First Patient Receives Lipocene's LPCN 1154 for Postpartum Depression in Phase 3 Clinical Trial

Lipocine Inc. has announced dosing of the first patient in a pivotal phase 3 clinical trial of LPCN 1154, an investigational oral formulation of brexanolone for the treatment of postpartum depression (PPD). The randomized, blinded, 2-arm study is being conducted in an outpatient setting without medical monitoring, per FDA guidance, and is designed to support a new drug application (NDA) submission anticipated in mid-2026, the company said in a statement.¹

The trial includes women aged 15 years and older diagnosed with severe PPD and will use a 48-hour dosing regimen based on pharmacokinetic bridging data with the FDA-approved injectable form of brexanolone, according to Lipocine.¹

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The study’s primary endpoint is change from baseline in the widely used Hamilton Depression Rating Scale. Secondary endpoints include change from baseline in the Montgomery-Åsberg Depression Rating Scale and the Hamilton Anxiety Rating Scale, along with safety and tolerability outcomes. The company explained that the sample size is statistically powered based on the treatment effect observed with injectable brexanolone. LPCN 1154 is a bioidentical formulation of allopregnanolone, a neuroactive steroid and positive allosteric modulator of the GABA receptor.¹

“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,” Mahesh Patel, CEO of Lipocine, said in the statement. “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.”¹

Postpartum depression (PPD) affects an estimated 10% to 20% of mothers in the US, though actual prevalence may be higher due to underdiagnosis and underreporting.^2,3 Despite growing awareness, there are persistent and substantial gaps in screening, timely diagnosis, and access to effective treatment.^4,5 The US Preventive Services Task Force recommends routine depression screening during and after pregnancy, but implementation varies widely across clinical settings.⁴ Contributing factors include lack of standardized protocols, limited provider training, and stigma associated with mental health care.⁵ Traditional antidepressants, while commonly prescribed, are not specifically approved for PPD and often have a delayed onset of action.^3,6 A rapid-onset, patient-administered treatment such as oral brexanolone could help address both clinical and logistical shortcomings in the current care paradigm for perinatal mood disorders.¹

Lipocine will host a virtual R&D investor event on July 9, 2025, at 11:00 AM ET. More details are available under ClinicalTrials.gov ID NCT06979544.

References

1. Lipocene announces first patient dosed in phase 3 clinical trial for LPCN 1154 in postpartum depression. News release. Lipocine Inc. June 26, 2025. Accessed June 27, 2025. https://ir.lipocine.com/2025-06-26-Lipocine-Announces-First-Patient-Dosed-in-Phase-3-Clinical-Trial-for-LPCN-1154-in-Postpartum-Depression
2. Centers for Disease Control and Prevention. Depression among women. Reviewed September 27, 2022. Accessed June 27, 2025. https://www.cdc.gov/reproductivehealth/depression/index.htm
3. Gavin NI, Gaynes BN, Lohr KN, Meltzer-Brody S, Gartlehner G, Swinson T. Perinatal depression: a systematic review of prevalence and incidence. Obstet Gynecol. 2005;106(5 Pt 1):1071–1083. doi:10.1097/01.AOG.0000183597.31630.db
4. US Preventive Services Task Force. Screening for depression in adults: US Preventive Services Task Force recommendation statement. JAMA. 2023;329(4):317–325. doi:10.1001/jama.2023.0205
5. Byatt N, Levin LL, Ziedonis DM, Moore Simas TA, Allison J. Enhancing participation in depression care in outpatient perinatal care settings: a systematic review. Obstet Gynecol. 2015;126(5):1048–1058. doi:10.1097/AOG.0000000000001067
6. Wisner KL, Sit DK, McShea MC, et al. Onset timing, thoughts of self-harm, and diagnoses in postpartum women with screen-positive depression findings. JAMA Psychiatry. 2013;70(5):490–498. doi:10.1001/jamapsychiatry.2013.87