Lipocine Announces Last Patient Last Visit in Pivotal Phase 3 Trial of LPCN 1154 for Postpartum Depression (PPD)

Rhea-AI Summary

Lipocine (NASDAQ: LPCN) announced completion of Last Patient Last Visit in its pivotal Phase 3 trial of LPCN 1154 (oral brexanolone) for postpartum depression on Feb 18, 2026. The randomized, double-blind, placebo-controlled study enrolled 90 patients with severe PPD (average baseline HAM-D 28.3).

The company reported a positive safety profile: all nervous system adverse events were mild-to-moderate, with no drug discontinuations, excessive sedation, loss of consciousness, or drug-related serious adverse events. LPCN 1154 achieved bio-equivalent systemic exposure to intravenous brexanolone; efficacy results are pending.

Positive

• Last Patient Last Visit completed in pivotal Phase 3 trial
• Study enrolled 90 patients with average baseline HAM-D 28.3
• No drug-related serious adverse events or treatment discontinuations reported
• LPCN 1154 achieved bio-equivalent systemic exposure to IV brexanolone

Negative

• Efficacy results not yet reported; primary endpoint outcomes pending
• Small sample size (<200) may limit generalizability until confirmatory data are published

Key Figures

Phase 3 sample size: 90 patients Baseline HAM-D score: 28.3 Treatment duration: 48 hours +1 more

4 metrics

Phase 3 sample size 90 patients Randomized, double-blind, placebo-controlled PPD trial

Baseline HAM-D score 28.3 Average baseline severity in severe PPD population

Treatment duration 48 hours Oral LPCN 1154 dosing period in Phase 3 trial

Primary endpoint timing Hour 60 Change from baseline in HAM-D at Hour 60

Market Reality Check

Price: $9.45 Vol: Volume 78,019 vs 20-day a...

normal vol

$9.45 Last Close

Volume Volume 78,019 vs 20-day average 83,876 (relative volume 0.93). normal

Technical Price 9.45 is trading above 200-day MA at 4.14 after this update.

Peers on Argus

LPCN gained 9.12% while peers were mixed; only MTVA appeared in momentum scans, ...

1 Up

LPCN gained 9.12% while peers were mixed; only MTVA appeared in momentum scans, moving up, and overall data flag this as a stock-specific move, not a sector-wide rotation.

Previous Clinical trial Reports

5 past events · Latest: Jan 20 (Positive)

Same Type Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Jan 20	Phase 3 completion	Positive	-10.9%	Reported full enrollment and dosing of 90 patients with favorable safety.
Jan 12	DSMB safety review	Positive	+12.7%	Second DSMB review found good safety and recommended trial continue unchanged.
Dec 16	80% enrollment	Positive	+0.0%	Phase 3 PPD study reached 80% enrollment with topline data timeline reaffirmed.
Nov 04	Obesity trial data	Positive	-4.5%	Presented Phase 2 LPCN 2401 data showing body composition and liver fat benefits.
Sep 30	Phase 3 progress	Positive	+1.4%	Provided LPCN 1154 Phase 3 progress, with one‑third of planned patients randomized.

Pattern Detected

Clinical-trial headlines have produced mixed reactions, with both sharp gains and selloffs on generally positive LPCN 1154 updates.

Recent Company History

Over recent months, Lipocine has steadily advanced LPCN 1154 for PPD, progressing from one‑third enrollment (Sep 30, 2025) to 80% enrollment (Dec 16, 2025), and then to full enrollment and dosing of 90 patients (Jan 20, 2026). Interim DSMB reviews reported favorable safety and continuation without modification. The current Last Patient Last Visit announcement builds directly on this sequence, confirming completion of follow-up in a trial designed to support a planned 505(b)(2) NDA in 2026.

Historical Comparison

-0.3% avg move · Past clinical-trial updates for Lipocine moved the stock an average of -0.25%. Today’s +9.12% reacti...

clinical trial

-0.3%

Average Historical Move clinical trial

Past clinical-trial updates for Lipocine moved the stock an average of -0.25%. Today’s +9.12% reaction to the Phase 3 LPLV milestone is stronger than typical for this tag.

Clinical news flow shows steady LPCN 1154 Phase 3 progression in PPD, from early enrollment milestones through DSMB reviews to full enrollment, dosing, and now Last Patient Last Visit.

Market Pulse Summary

This announcement marked completion of Last Patient Last Visit in Lipocine’s pivotal Phase 3 trial o...

Analysis

This announcement marked completion of Last Patient Last Visit in Lipocine’s pivotal Phase 3 trial of LPCN 1154 for postpartum depression, a 90-patient study with a 48-hour oral treatment course and a HAM-D primary endpoint at Hour 60. It followed earlier milestones on enrollment and safety. Investors may watch for topline efficacy and safety results, regulatory plans, and how this differentiated, at-home oral approach could position LPCN 1154 within existing PPD treatment options.

Key Terms

phase 3, double-blind, placebo-controlled, postpartum depression, +1 more

5 terms

phase 3 medical

"in its Phase 3 clinical trial evaluating LPCN 1154"

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.

double-blind medical

"The randomized, double-blind, placebo-controlled study enrolled"

A double-blind process means that neither the people conducting an activity nor the people involved know certain key details, such as who is receiving a treatment or a placebo. This approach helps prevent bias from influencing the results, making the outcome more trustworthy. For investors, it ensures that decisions or judgments are based on unbiased information rather than preconceived opinions or expectations.

placebo-controlled medical

"The randomized, double-blind, placebo-controlled study enrolled"

"Placebo-controlled" describes a testing method where one group receives the actual treatment or intervention, while another group receives a harmless, inactive version called a placebo. This approach helps determine whether the real treatment has genuine effects beyond psychological expectations. For investors, understanding this ensures confidence that reported benefits are real and not influenced by bias or false perceptions.

postpartum depression medical

"for the treatment of postpartum depression (PPD)"

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.

systemic exposure medical

"LPCN 1154 achieved bio-equivalent systemic exposure to the intravenous Brexanolone."

Systemic exposure refers to the level of risk that an individual or organization faces from potential problems within the entire financial system. It is like the amount of water in a boat that could be affected if the boat’s hull develops a leak; the more exposed, the greater the potential impact from widespread issues. Understanding systemic exposure helps investors gauge how vulnerable they might be to large-scale financial disruptions.

AI-generated analysis. Not financial advice.

SALT LAKE CITY, Feb. 18, 2026 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to develop innovative products with effective oral delivery, today announced that the last patient has completed the final study visit (Last Patient Last Visit) in its Phase 3 clinical trial evaluating LPCN 1154 (oral brexanolone) for the treatment of postpartum depression (PPD).

The randomized, double-blind, placebo-controlled study enrolled a total of 90 patients with severe PPD, having an average baseline Hamilton depression rating scale (HAM-D) of 28.3. LPCN 1154 has shown a positive safety profile, with all reported nervous system adverse events being mild to moderate in severity. Furthermore, there were no instances of drug discontinuation, excessive sedation, loss of consciousness, or drug-related serious adverse events.

"We are encouraged by the high study drug compliance and safety profile observed in this study. which we believe to be attributable to the short, 48-hour treatment duration, coupled with the regimen's ease of use and tolerability," said Mahesh Patel, CEO of Lipocine. "Provided the efficacy results are positive, the established safety profile could promote greater willingness among healthcare professionals to prescribe LPCN 1154 as a patient-centric treatment option for women suffering from postpartum depression."

Postpartum depression is a serious condition affecting a significant number of new mothers and can be life-threatening if left untreated. Existing treatment options are often limited by access to care, burdensome administration, or tolerability challenges, and may take weeks to months to provide relief. LPCN 1154 is designed to address these limitations with a differentiated profile that may deliver faster symptom relief, a shorter course of treatment, and better tolerability in a convenient oral medication taken at home.

The Phase 3 trial design is informed by a strong foundation of clinical and translational evidence. Brexanolone has demonstrated established antidepressant efficacy in multiple intravenous infusion studies, including the pivotal Phase 3 program that supported approval of Zulresso™ for PPD. LPCN 1154 achieved bio-equivalent systemic exposure to the intravenous Brexanolone. In addition, the current study aligns closely with the Zulresso registrational trials with respect to patient population (women with severe PPD and similar baseline HAM-D scores), treatment duration, sample size, and the primary efficacy endpoint (change from baseline in HAM-D score at Hour 60).

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 feedback from the U.S. Food and Drug Administration (FDA), this single confirmatory trial was conducted in an outpatient setting and administration of LPCN 1154 does not require medical monitoring by a healthcare provider. Nineteen clinical sites across the United States participated. Data from this Phase 3 trial are expected to support a 505(b)(2) NDA submission for LPCN 1154 in 2026. For more information about the phase 3 study, refer to clinicaltrials.gov: NCT06979544.

About LPCN 1154

LPCN 1154 is an oral formulation of brexanolone being developed to provide rapid relief of postpartum depression in a convenient, at-home treatment. It has potential as first line treatment choice for women with PPD. It also has characteristics that  could be particularly beneficial to patients with severe PPD (including those with elevated suicide risk) for whom rapid improvement is a priority. LPCN 1154 is expected to offer a compelling safety profile for breastfeeding mothers. Data from a qEEG study in healthy volunteers demonstrated target engagement consistent with robust central nervous system (CNS) activity, with concentration- and time-dependent post-dose changes in qEEG.

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. 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. As of January 30, 2026, the Company had cash and cash equivalents of approximately $19 million.

Lipocine's development pipeline includes: LPCN 1154 for the treatment of postpartum depression, LPCN 2201 for treatment of major depressive disorder, 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, including the timing and potential results of the study, 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.

 

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SOURCE Lipocine Inc.

FAQ

What does Lipocine's Feb 18, 2026 Last Patient Last Visit mean for LPCN 1154 (LPCN)?

It means the pivotal Phase 3 trial reached final patient follow-up and data collection is complete. According to Lipocine, this enables analysis and submission readiness pending positive efficacy results and safety review.

How many patients were enrolled in the LPCN 1154 Phase 3 trial and what was disease severity?

The trial enrolled 90 women with severe postpartum depression, average baseline HAM-D 28.3. According to Lipocine, the study population aligns with prior Zulresso registrational trials.

What safety results did Lipocine report for LPCN 1154 in the Phase 3 study?

Lipocine reported all nervous system adverse events were mild-to-moderate with no drug-related SAEs or discontinuations. According to Lipocine, there were no instances of excessive sedation or loss of consciousness.

Did LPCN 1154 achieve comparable exposure to intravenous brexanolone in the Phase 3 trial?

Yes; LPCN 1154 achieved bio-equivalent systemic exposure to intravenous brexanolone. According to Lipocine, that pharmacokinetic comparability informed the trial design and regulatory rationale.

What are the next steps and timing after Last Patient Last Visit for LPCN (LPCN)?

Next steps include data lock, statistical analysis, and potential regulatory submission if efficacy is positive. According to Lipocine, results will determine timing for filings and next regulatory interactions.