Lipocine (LPCN) has upcoming FDA regulatory milestones for LPCN 1154. The table below outlines estimated target dates and event types for these pending regulatory actions.
This section highlights FDA-related milestones and regulatory updates for drugs developed by Lipocine (LPCN).
Over the past two years, Lipocine has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
LPCN, LPCN, TLANDO, and LPCN. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
LPCN 1154 FDA Regulatory Timeline and Events
LPCN 1154 is a drug developed by Lipocine for the following indication: Postpartum depression (PPD).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- LPCN 1154
- Announced Date:
- April 2, 2026
- Indication:
- Postpartum depression (PPD)
Announcement
Lipocine Inc announced topline results from its Phase 3 placebo-controlled trial evaluating LPCN 1154 (oral brexanolone) for the treatment of postpartum depression (PPD). For more information on the trial design, refer to clinicaltrials.gov: NCT06979544.
AI Summary
Lipocine Inc. reported topline results from its Phase 3 placebo-controlled trial evaluating LPCN 1154 (oral brexanolone) for postpartum depression (PPD). In a post hoc analysis of participants with a history of psychiatric conditions diagnosed using the MINI interview, the company identified signals that could point to a possible development path for LPCN 1154. The analysis reported placebo-adjusted changes in HAM-D17 scores from baseline using a mixed model for repeated measures and least-squares means. Many comparisons were noted as not statistically significant (NSS), and reported p-values were nominal except for the Hour 60 result in the overall population.
Lipocine said it will complete its full trial analysis in the coming weeks and plans to present results at upcoming conferences. The company thanked patients, investigators, and site staff. For trial design details see clinicaltrials.gov: NCT06979544.
Read Announcement- Drug:
- LPCN 1154
- Announced Date:
- February 18, 2026
- Indication:
- Postpartum depression (PPD)
Announcement
Lipocine Inc 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).
AI Summary
Lipocine Inc. announced that the last patient has completed the final study visit in its Phase 3 clinical trial of LPCN 1154, an oral formulation of brexanolone, for the treatment of postpartum depression (PPD). This “Last Patient Last Visit” milestone means patient participation and primary data collection for the study are complete, allowing the company to move into data cleaning and analysis. Reaching LPLV is a key step toward evaluating the drug’s safety and effectiveness in a larger population.
LPCN 1154 aims to offer an oral treatment option for mothers with PPD, addressing unmet needs for accessible, convenient therapies. With patient follow-up finished, Lipocine will analyze study results and determine next steps, which may include reporting topline data and planning regulatory or development activities based on the trial outcomes. Timelines for those steps were not specified.
Read Announcement- Drug:
- LPCN 1154
- Announced Date:
- January 20, 2026
- Indication:
- Postpartum depression (PPD)
Announcement
Lipocine Inc announced that enrollment and participant dosing have been completed in its Phase 3 clinical trial evaluating LPCN 1154 (oral brexanolone) for the treatment of postpartum depression (PPD).
AI Summary
Lipocine Inc. announced that enrollment and participant dosing are complete in its Phase 3 trial of LPCN 1154 (oral brexanolone) for postpartum depression (PPD). The pivotal, randomized, double‑blind study randomized 90 patients, and to date LPCN 1154 has shown a favorable safety profile with no drug discontinuations, excessive sedation, loss of consciousness, or drug‑related serious adverse events reported.
The trial is being run entirely in an outpatient setting and the oral treatment does not require medical monitoring by a healthcare provider. Lipocine expects to report topline safety and efficacy results early in the second quarter of 2026.
LPCN 1154 is an oral formulation of brexanolone designed to provide rapid at‑home relief for women with PPD, including those with severe symptoms. Data from this study are intended to support a 505(b)(2) NDA submission for LPCN 1154 in 2026.Read Announcement
- Drug:
- LPCN 1154
- Announced Date:
- January 12, 2026
- Indication:
- Postpartum depression (PPD)
Announcement
Lipocine Inc announced the completion of a scheduled independent Data Safety Monitoring Board review of its ongoing Phase 3 clinical trial evaluating LPCN 1154 (oral brexanolone) for the rapid relief treatment of PPD.
AI Summary
Lipocine Inc. announced the completion of a scheduled independent Data Safety Monitoring Board (DSMB) review of its ongoing Phase 3 trial of LPCN 1154 (oral brexanolone) for rapid relief of postpartum depression. This was the second of two planned DSMB reviews, and the board recommended the trial continue as planned without modification.
The DSMB assessed safety data from 82 randomized participants, 74 of whom completed dosing. There have been no treatment discontinuations, no drug-related serious adverse events, and no reports of excessive sedation or loss of consciousness; one participant had a dose reduction due to an adverse event. The study has stopped screening new participants but continues to enroll individuals who already met eligibility. Lipocine said it remains on track to report topline safety and efficacy results early in the second quarter of 2026.
Read Announcement- Drug:
- LPCN 1154
- Announced Date:
- December 16, 2025
- Indication:
- Postpartum depression (PPD)
Announcement
Lipocine Inc. 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.
Read Announcement- Drug:
- LPCN 1154
- Announced Date:
- November 18, 2025
- Target Action Date:
- Q2 2026
- Estimated Target Date Range:
- April 1, 2026 - June 30, 2026
- Indication:
- Postpartum depression (PPD)
Announcement
Lipocine Inc announced that Topline results are on track for the second quarter of 2026
AI Summary
Lipocine Inc. announced that topline results from its ongoing clinical program are on track for the second quarter of 2026. The company expects these initial results to report the main study outcomes, offering an early look at how the investigational product performed in measures that matter most to regulators and clinicians. Lipocine described this milestone as a key step in its development timeline and said it remains focused on completing the study as planned.
Topline data could shape the company’s next actions, such as follow-up trials, regulatory planning, or partner discussions. Investors and other stakeholders will watch the Q2 2026 timing closely because the results may affect the company’s strategy and outlook. Lipocine also noted that timelines can change if enrollment or data review progresses differently, and it will release more details when the results are available.
Read Announcement- Drug:
- LPCN 1154
- Announced Date:
- November 18, 2025
- Indication:
- Postpartum depression (PPD)
Announcement
Lipocine Inc. announced the completion of a scheduled independent Data Safety Monitoring Board review of its ongoing Phase 3 clinical trial evaluating LPCN 1154 (oral brexanolone) for the rapid relief treatment of PPD.
AI Summary
Lipocine Inc. completed a scheduled independent Data Safety Monitoring Board (DSMB) review of its ongoing Phase 3 trial of LPCN 1154 (oral brexanolone) for rapid relief of postpartum depression. The first interim review occurred after about one-third of the planned 80 participants (n=30) reached the day seven follow-up. The DSMB recommended the study continue as planned without changes. More than half of participants (47) have completed dosing so far, and there have been no dose reductions, treatment discontinuations, drug‑related serious adverse events, cases of excessive sedation, or loss of consciousness reported to date.
The pivotal, randomized, double‑blind study compares LPCN 1154 to placebo in women aged 15 and older across 19 U.S. sites. Lipocine said topline results remain on track for the second quarter of 2026, with a second DSMB safety update targeted for early first quarter 2026. The company described the safety profile observed so far as encouraging.
Read Announcement- Drug:
- LPCN 1154
- Announced Date:
- September 30, 2025
- Target Action Date:
- Q2 2026
- Estimated Target Date Range:
- April 1, 2026 - June 30, 2026
- Indication:
- Postpartum depression (PPD)
Announcement
Lipocine Inc announced that The study is progressing on track with one-third of planned patients randomized. Topline results are anticipated in the second quarter of 2026.
AI Summary
Lipocine Inc. reported that its pivotal Phase 3 trial of LPCN 1154, an oral form of brexanolone for postpartum depression, is progressing on track. One-third of the planned participants have now been randomized into the study. Enrolled women aged 15 and older receive either LPCN 1154 or a placebo in a fully outpatient setting without extra medical monitoring.
An independent Data Safety Monitoring Board will review safety data from the first one-third of patients and issue an update in the fourth quarter of 2025. Lipocine anticipates topline results from this trial in the second quarter of 2026.
Mahesh Patel, Lipocine’s CEO, said the steady enrollment and 48-hour dosing schedule could offer rapid, meaningful relief for women with severe postpartum depression. The company plans to use these data to support a 505(b)(2) NDA submission in 2026.
Read Announcement- Drug:
- LPCN 1154
- Announced Date:
- September 30, 2025
- Indication:
- Postpartum depression (PPD)
Announcement
Lipocine Inc today provided an update on its ongoing pivotal Phase 3 clinical trial evaluating LPCN 1154 (oral brexanolone) for the treatment of postpartum depression (PPD).
AI Summary
Lipocine Inc. today announced that its pivotal Phase 3 trial of LPCN 1154 (oral brexanolone) for postpartum depression is on track, with one-third of the planned patients already randomized. The company expects topline results in the second quarter of 2026.
An independent Data Safety Monitoring Board will review safety data from the enrolled patients, and Lipocine plans to share a safety update in the fourth quarter of 2025. The randomized, double-blind study is fully outpatient and compares LPCN 1154 to placebo in women aged 15 and older with severe postpartum depression.
LPCN 1154 offers a 48-hour oral dosing schedule designed for rapid and meaningful relief. Lipocine believes this differentiated approach could set a new standard of care for women suffering from PPD. Data from this study are intended to support a 505(b)(2) NDA submission in 2026.
Read Announcement- Drug:
- LPCN 1154
- Announced Date:
- June 26, 2025
- Target Action Date:
- Q2 2026
- Estimated Target Date Range:
- April 1, 2026 - June 30, 2026
- Indication:
- Postpartum depression (PPD)
Announcement
Lipocine Inc announced that Phase 3 Top Line Results Expected Q2 2026
AI Summary
Lipocine Inc. has begun its pivotal Phase 3 clinical trial for LPCN 1154, an oral treatment for postpartum depression. The study, which takes place in an outpatient setting, is designed as a randomized, blinded trial comparing LPCN 1154 to a placebo over a 48-hour dosing period. The trial uses established measures like the Hamilton Depression Rating Scale to assess treatment effectiveness, and it also considers changes in anxiety levels.
Importantly, Lipocine expects to deliver the top line results from this Phase 3 study by Q2 2026. These findings will be used to support the submission of a New Drug Application later in 2026. The company aims to provide a rapid relief option for women suffering from severe postpartum depression, offering a promising treatment that could improve the standard of care in this challenging area.
Read Announcement- Drug:
- LPCN 1154
- Announced Date:
- June 26, 2025
- Indication:
- Postpartum depression (PPD)
Announcement
Lipocine Inc. 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).
AI Summary
Lipocine Inc. announced an important milestone by dosing the first patient in its pivotal Phase 3 clinical trial of LPCN 1154, an investigational oral treatment for postpartum depression (PPD). The trial is designed as a randomized, blinded, two-arm study that will compare LPCN 1154 with a placebo. The study will involve women aged 15 years and older who suffer from severe PPD. A unique aspect of the trial is its 48‐hour dosing period, modeled after previous successful studies with an injectable form of brexanolone. Additionally, the study is being conducted in an outpatient setting, which means patients do not require constant medical monitoring by a healthcare provider. Lipocine plans to use the data from this Phase 3 trial to support an NDA submission for LPCN 1154 in mid‑2026, aiming to address the urgent need for rapid relief in women with PPD.
Read Announcement- Drug:
- LPCN 1154
- Announced Date:
- June 23, 2025
- Indication:
- Postpartum depression (PPD)
Announcement
Lipocine Inc. announced that it will host a virtual research and development (R&D) investor event on Wednesday, July 9, 2025 at 11:00 AM ET featuring 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 postpartum depression (PPD).
AI Summary
Lipocine Inc. will host a virtual research and development investor event on Wednesday, July 9, 2025, at 11:00 AM ET. At the session, company management, along with Kristina M. Deligiannidis, MD from Zucker Hillside Hospital at Northwell Health in New York, will explore the current treatment landscape and the unmet needs in postpartum depression (PPD). This common yet serious mood disorder has significant effects on both mothers and infants, making effective and fast-acting treatments critical. The event will focus on discussing the challenges in treating PPD and the potential of new therapeutic approaches, including Lipocine’s promising clinical candidate for PPD. Attendees will gain insights into how Lipocine’s innovative strategies and ongoing research may lead to improved outcomes for women experiencing PPD, addressing a significant area of unmet need in mental health treatment.
Read Announcement- Drug:
- LPCN 1154
- Announced Date:
- March 26, 2025
- Indication:
- Postpartum depression (PPD)
Announcement
Lipocine Inc. announced the initiation of a Phase 3 trial for LPCN 1154 (oral brexanolone) which is in development for the treatment of postpartum depression (PPD).
AI Summary
Lipocine Inc. has announced the start of a Phase 3 trial for LPCN 1154 (oral brexanolone), an experimental treatment for postpartum depression (PPD). This study is a randomized, double-blind, placebo-controlled trial aimed at evaluating the safety and effectiveness of LPCN 1154 in women aged 15 and older suffering from severe PPD.
Patients in the trial will self-administer the drug at home during a 48-hour dosing period. Based on promising results from a previous pharmacokinetic study, the first patient is expected to be dosed in the second quarter of 2025. The trial’s outcomes, measured by changes in depression rating scales such as the Hamilton Depression Rating Scale (HAM-D), are designed to support a global registration package for LPCN 1154, potentially positioning it as a first-line option for rapid symptom relief in PPD.
Read Announcement- Drug:
- LPCN 1154
- Announced Date:
- June 25, 2024
- Target Action Date:
- Q4 2024
- Estimated Target Date Range:
- October 1, 2024 - December 31, 2024
- Indication:
- Postpartum depression (PPD)
Announcement
Lipocine Inc. announced that its On track for NDA filing, targeted by end of Q4 2024
AI Summary
Lipocine Inc. announced that its pivotal pharmacokinetic study of LPCN 1154, an oral formulation of brexanolone for treating postpartum depression, met standard bioequivalence criteria for key measures such as Cmax, AUC0-t, and AUC0-∞. The study showed that LPCN 1154 was well tolerated, with no sedation or somnolence observed, supporting its potential as a fast-acting treatment option. This important milestone reinforces the product’s promise to offer rapid relief for patients experiencing postpartum depression.
Building upon these positive results, Lipocine is on track for a New Drug Application (NDA) filing, which is now targeted for submission by the end of the fourth quarter of 2024. This planned filing represents a significant step forward in delivering an effective, oral therapeutic option to address this critical unmet need in postpartum depression care.
Read Announcement- Drug:
- LPCN 1154
- Announced Date:
- June 25, 2024
- Indication:
- Postpartum depression (PPD)
Announcement
Lipocine Inc. announced positive topline study results demonstrating bioequivalence of LPCN 1154 to IV brexanolone in an NDA enabling pivotal pharmacokinetic (PK) study.
AI Summary
Lipocine Inc. announced positive topline results from its pivotal pharmacokinetic (PK) study showing that LPCN 1154, an oral form of brexanolone, meets key bioequivalence criteria compared to the approved IV brexanolone. The study demonstrated comparable drug exposure between the oral and IV forms based on measures like Cmax, AUC0-t, and AUC0-∞, which all fell within the established 80% to 125% range. Importantly, LPCN 1154 was well tolerated, with no sedation or somnolence reported during the trial.
These results support the company’s proposal for a 505(b)(2) NDA filing with the FDA, paving the way for regulatory submission by the end of Q4 2024. The encouraging findings provide a promising step forward for LPCN 1154 as a potential fast-acting, convenient treatment option for postpartum depression.
Read Announcement
LPCN 2101 FDA Regulatory Events
LPCN 2101 is a drug developed by Lipocine for the following indication: Epilepsy.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- LPCN 2101
- Announced Date:
- August 26, 2025
- Indication:
- Epilepsy
Announcement
Lipocine Inc announced that two abstracts related to LPCN 2101 have been accepted for poster presentation at the 2025 American Epilepsy Society (AES) annual meeting to be held December 5-9 in Atlanta, Georgia.
AI Summary
Lipocine Inc. announced that two abstracts on LPCN 2101 have been accepted for poster presentation at the 2025 American Epilepsy Society annual meeting, December 5–9 in Atlanta, Georgia. LPCN 2101 is an experimental oral therapy being developed to treat epilepsy.
The first poster, “Oral Toxicokinetics of a Bioidentical GABAA Receptor Modulating Neuroactive Steroid Anti-seizure Medication Candidate for Women with Epilepsy,” will be presented on Sunday, December 7, from 12:00 PM to 2:00 PM (Abstract 2.331). The second, “Clinical Pharmacokinetics and Tolerability of a Novel Oral GABAA Receptor Positive Allosteric Modulating Candidate for Epilepsy,” is scheduled for Monday, December 8, from 12:00 PM to 1:45 PM (Abstract 3.354). Both studies examine LPCN 2101’s pharmacokinetics, safety, and tolerability, underscoring its potential as an innovative, patient-friendly oral anti-seizure therapy. Acceptance at AES highlights Lipocine’s progress in exploring oral neuroactive steroids for seizure control.
Read Announcement- Drug:
- LPCN 2101
- Announced Date:
- September 5, 2024
- Indication:
- Epilepsy
Announcement
Lipocine Inc announced that a poster featuring Phase 2 data on LPCN 2401 will be presented at the Obesity Society's Annual ObesityWeek® conference to be held November 3 – 6, 2024 in San Antonio, TX.
AI Summary
Lipocine Inc. recently announced that a poster featuring Phase 2 data on its investigational drug LPCN 2401 will be showcased at the Obesity Society’s Annual ObesityWeek® conference in San Antonio, TX, from November 3–6, 2024. The presentation, scheduled for Tuesday, November 5, 2024, from 2:30 to 3:30 pm CT at Exhibit Hall 4B, will detail findings from a study exploring the drug’s effects in adults with obesity or overweight individuals with weight-related health issues.
The poster, titled "Oral LPCN 2401 Reduces Fat Mass and Increases Lean Mass in Men With Obesity," will be presented by Dr. Frank Greenway. The study highlights LPCN 2401’s potential to help improve body composition by reducing fat and increasing lean muscle mass, offering a promising adjunct therapy for chronic weight management.
Read Announcement
TLANDO FDA Regulatory Events
TLANDO is a drug developed by Lipocine for the following indication: Oral testosterone.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- TLANDO
- Announced Date:
- June 9, 2025
- Indication:
- Oral testosterone
Announcement
Lipocine Inc. announced that its licensing partner, Verity Pharma, filed a New Drug Submission (NDS) for TLANDO® in Canada.
AI Summary
Lipocine Inc. announced that its licensing partner, Verity Pharma, has filed a New Drug Submission (NDS) for TLANDO® in Canada. This important filing marks the next step in making TLANDO® available in the Canadian market. The company sees a strong opportunity in Canada, where over 700,000 testosterone replacement therapy prescriptions are written annually. TLANDO® is already approved by the US Food and Drug Administration (FDA) as the first and only oral testosterone replacement therapy that does not require dose titration, and if approved in Canada, it could capture a significant share of this growing market.
Mahesh Patel, CEO of Lipocine, expressed confidence that the introduction of this unique oral TRT option will drive considerable market gains and offer an attractive treatment alternative for patients in Canada.
Read Announcement
LPCN 1148 FDA Regulatory Timeline and Events
LPCN 1148 is a drug developed by Lipocine for the following indication: Liver cirrhosis.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- LPCN 1148
- Announced Date:
- December 17, 2024
- Indication:
- Liver cirrhosis
Announcement
Lipocine Inc. announced that the U.S. Food and Drug Administration ("FDA") has granted Fast Track Designation to LPCN 1148 as a treatment for sarcopenia in patients with decompensated cirrhosis.
AI Summary
Lipocine Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to LPCN 1148 as a treatment for sarcopenia in patients with decompensated cirrhosis. LPCN 1148 is an oral prodrug of bioidentical testosterone and has shown promise in a Phase 2 proof-of-concept study, where it improved muscle loss and related clinical outcomes in patients with advanced liver disease. This Fast Track status is intended to speed up the drug’s development and review process, offering the potential for more frequent discussions with the FDA about the clinical trial design and additional data collection. Lipocine’s CEO, Dr. Mahesh Patel, expressed excitement over the FDA’s recognition, noting that the designation supports efforts to address an unmet need in treating sarcopenia in patients with cirrhosis.
Read Announcement- Drug:
- LPCN 1148
- Announced Date:
- November 18, 2024
- Indication:
- Liver cirrhosis
Announcement
Lipocine Inc announced the publication and discussion of a manuscript "Oral LPCN 1148 Improves Sarcopenia and Hepatic Encephalopathy in Male Patients with Cirrhosis: a randomized, placebo-controlled Phase 2 trial" in the journal Hepatology and discussion at The Liver Meeting (AASLD) 2024 Editor's Cut: Clinical Study Session held on November 16, 2024.
AI Summary
Lipocine Inc. recently announced that a manuscript titled "Oral LPCN 1148 Improves Sarcopenia and Hepatic Encephalopathy in Male Patients with Cirrhosis: a randomized, placebo-controlled Phase 2 trial" has been published in the journal Hepatology. The manuscript details a Phase 2 study evaluating LPCN 1148, a novel oral therapy aimed at treating both sarcopenia and overt hepatic encephalopathy in men with cirrhosis. In a double-blind, placebo-controlled trial, patients receiving LPCN 1148 showed significant improvements in muscle mass and quality, decreased episodes of overt hepatic encephalopathy, and benefits in hemoglobin levels and symptom relief compared to placebo.
The study’s findings were highlighted during a discussion at The Liver Meeting (AASLD) 2024 Editor’s Cut: Clinical Study Session on November 16, 2024. These promising results support further research into LPCN 1148 as a first-in-class treatment addressing critical unmet needs in patients with liver cirrhosis.
Read Announcement- Drug:
- LPCN 1148
- Announced Date:
- June 10, 2024
- Indication:
- Liver cirrhosis
Announcement
Lipocine Inc announced that Phase 2 results on LPCN 1148 in cirrhosis were featured in a late breaking oral presentation at the European Association for the Study of Liver (EASL) Congress on Saturday, June 8, in Milan, Italy.
AI Summary
Lipocine Inc recently announced promising Phase 2 results for LPCN 1148 in patients with cirrhosis. These results were featured during a late-breaking oral presentation at the European Association for the Study of Liver (EASL) Congress in Milan, Italy, on June 8, 2024. The study, led by Dr. Arun J. Sanyal of Virginia Commonwealth University, evaluated the use of oral LPCN 1148 over a 52-week period. The findings indicated that the treatment helped improve sarcopenia (loss of muscle mass) and reduce episodes of hepatic encephalopathy, a serious brain dysfunction linked to liver disease. This presentation highlighted important advances in managing cirrhosis and addressing its complications, offering hope in fulfilling unmet medical needs in liver disease care.
Read Announcement
