Testosterone undecanoate is under clinical development by Marius Pharmaceuticals and currently in Phase I for Male Infertility. According to GlobalData, Phase I drugs for Male Infertility does not have sufficient historical data to build an indication benchmark PTSR for Phase I. GlobalData uses proprietary data and analytics to create drugs-specific PTSR and LoA in the Testosterone undecanoate LoA Report. 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 undecanoate overview

Testosterone undecanoate (Kyzatrex) is a hormone replacement agent. It is formulated as capsules for oral route of administration. Kyzatrex is indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone, primary hypogonadism (congenital or acquired) and hypogonadotropic hypogonadism (congenital or acquired).

Testosterone undecanoate (SOV2012-F1) was under development for the treatment of Klinefelter syndrome and male fertility. The drug candidate is administered as oral capsule. It is a pro-drug of testosterone, acts by targeting androgen receptor. Testosterone undecanoate is developed based on a proprietary technology that uses pro-drug of testosterone to enhance the delivery of testosterone.

Marius Pharmaceuticals overview

Marius Pharmaceuticals (Marius) is a biopharmaceutical company. The company develops SOV-2012-F1, an oral testosterone replacement therapy (TRT). It’s testosterone therapeutic areas include obesity, type 2 diabetes and others. The therapy is developed to utilize phytosterols to enhance absorption through the lymphatic system for men with hypogonadism. The company also develops treatment for constitutional delay in growth and puberty (CDGP) in adolescent males. It operates in the US. Marius is headquartered in Raleigh, North Carolina, US.

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

This content was updated on 20 February 2024

Premium Insights


The gold standard of business intelligence.

Blending expert knowledge with cutting-edge technology, GlobalData’s unrivalled proprietary data will enable you to decode what’s happening in your market. You can make better informed decisions and gain a future-proof advantage over your competitors.


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 clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.