Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as TLANDO
LPCN 1021 · 3 trials · 1 indication
Change in average systolic blood pressure as measured by ambulatory blood pressure monitoring (ABPM) from Visit 3 (Baseline) to Visit 5 (End of Study)
Safety Set; Proportion of LPCN 1021-treated subjects who achieve a total testosterone average concentration \[Cavg\] in the normal range
| Arm | Type | Description |
|---|---|---|
| LPCN 1021 | EXPERIMENTAL | LPCN 1021 at a 225 mg dose taken twice daily (total daily dose of 450 mg taken as 225 mg in the morning and 225 mg in the evening), |
| Oral testosterone undecanoate, LPCN 1021 | EXPERIMENTAL | Oral testosterone undecanoate, LPCN 1021 150 mg TU three times a day |
| Name | Type | Description |
|---|---|---|
| LPCN 1021 | DRUG | LPCN 1021 is gelatin capsule product provided as 112.5 mg testosterone undecanoate per capsule. |
Inclusion Criteria: 1. Voluntarily sign and date the study consent form(s) which have been approved by an Institutional Review Board (IRB). Written consent must be obtained prior to the initiation of any study procedures. 2. Male between 18 and 80 years of age, inclusive, with documented onset of h...
LPCN 1021 is an oral testosterone undecanoate therapy being developed for the treatment of hypogonadism in adult men, a condition in which the body does not produce enough testosterone. It is an investigational small molecule product candidate in the endocrine therapeutic area.
LPCN 1021 targets testosterone. It is an oral formulation of testosterone undecanoate, an ester of the endogenous hormone testosterone, designed to restore circulating testosterone levels in hypogonadal men. Its target class is hormonal.
LPCN 1021 is being developed by Lipocine Inc., a biopharmaceutical company that trades under the ticker symbol LPCN. Lipocine is the sponsor of the clinical program evaluating the oral testosterone undecanoate candidate.
LPCN 1021 is in Phase 3 clinical development. It is an investigational product candidate and has completed three Phase 3 trials in hypogonadal men. It has not been established as approved for marketing.
Three completed Phase 3 trials have evaluated LPCN 1021: NCT03868059, an ambulatory blood pressure monitoring study in 138 hypogonadal men; NCT03242590, a dosing validation study in 95 men; and NCT03242408, a dosing flexibility study in 100 men. All enrolled adult males with hypogonadism.
LPCN 1021 is an oral formulation of testosterone undecanoate, so the two names refer to the same active agent in this program. LPCN 1021 is Lipocine's designation for its oral testosterone undecanoate product candidate being studied in hypogonadal men.