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-

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

NCT03779451

/ Unknown statusNot ApplicableIIT

Vaginal Progesterone Versus 17-Alpha-Hydroxyprogesterone Caproate for Prevention of Emergent Cesarean Delivery in Asymptomatic Pregnant Women With Placenta Previa: A Randomized Controlled Study

Purpose to evaluate the effects of Vaginal Progesterone versus 17-Alpha-Hydroxyprogesterone Caproate for prevention of Emergent Cesarean Delivery in Asymptomatic Pregnant Women with Placenta Previa

Start Date01 Jan 2019

Sponsor / Collaborator-

100 Clinical Results associated with Hydroxyprogesterone Caproate

100 Translational Medicine associated with Hydroxyprogesterone Caproate

100 Patents (Medical) associated with Hydroxyprogesterone Caproate

1,131

Literatures (Medical) associated with Hydroxyprogesterone Caproate

01 Jan 2025·Chemical Engineering Journal

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

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

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

BACKGROUNDMakena (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.OBJECTIVEThe 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 DESIGNData 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.RESULTSAnalysis 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.CONCLUSIONThe 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.

01 Dec 2024·Animal Nutrition

Maternal probiotic mixture supplementation optimizes the gut microbiota structure of offspring piglets through the gut–breast axis

Article

Author: Chen, Keyuan ; Xie, Fei ; Yang, Guiyan ; Wang, Jiufeng ; Yang, Lan ; Wu, Yi ; Zhu, Yaohong ; Hu, Ting ; Song, Zhiguan

Delivery and weaning are major stressful events in sows and piglets, adversely affecting production and growth performance and causing economic losses to swine farms. Probiotics as safe antibiotic alternatives have great potential for use across all stages of livestock farming. Here, 18 pregnant sows from clinical farms randomly were divided into two groups: one fed a basal diet (CON group) and the other fed a basal diet plus a probiotic mixture CBB-mix (containing 1×10¹² CFU/g of Lactobacillus johnsonii [CJ21], 1×10⁹ CFU/g of Bacillus subtilis [BS15], and 1×10⁹ CFU/g of Bacillus licheniformis [BL21]), for 20 days before delivery. The effects of maternal CBB-mix supplementation on sow colostrum metabolome and offspring piglets' clinical performance, immune status, and gut microbiota were investigated. Additionally, 177 piglets were randomly divided into 4 groups, including CC group (piglets and sows fed a basal diet, n = 40 from 5 litters), CP group (piglets fed the basal diet plus CBB-mix and sows fed the basal diet, n = 38 from 4 litters), PC group (piglets fed the basal diet and sows fed the basal diet plus CBB-mix, n = 50 from 4 litters), and PP group (both piglets and sows fed the basal diet plus CBB-mix, n = 49 from 5 litters). Among that, CP and PP groups were added CBB-mix in the creep feed from 11 days of age for 18 days to study the direct effects of CBB-mix on the growth performance of piglets. Maternal CBB-mix supplementation improved sow production performance, including litter size at birth and litter weight at birth (P < 0.05). Piglets born from CBB-mix-fed sows exhibited increased litter size at weaning and reduced diarrhea incidence from 1 to 10 days of age (P < 0.05). Additionally, systemic immune status and antioxidant capabilities were improved in both sows and piglets. Maternal CBB-mix supplementation reconstituted the gut microbiota structure and increased the Sobs index and Shannon index of fecal microbiota in both sows and piglets (P < 0.05). The relative abundance of Firmicutes and Clostridium_sensu_stricro_1 in sow feces was decreased after feeding CBB-mix (P < 0.05). In piglets, 10-day-old feces had relatively more Lactobacillus but less Escherichia-Shigella than 1-day-old feces (P < 0.05), indicating that maternal feeding CBB-mix alone affects the gut microbiota community of offspring piglets via the gut-breast axis. Piglets born from CBB-mix-fed sows had continuously decreased the relative abundance of fecal Escherichia-Shigella at 28 days of age (P < 0.05). Consistently, the metabolite profile in sow milk was also changed by CBB-mix. Colostrum metabolome showed that CBB-mix significantly regulated tryptophan metabolism and primary bile acid biosynthesis. Our data demonstrated that maternal CBB-mix supplementation effectively improved the production performance of sows and their offsprings' growth performance. Through the gut-breast axis (interaction between gut microbiota and mammary glands), feeding CBB-mix to sows impacted the gut microbiota of their offspring. This study provides strategy and evidence for maternal probiotic supplementation to improve immune status and gut microbiota homeostasis in response to delivery and weaning.

News (Medical) associated with Hydroxyprogesterone Caproate

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

06 Feb 2025

·www.prnewswire.com

Lipocine Receives Updated Regulatory Guidance on LPCN 1154

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. Food and Drug Administration (FDA or the Division) in Q1 2025 to discuss the NDA submission package of LPCN 1154. Following the meeting, the Company was advised that the Division believes, in addition to the previously completed PK bridge data, an efficacy and safety study of oral LPCN 1154 in the target population will be required for 505(b)(2) NDA submission. Lipocine remains committed to advancing a rapid relief treatment for postpartum depression. Based on the guidance received and observed comparable exposure of LPCN 1154 and the reference drug in the completed PK bridge study, Lipocine is planning next steps toward the execution of a phase 3 safety and efficacy study. "The regulatory guidance regarding a safety and efficacy study provides an opportunity to generate safety and depression symptom relief data with LPCN 1154, which we believe will be beneficial for potential inclusion in product labeling and eligibility for clinical investigation exclusivity for a 48-hour, oral treatment option," said Mahesh Patel, CEO of Lipocine. "Furthermore," Dr. Patel added, "the planned study will investigate the potential of oral brexanolone to treat anxiety disorders, representing another attractive commercial opportunity with a high unmet need." About LPCN 1154 LPCN 1154 is an oral formulation of brexanolone in development targeted for administration resulting in rapid relief of PPD. Brexanolone is a bioidentical to naturally occurring neuroactive steroid, allopregnanolone, a positive allosteric modulator of y-aminobutyric acid (GABAA) receptor. LPCN 1154 is expected to have characteristics that could be particularly appealing to patients with severe PPD, acutely elevated suicide risk, and in whom rapid improvement is a priority while presenting no significant risk of adverse reactions to breastfed infants from exposure to brexanolone. About Postpartum Depression and Unmet Needs PPD is a major depressive disorder with onset either during pregnancy or within four weeks of delivery, with symptoms persisting up to 12 months after childbirth. Hormonal changes leading to GABA dysfunction are common in depression and pregnancy. Symptoms of PPD include hallmarks of major depression, including, but not limited to, sadness, depressed mood, loss of interest, change in appetite, insomnia, sleeping too much, fatigue, difficulty thinking/concentrating, excessive crying, fear of harming the baby/oneself, and/or thoughts of death or suicide. Results from a recent survey (Truist Securities Research, January 2024) show that obstetricians believe approximately 20-40% of their patients may suffer from PPD. Further, obstetricians are comfortable making a diagnosis and prescribing antidepressants for PPD. Traditional antidepressants, not approved for PPD, have slow onset of action, side effects such as weight gain, and do not demonstrate adequate remission post-acute treatment. 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 non-cirrhotic NASH. 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, the timing of our submission of a NDA with the FDA for LPCN 1154, 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

Drug ApprovalNDA

17 Dec 2024

·www.drugs.com

FDA Grants Fast Track Designation to Lipocine for LPCN 1148 as a Treatment for Sarcopenia in Patients with Decompensated Cirrhosis

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 bioidentical testosterone, was recently studied in a proof-of-concept (POC) Phase 2 study in patients with decompensated cirrhosis. Treatment with LPCN 1148 in the POC study improved sarcopenia and associated clinical outcomes. LPCN 1148 is targeted to be a "First in Class" product candidate with a novel mechanism of action for management of cirrhosis. "We are excited the FDA has recognized that sarcopenia in patients with cirrhosis is a serious condition and that LPCN 1148 has the potential to provide clinical benefits for these patients where no therapy currently exists," said Dr. Mahesh Patel, President and Chief Executive Officer of Lipocine. "We are encouraged that the positive primary endpoint results from our successful proof-of-concept study were recognized by the FDA as evidence of clinical effectiveness of LPCN 1148 in improving sarcopenia in patients with cirrhosis." The Fast Track program is designed to accelerate the development and expedite the review of products, such as LPCN 1148, which are intended to treat serious diseases and for which there is an unmet medical need. Fast Track designation lends eligibility for some, or all, of the following: 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 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 Sarcopenia Sarcopenia, a progressive loss of muscle mass and function, is a common and debilitating complication in patients with decompensated cirrhosis. It significantly impacts quality of life and worsens clinical outcomes, including reduced survival rates. Patients with decompensated cirrhosis and sarcopenia exhibit significantly shorter overall survival than those without sarcopenia. Currently, the only curative therapy for decompensated cirrhosis is liver transplant. There are no FDA approved drugs to treat sarcopenia in decompensated cirrhosis beyond treatment of the underlying conditions. About LPCN 1148 LPCN 1148 comprises testosterone dodecanoate, a unique androgen receptor agonist. It is targeted as a differentiated intervention option with a novel multimodal MOA to elicit potential benefits in management of cirrhosis and associated comorbidities of cirrhosis. 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 non-cirrhotic NASH. TLANDO, a novel oral prodrug of testosterone containing testosterone undecanoate developed by Lipocine, is approved by the FDA for conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism, in adult males. For more information, please visit www.lipocine.com. Forward-Looking Statements This release contains "forward-looking statements" that are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and include statements that are not historical facts regarding development and commercialization of TLANDO and TLANDO XR (LPCN 1111) by our licensees, the amount of the license fee, milestone payments, and royalty payments we will ultimately receive, the ability of our licensees to grow the TLANDO franchise, our product development efforts, the application of our proprietary platform in developing new treatments for CNS disorders, our product candidates and related clinical trials, our development of our product candidates and related efforts with the FDA, including with respect to LPCN 1148 and LPCN 2401, the timing of our submission of a NDA with the FDA for LPCN 1154, 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 to treat CNS disorders, we may not have sufficient capital to complete the development processes for our product candidates, we may not be able to enter into partnerships or other strategic relationships to monetize our non-core assets, the FDA will not approve any of our products, risks related to our products, expected product benefits not being realized, clinical and regulatory expectations and plans not being realized, new regulatory developments and requirements, risks related to the FDA approval process including the receipt of regulatory approvals and our ability to utilize a streamlined approval pathway for LPCN 1154, the results and timing of clinical trials, patient acceptance of Lipocine's products, the manufacturing and commercialization of Lipocine's products, and other risks detailed in Lipocine's filings with the SEC, including, without limitation, its Form 10-K and other reports on Forms 8-K and 10-Q, all of which can be obtained on the SEC website at www.sec.gov. Lipocine assumes no obligation to update or revise publicly any forward-looking statements contained in this release, except as required by law. SOURCE Lipocine Inc. Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

Phase 2Fast TrackDrug ApprovalAccelerated ApprovalClinical Result

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
Obstetric Labor, Premature	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

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Pain	Phase 2	United States	AMAG Pharmaceuticals, Inc.	07 Oct 2016
HIV Infections	Discovery	Zambia	AMAG Pharmaceuticals, Inc.	07 Feb 2018
Obstetric Labor, Premature	Discovery	Switzerland	Covis Pharma GmbH	-

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03433040 (CTgov)	Phase 3	Obesity \| Obstetric Labor, Premature	44	17-Hydroxyprogesterone Capronate (Non Obese)	crruozeezi(mawqcdjedo) = osmfogaiyy iouczybqqw (rfcaxokvhn, wimgvgehlp - hckwkwkifg) View more	-	12 Jan 2022
				17-Hydroxyprogesterone Capronate (Obese - Control)	crruozeezi(mawqcdjedo) = apdngqykhi iouczybqqw (rfcaxokvhn, arffoxwlfl - zaopuctkcd) View more
NCT03297216 (Pubmed \| Lancet HIV) Manual	Phase 3	HIV Infections \| Obstetric Labor, Premature	800	Hydroxyprogesterone Caproate	zwgtigchjh(zfteaupdhg) = kminefelqn uvenxgasxx (mulpmymziq )	Negative	01 Oct 2021
				Placebo	zwgtigchjh(zfteaupdhg) = atjynfocqd uvenxgasxx (mulpmymziq )
NCT03297216 (IPOP, CTgov)	Phase 3	HIV Infections \| Obstetric Labor, Premature	800	17P (250 mg 17P)	razkbfaqjm(lucddfkjdh) = cxmjzfwmwv fbxbnzbooo (uduahkyark, ejfqymvbba - rddwcsorag) View more	-	09 Jul 2021
				Placebo (Placebo)	razkbfaqjm(lucddfkjdh) = fzhuqqciqk fbxbnzbooo (uduahkyark, dourodpibt - swbsivtiis) View more
NCT01004029 (PROLONG, CTgov)	Phase 3	Obstetric Labor, Premature	1,740	Vehicle	szapzvfuyf(oqykidquma) = yipxhldpbm asmlckonvc (rfphfnvpfg, cgntgxtudq - aljigdhpsj) View more	-	28 Jan 2021
NCT01004029 (PROLONG, Pubmed \| Am J Perinatol) Manual	Phase 3	Obstetric Labor, Premature	1,708	17-α-hydroxyprogesterone caproate or	(ffzttdgpdx) = jtweepsdnf ljtmsvyops (ufdhpticem ) View more	Negative	01 Jan 2020
				Placebo	(ffzttdgpdx) = rprgxuwfup ljtmsvyops (ufdhpticem ) View more
NCT00439374 (SCAN, CTgov)	Phase 3	Obstetric Labor, Premature	657	17 alpha-hydroxyprogesterone caproate (17 Alpha-hydroxyprogesterone Caproate)	naoomfywqy(xxdpyqewqa) = puivzakyvi wfsgxccthe (vbbtvnbhsu, isexhqgtes - tlctbgaoil) View more	-	11 Apr 2019
				Placebo Oil (Placebo)	naoomfywqy(xxdpyqewqa) = ujwsdzneuh wfsgxccthe (vbbtvnbhsu, puvtnoggph - grygmmnnva) View more
NCT02937766 (CTgov)	Phase 3	Pain	60	Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL) (Treatment A)	xmabrzztwo(swxthgetyk) = ymgcjuocdk hnvxawcdep (upyssvgxyd, tjuytpvjtu - cgvniqknoo) View more	-	12 Dec 2018
				Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL) (Treatment B)	xmabrzztwo(swxthgetyk) = ciphhdqlgw hnvxawcdep (upyssvgxyd, zdwryirwcv - jqvvmwsxtj) View more
NCT02940522 (CTgov)	Phase 1	-	122	Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL) (Treatment A)	(gvvanaroxk) = dnfqpfwjyt kknfqeqilo (ttdecldcmw, olyhyospox - rescmyqufl) View more	-	30 Nov 2018
				Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL) (Treatment B)	(gvvanaroxk) = kbcwnjwfjh kknfqeqilo (ttdecldcmw, pkmjfbzbjs - jzxfaitqjg) 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®)	lyibjfekof(xshmgxbzvf) = utffkbxlxl odhkkbkanw (okvaatcmqo, uuathlnsbu - uxrfpxxyhd) View more	-	30 May 2018
				Castor Oil (Placebo) (Placebo)	lyibjfekof(xshmgxbzvf) = evcwxnexsn odhkkbkanw (okvaatcmqo, pwzolckjmg - eiflcgzsfx) View more
NCT02940522 (Pubmed \| Clin Ther)	Phase 1	-	90	Hydroxyprogesterone Caproate (Subcutaneous injection in the back of the upper arm using a prefilled autoinjector syringe with a 27-gauge needle)	(qwlsywwvoq) = ajnfgansyo dqxfssinei (odxysbhxzw ) View more	-	01 Dec 2017
				Hydroxyprogesterone Caproate (Intramuscular injection in the gluteus maximus using a 21-gauge needle)	(qwlsywwvoq) = uhdfcfqdoj dqxfssinei (odxysbhxzw ) View more

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Hydroxyprogesterone Caproate

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