Lipocine granted FDA Fast Track Designation for LPCN 1148

Lipocine (LPCN) announced that the U.S. FDA has granted Fast Track Designation to LPCN 1148 as a treatment for sarcopenia in patients with decompensated cirrhosis. LPCN 1148, an oral prodrug of bioidentical testosterone, was recently studied in a proof-of-concept Phase 2 study in patients with decompensated cirrhosis. Treatment with LPCN 1148 in the POC study improved sarcopenia and associated clinical outcomes. LPCN 1148 is targeted to be a “First in Class” product candidate with a novel mechanism of action for management of cirrhosis.