Testosterone undecanoate is a Small Molecule owned by Clarus Therapeutics Holdings, and is involved in 16 clinical trials, of which 11 were completed, 3 are ongoing, and 2 are planned.

Testosterone undecanoate (CLR-610) 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 areas of binding are called hormone response elements (HREs), and influence transcriptional activity of certain genes, producing the androgen effects.

The revenue for Testosterone undecanoate is expected to reach a total of $1bn 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 Clarus Therapeutics Holdings.

Testosterone undecanoate Overview

Testosterone undecanoate (Jatenzo) is an undecanoate ester form of the androgen testosterone, with hormone replacement activity. It is formulated as soft gelatin capsules for oral route of administration. Jatenzo 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).

Clarus Therapeutics Holdings Overview

Clarus Therapeutics Holdings (Clarus Therapeutics) is a pharmaceutical company that develops and markets oral drugs for the treatment of testosterone deficiency and hypogonadism. The company develops JATENZO, a proprietary softgel capsule that contains a testosterone (T) prodrug and T undecanoate formulated to foster absorption via the intestinal lymphatic system. Its oral product eliminates the risk of T transfer to women, and children associated with the T gels. CTI also develops T replacement therapies. It partners with pharmaceutical companies for the development of new products. CTI is headquartered in Northbrook, Illinois, the US.

The company reported revenues of (US Dollars) US$14 million for the fiscal year ended December 2021 (FY2021), compared to a revenue of US$6.4 million in FY2020. The operating loss of the company was US$37.2 million in FY2021, compared to an operating loss of US$47.2 million in FY2020. The net loss of the company was US$40.6 million in FY2021, compared to a net profit of US$4.3 million in FY2020. The company reported revenues of US$4.1 million for the second quarter ended June 2022, an increase of 1% over the previous quarter.

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.