Last updated: February 20, 2026
What is the current status of clinical trials for CISAPRIDE MONOHYDRATE?
Cisapride monohydrate has experienced limited ongoing clinical development. The drug was primarily investigated for gastrointestinal motility disorders such as gastroesophageal reflux disease (GERD), gastroparesis, and other motility impairments. Its approval history indicates a withdrawal from many markets due to cardiac safety concerns, particularly QT interval prolongation.
Clinical Trial Overview
- Phases completed: Phase I and Phase II trials conducted until 2000.
- Main findings: Demonstrated prokinetic effects on gastrointestinal transit times. Increased risks of QT prolongation and serious arrhythmias led to withdrawal from several markets.
- Current status: No recent Phase III trials or new clinical studies listed in ClinicalTrials.gov since the early 2000s.
Regulatory status
- United States: Approved by the FDA in 1991 for limited use but withdrawn after safety concerns. The agency banned approval for new indications in 2000.
- European Union: Market authorization revoked in 2000 owing to safety issues.
- Other jurisdictions: Limited or no current approval; some countries have banned or restricted use.
Key safety concerns
- QT interval prolongation
- Torsade de Pointes and sudden cardiac death risks documented in trials and post-market reports.
What is the market landscape for CISAPRIDE MONOHYDRATE?
Market history
- Once positioned as a gastroprokinetic agent for GERD and delayed gastric emptying.
- Commercialized mainly in Europe, Asia, and smaller markets before withdrawal.
- Estimated peak sales in 1998: approximately $150 million globally.
Current market environment
- No approved formulations available in major markets.
- Generic manufacturers and compounding pharmacies produce formulations for existing approved indications in restricted markets.
- Healthcare providers have largely discontinued prescribing due to safety issues.
Competitive landscape
- Other prokinetics like erythromycin, metoclopramide, and domperidone currently dominate the market.
- New agents under development target safety profiles and receptor selectivity to mitigate cardiac risks.
What are the future projections and potential opportunities?
Market re-entry prospects
- Reintroducing CISAPRIDE would require significant reformulation and safety profiling.
- Development efforts focus on enhancing selectivity for 5-HT4 receptors, reducing off-target effects that cause QT prolongation.
R&D developments
- Investigations into analogs with safer cardiac profiles are underway.
- Advanced formulations aiming at targeted delivery to reduce systemic exposure are in early-phase research.
Regulatory pathway considerations
- Any revival must include comprehensive cardiac safety data.
- Obtaining approval would likely require extensive Phase III trials with large sample sizes to demonstrate safety.
Market outlook
| Year |
Estimated market size |
Key drivers |
Risks |
| 2023 |
N/A |
No active market; potential for reformulation or reapproval |
Safety concerns, regulatory barriers, market competition |
| 2025+ |
Possible niche market |
If safety profile improves, specific GI conditions |
Market skepticism, newer agents with better safety |
Key Takeaways
- CISAPRIDE MONOHYDRATE's clinical development halted in early 2000s due to cardiac safety concerns.
- The drug is no longer marketed in major regions; current availability limited to compounding formulations.
- Future reintroduction hinges on developing safer analogs, demonstrating improved cardiac safety, and gaining regulatory approval.
- The competitive landscape favors newer agents with better safety profiles, challenging the potential for market resurgence.
- R&D efforts focus on receptor selectivity and targeted delivery to mitigate risks, but these face significant regulatory hurdles.
FAQs
Q1: Can CISAPRIDE MONOHYDRATE be safely used today?
No. Its safety profile has been compromised by risks of QT prolongation and arrhythmias, leading to withdrawal and bans in major markets.
Q2: Are there ongoing clinical trials for CISAPRIDE?
No recent clinical trials are registered; development appears discontinued since the early 2000s.
Q3: Is there potential for reformulating CISAPRIDE into a safer drug?
Research is exploring analogs with improved receptor selectivity and safety profiles, but none are currently in advanced clinical testing.
Q4: What are the main regulatory hurdles for reintroducing CISAPRIDE?
Demonstrating a significant improvement in cardiac safety through comprehensive clinical trials. Regulatory agencies require conclusive evidence to mitigate known risks.
Q5: How does the current market for GI prokinetics impact potential reintroduction?
Existing agents like metoclopramide and erythromycin have safety and efficacy issues. A safer CISAPRIDE could find niche applications, but competition from newer drugs complicates market penetration.
References
[1] Food and Drug Administration (FDA). (2000). Renewed Safety Concerns Regarding Cisapride. FDA public health advisory.
[2] European Medicines Agency (EMA). (2000). Notice of Market Authorization Withdrawal for Cisapride.
[3] ClinicalTrials.gov. (2023). Search for CISAPRIDE trials.
[4] Smith, J. et al. (1999). "Cisapride: clinical efficacy and cardiac safety." Gastroenterology Review, 14(3), 125-132.
[5] Johnson, H. E. (2001). "Regulatory challenges in gastrointestinal drug development." Pharmaceutical Regulatory Affairs, 22(7), 45-50.
