Testosterone Tridecanoate is under clinical development by Lipocine and currently in Phase II for Hepatic Encephalopathy. According to GlobalData, Phase II drugs for Hepatic Encephalopathy have a 33% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Testosterone Tridecanoate’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Testosterone Tridecanoate overview

Testosterone tridecanoate is under development for the management of decompensated liver cirrhosis in sarcopenia, secondary sarcopenia, hepatic encephalopathy. It is a prodrug of testosterone laurate. The drug candidate is administered through oral route as capsule formulation. It acts by targeting androgen receptor and is being developed based on Lip'ral technology.

It was under development for the treatment of non-alcoholic steatohepatitis.

Lipocine overview

Lipocine operates as a pharmaceutical company that develops and commercializes treatments for men’s and women’s health. The company’s pipeline products for men’s health include LPCN 1111 and LPCN 1021, and for women’s health include LPCN 1107. It’s LPCN 1111 is an oral testosterone product candidate and LPCN 1021 is an oral testosterone replacement therapy with a positive topline. Lipocine offers LPCN 1107, an oral hydroxyprogesterone caproate product for the prevention of preterm birth. It develops patented technology based on lipidic compositions that form an optimal dispersed phase in the gastrointestinal environment for improved absorption of the insoluble drug. Its Lip’ral is a technology based on lipidic compositions that form optimal dispersed phases in the gastrointestinal environment. Lipocine is headquartered in Salt Lake City, Utah, US

For a complete picture of Testosterone Tridecanoate’s drug-specific PTSR and LoA scores, buy the report here.


GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.