Lipocine Announces First Patient Dosed in Phase 3 Clinical Trial for LPCN 1154 in Postpartum Depression
Lipocine (NASDAQ: LPCN) has initiated dosing in its pivotal Phase 3 clinical trial for LPCN 1154, an oral brexanolone treatment for postpartum depression (PPD). The trial is being conducted in an outpatient setting without required medical monitoring, following FDA feedback.
The two-arm, randomized, blinded study will evaluate LPCN 1154 against placebo in women aged 15+ with severe PPD, featuring a 48-hour dosing period. The primary endpoint measures changes in the Hamilton Depression Rating Scale (HAM-D). The company expects top-line results in Q2 2026 and plans an NDA submission by mid-2026.
Lipocine (NASDAQ: LPCN) ha iniziato la somministrazione nella sua cruciale sperimentazione clinica di Fase 3 per LPCN 1154, un trattamento orale a base di brexanolone per la depressione postpartum (PPD). Lo studio viene condotto in regime ambulatoriale senza necessità di monitoraggio medico, in linea con il feedback della FDA.
Lo studio, randomizzato, in doppio cieco e con due bracci, valuterà LPCN 1154 rispetto al placebo in donne di età superiore a 15 anni con PPD grave, con un periodo di somministrazione di 48 ore. L'endpoint primario misura le variazioni nella scala di valutazione della depressione di Hamilton (HAM-D). L'azienda prevede di ottenere risultati principali nel secondo trimestre 2026 e pianifica di presentare la domanda NDA entro la metà del 2026.
Lipocine (NASDAQ: LPCN) ha iniciado la dosificación en su ensayo clínico pivotal de Fase 3 para LPCN 1154, un tratamiento oral con brexanolona para la depresión posparto (PPD). El ensayo se realiza en un entorno ambulatorio sin necesidad de monitoreo médico, conforme a las indicaciones de la FDA.
El estudio aleatorizado, doble ciego y con dos grupos evaluará LPCN 1154 frente a placebo en mujeres mayores de 15 años con PPD severa, con un periodo de dosificación de 48 horas. El criterio principal mide los cambios en la Escala de Evaluación de la Depresión de Hamilton (HAM-D). La compañía espera resultados principales en el segundo trimestre de 2026 y planea presentar la solicitud NDA para mediados de 2026.
Lipocine (NASDAQ: LPCN)은 산후 우울증(PPD) 치료를 위한 경구용 브렉사놀론 치료제 LPCN 1154의 중대한 3상 임상시험에서 투약을 시작했습니다. 이 시험은 FDA 피드백에 따라 의료 모니터링 없이 외래 환경에서 진행됩니다.
두 그룹으로 나뉘어 무작위 배정되고 이중 맹검 방식으로 진행되는 이 연구는 15세 이상 중증 PPD 여성들을 대상으로 LPCN 1154와 위약을 비교하며, 48시간 투약 기간을 포함합니다. 주요 평가 지표는 해밀턴 우울증 평가 척도(HAM-D)의 변화입니다. 회사는 2026년 2분기 주요 결과를 기대하며 2026년 중반까지 NDA 제출을 계획하고 있습니다.
Lipocine (NASDAQ : LPCN) a commencé l'administration dans son essai clinique pivot de phase 3 pour LPCN 1154, un traitement oral à base de brexanolone pour la dépression post-partum (DPP). L'essai est réalisé en ambulatoire sans surveillance médicale obligatoire, conformément aux retours de la FDA.
Cette étude randomisée, en double aveugle et à deux bras, évaluera LPCN 1154 contre placebo chez des femmes de 15 ans et plus souffrant de DPP sévère, avec une période de dosage de 48 heures. Le critère principal mesure les changements sur l'échelle de dépression de Hamilton (HAM-D). La société prévoit des résultats principaux au deuxième trimestre 2026 et envisage un dépôt de NDA d'ici mi-2026.
Lipocine (NASDAQ: LPCN) hat mit der Dosierung in seiner entscheidenden Phase-3-Studie für LPCN 1154 begonnen, einer oralen Brexanolon-Behandlung für postpartale Depression (PPD). Die Studie wird ambulant ohne erforderliche medizinische Überwachung durchgeführt, gemäß dem Feedback der FDA.
Die randomisierte, verblindete Studie mit zwei Gruppen wird LPCN 1154 gegen Placebo bei Frauen ab 15 Jahren mit schwerer PPD evaluieren, mit einer 48-stündigen Dosierungsdauer. Der primäre Endpunkt misst Veränderungen auf der Hamilton-Depressionsskala (HAM-D). Das Unternehmen erwartet Ergebnisse im zweiten Quartal 2026 und plant eine NDA-Einreichung bis Mitte 2026.
- Trial design received FDA feedback and allows outpatient treatment without medical monitoring requirement
- Short 48-hour treatment duration could improve patient convenience and compliance
- Potential to become standard of care in postpartum depression treatment
- Study leverages proven efficacy data from injectable brexanolone for trial size calculations
- Phase 3 results not expected until Q2 2026, indicating significant time before potential commercialization
- Success not guaranteed despite positive bio-bridge study results
- Will face competition from existing PPD treatments
Insights
Lipocine's Phase 3 trial initiation for oral brexanolone represents significant advancement toward potential market disruption in postpartum depression treatment.
Lipocine has achieved a critical milestone by dosing the first patient in its Phase 3 trial for LPCN 1154 (oral brexanolone) for postpartum depression (PPD). This development carries substantial significance as it positions the company to potentially revolutionize PPD treatment through an outpatient oral therapy – a major improvement over the current standard.
The trial design includes several favorable elements: outpatient administration without healthcare provider monitoring, a compact 48-hour dosing regimen, and FDA alignment through prior feedback. The company is leveraging data from its successful PK bio-bridge study, suggesting confidence in the drug's pharmacokinetic profile compared to injectable brexanolone.
The market opportunity is compelling. PPD affects approximately
Importantly, the trial is powered based on treatment effects observed with the already-approved injectable form, suggesting a high probability of success if bioequivalence is maintained. The primary endpoint using HAM-D is the gold standard for depression trials, and inclusion of anxiety measures (HAM-A) could strengthen the clinical profile.
With topline results expected Q2 2026 and potential NDA submission mid-2026, Lipocine is approximately 12-18 months from potentially transforming PPD treatment, addressing a significant unmet medical need with a more accessible therapy option.
Phase 3 Top Line Results Expected Q2 2026
Following FDA feedback, this study is being conducted in an outpatient setting, with no requirement for medical monitoring by a healthcare provider. The Company anticipates using the data from this Phase 3 trial to support an NDA submission of LPCN 1154 for PPD in mid-2026.
The trial is a two-arm, randomized, blinded study evaluating LPCN 1154 compared to placebo in women aged 15 years and older with severe PPD. The treatment regimen involves a 48-hour dosing period which was informed by the dosing in Lipocine's successful PK bio-bridge study with injectable brexanolone. The study is being conducted at multiple clinical sites across the
The primary endpoint of the trial is the change from baseline in the Hamilton Depression Rating Scale (HAM-D), a widely recognized clinical measure of depression severity. Additional secondary endpoints include the change from baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) and the Hamilton Anxiety Rating Scale (HAM-A) to assess anxiety symptoms, as well as key safety and tolerability measures. The trial size is powered based on the treatment effect observed with the FDA approved injectable brexanolone. Brexanolone is a bioidentical to naturally occurring neuroactive steroid, allopregnanolone, a positive allosteric modulator of y-aminobutyric acid (GABA) receptor. For more information, refer to ClinicalTrials.gov ID NCT06979544.
"Given the unmet need for rapid relief, this Phase 3 trial is an important step in our development program to bring LPCN 1154 to women suffering from postpartum depression," said Mahesh Patel, CEO of Lipocine. "By offering a novel bioidentical oral treatment with 48-hour treatment duration and expected robust efficacy, LPCN 1154 is designed to be a differentiated, rapid relief product with the potential to be the standard of care."
Virtual Investor Event on LPCN 1154
Lipocine will host a virtual research and development (R&D) investor event to discuss LPCN 1154 on Wednesday, July 9, 2025 at 11:00 AM ET. The event will feature Kristina M. Deligiannidis, MD (Zucker Hillside Hospital, Northwell Health, New York), who will join company management to discuss the current treatment landscape and unmet needs in PPD. The Company will provide a clinical, regulatory, and development update, including further details on the Phase 3 trial. To register, click here.
About LPCN 1154
LPCN 1154 is an oral formulation of brexanolone in development targeted for administration resulting in rapid relief of PPD. LPCN 1154 is expected to have characteristics that could be particularly appealing to patients with PPD, acutely elevated suicide risk, and in whom rapid improvement is a priority while presenting no significant risk of adverse reactions to breastfed infants from exposure to brexanolone.
About Postpartum Depression and Unmet Needs
PPD is a major depressive disorder with onset either during pregnancy or within four weeks of delivery, with symptoms persisting up to 12 months after childbirth. Hormonal changes leading to GABA dysfunction are common in depression and pregnancy. Symptoms of PPD include hallmarks of major depression, including, but not limited to, sadness, depressed mood, loss of interest, change in appetite, insomnia, sleeping too much, fatigue, difficulty thinking/concentrating, excessive crying, fear of harming the baby/oneself, and/or thoughts of death or suicide. Results from a recent survey (Truist Securities Research, January 2024) show that obstetricians believe approximately 20
About Lipocine
Lipocine is a biopharmaceutical company leveraging its proprietary technology platform to develop innovative products with effective oral delivery. Lipocine has drug candidates in development as well as drug candidates for which we are exploring partnerships. Our drug candidates represent enablement of differentiated, patient friendly oral delivery options for favorable benefit to risk profile which target large addressable markets with significant unmet medical needs.
Lipocine's clinical development candidates include: LPCN 1154, oral brexanolone, for the potential treatment of postpartum depression, LPCN 2101 for the potential treatment of refractory epilepsy, LPCN 2203 an oral candidate targeted for the management of essential tremor, LPCN 2401 an oral proprietary anabolic androgen receptor agonist, as an adjunct therapy to incretin mimetics, as an aid for improved body composition in obesity management and LPCN 1148, a novel androgen receptor agonist prodrug for oral administration targeted for the management of symptoms associated with liver cirrhosis. Lipocine is exploring partnering opportunities for LPCN 1107, our candidate for prevention of preterm birth, LPCN 1154, for rapid relief of postpartum depression, LPCN 2401 for obesity management, LPCN 1148, for the management of decompensated cirrhosis, and LPCN 1144, our candidate for treatment of metabolic dysfunction-associated steatohepatitis (MASH). TLANDO, a novel oral prodrug of testosterone containing testosterone undecanoate developed by Lipocine, is approved by the FDA for conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism, in adult males. For more information, please visit www.lipocine.com.
Forward-Looking Statements
This release contains "forward-looking statements" that are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and include statements that are not historical facts regarding our product candidates and related clinical trials, our development of our product candidates and related efforts with the FDA, including with respect to LPCN 1154, our Phase 3 safety and efficacy study relating to LPCN 1154, the timing and potential results of the safety and efficacy study relating to LPCN 1154, potential partnering of our product candidates with third parties, and the potential uses and benefits of our product candidates. Investors are cautioned that all such forward-looking statements involve risks and uncertainties, including, without limitation, the risks that we may not be successful in developing product candidates, we may not have sufficient capital to complete the development processes for our product candidates or we may decide to allocate our available capital to other product candidates, we may not be able to enter into partnerships or other strategic relationships to monetize our non-core assets, safety and efficacy studies, including those relating to LPCN 1154, may not be successful or may not provide results that would support the submission of a NDA, the FDA may not approve any of our products, risks related to our products, expected product benefits not being realized, clinical and regulatory expectations and plans not being realized, new regulatory developments and requirements, risks related to the FDA approval process including the receipt of regulatory approvals and our ability to utilize a streamlined approval pathway for LPCN 1154, the results and timing of clinical trials, patient acceptance of Lipocine's products, the manufacturing and commercialization of Lipocine's products, and other risks detailed in Lipocine's filings with the SEC, including, without limitation, its Form 10-K and other reports on Forms 8-K and 10-Q, all of which can be obtained on the SEC website at www.sec.gov. Lipocine assumes no obligation to update or revise publicly any forward-looking statements contained in this release, except as required by law.
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SOURCE Lipocine Inc.
FAQ
When will Lipocine (LPCN) report Phase 3 results for LPCN 1154 in postpartum depression?
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When does Lipocine plan to submit the NDA for LPCN 1154?
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