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Fexuprazan Hydrochloride is a novel potassium-competitive acid blocker (P-CAB) developed for the management of acid-related disorders. As a next-generation acid secretion inhibitor, Fexuprazan offers a differentiated pharmacological profile compared to traditional proton pump inhibitors (PPIs), delivering effective gastric acid suppression with the potential for broader clinical utility.
Fexuprazan directly inhibits gastric acid secretion by reversibly and competitively blocking the H⁺/K⁺-ATPase enzyme (proton pump) in gastric parietal cells. Unlike traditional PPIs, which require acid-mediated activation before binding irreversibly to the proton pump, Fexuprazan binds competitively at the potassium binding site and can inhibit both active and inactive proton pumps without requiring an acidic environment. This mechanism results in rapid onset of action and sustained acid suppression.
Rapid and Durable Acid Suppression – Direct action on the proton pump allows quicker gastric pH control, with effects maintained over a full 24-hour period.
Food-Independent Absorption – Efficacy is not significantly influenced by food intake.
Predictable Metabolism – Fexuprazan’s metabolism is largely independent of CYP2C19 polymorphism, reducing variability in clinical response compared with many PPIs.
Reversible, Direct Action – Competitive inhibition at the proton pump facilitates consistent acid control without requiring activation steps.
Fexuprazan is indicated for the treatment of acid-related gastrointestinal disorders, including but not limited to:
Erosive Esophagitis (EE) – Demonstrated non-inferior efficacy to esomeprazole in phase III clinical studies for healing mucosal injury and symptom relief associated with erosive esophagitis.
Gastroesophageal Reflux Disease (GERD) – Widely studied for symptom control and mucosal healing in patients with reflux-related disease.
Acute and Chronic Gastritis – Clinical trials have shown superior healing rates compared with placebo in gastritis patients.
Laryngopharyngeal Reflux Disease (LPRD) – Evidence suggests symptomatic improvements comparable to esomeprazole, particularly in patients with severe symptoms.
Compared with standard PPIs, Fexuprazan’s mechanism and pharmacokinetics provide several potential clinical advantages:
Faster onset of acid suppression due to direct proton pump inhibition.
Sustained control of gastric acidity, reducing nocturnal acid breakthrough.
Reduced pharmacogenetic variability, improving consistency of clinical response among diverse patient populations.
Potential protective anti-inflammatory effects in esophageal mucosa observed in experimental models beyond acid suppression.
Fexuprazan has been approved in multiple markets, including South Korea and Mexico, for the treatment of acid-related diseases such as GERD and erosive esophagitis. In China, partnerships with leading domestic pharmaceutical firms have enabled regulatory submissions and clinical development aimed at addressing unmet needs in reflux and gastritis management.
As an active pharmaceutical ingredient (API), Fexuprazan Hydrochloride is supplied as a high-purity crystalline substance intended for formulation into prescription products such as film-coated tablets. The API is manufactured under robust quality control systems aligned with pharmacopoeial standards and regulatory expectations.
Fexuprazan Hydrochloride is a novel potassium-competitive acid blocker (P-CAB) developed for the management of acid-related disorders. As a next-generation acid secretion inhibitor, Fexuprazan offers a differentiated pharmacological profile compared to traditional proton pump inhibitors (PPIs), delivering effective gastric acid suppression with the potential for broader clinical utility.
Fexuprazan directly inhibits gastric acid secretion by reversibly and competitively blocking the H⁺/K⁺-ATPase enzyme (proton pump) in gastric parietal cells. Unlike traditional PPIs, which require acid-mediated activation before binding irreversibly to the proton pump, Fexuprazan binds competitively at the potassium binding site and can inhibit both active and inactive proton pumps without requiring an acidic environment. This mechanism results in rapid onset of action and sustained acid suppression.
Rapid and Durable Acid Suppression – Direct action on the proton pump allows quicker gastric pH control, with effects maintained over a full 24-hour period.
Food-Independent Absorption – Efficacy is not significantly influenced by food intake.
Predictable Metabolism – Fexuprazan’s metabolism is largely independent of CYP2C19 polymorphism, reducing variability in clinical response compared with many PPIs.
Reversible, Direct Action – Competitive inhibition at the proton pump facilitates consistent acid control without requiring activation steps.
Fexuprazan is indicated for the treatment of acid-related gastrointestinal disorders, including but not limited to:
Erosive Esophagitis (EE) – Demonstrated non-inferior efficacy to esomeprazole in phase III clinical studies for healing mucosal injury and symptom relief associated with erosive esophagitis.
Gastroesophageal Reflux Disease (GERD) – Widely studied for symptom control and mucosal healing in patients with reflux-related disease.
Acute and Chronic Gastritis – Clinical trials have shown superior healing rates compared with placebo in gastritis patients.
Laryngopharyngeal Reflux Disease (LPRD) – Evidence suggests symptomatic improvements comparable to esomeprazole, particularly in patients with severe symptoms.
Compared with standard PPIs, Fexuprazan’s mechanism and pharmacokinetics provide several potential clinical advantages:
Faster onset of acid suppression due to direct proton pump inhibition.
Sustained control of gastric acidity, reducing nocturnal acid breakthrough.
Reduced pharmacogenetic variability, improving consistency of clinical response among diverse patient populations.
Potential protective anti-inflammatory effects in esophageal mucosa observed in experimental models beyond acid suppression.
Fexuprazan has been approved in multiple markets, including South Korea and Mexico, for the treatment of acid-related diseases such as GERD and erosive esophagitis. In China, partnerships with leading domestic pharmaceutical firms have enabled regulatory submissions and clinical development aimed at addressing unmet needs in reflux and gastritis management.
As an active pharmaceutical ingredient (API), Fexuprazan Hydrochloride is supplied as a high-purity crystalline substance intended for formulation into prescription products such as film-coated tablets. The API is manufactured under robust quality control systems aligned with pharmacopoeial standards and regulatory expectations.
