Lipocine reports one-third enrollment in PPD treatment trial

SALT LAKE CITY - Lipocine Inc. (NASDAQ:LPCN), a small-cap biotech company with a market capitalization of $15.23 million, announced Tuesday that one-third of planned patients have been randomized in its Phase 3 clinical trial evaluating LPCN 1154, an oral formulation of brexanolone for postpartum depression (PPD).

The company expects topline results from the pivotal study in the second quarter of 2026. An independent Data Safety Monitoring Board will review safety data from the enrolled patients, with a safety update planned for the fourth quarter of 2025. According to InvestingPro analysis, Lipocine maintains a strong liquidity position with a current ratio of 12.71, though the company is rapidly burning through its cash reserves.

The Phase 3 trial is evaluating LPCN 1154 against placebo in women aged 15 and older diagnosed with severe PPD. Following FDA feedback, the study is being conducted entirely in an outpatient setting without requiring medical monitoring by healthcare providers.

LPCN 1154 is being developed with a 48-hour dosing schedule aimed at providing rapid relief of PPD symptoms. The company intends to use data from this trial to support a 505(b)(2) New Drug Application submission in 2026.

PPD is a major depressive disorder that occurs during pregnancy or within four weeks of delivery, with symptoms that can persist up to 12 months after childbirth. Traditional antidepressants used for PPD often have slow onset of action and side effects such as weight gain.

Lipocine’s development pipeline also includes candidates for epilepsy, essential tremor, and liver cirrhosis. The company is exploring partnership opportunities for several of its drug candidates.

The information in this article is based on a company press release statement.

In other recent news, Lipocine Inc. reported total revenue of $623,000 for the second quarter of 2025, which included $123,000 in royalties from TLANDO sales and $500,000 in license revenue. The company posted a net loss of $2.2 million, or ($0.41) per share, aligning with analyst expectations. H.C. Wainwright has maintained its Buy rating and $8.00 price target for Lipocine, citing the company’s ongoing clinical progress. The firm highlighted Lipocine’s recent R&D event focusing on postpartum depression (PPD) treatment, noting the potential for LPCN 1154 in addressing this condition. The Phase 3 trial for LPCN 1154 has begun, with the first patient dosed in a study designed to enroll 80 women diagnosed with severe PPD. H.C. Wainwright emphasized the challenges in current PPD treatments, such as low response rates and delayed improvement. These developments reflect Lipocine’s strategic focus on advancing its clinical pipeline and addressing unmet needs in mental health.

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