Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as LY900011, Testosterone, Testosterone Solution, Testosterone Solution 2%, Testosterone MD-Lotion, Topical Testosterone Solution
Axiron · 3 trials · 3 indications
Normal range for total serum testosterone was defined as 300 to 1050 nanograms per deciliter (ng/dL).
MSHQ-EjD-SF: 4 item, self-reported questionnaire assessing ejaculatory dysfunction. MSHQ-EjD-SF Ejaculatory Function Score: sum of scores for questions (Q)1 through Q3 about frequency and strength of ejaculations and volume of ejaculate for sexual activity attempts during past month. Ejaculation frequency was rated 1 (could not ejaculate) to 5 (all the time); strength and volume from 0 (could not ejaculate) to 5 (as strong/much as it always has been). Total Ejaculatory Function Score ranged from 1 to 15. Least-squares (LS) mean of change from baseline calculated using repeated measures mixed-effects model (MMRM) including treatment, visit, treatment-by-visit interaction, region, baseline total testosterone level \[≥200 nanograms per deciliter (ng/dL) versus (vs.) \<200 ng/dL\], baseline erectile dysfunction (ED) severity (normal, mild, moderate, severe), and centered baseline ejaculatory function score as fixed effects, and unstructured covariance structure for modeling correlation.
This is a summary of the amounts of testosterone measured on a 10 centimeters (cm) × 10 cm of material excised from the underarm area of participant's unwashed t-shirt halves.
| Arm | Type | Description |
|---|---|---|
| Placebo Solution | PLACEBO_COMPARATOR | Placebo Solution applied topically once daily for 12 weeks. |
| Testosterone Solution | EXPERIMENTAL | Testosterone Solution 60 milligram (mg) applied topically once daily with possible titration down to 30 milligram per day (mg/day) or up to 120 mg/day for 12 weeks and optional extension for 24 weeks. |
| Testosterone Solution 2% 60 milligrams (mg) | EXPERIMENTAL | Testosterone Solution 2% 60 mg applied topically once daily with possible 1-time titration to 30 milligrams per day (mg/day) or 90 mg/day for 16 weeks |
| Placebo | PLACEBO_COMPARATOR | Placebo solution applied topically once daily for 16 weeks |
| Axiron | EXPERIMENTAL | Axiron administered topically via metered dose pump to each underarm on Day 1 |
| Name | Type | Description |
|---|---|---|
| Testosterone Solution | DRUG | Administered topically to axillae. |
| Placebo Solution | DRUG | Administered topically to axillae. |
| Testosterone Solution 2% | DRUG | Administered topically |
| Axiron | DRUG | Solution administered topically using pump and applicator |
Inclusion Criteria: * Total testosterone level \<300 nanogram per deciliter (ng/dL) \[10.4 nanomole per Liter (nmol/L)\] at each of 2 screening visits * At least 1 symptom of testosterone deficiency, which must include decreased energy or decreased sexual drive * Prostate Specific Antigen (PSA) \<4...
Axiron is a small molecule therapeutic developed by Eli Lilly and Company. It has been studied in a Phase 1 clinical trial in healthy male volunteers. The specific medical conditions it is intended to treat have not been publicly disclosed.
Axiron is made by Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker symbol LLY. Eli Lilly is the developer responsible for the clinical program evaluating Axiron.
Axiron is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The program remains investigational and has not been approved by the FDA for any indication.
Axiron has been evaluated in one completed Phase 1 trial, NCT02004132, titled A Study of Axiron in Healthy Participants. The trial enrolled 12 healthy male volunteers aged 18 years and older in the United States. It was an uncontrolled study without randomization or double blinding.
The therapeutic indications for Axiron have not been publicly disclosed. The completed Phase 1 trial, NCT02004132, was conducted in healthy volunteers rather than in patients with a specific disease, which is typical of early-stage safety and tolerability studies.
Axiron is an investigational drug in Phase 1 clinical development and is not approved by the FDA for any indication. Only one Phase 1 trial has been completed, and no active trials are currently listed for the program.