Lipocine Completes Phase 3 Safety Review of LPCN 1154 for Postpartum Depression

Reuters

Jan 12

Lipocine Completes Phase 3 Safety Review of LPCN 1154 for Postpartum Depression

Lipocine Inc. has announced the completion of the second scheduled independent Data Safety Monitoring Board (DSMB) review for its ongoing Phase 3 clinical trial evaluating LPCN 1154, an oral formulation of brexanolone, for the rapid relief treatment of postpartum depression $(PPD)$. The DSMB assessed all available safety data from 82 randomized participants, with 74 having completed dosing, and recommended the trial continue as planned without modification. No drug discontinuations, excessive sedation, loss of consciousness, or drug-related serious adverse events have been reported. The company is no longer screening new participants but continues to enroll those who have already met eligibility criteria. Lipocine expects to report topline safety and efficacy results from the study early in the second quarter of 2026.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Lipocine Inc. published the original content used to generate this news brief on January 12, 2026, and is solely responsible for the information contained therein.

Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.

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The DSMB assessed all available safety data from 82 randomized participants, with 74 having completed dosing, and recommended the trial continue as planned without modification. No drug discontinuations, excessive sedation, loss of consciousness, or drug-related serious adverse events have been reported. The company is no longer screening new participants but continues to enroll those who have already met eligibility criteria. Lipocine expects to report topline safety and efficacy results from the study early in the second quarter of 2026.\n      </p>\n</div><div xmlns:xsd=\"http://www.w3.org/2001/XMLSchema\" xmlns:xsi=\"http://www.w3.org/2001/XMLSchema-instance\">\n<p>\n<i>Disclaimer: <span>This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Lipocine Inc. published the original content used to generate this news brief on January 12, 2026, and is solely responsible for the information contained therein.</span></i>\n</p>\n</div></body></html>\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"LPCN","symbol_name":"Lipocine Inc","start_time":0,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20260112:nNDL8QvdcB:1","article_id":"2602569510","we_media_id":"1032215980","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2602569510","pubTimestamp":1768223022,"columns":[],"sourceInfo":null,"weMediaInfo":{"media_name":"Reuters","introduction":"Reuters.com brings you the latest news from around the world, covering breaking news in markets, business, politics, entertainment and technology","home_visible":1,"id":"1032215980","head_image":"https://community-static.tradeup.com/news/4567337cbdf294b657b1fa87c5488b48"},"summary":"Lipocine Inc. has announced the completion of the second scheduled independent Data Safety Monitoring Board  review for its ongoing Phase 3 clinical trial evaluating LPCN 1154, an oral formulation of brexanolone, for the rapid relief treatment of postpartum depression . 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While PUBT strives to provide accurate and timely information, this AI-generat","collect":0,"end_time":0,"defaultTopTitle":"","property":[],"viewcount":null,"language":"en","relate_stocks":{"LPCN":"Lipocine Inc","BK4007":"制药"},"translate_title":"Lipocine完成LPCN 1154治疗产后抑郁症的3期安全性审查","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"LPCN":0.9},"content_text":"Lipocine Completes Phase 3 Safety Review of LPCN 1154 for Postpartum Depression\n    \n\nLipocine Inc. has announced the completion of the second scheduled independent Data Safety Monitoring Board (DSMB) review for its ongoing Phase 3 clinical trial evaluating LPCN 1154, an oral formulation of brexanolone, for the rapid relief treatment of postpartum depression $(PPD)$. The DSMB assessed all available safety data from 82 randomized participants, with 74 having completed dosing, and recommended the trial continue as planned without modification. No drug discontinuations, excessive sedation, loss of consciousness, or drug-related serious adverse events have been reported. The company is no longer screening new participants but continues to enroll those who have already met eligibility criteria. Lipocine expects to report topline safety and efficacy results from the study early in the second quarter of 2026.\n      \n\n\nDisclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. 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