Product Description
LPCN 1021, a novel oral prodrug of testosterone containing testosterone undecanoate, is designed to help restore normal testosterone levels in hypogonadal men. (Sourced from: https://ir.lipocine.com/Lipocine-Resubmits-NDA-for-Its-Oral-Testosterone-Product-Candidate-LPCN-1021-for-Treatment-of-Hypogonadism)
Mechanisms of Action: AR Agonist
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: None *
Approval Status: Not Approved
Approved Countries: None
Approved Indications: None
Known Adverse Events: None
Company: Lipocine
Company Location: SALT LAKE CITY X1 84108
Company CEO: Mahesh V. Patel
Additonal Commercial Interests: None
Clinical Description

Countries in Clinic:
Active Clinical Trial Count:
Highest Development Phases
Phase 3: Eunuchism|Hypogonadism
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
---|---|---|---|---|---|
LPCN 1021-18-001 | P3 |
Completed |
Eunuchism|Hypogonadism |
2019-02-19 |
|
DF | P3 |
Completed |
Hypogonadism|Eunuchism |
2017-05-01 |
|
DV | P3 |
Completed |
Hypogonadism|Eunuchism |
2017-03-01 |
|
SOAR | P3 |
Completed |
Eunuchism|Hypogonadism |
2015-05-01 |