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Rabeprazole Enteric-Coated Tablets
Rabeprazole Enteric-Coated Tablets is a Proton pump inhibitor (PPI) Small molecule drug developed by China-Japan Friendship Hospital. It is currently in Phase 3 development for Gastroesophageal reflux disease (GERD), Peptic ulcer disease, Zollinger-Ellison syndrome. Also known as: Rabeprazole.
Rabeprazole is a proton pump inhibitor that suppresses gastric acid secretion by irreversibly blocking the H+/K+-ATPase enzyme in gastric parietal cells.
Rabeprazole is a small molecule medication used to treat conditions such as Functional Dyspepsia, Gastroesophageal Reflux Disease, and Helicobacter Pylori Infection. It is an acid pump inhibitor that works by reducing the amount of acid produced in the stomach.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Rabeprazole Enteric-Coated Tablets |
|---|---|
| Also known as | Rabeprazole |
| Sponsor | China-Japan Friendship Hospital |
| Drug class | Proton pump inhibitor (PPI) |
| Target | H+/K+-ATPase |
| Modality | Small molecule |
| Therapeutic area | Gastroenterology |
| Phase | Phase 3 |
Mechanism of action
Rabeprazole binds to and inactivates the proton pump (H+/K+-ATPase) on the secretory surface of gastric parietal cells, preventing the final step of gastric acid production. This leads to sustained reduction of intragastric acidity, allowing healing of acid-damaged tissues and relief of acid-related symptoms. The enteric coating delays release until the tablet reaches the small intestine, protecting the drug from gastric acid degradation and improving bioavailability.
Approved indications
- Gastroesophageal reflux disease (GERD)
- Peptic ulcer disease
- Zollinger-Ellison syndrome
- Acid-related dyspepsia
Common side effects
- Headache
- Diarrhea
- Nausea
- Abdominal pain
- Constipation
- Rash
Key clinical trials
- Yiwei Jiaohuang Ointment for Gastrointestinal Bleeding Associated With Oral Antithrombotic Agents (EARLY_PHASE1)
- Efficacy and Safety of Rifasutenizol (TNP 2198), Rabeprazole and Amoxicillin in Participants With H. Pylori Infection (PHASE3)
- Evaluation of the Effect of Rifampin and Rabeprazole on the Pharmacokinetics of Camlipixant (PHASE1)
- Zuojin Wan Combined With Rabeprazole or Mosapride for the Treatment of Functional Dyspepsia Combined With Depression (NA)
- The Safety and Tolerability, Pharmacokinetics of TNP-2092 Capsules in Combination With Rabeprazole Sodium Enteric-coated Tablets (PHASE1)
- A Study to Compare Bioavailability of AZD5055 Film-coated Tablet With AZD5055 Oral Suspension and to Assess the Effect of Food and an Acid Reducing Agent on Pharmacokinetics (PK) of AZD5055 in Healthy Subjects. (PHASE1)
- Clinical Study of Jinsang Liyan Capsules Combined With PPI in the Treatment of LPRD (PHASE4)
- Efficacy and Safety After Multiple Doses of TNP-2198 Capsules, Rabeprazole Sodium Enteric-coated Tablets and Amoxicillin Capsules in Helicobacter Pylori Infected-positive Participants (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Rabeprazole Enteric-Coated Tablets CI brief — competitive landscape report
- Rabeprazole Enteric-Coated Tablets updates RSS · CI watch RSS
- China-Japan Friendship Hospital portfolio CI
Frequently asked questions about Rabeprazole Enteric-Coated Tablets
What is Rabeprazole Enteric-Coated Tablets?
How does Rabeprazole Enteric-Coated Tablets work?
What is Rabeprazole Enteric-Coated Tablets used for?
Who makes Rabeprazole Enteric-Coated Tablets?
Is Rabeprazole Enteric-Coated Tablets also known as anything else?
What drug class is Rabeprazole Enteric-Coated Tablets in?
What development phase is Rabeprazole Enteric-Coated Tablets in?
What are the side effects of Rabeprazole Enteric-Coated Tablets?
What does Rabeprazole Enteric-Coated Tablets target?
Related
- Drug class: All Proton pump inhibitor (PPI) drugs
- Target: All drugs targeting H+/K+-ATPase
- Manufacturer: China-Japan Friendship Hospital — full pipeline
- Therapeutic area: All drugs in Gastroenterology
- Indication: Drugs for Gastroesophageal reflux disease (GERD)
- Indication: Drugs for Peptic ulcer disease
- Indication: Drugs for Zollinger-Ellison syndrome
- Also known as: Rabeprazole
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing