Drugs / LPCN 1148
last change May 2025 re-read 3 minutes ago

LPCN 1148

Developed for
cirrhosis of liver · muscular atrophy
Investigated by
Lipocine Inc.

Trials 1

20222023202420252026
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 2 NCT04874350 Nov 2021 → Dec 2023 cirrhosis of liver, muscular atrophy Lipocine Inc. Completed Met primary

News releases announcing trial results or a regulatory action · 8

DateIssuerRelease
2025-05-22 Lipocine Inc. Results Lipocine's LPCN 1148 Highlighted in the June 2025 Edition of Hepatology lipocine.com ↗
Detailed results from the Phase 2 trial are published in the same issue of Hepatology (Vol. 81, Issue 6).
2024-12-17 Lipocine Inc. Regulatory FDA Grants Fast Track Designation to Lipocine for LPCN 1148 as a Treatment for Sarcopenia in Patients with Decompensated Cirrhosis lipocine.com ↗
2024-11-18 Lipocine Inc. Results Lipocine Announces Publication and Discussion of LPCN 1148 Manuscript at The Liver Meeting 2024 Editor's Cut Session lipocine.com ↗
The results at 24 weeks showed that LPCN 1148 therapy resulted in a significant improvement in sarcopenia when compared with placebo.
2024-06-10 Lipocine Inc. Results Lipocine Presents 52 Week Results from LPCN 1148 Phase 2 Study in Late Breaking Session at EASL Congress 2024 lipocine.com ↗
Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company, today announced that Phase 2 results on LPCN 1148 in cirrhosis were featured in a late breaking oral presentation at the European Association for the Study of Liver (EASL) Congress on Saturday, June 8 , in Milan, Italy .
2024-03-28 Lipocine Inc. Results Lipocine Announces Positive Week 52 Results from LPCN 1148 Phase 2 Study in Patients with Cirrhosis lipocine.com ↗
Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company today announced positive topline results from a Phase 2 clinical study of LPCN 1148.
2023-11-13 Lipocine Inc. Results Lipocine Releases Late Breaking Presentation on LPCN 1148 Phase 2 Results at The Liver Meeting® 2023 lipocine.com ↗
The data show that LPCN 1148 improved multiple additional clinically meaningful and surrogate outcomes, including hepatic encephalopathy.
2023-07-27 Lipocine Inc. Results LPCN 1148 Phase 2 Study Meets Primary Endpoint in Patients with Cirrhosis lipocine.com ↗
Met primary endpoint: treatment with LPCN 1148 increased L3 skeletal muscle index (L3-SMI) relative to placebo (P <0.01)
2020-05-05 Lipocine Inc. Regulatory FDA Clears LPCN 1148 IND Application for Phase 2 Cirrhosis Trial lipocine.com ↗

All press releases naming this drug 13 releases

DateIssuerRelease

Evidence & citations 2 cited values

Every value below carries the sentence it was read from. 1 source stands behind the page.

FieldValueCited text
Known as LPCN 1148 ClinicalTrials.gov intervention name — accepted as the source's own label NCT04874350 ↗
Route Oral “Oral LPCN 1148 capsules, administered as BID.” NCT04874350 ↗