Drugs / Olmesartan medoxomil

Regulatory milestones approvals, filings & regulatory actions · 2 recorded

MilestoneJurisdictionBrandIndicationDateSentence 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

PhaseRegistry idDatesIndicationSponsorStatusOutcome
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 · 1 met primary
Phase 2/3 NCT00151775 May 2005 → Sep 2008 hypertensive disorder Daiichi Sankyo Completed Met primary
Phase 323 trials · 6 met primary · 2 missed
Phase 3 NCT01838850 Apr 2013 → Aug 2014 essential hypertension Daiichi Sankyo Completed Met primary
Phase 3 NCT00923091 Jun 2009 → Jan 2011 essential hypertension Daiichi Sankyo Completed Met primary
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 Stop: Enrollment
Phase 3 NCT00649389 May 2008 → Apr 2009 hypertensive disorder Daiichi Sankyo Completed Met primary
Phase 3 NCT00527514 Sep 2007 → Apr 2008 hypertensive disorder Daiichi Sankyo Completed Met primary
Phase 3 NCT00430508 Feb 2007 → Mar 2008 essential hypertension Daiichi Sankyo Completed Met primary
Phase 3 NCT00430950 Feb 2007 → May 2008 essential hypertension Daiichi Sankyo Completed Missed primary
Phase 3 NCT00185133 May 2005 → Jan 2007 hypertensive disorder Daiichi Sankyo Completed No outcome recorded
Phase 420 trials · 7 met primary
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 Met primary
Phase 4 NCT02377661 Mar 2015 → May 2017 hypertensive disorder Wilhelminenspital Vienna Completed Met primary
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 Stop: Enrollment
Phase 4 NCT00949884 Aug 2009 → Jan 2010 hypertensive disorder Daiichi Sankyo Completed Met primary
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 not applicable1 trial
— NCT07679828 Jul 2026 → Dec 2029 expected hyperlipidemia, hypertensive disorder, type 2 diabetes mellitus China Medical University, China Recruiting No outcome recorded
Comparator or background therapy23 trials
Phase 1 NCT01493856 Comparator Jan → Feb 2012 — Daewoong Pharmaceutical Co. LTD. Completed No outcome recorded
Phase 2 NCT05033535 Comparator Jul 2020 → Dec 2021 essential hypertension Shenzhen People's Hospital Unknown No outcome recorded
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

News releases announcing trial results or a regulatory action · 20

DateIssuerRelease
2023-02-28 Zydus Lifesciences Limited Regulatory Zydus receives final approval from the USFDA for Olmesartan Medoxomil and Hydrochlorothiazide Tablets zyduslife.com ↗
Zydus Lifesciences Limited (including its subsidiaries/affiliates hereafter referred to as “Zydus”) has received final approval from the United States Food and Drug Administration (USFDA) for Olmesartan Medoxomil and Hydrochlorothiazide Tablets, 20 mg/12.5 mg, 40 mg/12.5 mg, and 40 mg/25 mg (USRLD: Benicar HCT ® Tablets).
2021-02-18 Daewoong Pharmaceutical Co. LTD. Results Daewoong Pharmaceutical’s Olostar confirmed better effect than co-administration of individual drugs daewoong.co.kr ↗
The results showed that the Olostar group showed a higher level of adherence and improved both systolic and diastolic blood pressure.
2020-11-30 Daewoong Pharmaceutical Co. LTD. Results Daewoong Pharmaceutical’s Olostar proved its excellent blood pressure reduction effects… Published in an SCI-grade journal daewoong.co.kr ↗
The results of the research indicated a meaningful decrease in both systolic and diastolic blood pressure on group with Olostar relative to the other group that was administered a combination of other ARBs and atorvastatin.
2019-03-04 Daewoong Pharmaceutical Co. LTD. Regulatory Daewoong Pharmaceutical has completed the lineup of hypertension medications with the approval of ‘Olomax.’ daewoong.co.kr ↗
Daewoong Pharmaceutical (CEO Sengho Jeon) announced last 27th that KFDA has approved ‘Olomax,’ the compound of Amlodipine added to ‘Olostar,’ the existing compound of Olmesartan and Rosuvastatin.
2017-04-28 Lupin Limited Regulatory Lupin receives FDA approval for generic Benicar® Tablets lupin.com ↗
2017-02-15 Daiichi Sankyo Regulatory Daiichi Sankyo Strengthens Authorized Generic Business through Daiichi Sankyo Espha daiichisankyo.com ↗
Today, Daiichi Sankyo Espha obtained approval for manufacturing and marketing for multiple AG products, including the following products:
2016-12-25 Lupin Limited Regulatory Lupin Receives Tentative Approval for Generic Benicar® Tablets lupin.com ↗
2016-03-17 Daewoong Pharmaceutical Co. LTD. Results Daewoong Pharmaceuticals - Daiichi-Sankyo Korea Expect sales of 30 billion won this year with Sevikar HCT daewoong.co.kr ↗
Whereas a double combination drug of Amlodipine and Olmesartan Medoxomil were not effective, Sevikar HCT displayed significant reduction in both systolic and diastolic pressure.
2014-02-10 Daewoong Pharmaceutical Co. LTD. Regulatory Daewoong Pharmaceutical received domestic approval for its OLOSTAR, the new complex combining the Olmesatan and rosuvastatin for the first time worldwide daewoong.co.kr ↗
Daewoong Pharmaceutical Co.,Ltd(President: Lee Jong-wook) received the approval from the Ministry of Food and Drug Safety(MFDS) for its OLOSTAR, a new anti-hypertensive drug which was developed with its proprietary technology.
2011-07-04 Daewoong Pharmaceutical Co. LTD. Results Sevikar, antihypertensive agent, proved 24 hours long effect daewoong.co.kr ↗
As a result, it was found that Sevikar reached target BP for 24 hours (70.9%), and had an excellent BP reduction in systolic pressure compared with placebo at 21.4mmHg.
2010-12-21 Daiichi Sankyo Regulatory Daiichi Sankyo Announces First European Approval for Sevikar HCT(R), a New Three-in-one Combination Product for the Treatment of High Blood Pressure* daiichisankyo.com ↗
Daiichi Sankyo Europe announced today that Sevikar HCT® is now approved in Germany, the first market to launch this new once-daily three-in-one combination product for the treatment of high blood pressure (BP).
2010-07-27 Daiichi Sankyo Regulatory FDA APPROVES TRIBENZOR™, A NEW THREE-IN-ONE COMBINATION PRODUCT FOR THE TREATMENT OF HIGH BLOOD PRESSURE daiichisankyo.com ↗
FDA APPROVES TRIBENZOR™, A NEW THREE-IN-ONE COMBINATION PRODUCT FOR THE TREATMENT OF HIGH BLOOD PRESSURE

All press releases naming this drug 33 releases

DateIssuerRelease

Evidence & citations 10 cited values

Every value below carries the sentence it was read from. 85 sources stand behind the page.

FieldValueCited 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 ↗ 2010
76

“These formulations include olmesartan medoxomil/amlodipine, rosuvastatin, ezetimibe, and dapagliflozin, with indapamide included in selected formulations.” NCT07679828 ↗

“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 ↗

“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 ↗

Show 66 more sources

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 2011
3

“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 ↗
1

NCT01415466 ↗

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