Testosterone undecanoate is a Small Molecule owned by Bayer, and is involved in 28 clinical trials, of which 25 were completed, and 3 are ongoing.

Testosterone undecanoate is an ester of testosterone, a steroid hormone. Testosterone undecanoate acts by activating androgen receptor (directly or as DHT), 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 can bind to the androgen receptor, or can be reduced to 5alpha-dihydrotestosterone (DHT) by the cytoplasmic enzyme 5alpha-reductase that binds to 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 $408m 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 Bayer. Endo International is the other company associated in development or marketing of Testosterone undecanoate.

Testosterone undecanoate Overview

Testosterone undecanoate (Nebid, Nebido, Androtardyl, Testoviron, Aveed, Primoteston, Reandron) is a hormone replacement agent. It is formulated as solution for injection for intramuscular route of administration. It  is indicated for the testosterone replacement therapy in male hypogonadal disorders, primary hypogonadism and hypogonadotropic hypogonadism.

Endo International Overview

Endo International (Endo) is a specialty healthcare company that develops, manufactures and commercializes various branded pharmaceuticals, generic pharmaceuticals, sterile injectables and other products through its operating companies. It sells generic products in the US in various categories including urology, pain management, central nervous system (CNS) disorders, immunosuppression, cancer, cardiovascular diseases and women’s health. The company offers branded pharmaceuticals for conditions related to urology, orthopedics, endocrine disorders and pain management. Endo also provides over-the-counter (OTC) products, which include dermatological products and anti-infectives. The company sells its products through independent wholesale distributors to retailers, government agencies, doctors, clinics, independent retail and specialty pharmacies and independent specialty distributors. Endo is headquartered in Dublin, Ireland.

The company reported revenues of (US Dollars) US$2,993.2 million for the fiscal year ended December 2021 (FY2021), an increase of 3.1% over FY2020. In FY2021, the company’s operating margin was 0.1%, compared to an operating margin of 17.3% in FY2020. The net loss of the company was US$613.3 million in FY2021, compared to a net profit of US$183.9 million in FY2020. The company reported revenues of US$541.7 million for the third quarter ended September 2022, a decrease of 4.8% over the previous quarter.

Quick View – Testosterone undecanoate

Report Segments
  • Innovator (Non-NME)
Drug Name
  • Testosterone undecanoate
Administration Pathway
  • Intramuscular
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.