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.
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Read More on LPCN:
- Lipocine announces publication, discussion of LPCN 1148
- LPCN Earnings this Week: How Will it Perform?
- Lipocine inks distribution, license agreement with SPC Korea for Tlando
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