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, LPCN, LPCN, and TLANDO. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
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- Drug:
- LPCN 1148
- Announced Date:
- May 8, 2024
- Indication:
- Liver cirrhosis
Announcement
Lipocine Inc announced that data from the Phase 2 study of LPCN 1148 has been selected for a late breaking oral presentation at the European Association for the Study of Liver ("EASL") Congress, to take place June 5 to 8, 2024 in Milan, Italy.
AI Summary
Lipocine Inc. announced an important milestone for its experimental treatment LPCN 1148. Data from the Phase 2 study of the drug has been chosen for a late breaking oral presentation at the upcoming European Association for the Study of Liver (EASL) Congress. This decision highlights the significance of the study results and the growing interest in innovative treatments for liver conditions.
The EASL Congress will be held in Milan, Italy, from June 5 to 8, 2024. The presentation slot is a key opportunity for Lipocine Inc. to share its latest findings with a wide audience of clinical experts and industry professionals. This move underscores the company’s commitment to advancing research and fostering discussions around effective liver disease therapies.
Read Announcement
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:
- June 26, 2025
- Estimated Event Date Range:
- April 1, 2026 - June 30, 2026
- Target Action Date:
- Q2 - 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
- 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- Drug:
- LPCN 1154
- Announced Date:
- June 25, 2024
- Estimated Event Date Range:
- October 1, 2024 - December 31, 2024
- Target Action Date:
- Q4 - 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:
- May 1, 2024
- Estimated Event Date Range:
- October 1, 2024 - December 31, 2024
- Target Action Date:
- Q4 - 2024
- Indication:
- Postpartum depression (PPD)
Announcement
Lipocine anticipates NDA submission by the end of the fourth quarter of 2024.
AI Summary
Lipocine announced that dosing for its key pharmacokinetic study is now complete. The study is a crucial step toward the company’s New Drug Application (NDA) for LPCN 1154, an oral formulation of brexanolone designed to treat postpartum depression. Topline results from the study are expected in late second quarter 2024, and Lipocine is working diligently to meet its goal of submitting the NDA by the end of the fourth quarter of 2024. This plan is seen as a major milestone in the effort to introduce a fast-acting and patient-friendly treatment alternative for postpartum depression, a condition that lacks sufficient effective therapies. The anticipated NDA filing could pave the way for a new treatment option that offers rapid relief for those struggling with this challenging disorder.
Read Announcement- Drug:
- LPCN 1154
- Announced Date:
- May 1, 2024
- Indication:
- Postpartum depression (PPD)
Announcement
Lipocine Inc announced that dosing of subjects has been completed in the pivotal pharmacokinetic (PK) study designed to support a New Drug Application (NDA) for LPCN 1154. LPCN 1154, oral brexanolone, is being developed as a treatment of postpartum depression (PPD).
AI Summary
Lipocine Inc. announced that dosing of subjects has been completed in its pivotal pharmacokinetic (PK) study for LPCN 1154, an oral formulation of brexanolone under development to treat postpartum depression (PPD). This PK study is a key step toward supporting a New Drug Application (NDA) filing with the FDA. The study’s results will help demonstrate the drug’s exposure and effectiveness compared to existing treatment options. Lipocine expects to release topline results in late Q2 2024 and plans to submit the NDA by the end of Q4 2024, advancing LPCN 1154 through the streamlined approval pathway agreed upon with the FDA. This development may fill an unmet need in treating PPD by offering a fast-acting, effective oral treatment for patients experiencing severe depressive symptoms after childbirth.
Read Announcement- Drug:
- LPCN 1154
- Announced Date:
- May 1, 2024
- Estimated Event Date Range:
- April 1, 2024 - June 30, 2024
- Target Action Date:
- Q2 - 2024
- Indication:
- Postpartum depression (PPD)
Announcement
Lipocine anticipates topline results late in the second quarter of 2024
AI Summary
Lipocine Inc. has completed dosing for its pivotal pharmacokinetic study, which is designed to support the New Drug Application (NDA) for LPCN 1154, a treatment for postpartum depression. The results of this study are expected by the end of the second quarter of 2024. Lipocine emphasized that these topline results will be a critical indicator in their pursuit to file an NDA by the end of the fourth quarter of 2024.
The company’s strategy involves using a streamlined pathway approved by the U.S. Food and Drug Administration. By focusing on rapid relief through this oral formulation of brexanolone, Lipocine aims to meet the urgent need for an effective treatment for postpartum depression. The upcoming topline results will offer important insights into the potential benefits of LPCN 1154, with hopes of addressing significant unmet medical needs in this area.
Read Announcement
LPCN 2101 - FDA Regulatory Timeline and 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:
- 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
LPCN 2401 - FDA Regulatory Timeline and Events
LPCN 2401 is a drug developed by Lipocine for the following indication: receptor aganist and α-alpha tocopherol, an antioxidant metabolic modifier.
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 2401
- Announced Date:
- April 11, 2024
- Indication:
- receptor aganist and α-alpha tocopherol, an antioxidant metabolic modifier.
Announcement
Lipocine Inc announced results from a Phase 2 clinical trial (NCT04134091) which includes LPCN 2401, an oral proprietary combination of anabolic androgen receptor agonist and α-tocopherol, an antioxidant.
AI Summary
Lipocine Inc. announced positive results from a Phase 2 clinical trial (NCT04134091) for LPCN 2401, an oral proprietary combination of an anabolic androgen receptor agonist and α-tocopherol, an antioxidant. In the study, treatment with LPCN 2401 in obese men or those with weight-related comorbidities showed significant improvements in body composition. Participants experienced a 4.4% increase in lean mass and a 6.7% decrease in fat mass. The trial also reported a 4.1% reduction in abdominal (android) fat and a 2.8% increase in bone mineral content.
The treatment was well-tolerated, with adverse events similar to those of a placebo. These promising results suggest LPCN 2401 could be used either on its own or in combination with incretin mimetics to maintain weight loss and improve muscle quality, supporting its further development as a weight management aid with the FDA.
Read Announcement
TLANDO - FDA Regulatory Timeline and 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
