Vonoprazan

also known as TAK-438 · Vonoprazan fumarate · VOCINTI · VPZ · TAK-438 monofumarate · Takecab · Vonaspire · Vonoprazan monofumarate · +2 more

Other / unclassified

Developed for: Helicobacter pylori infectious disease · gastroesophageal reflux disease · esophagitis · gastric ulcer · duodenal ulcer · dyspepsia · gastritis · peptic ulcer disease
+10 more
· gastric cancer · active peptic ulcer disease · bacterial gastritis · cirrhosis of liver · eosinophilic esophagitis · esophageal varices · esophageal varices with bleeding · peptic esophagitis · stomach disorder · ulcer disease
Investigated by: Takeda · Phathom Pharmaceuticals, Inc. · Shandong University · Alexandria University · Fu Jen Catholic University Hospital · Qilu Hospital of Shandong University
+83 more
· Xijing Hospital of Digestive Diseases · Dow University of Health Sciences · First People's Hospital of Hangzhou · Heze Municipal 3rd people's hospital · Maternity and Child Care Health Center of Dezhou · Peking University Care Luzhong Hospital · Second Affiliated Hospital, School of Medicine, Zhejiang University · Shandong University of Traditional Chinese Medicine · Sixth Affiliated Hospital, Sun Yat-sen University · The First Affiliated Hospital with Nanjing Medical University · The People's Hospital of Jimo.Qingdao · Yongquan Shi · Zaozhuang Municipal Hospital · Ain Shams University · Alexandria University Hospital, Alexandria, Alexandria Governorate, Egypt · An-Nan Hospital, China Medical University · Asian Institute of Gastroenterology, India · Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh · Boston Children's Hospital · Changi General Hospital · Chinese University of Hong Kong · Dezhou Hospital Qilu Hospital of Shandong University · Feicheng Municipal People's Hospital · First Affiliated Hospital of Chongqing Medical University · First Affiliated Hospital of Jinan University · First Affiliated Hospital of Shantou University Medical College · First People's Hospital of Foshan · Guangzhou Panyu Central Hospital · Guanxian County People's Hospital · Hamamatsu University · Huazhong University of Science and Technology · Indonesia University · Jining No.2 People's Hospital · Kaohsiung Medical University · Kashi Prefecture Hospital of Traditional Chinese Medicine · King Edward Medical University · King George's Medical University · Maoming People's Hospital · Muhammad Aamir Latif · NRG Oncology · Nanfang Hospital, Southern Medical University · Nanjing First Hospital, Nanjing Medical University · National Taiwan University Hospital · Peking University First Hospital · People's Hospital of Chongqing · Qihe County City Hospital · Qilu Hospital of Shandong University, Dezhou Branch · Rehman Medical Institute - RMI · Richmond Pharmacology Limited · Seoul National University Hospital · Shandong Electric Power Central Hospital · Shandong Province Third hospital · Shanghai Changzheng Hospital · Shanghai Jiao Tong University School of Medicine · Shengjing Hospital · Shicai Ye · Southern Medical University, China · St. Luke's Medical Center, Philippines · Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Taian City Central Hospital · Tanta University · The Affiliated Hospital of Qingdao University · The First Affiliated Hospital of Guangzhou Medical University · The People's Hospital of Guangrao · The Second Affiliated Hospital of Dalian Medical University · The Second People's Hospital of Huaihua · The Seventh Affiliated Hospital, Southern Medical University · The Third Xiangya Hospital of Central South University · Tianjin Medical University General Hospital · Uayporn Kaosombatwattana · University of Miami · Weifang People's Hospital · Weihai Municipal Hospital · Xiuli Zuo · all 89 on the full record

Regulatory milestones approvals, filings & regulatory actions · 2 recorded

Milestone	Jurisdiction	Brand	Indication	Date	Sentence it was read from
Approved	US (FDA)	VOQUEZNA TRIPLE PAK	—	2022-05-03	fda.gov ↗
Filed	Japan (PMDA)	—	erosive esophagitis, gastric ulcer, duodenal ulcer, Helicobacter pylori eradication	2014-02-28	“TAK-438, whose New Drug Application was submitted in Japan by Takeda and is currently undergoing regulatory review.” otsuka.co.jp ↗ “it has submitted a New Drug Application to the Ministry of Health, Labour and Welfare for TAK-438” takeda.com ↗

Trials 105 · started per year

today

US approved 2022

200820092010201120122013201420152016201720182019202020212022202320242025202620272028

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 01 trial · 1 met primary
Phase 0	NCT05005910	Sep 2021 → Dec 2022	peptic ulcer disease	Uayporn Kaosombatwattana	Completed	Met primary
Phase 117 trials · 2 met primary
Phase 1	NCT06831344	Feb → Apr 2025	—	Phathom Pharmaceuticals, Inc.	Completed	No outcome recorded
Phase 1	NCT06391177	May → Sep 2024	Helicobacter pylori infectious disease, dyspepsia, esophagitis, gastroesophageal reflux disease	Phathom Pharmaceuticals, Inc.	Completed	No outcome recorded
Phase 1	NCT06106022	Nov 2023 → Apr 2024	gastroesophageal reflux disease	Phathom Pharmaceuticals, Inc.	Completed	No outcome recorded
Phase 1	NCT05366738	May → Jul 2022	—	Phathom Pharmaceuticals, Inc.	Completed	Met primary
Phase 1	NCT05343364	May 2022 → May 2023	gastroesophageal reflux disease	Phathom Pharmaceuticals, Inc.	Completed	No outcome recorded
Phase 1	NCT04753437	Apr → Sep 2021	Helicobacter pylori infectious disease	Takeda	Completed	No outcome recorded
Phase 1	NCT04729101	Jan → Jun 2021	—	Phathom Pharmaceuticals, Inc.	Completed	Met primary
Phase 1	NCT04568772	Nov 2020 → Jul 2021	gastroesophageal reflux disease	Seoul National University Hospital	Completed	No outcome recorded
Phase 1	NCT04558216	Sep 2020 → Feb 2021	—	Phathom Pharmaceuticals, Inc.	Withdrawn	No outcome recorded
Phase 1	NCT04545944	Sep → Nov 2020	—	Phathom Pharmaceuticals, Inc.	Completed	No outcome recorded
Phase 1	NCT03085836	Apr → Aug 2017	—	Takeda	Completed	No outcome recorded
Phase 1	NCT02892409	Sep 2016 → Apr 2017	Helicobacter pylori infectious disease	Takeda	Completed	No outcome recorded
Phase 1	NCT02774902	Aug → Sep 2010	—	Takeda	Completed	No outcome recorded
Phase 1	NCT02123953	Oct 2008 → Mar 2009	—	Takeda	Completed	No outcome recorded
Phase 1	NCT02141711	Oct 2008 → Feb 2009	esophagitis, gastroesophageal reflux disease	Takeda	Completed	No outcome recorded
Phase 1	NCT02141698	Oct 2007 → Feb 2008	—	Takeda	Completed	No outcome recorded
Phase 1	NCT02123927	Sep → Dec 2007	—	Takeda	Completed	No outcome recorded

Phase 1/21 trial
Phase 1/2	NCT07275632	Dec 2025 → Oct 2026 expected	—	First Affiliated Hospital of Chongqing Medical University	Recruiting	No outcome recorded
Phase 25 trials · 1 met primary · 1 missed
Phase 2	NCT07860112	Nov 2026 → Dec 2027 expected	Helicobacter pylori infectious disease	Boston Children's Hospital	Not yet recruiting	No outcome recorded
Phase 2	NCT07267260	Dec 2025 → Jan 2026 overdue	cirrhosis of liver	King Edward Medical University	Recruiting	No outcome recorded
Phase 2	NCT06851559	Oct 2025 → Oct 2026 expected	eosinophilic esophagitis	Phathom Pharmaceuticals, Inc.	Active not recruiting	No outcome recorded
Phase 2	NCT04799158	Mar → Dec 2021	dyspepsia, gastroesophageal reflux disease	Phathom Pharmaceuticals, Inc.	Completed	Met primary
Phase 2	NCT02743949	Jul 2016 → Oct 2018	gastroesophageal reflux disease	Takeda	Completed	Missed primary
Phase 2/31 trial
Phase 2/3	NCT07242456	Feb → Nov 2025 overdue	Helicobacter pylori infectious disease	First People's Hospital of Hangzhou	Recruiting	No outcome recorded
Phase 332 trials · 11 met primary · 2 missed
Phase 3	NCT07752407	Sep 2026 → Oct 2027 expected	gastroesophageal reflux disease	Phathom Pharmaceuticals, Inc.	Recruiting	No outcome recorded
Phase 3	NCT07608536	May → Jul 2026 overdue	esophageal varices	King George's Medical University	Not yet recruiting	No outcome recorded
Phase 3	NCT06576882	Jun → Nov 2024	Helicobacter pylori infectious disease, gastritis	Alexandria University	Completed	No outcome recorded
Phase 3	NCT06162949	Jan → Aug 2024	—	Alexandria University	Completed	Met primary
Phase 3	NCT05719831	Feb → Sep 2023	—	Sixth Affiliated Hospital, Sun Yat-sen University	Completed	Mixed
Phase 3	NCT05227833	Feb → Nov 2022	esophageal varices with bleeding, portal hypertension, ulcer disease	Alexandria University	Completed	No outcome recorded
Phase 3	NCT05195528	Jan → Nov 2022	dyspepsia, gastroesophageal reflux disease	Phathom Pharmaceuticals, Inc.	Completed	Met primary
Phase 3	NCT06101420	Jan 2022 → Jun 2023	—	Ain Shams University	Completed	No outcome recorded
Phase 3	NCT04198363	Apr 2020 → Nov 2021	Helicobacter pylori infectious disease	Takeda	Completed	Met primary
Phase 3	NCT04167670	Dec 2019 → Mar 2021	Helicobacter pylori infectious disease	Phathom Pharmaceuticals, Inc.	Completed	Met primary
Phase 3	NCT04124926	Oct 2019 → Jul 2021	esophagitis	Phathom Pharmaceuticals, Inc.	Completed	Met primary
Phase 3	NCT03050307	Apr 2017 → Feb 2020	gastric ulcer	Takeda	Completed	No outcome recorded
Phase 3	NCT03050359	Apr 2017 → Mar 2019	duodenal ulcer	Takeda	Completed	No outcome recorded
Phase 3	NCT02954848	Nov 2016 → Feb 2018	gastroesophageal reflux disease	Takeda	Completed	Mixed
Phase 3	NCT02827942	Jul 2016 → Dec 2018	bacterial gastritis	Hamamatsu University	Completed	No outcome recorded
Phase 3	NCT02388737	Apr 2015 → Dec 2018	esophagitis	Takeda	Completed	Met primary
Phase 3	NCT02388724	Mar 2015 → Jul 2017	esophagitis	Takeda	Completed	Met primary
Phase 3	NCT02037477	Jan → Mar 2014	—	Takeda	Completed	No outcome recorded
Phase 3	NCT01630746	Jul 2012 → Sep 2013	esophagitis	Takeda	Completed	No outcome recorded
Phase 3	NCT01568398	May 2012 → Aug 2013	duodenal ulcer, gastric ulcer	Takeda	Completed	No outcome recorded
Phase 3	NCT01568385	Apr 2012 → Sep 2013	duodenal ulcer, gastric ulcer	Takeda	Completed	No outcome recorded
Phase 3	NCT01456247	Mar 2012 → Oct 2013	duodenal ulcer, gastric ulcer	Takeda	Completed	No outcome recorded
Phase 3	NCT01505127	Jan 2012 → Jun 2013	Helicobacter pylori infectious disease	Takeda	Completed	Met primary
Phase 3	NCT01474369	Dec 2011 → Feb 2013	gastroesophageal reflux disease	Takeda	Completed	Missed primary
Phase 3	NCT01452711	Nov 2011 → Dec 2012	gastric ulcer	Takeda	Completed	Met primary
Phase 3	NCT01452724	Oct 2011 → Feb 2013	duodenal ulcer	Takeda	Completed	Missed primary
Phase 3	NCT01452750	Oct 2011 → Jun 2013	duodenal ulcer, gastric ulcer	Takeda	Completed	Met primary
Phase 3	NCT01452763	Oct 2011 → Apr 2013	duodenal ulcer, gastric ulcer	Takeda	Completed	Met primary
Phase 3	NCT01459367	Oct 2011 → Mar 2013	esophagitis	Takeda	Completed	No outcome recorded
Phase 3	NCT01452776	Sep 2011 → Jul 2013	esophagitis	Takeda	Completed	No outcome recorded
Phase 3	NCT01456260	Sep 2011 → Dec 2013	duodenal ulcer, gastric ulcer	Takeda	Completed	No outcome recorded
Phase 3	NCT01452698	? → Aug 2012	esophagitis	Takeda	Completed	No outcome recorded

Phase 434 trials · 6 met primary · 1 missed
Phase 4	NCT07720037	Sep 2026 overdue	Helicobacter pylori infectious disease	Shandong University	Not yet recruiting	No outcome recorded
Phase 4	NCT07537634	Apr → Aug 2026 overdue	Helicobacter pylori infectious disease, dyspepsia, peptic ulcer disease	Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh	Recruiting	No outcome recorded
Phase 4	NCT07232095	Jan 2026 → Jun 2027 expected	Helicobacter pylori infectious disease	The First Affiliated Hospital with Nanjing Medical University	Recruiting	No outcome recorded
Phase 4	NCT07040839	Jul 2025 → Feb 2026 overdue	Helicobacter pylori infectious disease	Rehman Medical Institute - RMI	Not yet recruiting	No outcome recorded
Phase 4	NCT07344506	May 2025 → May 2026 overdue	Helicobacter pylori infectious disease	Dow University of Health Sciences	Recruiting	No outcome recorded
Phase 4	NCT06929962	Apr 2025 → Dec 2026 expected	Helicobacter pylori infectious disease	The First Affiliated Hospital with Nanjing Medical University	Recruiting	No outcome recorded
Phase 4	NCT07068607	Apr → Oct 2025 overdue	Helicobacter pylori infectious disease, dyspepsia, gastric cancer, gastritis +1	Yongquan Shi	Recruiting	Missed primary
Phase 4	NCT06723197	Dec 2024 → Oct 2025 overdue	Helicobacter pylori infectious disease	Shandong University	Recruiting	No outcome recorded
Phase 4	NCT06720610	Dec 2024 → Apr 2025 overdue	esophagitis	Indonesia University	Not yet recruiting	No outcome recorded
Phase 4	NCT06514274	Sep 2024 → Apr 2025	Helicobacter pylori infectious disease, chronic gastritis	Xijing Hospital of Digestive Diseases	Completed	No outcome recorded
Phase 4	NCT06561698	Aug 2024 → Aug 2026 overdue	Helicobacter pylori infectious disease	Shanghai Jiao Tong University School of Medicine	Recruiting	No outcome recorded
Phase 4	NCT06526455	Aug 2024 → Jun 2029 expected	gastric ulcer	Shicai Ye	Not yet recruiting	No outcome recorded
Phase 4	NCT06156085	Nov 2023 → Nov 2024	Helicobacter pylori infectious disease	Fu Jen Catholic University Hospital	Completed	Met primary
Phase 4	NCT06168214	Sep 2023 → Nov 2024 overdue	—	Xijing Hospital of Digestive Diseases	Recruiting	No outcome recorded
Phase 4	NCT06168084	Jun 2023 → May 2024	stomach disorder	Yongquan Shi	Completed	Met primary
Phase 4	NCT05582174	May 2023 → Jan 2028 expected	active peptic ulcer disease	Chinese University of Hong Kong	Recruiting	No outcome recorded
Phase 4	NCT04728516	Apr 2023 → Jun 2026 overdue	Helicobacter pylori infectious disease, acute coronary syndrome	Qilu Hospital of Shandong University	Recruiting	No outcome recorded
Phase 4	NCT07224035	Oct 2022 → Feb 2026	Helicobacter pylori infectious disease, gastric cancer, gastritis	University of Miami	Completed	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	NCT05469685	Aug 2022 → Aug 2023	Helicobacter pylori infectious disease	Nanjing First Hospital, Nanjing Medical University	Completed	Met primary
Phase 4	NCT05614934	Jun 2022 → May 2023	Helicobacter pylori infectious disease	Alexandria University	Completed	No outcome recorded
Phase 4	NCT05590286	Jun 2022 → Dec 2024	Helicobacter pylori infectious disease, proton-pump inhibitor-responsive esophageal eosinophilia	First People's Hospital of Hangzhou	Unknown	No outcome recorded
Phase 4	NCT05196945	Mar → Dec 2022	—	Sixth Affiliated Hospital, Sun Yat-sen University	Unknown	No outcome recorded
Phase 4	NCT05371249	Dec 2021 → Dec 2023	Helicobacter pylori infectious disease	Fu Jen Catholic University Hospital	Completed	Met primary
Phase 4	NCT05014334	Dec 2021 → Mar 2022	Helicobacter pylori infectious disease, chronic gastritis	Xijing Hospital of Digestive Diseases	Completed	No outcome recorded
Phase 4	NCT05049902	Sep 2021 → May 2023	Helicobacter pylori infectious disease	Shandong University	Completed	Met primary
Phase 4	NCT04901663	Jun → Aug 2021	Helicobacter pylori infectious disease	Dow University of Health Sciences	Completed	No outcome recorded
Phase 4	NCT04901117	Jun 2021 → Jun 2023	Helicobacter pylori infectious disease	Shandong University	Unknown	No outcome recorded
Phase 4	NCT04907747	May 2021 → Apr 2022	Helicobacter pylori infectious disease	Second Affiliated Hospital, School of Medicine, Zhejiang University	Unknown	Met primary
Phase 4	NCT04713670	Mar 2021 → Dec 2025 overdue	Helicobacter pylori infectious disease	National Taiwan University Hospital	Recruiting	No outcome recorded
Phase 4	NCT04028466	May 2019 → Mar 2020	gastroesophageal reflux disease	St. Luke's Medical Center, Philippines	Terminated	No outcome recorded
Phase 4	NCT03908619	Apr 2019 → Mar 2021	Helicobacter pylori infectious disease	Changi General Hospital	Unknown	No outcome recorded
Phase 4	NCT03116841	Aug → Dec 2017	peptic esophagitis	Takeda	Completed	No outcome recorded
Phase 4	NCT02679508	Mar 2016 → Mar 2022	esophagitis	Takeda	Completed	No outcome recorded

Phase not applicable14 trials
—	NCT07439445	Apr 2026 → Feb 2027 expected	Helicobacter pylori infectious disease	Peking University First Hospital	Recruiting	No outcome recorded
—	NCT07352098	Feb 2026 → Feb 2028 expected	Helicobacter pylori infectious disease	Yueyue Li	Not yet recruiting	No outcome recorded
—	NCT07437768	Dec 2025 → Feb 2026 overdue	gastroesophageal reflux disease	Fu Jen Catholic University Hospital	Enrolling by invitation	No outcome recorded
—	NCT06953986	Dec 2025 → Nov 2026 expected	gastroesophageal reflux disease	Asian Institute of Gastroenterology, India	Recruiting	No outcome recorded
—	NCT07165444	Sep 2025 → Feb 2026 overdue	Helicobacter pylori infectious disease, proton-pump inhibitor-responsive esophageal eosinophilia	Tanta University	Recruiting	No outcome recorded
—	NCT07563491	Jan → Sep 2025	gastroesophageal reflux disease	Muhammad Aamir Latif	Completed	No outcome recorded
—	NCT07142798	Sep 2024 → Dec 2025 overdue	Helicobacter pylori infectious disease	Kaohsiung Medical University	Enrolling by invitation	No outcome recorded
—	NCT06250634	Feb → May 2024	Helicobacter pylori infectious disease	The Third Xiangya Hospital of Central South University	Completed	No outcome recorded
—	NCT06004401	Aug 2023 → Aug 2025	—	Shanghai Changzheng Hospital	Unknown	No outcome recorded
—	NCT05189444	Mar → Dec 2022	Helicobacter pylori infectious disease	Huazhong University of Science and Technology	Unknown	No outcome recorded
—	NCT05126121	Nov 2021 → Jun 2022	Helicobacter pylori infectious disease	Xiuli Zuo	Unknown	No outcome recorded
—	NCT05133193	Nov 2021 → Jun 2022	Helicobacter pylori infectious disease	Shandong University	Unknown	No outcome recorded
—	NCT04991584	Aug 2021 → Jun 2022	Helicobacter pylori infectious disease	Shandong University	Unknown	No outcome recorded
—	NCT05097846	Jun 2021 → Jun 2022	Helicobacter pylori infectious disease	wang xiaoyan	Unknown	No outcome recorded

Comparator or background therapy39 trials
Phase 0	NCT06901375 Background	May → Aug 2025	Helicobacter pylori infectious disease	Nanjing First Hospital, Nanjing Medical University	Unknown	No outcome recorded
Phase 1/2	NCT05461508 Background	Oct 2022 → Jun 2024	Helicobacter pylori infectious disease, post-bacterial disorder	Nanjing First Hospital, Nanjing Medical University	Unknown	No outcome recorded
Phase 2	NCT07293910 Comparator	Feb → Dec 2026 expected	Helicobacter pylori infectious disease	Tanta University	Recruiting	No outcome recorded
Phase 2	NCT05957432 Comparator	Aug 2023 → Oct 2025 overdue	Helicobacter pylori infectious disease	Ain Shams University	Active not recruiting	No outcome recorded
Phase 2	NCT02761005 Background	May 2016 → Mar 2018	Helicobacter pylori infectious disease	Hamamatsu University	Unknown	No outcome recorded
Phase 3	NCT07576959 Background	Apr 2026 → Dec 2030 expected	Helicobacter pylori infectious disease	National Taiwan University Hospital	Recruiting	No outcome recorded
Phase 3	NCT07275827 Comparator	Feb → Dec 2026 expected	Helicobacter pylori infectious disease	Tanta University	Recruiting	No outcome recorded
Phase 3	NCT06811207 Comparator	Feb 2025	Helicobacter pylori infectious disease	Chang Gung Memorial Hospital	Unknown	Missed primary
Phase 3	NCT06340724 Background	Feb → Nov 2024	Helicobacter pylori infectious disease	Nanjing First Hospital, Nanjing Medical University	Completed	No outcome recorded
Phase 3	NCT06414707 Comparator	Oct 2023 → Apr 2024	Helicobacter pylori infectious disease	Ain Shams University	Completed	No outcome recorded
Phase 3	NCT05728424 Comparator	Sep 2022 → Apr 2023	Helicobacter pylori infectious disease	Aga Khan University	Unknown	No outcome recorded
Phase 4	NCT07624422 Comparator	Nov 2026 → Dec 2027 expected	Helicobacter pylori infectious disease, gastritis, peptic ulcer disease	Damascus Hospital	Not yet recruiting	No outcome recorded
Phase 4	NCT07306988 Background	Apr 2025 → Jun 2026 overdue	Helicobacter pylori infectious disease, metabolic syndrome X	Nanjing First Hospital, Nanjing Medical University	Recruiting	No outcome recorded
Phase 4	NCT06959368 Comparator	Mar 2025 → Mar 2026 overdue	Helicobacter pylori infectious disease	Asian Institute of Gastroenterology, India	Recruiting	No outcome recorded
Phase 4	NCT06778395 Comparator	Oct → Dec 2024	gastroesophageal reflux disease	Ayman Magd Eldin Mohammad Sadek	Completed	No outcome recorded
Phase 4	NCT06564246 Comparator	Sep 2024 → Aug 2026 overdue	gastroesophageal reflux disease	Tanta University	Recruiting	No outcome recorded
Phase 4	NCT06561711 Background	Aug 2024 → Feb 2026	Helicobacter pylori infectious disease	Shanghai Jiao Tong University School of Medicine	Completed	No outcome recorded
Phase 4	NCT05658055 Background	Jun → Dec 2023	Helicobacter pylori infectious disease, post-bacterial disorder	Nanjing First Hospital, Nanjing Medical University	Unknown	No outcome recorded
Phase 4	NCT05874544 Background	May 2023 → Jan 2025	Helicobacter pylori infectious disease	Shanghai Jiao Tong University School of Medicine	Completed	Mixed
Phase 4	NCT05749081 Background	May 2023 → Jul 2024	Helicobacter pylori infectious disease	The First Affiliated Hospital of Nanchang University	Unknown	No outcome recorded
Phase 4	NCT05649709 Background	Feb 2023 → Jan 2024	Helicobacter pylori infectious disease	The First Affiliated Hospital of Nanchang University	Completed	Met primary
Phase 4	NCT05726734 Comparator	Feb 2023 → Feb 2025	Helicobacter pylori infectious disease	Shanghai East Hospital	Unknown	No outcome recorded
Phase 4	NCT05649540 Background	Jan 2023 → Jul 2024	Helicobacter pylori infectious disease	Nanjing First Hospital, Nanjing Medical University	Completed	Mixed
Phase 4	NCT05345210 Comparator	Apr 2022 → Feb 2023	Helicobacter pylori infectious disease	Xijing Hospital of Digestive Diseases	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	NCT05901051 Background	Mar 2021 → Sep 2023	Helicobacter pylori infectious disease	Shanghai Jiao Tong University School of Medicine	Completed	No outcome recorded
—	NCT07533422 Comparator	May → Dec 2026 expected	Helicobacter pylori infectious disease	Second Affiliated Hospital, School of Medicine, Zhejiang University	Not yet recruiting	No outcome recorded
—	NCT07358130 Comparator	Oct 2025 → Nov 2027 expected	Helicobacter pylori infectious disease	Kaohsiung Medical University	Recruiting	No outcome recorded
—	NCT07179159 Background	Sep 2025 → Aug 2026 overdue	Helicobacter pylori infectious disease	Yanqing Li	Recruiting	No outcome recorded
—	NCT07159412 Background	Aug 2025 → Aug 2026 overdue	Helicobacter pylori infectious disease, metabolic dysfunction-associated steatohepatitis	Nanjing First Hospital, Nanjing Medical University	Not yet recruiting	No outcome recorded
—	NCT07130253 Background	Aug 2025 → Jun 2028 expected	Helicobacter pylori infectious disease	National Taiwan University Hospital	Not yet recruiting	No outcome recorded
—	NCT07045688 Comparator	May → Nov 2025 overdue	Helicobacter pylori infectious disease	Sohag University	Recruiting	No outcome recorded
—	NCT06955520 Comparator	Apr 2025 → Dec 2027 expected	gastroesophageal reflux disease	Asian Institute of Gastroenterology, India	Recruiting	No outcome recorded
—	NCT06881524 Background	Apr → Jul 2025 overdue	Helicobacter pylori infectious disease	Second Affiliated Hospital, School of Medicine, Zhejiang University	Not yet recruiting	No outcome recorded
—	NCT06299605 Comparator	Nov 2024 → Oct 2025	Helicobacter pylori infectious disease	Shandong University	Unknown	No outcome recorded
—	NCT06412588 Comparator	Jun 2024 → Jan 2026	Helicobacter pylori infectious disease	Nanjing First Hospital, Nanjing Medical University	Completed	No outcome recorded
—	NCT06292546 Background	Jan → Dec 2024	metabolic disease	Zhongshan Hospital (Xiamen), Fudan University	Completed	No outcome recorded
—	NCT06349486 Comparator	Nov 2023 → Dec 2026 expected	—	Kaohsiung Medical University	Recruiting	No outcome recorded
—	NCT04720781 Comparator	Jan 2021 → Dec 2024	gastroesophageal reflux disease	Showa Inan General Hospital	Completed	No outcome recorded

News releases announcing trial results or a regulatory action · 5

Date	Issuer	Release
2016-02-26	Takeda	Regulatory Takeda Obtains New Drug Application Approval for Helicobacter pylori [※] Eradication triple-drug Blister Packs Containing TAKECAB tablet, "VONOSAP ® pack 400", "VONOSAP ® pack 800" and "VONOPION ® pack" in Japan takeda.com ↗ Approval was also received for “VONOPION ® pack”, a triple-drug blister pack containing “TAKECAB ® tablet” for secondary eradication of H. pylori .
2015-03-26	Takeda	Regulatory New Drug Application for a Single Pack Containing TAKECAB for Eradication of Helicobacter pylori in Japan takeda.com ↗
2014-12-26	Takeda	Regulatory New Drug Application Approval of TAKECAB ® for the treatment of Acid-related Diseases in Japan takeda.com ↗ Takeda received approval of its New Drug Application for TAKECAB ® for the treatment of acid-related diseases in Japan.
2014-05-07	Takeda	Results Presentation of Highlight Results from recent Phase 3 Trials of Vonoprazan Fumarate for the Treatment of Acid-related Diseases at the DDW 2014 Meeting takeda.com ↗ Takeda Pharmaceutical Company Limited (“Takeda”) announced today that the results of five Phase 3 trials for Vonoprazan Fumarate (development code:TAK-438) were presented at the poster session of Digestive Disease Week (DDW) being held May 3-6, 2014 in Chicago, Illinois.
2014-02-28	Takeda	Regulatory Takeda Submits a New Drug Application for TAK-438 in Japan for the Treatment of Acid-related Diseases takeda.com ↗ Takeda Pharmaceutical Company Limited (“Takeda”) announced today that it has submitted a New Drug Application to the Ministry of Health, Labour and Welfare for TAK-438 (generic name: Vonoprazan Fumarate).

All press releases naming this drug 14 releases

Date	Issuer	Release
2016-06-07	Takeda	VONOSAP ® pack 400, VONOSAP ® pack 800 and VONOPION ® pack (triple-drug blister packs containing TAKECAB ® tablet) Now Available for Helicobacter pylori [*] Eradication in Japan takeda.com ↗
2016-06-07	Otsuka Pharmaceutical Development & Commercialization, Inc.	VONOSAP pack 400, VONOSAP pack 800 and VONOPIONpack (triple-drug blister packs containing TAKECAB® tablet) Now Available for Eradication in Japan®®®Helicobacter pylori* otsuka.co.jp ↗
2016-02-26	Takeda	Takeda Obtains New Drug Application Approval for Helicobacter pylori [※] Eradication triple-drug Blister Packs Containing TAKECAB tablet, "VONOSAP ® pack 400", "VONOSAP ® pack 800" and "VONOPION ® pack" in Japan takeda.com ↗
2016-02-26	Otsuka Pharmaceutical Development & Commercialization, Inc.	Takeda Obtains NDA Approval for Eradication triple-drug Blister Packs Containing TAKECAB tablet, "VONOSAP pack 400", "VONOSAP pack 800" and "VONOPION pack" in JapanHelicobacter pylori*®®® otsuka.co.jp ↗
2015-03-26	Takeda	New Drug Application for a Single Pack Containing TAKECAB for Eradication of Helicobacter pylori in Japan takeda.com ↗
2015-03-26	Otsuka Pharmaceutical Development & Commercialization, Inc.	New Drug Application for a Single Pack Containing TAKECAB for Eradication of Helicobacter pylori in Japan otsuka.co.jp ↗
2015-02-26	Takeda	TAKECAB ® Now Available for the Treatment of Acid-related Diseases in Japan takeda.com ↗
2015-02-26	Otsuka Pharmaceutical Development & Commercialization, Inc.	TAKECAB® Now Available for the Treatment of Acid-related Diseases in Japan otsuka.co.jp ↗
2014-12-26	Takeda	New Drug Application Approval of TAKECAB ® for the treatment of Acid-related Diseases in Japan takeda.com ↗
2014-12-26	Otsuka Pharmaceutical Development & Commercialization, Inc.	New Drug Application Approval of TAKECAB for the Treatment of Acid-related Diseases in Japan® otsuka.co.jp ↗
2014-05-07	Takeda	Presentation of Highlight Results from recent Phase 3 Trials of Vonoprazan Fumarate for the Treatment of Acid-related Diseases at the DDW 2014 Meeting takeda.com ↗
2014-03-27	Takeda	Otsuka and Takeda Announce a Co-promotion Agreement in Japan of TAK-438 For the Treatment of Acid-related Diseases in the Gastrointestinal Therapeutic Area takeda.com ↗
2014-03-27	Otsuka Pharmaceutical Development & Commercialization, Inc.	Otsuka and Takeda Announce a Co-promotion Agreement in Japan of TAK-438 For the Treatment of Acid-related Diseases in the Gastrointestinal Therapeutic Area otsuka.co.jp ↗
2014-02-28	Takeda	Takeda Submits a New Drug Application for TAK-438 in Japan for the Treatment of Acid-related Diseases takeda.com ↗

Evidence & citations 14 cited values

Every value below carries the sentence it was read from. 150 sources stand behind the page.

Field	Value	Cited text
Known as	vonoprazan	“Randomised clinical trial: safety, tolerability, pharmacokinetics and pharmacodynamics of repeated doses of TAK-438 (vonoprazan), a novel potassium-competitive acid blocker, in...” PMID 25707624 ↗ Feb 2015 119 “The eligible patients received 14-day concomitant therapy, including vonoprazan and three kinds of antibiotics according to the previous eradication regimens and antibiotic use.” NCT05133193 ↗ “Vonoprazan, a novel potassium-competitive acid blocker (P-CAB), has a stronger and more sustained inhibitory effect on gastric acid secretion compared to traditional PPIs.” NCT06881524 ↗ “Potassium-competitive acid blockers (P-CABs), such as vonoprazan, provide rapid, consistent, and strong acid suppression regardless of the CYP2C19 genotype.” NCT07165444 ↗ “In this arm, they are treated with vonoprazan 20 mg bid, amoxicillin 750 mg bid and clarithromycin 200 mg bid for 1 week for the eradication of H. pylori.” NCT02761005 ↗ “2400mg lacidophilin tablets three times daily,1000mg amoxicillin capsules three times daily and 20mg vonoprazan Fumarate Tablets twice daily for 10 days” NCT05749081 ↗ “Patients sensitive to clarithromycin are assigned to the Clarithromycin Group (receiving a regimen of vonoprazan, amoxicillin, and clarithromycin)” NCT07533422 ↗ “FDA-approved combination therapy for H. pylori infection, consisting of: Vonoprazan tablets 20 mg (1 tablet twice daily for 14 days)” NCT07224035 ↗ “vonoprazan 20mg， Twice a day amoxicillin 750mg，Four times a day tripotassium dicitrate bismuthate 300mg，Four times a day for 14 days” NCT07142798 ↗ “1000mg amoxicillin capsules twice times daily and 20mg vonoprazan Fumarate Tablets twice daily for 14 days” NCT05649709 ↗ “Vonoprazan 20mg twice daily+Amoxicillin 1g three times daily+Bismuth 220mg twice daily for 7 days” NCT07232095 ↗ Show 109 more sources
Known as	TAK-438	ClinicalTrials.gov intervention name — accepted as the source's own label NCT01459367 ↗ 23 NCT02141711 ↗ NCT02141698 ↗ NCT02892409 ↗ NCT01505127 ↗ NCT01456260 ↗ NCT01456247 ↗ NCT03085836 ↗ NCT02123927 ↗ NCT01452776 ↗ NCT01474369 ↗ Show 13 more sources
Known as	TAK-438 monofumarate	ChEMBL registry synonym — accepted as the source's own label CHEMBL2079130 ↗
Known as	Takecab	ChEMBL registry synonym — accepted as the source's own label CHEMBL2079130 ↗
Known as	VOCINTI	“Vonoprazan fumarate (VOCINTI, Takeda Pharmaceutical Company Limited, Hikari Plant) 20mg bid” NCT04901117 ↗ 3 “Vonoprazan fumarate (VOCINTI, Takeda Pharmaceutical Company Limited, Hikari Plant) 20mg bid” NCT05049902 ↗ “Patients then received a 4-week treatment of vonoprazan 20 mg once daily (VOCINTI®).” NCT07437768 ↗ “vonoprazan(vocinti)-based triple therapy for 14 days (T-V14)” NCT04713670 ↗
Known as	Vonaspire	“Vonoprazan fumarate (Vonaspire)” NCT05227833 ↗
Known as	Vonoprazan fumarate	“BACKGROUND: Vonoprazan fumarate is a novel potassium-competitive acid blocker more effective in suppressing acid production than proton pump inhibitors (PPIs) and when combined...” PMID 34247436 ↗ Jul 2021 8 “To overcome this, newer agents like Vonoprazan Fumarate, a Potassium-Competitive Acid Blocker (P-CAB), are being adopted.” NCT07293910 ↗ “1000mg amoxicillin capsules twice times daily and 20mg vonoprazan Fumarate Tablets twice daily for 14 days” NCT05649709 ↗ “vonoprazan fumarate 20 mg/time, 2 times/day, oral Amoxicillin 750mg/ time, 4 times/day, oral” NCT05196945 ↗ “Vonoprazan fumarate (VOCINTI, Takeda Pharmaceutical Company Limited, Hikari Plant) 20mg bid” NCT05049902 ↗ “Vonoprazan fumarate (VOCINTI, Takeda Pharmaceutical Company Limited, Hikari Plant) 20mg bid” NCT04901117 ↗ “received vonoprazan fumarate tablets 20 mg three times daily” NCT07352098 ↗ “Vonoprazan fumarate (Vonaspire)” NCT05227833 ↗ NCT07275632 ↗
Known as	Vonoprazan monofumarate	ChEMBL registry synonym — accepted as the source's own label CHEMBL2079130 ↗
Known as	Vonseca	“Vonoprazan 20mg (Vonseca) and placebo of pantoprazole (pantoloc) daily for 8 weeks” NCT06564246 ↗
Known as	Voquezna	ChEMBL registry synonym — accepted as the source's own label CHEMBL2079130 ↗
Known as	VPZ	“The combination of vonoprazan (VPZ) and amoxicillin (VA therapy) has been shown to achieve acceptable eradication rates for Helicobacter pylori (H. pylori).” PMID 35719338 ↗ Jun 2022 1 “Vonoprazan (VPZ) produces a strong acid-inhibitory effect” PMID 37214450 ↗ May 2023
Action	Inhibit	“potassium-competitive acid blocker” PMID 27891632 ↗ Nov 2016
Modality	Other / unclassified	“a potassium-competitive acid blocker” PMID 25707624 ↗ Feb 2015
Route	Oral	“TAK-438 20 mg, tablets, orally, once daily for up to 8 weeks.” NCT01452698 ↗