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Fexuprazan

Generic Name
Fexuprazan

Overview

No overview information available.

Indication

用于胃食管反流病(GERD)的治疗。

Associated Conditions

No associated conditions information available.

Research Report

Published: Aug 29, 2025

Fexuprazan (Fexuclue®): A Comprehensive Monograph on a Novel Potassium-Competitive Acid Blocker

The Evolving Landscape of Acid Suppression and the Advent of Fexuprazan

The Global Burden of Acid-Related Disorders (ARDs)

Acid-related disorders (ARDs), a group of conditions primarily caused by the excessive or imbalanced production of gastric acid, represent a significant and growing global health burden.[1] Conditions such as gastroesophageal reflux disease (GERD), peptic ulcer disease, and gastritis are among the most common diagnoses made in clinical practice worldwide. The prevalence of GERD, in particular, has been steadily increasing in both Asian and Western nations, with a recent estimate placing its worldwide prevalence at 13.3%.[2] This high incidence underscores the vast and persistent clinical need for effective, reliable, and convenient acid-suppressive therapies.

The Era of Proton Pump Inhibitors (PPIs): The Gold Standard and Its Limitations

Since their introduction in the late 1980s, proton pump inhibitors (PPIs) have been the cornerstone of ARD management, establishing themselves as the first-line therapeutic gold standard due to their potent acid-suppressing capabilities.[1] However, despite their widespread efficacy, the PPI class possesses several inherent pharmacological and clinical limitations that have created a distinct unmet clinical need.[5] These limitations include:

Continue reading the full research report

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2024/05/31
Phase 1
Not yet recruiting
Daewoong Pharmaceutical Co. LTD.
2023/07/14
Phase 4
Not yet recruiting
2023/06/02
N/A
Completed
Daewoong Pharmaceutical Co. LTD.
2023/04/14
Phase 3
Completed
Daewoong Pharmaceutical Co. LTD.
2023/04/13
Phase 1
Active, not recruiting
Daewoong Pharmaceutical Co. LTD.
2022/12/21
N/A
Completed
Daewoong Pharmaceutical Co. LTD.
2022/11/14
N/A
Completed
Daewoong Pharmaceutical Co. LTD.
2022/10/10
Phase 1
Completed
Daewoong Pharmaceutical Co. LTD.
2022/03/31
Phase 1
Completed
Daewoong Pharmaceutical Co. LTD.
2021/05/17
Not Applicable
UNKNOWN

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

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Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

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No HSA approvals found for this drug.

NMPA Drug Approvals

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No NMPA approvals found for this drug.

PPB Drug Approvals

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No PPB approvals found for this drug.

TGA Drug Approvals

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ARTG ID
Sponsor
Registration Type
Status
Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

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Strength
Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

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Company
Registration Number
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Prescription Type
Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

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License Number
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Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

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Company
License Number
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No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

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Company
Registration Number
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Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

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