FDA grants Fast Track Designation to Lipocine for LPCN 1148 in decompensated cirrhosis sarcopenia

Lipocine Inc.

FDA Fast Track Designation granted to LPCN 1148 for sarcopenia in decompensated cirrhosis, an unmet medical need.
LPCN 1148 is an oral prodrug of bioidentical testosterone; POC Phase 2 study showed improved sarcopenia and clinical outcomes.
Fast Track benefits include more frequent FDA meetings, eligibility for Accelerated Approval, Priority Review, and Rolling Review.
Over 382,000 U.S. patients with decompensated cirrhosis; no FDA-approved treatments for associated sarcopenia.

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