NDAORALCAPSULE, DELAYED RELEASEPriority Review
Approved
Mar 2013
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
15
Data completeness
3/8 — Basic
Priority Review
ACIPHEX SPRINKLE (rabeprazole sodium) by Aytu BioPharma is (substituted benzimidazole proton-pump inhibitors) that do not exhibit anticholinergic or histamine h 2 -receptor antagonist properties, but suppress gastric acid secretion by inhibiting the gastric h , k atpase at the secretory surface of the gastric parietal cell. First approved in 2013.
Drug data last refreshed 10h ago · AI intelligence enriched 5d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ACIPHEX SPRINKLE is a delayed-release oral capsule formulation of rabeprazole sodium, a proton-pump inhibitor (PPI) that suppresses gastric acid secretion by inhibiting the H+,K+-ATPase enzyme in gastric parietal cells. It is indicated for acid-reflux and related gastroesophageal conditions, with a sprinkle formulation designed for patients who cannot swallow intact capsules. The drug blocks the final step of gastric acid production through rapid chemical activation and irreversible enzyme inhibition.
Peak
Product is at peak lifecycle stage with moderate competitive pressure (30%), suggesting mature portfolio positioning and stable but not expanding team headcount.
Mechanism of Action
(substituted benzimidazole proton-pump inhibitors) that do not exhibit anticholinergic or histamine H 2 -receptor antagonist properties, but suppress gastric acid secretion by inhibiting the gastric H , K ATPase at the secretory surface of the gastric parietal cell. Because this enzyme is regarded…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (15)
Study to Evaluate the Effect of Rabeprazole Sodium Enteric-coated Tablets on the Pharmacokinetics of TQ05105 Tablets
Started Jul 2026
17 enrolled
Myelofibrosis
Efficacy and Safety After Multiple Doses of TNP-2198 Capsules, Rabeprazole Sodium Enteric-coated Tablets and Amoxicillin Capsules in Helicobacter Pylori Infected-positive Participants
Started Jun 2022
80 enrolled
Helicobacter Pylori Infection
A Study to Evaluate Preliminary Helicobacter Pylori Eradication After Multiple Doses of TNP-2198 Capsules Combined With Rabeprazole Sodium Enteric-coated Tablets, or Rabeprazole Sodium Enteric-coated Tablets and Amoxicillin Capsules
Started Sep 2021
40 enrolled
Helicobacter Pylori Infection
The Safety and Tolerability, Pharmacokinetics of TNP-2092 Capsules in Combination With Rabeprazole Sodium Enteric-coated Tablets
Started Oct 2017
20 enrolled
Helicobacter Pylori Infection
The Study to Evaluate Efficacy and Safety of Newrabell® Tab.(Rabeprazole Sodium) 10mg b.i.d in Refractory GERD
Started Apr 2013
39 enrolled
Reflux Esophagitis
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.