TheraRadar
Data updated: May 26, 2026

ACIPHEX SPRINKLE (rabeprazole sodium)

Trial Activity: Declining
Gastrointestinal Approved 2013-03-26
Jump to: Indications Approvals Trials Competitors Safety Patents

Development Insights

Eisai Inc. conducting 4 trials (27%)
9 indications explored (Moderate)
→ gastroesophageal reflux (4 trials)
→ gastroesophageal reflux disease (gerd) (3 trials)
→ helicobacter pylori infection (2 trials)
1
Indication
--
Phase 3 Trials
1
Priority Reviews
13
Years on Market

Details

Status
Discontinued
First Approved
2013-03-26
Routes
ORAL
Dosage Forms
CAPSULE, DELAYED RELEASE

Companies

AYTU
Active Ingredient: RABEPRAZOLE SODIUM

ACIPHEX SPRINKLE Approval History

2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
20 FDA actions from 2013 to 2020
Nov 2020 SUPPL
Label · Labeling
FDA Letter Label
Jun 2018 SUPPL
Label · Labeling
FDA Letter Label
Jul 2017 SUPPL
Label · Labeling
FDA Letter Label

What ACIPHEX SPRINKLE Treats

1 FDA approvals

Originally approved for its first indication in 2013 .

  • Other (1)
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Clinical Trial Registry

13 trials
Trial Sponsor ID Phase Status Title
NCT05380947 results posted 1479-0003 2022-000268-23 Ph 1 completed A Study in Healthy Men to Compare Two Different Oral Formulations of BI 1810631 and to Test How Food or Rabeprazole Influence the Amount of BI 1810631 in the Blood
NCT06076694 results posted TNP-2198-06 Ph 2 completed Efficacy and Safety After Multiple Doses of TNP-2198 Capsules, Rabeprazole Sodium Enteric-coated Tablets and Amoxicillin Capsules in Helicobacter Pylori Infected-positive Participants
NCT06076681 results posted TNP-2198-04 Ph 1, Ph 2 completed 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
NCT04503629 3571-DU-2001 Ph 2 completed A Phase 2 Randomised Controlled Trial to Evaluate Efficacy and Safety of Anaprazole in Patients With Duodenal Ulcers.
NCT02463643 Z215-01 Ph 2 completed To Evaluate Efficacy and Safety of Z-215 in Erosive Esophagitis
NCT02037477 results posted TAK-438/CPH-010 U1111-1152-3926, NCT02037477 Ph 3 completed Phase 3 Study to Evaluate the Acid-Inhibitory Effect of Multiple Oral Doses of Vonoprazan (TAK-438)
NCT00658632 results posted E3810-G000-303 Ph 3 completed Rabeprazole Extended-Release 50 mg Versus Esomeprazole 40 mg for Healing and Symptomatic Relief of Mild to Moderate Erosive Gastroesophageal Reflux Disease (GERD)
NCT00911534 results posted E3810-A001-307 Ph 3 completed Comparing the Efficacy, Safety, and Tolerability of Rabeprazole ER 50 mg With Placebo in Subjects With Symptomatic Gastroesophageal Reflux Disease (sGERD)
NCT00658775 results posted E3810-G000-302 2007-006046-17 Ph 3 completed Rabeprazole Extended-Release, 50 mg, Versus Esomeprazole, 40 mg, for Healing and Symptomatic Relief of Moderate to Severe Erosive Gastroesophageal Reflux Disease (GERD)
NCT00658528 results posted E3810-G000-301 2007-005570-32 Ph 3 completed Rabeprazole Extended-Release 50 mg Versus Esomeprazole 40 mg for Healing and Symptomatic Relief of Moderate to Severe Erosive Gastroesophageal Reflux Disease (GERD)
NCT01101646 CR014827 RABGRD1006 Ph 1 completed A Pharmacokinetic and Relative Bioavailability Study With Rabeprazole Sodium in Healthy Adult Volunteers
NCT00855361 CR014824 RABGRD1005 Ph 1 completed A Pharmacokinetics, Pharmacodynamics and Safety Study of Rabeprazole in New Born Infants With Gastroesophageal Reflux Disease (GERD)
NCT00747695 CR013945 Ph 1 completed A Pharmacokinetic and Safety Study of Single and Multiple Doses of Rabreprazole in Pediatric Patients With Gastroesophageal Reflux Disease (GERD) 1 to 11 Years Old, Inclusive
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

ACIPHEX SPRINKLE FDA Label Details

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Data Sources

FDA Approval: NDA204736 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.

How We Calculate These Metrics

Trial Activity Stage

Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.

Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.

  • Growth: High proportion of early-phase trials (Phase 1/2), active development
  • Expansion: Significant Phase 3 activity, approaching or pursuing approvals
  • Mature: Substantial Phase 4 post-marketing studies
  • Stable: Mixed phase distribution, steady development
  • Declining: Low active trial ratio, reduced R&D investment