Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Testosterone, Testosterone enanthate, QuickShot® Testosterone (QST)
Testosterone enanthate auto-injector · 4 trials · 1 indication
Number of participants experiencing adverse events that started on or after the first dose of QST, or existed prior to the first dose and woresened in severity or relatedness to QST after dosing, were evaluated in this population. Although a patient may have had 2 or more TEAEs or SAEs, the patient was counted only once within a SOC category. The same patient may have contributed to 2 or more preferred term categories. (Four patients had a total of 9 SAEs during the study)
The primary objective of this study was to demonstrate the efficacy of QST (QuickShot Testosterone) administered subcutaneously once each week to adult males with hypogonadism.
Intended users were patients experiencing an adverse event that was considered to be a TEAE if the adverse event started on or after randomization, or existed prior to randomization and worsened in severity or relatedness to QST (QuickShot® Testosterone auto-injector) after randomization.
Cmax = Maximum blood concentration (ng/dL) of TT=Total Testosterone and TE=Testosterone Enanthate
AUC(0-168h) (ng⋅hr/dL) = area under the concentration-time curve from time zero to Day 8 (1 week);
AUC(0-inf) (ng⋅hr/dL) = area under the concentration-time curve from time zero to infinity
| Arm | Type | Description |
|---|---|---|
| Testosterone enanthate auto-injector | EXPERIMENTAL | Testosterone enanthate 50 mg / 75 mg / 100 mg administered subcutaneously once each week with possible titration to a higher or lower dose at scheduled intervals during study. |
| Testosterone enanthate auto-injector - 50 mg | EXPERIMENTAL | Testosterone enanthate auto-injector - 50 mg (SC injection) |
| Testosterone enanthate auto-injector - 200 mg | EXPERIMENTAL | Testosterone enanthate auto-injector- 200 mg (SC injection) |
| Name | Type | Description |
|---|---|---|
| Testosterone enanthate auto-injector | COMBINATION_PRODUCT | Dose Adjustment 50 mg or 75 mg or 100 mg based upon Testosterone levels |
Inclusion Criteria: * Adult men ≥18 and ≤75 years of age with a documented history of hypogonadism * Total testosterone levels \< 300 ng/dL at two qualification visits * Patients in good general health Exclusion Criteria: * Allergy to sesame or testosterone products * BMI ≥ 40 kg/m2 * Hematocrit ...
Testosterone enanthate auto-injector is an investigational subcutaneous formulation of testosterone enanthate delivered by an auto-injector device. It is being developed by Halozyme Therapeutics, Inc. for testosterone replacement in adult men diagnosed with hypogonadism, a condition in which the body produces insufficient testosterone.
Testosterone enanthate auto-injector targets the androgen receptor (AR), where it acts as an agonist. By binding and activating the androgen receptor, testosterone enanthate replaces endogenous testosterone and supports androgen-dependent physiological functions in men with hypogonadism.
Halozyme Therapeutics, Inc. (ticker: HALO) is developing the testosterone enanthate auto-injector. The company is advancing the subcutaneous formulation for testosterone replacement therapy in adult male hypogonadism.
Testosterone enanthate auto-injector is in Phase 3 clinical development. It is an investigational product and has not been approved by the FDA. Four trials have been completed, including two Phase 3 studies, one Phase 2 study, and one Phase 1 pharmacokinetic study.
Completed trials include NCT02159469, a Phase 3 efficacy and safety study in 150 men; NCT02504541, a Phase 3 safety study in 133 men; NCT02777242, a Phase 2 safety study in 66 men; and NCT02233751, a Phase 1 pharmacokinetic study in 12 healthy volunteers. All enrolled adult males in the United States.
Testosterone enanthate auto-injector is being developed for hypogonadism, also called testosterone deficiency, in adult men. It is intended as testosterone replacement therapy delivered subcutaneously via an auto-injector device. The clinical program enrolled 361 participants across four completed trials, all conducted in the United States.