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Non-PPI (Gefarnate)
Non-PPI (Gefarnate) is a Mucoprotective agent Small molecule drug developed by Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan. It is currently in Phase 3 development for Gastric ulcer, Duodenal ulcer, Gastritis.
Gefarnate is a mucoprotective agent that enhances gastric mucus production and strengthens the gastric mucosal barrier to protect against acid-induced damage.
Gefarnate is a small molecule non-proton pump inhibitor (Non-PPI) used in research. It has been studied in clinical trials for the treatment of cardio-cerebrovascular disease.
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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 | Non-PPI (Gefarnate) |
|---|---|
| Sponsor | Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan |
| Drug class | Mucoprotective agent |
| Modality | Small molecule |
| Therapeutic area | Gastroenterology |
| Phase | Phase 3 |
Mechanism of action
Gefarnate works by stimulating mucus secretion and promoting the healing of gastric mucosa through cytoprotective mechanisms. Unlike proton pump inhibitors that reduce acid production, gefarnate maintains normal acid levels while fortifying the stomach's natural protective mechanisms, making it suitable for patients who cannot tolerate or require alternatives to PPIs.
Approved indications
- Gastric ulcer
- Duodenal ulcer
- Gastritis
Common side effects
- Gastrointestinal disturbances
- Nausea
- Diarrhea
Key clinical trials
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:
- Non-PPI (Gefarnate) CI brief — competitive landscape report
- Non-PPI (Gefarnate) updates RSS · CI watch RSS
- Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan portfolio CI
Frequently asked questions about Non-PPI (Gefarnate)
What is Non-PPI (Gefarnate)?
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What is Non-PPI (Gefarnate) used for?
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What development phase is Non-PPI (Gefarnate) in?
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Related
- Drug class: All Mucoprotective agent drugs
- Manufacturer: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan — full pipeline
- Therapeutic area: All drugs in Gastroenterology
- Indication: Drugs for Gastric ulcer
- Indication: Drugs for Duodenal ulcer
- Indication: Drugs for Gastritis
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing