Last updated: May 12, 2026
Propulsid (cisapride) has no current FDA-commercial market availability in the US after withdrawal; therefore “clinical trials update” and forward market projection are constrained to historical status, residual international sales exposure where cisapride remains authorized, and post-withdrawal IP and regulatory pathways. Market projection in the US is effectively zero under current FDA availability.
What is PROPULSID (cisapride) and where is it still authorized?
Answer: Propulsid is the brand name for cisapride, a prokinetic that increases gastrointestinal motility by facilitating acetylcholine release in the enteric nervous system. US commercialization ended after FDA action; authorization status outside the US depends on local regulators and ongoing pharmacovigilance.
What was Propulsid approved for
Propulsid was used for gastrointestinal motility disorders including:
- Gastroesophageal reflux disease (GERD) in adults and children
- Gastroparesis
- Other refractory motility-related indications depending on label jurisdiction and timeframe
Why the US market exited
US access narrowed and then ended due to safety concerns tied to cardiac rhythm risk, particularly QT prolongation and torsades de pointes risk associated with drug-drug interactions (notably with CYP3A4 inhibitors).
US availability
Propulsid is not a live FDA-listed commercial product for routine US dispensing following withdrawal. That drives the practical market forecast: no ongoing prescription-driven US revenue stream.
What clinical trial evidence exists for cisapride (PROPULSID), and what is the latest “update”?
Answer: The pivotal cisapride trial program is historical and centered on efficacy in reflux and motility disorders plus safety characterization, with later risk management actions rather than late-stage “new pivotal” trials.
Core efficacy trial categories
Trials generally fall into:
- GERD symptom improvement (heartburn/regurgitation) and endoscopic outcomes in some studies
- Gastroparesis and gastric emptying endpoints (scintigraphy and symptom scores)
- Pediatric motility indications in earlier eras
Safety evidence that shaped risk posture
The post-marketing safety narrative that drove restrictions relied on:
- QT prolongation signal and torsades reports
- Interaction risk with CYP3A4 inhibitors
- Risk amplification in patients with predisposition to arrhythmias or electrolyte disturbances
Recent-era trials
No current, widely indexed late-stage clinical development program for cisapride as a modern standalone product is reflected in mainstream registries in a way that would justify a “progress-to-Phase 3/registration” update for market projection. The regulatory story is dominated by access restrictions and withdrawal rather than continued clinical development.
What patents protect cisapride (PROPULSID) in key jurisdictions, and how strong is the estate?
Answer: Cisapride itself is an older small molecule; the remaining US enforceability posture is typically limited to formulation, method-of-use, manufacturing, and pediatric or data exclusivity concepts rather than “composition of matter” for the base API, which are generally long expired.
Patent estate structure that matters for market re-entry
For an older API, remaining enforceable value usually comes from one or more of:
- Specific formulations (eg, dosage form or delivery system)
- Methods of treatment with defined patient subsets or dosing regimens
- Manufacturing process constraints or impurity specifications
- New combination regimens (if any) and related dosing instructions
Litigation and paragraph IV relevance
For an older product that is not commercially marketed, Paragraph IV incentives and generic-entry risk calculations in the US change:
- If no FDA marketing status exists, the generic market entry question becomes separate from “Orange Book” launch timing.
- Patent challenges, if any, are usually historical or tied to prior exclusivity windows, not a live commercial launch calendar.
What is the Orange Book status of PROPULSID, and when would exclusivity end?
Answer: Cisapride’s branded US status is not consistent with an active Orange Book “current listing driving launch schedules” model. The practical exclusivity question in the US is dominated by withdrawal rather than an approaching patent expiry date.
How to interpret Orange Book when a drug is withdrawn
When a branded product is withdrawn:
- Orange Book listings may still exist historically, but they do not necessarily correspond to an active market for revenue projection.
- Generic viability becomes less about “launch after patent expiry” and more about whether FDA marketing is possible under current regulatory posture.
When does PROPULSID lose exclusivity, and what generic entry risks exist?
Answer: For a withdrawn older small molecule, the “generic entry risk” is not primarily about remaining exclusivity. The dominant gating factor is whether FDA marketing for cisapride is still permitted and under what risk-management constraints.
Generic entry scenario mechanics
A generic cisapride entry would require:
- Ability to obtain appropriate manufacturing authorization
- A regulatory pathway that permits marketing given the safety profile and interaction restrictions
- Alignment with label restrictions and risk mitigation expectations
Because the brand is not effectively available in the US market, even an approval would not automatically recreate prior utilization patterns. The demand signal is constrained by prescriber and regulator risk posture.
How much market revenue could PROPULSID generate going forward, and what is the plausible projection?
Answer: US revenue projection is effectively nil under current FDA-commercial availability. Any projection value is driven by non-US markets where cisapride remains authorized and where local physicians continue prescribing under restrictions.
US projection
- Revenue: near zero, because the product is not distributed for routine US prescribing.
- Forecast horizon impact: flat at zero, absent re-authorization.
International projection
A defensible market forecast requires jurisdiction-by-jurisdiction authorization status and prescribing patterns. In the absence of live, jurisdiction-specific authorization and pricing data, only directional conclusions are supportable:
- If cisapride remains authorized in certain countries with active prescribing, a limited “legacy” market can persist.
- Growth is constrained by safety perception, substitution by safer alternatives, and regulatory restrictions that reduce eligible patients and broaden contraindicated co-medications.
Practical business projection framing
- Base case: low single-digit share of legacy GI prokinetic volume in jurisdictions that still permit use.
- Upside case: sustained niche use where alternative access is limited or where local regulators allow cisapride with strict interaction control.
- Downside case: progressive restrictions, substitution by other prokinetics, and further withdrawals.
What competing drugs displace cisapride, and how do they affect demand?
Answer: Cisapride’s historical segment overlaps with multiple prokinetic and antiemetic therapies that offer different safety and interaction profiles.
Key displacement classes include:
- Other prokinetics (where approved), including agents with less QT-driven risk
- Antiemetics and reflux therapies with broader safety acceptability
- GERD management regimens (PPIs and H2 blockers), reducing need for prokinetic rescue
Competitive impact on volume
Because cisapride was used for reflux and motility, PPIs and modern GI care pathways reduced prokinetic demand. Add the QT risk stigma and the net effect is durable pressure on utilization even if cisapride is authorized.
What current clinical or regulatory developments could change the market for cisapride?
Answer: The most likely market-moving events are regulatory re-access decisions, risk-management updates, or renewed approvals in specific territories. The clinical landscape update, as a practical driver, is not new efficacy but safety governance.
What would increase commercial viability
- Relaxation of interaction restrictions by new evidence
- Enhanced prescriber controls and patient selection rules
- Evidence supporting safer co-administration frameworks
What would reduce commercial viability
- Additional withdrawals in more jurisdictions
- Stricter monitoring requirements that reduce prescriber uptake
- Further safety communications that increase contraindication breadth
Key Takeaways
- Propulsid (cisapride) is an older prokinetic with US commercial exit driven by QT/torsades risk and interaction concerns; practical US market projection is near zero under current availability.
- “Clinical trials update” is historical rather than a live late-stage pipeline that would reshape near-term market dynamics.
- Patent-driven exclusivity and Paragraph IV timing are not the primary determinants of future US revenue because the branded product is not effectively accessible for routine prescribing.
- Internationally, demand may persist only in jurisdictions that still authorize cisapride, but growth is structurally constrained by safety posture and displacement by alternative GI therapies.
FAQs
- Is cisapride still available in the US?
- What QT interaction risks are most relevant to cisapride prescribing?
- What conditions was Propulsid labeled for historically, and which therapies replaced it?
- If cisapride is still authorized outside the US, which regulatory safeguards typically apply?
- How do older API withdrawals affect generic entry and Orange Book launch calendars?
References
No sources were provided in the prompt, and no citable materials are included in this response.
