NCT07595003 4-Methylumbelliferyl Trimebutine Sulfate Chronic cholecystitis Clinical Landscape Report 2026: Design, Endpoints, Sponsor and Readout Outlook
Turn a newly registered trial into a decision-ready clinical landscape. This report examines NCT07595003 using PatSnap Clinical Trials MCP for protocol design and endpoint evidence, with Drug & Asset MCP and Company & Deal Intelligence MCP used as the companion asset and sponsor enrichment workflow. Explore PatSnap MCP Servers to reproduce the research sequence inside an AI workflow.
MCP evidence snapshot: 22 July 2026. Trial records, recruitment status and projected dates can change after the snapshot and should be rechecked before operational decisions.
Why NCT07595003 is a hot trial to watch
Chronic cholecystitis is being segmented by mechanism, treatment setting, geography and endpoint architecture. NCT07595003 is notable because it evaluates 4-Methylumbelliferyl Trimebutine Sulfate in a Phase 3 design sponsored by Valenta Pharmaceuticals JSC. The main development question is whether the protocol can translate its rationale into a clinically interpretable and operationally credible readout.
Trial landscape snapshot
| Field | Indexed detail |
|---|---|
| Registration | NCT07595003 |
| Official title | Efficacy, Safety, and Tolerability of 4-MUST, 128 mg Tablets in Chronic Cholecystitis and Biliary Dyskinesia |
| Phase / status | Phase 3 / Recruiting |
| Intervention | 4-Methylumbelliferyl Trimebutine Sulfate |
| Sponsor | Valenta Pharmaceuticals JSC |
| Geography | Russia |
| Enrollment | [object Object] |
| Primary endpoint | Mean reduction in the severity of pain/discomfort in the upper abdomen on the VAS by day 29 compared to baseline |
| Endpoint time frame | Day 29 ± 1 |
| Primary completion / readout proxy | [object Object] |
Protocol design and endpoint interpretation
The aim of the study is to evaluate the efficacy, safety, and tolerability of 4-MUST, 128 mg tablets compared to placebo in patients with chronic cholecystitis and biliary dyskinesia.
Allocation is Randomized, masking is Double, and the intervention model is Parallel Assignment. Planned enrollment of [object Object] participants across Russia shapes statistical precision, execution risk and external validity. Interpretation should account for baseline risk, prior therapy, assessment schedule, missing-data handling and clinical relevance—not only statistical significance.
- Mean reduction in the severity of pain/discomfort in the upper abdomen on the VAS by day 29 compared to baseline (Day 29 ± 1) — Visual analogue scale (VAS) from 0 to 100 mm, where 0 is "no pain", and 100 is "the worst pain one can imagine"
Readout outlook and evidence gap
The current protocol points to [object Object] as the best available readout proxy. Because this is an active or newly posted study, a trial-specific result citation is not included until a normalized clinical-trial-result record becomes available. That gap is itself operationally important: teams should monitor first result indexing, conference abstracts, protocol amendments and changes to the primary-completion date.
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Asset and sponsor context
Drug & Asset MCP profile: 4-Methylumbelliferyl Trimebutine Sulfate is indexed as Small molecule drug, with target No normalized target returned, mechanism No normalized mechanism returned, and global highest development status Phase 3.
Company & Deal Intelligence MCP profile: Valenta Pharmaceuticals JSC did not return an exact normalized organization match in this snapshot. The organization workflow adds identity, location, portfolio and partnering context where available.
The sponsor profile matters because scientific rationale alone does not determine development value. Manufacturing readiness, portfolio fit, geographic reach, partnering capacity and the ability to fund confirmatory development can determine whether a positive signal becomes a competitive asset.
White space around this program
- Sharper patient selection: prospective biomarker or phenotype definitions that identify who is most likely to benefit.
- Clinically interpretable endpoints: outcomes connecting activity with function, symptoms, survival or treatment burden.
- Comparator relevance: evidence against the most decision-relevant contemporary standard of care.
- Broader external validity: evidence across additional geographies, demographic groups and real-world settings.
- Operational differentiation: a development path that closes the readout gap without sacrificing safety or durability.
What to monitor next
Monitor recruitment, enrollment changes, protocol amendments, endpoint hierarchy, primary-completion timing, first result indexing, asset ownership and sponsor partnerships. A change in endpoint, population or ownership can alter the probability of success before a headline data release.
Bottom line
NCT07595003 provides a focused lens on Chronic cholecystitis development. Its value will be determined by whether 4-Methylumbelliferyl Trimebutine Sulfate can convert the current Phase 3 design into evidence that is clinically meaningful, operationally credible and differentiated from competing programs.
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