LTD. | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT05033535 Comparator | Jul 2020 → Dec 2021 | essential hypertension | Shenzhen People's Hospital | Unknown | No outcome recorded |
| Phase 312 trials | ||||||
| Phase 3 | NCT02609490 Comparator | Sep 2015 → Feb 2017 | essential hypertension | Lee's Pharmaceutical Limited | Completed | No outcome recorded |
| Phase 3 | NCT02407210 Comparator | Jan → Oct 2015 | essential hypertension | Jiangsu HengRui Medicine Co., Ltd. | Unknown | No outcome recorded |
| Phase 3 | NCT01309828 Comparator | Mar 2011 → Oct 2012 | — | Takeda | Completed | No outcome recorded |
| Phase 3 | NCT01033071 Comparator | Jan → Oct 2010 | essential hypertension | Takeda | Completed | No outcome recorded |
| Phase 3 | NCT00996281 Comparator | Oct 2009 → Nov 2011 | essential hypertension | Takeda | Completed | No outcome recorded |
| Phase 3 | NCT00902538 Background | Apr 2009 → Sep 2010 | essential hypertension | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 3 | NCT00846365 Comparator | Mar 2009 → Jun 2010 | essential hypertension | Takeda | Completed | No outcome recorded |
| Phase 3 | NCT00523744 Background | Jul → Dec 2007 | hypertensive disorder | Novartis | Completed | No outcome recorded |
| Phase 3 | NCT00441350 Comparator | Jul 2007 → May 2008 | hypertensive disorder | Menarini Group | Completed | No outcome recorded |
| Phase 3 | NCT00417222 Comparator | Nov 2006 → Mar 2013 | heart failure | Tohoku University | Completed | No outcome recorded |
| Phase 3 | NCT00872586 Comparator | Aug 2006 → Jul 2007 | essential hypertension | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 3 | NCT00220220 Background | Apr 2005 → Apr 2007 | essential hypertension | Sankyo Pharma Gmbh | Completed | No outcome recorded |
| Phase 47 trials | ||||||
| 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 4 | NCT01180205 Comparator | Aug 2010 → Oct 2011 | hypertensive disorder | Johannes Gutenberg University Mainz | Unknown | No outcome recorded |
| Phase 4 | NCT01907373 Comparator | Aug → Sep 2009 | — | Central South University | Completed | No outcome recorded |
| Phase 4 | NCT00454662 Comparator | Apr 2007 → Sep 2011 | diabetes mellitus, hypertensive disorder | COLM Study Research Organization | Completed | No outcome recorded |
| Phase 4 | NCT00607035 Background | May 2006 → Apr 2008 | hypertensive disorder | Jichi Medical University | Completed | No outcome recorded |
| Phase 4 | NCT00134160 Comparator | Aug 2005 → May 2010 | hypertensive disorder | OSCAR Study | Completed | No outcome recorded |
| Phase 4 | NCT00858702 Background | Feb → Jul 2005 | essential hypertension | Daiichi Sankyo | Completed | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT03015311 Background | Jan 2017 → Dec 2020 | essential hypertension | Chinese Academy of Medical Sciences, Fuwai Hospital | Unknown | No outcome recorded |
| — | NCT02848170 Comparator | Aug 2016 → Apr 2017 | essential hypertension | Daiichi Sankyo | Completed | No outcome recorded |
Press releases naming this drug 13 releases
| Date | Issuer | Release |
|---|---|---|
| 2018-03-30 | Daiichi Sankyo | Daiichi Sankyo Agrees to Modify the Terms of the Settlement Program for U.S. Olmesartan Products Liability Litigation daiichisankyo.com ↗ |
| 2012-06-11 | Daiichi Sankyo | Daiichi Sankyo Launches Antihypertensive Agent Olmesartan in Mexico daiichisankyo.com ↗ |
| 2010-09-10 | Daiichi Sankyo | APPELLATE COURT AFFIRMS U.S. DISTRICT COURT DECISION IN FAVOR OF DAIICHI SANKYO PATENT FOR BENICAR(R), BENICAR HCT(R), and AZOR(R) daiichisankyo.com ↗ |
| 2010-02-15 | Daiichi Sankyo | FDA Approves Benicar(R) for the Treatment of High Blood Pressure in Children and Adolescents aged 6-16(1) daiichisankyo.com ↗ |
| 2009-12-21 | Daiichi Sankyo | Daiichi Sankyo to Leverage Ranbaxy's Presence in Africa for Marketing and Distribution Olmesartan to be launched in six African countries daiichisankyo.com ↗ |
| 2009-08-03 | Daiichi Sankyo | THE U.S. DISTRICT COURT HAS ISSUED A DECISION IN OUR FAVOR IN OUR U.S. PATENT LITIGATION REGARDING BENICAR(R), BENICAR HCT(R) AND AZOR® daiichisankyo.com ↗ |
| 2008-06-18 | Daiichi Sankyo | New Study Shows Benicar(R) (olmesartan medoxomil) Reverses Blood Vessel Damage Independent of Blood Pressure Lowering daiichisankyo.com ↗ |
| 2007-10-01 | Daiichi Sankyo | DAIICHI SANKYO EUROPE is applying for approval of its new combination product of Olmesartan and Amlodipin daiichisankyo.com ↗ |
| 2007-05-22 | Daiichi Sankyo | Amlodipine and Olmesartan Study Results Released; Late Breaker Presented at American Society of Hypertension Twenty-Second Annual Scientific Meeting (ASH 2007) First Release of Data for New Combination daiichisankyo.com ↗ |
| 2006-11-29 | Daiichi Sankyo | DAIICHI SANKYO, INC. ANNOUNCES FILING OF NEW DRUG APPLICATION FOR AMLODIPINE BESYLATE / OLMESARTAN MEDOXOMIL COMBINATION FOR THE TREATMENT OF HYPERTENSION daiichisankyo.com ↗ |
| 2006-08-02 | Daiichi Sankyo | Sales of Antihypertensive Agent Olmetec® Begin in China daiichisankyo.com ↗ |
| 2006-08-02 | Daiichi Sankyo | SANKYO COMMENCES PATENT LITIGATION AGAINST BENICAR® ANDA FILING IN THE UNITED STATES daiichisankyo.com ↗ |
| 2005-10-12 | Daiichi Sankyo | Completion of the Registration of Trial Subjects for ORIENT on the Suppressive Effects of the Angiotensin II Receptor Blocker Olmetec® against the Progression of Diabetic Nephropathy daiichisankyo.com ↗ |
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 85 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Olmesartanmedoxomil | “This study was designed to assess the antihypertensive benefit of the olmesartan medoxomil 40 mg/hydrochlorothiazide (HCTZ) 12.5 mg combination versus olmesartan medoxomil 40...” PMID 20593911 ↗ 201076“In intervention group, patients had a pill of fixed-dose combination of Olmesartan medoxomil and Rosuvastatin, rather taking separated two pills.” NCT04061824 ↗ “For all participants, Olmesartan Medoxomil tablets or Amlodipine Besylate tablets will be used as an initial therapy.” NCT03015311 ↗ “Coated, Oral tablet containing Olmesartan medoxomil(OM)-Hydrochlorothiazide(HCTZ) 20-12.5mg, given once a day.” NCT01838850 ↗ “ATB-U101 is a fixed-dose combination tablet containing Olmesartan medoxomil 40 mg and Dapagliflozin 10 mg.” NCT07590466 ↗ “Olmesartan medoxomil 40 mg, Amlodipine 10 mg and Hydrochlorothiazide 25 mg” NCT02962258 ↗ “olmesartan medoxomil/amlodipine at 10/2.5 mg or 20/5 mg” NCT07679828 ↗ “Amlodipine orotate 10mg/Olmesartan medoxomil 40mg” NCT02058472 ↗ “Olmesartanmedoxomil (OM)40 mg tablets once daily” NCT00441350 ↗ “tablet, olmesartan medoxomil(CS-866) 40mg” NCT01493856 ↗ “Drug: Olmesartan medoxomil” NCT01180205 ↗ |
| Known as | ATB-1011 | “ATB-1011 (Olmetec, Olmesartan medoxomil 40 mg) and ATB-1012 (Forxiga, Dapagliflozin 10 mg) will be co-administered as a single oral dose under fasting conditions (minimum 10...” NCT07590466 ↗ |
| Known as | Benicar | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07547878 ↗ |
| Known as | Benicar (olmesartan medoxomil) | “Benicar (olmesartan medoxomil)” NCT00151775 ↗ |
| Known as | CS-866 | “tablet, olmesartan medoxomil(CS-866) 40mg” NCT01493856 ↗ |
| Known as | OLM | “range of olmesartan medoxomil (OLM)/amlodipine (AML) doses” PMID 22909147 ↗ Oct 2012 |
| Known as | olmesartan | “We examined the effects of olmesartan, an ARB, on primary composite outcome of doubling of serum creatinine, endstage renal disease and death in type 2 diabetic patients with...” PMID 21993710 ↗ Oct 20113“Patients received olmesartan monotherapy for 12 weeks, followed by additional use of azelnidipine (n=103) or hydrochlorothiazide (n=104) for 24 weeks after randomization.” PMID 19667251 ↗ Aug 2009 “adding amlodipine 5 or 10 mg/day to olmesartan medoxomil (hereafter olmesartan) 20 mg/day in patients not adequately controlled on olmesartan monotherapy.” PMID 19499960 ↗ 2009 “we assigned 4447 patients with type 2 diabetes to receive olmesartan (at a dose of 40 mg once daily) or placebo for a median of 3.2 years.” PMID 21388309 ↗ Mar 2011 |
| Known as | Olmetec | “ATB-1011 (Olmetec, Olmesartan medoxomil 40 mg) and ATB-1012 (Forxiga, Dapagliflozin 10 mg) will be co-administered as a single oral dose under fasting conditions (minimum 10...” NCT07590466 ↗ |
| Action | Inhibit | “angiotensin II receptor blocker” NCT00134160 ↗ |
| Route | Oral | “All patients received a single oral dose of olmesartan medoxomil based on the individual's age and bodyweight.” PMID 22880942 ↗ Dec 2012 |