Drug intelligence / Profile preview

LPCN 1148

Development stage
Phase 2
Lead developer
Lipocine
Modality
Metabolically Activated Prodrugs → Prodrugs/Conditional Activator Small Molecules → Small Molecules
Administration
Oral
01

Overview

LPCN 1148 is an oral prodrug of bioidentical testosterone, specifically comprising testosterone dodecanoate. It is being developed as a first-in-class therapy for the management of cirrhosis, with a focus on treating sarcopenia (loss of muscle mass and strength) and preventing recurrence of overt hepatic encephalopathy (OHE) in patients with decompensated cirrhosis. The drug acts as an androgen receptor agonist, leveraging multimodal mechanisms to improve skeletal muscle index and reduce OHE episodes. Clinical studies have shown that LPCN 1148 significantly improves sarcopenia and reduces the number of OHE events compared to placebo in men awaiting liver transplantation due to cirrhosis. The drug has received FDA Fast Track Designation for sarcopenia in this patient population[1][2][3][4][5][6][7][8].

Other names
testosterone dodecanoate
02

Targets

AR (Adrenergic receptors)

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