Lipocine's PPD Phase 3 Study (LPCN 1154) Hits 80% Enrollment Milestone

Rhea-AI Summary

Lipocine (NASDAQ: LPCN) announced that its Phase 3 trial of LPCN 1154 for postpartum depression has reached 80% enrollment, with 66 of 80 planned participants randomized as of Dec. 16, 2025. The company said topline results remain on track for Q2 2026.

The release notes a prior Data Safety Monitoring Board review that recommended the trial continue without modification and that a second DSMB meeting is planned for early January 2026.

Positive

• 80% enrollment achieved (66 of 80 randomized)
• Topline results on track for Q2 2026
• First DSMB review recommended the trial continue without modification

Negative

• 20% of enrollment remains (14 of 80 participants not yet randomized)
• Topline readout not available until Q2 2026, leaving near-term data uncertainty

News Market Reaction

% 1.9x vol

25 alerts

% News Effect

+13.4% Peak Tracked

-13.2% Trough Tracked

$22M Market Cap

1.9x Rel. Volume

On the day this news was published, LPCN declined NaN%, reflecting a moderate negative market reaction. Argus tracked a peak move of +13.4% during that session. Argus tracked a trough of -13.2% from its starting point during tracking. Our momentum scanner triggered 25 alerts that day, indicating elevated trading interest and price volatility. Trading volume was above average at 1.9x the daily average, suggesting increased trading activity.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Enrollment completion: 80% Planned participants: 80 patients Randomized to date: 66 patients +3 more

6 metrics

Enrollment completion 80% Phase 3 LPCN 1154 PPD trial enrollment status

Planned participants 80 patients Total planned Phase 3 LPCN 1154 PPD study size

Randomized to date 66 patients Number of Phase 3 LPCN 1154 participants randomized so far

DSMB meetings 2 reviews Two independent Data Safety Monitoring Board reviews planned/completed

Next DSMB timing mid-January 2026 Second DSMB meeting for LPCN 1154 Phase 3 trial

Topline results timing Q2 2026 Planned release of LPCN 1154 Phase 3 topline data

Market Reality Check

Price: $9.00 Vol: Volume 35,759 vs 20-day a...

normal vol

$9.00 Last Close

Volume Volume 35,759 vs 20-day average 48,079 (relative volume 0.74x) shows subdued trading ahead of the update. normal

Technical Price $3.15 is slightly above the 200-day MA of $3.13, near longer-term trend.

Peers on Argus

Momentum scanner shows only one peer (NBY) with notable move, up 4.43% without n...

1 Up

Momentum scanner shows only one peer (NBY) with notable move, up 4.43% without news, while other biotech peers show mixed moves, suggesting stock-specific focus on LPCN’s trial progress.

Historical Context

5 past events · Latest: Nov 06 (Negative)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Nov 06	Q3 2025 earnings	Negative	+3.1%	Quarterly loss and cash decline alongside pipeline and guidance updates.
Nov 04	Clinical data update	Positive	-4.5%	Phase 2 LPCN 2401 data showing body composition and liver fat benefits.
Sep 30	PPD trial progress	Positive	+1.4%	Phase 3 LPCN 1154 PPD trial progress with one‑third enrollment and DSMB plan.
Sep 05	Investor conference	Neutral	+0.7%	Participation in H.C. Wainwright conference with investor presentation availability.
Aug 26	Epilepsy abstracts	Positive	+2.6%	Two LPCN 2101 epilepsy abstracts accepted for AES 2025 presentations.

Pattern Detected

Clinical trial updates have produced mixed reactions, with both positive and negative moves around LPCN’s pipeline news.

Recent Company History

Over recent months, Lipocine has advanced multiple oral neuroactive steroid programs. Key steps include initiation and progression of the Phase 3 LPCN 1154 PPD trial, with prior milestones such as first patient dosing and one‑third enrollment. The company also highlighted positive LPCN 2401 obesity data and presented epilepsy candidate LPCN 2101 abstracts. Q3 2025 results showed ongoing R&D investment and modest royalty revenue. Today’s 80% enrollment milestone builds directly on the earlier LPCN 1154 progress updates.

Market Pulse Summary

This announcement reports 80% enrollment and 66 of 80 participants randomized in Lipocine’s Phase 3 ...

Analysis

This announcement reports 80% enrollment and 66 of 80 participants randomized in Lipocine’s Phase 3 LPCN 1154 trial for postpartum depression, with another DSMB review in mid‑January 2026 and topline data expected in Q2 2026. It extends the steady progression seen in earlier LPCN 1154 updates. Investors may watch DSMB outcomes, adherence to the Q2 2026 timeline, and any future financing or partnership disclosures as the trial nears completion.

Key Terms

data safety monitoring board, phase 3, oral brexanolone, postpartum depression

4 terms

data safety monitoring board medical

"the second of two independent Data Safety Monitoring Board reviews is planned"

A data safety monitoring board is a group of experts who regularly review information from a research or testing process to ensure it is safe and ethical. Think of them as watchdogs that watch over ongoing projects to protect participants and ensure everything is proceeding correctly. Their oversight helps maintain trust and safety, which is important for investors who want to see responsible management and reliable results.

phase 3 medical

"80% completion of enrollment in the ongoing Phase 3 clinical trial evaluating"

Phase 3 is the late-stage clinical testing step for a new drug or medical treatment, where the product is given to large groups of patients to confirm effectiveness, monitor side effects, and compare it to standard care. Successful Phase 3 results are often the final scientific hurdle before regulators decide on approval and market launch—like passing a final exam before graduation—and can sharply change a company's valuation and future revenue prospects.

oral brexanolone medical

"clinical trial evaluating LPCN 1154 (oral brexanolone) for the rapid relief"

Oral brexanolone is a pill form of a brain-active steroid-like medication designed to quickly reduce certain types of severe depression by calming overactive stress and mood circuits. For investors it matters because an oral formulation can be taken at home rather than given by IV in a clinic, potentially expanding the number of patients, lowering treatment delivery costs, and changing revenue and prescribing patterns for companies developing or selling the drug.

postpartum depression medical

"Phase 3 study for postpartum depression, which may be indicative"

A mood disorder that can arise after childbirth, characterized by persistent sadness, anxiety, exhaustion and difficulty caring for oneself or a baby; it can range from moderate to severe and often requires medical or therapeutic treatment. Investors care because its prevalence affects demand for medical treatments, mental-health services and parental workplace policies, and can influence healthcare spending, drug development programs, and productivity in sectors that depend on caregiver labor — much like a widespread recurring expense that changes consumer and employer behavior.

AI-generated analysis. Not financial advice.

• Second Drug Safety Monitoring Board (DSMB) meeting update planned for mid-January 2026
• Topline results on track for the second quarter of 2026

SALT LAKE CITY, Dec. 16, 2025 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to develop innovative products with effective oral delivery, today announced 80% completion of enrollment in the ongoing Phase 3 clinical trial evaluating LPCN 1154 (oral brexanolone) for the rapid relief treatment of PPD, with 66 of the 80 planned study participants randomized. In addition, the second of two independent Data Safety Monitoring Board reviews is planned for early-January 2026. Following the first DSMB review, the board recommended that the trial continue as planned without modification.

"We are encouraged by the recruiting rate in our Phase 3 study for postpartum depression, which may be indicative of this population's unmet medical need," said Mahesh Patel, CEO of Lipocine. "We extend our deepest gratitude to the patients, their families, and the dedicated clinical teams at the trial sites whose commitment has made this progress possible."

About the Phase 3 Study

The pivotal, randomized, double-blind study is evaluating LPCN 1154 compared to placebo in women aged 15 years and older diagnosed with severe PPD. Following constructive feedback from the U.S. Food and Drug Administration (FDA), the trial is being conducted entirely in an outpatient setting and does not require medical monitoring by a healthcare provider. Data from this Phase 3 trial are expected to support a 505(b)(2) NDA submission for LPCN 1154 in 2026. For more information, refer to clinicaltrials.gov: NCT06979544.

About LPCN 1154

LPCN 1154 is an oral formulation of brexanolone in development targeted for administration resulting in rapid relief of PPD. While it is expected that LPCN 1154 could be the first line treatment choice for women with PPD, it may 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. 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.

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 development pipeline includes: LPCN 1154 for the treatment of postpartum depression, LPCN 2201 for treatment of major depressive disorder, LPCN 2202 for treatment of treatment resistant depression, LPCN 2101 for the treatment of epilepsy, LPCN 2203 targeted for the management of essential tremor, LPCN 2401 as an aid for improved body composition in obesity management, LPCN 1148 targeted for the management of symptoms associated with liver cirrhosis, and LPCN 1107 our candidate for prevention of preterm birth. 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, including the impact of LPCN 1154 on the treatment of PPD. 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 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.

View original content to download multimedia:https://www.prnewswire.com/news-releases/lipocines-ppd-phase-3-study-lpcn-1154-hits-80-enrollment-milestone-302642892.html

SOURCE Lipocine Inc.

FAQ

How much of the LPCN 1154 Phase 3 trial is enrolled as of Dec 16, 2025?

The trial is 80% enrolled with 66 of 80 planned participants randomized.

When does Lipocine expect topline results for LPCN 1154 (LPCN)?

Topline results are on track for the second quarter of 2026.

What did the first DSMB review recommend for Lipocine's LPCN 1154 trial?

The first independent DSMB recommended the trial continue as planned without modification.

When is the next DSMB meeting for Lipocine's LPCN 1154 study scheduled?

A second DSMB meeting update is planned for early January 2026.

How many participants remain to complete enrollment in LPCN 1154?

There are 14 participants remaining to reach the planned 80-subject enrollment (80 minus 66).

What does 80% enrollment mean for LPCN shareholders (LPCN)?

It indicates the trial is substantially enrolled and proceeding toward a planned topline readout in Q2 2026, reducing but not eliminating data-timing risk.