Pharmaceutical aqueous formulation comprising 1-(4-{[4-(dimethylamino)piperidin-1-yl]carbonyl}phenyl)-3-[4-(4,6-dimorpholin-4-yl-1,3,5-triazin-2-yl)phenyljurea
Inventors
HUSSEY, JAMES JOSEPH • BRIGHT, ANDREW GILBERT
Assignees
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Publication Number
US-12642803-B2
Publication Date
2026-06-02
Expiration Date
Abstract
The present invention relates to a pharmaceutical aqueous formulation comprising 1-(4-{[4-(dimethylamino)piperidin-1-yl]carbonyl}phenyl)-3-[4-(4,6-dimorpholin-4-yl-1,3,5-triazin-2-yl)phenyl]urea, or a pharmaceutically acceptable alkanesulphonate salt thereof, that is a clear solution. Such a formulation is particularly suitable for intravenous or parenteral administration to a patient.
Core Innovation
The invention describes a clear pharmaceutical aqueous solution containing gedatolisib or an alkanesulphonate salt thereof, for administration in a method of treating cancer in a mammal. The disclosed formulations use methanesulphonic or ethanesulphonic acid, and may include cyclodextrins. The document also describes formulations that may be lyophilised and reconstituted.
The supplied content reports clear, particle-free solutions and chemical stability in lyophilised samples, and describes cyclodextrin-containing formulations as enabling higher concentrations. The background section is not included in the supplied content, so the problem identified in that section is not explicitly described in patent. The disclosed purpose is cancer treatment using the aqueous solution formulation.
Claims Coverage
The supplied claims identify one independent claim with one primary inventive feature, directed to a method of treating cancer in a mammal by administering a clear pharmaceutical aqueous solution formulation containing gedatolisib or an alkanesulphonate salt thereof.
Cancer treatment using a clear aqueous solution
The independent claim covers administering an effective amount of a clear pharmaceutical aqueous solution formulation comprising gedatolisib or an alkanesulphonate salt thereof to a mammal in need of cancer treatment. Dependent claims further specify formulation components, including methanesulphonic acid, water, and cyclodextrins; identify particular cancer types; and add formulation and administration limitations.
The claim coverage centers on the use of a clear aqueous gedatolisib formulation or its alkanesulphonate salt in cancer treatment, with dependent claims refining the formulation and its use.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Treatment of cancer in a mammal using a clear aqueous solution formulation containing gedatolisib or an alkanesulphonate salt thereof.
Intravenous or parenteral use of the disclosed aqueous formulations.
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