Lipocine Announces First Patient Dosed in Phase 3 Clinical Trial for LPCN 1154 in Postpartum Depression

Lipocine Announces First Patient Dosed in Phase 3 Clinical Trial for LPCN 1154 in Postpartum Depression

By, Admin 27 June 2025

Overview

Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to develop innovative products with effective oral delivery, today announced that the first patient has been dosed in its pivotal Phase 3 clinical trial of LPCN 1154 (oral brexanolone), its investigational oral treatment for postpartum depression (PPD).

The trial

  • 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 U.S.

Lipocine Trial Evaluates Oral Brexanolone for Postpartum Depression with Efficacy and Safety Endpoints

  • The trial’s primary endpoint is the change from baseline in the Hamilton Depression Rating Scale (HAM-D) — a standard measure for assessing depression severity.

• Secondary endpoints include:

Change in Montgomery-Åsberg Depression Rating Scale (MADRS)
Change in Hamilton Anxiety Rating Scale (HAM-A)

Safety and tolerability assessments

  • The trial size and statistical power are based on treatment effects observed with FDA-approved injectable brexanolone.
  • Brexanolone is a bioidentical form of allopregnanolone, a neuroactive steroid that functions as a positive allosteric modulator of the GABA receptor, which plays a key role in mood regulation.
  • For more details, visit the study listing at ClinicalTrials.gov ID: NCT06979544.

Comments from Mahesh Patel: CEO of Lipocine

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 20-40% of their patients may suffer from PPD. 
  • Further, obstetricians are comfortable making a diagnosis and prescribing antidepressants for PPD. 
  • Traditional antidepressants, not approved for PPD, have slow onset of action, side effects such as weight gain, and do not demonstrate adequate remission post-acute treatment.

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 Advances Broad Pipeline Targeting CNS, Metabolic, and Hormonal Disorders

• Lipocine’s clinical development pipeline features several oral candidates across neurological, metabolic, and hormonal indications:

LPCN 1154 – Oral brexanolone for postpartum depression
LPCN 2101 – For refractory epilepsy
LPCN 2203 – Oral candidate targeting essential tremor
LPCN 2401 – An oral anabolic androgen receptor agonist for use with incretin mimetics to support obesity management and improve body composition
LPCN 1148 – Oral androgen receptor agonist prodrug for managing symptoms of liver cirrhosis

• Lipocine is actively exploring partnership opportunities for:

LPCN 1107 – Prevention of preterm birth
LPCN 1154 – For rapid relief of postpartum depression
LPCN 2401 – For obesity management
LPCN 1148 – For decompensated cirrhosis
LPCN 1144 – For MASH (metabolic dysfunction-associated steatohepatitis)
• The company’s FDA-approved product, TLANDO, is an oral testosterone undecanoate prodrug for treating male hypogonadism.
• For more details, visit: www.lipocine.com.

Forward-Looking Statements
• This release includes forward-looking statements under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, which are not historical facts.

• Statements involve expectations around:

- Product candidates and clinical trials, including LPCN 1154
- Ongoing Phase 3 safety and efficacy studies
- Regulatory interactions with the FDA
- Timing and outcomes of trials and potential New Drug Application (NDA) submissions
- Strategic partnerships and commercialization plans
- Intended uses and benefits of Lipocine’s therapies

• These statements are subject to risks and uncertainties, including but not limited to:

- Failure to develop or fund product candidates
- Unsuccessful clinical or regulatory outcomes
- Inability to secure partnerships or monetization opportunities
- FDA disapproval or delays
- Market, manufacturing, or patient acceptance challenges
- Changes in regulatory requirements or pathways
• Full risk disclosures are detailed in Lipocine’s SEC filings, including its Form 10-K, Forms 8-K, and 10-Q, accessible at www.sec.gov.
• Lipocine disclaims any obligation to publicly update forward-looking statements unless legally required.

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