The Beta-blockers in Takotsubo syndrome (TTS) (β-Tako) trial, is an academic, pragmatic, prospective, multicenter randomized clinical trial, aiming to assess the efficacy of beta-blockers (BB) in TTS patients. Two-hundred patients with TTS will be randomized (1:1) to BB (n=100) or no BB (n=100). BB with alpha or nitric oxide release activity will be used in the treatment arm. The primary endpoint will be the comparison of the wall motion score index by echocardiography at 7 days. A composite clinical endpoint (death, stroke, admission for recurrent TTS, ACS, heart failure or atrial fibrillation) at 1 year, will be assessed by an independent clinical events committee. Several sub-studies will be performed. The β-Tako trial will inform treatment decisions in this uniquely challenging clinical entity.

Start Date01 Aug 2024

Sponsor / Collaborator-

CTRI/2021/12/038848

/ RecruitingPhase 2

A Phase 2, Randomized, Double blind, Placebo-controlled, Two-arm Study to Evaluate the Efficacy and Safety of Hydroxyprogesterone Caproate Intramuscular Injection Plus Dexamethasone Compared to Dexamethasone Alone in Patients with Moderate COVID-19 disease (Non-intubated, Nonmechanical Ventilation). - NA

Start Date30 Dec 2021

Sponsor / Collaborator

Evergreen Therapeutics, Inc

NCT04077853

/ CompletedPhase 4IIT

Efficacy of 17-Hydroxyprogesterone Caproate in Expectantly Managed Early-onset Preeclampsia: A Randomized Controlled Study

Preeclampsia is a disorder of widespread vascular endothelial malfunction and vasospasm that occurs after 20 weeks' gestation and can present as late as 4-6 weeks postpartum

Start Date15 Dec 2019

Sponsor / Collaborator

Assiut University

100 Clinical Results associated with Hydroxyprogesterone Caproate

100 Translational Medicine associated with Hydroxyprogesterone Caproate

100 Patents (Medical) associated with Hydroxyprogesterone Caproate

1,099

Literatures (Medical) associated with Hydroxyprogesterone Caproate

01 Feb 2025·SCIENCE OF THE TOTAL ENVIRONMENT

Characteristics and management of fecal sludge in Ethiopia with a focus on resource recovery

Article

Author: Woldeyohans, Akalu Melketsadik ; Van Hulle, Stijn W H ; Alemayehu, Esayas ; Dong, Pengyu ; Mereta, Seid Tiku ; Linnemann, Volker ; Rousseau, Diederik P L

To gain a comprehensive understanding of the potential environmental and public health implications of current fecal sludge (FS) handling practices in developing countries, investigating its composition is crucial. This study addresses quantitatively the variability of common water and wastewater parameters, parasite eggs and pollutants of concern, such as heavy metals, across different FS handling technologies. Additionally, it presents a qualitative screening of other micropollutants such as pharmaceuticals, hormones and pesticides, along with an assessment of resource recovery potential. Based on sanitation records provided by the local government, FS dislodging practices were categorized into six types (septic tanks and pits for institutions, septic tanks and pits for private houses and septic tank and pit for communal latrines). The quality of FS across these dislodging types was evaluated using 31 FS samples directly obtained from FS dislodging trucks in Ethiopia. The study found that the average moisture content of the sludge was 98.7 %, with a calorific value of 16 MJ/kg of total solids (TS), indicating its potential for water and energy recovery. Furthermore, the study revealed a prevalence ranking of Ascaris lumbricoides egg > Taenia egg > Hookworm egg> Hymenolepis nana egg> Enterobius vermicularis egg> Trichuris trichiura egg, with a mean value of 689 eggs/L of fecal sludge and a 100 % prevalence of Ascaris lumbricoides eggs. Additionally, 14 heavy metals with mean concentrations ranging between 0.002 and 6.25 mg/L were identified. For most of these metals, the concentration was significantly positively correlated with the TS content. Moreover, in this study 32 drugs and their derivatives, 6 hormones, and 1 insecticide have been detected. Overall, the compositional profile of the FS in this study indicates that improper handling of the sludge may pose potential public health and environmental threats. However, it also highlights the valuable potential of water and energy recovery from FS.

01 Jan 2025·CHEMICAL ENGINEERING JOURNAL

Interfacial engineering of ZnS-FeS heterostructure accelerates Li2S2 reduction and impedes the dendritic Li growth

Author: Chen, You ; Lu, Chunxiang ; Yuan, Shuxia ; Su, Fangyuan ; Yi, Zonglin ; Ren, Xiaodan ; Liu, Zhifei ; Wu, Shijie ; Yang, Yu

The andante electrocatalytic conversion and grievous shuttle effect of lithium polysulfides (LiPSs) lead to stagnant applications of lithium-sulfur (Li-S) batteries.Plentiful catalysts such as ZnS-FeS heterostructures have been employed to solve those problems.However, the mechanism of this heterostructures on sulfur reduction reaction (SRR) especially the conversion of Li₂S₂ to Li₂S (Li₂S₂RR) and Li+ migration has not been revealed.Herein, a ZnS-FeS heterostructures embedded in hierarchical porous carbon (ZnS-FeS/HPC) was demonstrated that can act as effective catalyst to accelerate Li₂S₂RR and promote the Li+ diffusion simultaneously.This improvement can be attributed to the moderate adsorption energy and lower d-band center of the heterostructures to reaction intermediates.Moreover, with both homogeneous porous structure and abundant polarity sites, the modified separator using ZnS-FeS/HPC was endowed with selectivity to promote uniform Li+ flux and migration, as well as impede the dendritic Li growth and LiPSs shuttling.Benefited from above advantages, the batteries exhibited superior initial capacity of 1674.7 mAh/g (c.d.: 0.2C).Even at 3C, the batteries can cycle steadily for over 1500 cycles along with ultralow rate of capacity decay (0.044%).This work opens up a new insight to explore bidirectional catalyst for realizing remarkable performance Li-S batteries.

01 Jan 2025·American journal of obstetrics and gynecology

The dosing regimen for 17-hydroxyprogesterone caproate was suboptimal: lessons for future pharmacotherapy for pregnant women

Article

Author: Venkataramanan, Raman ; Zhao, Wenchen ; Caritis, Steve N ; Sharma, Shringi ; Dodeja, Prerna

BACKGROUND:

Makena (17-hydroxyprogesterone caproate) was approved by the United States Food and Drug Administration for the prevention of recurrent spontaneous preterm birth in 2011 under the accelerated approval pathway, but fundamental pharmacokinetic or pharmacodynamic (Phase 1 and Phase 2) studies were not performed. At the time, there were no dose-response or concentration-response data. The therapeutic concentration was not known. The lack of such data brings into question the dosing regimen for 17-hydroxyprogesterone caproate and if it was optimized.

OBJECTIVE:

The purpose of this study was to evaluate the dosing regimen for 17-hydroxyprogesterone by analyzing 3 data sets in which the 17-hydroxyprogesterone caproate pharmacology was evaluated, namely the Maternal-Fetal Medicine Omega 3 study, the Obstetric-Fetal Pharmacology Research Units study, and the Obstetrical-Fetal Pharmacology Research Centers study. If an inappropriate dosing regimen could be identified, such information could inform future studies of pharmacotherapy in pregnancy.

STUDY DESIGN:

Data from the Omega 3 study were used to determine if plasma concentration was related to spontaneous preterm birth risk and if a threshold concentration could be identified. Data from the Obstetric-Fetal Pharmacology Research Units study were used to determine the half-life of 17-hydroxyprogesterone caproate and to develop a model to simulate drug concentrations with various dosing regimens. Data from the Obstetrical-Fetal Pharmacology Research Centers study were used to determine the relationship between dose and safety outcomes.

RESULTS:

Analysis of the Omega 3 data set indicated that the risk for spontaneous preterm birth decreased as the log concentration of 17-hydroxyprogesterone caproate increased (odds ratio, 0.04; 95% confidence interval, 0.00-0.90). A steady state concentration of >9 ng/mL (equivalent to >8 ng/mL at 25-28 weeks) was associated with the lowest risk for spontaneous preterm birth (hazard ratio, 0.52; 95% confidence interval, 0.27-0.98; P=.04); this concentration was not achieved in 25% of subjects who received the 250 mg weekly dose. In the Obstetrical-Fetal Pharmacology Research Units study, the adjusted half-life (median and interquartile range) of 17-hydroxyprogesterone caproate was 14.0 (11.5-17.2) days. Simulations indicated that with the 250 mg weekly dose, >5 weekly injections were required to reach the 9 ng/mL target; however, those with the shortest half-life (corresponding to higher clearance), never reached the targeted 9 ng/mL concentration. In 75% of subjects, a loading dose of 500 mg weekly for 2 weeks followed by 250 mg weekly achieved and maintained the 9 ng/mL concentration within 2 weeks but in those 25% with the shortest half-life, concentrations exceeded the 9 ng/mL target for only 3 weeks. In the Obstetrical-Fetal Pharmacology Research Centers study, all 65 subjects who received a weekly dose of 500 mg exceeded the 9 ng/mL steady state.

CONCLUSION:

The dosing regimen for 17-hydroxyprogesterone caproate was inadequate. There is a significant inverse relationship between drug concentration and spontaneous preterm birth. The risk was lowest when the concentration exceeded 9 ng/mL, but 25% of women who received the 250 mg weekly dose never reached or maintained this concentration. The drug's long half-life necessitates a loading dose to achieve therapeutic concentrations rapidly. The omission of basic pharmacologic studies to determine the proper dosing may have compromised the effectiveness of 17-hydroxyprogesterone caproate. Future pharmacotherapy trials in pregnancy must first complete fundamental pharmacology studies.

106

News (Medical) associated with Hydroxyprogesterone Caproate

22 May 2025

·www.prnewswire.com

Lipocine's LPCN 1148 Highlighted in the June 2025 Edition of Hepatology

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 memory in cirrhosis patients" was contributed by Dr. Kevin Harris of the Division of Gastroenterology and Hepatology, Mayo Clinic, Minnesota. LPCN 1148 is targeted to be a "First in Class" product candidate with a novel mechanism of action for overt hepatic encephalopathy and sarcopenia indications. Detailed results from the Phase 2 trial are published in the same issue of Hepatology (Vol. 81, Issue 6). The publication reports the analyses from Stage 1 of the study, during which participants were randomized 1:1 to receive either oral LPCN 1148 or placebo for 24 weeks. The full corresponding article (Benjamin Bruno et al) can be found here. "This coverage of LPCN 1148 in Hepatology reflects the growing recognition of LPCN 1148 for management of cirrhosis," said Mahesh Patel, CEO of Lipocine. "Treatment of sarcopenia in cirrhosis is currently limited to diet and exercise. The highlight of LPCN 1148 in the premier journal of the American Association for the Study of Liver Diseases underscores the potential value of Lipocine's novel treatment approach to improve outcomes for patients with cirrhosis." The study results, including for the Stage 2 open label extension period, were discussed during the Late Breaking Session at EASL Congress 2024 which can be found here. The US FDA has granted fast track designation to LPCN 1148 as a treatment for sarcopenia in patients with decompensated cirrhosis. Lipocine is exploring partnering LPCN 1148. About Cirrhosis Cirrhosis is an end stage liver disease of varying etiologies such as alcoholic liver disease, chronic viral hepatitis, nonalcoholic fatty liver disease and primary cholangitis. Complications of cirrhosis include decompensation events such as hepatic encephalopathy (HE) due to systemic ammonia buildup, variceal bleeding, and ascites, which require frequent hospitalizations. In addition, many patients exhibit sarcopenia (low muscle mass). Over 382,000 patients have been diagnosed with decompensated liver cirrhosis in the US, with few options for managing their disease other than liver transplant. Poor quality of life is common while waiting for a liver transplant. Although there is a limited supply of donor livers, transplant is the only cure for end-stage cirrhosis. About HE HE is a frequent complication and one of the most debilitating manifestations of liver disease, severely affecting the lives of patients and their caregivers. For patients with decompensated liver cirrhosis and sarcopenia, clinical outcomes tend to be worse - both sarcopenia and myosteatosis are associated with an increased risk of HE. HE is an episodic neurological disorder with a high recurrence rate. Up to 50% of patients with cirrhosis will experience an HE episode in their lifetime. Patients can exhibit global neurological, psychiatric, and musculoskeletal deficits. HE has a complex pathophysiology that includes impairment of ammonia clearance and increased inflammatory cytokine and HE recurrence is common, despite use of standard-of-care therapies. Options for prevention/treatment are limited, resulting in significant enduring unmet medical need as the 1-year survival for patients with HE is ~50%. Furthermore, cognitive impairment associated with cirrhosis results in utilization of more health care resources. About the Phase 2 study This multi-center study enrolled and dosed a total of 29 patients across 8 centers in the United States. The primary objective was to evaluate the efficacy of 24 weeks of LPCN 1148 treatment in men with cirrhosis and sarcopenia. The secondary objective was to evaluate the safety and tolerability of LPCN 1148. Following Week 24, the open-label stage of the study began (Stage 2), wherein all participants received LPCN 1148 (no placebo in Stage 2). Baseline characteristics, including age, disease etiology baseline L3-SMI, and other comorbidities were generally well-balanced between groups. Overall, the average baseline Model for End-Stage Liver Disease (MELD) score was 16.8, and 97% of patients had previously experienced at least one clinical decompensation event. Sarcopenia, or low muscle mass, was assessed by computed tomography (CT) scan; total skeletal muscle area at the third lumbar vertebra was measured by CT scan and normalized by participant height (L3-SMI, L3-skeletal muscle index). Patients had study visits every four weeks, with CTs performed at Weeks 12, 24, 36, and 52. Patients with a variety of cirrhosis etiologies were eligible. During the study there were no restrictions on standard of care medications, procedures, or other interventions. Further details on the study design, including inclusion and exclusion criteria, can be found on Clinicaltrials.gov (NCT04874350). About LPCN 1148 Lipocine is currently evaluating LPCN 1148 comprising testosterone laurate ("TL") for the management of decompensated cirrhosis. The Company believes LPCN 1148 targets unmet needs for patients with cirrhosis including improvement in the quality of life of patients while on the liver transplant waiting list, prevention or reduction in the occurrence of new decompensation events such as HE, and improvement in post liver transplant survival, including outcomes and costs. About Lipocine Lipocine is a biopharmaceutical company leveraging its proprietary technology platform to enable effective oral delivery of therapeutics. 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 clinical development candidates include: LPCN 1154, oral brexanolone, for the potential treatment of postpartum depression, LPCN 2101 for the potential treatment of epilepsy, LPCN 2203 an oral candidate targeted for the management of essential tremor, LPCN 2401 an oral proprietary anabolic androgen receptor agonist, as an adjunct therapy to incretin mimetics, as an aid for improved body composition in obesity management and LPCN 1148, a novel androgen receptor agonist prodrug for oral administration targeted for the management of symptoms associated with liver cirrhosis. Lipocine is exploring partnering opportunities for LPCN 1107, our candidate for prevention of preterm birth, LPCN 1154, for rapid relief of postpartum depression, LPCN 2401 for obesity management, LPCN 1148, for the management of decompensated cirrhosis, and LPCN 1144, our candidate for treatment of metabolic dysfunction-associated steatohepatitis (MASH). 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 . 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 P3 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. 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 non-core 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 . Lipocine assumes no obligation to update or revise publicly any forward-looking statements contained in this release, except as required by law. SOURCE Lipocine Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultPhase 2Fast TrackDrug Approval

08 May 2025

·www.prnewswire.com

Lipocine Announces Financial Results for the First Quarter Ended March 31, 2025

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 non-invasive, rapid onset, oral formulation of brexanolone for the treatment of postpartum depression (PPD). Dosing of the first patient is anticipated in the second quarter of 2025. The Phase 3 study is expected to support a 505(b)(2) New Drug Application (NDA) submission in 2026. Lipocine is exploring the possibility of partnering LPCN 1154 with a third party. LPCN 2401 for Obesity Management LPCN 2401 is targeted to be a once daily oral formulation comprising a proprietary anabolic androgen receptor agonist. It is expected to have a favorable benefit to risk profile as a non-invasive option for use as an adjunct to GLP-1 receptor agonist therapies and/or as a monotherapy post cessation of GLP-1 receptor agonist therapies with demonstrated benefits to the liver. Based on a pre-IND meeting and 2025 FDA draft guidance on Obesity and Overweight, the FDA recommends identifying the appropriate patient population for treatment, and also recommends that an approvable endpoint would be one that measures how a patient feels, functions, or survives. Therefore, in an upcoming proof-of-concept study of LPCN 2401 as an adjunct to GLP-1 agonist, Lipocine plans to target the elderly patient population, reportedly the population most vulnerable to lean mass and functionality loss while on GLP-1 agonist treatment, with plans to include functionality measures. Lipocine is exploring the possibility of partnering LPCN 2401 with a third party. TLANDO® Lipocine has an exclusive License Agreement with Verity Pharma (Verity), entered into in 2024, under which Verity has the rights to market TLANDO, its oral testosterone replacement therapy, in the United States and Canada, if approved. In April 2025, Lipocine entered into a license and supply agreement with Aché granting exclusive rights to market TLANDO® in Brazil. Aché is a Brazilian pharmaceutical company founded nearly 60 years ago with a mission to improve people's lives. Today, Aché's products reach more than 20 countries across Latin America, Africa, Asia, and Europe, in addition to its home base in Brazil. Lipocine continues to explore partnering TLANDO in territories outside the U.S., Canada, South Korea, the GCC countries and Brazil. First Quarter Ended March 31, 2025, Financial Results As of March 31, 2025, Lipocine had $19.7 million of unrestricted cash, cash equivalents and marketable investment securities compared to $21.6 million at December 31, 2024. Lipocine reported a net loss of $1.9 million, or ($0.35) per diluted share, for the quarter ended March 31, 2025, compared with net income of $3.5 million, or $0.66 per diluted share, for the quarter ended March 31, 2024. The company recognized royalty revenue from TLANDO sales of $94,000 during the quarter ended March 31, 2025, compared to royalty revenue of $117,000 during the quarter ended March 31, 2024. No license revenue was recognized during the quarter ended March 31, 2025, compared to $7.5 million in the quarter ended March 31, 2024. The license revenue in 2024 resulted from our license with Verity. Research and development expenses were $1.1 million and $2.8 million, respectively, for the quarters ended March 31, 2025 and 2024. The decrease in research and development expenses was primarily a result of a decrease in costs related to our LPCN 1154 clinical studies in 2025 as compared to 2024, a decrease related to the wind down of our LPCN 1148 study in 2024, and a decrease in TLANDO related costs in 2025. These were offset by an increase in other research and development related costs and supplies in 2025. General and administrative expenses were $1.1 million and $1.6 million, respectively, for the quarters ended March 31, 2025 and 2024. The decrease in general and administrative expenses primarily consisted of a decrease related to the one-time business development fees incurred in 2024 in conjunction with the Verity Pharmaceutical license agreement. About Lipocine Lipocine is a biopharmaceutical company leveraging its proprietary technology platform to enable effective oral delivery of therapeutics. 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 clinical development candidates include: LPCN 1154, oral brexanolone, for the potential treatment of postpartum depression, LPCN 2101 for the potential treatment of epilepsy, LPCN 2203 an oral candidate targeted for the management of essential tremor, LPCN 2401 an oral proprietary anabolic androgen receptor agonist, as an adjunct therapy to incretin mimetics, as an aid for improved body composition in obesity management and LPCN 1148, a novel androgen receptor agonist prodrug for oral administration targeted for the management of symptoms associated with liver cirrhosis. Lipocine is exploring partnering opportunities for LPCN 1107, our candidate for prevention of preterm birth, LPCN 1154, for rapid relief of postpartum depression, LPCN 2401 for obesity management, LPCN 1148, for the management of decompensated cirrhosis, and LPCN 1144, our candidate for treatment of metabolic dysfunction-associated steatohepatitis (MASH). 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 . 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 P3 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. 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 non-core 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 . Lipocine assumes no obligation to update or revise publicly any forward-looking statements contained in this release, except as required by law. SOURCE Lipocine Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

License out/inPhase 3Financial Statement

13 Mar 2025

·www.prnewswire.com

Lipocine Announces Financial Results for the Full Year Ended December 31, 2024

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 developing for the rapid treatment of postpartum depression (PPD). Lipocine held a meeting with the U.S. Food and Drug Administration (FDA) in the first quarter of 2025 to discuss the NDA submission package for LPCN 1154 (oral brexanolone) as a treatment for PPD. In the meeting, Lipocine was advised that the FDA believes that, in addition to the previously completed PK bridge data, a safety and efficacy study of oral LPCN 1154 in the target population will be required for 505(b)(2) NDA submission. Based on observed comparable exposure of LPCN 1154 and the reference drug in the PK bridge study, the company is initiating a phase 3 safety and efficacy study with expected first patient dosed in the second quarter of 2025. The Company has completed registration stability studies required for NDA submission. A Phase 3 safety and efficacy study will provide the opportunity to generate safety and depression symptom relief data with LPCN 1154. Lipocine believes this data will be beneficial for potential inclusion in product labeling and for eligibility for clinical investigation exclusivity for a 48-hour, oral treatment option. In addition, the planned study will investigate the potential of oral brexanolone to treat anxiety disorders, representing another attractive commercial opportunity with a high unmet need. In October 2024, Lipocine announced positive data from a quantitative EEG (qEEG) study of oral brexanolone. The results indicate robust central nervous system (CNS) activity of oral brexanolone, with concentration- and time-dependent post-dose changes in qEEG. These results confirm GABAA positive allosteric modulation and support future development of oral brexanolone in neuropsychiatric indications. Lipocine is exploring the possibility of partnering LPCN 1154 with a third party. LPCN 2401 for Obesity Management LPCN 2401 is targeted to be a once daily oral formulation comprising a proprietary anabolic androgen receptor agonist for obesity management. It is expected to have a favorable benefit to risk profile as an oral option for use as an adjunct to GLP-1 receptor agonist chronic weight management therapies and/or as a monotherapy post cessation of GLP-1 receptor agonist therapies, with demonstrated benefits to the liver. Lipocine is exploring the possibility of partnering LPCN 2401 with a third party. LPCN 2401 was featured in a virtual key opinion leader (KOL) event hosted by Lipocine in October 2024 The event highlighted positive data from the Phase 2 study of LPCN 2401 which support the potential for the product to be used as an adjunct with incretin mimetics (GLP-1/GIP agonists) or as a monotherapy post incretin mimetic discontinuation. A poster "Oral LPCN 2401 Reduces Fat Mass and Increases Lean Mass in Men with Obesity" featuring the Phase 2 data was presented by Dr. Frank Greenway (Chief Medical Officer at Pennington Biomedical Research Center) at the Obesity Society's Annual Obesity Week conference in November 2024, in San Antonio, TX. LPCN 1148 LPCN 1148 is targeted to be a "First in Class" product candidate with a novel mechanism of action for the management of decompensated cirrhosis. A manuscript "Oral LPCN 1148 Improves Sarcopenia and Hepatic Encephalopathy in Male Patients with Cirrhosis: a randomized, placebo-controlled Phase 2 trial" was published in the journal Hepatology and also discussed at The Liver Meeting (AASLD) 2024 Editor's Cut: Clinical Study Session in November 2024. The publication and conference discussion highlighted updated results from Lipocine's Phase 2 proof-of-concept clinical trial (LPCN 1148-21-001) that evaluated LPCN 1148 in men with decompensated cirrhosis and sarcopenia awaiting liver transplantation. The results at 24 weeks showed that LPCN 1148 therapy resulted in a significant improvement in sarcopenia when compared with placebo. Participants receiving LPCN 1148 also experienced significantly fewer episodes of overt hepatic encephalopathy (OHE) compared to those on placebo, even though most participants were already on background therapies for HE. The US FDA granted fast track designation to LPCN 1148 as a treatment for sarcopenia in patients with decompensated cirrhosis in December 2024. Lipocine is exploring the possibility of partnering LPCN 1148 with a third party. TLANDO™ Lipocine entered into an exclusive License Agreement with Verity Pharma in January 2024 under which Verity Pharma has the rights to market its oral testosterone replacement therapies TLANDO and, if approved, TLANDO XR, in the United States and Canada. Under the terms of the License Agreement, Verity Pharma agreed to pay Lipocine license fees totaling $11 million. Of this amount, Lipocine received payments totaling $10 million during 2024 and is to receive a further payment of $1 million in 2025. Lipocine is entitled to receive up to $259 million in development and sales-based commercial milestone payments, as well as tiered royalty payments ranging from 12% up to 18% on net sales of TLANDO franchise products. In September 2024, we entered into a distribution and license agreement with SPC Korea Limited for the development and commercialization of TLANDO for TRT in South Korea. In October 2024, Lipocine signed an exclusive supply and distribution agreement with Pharmalink to commercialize TLANDO in the Gulf Cooperation Council (GCC) countries consisting of Saudi Arabia, Kuwait, the United Arab Emirates (UAE), Qatar, Bahrain, and Oman. The Company is exploring further partnerships for TLANDO outside of North America, South Korea and the GCC countries. Testosterone On February 28, 2025, the FDA informed sponsors of testosterone products about new labeling changes following the agency's review of the findings from the Testosterone Replacement Therapy for Assessment of Long-term Vascular Events and Efficacy Response in Hypogonadal Men (TRAVERSE) clinical trial and the results from required post-market ambulatory blood pressure (ABPM) studies. The changes include adding the TRAVERSE trial results to testosterone products, retaining "Limitation of Use" language for age-related hypogonadism, and removal of language from the Boxed Warning related to an increased risk of adverse cardiovascular outcomes for all testosterone products, in addition to other changes led by results of the ABPM studies. Year Ended December 31, 2024 Financial Results As of December 31, 2024, Lipocine had $21.6 million of unrestricted cash, cash equivalents and marketable investment securities compared to $22.0 million as of December 31, 2023. Lipocine reported a net income of approximately $8,400 for the year ended December 31, 2024, compared with a net loss of $16.4 million, or ($3.14) per diluted share, for the year ended December 31, 2023. The company recognized revenue of $11.2 million during the year ended December 31, 2024, compared to a net reversal of variable consideration revenue of $2.9 million during the year ended December 31, 2023. Revenue in 2024 primarily consisted of license revenue from the company's licensees, Verity Pharma, SPC Korea and Pharmalink and royalty revenue from TLANDO sales. Research and development expenses were $7.4 million and $10.2 million, respectively, for the years ended December 31, 2024 and 2023. The decrease in research and development expenses in 2024 compared with the prior year was primarily due to completion of patient dosing expenses in the LPCN 1148 Phase 2 POC study in male patients with cirrhosis in 2023, a decrease in TLANDO related costs, and a decrease in personnel related costs. These decreases were offset by an increase in LPCN 1154 clinical studies, an increase in other lab supplies and research costs, and an increase in LPCN 2401 costs. General and administrative expenses were $5.0 million and $4.9 million, respectively, for the years ended December 31, 2024 and 2023. Interest and investment income was $1.2 million and $1.4 million, respectively, for the years ended December 31, 2024 and 2023. About Lipocine Lipocine is a biopharmaceutical company leveraging its proprietary technology platform to augment therapeutics through effective oral delivery to develop differentiated products. 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 clinical development candidates include: LPCN 1154, oral brexanolone, for the potential treatment of postpartum depression, LPCN 2101 for the potential treatment of epilepsy, LPCN 2203 an oral candidate targeted for the management of essential tremor, LPCN 2401 an oral proprietary anabolic androgen receptor agonist, as an adjunct therapy to incretin mimetics, as an aid for improved body composition in obesity management and LPCN 1148, a novel androgen receptor agonist prodrug for oral administration targeted for the management of symptoms associated with liver cirrhosis. Lipocine is exploring partnering opportunities for LPCN 1107, our candidate for prevention of preterm birth, LPCN 1154, for rapid relief of postpartum depression, LPCN 2401 for obesity management, LPCN 1148, for the management of decompensated cirrhosis, and LPCN 1144, our candidate for treatment of metabolic dysfunction-associated steatohepatitis (MASH). 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 . 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 current intention to conduct a 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. 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 non-core 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 . Lipocine assumes no obligation to update or revise publicly any forward-looking statements contained in this release, except as required by law. SOURCE Lipocine Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultPhase 2License out/in

100 Deals associated with Hydroxyprogesterone Caproate

External Link

KEGG	Wiki	ATC	Drug Bank
D00949	Hydroxyprogesterone Caproate	G03DA03	DB06789

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Endometriosis	China	Hubei Huazhong Pharmaceutical Co. Ltd.	01 Jan 1981
Menstruation Disturbances	China	Hubei Huazhong Pharmaceutical Co. Ltd.	01 Jan 1981
Uterine Hemorrhage	China	Hubei Huazhong Pharmaceutical Co. Ltd.	01 Jan 1981
Abortion, Habitual	Japan	Mochida Pharmaceutical Co., Ltd.	26 Jun 1975
Abortion, Threatened	Japan	Mochida Pharmaceutical Co., Ltd.	26 Jun 1975
Amenorrhea	Japan	Mochida Pharmaceutical Co., Ltd.	26 Jun 1975
Infertility	Japan	Mochida Pharmaceutical Co., Ltd.	26 Jun 1975
Metrorrhagia	Japan	Mochida Pharmaceutical Co., Ltd.	26 Jun 1975
Obstetric Labor, Premature	United States	Allergan Sales LLC	26 Dec 1974

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
HIV Infections	Phase 3	Zambia	AMAG Pharmaceuticals, Inc.	07 Feb 2018
Pain	Phase 3	United States	AMAG Pharmaceuticals, Inc.	07 Oct 2016

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03292731 (Pubmed \| Am J Obstet Gynecol MFM)	Phase 1/2	Obstetric Labor, Premature 17-hydroxyprogesterone caproate	-	17-hydroxyprogesterone caproate 250mg	ubalxyzvgc(moirjdpjjv) = vvgdupdkde mwdnyhlvhg (yzktvcddsj )	-	01 Jul 2023
				17-hydroxyprogesterone caproate 500mg	ubalxyzvgc(moirjdpjjv) = kovhsetjxv mwdnyhlvhg (yzktvcddsj )
NCT03433040 (CTgov)	Phase 3	Obesity \| Obstetric Labor, Premature	44	17-Hydroxyprogesterone Capronate (Non Obese)	ohwpxndewx(mqzffquwzn) = taojbcickf qjdqjycfms (unviwygocs, 4.5) View more	-	12 Jan 2022
				17-Hydroxyprogesterone Capronate (Obese - Control)	ohwpxndewx(mqzffquwzn) = fnzjhcgmnb qjdqjycfms (unviwygocs, 5.1) View more
NCT03297216 (Pubmed \| Lancet HIV) Manual	Phase 3	HIV Infections \| Obstetric Labor, Premature	800	Hydroxyprogesterone Caproate	wsnsdazfkk(tnynamubvq) = dhzwwccdmz gtrlqndnpk (vcvecqwjnc )	Negative	01 Oct 2021
				Placebo	wsnsdazfkk(tnynamubvq) = ktqlbymabn gtrlqndnpk (vcvecqwjnc )
NCT03297216 (IPOP, CTgov)	Phase 3	HIV Infections \| Obstetric Labor, Premature	800	17P (250 mg 17P)	eqymuogtkw = oknkkbxyth lwynvtztwz (mtknuecdkz, hxurdvvtqm - plkblohoky) View more	-	09 Jul 2021
				Placebo (Placebo)	eqymuogtkw = gkpgyeyena lwynvtztwz (mtknuecdkz, zocfcsrrzq - vlcpnpwelk) View more
NCT01004029 (PROLONG, CTgov)	Phase 3	Obstetric Labor, Premature	1,740	Vehicle	jkdluafhye = ykyxzzaygj bvfhsbotqk (fwosllnfae, gomuxdvzms - sovqtmkpqb) View more	-	28 Jan 2021
NCT01004029 (PROLONG, Pubmed \| Am J Perinatol) Manual	Phase 3	Obstetric Labor, Premature	1,708	17-α-hydroxyprogesterone caproate or	flwfoequma(klkcezzycc) = rzdwvsiayh sochqqdiwp (bkvjywlkfp ) View more	Negative	01 Jan 2020
				Placebo	flwfoequma(klkcezzycc) = blamkanohw sochqqdiwp (bkvjywlkfp ) View more
NCT00439374 (SCAN, CTgov)	Phase 3	Obstetric Labor, Premature	657	17 alpha-hydroxyprogesterone caproate (17 Alpha-hydroxyprogesterone Caproate)	uelqxfkieg = wlfxxftvfe mrcxucryly (itlkdnqgmt, gqobptswup - csrknqshhl) View more	-	11 Apr 2019
				Placebo Oil (Placebo)	uelqxfkieg = hnpopcfris mrcxucryly (itlkdnqgmt, zzcfemshel - khecqintqv) View more
NCT02937766 (CTgov)	Phase 3	Pain	60	Hydroxyprogesterone Caproate (Treatment A)	ukqlumjtex = xxagmjyvpm pvlrpxqvrv (iqukwewhzh, huxvhlksyf - abbfdnnrof) View more	-	12 Dec 2018
				Hydroxyprogesterone Caproate (Treatment B)	ukqlumjtex = imfwxkxciy pvlrpxqvrv (iqukwewhzh, qslefqyjug - eogcpjyysv) View more
NCT02940522 (CTgov)	Phase 1	-	122	Hydroxyprogesterone Caproate (Treatment A)	frajzqhwhg(vyclihueho) = vvpeemsuns qkiymfyahn (pqvlssyzks, 23.5) View more	-	30 Nov 2018
				Hydroxyprogesterone Caproate (Treatment B)	frajzqhwhg(vyclihueho) = ltfhyelhcj qkiymfyahn (pqvlssyzks, 27.7) View more
NCT01119963 (17PinPROM, CTgov)	Phase 2/3	Obstetric Labor, Premature \| Fetal Membranes, Premature Rupture	152	17-alpha-hydroxy-progesterone caproate, Makena® (17-alpha Hydroxyprogesterone Caproate, Makena®)	volvoacfnx(dieuyyqitl) = gjybvbckhi pofjadurcm (zmdqlxqjsm, 2.72) View more	-	30 May 2018
				Castor Oil (Placebo) (Placebo)	volvoacfnx(dieuyyqitl) = hrkmbadwxs pofjadurcm (zmdqlxqjsm, 2.74) View more

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Hydroxyprogesterone Caproate

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