Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Androxal · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| 70 years or older | EXPERIMENTAL | Non-smoking healthy adult males \>or equal to 70 years of age. |
| Under 60 years of age | EXPERIMENTAL | Non-smoking healthy adult males\<60 years of age. |
| Name | Type | Description |
|---|---|---|
| Androxal 25 mg | DRUG | - |
Inclusion Criteria: 1. Speak, read, and understand English or Spanish and is willing and able to provide written informed consent on an IRB-approved form prior to the initiation of any study procedures; 2. Male; age \<60 or ≥70 years of age 3. No significant abnormal findings at the screening physi...
Androxal is a small molecule being studied for pharmacokinetics, meaning the way the drug is absorbed, distributed, metabolized, and eliminated by the body. It is currently in Phase 1 clinical development, and the completed trial enrolled healthy male volunteers aged 18 years and older in the United States.
Androxal is being developed by cbdMD, Inc., a company listed on the stock exchange under the ticker YCBD. The company is conducting clinical research on this small molecule drug candidate, which is currently in Phase 1 development.
Androxal is in Phase 1 clinical development. The drug is investigational and has not been approved by regulatory authorities. One Phase 1 study has been completed, and the drug is no longer in active clinical trials.
Androxal has one completed clinical trial, identified as NCT02169804. This was an open-label study titled "An Open-Label Study to Evaluate the Effect of Age Upon the Pharmacokinetics of Androxal," which enrolled 24 healthy male volunteers in the United States.
Androxal is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The completed trial focused on pharmacokinetics in healthy volunteers, and the drug has not yet progressed to later stages of clinical testing or regulatory submission.
Androxal is being studied with biomarker selection, meaning the clinical trial included a biomarker-based approach. However, the specific biomarker targeted has not been disclosed in the available information. The Phase 1 study focused on pharmacokinetics in healthy male volunteers.