Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
testosterone undecanoate, LPCN 1021 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Oral testosterone undecanoate, LPCN 1021 | EXPERIMENTAL | Oral testosterone undecanoate: Initial dose: 225 mg TU BID. Dose titrated up to 300 mg TU BID or down to 150 mg TU BID based on serum T at Week 3 and 7. |
| Topical testosterone gel 1.62 % | OTHER | Topical testosterone gel 1.62%: Initial dose: 40.5 mg T once daily. Dose titrated down to 20.25 mg or up to 81 mg based on serum T on Days 14 and 28 |
| Name | Type | Description |
|---|---|---|
| Oral testosterone undecanoate, LPCN 1021 | DRUG | - |
| Topical testosterone gel 1.62 % | DRUG | - |
Inclusion Criteria: 1. Documented diagnosis of primary hypogonadism (congenital or acquired) or hypogonadotropic hypogonadism (congenital or acquired). 2. Serum total testosterone \< 300 ng/dL based on 2 consecutive blood samples Exclusion Criteria: A subject will not be eligible for study partic...
Testosterone undecanoate, also known as LPCN 1021, is being developed for the treatment of male hypogonadism, a condition in which men have low testosterone levels. It is an oral formulation studied in adult men aged 18 years and older with low testosterone or hypogonadism.
Testosterone undecanoate acts as an agonist at the androgen receptor (AR). By binding and activating this receptor, it is designed to restore androgen activity in men with low endogenous testosterone. It is a small molecule administered orally.
LPCN 1021, an oral testosterone undecanoate product, is being developed by Lipocine Inc., which trades under the ticker LPCN. The company is the sponsor of the clinical program evaluating this candidate in male hypogonadism.
LPCN 1021 has completed a Phase 3 clinical trial in male hypogonadism. It is an investigational product and is not described as approved; the completed Phase 3 study evaluated its safety and efficacy in men with low testosterone or hypogonadism.
LPCN 1021 has been studied in the Phase 3 trial NCT02081300, titled Safety and Efficacy of Oral LPCN 1021 in Men With Low Testosterone or Hypogonadism. That trial enrolled 315 male participants aged 18 years and older and is completed.
Yes. LPCN 1021 is an oral testosterone undecanoate formulation, so the names oral testosterone undecanoate and LPCN 1021 refer to the same investigational product developed by Lipocine for male hypogonadism.