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Rabeprazole, Delayed-release tablet
Rabeprazole, Delayed-release tablet is a Small molecule drug developed by AstraZeneca. It is currently in Phase 1 development.
Rabeprazole is a small molecule medication used to treat various conditions, including Helicobacter Pylori infection. It is available in the form of delayed-release tablets, such as Rabeprazole Sodium Delayed-Release Tablets 20 mg, which have been shown to be bioequivalent to Aciphex Tablets 20 mg in a single-dose food study.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Big-pharma sponsor
+3.0pp
AstraZeneca is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +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, Delayed-release tablet |
|---|---|
| Sponsor | AstraZeneca |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
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)
- Food Study of Rabeprazole Sodium Delayed-Release Tablets 20 mg to Aciphex® Tablets 20 mg (PHASE1)
- Fasting Study of Rabeprazole Sodium Delayed-Release Tablets 20 mg to Aciphex® Delayed-Release Tablets 20 mg (PHASE1)
- 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)
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, Delayed-release tablet CI brief — competitive landscape report
- Rabeprazole, Delayed-release tablet updates RSS · CI watch RSS
- AstraZeneca portfolio CI
Frequently asked questions about Rabeprazole, Delayed-release tablet
What is Rabeprazole, Delayed-release tablet?
Who makes Rabeprazole, Delayed-release tablet?
What development phase is Rabeprazole, Delayed-release tablet in?
Related
- Manufacturer: AstraZeneca — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing