Testosterone undecanoate is a Small Molecule owned by Halozyme Therapeutics, and is involved in 1 clinical trial, which is planned.

Testosterone undecanoate acts by activation of the androgen receptor and by conversion to estradiol and activation of certain estrogen receptors. Free testosterone (T) is transported into the cytoplasm of target tissue cells, where it binds to the androgen receptor, or reduces to 5alpha-dihydrotestosterone (DHT) by the cytoplasmic enzyme 5alpha-reductase. DHT binds to the same androgen receptor even more strongly. The T-receptor or DHT-receptor complex undergoes a structural change that allows it to move into the cell nucleus and bind directly to specific nucleotide sequences of the chromosomal DNA.

The revenue for Testosterone undecanoate is expected to reach a total of $170m through 2038. This change impacts the valuation of this asset and is an important factor to understand the current value of the drug in a clinical process. View the complete picture with the Testosterone undecanoate NPV Report.

Testosterone undecanoate is currently owned by Halozyme Therapeutics. Lipocine is the other company associated in development or marketing of Testosterone undecanoate.

Testosterone undecanoate Overview

Testosterone undecanoate (Tlando) is a synthetic form of the endogenous androgenic steroid testosterone is developed based on Lip'ral technology. It is formulated as capsules for oral route of administration. Tlando is indicated for the testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone like primary hypogonadism (congenital or acquired) and hypogonadotropic hypogonadism (congenital or acquired).

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

The company reported revenues of (US Dollars) US$16.1 million for the fiscal year ended December 2021 (FY2021). The operating loss of the company was US$0.9 million in FY2021, compared to an operating loss of US$17.8 million in FY2020. The net loss of the company was US$0.6 million in FY2021, compared to a net loss of US$21 million in FY2020.

Quick View – Testosterone undecanoate

Report Segments
  • Innovator (Non-NME)
Drug Name
  • Testosterone undecanoate
Administration Pathway
  • Oral
Therapeutic Areas
  • Male Health
Key Companies
Highest Development Stage
  • Marketed

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

To create this model, GlobalData takes into account factors including patent law, known and projected regulatory approval processes, cash flows, potential applicable patients, drug margins, company expenses, and pricing estimates. Combining these data points with GlobalData’s world class analysis creates high value models that companies can use to help in evaluation processes for each drug or company.

The rNPV method integrates the probability of a drug reaching a clinical stage into the cash flow at that time, which provides a more accurate rNPV, as it considers the probability that the drug never makes it through the clinical pathway to commercialization. GlobalData’s rNPV model uses proprietary likelihood of approval (LoA)and phase transition success rate(PTSR) data for the indication in the highest development stage, which can be found on GlobalData’s Pharmaceutical Intelligence Center.