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# Lipocine Proposes Phase 2 Trial for Cirrhosis Drug
- URL: https://www.fdaweb.com/lipocine-proposes-phase-2-trial-for-cirrhosis-drug/
- Published: 2020-05-05T12:00:00.000Z
- Updated: 2026-09-14T16:13:39.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5146724

FDA has accepted a Lipocine IND to begin a Phase 2 proof-of-concept study to evaluate the therapeutic potential of LPCN 1148, an oral prodrug of bioidentical testosterone, for treating liver cirrhosis in adult males. The planned study is a prospective, multi-center, randomized, placebo-controlled 52-week trial in male cirrhotic patients awaiting a liver transplant. The study is expected to begin later this year or early 2021\. “Low testosterone affects up to 90% of cirrhotic men, and is a predictor of mortality and increased adverse events including ascites, hepatic encephalopathy, and clinically significant portal hypertension,” the company says.