Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Testosterone undecanoate (TU) - NebidoTM
Testosterone undecanoate- NebidoTM · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Arm 1 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Testosterone undecanoate (TU) - NebidoTM | DRUG | Drug treatment with 14 injections of one ampoule of Nebido (1000 mg of testosterone undecanoate) at individually adjusted injection intervals |
Inclusion Criteria: * Hypogonadal men, aged 18-75 years with low serum total testosterone (TT) levels and symptoms of androgen deficiency Exclusion Criteria: * Tumors of the prostate or the male mammary gland including suspicion thereof. Past or present liver tumors or chronic hepatic disease wit...
Testosterone undecanoate- Nebido is used for the treatment of hypogonadism, a condition in which the body does not produce enough testosterone. It is an androgen replacement therapy in the endocrine therapeutic area. The drug is a small molecule developed by Bayer AG under the ticker BAYRY.
Testosterone undecanoate- Nebido works as an agonist of the androgen receptor (AR). By binding to and activating this receptor, it mimics the action of endogenous testosterone. This target class of agonist activity supports its use in hypogonadism, where androgen receptor stimulation is needed to restore testosterone effects.
Testosterone undecanoate- Nebido is made by Bayer AG, which trades under the ticker BAYRY. Bayer AG is the developer of this androgen receptor agonist for hypogonadism.
Testosterone undecanoate- Nebido is in Phase 3 development. It is an investigational therapy that has been studied in a completed Phase 3 trial. The drug is not described as approved, and it remains in clinical development for hypogonadism.
Testosterone undecanoate- Nebido has been studied in one completed Phase 3 trial, NCT00220298, titled Assessment of Long Term Treatment With Testosterone Undecanoate in Males With Hypogonadism. The trial enrolled 96 male participants aged 18 years and older in Germany. It was an uncontrolled study.
Yes, Testosterone undecanoate- Nebido is also known as testosterone undecanoate (TU). The name Nebido refers to the same active substance, testosterone undecanoate, which is a small molecule androgen receptor agonist developed by Bayer AG for hypogonadism.