Tracers / [68Ga]Ga-DOTA-Z09591

[68Ga]Ga-DOTA-Z09591

Also written as [68Ga]Ga-ATH001; [68Ga]Ga-DOTA-Z09591; [Ga-68]Ga-DOTA-Z09591

Radionuclide: Ga-68 t½ 67.71 min
Modality: PET
Production route: —
Stage: phase 0 clinical study
Syntheses indexed: 1

Fibrosis (non-oncologic)

What it is

Compound class: Affibody molecule (DOTA-conjugated Cys-ATH001)
Target / mechanism: Platelet-derived growth factor receptor beta (PDGFRβ) PMID 41471324
Clinical application: PET imaging of PDGFRβ-expressing fibrotic remodeling in post-infarction myocardium PMID 41471324
Theranostic pair: —

Regulatory status

FDA: —
EMA (centralised): —
Other approvals: —
Brand names: —

Clinical use

Typical injected activity: —
Uptake time: —

Reported in the literature. Not a dosing recommendation.

Published syntheses

Module	Cassette	Purification	Yield %	RCP %	Precursor / supplier	Source
Modular-Lab PharmTracer Eckert & Ziegler	vendor cassette	SPE	61.7 ± 4.9% yes	98.1 ± 0.7%	DOTA-Cys-ATH001 Almac / Antaros Tracer AB	41471324 2025 Pharmaceuticals (Basel) the fully automated, cassette-based synthesis of [68Ga]Ga-ATH001 (Figure 4) was performed using the commercially available Modular-Lab PharmTracer platform — Decay-corrected radiochemical yield was 61.7 ± 4.9% with a duration of the production of 45–60 min.

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Quality control Preliminary — inferred from compound class

Ph. Eur. monograph: —
USP monograph: —

AppearancepHRCP HPLCHPLC UVRadionuclidic (HPGe)Half-lifeActivityEndotoxins (LAL)SterilityFilter integrityMolar activityMetal impuritiesGe-68 breakthrough

How this set was arrived at. base set per Ph. Eur. general monograph 0125 (rule); radiometal tracer -> metal impurities (rule); Ga-68, generator production assumed (no synthesis data found) -> Ge-68 breakthrough (preliminary); receptor ligand with a saturable target -> molar activity (rule)

Tests listed by reference only. Monograph texts are copyrighted and are not reproduced here. How these are derived

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Notes

Added from reverse module search (stage 6); 1 article(s) with Ga-68. Compound class inferred from precursor name (not stated outright) -- PMID 41471324: 'DOTA-Cys-ATH001'. Stage set/updated at stage 23 from PMID 41471324: '[68Ga]Ga-ATH001 was successfully developed and validated for phase 0 clinical study.'.