ACIPHEX (rabeprazole sodium)
Aciphex helps patients manage various acid-related conditions of the stomach and esophagus, including gastroesophageal reflux disease (GERD) and duodenal ulcers. In adults, it is used to heal esophageal damage, maintain that healing, and provide relief from symptoms like daytime and nighttime heartburn. It also treats pathological hypersecretory conditions such as Zollinger-Ellison Syndrome and is used in combination with specific antibiotics to eliminate H. pylori bacteria. Adolescents aged 12 and older may also use it for short-term relief of GERD symptoms.
How ACIPHEX Works
Aciphex works by inhibiting the H+, K+ ATPase enzyme, commonly known as the proton pump, found on the secretory surface of gastric parietal cells. Once the drug is converted into its active form within these cells, it blocks the final step of gastric acid secretion. This process effectively suppresses the amount of acid the stomach produces to allow for tissue healing and symptom relief.
Details
- Status
- Discontinued
- First Approved
- 1999-08-19
- Routes
- ORAL, Oral
- Dosage Forms
- TABLET, DELAYED RELEASE, Tablet, Delayed Release
ACIPHEX Approval History
What ACIPHEX Treats
5 indicationsACIPHEX is approved for 5 conditions since its original approval in 1999. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Gastroesophageal Reflux Disease
- Duodenal Ulcer
- Helicobacter pylori Infection
- Zollinger-Ellison Syndrome
- Pathological Hypersecretory Conditions
ACIPHEX Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
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 |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
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 FDA Label Details
Indications & Usage
FDA Label (PDF)ACIPHEX is indicated for the treatment of Gastroesophageal Reflux Disease; Duodenal Ulcer; Helicobacter pylori Infection; Zollinger-Ellison Syndrome; Pathological Hypersecretory Conditions.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.