18F-FD4 in Multiple System Atrophy: NCT07604116 Clinical Landscape Report 2026
Explore the PatSnap Life Sciences MCP marketplace
This Clinical Landscape Report was built with PatSnap Life Sciences MCP workflows. Clinical Trials MCP supplies protocol and result records, Drug & Asset MCP adds asset context, and Company & Deal Intelligence MCP resolves sponsor background. Use the same structured MCP building blocks in your research workflow.
Data snapshot: 28 September 2026. This strategic research report is not medical, regulatory or investment advice. Trial status and dates can change.
Phase 1
Clinical phase
Recruiting
Recruitment status
30
Planned enrollment
2026-12-01
Primary-completion proxy
Executive view
NCT07604116 evaluates 18F-FD4 in Multiple System Atrophy. The disclosed sponsor is SynuSight Biotech (Shanghai) Co., Ltd, the design is Interventional, and the geographic footprint is China. The first listed primary endpoint is Incidence of Adverse Events, assessed over 5 days.
The key landscape question is whether this protocol can generate a clinically interpretable signal relative to nearby programs. Phase alone is not a measure of evidence quality. Endpoint relevance, comparator choice, masking, enrollment feasibility, patient selection, country coverage and follow-up must be considered together.
PatSnap MCP Servers make this assessment reproducible by keeping protocol facts, result evidence, asset attributes and sponsor identity in separate structured calls.
How the MCP evidence stack was assembled
Clinical Trials MCP clinical_trial_fetch retrieved the design, outcomes, phase, status, enrollment, sponsor, countries and timing for NCT07604116 and selected peers. clinical_trial_result_fetch supplied detailed result records from the wider Multiple System Atrophy landscape. Drug & Asset MCP drug_fetch was queried for 18F-FD4, while Company & Deal Intelligence MCP organization_fetch was queried for SynuSight Biotech (Shanghai) Co., Ltd.
This separation reduces a common diligence error: treating a registry label, a company description or a result excerpt as if each represented the complete evidence package. Explore the source workflow at the PatSnap MCP marketplace.
Trial landscape table
| Trial | Asset / intervention | Phase / status | Sponsor | Geography | Primary endpoint | Readout proxy |
|---|---|---|---|---|---|---|
| NCT07604116 | 18F-FD4 | Phase 1 / Recruiting | SynuSight Biotech (Shanghai) Co., Ltd | China | Incidence of Adverse Events 5 days | 2026-12-01 |
| NCT07630545 | MTX-325 | Phase 1 / Recruiting | MISSION Therapeutics Ltd. | United Kingdom, France, Australia, Germany | Safety and Tolerability up to 28 days post dose | 2027-06-30 |
| PACTR202605760621936 | Apomorphine Hydrochloride | Phase 4 / Recruiting | Sponsor not reported | Iraq | Timing not reported |
The table aligns endpoints, sponsors, phases, geographies and readout proxies. It is descriptive, not a head-to-head efficacy comparison. Differences in population, baseline risk, intervention schedule and follow-up can dominate apparent cross-trial differences.
Reproduce the trial-to-asset workflow with PatSnap MCP
Protocol design and endpoint interpretation
NCT07604116 is a Phase 1, recruiting study with 30 planned participants. Allocation is N/A, masking is None (Open Label), and the intervention model is Single Group Assignment.
The primary endpoint is “Incidence of Adverse Events” over “5 days.” The retrieved endpoint description is: Number of participants with adverse events, serious adverse events, physical examination abnormalities, vital sign abnormalities, ECG abnormalities, clinical laboratory abnormalities, injection site reaction after drug injection..
Interpretation should test whether the endpoint captures a clinically meaningful change, whether its time horizon matches the proposed biology, and whether treatment discontinuation or missing data can bias the estimate. The planned enrollment of 30 should be assessed against expected effect size, event frequency, multiplicity, subgroup plans and attrition.
No named control drug was returned in the protocol field set. A placebo comparator can strengthen internal efficacy assessment, while an active comparator may better test clinical differentiation. Single-arm and open-label programs require greater weight on objective outcomes, independent assessment and external benchmarks.
Indexed readouts in the surrounding landscape
5 recent result records were selected as contextual evidence for Multiple System Atrophy. These records do not establish direct evidence for NCT07604116 unless the registration number matches.
Istradefylline for Parkinson Disease Cognitive Impairment
Phase 2; n=15; Change in Executive Function - Card Sort Test(Median) = 4 T-score (Inter-Quartile Range, 0 - 6) Source: https://clinicaltrials.gov/ct2/show/results/NCT05333549
Psilocybin Therapy for Depression and Anxiety in Parkinson's Disease: a Pilot Study
Phase 2; n=12; 7 days following first drug dose(Mean) = 56.455 Total score (Standard Deviation, 19.154) Source: https://clinicaltrials.gov/ct2/show/results/NCT04932434
A Randomized, Double-blind, Placebo-controlled Trial of Allogeneic Bone Marrow-derived Mesenchymal Stem Cells as a Disease-modifying Therapy for Idiopathic Parkinson's Disease
Phase 2; n=45; Bayesian Mean Estimate of the Proportion of Participants Achieving a ≥5-point Improvement on MDS-UPDRS Part III From Screening to Week 62, Compared Between Each Active MSC Dose Arm and Placebo(Mean) = 94.4 percentage of participants (95% Confidence Interval, 74.7 - 99.7); Bayesian Mean Estimate of the Proportion of Participants Achieving a ≥5-point Improvement on MDS-UPDRS Part III From Screening to Week 62, Compare… Source: https://clinicaltrials.gov/ct2/show/results/NCT04506073
Result fields should be reconciled with the source record before quantitative comparison. Population definitions, analysis sets, dose cohorts, estimands, confidence intervals, rescue therapy and follow-up can materially change the meaning of a numerical endpoint. Clinical Trials MCP supports repeatable refreshes as result records change.
Asset and sponsor context
18F-FD4 is indexed as Diagnostic radiopharmaceuticals with α-synuclein biology and a global stage of Phase 1. The asset profile lists SynuSight Biotech (Shanghai) Co., Ltd as an originator or developer.
SynuSight Biotech (Shanghai) Co., Ltd is indexed in China with the website http://synusight.com. The organization record is used to resolve sponsor identity. The record lists 3 development-stage drug assets.
For execution diligence, monitor sponsor ownership, collaborator additions, site expansion, protocol amendments and enrollment revisions. A change in ownership or geography can alter operational confidence as well as the commercial meaning of a future readout.
Development white space
- Endpoint white space. Determine whether a more patient-relevant outcome, longer durability window or blinded central assessment would resolve uncertainty left by the current endpoint.
- Population white space. Test biomarker-defined, treatment-line or risk-stratified subgroups where effect size and unmet need could be clearer.
- Comparator white space. Identify whether the study can support differentiation against the current standard of care rather than only activity against baseline or placebo.
- Geographic white space. Assess whether the disclosed footprint supports recruitment, regulatory transferability and commercial generalizability.
- Sequencing white space. Clarify whether 18F-FD4 is intended for monotherapy, combination, maintenance, rescue or an earlier treatment line.
White space should be framed as an unanswered development question, not merely an unoccupied mechanism label. A credible program closes a measurable clinical uncertainty with a design that can be executed and interpreted.
Strategic implications and next readouts
For sponsors, the endpoint hierarchy, safety window, enrollment pace and protocol amendment history should all support the same target product profile. Advancement criteria should be set before the readout and tied to clinical effect, uncertainty, tolerability and operational feasibility.
For business-development teams, differentiation may come from a sharper population, stronger comparator, more durable benefit, simpler delivery or clearer sequencing role. For investors, the central risk is evidence quality relative to time and capital, not the phase label in isolation.
Track recruitment status, enrollment changes, primary-completion timing, endpoint revisions, new result records, sponsor ownership and collaborator changes. Re-run the PatSnap MCP workflow when a surrogate becomes a clinical outcome, a single-country study expands, the comparator changes or a new result materially shifts the competitive benchmark.
Source trail and bottom line
Anchor trial: NCT07604116
Protocol source: https://clinicaltrials.gov/study/NCT07604116
MCP sources: Clinical Trials MCP (clinical_trial_fetch and clinical_trial_result_fetch); Drug & Asset MCP (drug_fetch); Company & Deal Intelligence MCP (organization_fetch).
Data snapshot: 28 September 2026.
18F-FD4 in Multiple System Atrophy is best understood through the interaction of protocol design, surrounding readouts, asset context and sponsor execution. The current record makes Incidence of Adverse Events and 2026-12-01 the leading decision points.
Build and refresh clinical landscape reports with PatSnap MCP
