One-Third of Patients Randomized; Topline Results Expected in 2Q 2026 DSMB Safety Review Update Planned for 4Q 2025 SALT LAKE CITY , Sept. 30, 2025 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to develop innovative products with effective oral delivery, today provided an update on its ongoing pivotal Phase 3 clinical trial evaluating LPCN 1154 (oral... Read More

SALT LAKE CITY , Sept. 5, 2025 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to develop innovative products with effective oral delivery, today announced that Company Management will present and meet with investors at the H.C. Wainwright 27 th Annual Global Investment Conference being held in-person and virtually on September 8-10, 2025. Presentation... Read More

SALT LAKE CITY , Aug. 26, 2025 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to develop innovative products with effective oral delivery, today 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 . LPCN 2101... Read More

SALT LAKE CITY , Aug. 5, 2025 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to develop innovative products with effective oral delivery, today announced financial results for the second quarter ended June 30, 2025 and provided a corporate update. Neuroactive Steroids LPCN 1154 (oral brexanolone product candidate) is a non-invasive, 48-hour treatment... Read More

Phase 3 Top Line Results Expected Q2 2026 SALT LAKE CITY , June 26, 2025 /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 first patient has been dosed in its pivotal Phase 3 clinical trial of LPCN 1154 (oral brexanolone), its investigational oral treatment for... Read More

SALT LAKE CITY , June 23, 2025 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to enable effective oral delivery of therapeutics, today 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... Read More

New Drug Submission filed by Lipocine's licensing partner Verity Pharma Over 700,000 total prescriptions written annually for testosterone replacement therapy (TRT) in Canada , representing large commercial opportunity SALT LAKE CITY , June 9, 2025 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to enable effective oral delivery of therapeutics, today... Read More

SALT LAKE CITY , May 22, 2025 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to augment therapeutics through effective oral delivery, today announced that its development candidate LPCN 1148 for men with cirrhosis is featured in the "Hepatology Highlights" section of the June 2025 edition of Hepatology . The article " LPCN 1148: Rebuilding muscle... Read More

SALT LAKE CITY , May 14, 2025 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to augment therapeutics through effective oral delivery, today announced that it will present at A.G.P.'s Annual Healthcare Company Showcase being held virtually on Wednesday, May 21, 2025 . Presentation Details Time: 4:00 pm ET Date: Wednesday, May 21, 2025 Webcast Link:... Read More

SALT LAKE CITY , May 8, 2025 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to augment therapeutics through effective oral delivery, today announced financial results for the first quarter ended March 31, 2025 and provided a corporate update. Neuroactive Steroids Lipocine has initiated an outpatient Phase 3 safety and efficacy study of LPCN 1154, a... Read More

SALT LAKE CITY , May 6, 2025 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to enable effective oral delivery of therapeutics, today announced that it has entered into license and supply agreement with Aché Laboratórios Farmacêuitcos S.A (Aché) granting exclusive rights to market TLANDO ® in Brazil. The market for prescription testosterone products in... Read More

48 hour at-home dosing Patient dosing expected in Q2/2025 SALT LAKE CITY , March 26, 2025 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to enable effective oral delivery of therapeutics, today announced the initiation of a Phase 3 trial for LPCN 1154 (oral brexanolone) which is in development for the treatment of postpartum depression (PPD). Based on... Read More

SALT LAKE CITY , March 13, 2025 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to augment therapeutics through effective oral delivery, today announced financial results for the year ended December 31, 2024 , and provided a corporate update. Oral Brexanolone LPCN 1154 is an oral formulation of the neuroactive steroid brexanolone that Lipocine is... Read More

SALT LAKE CITY , March 12, 2025 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to augment therapeutics through effective oral delivery, today announced that the U.S. Food and Drug Administration (FDA) has recently informed sponsors of approved testosterone products about class-wide labeling changes. This decision follows the Agency's review of the... Read More

SALT LAKE CITY , Feb. 6, 2025 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to augment therapeutics through effective oral delivery, today announced receipt of revised regulatory guidance for LPCN 1154 which the Company is developing for postpartum depression (PPD) treatment. As previously disclosed, the Company was scheduled to meet with the U.S.... Read More

SALT LAKE CITY , Dec. 17, 2024 /PRNewswire/ -- Lipocine Inc . (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to augment therapeutics through effective oral delivery, today 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, an oral prodrug of... Read More

SALT LAKE CITY , Nov. 18, 2024 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to augment therapeutics through effective oral delivery, today 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... Read More

SALT LAKE CITY , Nov. 7, 2024 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to augment therapeutics through effective oral delivery, today announced financial results for the third quarter and nine months ended September 30, 2024 and provided a corporate update. Neuroactive Steroids LPCN 1154, oral brexanolone, is being developed as a treatment for... Read More

SALT LAKE CITY , Oct. 31, 2024 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to augment therapeutics through effective oral delivery, today announced a license, development and supply agreement with to SPC Korea http://spcpharm.co.kr granting exclusive rights to market TLANDO® in South Korea . Under the terms of the distribution and license agreement,... Read More

Quantitative Electroencephalogram (qEEG) in healthy subjects administered single doses of oral brexanolone, a neuroactive steroid (NAS), confirmed GABA A modulation Rapid and durable CNS target engagement confirms effective oral delivery of bioidentical brexanolone Promising results support continued development of oral... Read More

SALT LAKE CITY , Oct. 8, 2024 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to augment therapeutics through effective oral delivery, today announced an exclusive supply and distribution agreement with Pharmalink https://pharmalink.ae/ to commercialize TLANDO®, its oral testosterone replacement therapy, in the Gulf Cooperation Council (GCC) countries... Read More

SALT LAKE CITY , Oct. 2, 2024 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to augment therapeutics through effective oral delivery, today announced that it will host a virtual key opinion leader (KOL) event on LPCN 2401 for improved body composition in obesity management on Wednesday, October 16, 2024 at 11:00 am ET . To register, click here. The... Read More

SALT LAKE CITY , Sept. 30, 2024 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to augment therapeutics through effective oral delivery, today announced that it will present and meet with investors at the H.C. Wainwright 8 th Annual MASH Investor Conference , to take place virtually on October 7, 2024 . Presentation Details Time: 2:00 to 2:30pm ET Date:... Read More

Study evaluated LPCN 2401 in participants with obesity (BMI ≥30) and participants with BMI ≥27 with at least one weight-related comorbidity SALT LAKE CITY , Sept. 5, 2024 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to augment therapeutics through effective oral delivery, today announced that a poster featuring Phase 2 data on LPCN 2401 will be... Read More

SALT LAKE CITY , Aug. 27, 2024 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to augment therapeutics through effective oral delivery, today announced that Dr. Mahesh V. Patel , President and Chief Executive Officer, will present and meet with investors at the H.C. Wainwright 26th Annual Global Investment Conference being held in-person and virtually... Read More

SALT LAKE CITY , Aug. 8, 2024 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to augment therapeutics through effective oral delivery, today announced financial results for the second quarter ended June 30, 2024 and provided a corporate update. LPCN 1154 for Postpartum Depression (PPD) In June 2024 , Lipocine announced positive topline study results... Read More

Met standard bioequivalence (BE) criteria C max, AUC 0-t , and AUC 0- ∞ C trough criterion was met LPCN 1154 was well tolerated with no sedation or somnolence events observed On track for NDA filing, targeted by end of Q4 2024 SALT LAKE CITY , June 25, 2024 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to augment therapeutics through effective oral... Read More

SALT LAKE CITY , June 10, 2024 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company, today 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 . The presentation "Intervention with oral LPCN 1148 improves sarcopenia and hepatic encephalopathy... Read More

SALT LAKE CITY , May 9, 2024 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company, today announced financial results for the first quarter ended March 31, 2024 and provided a corporate update. LPCN 1154 for Postpartum Depression In May 2024 , dosing of subjects was completed in the pivotal pharmacokinetic (PK) study designed to support a New Drug Application (NDA) for LPCN 1154. LPCN 1154, oral... Read More

SALT LAKE CITY , May 8, 2024 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company, today 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 . Presentation Details Title Intervention with oral LPCN 1148 improves sarcopenia and... Read More

Pivotal study design aligned with FDA on streamlined pathway to NDA submission goal in 2024 Topline results anticipated late in 2Q 2024 SALT LAKE CITY , May 1, 2024 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company, today 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... Read More

LPCN 2401 treatment resulted in statistically significant body composition improvement in men Increased lean mass (LM) by 4.4% and decreased fat mass (FM) by 6.7% Reduced android fat (AF) by 4.1% and increased bone mineral content (BMC) by 2.8% Well-tolerated, adverse events (AEs) similar to placebo Potential for use in combination with incretin mimetics (GLP-1/GIP agonists and/or post GLP-1/GIP agonist) or as a monotherapy... Read More

Met primary and Hepatic Encephalopathy (HE) endpoints in Phase 2 study Increase in Skeletal Muscle Index (SMI) observed at Week 24 was maintained through 52 weeks Participants on placebo increased SMI when switched to LPCN 1148 Fewer Overt Hepatic Encephalopathy (OHE) events and time to first recurrent OHE event was longer while on LPCN 1148 therapy LPCN 1148 was well-tolerated, with AE rates and severities similar to... Read More

Company anticipates topline results from this crossover pivotal study late in the second quarter of 2024 SALT LAKE CITY , March 25, 2024 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company focused on treating Central Nervous System (CNS) disorders by leveraging its proprietary platform, today announced that study enrollment is complete and the first cohort of subjects has been dosed in pivotal... Read More

SALT LAKE CITY , March 7, 2024 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company focused on treating Central Nervous System ("CNS") disorders, today announced financial results for the year ended December 31, 2023 and provided a corporate update. Neuroactive Steroids Lipocine announced positive topline results from a pharmacokinetics ("PK") pilot bridge study of LPCN 1154 (oral brexanolone). Lipocine... Read More

SALT LAKE CITY , March 6, 2024 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company focused on treating Central Nervous System (CNS) disorders, today announced that Dr. Mahesh V. Patel , President and Chief Executive Officer, will participate in a fireside chat and meet with investors at the 36 th Annual Roth Conference, to take place in Laguna Niguel, CA , on March 18 . Presentation Details Date:... Read More

Positive clinical study results confirm 48-hour dosing regimen for the pivotal PK study On track for Q2-24 pivotal study topline results and planned Q4-24 NDA filing SALT LAKE CITY , Feb. 6, 2024 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company focused on treating Central Nervous System (CNS) disorders by leveraging its proprietary platform, today announced that results from a multi-dose clinical... Read More

SALT LAKE CITY , Feb. 2, 2024 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company focused on treating Central Nervous System (CNS) disorders, today announced that commercialization of TLANDO® in the U.S. has been transitioned to its licensee Verity Pharma, effective February 1, 2024 , enabling the continuity of patient access to TLANDO. TLANDO is the first and only oral testosterone replacement therapy... Read More

Lipocine to receive $11 million license fee Up to $259 million in development and commercial sales milestones Tiered royalties on net sales of licensed products up to 18% Commercialization of TLANDO transitions to Verity Pharma effective Feb.1 2024 Lipocine retains all rights for territories outside the United States and Canada , and all non-TRT rights globally SALT LAKE CITY , Jan. 18, 2024 /PRNewswire/ -- Lipocine Inc.... Read More

Company Management Will Also Host Meetings at LifeSci Partners Corporate Access Event SALT LAKE CITY , Dec. 19, 2023 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company focused on treating Central Nervous System (CNS) disorders, today announced that it will present at the Biotech Showcase and host institutional investor and partnering meetings at this event and at a Corporate Access Event organized by... Read More

Results demonstrate improvements in sarcopenia and other clinically meaningful outcomes Patients converting from placebo to LPCN 1148 in the ongoing open label extension also showed improvement in sarcopenia SALT LAKE CITY , Nov. 13, 2023 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company focused on treating Central Nervous System (CNS) disorders, today announced that results of its Phase 2 study... Read More

SALT LAKE CITY , Nov. 8, 2023 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company focused on treating Central Nervous System (CNS) disorders by leveraging its proprietary platform to develop differentiated products, today announced financial results for the third quarter and nine months ended September 30, 2023 , and provided a corporate update. Clinical Program Highlights Neuroactive Steroids On... Read More

"Late Breaking" abstract scheduled for oral presentation on November 13 SALT LAKE CITY , Nov. 1, 2023 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company focused on treating Central Nervous System (CNS) disorders, today announced that an abstract on LPCN 1148 has been selected for a late breaking oral presentation at The American Association for the Study of Liver Diseases (AASLD) – The Liver Meeting®... Read More

Lipocine and FDA agreed on the acceptance criteria for the pivotal study which enables advancement of LPCN 1154 for postpartum depression (PPD) Company on track to initiate dosing in the pivotal study Q1'24 SALT LAKE CITY , Oct. 26, 2023 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company focused on treating Central Nervous System (CNS) disorders by leveraging its proprietary platform, today announced... Read More

SALT LAKE CITY , Oct. 23, 2023 /PRNewswire/ -- L ipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company focused on treating Central Nervous System (CNS) disorders, today announced that it will present and meet with investors at the H.C. Wainwright 7th Annual NASH Investor Conference, taking place virtually October 24, 2023 . Presentation Details Presenter: Dr. Benjamin Bruno, Senior Director, Clinical Development Date/... Read More

SALT LAKE CITY , Sept. 19, 2023 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company focused on treating Central Nervous System (CNS) disorders, today announced that Dr. Mahesh Patel, President and Chief Executive Officer, will present and meet with investors at the 2023 Cantor Fitzgerald Global Healthcare Conference to take place September 26th to September 28th in New York City. Presentation Details... Read More

SALT LAKE CITY , Aug. 10, 2023 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company focused on treating Central Nervous System (CNS) disorders, today announced financial results for the second quarter and six months ended June 30, 2023 , and provided a corporate update. Clinical Program Highlights Neuroactive Steroids Lipocine announced positive topline results from a pilot pharmacokinetics ("PK") bridge... Read More

Met primary endpoint: treatment with LPCN 1148 increased L3 skeletal muscle index (L3-SMI) relative to placebo (P <0.01) Fewer hepatic encephalopathy (HE) events of grade >1 in the LPCN 1148 treatment arm relative to placebo (P < 0.05) More patients on LPCN 1148 reported symptom improvement compared to placebo (P < 0.05) LPCN 1148 was well-tolerated, with AE rates and severities similar to placebo Conference call and webcast... Read More

SALT LAKE CITY , June 14, 2023 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company focused on treating Central Nervous System (CNS) disorders by leveraging its proprietary platform to develop differentiated products, today announced that Dr. Mahesh Patel , President and Chief Executive Officer, will present virtually and meet with investors at the H.C. Wainwright 4th Annual Neuropsychiatry Virtual... Read More

Phase 2 proof-of-concept study of LPCN 1148 in male cirrhotic patients with sarcopenia is fully enrolled with topline 24-week results expected mid-2023 SALT LAKE CITY , June 7, 2023 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company focused on treating Central Nervous System (CNS) disorders by leveraging its proprietary technology platform to develop differentiated products, today announced that it... Read More

Identified dosing regimen that enables reliance on a single confirmatory pivotal pharmacokinetic (PK) study to establish efficacy for postpartum depression (PPD) and support NDA submission LPCN 1154 treatment was well-tolerated with no hypoxia or sedation-related adverse events Lipocine plans to initiate the confirmatory pivotal PK study in 2H 2023 Conference call and webcast today at 8:30am ET SALT LAKE CITY , May 16, 2023... Read More

SALT LAKE CITY , May 11, 2023 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company focused on treating Central Nervous System (CNS) disorders by leveraging its proprietary platform to develop differentiated products, today announced financial results for the first quarter ended March 31, 2023 , and provided a corporate update. First Quarter Highlights Neuroactive Steroid for Depression Dosing was... Read More

LPCN 1154 is an oral formulation of brexanolone in development for the rapid relief of postpartum depression (PPD) Topline study results expected in H1 2023 SALT LAKE CITY , April 3, 2023 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company focused on treating Central Nervous System (CNS) disorders by leveraging its proprietary platform to develop differentiated products, today announced that the first... Read More

SALT LAKE CITY , March 10, 2023 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company focused on treating Central Nervous System ("CNS") disorders by leveraging its proprietary platform to develop differentiated products, today announced financial results for the year ended December 31, 2022 and provided a corporate update. In 2022, Lipocine announced a new strategic direction, focusing on the development... Read More

SALT LAKE CITY , March 10, 2023 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced that its Board of Directors declared a dividend of one one-thousandth of a share of newly designated Series B Preferred Stock, par value $0.0001 per share, for each outstanding share of the Company's common stock held of record as of 5:00 p.m.... Read More

Company Management Will Also Host Meetings at LifeSci Partners Corporate Access Event SALT LAKE CITY , Jan. 5, 2023 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company focused on treating Central Nervous System ("CNS") disorders by leveraging its proprietary platform to develop differentiated products, today announced that its management will present at the Biotech Showcase and host institutional... Read More

Top-line 24-week results from proof-of-concept study expected mid-2023 SALT LAKE CITY , Dec. 19, 2022 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company focused on treating Central Nervous System ("CNS") disorders by leveraging its proprietary platform to develop differentiated products, today announced that it has completed enrollment in its Phase 2 proof-of-concept ("POC") study evaluating the... Read More