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Prescription, Nonprescription and Orphan Drugs

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Prescription drugs require a prescription from a medical practitioner and can only be obtained from a pharmacy. They have many applications, including treating pain, anxiety, and hypertension.
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Drugs, the chemical agents used in diagnosing, treating, or preventing diseases, undergo a four-phase process of development: pharmaceutic, pharmacokinetics, pharmacodynamics, and therapeutic.
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Post-marketing surveillance is a critical component of pharmaceutical regulation, often uncovering unanticipated adverse drug reactions (ADRs) once a drug is widely used over an extended period.
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Liddle syndrome is a genetically inherited form of hypertension characterized by the overactivity of epithelial sodium channels in the nephron, the functional unit of the kidney. This heightened activity leads to increased sodium reabsorption and excessive excretion of potassium. To counteract this, potassium-sparing diuretics such as amiloride are used. They function by blocking these sodium channels, thereby reducing the influx of sodium into the epithelial cells and minimizing the loss of...
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Keverprazan Hydrochloride: First Approval.

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  • 1Springer Nature, Mairangi Bay, Private Bag 65901, Auckland, 0754, New Zealand. dru@adis.com.

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Summary

Keverprazan hydrochloride, a novel potassium-ion-competitive acid blocker, has gained approval in China for treating reflux esophagitis and duodenal ulcers. This marks a significant milestone in managing acid-related gastrointestinal diseases.

Area of Science:

  • Gastroenterology
  • Pharmacology

Background:

  • Acid-related diseases pose a significant global health burden.
  • Potassium-ion-competitive acid blockers (P-CABs) represent a newer class of acid suppressants.
  • Keverprazan hydrochloride is a P-CAB developed by Jiangsu Carephar Pharmaceuticals.

Purpose of the Study:

  • To summarize the key developmental milestones of keverprazan hydrochloride.
  • To highlight the regulatory approval process in China for acid-related diseases.

Main Methods:

  • Review of preclinical and clinical development data.
  • Analysis of regulatory submission and approval pathway.

Main Results:

  • Keverprazan hydrochloride demonstrated efficacy in treating acid-related conditions.

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  • Successful completion of development phases leading to regulatory submission.
  • Received approval in China for reflux esophagitis and duodenal ulcer treatment.
  • Conclusions:

    • Keverprazan hydrochloride's approval signifies a therapeutic advancement for acid-related disorders.
    • The drug's development journey offers insights into P-CABs' therapeutic potential.