ChiCTR2600120535 Butaselen Cryptogenic Organizing Pneumonia Clinical Landscape Report 2026: Design, Endpoints, Sponsor and Readout Outlook
Turn a newly registered trial into a decision-ready clinical landscape. This report examines ChiCTR2600120535 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: 27 August 2026. Trial records, recruitment status and projected dates can change after the snapshot and should be rechecked before operational decisions.
Why ChiCTR2600120535 is a hot trial to watch
Cryptogenic Organizing Pneumonia is being segmented by mechanism, treatment setting, geography and endpoint architecture. ChiCTR2600120535 is notable because it evaluates Butaselen in a Phase 2 design sponsored by China-Japan Friendship 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 | ChiCTR2600120535 |
| Official title | A multiple-center, randomized, double-blind, placebo-controlled phase IIb clinical trial evaluating the safety and efficacy of standard treatment in combination with butaselen tablets in patients with fibrosing interstitial lung disease |
| Phase / status | Phase 2 / Recruiting |
| Intervention | Butaselen |
| Sponsor | China-Japan Friendship Hospital |
| Geography | China |
| Enrollment | 12 |
| Primary endpoint | Adverse event |
| Endpoint time frame | W4/W12/W24 |
| Primary completion / readout proxy | 2026-12-31 |
Protocol design and endpoint interpretation
The indexed record describes a Phase 2 study of Butaselen in Cryptogenic Organizing Pneumonia.
Allocation is not reported, masking is not reported, and the intervention model is Parallel Assignment. Planned enrollment of 12 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.
- Adverse event (W4/W12/W24) — Evaluate the frequency and severity of adverse events (AE) Serious Adverse event
- Serious Adverse event (W4/W12/W24) — Evaluate the frequency and severity of serious adverse events (SAEs)
- adverse drug reactions (W4/W12/W24) — Evaluate the frequency and severity of adverse drug reactions(ADR)
Readout outlook and evidence gap
The current protocol points to 2026-12-31 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: Butaselen 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: China-Japan Friendship Hospital is resolved to a normalized organization record in Beijing 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
ChiCTR2600120535 provides a focused lens on Cryptogenic Organizing Pneumonia development. Its value will be determined by whether Butaselen can convert the current Phase 2 design into evidence that is clinically meaningful, operationally credible and differentiated from competing programs.
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