Breaking News, Trials & Filings

FDA Grants Fast Track Designation to LPCN 1148 as Treatment for Sarcopenia

LPCN 1148 is targeted to be a ‘First in Class’ product candidate with a novel mechanism of action for management of cirrhosis.

Author Image

By: Charlie Sternberg

Associate Editor

The U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to Lipocine Inc.’s 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 (POC) 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&#822...

Continue reading this story and get 24/7 access to Contract Pharma for FREE


Already a subscriber? Sign in

Keep Up With Our Content. Subscribe To Contract Pharma Newsletters