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Mosapride Citrate Tablets
Mosapride Citrate Tablets is a 5-HT4 receptor agonist Small molecule drug developed by Xiyuan Hospital of China Academy of Chinese Medical Sciences. It is currently in Phase 3 development for Functional dyspepsia, Gastroesophageal reflux disease (GERD), Postoperative ileus. Also known as: The Control Group.
Mosapride citrate is a 5-HT4 receptor agonist that enhances gastric motility and accelerates gastric emptying.
Mosapride citrate is a 5-HT4 receptor agonist that enhances gastric motility and accelerates gastric emptying. Used for Functional dyspepsia, Gastroesophageal reflux disease (GERD), Postoperative ileus.
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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 | Mosapride Citrate Tablets |
|---|---|
| Also known as | The Control Group |
| Sponsor | Xiyuan Hospital of China Academy of Chinese Medical Sciences |
| Drug class | 5-HT4 receptor agonist |
| Target | 5-HT4 receptor |
| Modality | Small molecule |
| Therapeutic area | Gastroenterology |
| Phase | Phase 3 |
Mechanism of action
Mosapride selectively binds to and activates 5-HT4 (serotonin-4) receptors in the gastrointestinal tract, which increases acetylcholine release and enhances smooth muscle contractions in the stomach. This promotes more efficient gastric emptying and improves overall gastric motility, helping to relieve symptoms associated with functional dyspepsia and gastroesophageal reflux.
Approved indications
- Functional dyspepsia
- Gastroesophageal reflux disease (GERD)
- Postoperative ileus
Common side effects
- Diarrhea
- Abdominal pain
- Headache
- Nausea
Key clinical trials
- Efficacy of Clostridium Butyricum in Alleviating Anxiety and Depression in Patients With Functional Dyspepsia (PHASE4)
- Efficacy of Bacillus Coagulans in Alleviating Anxiety and Depression in Patients With Functional Dyspepsia (PHASE4)
- A Comparative Evaluation of Mosapride Versus Metoclopramide for Enteral Feeding Intolerance in Critically Ill Patients (PHASE3)
- Zuojin Wan Combined With Rabeprazole or Mosapride for the Treatment of Functional Dyspepsia Combined With Depression (NA)
- Deep Needling at Zhongliao Point to Stimulate the Sacral Nerve for the Treatment of Slow Transit Constipation (NA)
- Efficacy Assessment of Chinese Herbal Medicine Tangweian Recipe Treating Participants With Diabetic Gastroenteropathy (PHASE1, PHASE2)
- The Comparative Analysis Between Motilitone and Gasmotin for the Symptom Relief in Gallstone Patients With Functional Dyspepsia (NA)
- Clinical Study on Post Evaluation After Listing of Qizhi Weitong Granules (PHASE1, 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:
- Mosapride Citrate Tablets CI brief — competitive landscape report
- Mosapride Citrate Tablets updates RSS · CI watch RSS
- Xiyuan Hospital of China Academy of Chinese Medical Sciences portfolio CI
Frequently asked questions about Mosapride Citrate Tablets
What is Mosapride Citrate Tablets?
How does Mosapride Citrate Tablets work?
What is Mosapride Citrate Tablets used for?
Who makes Mosapride Citrate Tablets?
Is Mosapride Citrate Tablets also known as anything else?
What drug class is Mosapride Citrate Tablets in?
What development phase is Mosapride Citrate Tablets in?
What are the side effects of Mosapride Citrate Tablets?
What does Mosapride Citrate Tablets target?
Related
- Drug class: All 5-HT4 receptor agonist drugs
- Target: All drugs targeting 5-HT4 receptor
- Manufacturer: Xiyuan Hospital of China Academy of Chinese Medical Sciences — full pipeline
- Therapeutic area: All drugs in Gastroenterology
- Indication: Drugs for Functional dyspepsia
- Indication: Drugs for Gastroesophageal reflux disease (GERD)
- Indication: Drugs for Postoperative ileus
- Also known as: The Control Group
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing