ChiCTR2600126528 Denifanstat Acne Vulgaris Clinical Landscape Report 2026: Design, Endpoints, Sponsor and Readout Outlook
Turn a newly registered trial into a decision-ready clinical landscape. This report examines ChiCTR2600126528 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: 7 August 2026. Trial records, recruitment status and projected dates can change after the snapshot and should be rechecked before operational decisions.
Why ChiCTR2600126528 is a hot trial to watch
Acne Vulgaris is being segmented by mechanism, treatment setting, geography and endpoint architecture. ChiCTR2600126528 is notable because it evaluates Denifanstat in a Phase 3 design sponsored by Shanghai Huashan Hospital. 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 | ChiCTR2600126528 |
| Official title | A Phase III Open, extended, Multi-center Study to Evaluate the long-term Safety of ASC40 (Denifanstat) Tablets in Subjects With Moderate to Severe Acne Vulgaris |
| Phase / status | Phase 3 / Completed |
| Intervention | Denifanstat |
| Sponsor | Shanghai Huashan Hospital |
| Geography | China |
| Enrollment | [object Object] |
| Primary endpoint | Number and percentage of subjects with treatment-phase adverse events (TEAE) |
| Endpoint time frame | from the first dose to 40 weeks of treatment. |
| Primary completion / readout proxy | [object Object] |
Protocol design and endpoint interpretation
The indexed record describes a Phase 3 study of Denifanstat in Acne Vulgaris.
Allocation is not reported, masking is NA, and the intervention model is Single Group Assignment. Planned enrollment of [object Object] participants across China 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.
- Number and percentage of subjects with treatment-phase adverse events (TEAE) (from the first dose to 40 weeks of treatment.) — Adverse events that occur or worsen in severity from baseline (pre-treatment) during or after initial administration of the investigational drug product until termination of the investigational drug product or initiation of new treatment, whichever occurs first.
- Number and percentage of subjects with a serious adverse event (SAE). (from the first dose to 40 weeks of treatment.) — Serious adverse events were collected from the first administration to the last visit.
- Number and percentage of subjects who discontinued due to adverse events. (from the first dose to 40 weeks of treatment.) — Number and percentage of subjects who discontinued due to adverse events from the first dose to 40 weeks of treatment.
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: Denifanstat is indexed as No normalized modality returned, with target No normalized target returned, mechanism No normalized mechanism returned, and global highest development status No normalized global status returned.
Company & Deal Intelligence MCP profile: Shanghai Huashan Hospital is resolved to a normalized organization record in Shanghai Shi, China. 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
ChiCTR2600126528 provides a focused lens on Acne Vulgaris development. Its value will be determined by whether Denifanstat can convert the current Phase 3 design into evidence that is clinically meaningful, operationally credible and differentiated from competing programs.
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