Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Testosterone enanthate · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Participants | EXPERIMENTAL | XYOSTED Injection (Testosterone enanthate) 25 mg / 0.5 mL, 50 mg / 0.5 mL, 75 mg / 0.5 mL, 100 mg / 0.5 mL |
| Name | Type | Description |
|---|---|---|
| Testosterone enanthate | COMBINATION_PRODUCT | XYOSTED 25 mg / 0.5 mL; XYOSTED 50 mg / 0.5 mL; XYOSTED 75 mg / 0.5 mL; XYOSTED 100 mg / 0.5 mL |
Inclusion Criteria: 1. Diagnosed with a deficiency or absence of endogenous testosterone due to primary or secondary hypogonadism of a known etiology. Children with combined hormone deficiencies are permitted to enroll (but the child must already be receiving treatment for concomitant hormonal defi...
Testosterone enanthate is used for testosterone replacement therapy in male adolescents with hypogonadism. It is being studied in a Phase 3 clinical trial to evaluate its safety, pharmacokinetics, and efficacy in this patient population. The drug is administered to address the symptoms associated with low testosterone levels in adolescent males.
Testosterone enanthate is being developed by Halozyme Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol HALO. The company is conducting a Phase 3 clinical trial to assess the drug's safety and efficacy in male adolescents with hypogonadism.
Testosterone enanthate is currently in Phase 3 clinical development. It is an investigational drug being studied for the treatment of male hypogonadism in adolescents. The ongoing Phase 3 trial is recruiting participants and is designed to evaluate the drug's safety, pharmacokinetics, and efficacy over a 52-week treatment period followed by a 24-month long-term extension.
Testosterone enanthate is being evaluated in a Phase 3 clinical trial with the identifier NCT06689085. This study is a 52-week study with a 24-month long-term extension, focusing on the safety, pharmacokinetics, and efficacy of the drug for testosterone replacement in male adolescents with hypogonadism. The trial is currently recruiting participants in the United States.
Testosterone enanthate is not FDA approved for the indication being studied. It is an investigational drug currently in Phase 3 clinical development for the treatment of male hypogonadism in adolescents. The ongoing clinical trial is designed to gather data on its safety and efficacy, which would be necessary for regulatory approval.
Testosterone enanthate is a small molecule that works by providing exogenous testosterone to replace deficient endogenous levels in males with hypogonadism. By supplementing testosterone, the drug aims to restore normal physiological levels and alleviate symptoms associated with low testosterone, such as delayed puberty and other hypogonadal manifestations.