Testosterone dodecanoate compositions and methods
Inventors
Patel, Mahesh V. • Papangkorn, Kongnara • Ogle, Jonathan • Chidambaram, Nachiappan • BRUNO, Benjamin J.
Assignees
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Publication Number
US-12257257-B2
Publication Date
2025-03-25
Expiration Date
Abstract
Disclosed is a method and oral composition for treating a plurality of End stage diseases such as end-stage renal disease, chronic kidney disease, liver cirrhosis, chronic liver failure, end stage liver disease, Cancer, congestive Heart failure, pulmonary fibrosis, chronic obstructive pulmonary disease. In an embodiment of the invention, the composition comprises testosterone duodecanoate.
Core Innovation
The invention is directed to oral administration of a pharmaceutical substance comprising or prepared from a TDPC, wherein the administration results in at least one of no deterioration in a subject and an improvement in the subject. The outcomes are assessed in comparison to at least one of a TDPC pre-administration state of the subject and a placebo administration, with explicit health domains including cardiovascular risk, cardiovascular health, prostate health, muscle health, CNS health, GI health, cell health, and median hospitalization duration.
The invention addresses treatment of a condition in a subject with end-stage diseases, especially liver cirrhosis and sarcopenia, including subjects independent of gonadal status, while maintaining or improving multiple aspects of health. The disclosed outcomes include no deterioration or improvement in cardiovascular risk and health, prostate health, muscle health, CNS health, GI health, and cell health, as well as median hospitalization duration.
The TDPC is associated with improved oral performance relative to comparisons including placebo, TDPC pre-administration state, oral testosterone undecanoate (TU), and non-TD testosterone ester compositions (NDPC). The disclosed formulation approach emphasizes solubilization and stability, including observations of undissolved TD crystals for certain selected formulations and solubility/stability for others.
The invention further relates to treatment regimens and TDPC composition features used to achieve the stated outcomes, including TDPC formulation ratios and weight/weight ratios of TD to lipophilic additive and TD to hydrophilic additive. The outcomes described include measures relevant to hepatic encephalopathy risk and events, cardiovascular risk markers, prostate-related measures, muscle indices, hospitalization duration, and quality-of-life scoring.
Claims Coverage
The provided material supports one independent claim directed to oral administration of a TDPC-based pharmaceutical substance, where treatment yields either no deterioration and/or improvement in multiple health domains compared with a TDPC pre-administration state and/or placebo. The claim coverage explicitly includes cardiovascular risk/health, prostate health, muscle health, CNS health, GI health, cell health, and median hospitalization duration.
Oral TDPC-based treatment producing multi-domain no deterioration
Orally administering a pharmaceutical substance comprising or prepared from a TDPC, wherein compared with at least one of a TDPC pre-administration state and a placebo administration, the administration results in no deterioration in at least one of cardiovascular risk, cardiovascular health, prostate health, muscle health, CNS health, GI health, cell health, and median hospitalization duration.
Oral TDPC-based treatment producing multi-domain improvement
Orally administering a pharmaceutical substance comprising or prepared from a TDPC, wherein compared with at least one of a TDPC pre-administration state and a placebo administration, the administration results in an improvement in at least one of cardiovascular risk, cardiovascular health, prostate health, muscle health, CNS health, GI health, cell health, and median hospitalization duration.
Coverage is centered on oral administration of a TDPC-based pharmaceutical substance where treatment yields either no deterioration or improvement across one or more of the listed health domains, relative to a TDPC pre-administration state and/or placebo, including median hospitalization duration.
Stated Advantages
No deterioration in at least one of cardiovascular risk, cardiovascular health, prostate health, muscle health, CNS health, GI health, cell health, and median hospitalization duration compared with TDPC pre-administration state and/or placebo.
Improvement in at least one of cardiovascular risk, cardiovascular health, prostate health, muscle health, CNS health, GI health, cell health, and median hospitalization duration compared with TDPC pre-administration state and/or placebo.
Improved oral performance outcomes described as favorable comparative outcomes versus placebo and versus oral testosterone undecanoate (TU) and non-TD testosterone ester compositions (NDPC).
Solubilization and stability advantages are described through observations of solubilized/stable formulations versus formulations with undissolved TD crystals.
Documented Applications
Treatment of end-stage diseases, especially liver cirrhosis and sarcopenia, including subjects independent of gonadal status.
Treatment outcomes described for hepatic encephalopathy in the context of liver disease and pre-liver transplant conditions.
Use of TDPC-based oral administration with comparative outcomes including median hospitalization duration and quality-of-life scoring in sarcopenic cirrhosis awaiting transplant.
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