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Ganaton (ITOPRIDE)
Ganaton (generic name: ITOPRIDE) is a itopride drug. It is currently in Phase 3 development for Chronic gastritis.
Itopride works by increasing the release of a natural chemical called acetylcholine in the stomach, which helps to stimulate digestive processes.
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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 | ITOPRIDE |
|---|---|
| Drug class | itopride |
| Modality | Small molecule |
| Therapeutic area | Gastroenterology |
| Phase | Phase 3 |
Mechanism of action
Think of it like a key that unlocks the stomach's digestive machinery. Acetylcholine is a natural chemical that helps to stimulate the muscles in the stomach to move food along and help with digestion. By increasing the release of acetylcholine, itopride helps to improve the stomach's ability to digest food and reduce inflammation.
Approved indications
- Chronic gastritis
Common side effects
- Diarrhoea
- Dizziness
- Headache
- Abdominal pain
- Nausea
- Abdominal pain upper
- Influenza
- Dyspnoea
- Hypertension
- Abdominal discomfort
- Anal fissure
- Nasopharyngitis
Key clinical trials
- Comparing Acotiamide and Itopride for the Management of Indigestion (PHASE4)
- Effect of Itopride on Semaglutide Gastroparesis (PHASE4)
- Acotiamide vs Itopride in Postprandial Distress Syndrome (PHASE3)
- Postprandial Distress Itopride Cohort Trial
- Efficacy of Itopride Versus Metoclopramide in Hospitalized Medicine Patients With High Gastric Residual Volume (PHASE4)
- Trial of Itopride 150mg Once a Day Versus Itopride 50 mg Thrice a Day; in Patients With Functional Dyspepsia (PHASE3)
- A Trial of Transcranial Magnetic Stimulation in the Treatment of Functional Dyspepsia
- Potential Benefits of Itopride in the Management of Patients With Metabolic Associated Fatty Liver Disease (MAFLD) (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:
- Ganaton CI brief — competitive landscape report
- Ganaton updates RSS · CI watch RSS
Frequently asked questions about Ganaton
What is Ganaton?
How does Ganaton work?
What is Ganaton used for?
What is the generic name of Ganaton?
What drug class is Ganaton in?
What development phase is Ganaton in?
What are the side effects of Ganaton?
Related
- Drug class: All itopride drugs
- Therapeutic area: All drugs in Gastroenterology
- Indication: Drugs for Chronic gastritis
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing