SALT LAKE CITY, May 1, 2024 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company, today announced that dosing of subjects has been completed in the pivotal pharmacokinetic (PK) study designed to support a New Drug Application (NDA) for LPCN 1154. LPCN 1154, oral brexanolone, is being developed as a treatment of postpartum depression (PPD). Lipocine anticipates topline results late in the second quarter of 2024, with the goal of NDA submission by the end of the fourth quarter of 2024.
Lipocine Announces Positive LPCN 2401 Clinical Results
SALT LAKE CITY, April 11, 2024 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company, today announced results from a Phase 2 clinical trial (NCT04134091) which includes LPCN 2401, an oral proprietary combination of anabolic androgen receptor agonist and ?-tocopherol, an antioxidant. The results showed significant improvement in body composition through decreased FM and increased LM or fat free mass (FFM) in patients with BMI ? 30 (obese) or BMI ? 27 with at least one weight-related comorbidity.
Lipocine Announces First Cohort Dosed in Pivotal Study of LPCN 1154
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SALT LAKE CITY, Feb. 6, 2024 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company focused on treating Central Nervous System (CNS) disorders by leveraging its proprietary platform, today announced that results from a multi-dose clinical study have confirmed the LPCN 1154 48-hour dosing regimen for the upcoming NDA enabling pivotal pharmacokinetic (PK) study. LPCN 1154 is an oral neurosteroid being developed by Lipocine for the treatment of postpartum depression (PPD).