Stable Radionuclide Complex Formulations, ITM Solucin GmbH
Summary
USPTO granted Patent US12605447B2 to ITM Solucin GmbH on April 21, 2026, covering pharmaceutical compositions of radiolabeled radionuclide complexes with ascorbic acid-based stabilization against radiolytic degradation. The patent names Sebastian Marx, Oliver Leib, Luke Heames, and Elena Maria Andreolli as inventors and specifies 20 claims. Assignees and licensees in radiopharmaceutical development may wish to review freedom-to-operate implications for radionuclide targeting formulations using ascorbic acid stabilizers.
“The present invention provides a pharmaceutical composition comprising a radiolabeled complex comprising a radionuclide and a targeting molecule linked to a chelating agent; and a stabilizer against radiolytic degradation comprising ascorbic acid and/or a salt thereof; wherein the composition does not comprise gentisic acid or a salt thereof.”
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GovPing monitors USPTO Patent Grants - Pharma (A61K) for new healthcare & life sciences regulatory changes. Every update since tracking began is archived, classified, and available as free RSS or email alerts — 29 changes logged to date.
What changed
USPTO granted Patent US12605447B2 to ITM Solucin GmbH for stable pharmaceutical compositions of radiolabeled radionuclide complexes. The compositions contain a stabilizer against radiolytic degradation comprising ascorbic acid and/or a salt thereof, specifically excluding gentisic acid or its salts. The patent covers 20 claims across CPC classifications A61K 47/00 through A61K 2121/00.
Affected parties developing radiopharmaceuticals or radionuclide targeting agents should conduct freedom-to-operate analyses to assess whether their formulations may fall within the scope of these claims. The exclusion of gentisic acid from the claimed stabilizer system defines a specific compositional space that may differentiate ITM's approach from prior art.
Archived snapshot
Apr 26, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Stable formulations for radionuclide complexes
Grant US12605447B2 Kind: B2 Apr 21, 2026
Assignee
ITM Solucin GmbH
Inventors
Sebastian Marx, Oliver Leib, Luke Heames, Elena Maria Andreolli
Abstract
The present invention provides a pharmaceutical composition comprising a radiolabeled complex comprising a radionuclide and a targeting molecule linked to a chelating agent; and a stabilizer against radiolytic degradation comprising ascorbic acid and/or a salt thereof; wherein the composition does not comprise gentisic acid or a salt thereof. The pharmaceutical composition of the present invention provides high stability against radiolytic degradation. The present invention also provides a process for preparing such a pharmaceutical composition.
CPC Classifications
A61K 47/00 A61K 47/22 A61K 51/00 A61K 51/08 A61K 51/088 A61K 2121/00 A61K 9/0019 A61K 9/0021 A61K 9/08 A61K 47/12 A61K 51/082
Filing Date
2025-01-17
Application No.
19028880
Claims
20
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