Clinical Trials

Vonoprazan Fumarate has been evaluated in numerous clinical trials spanning Early Phase 1 through Phase 4, focusing on conditions such as gastroesophageal reflux disease, erosive esophagitis, Helicobacter pylori infection, peptic ulcer bleeding, and portal hypertension with variceal hemorrhage, as well as healthy participant bioequivalence and dose-finding studies. Conducted by major pharmaceutical companies like Takeda alongside academic medical centers, these investigations include completed, actively recruiting, and not yet recruiting trials aimed at defining its pharmacokinetic and therapeutic profile.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07352098 NOT_YET_RECRUITING
Helicobacter
Yueyue Li
 2026-02-01
NCT07757919 NOT_YET_RECRUITING
HELICOBACTER PYLORI INFECTIONS
Qilu Hospital of Shandong University
 2026-09-01 PHASE4
NCT06783257 NOT_YET_RECRUITING
Peptic Ulcer Bleeding
Shandong New Time Pharmaceutical Co., LTD
 2025-02 PHASE2
NCT07275632 RECRUITING
Delayed Graft Function; Kidney Transplantation
First Affiliated Hospital of Chongqing Medical University
 2025-12-10 PHASE1; PHASE2
NCT06901375 UNKNOWN
Helicobacter Pylori Infection
Nanjing First Hospital, Nanjing Medical University
 2025-05 EARLY_PHASE1
NCT06340724 COMPLETED
Helicobacter Pylori Infection
Nanjing First Hospital, Nanjing Medical University
 2024-02-15 PHASE3
NCT06250634 COMPLETED
Helicobacter Pylori Infection
The Third Xiangya Hospital of Central South University
 2024-02-10
NCT05649709 COMPLETED
Helicobacter Pylori
The First Affiliated Hospital of Nanchang University
 2023-02-13 PHASE4
NCT06642987 COMPLETED
Gastric Ulcer
Hanlim Pharm. Co., Ltd.
 2023-10-23 PHASE1
NCT05719831 COMPLETED
Helicobacter Pylori Eradication Rate
Sixth Affiliated Hospital, Sun Yat-sen University
 2023-02-01 PHASE3
NCT04901117 UNKNOWN
Helicobacter Pylori Infection
Shandong University
 2021-06 PHASE4
NCT05049902 COMPLETED
Helicobacter Pylori Infection
Shandong University
 2021-09-21 PHASE4
NCT05345210 UNKNOWN
Helicobacter Pylori
Xijing Hospital of Digestive Diseases
 2022-04-25 PHASE4
NCT05196945 UNKNOWN
Helicobacter Pylori Eradication Rate
Sixth Affiliated Hospital, Sun Yat-sen University
 2022-03-31 PHASE4
NCT05227833 COMPLETED
Portal Hypertension; Variceal Hemorrhage; Ulcer Hemorrhage
Alexandria University
 2022-02-15 PHASE3
NCT04991584 UNKNOWN
Helicobacter Pylori Infection
Shandong University
 2021-08-04
NCT05097846 UNKNOWN
Helicobacter Pylori Infection
wang xiaoyan
 2021-06-17
NCT02679508 COMPLETED
Erosive Esophagitis
Takeda
 2016-03-20 PHASE4
NCT04198363 COMPLETED
Helicobacter Pylori
Takeda
 2020-04-30 PHASE3
NCT03050307 COMPLETED
Gastric Ulcer
Takeda
 2017-04-17 PHASE3
NCT03050359 COMPLETED
Duodenal Ulcer
Takeda
 2017-04-05 PHASE3
NCT03808493 COMPLETED
Japanese Healthy Adult Male
Takeda
 2019-01-30 PHASE1
NCT03808493 Completed
Japanese Healthy Adult Male
Takeda
 2019-01-30 Phase 1
NCT02388737 COMPLETED
Erosive Esophagitis
Takeda
 2015-04-01 PHASE3
NCT03456960 COMPLETED
Healthy Volunteers
Takeda
 2018-03-08 PHASE1
NCT03456960 Completed
Healthy Volunteers
Takeda
 2018-03-08 Phase 1
NCT02954848 COMPLETED
Non-erosive Gastroesophageal Reflux Disease
Takeda
 2016-11-15 PHASE3
NCT03085836 COMPLETED
Healthy Participants
Takeda
 2017-04-19 PHASE1
NCT02388724 COMPLETED
Erosive Esophagitis
Takeda
 2015-03-24 PHASE3
NCT02892409 COMPLETED
Helicobacter Pylori
Takeda
 2016-09-05 PHASE1
NCT03085836 Completed
Healthy Participants
Takeda
 2017-04-19 Phase 1
NCT02037477 COMPLETED
Healthy Volunteers
Takeda
 2014-01 PHASE3
NCT01456247 COMPLETED
Gastric Ulcers; Duodenal Ulcers
Takeda
 2012-03 PHASE3
NCT01568385 COMPLETED
Gastric Ulcer; Duodenal Ulcer
Takeda
 2012-04 PHASE3
NCT01630746 COMPLETED
Erosive Esophagitis
Takeda
 2012-07 PHASE3
NCT01568398 COMPLETED
Gastric Ulcer; Duodenal Ulcer
Takeda
 2012-05 PHASE3
NCT01452776 COMPLETED
Erosive Esophagitis
Takeda
 2011-09 PHASE3
NCT01452750 COMPLETED
Gastric Ulcers; Duodenal Ulcers
Takeda
 2011-10 PHASE3
NCT01505127 COMPLETED
H. Pylori Infection
Takeda
 2012-01 PHASE3
NCT01452763 COMPLETED
Gastric Ulcers; Duodenal Ulcers
Takeda
 2011-10 PHASE3
NCT01459367 COMPLETED
Erosive Esophagitis
Takeda
 2011-10 PHASE3
NCT01474369 COMPLETED
Non-erosive Gastroesophageal Reflux Disease
Takeda
 2011-12 PHASE3
NCT01452724 COMPLETED
Duodenal Ulcer
Takeda
 2011-10 PHASE3
NCT01452711 COMPLETED
Gastric Ulcer
Takeda
 2011-11 PHASE3
NCT01452698 COMPLETED
Erosive Esophagitis
Takeda
 PHASE3
NCT02774902 COMPLETED
Healthy Volunteers
Takeda
 2010-08 PHASE1
NCT02774902 Completed
Healthy Volunteers
Takeda
 2010-08 Phase 1
NCT02123953 COMPLETED
Dose Finding Study
Takeda
 2008-10 PHASE1
NCT02141711 COMPLETED
Erosive Esophagitis(EE); Gastroesophageal Reflux Disease (GERD)
Takeda
 2008-10 PHASE1
NCT02141711 Completed
Erosive Esophagitis(EE)|Gastroesophageal Reflux Disease (GERD)
Takeda
 2008-10 Phase 1
NCT02123953 Completed
Dose Finding Study
Takeda
 2008-10 Phase 1
NCT02141698 COMPLETED
Dose Finding Study
Takeda
 2007-10 PHASE1
NCT02123927 COMPLETED
Ascending Single Dose Study
Takeda
 2007-09 PHASE1
NCT01456260 COMPLETED
Gastric Ulcers; Duodenal Ulcers
Takeda
 2011-09 PHASE3

(data from https://clinicaltrials.gov, updated on 2026-01-20)

Check the Vonoprazan Fumarate (TAK-438) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Vonoprazan Fumarate (TAK-438) is a potassium-competitive acid blocker that reversibly inhibits gastric H+/K+-ATPase, thereby blocking the final enzymatic step of hydrogen ion secretion by gastric parietal cells. By suppressing gastric acid output and elevating intragastric pH, this targeted inhibition promotes mucosal healing, rendering it clinically relevant for managing gastroesophageal reflux disease, erosive esophagitis, and Helicobacter pylori infection.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.