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SALT LAKE CITY - Lipocine Inc. (NASDAQ:LPCN) has dosed the first patient in its pivotal Phase 3 clinical trial of LPCN 1154, an investigational oral formulation of brexanolone for postpartum depression (PPD), the company announced Thursday. According to InvestingPro data, the clinical-stage company maintains a strong liquidity position with more cash than debt and a healthy current ratio of 15.6x, though it’s currently experiencing accelerated cash burn.
The two-arm, randomized, blinded study is evaluating LPCN 1154 against placebo in women aged 15 and older with severe PPD. The treatment involves a 48-hour dosing period and is being conducted at multiple U.S. clinical sites in an outpatient setting without requiring medical monitoring by healthcare providers.
The primary endpoint measures change from baseline in the Hamilton Depression Rating Scale (HAM-D), with secondary endpoints including changes in the Montgomery-Åsberg Depression Rating Scale and Hamilton Anxiety Rating Scale.
Lipocine expects to use data from this trial to support a New Drug Application submission for LPCN 1154 in mid-2026, with top-line results anticipated in the second quarter of 2026.
The company’s oral formulation aims to provide rapid relief of PPD symptoms. Brexanolone is bioidentical to allopregnanolone, a naturally occurring neuroactive steroid that acts as a positive allosteric modulator of GABA receptors. With a market capitalization of $17.3 million, InvestingPro analysis suggests the stock is currently undervalued, with analysts setting price targets between $6.75 and $8.00 per share.
According to a recent survey cited in the press release, obstetricians believe approximately 20-40% of their patients may suffer from PPD. Traditional antidepressants not specifically approved for PPD typically have a slow onset of action.
Lipocine will host a virtual investor event on July 9, 2025, featuring Dr. Kristina M. Deligiannidis from Zucker Hillside Hospital to discuss the PPD treatment landscape and provide further details on the Phase 3 trial.
The information in this article is based on a company press release statement.
In other recent news, Lipocine Inc. announced that its licensing partner, Verity Pharma, has submitted a New Drug Submission in Canada for TLANDO, an oral testosterone replacement therapy. TLANDO is already approved by the US FDA and does not require dose titration, which could make it an attractive option in Canada, where over 700,000 TRT prescriptions are written annually. Additionally, Lipocine has entered into a licensing agreement with Aché Laboratórios Farmacêuticos S.A. to market TLANDO in Brazil. This partnership is significant given the 34% compound annual growth rate in Brazil’s market from 2019 to 2023 and the absence of registered oral testosterone treatments in the country. Aché will be responsible for the regulatory submission and approval process in Brazil, and Lipocine stands to receive regulatory milestone payments and royalties on net sales. These developments highlight Lipocine’s efforts to expand TLANDO’s market presence in North America and Brazil. Both partnerships leverage Lipocine’s proprietary Lip’ral drug delivery technology, aiming to meet unmet medical needs in these regions.
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