Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 investigational oral testosterone undecanoate being developed for the treatment of male hypogonadism, a condition in which the body does not produce enough testosterone. It is a small molecule endocrine therapy currently in Phase 3 clinical development, though it is not yet approved by regulatory authorities.
LPCN 1021 is an oral formulation of testosterone undecanoate, a testosterone replacement therapy. It works by delivering testosterone to the body to restore normal levels in men with hypogonadism. The drug is designed to be taken orally, providing an alternative to injectable or topical testosterone products.
LPCN 1021 is being developed by Lipocine Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol LPCN. Lipocine specializes in oral drug delivery technologies and is advancing this product candidate through late-stage clinical trials for male hypogonadism.
LPCN 1021 is in Phase 3 clinical development. It has completed three Phase 3 trials, all of which are finished, and no active trials are currently ongoing. The drug remains investigational and has not received FDA approval, as it is still undergoing clinical evaluation for safety and efficacy.
LPCN 1021 has completed three Phase 3 clinical trials. These include NCT03242408, a dosing flexibility study with 100 participants; NCT03242590, a dosing validation study with 95 participants; and NCT03868059, an ambulatory blood pressure monitoring study with 138 participants. All trials enrolled men aged 18 years and older with male hypogonadism.
Yes, LPCN 1021 is an oral formulation of testosterone undecanoate, also referred to as TU. It is designed to deliver testosterone orally to treat male hypogonadism. The drug is being developed by Lipocine Inc. and is currently in Phase 3 clinical trials, though it is not yet approved for commercial use.