Rabeprazole

also known as Rabeprazole sodium · Aciphex · Pariet · Pariet(rabeprazole) · Proton pump inhibitor, Rabeprazole, Pariet · Rabeprazole Enteric-Coated Tablets · Rabeprazole: Pariet

Small molecule

Developed for: gastroesophageal reflux disease · Helicobacter pylori infectious disease · dyspepsia · asthma · duodenal ulcer · gastric ulcer · peptic ulcer disease · active peptic ulcer disease
+18 more
· gastritis · bacterial gastritis · chronic gastritis · esophageal disorder · esophageal varices with bleeding · esophagitis · gastric adenocarcinoma · gastric cancer · insomnia · intermediate coronary syndrome · laryngitis · lung disorder · peptic esophagitis · primary bacterial infectious disease · tubular adenocarcinoma · esophageal varices · stomach disorder · upper respiratory tract disorder
Investigated by: Eisai Inc. · Pfizer · National Taiwan University Hospital · Genentech, Inc. · AstraZeneca · Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
+108 more
· PriCara, Unit of Ortho-McNeil, Inc. · Kaohsiung Medical University · Acerta Pharma BV · Hutchmed · Janssen Korea, Ltd., Korea · Janssen Research & Development, LLC · Mylan Pharmaceuticals Inc · Seoul National University Hospital · The Catholic University of Korea · Addpharma Inc. · American University of Beirut Medical Center · Biogen · Bristol-Myers Squibb · Celgene Corporation · Chang Gung Memorial Hospital · Hospital Authority, Hong Kong · Janssen Cilag Pharmaceutica S.A.C.I., Greece · Janssen Pharmaceutica N.V., Belgium · Janssen-Ortho Inc., Canada · Kaohsiung Medical University Chung-Ho Memorial Hospital · National Science and Technology Council, Taiwan · Parexel · Second Affiliated Hospital, School of Medicine, Zhejiang University · Shandong University · Shanghai Zhongshan Hospital · Takeda · The University of Hong Kong · Akebia Therapeutics · Alumis Inc · Associated Scientists to Help Minimize Allergies · Beijing Changping Integrative Medicine Hospital · Beijing Children's Hospital · Beijing Geriatric Hospital · Bellus Health Inc. - a GSK company · Boehringer Ingelheim · Boston Pharmaceuticals · Bucheon St. Mary's Hospital · Buddhist Tzu Chi General Hospital · Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Chong Kun Dang Pharmaceutical · Daewoong Pharmaceutical Co. LTD. · GlaxoSmithKline · Haemonetics Corporation · Hamamatsu University · Hamilton Health Sciences Corporation · IRCCS Azienda Ospedaliero-Universitaria di Bologna · IlDong Pharmaceutical Co Ltd · Indonesia University · JDWNRH · Janssen Cilag S.A.S. · Janssen Pharmaceuticals · Japan International Cooperation Agency · Jeil Pharmaceutical Co., Ltd. · Jiangxi Hospital of Traditional Chinese Medicine · Jiangxi University of Traditional Chinese Medicine · Jiujiang Hospital of Traditional Chinese Medicine · Jiujiang No.1 People's Hospital · Kadmon Corporation, LLC · Kaohsiung Veterans General Hospital. · Khesar Gyalpo University of Medical Sciences of Bhutan · King Saud University · Lomond Therapeutics Holdings, Inc. · London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Medical College of Wisconsin · Ministry of Science and Technology, Taiwan · Nanchang Hongdu Hospital of Traditional Chinese Medicine · Nanchang Hospital of Integrated Traditional Chinese and Western Medicine · Nantes University Hospital · Neutec Ar-Ge San ve Tic A.Ş · Oita University · Ono Pharmaceutical Co., Ltd. · Ortho-McNeil, Inc. · PMV Pharmaceuticals, Inc · Peking University First Hospital · all 114 on the full record

Regulatory milestones approvals, filings & regulatory actions · 10 recorded

Milestone	Jurisdiction	Brand	Indication	Date	Sentence it was read from
Filed duodenal ulcer 1 milestone
Filed	Japan (PMDA)	Pariet	duodenal ulcer	2013-11-28	“submitted an application for the proton pump inhibitor Pariet® (rabeprazole sodium, “rabeprazole”) in Japan” eisai.com ↗
Filed gastroesophageal reflux disease 3 milestones
Filed	US (FDA)	AcipHex®	gastroesophageal reflux disease	2012-11-30	“FDA has accepted for review Eisai's New Drug Application (NDA) for a new sprinkle capsule formulation (5mg and 10mg) of the proton-pump inhibitor AcipHex®” eisai.com ↗
Rejected (CRL)	US (FDA)	AcipHex®	gastroesophageal reflux disease	2011-02-01	“Complete Response Letter from the U.S. Food and Drug Administration (FDA) on February 1 (local time) regarding the New Drug Application (NDA) of AcipHex®” eisai.com ↗
Filed	Japan (PMDA)	PARIET®	gastroesophageal reflux disease	2009-09-29	“submitted an application for additional indication of its proton pump inhibitor PARIET® (generic name: rabeprazole sodium) for non-erosive gastro-esophageal reflux disease...” eisai.com ↗
Filed peptic esophagitis 2 milestones
Filed	Japan (PMDA)	Pariet	peptic esophagitis	2016-10-28	“Eisai has submitted an application in Japan seeking approval for additional dosage and administration of 10 mg twice-daily dosing of the proton pump inhibitor Pariet®” eisai.com ↗
Filed	Japan (PMDA)	Pariet®	peptic esophagitis	2010-05-06	“submitted applications to the health authorities in Japan seeking approval of 10mg twice-daily dosing and 20mg twice-daily dosing of its proton pump inhibitor Pariet®” eisai.com ↗
Approved Indication not stated 2 milestones
Label expansions (3)	US (FDA)	ACIPHEX	—	2002-02-12 – 2008-06-30	fda.gov ↗
Approved	US (FDA)	ACIPHEX	—	1999-08-19	fda.gov ↗

Trials 148 · started per year

today

US approved 1999

199920002001200220032004200520062007200820092010201120122013201420152016201720182019202020212022202320242025202620272028

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 165 trials · 1 met primary
Phase 1	NCT07797478	Aug 2026 → Jun 2027 expected	—	Genentech, Inc.	Recruiting	No outcome recorded
Phase 1	NCT07608666	Jul → Dec 2026 expected	myelofibrosis	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	Not yet recruiting	No outcome recorded
Phase 1	NCT07597928	May → Aug 2026	—	Pfizer	Completed	No outcome recorded
Phase 1	NCT07563894	Apr → Jun 2026	—	Pfizer	Completed	No outcome recorded
Phase 1	NCT07284173	Nov → Dec 2025	—	Pfizer	Completed	No outcome recorded
Phase 1	NCT07141381	Aug → Dec 2025	—	Voronoi, Inc	Completed	No outcome recorded
Phase 1	NCT06417229	May 2024 → Feb 2025	—	Celgene Corporation	Completed	No outcome recorded
Phase 1	NCT06264440	Feb → Jun 2024	—	Biogen	Completed	No outcome recorded
Phase 1	NCT07838987	Dec 2023 → Jun 2026	—	Terns, Inc.	Completed	No outcome recorded
Phase 1	NCT06105983	Nov 2023 → Jul 2024	—	Pfizer	Completed	No outcome recorded
Phase 1	NCT06054464	Sep → Nov 2023	—	PMV Pharmaceuticals, Inc	Completed	No outcome recorded
Phase 1	NCT06399315	Jul 2023 → Jun 2025	acute myeloid leukemia	Lomond Therapeutics Holdings, Inc.	Completed	No outcome recorded
Phase 1	NCT05918822	Jul → Aug 2023	—	Takeda	Completed	No outcome recorded
Phase 1	NCT05899829	Jun → Aug 2023	—	Bellus Health Inc. - a GSK company	Completed	No outcome recorded
Phase 1	NCT05930119	Mar → Aug 2023	intrahepatic cholangiocarcinoma	Hutchmed	Completed	No outcome recorded
Phase 1	NCT05699070	Feb → Apr 2023	—	Daewoong Pharmaceutical Co. LTD.	Unknown	No outcome recorded
Phase 1	NCT05630677	Nov 2022 → Feb 2023	—	AstraZeneca	Completed	No outcome recorded
Phase 1	NCT05571787	Jul → Sep 2022	lymphoma	Hutchmed	Completed	No outcome recorded
Phase 1	NCT05446142	Jul → Sep 2022	—	Pfizer	Completed	No outcome recorded
Phase 1	NCT05380947	Jun → Sep 2022	—	Boehringer Ingelheim	Completed	No outcome recorded
Phase 1	NCT05602597	Jun → Aug 2022	lymphoma	Hutchmed	Completed	No outcome recorded
Phase 1	NCT05330858	Mar → Jun 2022	—	Alumis Inc	Completed	No outcome recorded
Phase 1	NCT04703868	Jan → Jun 2021	gastroesophageal reflux disease	Yungjin Pharm. Co., Ltd.	Completed	No outcome recorded
Phase 1	NCT04622358	Dec 2020 → Mar 2021	gastroesophageal reflux disease	Addpharma Inc.	Completed	No outcome recorded
Phase 1	NCT04565574	Oct 2020 → Mar 2021	—	Eisai Inc.	Completed	No outcome recorded
Phase 1	NCT04564040	Oct → Dec 2020	COVID-19, mantle cell lymphoma	AstraZeneca	Completed	No outcome recorded
Phase 1	NCT04564612	Sep 2020 → Sep 2022	—	Biogen	Completed	No outcome recorded
Phase 1	NCT04494243	Aug 2020 → Jan 2021	gastroesophageal reflux disease	Addpharma Inc.	Completed	No outcome recorded
Phase 1	NCT04489797	Jul → Aug 2020	infectious disease	AstraZeneca	Completed	No outcome recorded
Phase 1	NCT04488016	Jun 2020 → Jan 2021	B-cell neoplasm	AstraZeneca	Completed	No outcome recorded
Phase 1	NCT04435483	May → Jun 2020	—	AstraZeneca	Completed	No outcome recorded
Phase 1	NCT04211545	Oct → Dec 2019	—	Celgene Corporation	Completed	No outcome recorded
Phase 1	NCT03979248	May → Jul 2019	—	Bristol-Myers Squibb	Completed	No outcome recorded
Phase 1	NCT03789032	Oct → Nov 2018	—	Akebia Therapeutics	Completed	No outcome recorded
Phase 1	NCT03530995	Apr 2018 → Feb 2019	autoimmune disease	Kadmon Corporation, LLC	Completed	No outcome recorded
Phase 1	NCT03464058	Mar → Oct 2018	—	Boston Pharmaceuticals	Completed	No outcome recorded
Phase 1	NCT03220191	Jul → Sep 2017	—	Pfizer	Completed	No outcome recorded
Phase 1	NCT03290703	Apr 2017 → Oct 2018	—	Genentech, Inc.	Completed	No outcome recorded
Phase 1	NCT02655614	May 2016 → Mar 2020	amyotrophic lateral sclerosis	Genentech, Inc.	Completed	No outcome recorded
Phase 1	NCT02569554	Dec 2015 → Apr 2016	—	Pfizer	Completed	No outcome recorded
Phase 1	NCT02509923	Jul 2015 → Mar 2016	—	Zeria Pharmaceutical	Completed	No outcome recorded
Phase 1	NCT02475161	Jun → Jul 2015	—	Janssen Research & Development, LLC	Completed	No outcome recorded
Phase 1	NCT02311946	Jan → Apr 2015	—	Pfizer	Completed	No outcome recorded
Phase 1	NCT02524210	May 2014 → May 2015	—	University Hospital of Saint-Etienne	Completed	No outcome recorded
Phase 1	NCT02097329	Apr → Jun 2014	—	Pfizer	Completed	No outcome recorded
Phase 1	NCT01954043	Dec 2013 → Feb 2016	cancer	GlaxoSmithKline	Completed	No outcome recorded
Phase 1	NCT01918176	Sep → Dec 2013	—	Pfizer	Completed	No outcome recorded
Phase 1	NCT01772290	Feb → May 2013	—	Genentech, Inc.	Completed	No outcome recorded
Phase 1	NCT01759875	Jan 2013 → Jan 2014	—	University of California, San Francisco	Completed	No outcome recorded
Phase 1	NCT01702506	Oct 2012 → Jan 2013	—	Pfizer	Completed	No outcome recorded
Phase 1	NCT01857609	Aug → Dec 2012	—	Seoul National University Hospital	Completed	No outcome recorded
Phase 1	NCT01277718	Jan → Feb 2011	—	Genentech, Inc.	Completed	No outcome recorded
Phase 1	NCT01287091	Oct 2010 → Feb 2011	—	Genentech, Inc.	Completed	No outcome recorded
Phase 1	NCT01186497	Aug → Nov 2010	—	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	Completed	Met primary
Phase 1	NCT00989300	Nov 2009 → Mar 2010	—	Janssen Cilag S.A.S.	Completed	No outcome recorded
Phase 1	NCT00999128	Oct 2009 → Feb 2010	—	Genentech, Inc.	Completed	No outcome recorded
Phase 1	NCT00855361	Jul 2009 → Dec 2011	gastroesophageal reflux disease	Janssen Research & Development, LLC	Completed	No outcome recorded
Phase 1	NCT01101646	Aug → Sep 2008	gastroesophageal reflux disease	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	Completed	No outcome recorded
Phase 1	NCT00747695	Mar 2008 → Sep 2009	gastroesophageal reflux disease	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	Completed	No outcome recorded
Phase 1	NCT00747526	Dec 2007 → Feb 2012	gastroesophageal reflux disease	Janssen Research & Development, LLC	Completed	No outcome recorded
Phase 1	NCT01699113	Aug 2006 → Jun 2007	gastrin secretion abnormality	Trio Medicines Ltd.	Completed	No outcome recorded
Phase 1	NCT00378287	Oct → Dec 2005	gastroesophageal reflux disease	Janssen-Ortho Inc., Canada	Completed	No outcome recorded
Phase 1	NCT00649194	Aug 2003	—	Mylan Pharmaceuticals Inc	Completed	No outcome recorded
Phase 1	NCT00648349	May → Jun 2003	—	Mylan Pharmaceuticals Inc	Completed	No outcome recorded
Phase 1	NCT00649493	May → Jun 2003	—	Mylan Pharmaceuticals Inc	Completed	No outcome recorded

Phase 1/21 trial
Phase 1/2	NCT05407675	Aug 2022 → Aug 2024	cancer	Bristol-Myers Squibb	Completed	No outcome recorded
Phase 29 trials · 1 met primary · 1 missed
Phase 2	NCT07076914	Oct 2025 → Jan 2028 expected	non-small cell lung carcinoma, small cell lung carcinoma	London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's	Not yet recruiting	No outcome recorded
Phase 2	NCT06076694	Jun → Sep 2022	Helicobacter pylori infectious disease	TenNor Therapeutics Inc.	Completed	No outcome recorded
Phase 2	NCT01202071	Sep → Dec 2010	—	Eisai Inc.	Completed	No outcome recorded
Phase 2	NCT01136317	Apr → Jul 2010	gastroesophageal reflux disease	Nantes University Hospital	Completed	Missed primary
Phase 2	NCT01089543	Apr 2010 → Aug 2011	dyspepsia	Eisai Inc.	Completed	No outcome recorded
Phase 2	NCT00132496	Aug 2005 → May 2006	gastroesophageal reflux disease	Eisai Inc.	Completed	No outcome recorded
Phase 2	NCT00222170	May 2005 → May 2007	gastroesophageal reflux disease	University of Kansas	Completed	No outcome recorded
Phase 2	NCT00165841	Oct 2004 → Dec 2005	gastroesophageal reflux disease	Eisai Inc.	Completed	Met primary
Phase 2	NCT00199953	Jun 2002 → Dec 2007	—	Medical College of Wisconsin	Completed	No outcome recorded
Phase 2/33 trials
Phase 2/3	NCT01398410	Dec 2011 → Dec 2013	active peptic ulcer disease	Eisai Inc.	Completed	No outcome recorded
Phase 2/3	NCT00197418	Aug 2003 → ?	Helicobacter pylori infectious disease, duodenal ulcer, gastric ulcer, gastritis	Hamamatsu University	Unknown	No outcome recorded
Phase 2/3	NCT00204672	Oct 2000 → Sep 2005	asthma	University of Utah	Completed	No outcome recorded
Phase 318 trials · 4 met primary · 1 missed
Phase 3	NCT04215653	Jan 2020 → Feb 2021	duodenal ulcer	Sihuan Pharmaceutical Holdings Group Ltd.	Unknown	Met primary
Phase 3	NCT02037477	Jan → Mar 2014	—	Takeda	Completed	No outcome recorded
Phase 3	NCT02135107	Sep 2013 → May 2016	gastroesophageal reflux disease	Eisai Inc.	Completed	Met primary
Phase 3	NCT04001400	Oct 2012 → May 2014	esophageal disorder	Seoul National University Hospital	Completed	No outcome recorded
Phase 3	NCT00992589	Nov 2009 → Nov 2011	gastroesophageal reflux disease	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	Completed	Missed primary
Phase 3	NCT00787891	Jan 2009 → Jan 2011	gastroesophageal reflux disease	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	Completed	No outcome recorded
Phase 3	NCT00911534	Jan → Jul 2009	gastroesophageal reflux disease	Eisai Inc.	Completed	No outcome recorded
Phase 3	NCT00838526	Aug 2008 → Jul 2009	gastroesophageal reflux disease	Eisai Inc.	Completed	No outcome recorded
Phase 3	NCT00658528	Feb 2008 → Sep 2009	gastroesophageal reflux disease	Eisai Inc.	Completed	Mixed
Phase 3	NCT00658632	Feb 2008 → Apr 2009	gastroesophageal reflux disease	Eisai Inc.	Completed	No outcome recorded
Phase 3	NCT00658775	Feb 2008 → Sep 2009	gastroesophageal reflux disease	Eisai Inc.	Completed	Mixed
Phase 3	NCT00236184	Oct 2005 → Mar 2006	dyspepsia	Eisai Inc.	Completed	No outcome recorded
Phase 3	NCT00236197	Oct 2005 → Mar 2006	dyspepsia	Eisai Inc.	Completed	No outcome recorded
Phase 3	NCT00165672	May → Oct 2005	gastroesophageal reflux disease	Eisai Inc.	Completed	No outcome recorded
Phase 3	NCT00553449	Jul 2004 → Sep 2005	dyspepsia, gastroesophageal reflux disease	Janssen-Ortho Inc., Canada	Completed	No outcome recorded
Phase 3	NCT00214552	Sep 2002 → Mar 2005	asthma, gastroesophageal reflux disease	Associated Scientists to Help Minimize Allergies	Completed	No outcome recorded
Phase 3	NCT00236392	Oct 2001 → Oct 2002	dyspepsia, gastroesophageal reflux disease	Janssen Pharmaceutica N.V., Belgium	Completed	Met primary
Phase 3	NCT00132171	Jan → Dec 2001	Helicobacter pylori infectious disease, chronic gastritis, duodenal ulcer, dyspepsia +1	IRCCS Azienda Ospedaliero-Universitaria di Bologna	Completed	Met primary

Phase 436 trials · 2 met primary · 1 missed
Phase 4	NCT07611162	May 2026 → May 2030 expected	gastroesophageal reflux disease	University of Mons	Not yet recruiting	No outcome recorded
Phase 4	NCT07471867	Apr 2026 → Jul 2028 expected	coronary artery disorder	Yonsei University	Recruiting	No outcome recorded
Phase 4	NCT05624229	Oct 2023 → Dec 2025 overdue	esophageal varices with bleeding	West China Hospital	Not yet recruiting	No outcome recorded
Phase 4	NCT05419674	Aug 2022 → Aug 2023	Helicobacter pylori infectious disease	Second Affiliated Hospital, School of Medicine, Zhejiang University	Unknown	No outcome recorded
Phase 4	NCT05332444	Apr 2022 → Dec 2026 expected	Helicobacter pylori infectious disease	National Taiwan University Hospital	Recruiting	No outcome recorded
Phase 4	NCT05061732	Sep 2021 → Jun 2026	Helicobacter pylori infectious disease	Shanghai Zhongshan Hospital	Unknown	No outcome recorded
Phase 4	NCT05014685	Aug 2021 → Dec 2022	Helicobacter pylori infectious disease	Shanghai Zhongshan Hospital	Unknown	No outcome recorded
Phase 4	NCT04157881	Jan 2020 → Jan 2022	atrial fibrillation, venous thromboembolism	Population Health Research Institute	Completed	No outcome recorded
Phase 4	NCT03897244	May 2019 → Feb 2025	Helicobacter pylori infectious disease	National Taiwan University Hospital	Completed	No outcome recorded
Phase 4	NCT03616405	Apr → Nov 2019	Helicobacter pylori infectious disease	Shandong University	Unknown	No outcome recorded
Phase 4	NCT03565484	Jan 2019 → May 2020	Helicobacter pylori infectious disease	Shandong University	Unknown	No outcome recorded
Phase 4	NCT03037606	Aug 2017 → Dec 2018	gastroesophageal reflux disease	Neutec Ar-Ge San ve Tic A.Ş	Completed	No outcome recorded
Phase 4	NCT03134378	Oct 2016 → May 2017	Helicobacter pylori infectious disease	Indonesia University	Unknown	No outcome recorded
Phase 4	NCT02934152	Oct 2016 → Sep 2019	gastroesophageal reflux disease	National Taiwan University Hospital	Unknown	No outcome recorded
Phase 4	NCT02490839	Jul 2015 → Nov 2018	Helicobacter pylori infectious disease	National Taiwan University Hospital	Completed	No outcome recorded
Phase 4	NCT02483715	Jul 2015 → Mar 2018	Helicobacter pylori infectious disease	National Taiwan University Hospital	Completed	No outcome recorded
Phase 4	NCT02541786	Jan → Jun 2015	Helicobacter pylori infectious disease	Kaohsiung Medical University	Completed	No outcome recorded
Phase 4	NCT02635191	Mar 2014 → Mar 2016	Helicobacter pylori infectious disease	Beijing Children's Hospital	Unknown	No outcome recorded
Phase 4	NCT01922765	Aug 2013 → Feb 2014	peptic ulcer disease	The Catholic University of Korea	Unknown	No outcome recorded
Phase 4	NCT01860482	Apr 2013 → May 2015	peptic esophagitis	Chong Kun Dang Pharmaceutical	Completed	No outcome recorded
Phase 4	NCT02703896	Jan 2012	lung disorder	King Saud University	Completed	No outcome recorded
Phase 4	NCT01566643	Jan 2011 → Dec 2012	Helicobacter pylori infectious disease	Buddhist Tzu Chi General Hospital	Unknown	No outcome recorded
Phase 4	NCT01265069	Nov 2010 → Jun 2013	Helicobacter pylori infectious disease	National Taiwan University Hospital	Unknown	No outcome recorded
Phase 4	NCT01219764	Oct 2010 → Mar 2013	Helicobacter pylori infectious disease	American University of Beirut Medical Center	Completed	No outcome recorded
Phase 4	NCT01163435	Aug 2010 → Jul 2013	Helicobacter pylori infectious disease	National Taiwan University Hospital	Completed	Met primary
Phase 4	NCT00861640	Mar 2009 → Mar 2010	—	Kaohsiung Medical University Chung-Ho Memorial Hospital	Unknown	No outcome recorded
Phase 4	NCT01023360	May 2008 → Oct 2010	—	National Taiwan University Hospital	Unknown	No outcome recorded
Phase 4	NCT00844675	Oct 2007 → Dec 2011	gastric adenocarcinoma, tubular adenocarcinoma	The Catholic University of Korea	Completed	No outcome recorded
Phase 4	NCT01008696	May 2007 → Aug 2008	esophagitis	Janssen Korea, Ltd., Korea	Completed	Missed primary
Phase 4	NCT00838682	Apr 2006 → Jan 2009	peptic ulcer disease	The Catholic University of Korea	Terminated	Met primary Stop: Enrollment
Phase 4	NCT00220857	Sep 2005 → Sep 2007	—	Temple University	Completed	No outcome recorded
Phase 4	NCT00216450	Oct 2004 → Feb 2006	Helicobacter pylori infectious disease, primary bacterial infectious disease	Janssen Cilag Pharmaceutica S.A.C.I., Greece	Completed	No outcome recorded
Phase 4	NCT00287391	Sep 2004 → Dec 2006	gastroesophageal reflux disease, insomnia	University of North Carolina	Completed	No outcome recorded
Phase 4	NCT00304421	Jan 2004 → Sep 2007	gastroesophageal reflux disease	VA Greater Los Angeles Healthcare System	Completed	No outcome recorded
Phase 4	NCT00216489	Mar 2003 → Nov 2005	dyspepsia, gastroesophageal reflux disease	Janssen Cilag Pharmaceutica S.A.C.I., Greece	Completed	No outcome recorded
Phase 4	NCT00237367	? → Apr 2005	gastroesophageal reflux disease	PriCara, Unit of Ortho-McNeil, Inc.	Completed	No outcome recorded

Phase not applicable16 trials · 1 missed
—	NCT05364619	Aug 2022 → Dec 2024	Helicobacter pylori infectious disease	Peking University First Hospital	Unknown	No outcome recorded
—	NCT05226819	Feb → Sep 2022	Helicobacter pylori infectious disease	Second Affiliated Hospital of Xi'an Jiaotong University	Unknown	No outcome recorded
—	NCT04923113	Jun 2021 → Jan 2022	Helicobacter pylori infectious disease	Second Affiliated Hospital, School of Medicine, Zhejiang University	Completed	No outcome recorded
—	NCT07211880	Dec 2019 → Dec 2020	Helicobacter pylori infectious disease, gastric cancer	Zero Helicobacter IGAN Network	Completed	No outcome recorded
—	NCT03802318	Jan 2019 → Dec 2020	Helicobacter pylori infectious disease, bacterial gastritis, gastric ulcer	Chang Gung Memorial Hospital	Unknown	No outcome recorded
—	NCT05152004	Sep 2018 → Nov 2021	Helicobacter pylori infectious disease	Chang Gung Memorial Hospital	Completed	Missed primary
—	NCT03320538	Jul 2017 → Sep 2020	peptic ulcer disease	Jiangxi University of Traditional Chinese Medicine	Completed	No outcome recorded
—	NCT04061447	Feb 2016 → May 2019	Helicobacter pylori infectious disease	Kaohsiung Medical University	Completed	No outcome recorded
—	NCT02149914	May 2014 → Jul 2016	Barrett esophagus, gastroesophageal reflux disease	Taichung Tzu Chi Hospital	Unknown	No outcome recorded
—	NCT02547025	Aug 2012 → Oct 2021	Helicobacter pylori infectious disease	Kaohsiung Veterans General Hospital.	Completed	No outcome recorded
—	NCT01139645	Oct 2009 → Jul 2010	calcium metabolic disease	American University of Beirut Medical Center	Completed	No outcome recorded
—	NCT00539786	Mar 2006 → Apr 2011	gastroesophageal reflux disease	Samsung Medical Center	Unknown	No outcome recorded
—	NCT00234117	Jul 2005 → ?	asthma, gastroesophageal reflux disease	Ponce Gastroenterology Research	Completed	No outcome recorded
—	NCT00517114	Jan 2005 → Dec 2008	gastroesophageal reflux disease, laryngitis	Hospital Authority, Hong Kong	Completed	No outcome recorded
—	NCT00162877	Jun 2004 → Apr 2005	active peptic ulcer disease, gastritis	National Taiwan University Hospital	Unknown	No outcome recorded
—	NCT00517270	Mar 2003 → Apr 2008	intermediate coronary syndrome	Hospital Authority, Hong Kong	Unknown	No outcome recorded

Comparator or background therapy85 trials
Phase 0	NCT07339956 Background	Jan → Aug 2026 overdue	—	China-Japan Friendship Hospital	Not yet recruiting	No outcome recorded
Phase 1	NCT07643272 Background	Jun → Jul 2026	—	Hutchmed	Completed	No outcome recorded
Phase 1	NCT07329972 Background	Nov → Dec 2025	—	Genentech, Inc.	Completed	No outcome recorded
Phase 1	NCT07171619 Comparator	Aug → Nov 2025	—	SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany	Completed	No outcome recorded
Phase 1	NCT06916143 Background	Apr 2025	—	Eli Lilly and Company	Terminated	No outcome recorded
Phase 1	NCT06899061 Comparator	Mar 2025 → Feb 2026 overdue	high grade malignant neoplasm	AstraZeneca	Active not recruiting	No outcome recorded
Phase 1	NCT06787131 Background	May 2024 → Jul 2025	—	Lomond Therapeutics Holdings, Inc.	Completed	No outcome recorded
Phase 1	NCT04944771 Background	Jul 2021 → May 2022	hematopoietic and lymphoid cell neoplasm	AstraZeneca	Completed	No outcome recorded
Phase 1	NCT04645940 Background	Sep → Nov 2020	—	Hutchison Medipharma Limited	Completed	No outcome recorded
Phase 1	NCT04510649 Background	Jul → Sep 2020	—	Hutchison Medipharma Limited	Completed	No outcome recorded
Phase 1	NCT04471922 Comparator	Mar 2019	—	Sihuan Pharmaceutical Holdings Group Ltd.	Completed	No outcome recorded
Phase 1	NCT06337604 Background	Oct → Nov 2017	Helicobacter pylori infectious disease	TenNor Therapeutics Limited	Completed	No outcome recorded
Phase 1	NCT03237741 Background	Aug → Dec 2017	amyotrophic lateral sclerosis	Genentech, Inc.	Completed	No outcome recorded
Phase 1	NCT02699710 Background	Sep 2015 → May 2016	—	Genentech, Inc.	Completed	No outcome recorded
Phase 1	NCT01398046 Background	Aug 2011 → Feb 2014	—	University of California, San Francisco	Completed	No outcome recorded
Phase 1	NCT01153659 Comparator	Jul → Aug 2010	—	Eisai Inc.	Completed	No outcome recorded
Phase 1	NCT01085695 Comparator	Apr → May 2010	—	Eisai Inc.	Completed	No outcome recorded
Phase 1/2	NCT06076681 Background	Sep 2021 → Jan 2022	Helicobacter pylori infectious disease	TenNor Therapeutics Inc.	Completed	No outcome recorded
Phase 2	NCT05604261 Comparator	Dec 2022 → Jul 2023	dyskinesia of esophagus, gastroesophageal reflux disease, peptic esophagitis	Xuanzhu Biopharmaceutical Co., Ltd.	Unknown	No outcome recorded
Phase 2	NCT04503629 Comparator	Oct 2018 → May 2019	duodenal ulcer	Sihuan Pharmaceutical Holdings Group Ltd.	Completed	No outcome recorded
Phase 2	NCT02637557 Background	Mar 2016 → Apr 2017	gastroesophageal reflux disease	Ironwood Pharmaceuticals, Inc.	Completed	Met primary
Phase 2	NCT02463643 Comparator	May 2015 → Oct 2016	gastroesophageal reflux disease	Zeria Pharmaceutical	Completed	No outcome recorded
Phase 2	NCT01805934 Comparator	May → Dec 2012	—	Shanghai Jiao Tong University School of Medicine	Completed	No outcome recorded
Phase 2	NCT01513785 Comparator	Apr → Oct 2011	dyspepsia	Shanghai Jiao Tong University School of Medicine	Completed	No outcome recorded
Phase 2	NCT00978016 Background	Sep 2009 → Dec 2010	gastroesophageal reflux disease	XenoPort, Inc.	Completed	Missed primary
Phase 2	NCT01002443 Comparator	Jul 2003 → Mar 2006	gastric cancer	National Cancer Center, Korea	Completed	No outcome recorded
Phase 2/3	NCT02847455 Comparator	Aug 2008 → Oct 2009	duodenal ulcer	Livzon Pharmaceutical Group Inc.	Completed	No outcome recorded
Phase 2/3	NCT00539240 Comparator	Apr 2006 → Apr 2010	gastroesophageal reflux disease	US Department of Veterans Affairs	Completed	No outcome recorded
Phase 2/3	NCT00204698 Comparator	Aug 2003 → May 2006	upper respiratory tract disorder	University of Utah	Completed	No outcome recorded
Phase 3	NCT07608536 Comparator	May → Jul 2026 overdue	esophageal varices	King George's Medical University	Not yet recruiting	No outcome recorded
Phase 3	NCT07010107 Comparator	Jul 2025 → Apr 2026 overdue	peptic esophagitis	Xuanzhu Biopharmaceutical Co., Ltd.	Recruiting	No outcome recorded
Phase 3	NCT05857163 Background	May → Dec 2023	Helicobacter pylori infectious disease	TenNor Therapeutics Inc.	Completed	Met primary
Phase 3	NCT03779074 Comparator	Sep 2018 → Dec 2021	Helicobacter pylori infectious disease	Kaohsiung Veterans General Hospital.	Completed	No outcome recorded
Phase 3	NCT02368470 Background	Feb → Aug 2015	Helicobacter pylori infectious disease	Samsung Medical Center	Unknown	No outcome recorded
Phase 3	NCT03658473 Comparator	Nov 2014	stomach disorder	Galeno Desenvolvimento de Pesquisas Clínicas	Completed	No outcome recorded
Phase 3	NCT02767479 Comparator	Jul 2012 → Apr 2016	Helicobacter pylori infectious disease	Hamamatsu University	Completed	No outcome recorded
Phase 3	NCT01391715 Comparator	Aug 2011 → Oct 2012	gastroesophageal reflux disease	Inje University	Withdrawn	No outcome recorded
Phase 3	NCT01408186 Comparator	Jan 2011 → Nov 2015	peptic ulcer disease	Chinese University of Hong Kong	Completed	No outcome recorded
Phase 3	NCT01140828 Comparator	May 2009 → Oct 2012	dyspepsia, osteoarthritis, rheumatoid arthritis	Chinese University of Hong Kong	Completed	No outcome recorded
Phase 3	NCT00857597 Comparator	Mar 2009 → Dec 2011	gastroesophageal reflux disease	University of Pittsburgh	Terminated	No outcome recorded
Phase 3	NCT01051388 Comparator	Aug 2008 → Jul 2010	cardiovascular disorder	Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan	Completed	No outcome recorded
Phase 3	NCT02407119 Comparator	Jun 2003 → Jun 2016 overdue	Helicobacter pylori infectious disease, gastric carcinoma	National Cancer Center, Korea	Active not recruiting	No outcome recorded
Phase 4	NCT07122024 Comparator	Feb 2024 → Aug 2025 overdue	Helicobacter pylori infectious disease	Second Affiliated Hospital, School of Medicine, Zhejiang University	Recruiting	No outcome recorded
Phase 4	NCT06168214 Comparator	Sep 2023 → Nov 2024 overdue	—	Xijing Hospital of Digestive Diseases	Recruiting	No outcome recorded
Phase 4	NCT05879029 Background	Jul 2023 → Dec 2024	upper respiratory tract disorder	Tongji Hospital	Unknown	No outcome recorded
Phase 4	NCT05718609 Background	Mar 2023 → Mar 2024	Helicobacter pylori infectious disease	Second Affiliated Hospital, School of Medicine, Zhejiang University	Unknown	Met primary
Phase 4	NCT05014334 Comparator	Dec 2021 → Mar 2022	Helicobacter pylori infectious disease, chronic gastritis	Xijing Hospital of Digestive Diseases	Completed	No outcome recorded
Phase 4	NCT05023577 Background	Aug 2021 → Dec 2022	Helicobacter pylori infectious disease	Shanghai Zhongshan Hospital	Unknown	No outcome recorded
Phase 4	NCT05018923 Background	Aug 2021 → Dec 2022	Helicobacter pylori infectious disease	Shanghai Zhongshan Hospital	Unknown	No outcome recorded
Phase 4	NCT05191888 Comparator	Aug 2021 → Dec 2024	active peptic ulcer disease	Kaohsiung Medical University	Unknown	No outcome recorded
Phase 4	NCT04416581 Comparator	May 2021 → Dec 2027 expected	acute coronary syndrome, coronary artery disorder, myocardial infarction	Duk-Woo Park, MD	Recruiting	No outcome recorded
Phase 4	NCT04697186 Comparator	Jan → Dec 2021	Helicobacter pylori infectious disease, chronic gastritis, dyspepsia, gastric cancer	Xijing Hospital of Digestive Diseases	Completed	No outcome recorded
Phase 4	NCT04660123 Background	Dec 2020 → Dec 2021	Helicobacter pylori infectious disease, gastric cancer	Xijing Hospital of Digestive Diseases	Completed	No outcome recorded
Phase 4	NCT04667299 Background	Dec 2020 → Nov 2021	Helicobacter pylori infectious disease	Shanghai Zhongshan Hospital	Unknown	No outcome recorded
Phase 4	NCT04209933 Comparator	May → Aug 2020	Helicobacter pylori infectious disease, gastric cancer	Xijing Hospital of Digestive Diseases	Completed	No outcome recorded
Phase 4	NCT03997279 Background	Jun 2019 → Jun 2020	Helicobacter pylori infectious disease	Clinical Centre of Serbia	Unknown	No outcome recorded
Phase 4	NCT03908619 Comparator	Apr 2019 → Mar 2021	Helicobacter pylori infectious disease	Changi General Hospital	Unknown	No outcome recorded
Phase 4	NCT03658746 Background	Jan → Dec 2019	Helicobacter pylori infectious disease	Shandong University	Completed	No outcome recorded
Phase 4	NCT03658733 Comparator	Dec 2018 → Aug 2019	Helicobacter pylori infectious disease	Shandong University	Unknown	No outcome recorded
Phase 4	NCT03094416 Background	Jul 2018 → Jun 2020	postsurgical hypothyroidism	IBSA Institut Biochimique SA	Completed	No outcome recorded
Phase 4	NCT03521726 Background	May 2018 → Feb 2019	Helicobacter pylori infectious disease	Mackay Memorial Hospital	Completed	No outcome recorded
Phase 4	NCT04132479 Comparator	Jan → Dec 2018	Helicobacter pylori infectious disease	Kirby Institute	Completed	No outcome recorded
Phase 4	NCT02986685 Background	Nov 2016 → Oct 2017	peptic esophagitis	Xijing Hospital of Digestive Diseases	Withdrawn	No outcome recorded Stop: Business
Phase 4	NCT02776371 Background	Sep 2016 → Jan 2018	—	Shandong University	Completed	No outcome recorded
Phase 4	NCT02638584 Comparator	Dec 2015 → Mar 2018	gastric cancer	Il-Yang Pharm. Co., Ltd.	Completed	Missed primary
Phase 4	NCT03108287 Background	Apr 2013 → Jan 2015	Helicobacter pylori infectious disease	Kaohsiung Medical University Chung-Ho Memorial Hospital	Completed	No outcome recorded
Phase 4	NCT01572597 Background	Jun 2011 → Dec 2012	Helicobacter pylori infectious disease	Buddhist Tzu Chi General Hospital	Unknown	No outcome recorded
Phase 4	NCT01573975 Background	Jan 2009 → May 2011	Helicobacter pylori infectious disease	Buddhist Tzu Chi General Hospital	Completed	No outcome recorded
Phase 4	NCT01967329 Comparator	Nov 2008 → May 2019	Helicobacter pylori infectious disease	University of Alberta	Completed	No outcome recorded
Phase 4	NCT01575899 Comparator	Dec 2007 → Dec 2009	Helicobacter pylori infectious disease	Buddhist Tzu Chi General Hospital	Terminated	Met primary
Phase 4	NCT00464308 Comparator	Nov 2006 → May 2008	gastroesophageal reflux disease	Janssen-Cilag Pty Ltd	Completed	No outcome recorded
Phase 4	NCT00125736 Background	Aug 2005 → Apr 2007	gastric ulcer	Eisai Inc.	Completed	No outcome recorded
Phase 4	NCT00354757 Comparator	Jun 2005 → Jun 2008	gastroesophageal reflux disease	National Taiwan University Hospital	Completed	No outcome recorded
Phase 4	NCT00251732 Comparator	Mar 2005 → May 2010	gastroesophageal reflux disease	University of Arizona	Completed	No outcome recorded
—	NCT07358130 Comparator	Oct 2025 → Nov 2027 expected	Helicobacter pylori infectious disease	Kaohsiung Medical University	Recruiting	No outcome recorded
—	NCT07165444 Comparator	Sep 2025 → Feb 2026 overdue	Helicobacter pylori infectious disease, proton-pump inhibitor-responsive esophageal eosinophilia	Tanta University	Recruiting	No outcome recorded
—	NCT06349486 Comparator	Nov 2023 → Dec 2026 expected	—	Kaohsiung Medical University	Recruiting	No outcome recorded
—	NCT06004401 Comparator	Aug 2023 → Aug 2025	—	Shanghai Changzheng Hospital	Unknown	No outcome recorded
—	NCT04723472 Background	Aug 2023 → Dec 2025	Helicobacter pylori infectious disease	Shanghai East Hospital	Suspended	No outcome recorded
—	NCT05320133 Background	Jun 2022 → Nov 2024	Helicobacter pylori infectious disease	Peking University First Hospital	Unknown	No outcome recorded
—	NCT02826408 Comparator	Oct 2016 → Mar 2018	—	Jordan Collaborating Cardiology Group	Completed	No outcome recorded
—	NCT01643785 Background	Jun 2012 → Jun 2013	Helicobacter pylori infectious disease	Chuncheon Sacred Heart Hospital	Terminated	No outcome recorded
—	NCT01237353 Background	Mar → Jul 2011	—	University of California, San Francisco	Completed	No outcome recorded
—	NCT01037491 Comparator	Oct 2009 → Dec 2010	duodenal ulcer, gastric ulcer	Taipei Veterans General Hospital, Taiwan	Unknown	No outcome recorded
—	NCT00681005 Comparator	Apr 2006 → Jan 2008	gastroesophageal reflux disease	National Taiwan University Hospital	Completed	No outcome recorded

News releases announcing trial results or a regulatory action · 31

Date	Issuer	Release
2025-03-21	Eisai Inc.	Regulatory Proton Pump Inhibitor “Pariet® S” Approved in Japan as RX-to-OTC Switch Same Dosage of the Active Ingredient Rabeprazole Sodium as the Prescription Product eisai.com ↗
2020-02-17	Upsher-Smith Laboratories	Regulatory Sawai Receives Approvals for 15 Generic Drugs with 31 Strengths upsher-smith.com ↗ Sawai Pharmaceutical Co., Ltd. (Sawai, Head office: Osaka, Japan, President: Mitsuo Sawai) received approvals by the Ministry of Health, Labour and Welfare for 15 generic drugs with 31 strengths.
2017-09-22	Eisai Inc.	Regulatory Additional Dosage and Administration of Proton Pump Inhibitor Pariet® 5 mg Tablets, 10 mg Tablets Approved in Japan for Maintenance Therapy of Proton Pump Inhibitor Resistant Reflux Esophagitis eisai.com ↗
2016-10-28	Eisai Inc.	Regulatory Application Submitted for Proton Pump Inhibitor Pariet® in Japan Seeking Approval for Additional Dosage and Administration for Maintenance Therapy of Proton Pump Inhibitor Resistant Reflux Esophagitis eisai.com ↗
2014-12-26	Eisai Inc.	Regulatory EISAI RECEIVES APPROVAL FOR INDICATION EXPANSION OF PROTON PUMP INHIBITOR PARIET® FOR USE IN PREVENTION OF RECURRENT GASTRIC OR DUODENAL ULCER CAUSED BY LOW-DOSE ASPIRIN THERAPY AND ADDITIONAL 5 MG TABLET FORMULATION IN JAPAN eisai.com ↗ In addition, Eisai has also received approval of a 5 mg tablet formulation with the same indication as Pariet Tablets 10 mg.
2013-11-28	Eisai Inc.	Regulatory EISAI SUBMITS APPLICATION FOR PROTON PUMP INHIBITOR PARIET® IN JAPAN SEEKING INDICATION EXPANSION FOR PREVENTION OF RECURRENT GASTRIC OR DUODENAL ULCER CAUSED BY LOW-DOSE ASPIRIN THERAPY AND APPROVAL OF NEW FORMULATION eisai.com ↗
2013-08-21	Eisai Inc.	Regulatory EISAI RECEIVES APPROVAL TO MARKET PARIET® TRIPLE FORMULATION PACKS RABECURE® 400 AND 800 AND RABEFINE®, FOR PRIMARY AND SECONDARY H. PYLORI ERADICATION RESPECTIVELY, IN JAPAN eisai.com ↗
2013-03-27	Eisai Inc.	Regulatory NEW DRUG APPLICATION FOR PEDIATRIC FORMULATION ACIPHEX® SPRINKLE™ APPROVED BY U.S. FDA eisai.com ↗
2013-02-21	Tanabe Pharma Corporation	Regulatory Helicobacter pylori Gastritis Approved as Additional Indication in Japan for Helicobacter pylori Eradication by Triple Therapy with Proton Pump Inhibitor tanabe-pharma.com ↗ Helicobacter pylori Gastritis Approved as Additional Indication in Japan for Helicobacter pylori Eradication by Triple Therapy with Proton Pump Inhibitor
2013-02-21	Kyowa Kirin, Inc.	Regulatory Pasetocin® and Sawacillin®: Approval for Additional Indication for Helicobacter pylori Eradication by Triple Therapy with Proton Pump Inhibitors and either Clarithromycin or Metronidazole kyowakirin.com ↗ has been approved by Japan's Ministry of Health, Labour and Welfare.
2013-02-21	Eisai Inc.	Regulatory Helicobacter pylori Gastritis Approved as Additional Indication in Japan for Helicobacter pylori Eradication by Triple Therapy with Proton Pump Inhibitor eisai.com ↗
2012-12-10	Eisai Inc.	Regulatory EISAI RECEIVES SIX-MONTH PEDIATRIC EXCLUSIVITY FOR PROTON-PUMP INHIBITOR ACIPHEX® IN THE U.S. eisai.com ↗
2012-11-30	Eisai Inc.	Regulatory PEDIATRIC NDA FOR PROTON-PUMP INHIBITOR ACIPHEX® GRANTED PRIORITY REVIEW IN THE U.S. eisai.com ↗ Furthermore, the FDA has indicated that this NDA will receive a priority review, which provides for a six-month review period, with a Prescription Drugs User Fee Act (PDUFA) action date (proposed review deadline) of March 27, 2013.
2012-08-31	Tanabe Pharma Corporation	Regulatory Companies Submit Joint Application Seeking Approval for Additional Indication for Helicobacter pylori Eradication by Concomitant Therapy with Proton Pump Inhibitors, Amoxicillin Hydrate and either Clarithromycin or Metronidazole tanabe-pharma.com ↗ Companies Submit Joint Application Seeking Approval for Additional Indication for Helicobacter pylori Eradication by Concomitant Therapy with Proton Pump Inhibitors, Amoxicillin Hydrate and either Clarithromycin or Metronidazole
2012-08-31	Eisai Inc.	Regulatory Companies Submit Joint Application Seeking Approval for Additional Indication for Helicobacter pylori Eradication by Concomitant Therapy with Proton Pump Inhibitors, Amoxicillin Hydrate and either Clarithromycin or Metronidazole eisai.com ↗ they have submitted a joint application * to Japan’s Ministry of Health, Labour and Welfare seeking approval of Helicobacter pylori (“ H. pylori ”) gastritis as an additional indication
2012-05-31	Eisai Inc.	Regulatory EISAI SEEKS APPROVAL TO MARKET PARIET® TRIPLE FORMULATION PACK IN JAPAN FOR HELICOBACTER PYLORI ERADICATION eisai.com ↗ announced today that it has submitted a marketing authorization application to Japan’s Ministry of Health, Labour and Welfare seeking approval for two types of new triple formulation packs
2011-02-02	Eisai Inc.	Regulatory EISAI RECEIVES COMPLETE RESPONSE LETTER FROM U.S. FDA FOR INVESTIGATIONAL PROTON PUMP INHIBITOR ACIPHEX® EXTENDED-RELEASE CAPSULES, 50 MG eisai.com ↗ Eisai Inc. received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) on February 1 (local time)
2010-12-21	Eisai Inc.	Regulatory EISAI RECEIVES APPROVAL FOR TWICE-DAILY DOSING OF PROTON PUMP INHIBITOR PARIET® FOR TREATMENT OF REFLUX ESOPHAGITIS Offers New Option to Patients Unable to Obtain Satisfactory Relief with Conventional Proton Pump Inhibitor Treatment eisai.com ↗
2010-06-24	Eisai Inc.	Regulatory EISAI RECEIVES APPROVAL FOR ADDITIONAL INDICATION OF PROTON PUMP INHIBITOR PARIET® FOR NON-EROSIVE GERD IN JAPAN eisai.com ↗ Eisai Co., Ltd. (Headquarters: Tokyo, President & CEO: Haruo Naito) announced today that the Company has received approval for an additional indication of its proton pump inhibitor Pariet® (generic name: rabeprazole sodium) for non-erosive gastroesophageal reflux disease (GERD) in Japan.
2010-06-18	Tanabe Pharma Corporation	Regulatory Approval of Additional Indications for Helicobacter pylori Eradication by Concomitant Therapy with Proton Pump Inhibitors tanabe-pharma.com ↗ they have received approval from the Japanese Ministry of Health, Labor and Welfare for additional indications for Helicobacter pylori (“H. pylori”) eradication by concomitant therapy
2010-06-18	Eisai Inc.	Regulatory Approval of Additional Indications for Helicobacter pylori Eradication by Concomitant Therapy with Proton Pump Inhibitors eisai.com ↗
2010-06-03	Eisai Inc.	Regulatory FDA ACCEPTS FOR REVIEW EISAI'S NDA FOR PROTON PUMP INHIBITOR ACIPHEX® EXTENDED-RELEASE 50 mg FORMULATION eisai.com ↗
2010-05-06	Eisai Inc.	Regulatory EISAI SUBMITS APPLICATION IN JAPAN FOR TWICE-DAILY DOSING OF ITS PROTON PUMP INHIBITOR PARIET® FOR THE TREATMENT OF REFLUX ESOPHAGITIS eisai.com ↗ has submitted applications to the health authorities in Japan seeking approval of 10mg twice-daily dosing and 20mg twice-daily dosing of its proton pump inhibitor Pariet®
2009-10-01	Eisai Inc.	Regulatory Application Submitted for Additional Indications for Helicobacter pylori Eradication by Concomitant Therapy with Proton Pump Inhibitors eisai.com ↗
2009-09-29	Eisai Inc.	Regulatory Eisai Submits Application for Additional Indication of its Proton Pump Inhibitor PARIET® for Non-erosive GERD in Japan eisai.com ↗ Eisai Co., Ltd. (Headquarters: Tokyo, President and CEO: Haruo Naito) announced today that it had submitted an application for additional indication of its proton pump inhibitor PARIET® (generic name: rabeprazole sodium) for non-erosive gastro-esophageal reflux disease (GERD) in Japan.
2008-07-01	Eisai Inc.	Regulatory Proton Pump Inhibitor ACIPHEX® 20 mg Receives Approval for Short-Term Treatment of GERD in Adolescents in United States eisai.com ↗ the Food and Drug Administration (FDA) has approved ACIPHEX® 20 mg (product name in Japan: PARIET®) for the short-term (up to eight weeks) treatment of gastroesophageal reflux disease (GERD) in adolescents ages 12 and above.
2008-03-01	Eisai Inc.	Regulatory FDA Grants Priority Review for ACIPHEX® sNDA for Short-Term Treatment of GERD in Adolescents eisai.com ↗ Further, FDA has indicated that the sNDA will receive priority review in accordance with the Best Pharmaceuticals for Children Act, which provides for a 180-day review period.
2008-02-01	Eisai Inc.	Regulatory Eisai Decides Additional Study for Pariet® for New Indication of Non-Erosive Gastro-Esophageal Reflux Disease in Japan eisai.com ↗ Therefore, Eisai will withdraw the application at this time, and aims to resubmit it in FY2008.
2007-08-24	Eisai Inc.	Regulatory Approval of an additional dosage and administration for secondary eradication of Helicobacter pylori for proton pump inhibitors in Japan eisai.com ↗
2007-01-30	Eisai Inc.	Regulatory Proton Pump Inhibitor Pariet® Tablets 10mg Receives Approval in Japan for Helicobacter Pylori Eradication eisai.com ↗ Pariet ® Tablets 10mg (generic name: rabeprazole sodium), in combination with the antibiotics amoxicillin and clarithromycin, received an approval in Japan for a new indication to eradicate Helicobacter pylori ( H. pylori ) infection related to gastric/duodenal ulcers.
2006-02-16	Teva Branded Pharmaceutical Products R&D, Inc.	Regulatory Teva Announces Tentative Approval of Rabeprazole Sodium Delayed-Release Tablets tevapharm.com ↗ Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration has granted tentative approval for the Company's ANDA for Rabeprazole Sodium Delayed-Release Tablets, 20 mg.

All press releases naming this drug 40 releases

Date	Issuer	Release
2025-06-02	Eisai Inc.	Eisai to Launch “Pariet® S,” the First Proton Pump Inhibitor RX-to-OTC in Japan - Same Dosage of the Active Ingredient Rabeprazole Sodium as the Prescription Product - eisai.com ↗
2025-03-28	Eisai Inc.	EISAI TO DIVEST RIGHTS FOR PARIET® IN CHINA TO PEAK PHARMA eisai.com ↗
2025-03-21	Eisai Inc.	Proton Pump Inhibitor “Pariet® S” Approved in Japan as RX-to-OTC Switch Same Dosage of the Active Ingredient Rabeprazole Sodium as the Prescription Product eisai.com ↗
2020-02-17	Upsher-Smith Laboratories	Sawai Receives Approvals for 15 Generic Drugs with 31 Strengths upsher-smith.com ↗
2019-02-27	Trio Medicines Ltd.	Effect of netazepide, a gastrin/CCK2 receptor antagonist, on gastric acid secretion and rabeprazole-induced hypergastrinaemia in healthy subjects. triomedicines.com ↗
2017-09-22	Eisai Inc.	Additional Dosage and Administration of Proton Pump Inhibitor Pariet® 5 mg Tablets, 10 mg Tablets Approved in Japan for Maintenance Therapy of Proton Pump Inhibitor Resistant Reflux Esophagitis eisai.com ↗
2016-10-28	Eisai Inc.	Application Submitted for Proton Pump Inhibitor Pariet® in Japan Seeking Approval for Additional Dosage and Administration for Maintenance Therapy of Proton Pump Inhibitor Resistant Reflux Esophagitis eisai.com ↗
2015-02-24	Eisai Inc.	EISAI LAUNCHES PROTON PUMP INHIBITOR PARIET® TABLETS 5 MG IN JAPAN eisai.com ↗
2014-12-26	Eisai Inc.	EISAI RECEIVES APPROVAL FOR INDICATION EXPANSION OF PROTON PUMP INHIBITOR PARIET® FOR USE IN PREVENTION OF RECURRENT GASTRIC OR DUODENAL ULCER CAUSED BY LOW-DOSE ASPIRIN THERAPY AND ADDITIONAL 5 MG TABLET FORMULATION IN JAPAN eisai.com ↗
2014-02-13	Eisai Inc.	EISAI ANNOUNCES LAUNCH OF PARIET® TRIPLE FORMULATION COMBINATION PACKS RABECURE® 400 AND 800 AND RABEFINE®, FOR PRIMARY AND SECONDARY H. PYLORI ERADICATION RESPECTIVELY, IN JAPAN eisai.com ↗
2013-11-28	Eisai Inc.	EISAI SUBMITS APPLICATION FOR PROTON PUMP INHIBITOR PARIET® IN JAPAN SEEKING INDICATION EXPANSION FOR PREVENTION OF RECURRENT GASTRIC OR DUODENAL ULCER CAUSED BY LOW-DOSE ASPIRIN THERAPY AND APPROVAL OF NEW FORMULATION eisai.com ↗
2013-08-21	Eisai Inc.	EISAI RECEIVES APPROVAL TO MARKET PARIET® TRIPLE FORMULATION PACKS RABECURE® 400 AND 800 AND RABEFINE®, FOR PRIMARY AND SECONDARY H. PYLORI ERADICATION RESPECTIVELY, IN JAPAN eisai.com ↗
2013-03-27	Eisai Inc.	NEW DRUG APPLICATION FOR PEDIATRIC FORMULATION ACIPHEX® SPRINKLE™ APPROVED BY U.S. FDA eisai.com ↗
2013-02-21	Tanabe Pharma Corporation	Helicobacter pylori Gastritis Approved as Additional Indication in Japan for Helicobacter pylori Eradication by Triple Therapy with Proton Pump Inhibitor tanabe-pharma.com ↗
2013-02-21	Kyowa Kirin, Inc.	Pasetocin® and Sawacillin®: Approval for Additional Indication for Helicobacter pylori Eradication by Triple Therapy with Proton Pump Inhibitors and either Clarithromycin or Metronidazole kyowakirin.com ↗
2013-02-21	Eisai Inc.	Helicobacter pylori Gastritis Approved as Additional Indication in Japan for Helicobacter pylori Eradication by Triple Therapy with Proton Pump Inhibitor eisai.com ↗
2012-12-10	Eisai Inc.	EISAI RECEIVES SIX-MONTH PEDIATRIC EXCLUSIVITY FOR PROTON-PUMP INHIBITOR ACIPHEX® IN THE U.S. eisai.com ↗
2012-11-30	Eisai Inc.	PEDIATRIC NDA FOR PROTON-PUMP INHIBITOR ACIPHEX® GRANTED PRIORITY REVIEW IN THE U.S. eisai.com ↗
2012-08-31	Tanabe Pharma Corporation	Companies Submit Joint Application Seeking Approval for Additional Indication for Helicobacter pylori Eradication by Concomitant Therapy with Proton Pump Inhibitors, Amoxicillin Hydrate and either Clarithromycin or Metronidazole tanabe-pharma.com ↗
2012-08-31	Eisai Inc.	Companies Submit Joint Application Seeking Approval for Additional Indication for Helicobacter pylori Eradication by Concomitant Therapy with Proton Pump Inhibitors, Amoxicillin Hydrate and either Clarithromycin or Metronidazole eisai.com ↗
2012-05-31	Eisai Inc.	EISAI SEEKS APPROVAL TO MARKET PARIET® TRIPLE FORMULATION PACK IN JAPAN FOR HELICOBACTER PYLORI ERADICATION eisai.com ↗
2011-09-02	Eisai Inc.	EISAI DISCONTINUES DEVELOPMENT OF PARIET®/ACIPHEX® EXTENDED-RELEASE CAPSULES, 50 MG eisai.com ↗
2011-02-02	Eisai Inc.	EISAI RECEIVES COMPLETE RESPONSE LETTER FROM U.S. FDA FOR INVESTIGATIONAL PROTON PUMP INHIBITOR ACIPHEX® EXTENDED-RELEASE CAPSULES, 50 MG eisai.com ↗
2010-12-21	Eisai Inc.	EISAI RECEIVES APPROVAL FOR TWICE-DAILY DOSING OF PROTON PUMP INHIBITOR PARIET® FOR TREATMENT OF REFLUX ESOPHAGITIS Offers New Option to Patients Unable to Obtain Satisfactory Relief with Conventional Proton Pump Inhibitor Treatment eisai.com ↗
2010-06-24	Eisai Inc.	EISAI RECEIVES APPROVAL FOR ADDITIONAL INDICATION OF PROTON PUMP INHIBITOR PARIET® FOR NON-EROSIVE GERD IN JAPAN eisai.com ↗
2010-06-18	Tanabe Pharma Corporation	Approval of Additional Indications for Helicobacter pylori Eradication by Concomitant Therapy with Proton Pump Inhibitors tanabe-pharma.com ↗
2010-06-18	Eisai Inc.	Approval of Additional Indications for Helicobacter pylori Eradication by Concomitant Therapy with Proton Pump Inhibitors eisai.com ↗
2010-06-03	Eisai Inc.	FDA ACCEPTS FOR REVIEW EISAI'S NDA FOR PROTON PUMP INHIBITOR ACIPHEX® EXTENDED-RELEASE 50 mg FORMULATION eisai.com ↗
2010-05-06	Eisai Inc.	EISAI SUBMITS APPLICATION IN JAPAN FOR TWICE-DAILY DOSING OF ITS PROTON PUMP INHIBITOR PARIET® FOR THE TREATMENT OF REFLUX ESOPHAGITIS eisai.com ↗
2009-10-01	Eisai Inc.	Application Submitted for Additional Indications for Helicobacter pylori Eradication by Concomitant Therapy with Proton Pump Inhibitors eisai.com ↗
2009-09-29	Eisai Inc.	Eisai Submits Application for Additional Indication of its Proton Pump Inhibitor PARIET® for Non-erosive GERD in Japan eisai.com ↗
2008-07-22	Eisai Inc.	U.S. FEDERAL CIRCUIT COURT OF APPEALS FULLY UPHOLDS EISAI'S FAVORABLE RULING IN ACIPHEX® PATENT INFRINGEMENT LAWSUIT AGAINST TEVA PHARMACEUTICALS AND DR. REDDY'S LABORATORIES eisai.com ↗
2008-07-01	Eisai Inc.	Proton Pump Inhibitor ACIPHEX® 20 mg Receives Approval for Short-Term Treatment of GERD in Adolescents in United States eisai.com ↗
2008-03-01	Eisai Inc.	FDA Grants Priority Review for ACIPHEX® sNDA for Short-Term Treatment of GERD in Adolescents eisai.com ↗
2008-02-01	Eisai Inc.	Eisai Decides Additional Study for Pariet® for New Indication of Non-Erosive Gastro-Esophageal Reflux Disease in Japan eisai.com ↗
2007-08-24	Eisai Inc.	Approval of an additional dosage and administration for secondary eradication of Helicobacter pylori for proton pump inhibitors in Japan eisai.com ↗
2007-05-12	Eisai Inc.	EISAI OBTAINS FAVORABLE RULING IN ACIPHEX® PATENT INFRINGEMENT LAWSUIT AGAINST TEVA PHARMACEUTICALS AND DR. REDDY'S LABORATORIES eisai.com ↗
2007-05-11	Teva Branded Pharmaceutical Products R&D, Inc.	Teva Provides Update on Generic Aciphex® Litigation tevapharm.com ↗
2007-01-30	Eisai Inc.	Proton Pump Inhibitor Pariet® Tablets 10mg Receives Approval in Japan for Helicobacter Pylori Eradication eisai.com ↗
2006-02-16	Teva Branded Pharmaceutical Products R&D, Inc.	Teva Announces Tentative Approval of Rabeprazole Sodium Delayed-Release Tablets tevapharm.com ↗

Evidence & citations 11 cited values

Every value below carries the sentence it was read from. 233 sources stand behind the page.

Field	Value	Cited text
Known as	rabeprazole	“Allowable PPIs : Rabeprazole Sodium 20 mg QD, Esomeprazole Magnesium 20 mg or 40 mg QD, Lansoprazole 15 mg or 30 mg QD, Pantoprazole 20 mg or 40 mg QD, Omeprazole 20 mg or 40...” NCT00978016 ↗ 225 “This phase 1, open-label crossover study evaluated the relative bioavailability of dacomitinib in healthy volunteers under fed and fasted conditions and following...” PMID 26179237 ↗ Oct 2015 “Each subject will receive four single oral doses of 100 mg PF-06463922 as tablets alone, tablets with food, tablets with rabeprazole, and oral solution after overnight fasting...” NCT02569554 ↗ “Subjects will receive Rabeprazole 20 mg QD (fasted) at 2 hours before administration of 100 mg acalabrutinib tablet (Variant 1) and following prior administration of...” NCT04488016 ↗ “All participants were taking a standard dose QD PPI (dexlansoprazole, esomeprazole, esomeprazole magnesium, lansoprazole, omeprazole, pantoprazole, pantoprazole sodium...” NCT02637557 ↗ “Bismuth potassium citrate:given for 14 days at a dose of bismuth potassium citrate 220 mg 0 BID,rabeprazole 10 mg BID, amoxicillin 1000 mg BID, and clarithromycin 500 mg BID” NCT04209933 ↗ “in Part A, all subjects will receive Surufatinib 300 mg in a single dose on study days 1 and 11 and receive Rabeprazole 30 mg single dose on study days 5 through 11” NCT04510649 ↗ “rabeprazole 20mg bid + amoxicillin 1g bid treated for 5 days, then rabeprazole 20mg bid + amoxicillin 1g bid + clarithromycin 0.5g bid + metronidazole 0.5g bid” NCT01566643 ↗ “rabeprazole 20mg b.i.d + amoxicillin 1000mg b.i.d x 5 days + rabeprazole 20mg b.i.d + clarithromycin 500mg b.i.d + metronidazole 500mg b.i.d x last 5 days.” NCT01573975 ↗ “H. pylori infected patients treated with 10 mg rabeprazole twice a day, and 1g amoxicillin, 500 mg tinidazole three times a day for 14 days.” NCT02776371 ↗ “Subjects will receive the rabeprazole 10mg, moxycillin 1.0g, clarithromycin 500mg and Jinghua Weikang Capsule 240mg twice daily for 14 days.” NCT05320133 ↗ Show 215 more sources
Known as	Aciphex	“This study will also investigate the effect of Rabeprazole, (brand name Aciphex) on patients with known insomnia.” NCT00287391 ↗ 3 “20 mg Aciphex QD and placebo QPM” NCT00204672 ↗ NCT00204698 ↗ NCT01153659 ↗
Known as	Pariet	“1/3 of the patients are taking Pariet (Rabeprazole) 20 mg once daily” NCT01139645 ↗ 3 “High Dose Rabeprazole (Pariet) in the Treatment” NCT00517114 ↗ “Rabeprazole(Pariet) for 7 days.” NCT01575899 ↗ NCT05152004 ↗
Known as	Pariet(rabeprazole)	“Pariet (rabeprazole)” NCT02037477 ↗ 1 “Pariet(rabeprazole)” NCT00844675 ↗
Known as	Proton pump inhibitor, Rabeprazole, Pariet	“Proton pump inhibitor, Rabeprazole, Pariet®” NCT03897244 ↗
Known as	Rabeprazole Enteric-Coated Tablets	“Rabeprazole Enteric-Coated Tablets10mg once a day for 2 weeks” NCT07339956 ↗
Known as	Rabeprazole sodium	“All participants were taking a standard dose QD PPI (dexlansoprazole, esomeprazole, esomeprazole magnesium, lansoprazole, omeprazole, pantoprazole, pantoprazole sodium...” NCT02637557 ↗ 11 “Patients will receive rabeprazole sodium as single daily oral doses for 5 successive days (Option 1), or up to 14 successive days (10 days minimum) (Option 2) as a bead formulation.” NCT00747526 ↗ “Rabeprazole sodium enteric-coated tablets (20 mg BID): Taken with 240 mL of warm water 30 minutes (± 5 minutes) before breakfast and dinner for 14 consecutive days.” NCT06337604 ↗ “The drug being studied is rabeprazole sodium, the active pharmaceutical ingredient in AcipHex.” NCT00855361 ↗ “rabeprazole sodium in healthy volunteers” NCT01101646 ↗ “Rabeprazole Sodium Tablets 20 mg” NCT00649493 ↗ “Rabeprazole sodium 10mg” NCT04503629 ↗ NCT00911534 ↗ NCT00125736 ↗ NCT06076694 ↗ NCT06076681 ↗ Show 1 more source
Known as	Rabeprazole: Pariet	“Rabeprazole: Pariet” NCT01219764 ↗
Action	Inhibit	“These measurement will be used to compare the degree of inhibition of gastric acid secretion between the two drugs.” NCT00304421 ↗
Modality	Small molecule	“rabeprazole, which is a newly developed benzimidazole proton pump inhibitor” NCT00517270 ↗
Route	Oral	“One 10mg tablet is administered orally each day” NCT00125736 ↗