[18F]MODAG-009 NCT07640555 Clinical Landscape 2026

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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: 18 September 2026. This strategic research report is not medical, regulatory or investment advice. Trial status and dates can change.

Early Phase 1

Clinical phase

Recruiting

Recruitment status

13

Planned enrollment

2027-05-01

Primary-completion proxy

Executive view

NCT07640555 evaluates [18F]MODAG-009 in Multiple System Atrophy. The disclosed sponsor is MODAG GmbH, the design is Interventional, and the geographic footprint is United States. The first listed primary endpoint is Standard Uptake Value Ratios (SUVR), assessed over Up to 3 hours after tracer injection..

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 NCT07640555 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]MODAG-009, while Company & Deal Intelligence MCP organization_fetch was queried for MODAG GmbH.

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
NCT07640555	[18F]MODAG-009	Early Phase 1 / Recruiting	MODAG GmbH	United States	Standard Uptake Value Ratios (SUVR) Up to 3 hours after tracer injection.	2027-05-01
NCT07685444	LY-N001(Lingyi (Hangzhou) Biotechnology)	Early Phase 1 / Not yet recruiting	Lingyi (Hangzhou) Biotechnology Co., Ltd.	China	Incidence of dose-limiting toxicity (DLT) events occurring within at least 28 days following a single intracranial admi… Within 28 days post-administration	2028-07-07
ACTRN12626000769381	Levodopa hydrate	Phase 1 / Not yet recruiting	University of Edith Cowan	Australia		Timing not reported
ACTRN12626000740392	Probucol	Phase 2 / Not yet recruiting	Curtin University	Australia		Timing not reported
NCT07647913	Levodopa hydrate	Not Applicable / Not yet recruiting	McMaster University	Canada	Changes in mean inter-tap intervals following Levodopa withdrawal during rhythmic tapping tasks. Between experimental sessions one and two, which will take place appr…	2027-09-30

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.

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Protocol design and endpoint interpretation

NCT07640555 is a Early Phase 1, recruiting study with 13 planned participants. Allocation is N/A, masking is None (Open Label), and the intervention model is Single Group Assignment.

The primary endpoint is “Standard Uptake Value Ratios (SUVR)” over “Up to 3 hours after tracer injection..” The retrieved endpoint description is: To evaluate Standard Uptake Value Ratios (SUVR) in brain regions from \[18F\]MODAG-009 in participants with PD..

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 13 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 NCT07640555 unless the registration number matches.

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

Effect of Midodrine vs Abdominal Compression on Cardiovascular Risk Markers in Autonomic Failure Patients

Early Phase 1; n=31; Augmentation Index(Mean) = 30 Percentage (Standard Deviation, 25); Augmentation Index(Mean) = -20 Percentage (Standard Deviation, 7) Source: https://clinicaltrials.gov/ct2/show/results/NCT04620382

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]MODAG-009 is indexed as Diagnostic radiopharmaceuticals with target not reported biology and a global stage of Early Phase 1. The asset profile lists MODAG GmbH as an originator or developer.

MODAG GmbH is indexed in Germany with the website http://www.modag.net. MODAG aims to provide a novel approach for treating neurodegenerative diseases by combining targeted small molecule therapeutics. The record lists 2 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]MODAG-009 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: NCT07640555
Protocol source: https://clinicaltrials.gov/study/NCT07640555
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: 18 September 2026.

[18F]MODAG-009 in Multiple System Atrophy is best understood through the interaction of protocol design, surrounding readouts, asset context and sponsor execution. The current record makes Standard Uptake Value Ratios (SUVR) and 2027-05-01 the leading decision points.

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[18F]MODAG-009 in Multiple System Atrophy: NCT07640555 Clinical Landscape Report 2026