Drug intelligence / Profile preview

LPCN 1144 (testosterone undecanoate)

Development stage
Phase 2
Lead developer
Lipocine
Modality
Orthosteric Ligands → Classical Binding Small Molecules → Small Molecules
Administration
Oral
01

Overview

LPCN 1144 is an oral prodrug of bioidentical testosterone (specifically, testosterone undecanoate) developed by Lipocine for the treatment of pre-cirrhotic non-alcoholic steatohepatitis (NASH). It is designed to deliver testosterone via intestinal lymphatic absorption, bypassing first-pass liver metabolism. The drug acts as an androgen receptor agonist and functions as a hormonal replacement therapy. Clinical studies have shown that LPCN 1144 reduces liver fat content and improves markers of liver injury in hypogonadal males with NASH or NAFLD. The drug has demonstrated a favorable safety profile in Phase II trials, with improvements noted in steatosis, inflammation, and ballooning without worsening fibrosis[1][4][5][7][8].

Other names
LPCN 1144LPCN1144LPCN-1144testosterone undecanoate
02

Targets

AR (Adrenergic receptors)

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