NCT07741045 TJ-0113 Young onset Parkinson disease Clinical Landscape Report 2026: Design, Endpoints, Sponsor and Readout Outlook

Turn a newly registered trial into a decision-ready clinical landscape. This report examines NCT07741045 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: 5 August 2026. Trial records, recruitment status and projected dates can change after the snapshot and should be rechecked before operational decisions.

Why NCT07741045 is a hot trial to watch

Young onset Parkinson disease is being segmented by mechanism, treatment setting, geography and endpoint architecture. NCT07741045 is notable because it evaluates TJ-0113 in a Phase 3 design sponsored by Hangzhou Tianji Jishi Biotechnology Co., Ltd.. The main development question is whether the protocol can translate its rationale into a clinically interpretable and operationally credible readout.

Trial landscape snapshot

Protocol design and endpoint interpretation

This study is a randomized, double-blind, multicenter, placebo-controlled Phase III clinical trial designed to evaluate the efficacy, safety, and Pop PK characteristics of TJ0113 Capsules in treating EOPD patients. This study plans to enroll approximately 300 EOPD participants, who will be randomized in a 1:1 ratio to two cohorts (Cohort 1: 200 mg dose group; Cohort 2: 400 mg dose group). Within each cohort, successfully screened participants will be stratified by stable use of dopamine receptor agonists (Yes vs. No) and stable use of Monoamine Oxidase B (MAO-B) inhibitors (Yes vs. No), and within each stratum, randomized in a 2:1 ratio to the TJ0113 Capsules group and the placebo group, with approximately 100 assigned to the TJ0113 Capsules group and approximately 50 assigned to the placebo group. In this trial, the sample size for the TJ0113 Capsules 200 mg group, TJ0113 Capsules 400 mg group, and placebo group will each be approximat

Allocation is Randomized, masking is Quadruple, and the intervention model is Parallel 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.

• Change from baseline in the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III score in off-anti-PD medication state at Week 26. "Off-anti-PD medication state" is defined as: ≥12 hours after the last dose of anti-PD medication (After 26 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: TJ-0113 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: Hangzhou Tianji Jishi Biotechnology Co., Ltd. is resolved to a normalized organization record in Hangzhou, 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

NCT07741045 provides a focused lens on Young onset Parkinson disease development. Its value will be determined by whether TJ-0113 can convert the current Phase 3 design into evidence that is clinically meaningful, operationally credible and differentiated from competing programs.

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