Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LPCN 1144 · 1 trial · 1 indication
Number of subjects presenting with a treatment-emergent adverse events
| Arm | Type | Description |
|---|---|---|
| Treatment A | EXPERIMENTAL | LPCN 1144 |
| Name | Type | Description |
|---|---|---|
| LPCN 1144 | DRUG | Oral LPCN 1144, total daily dose of 450 mg testosterone undecanoate administered as BID (225 mg testosterone undecanoate per dose). |
Inclusion Criteria: 1. Subjects who have completed the 38 week study LPCN 1144-18-002 and wish to be treated with LPCN 1144 2. Subject must sign the Informed Consent Form to participate in the study Exclusion Criteria: 1. Has participated or is participating in any other clinical (investigational...
LPCN 1144 is an investigational small molecule being developed for the treatment of nonalcoholic steatohepatitis (NASH), a metabolic liver condition. It is currently in Phase 2 clinical development and has not been approved by the FDA. The drug is intended for adult male patients with NASH.
LPCN 1144 is being developed by Lipocine Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol LPCN. The company is conducting clinical trials to evaluate the safety and tolerability of this investigational drug for the treatment of nonalcoholic steatohepatitis (NASH).
LPCN 1144 is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by the FDA for any use. The drug is being studied for the treatment of nonalcoholic steatohepatitis (NASH) in adult male patients.
LPCN 1144 has one completed Phase 2 clinical trial registered as NCT04685993. This study evaluated the safety and tolerability of LPCN 1144 in 25 adult male subjects with nonalcoholic steatohepatitis (NASH) in the United States. The trial was uncontrolled and not randomized or double-blinded.
The specific molecular target and mechanism of action for LPCN 1144 have not been disclosed in available clinical trial information. The drug is classified as a small molecule and is being investigated for its potential therapeutic effect in nonalcoholic steatohepatitis (NASH), a metabolic liver disease.