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

Fundación para la Investigación Biomédica del Hospital

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

741

Literatures (Medical) associated with Hydroxyprogesterone Caproate

01 Sep 2025·European journal of obstetrics & gynecology and reproductive biology: X

Treatment strategies for intra-amniotic infection and/or inflammation in preterm labor cases

Article

Author: Niimi, Hideki ; Yoneda, Noriko ; Yoneda, Satoshi ; Saito, Shigeru

Spontaneous preterm birth (sPTB) is caused by multiple factors; however, the main cause is intra-amniotic infection and/or inflammation. The frequency of intra-amniotic infection/inflammation is higher in extremely sPTB (<28 weeks) and causes long-term cognitive impairments, such as cerebral palsy and mental retardation. The rate of intra-amniotic superinfections, such as Ureaplasma/Mycoplasma and bacteria, is high in sPTB < 27 weeks of gestation. Obstetrical strategies based on accurate information on intra-amniotic infection/inflammation are needed to prevent sPTB (particularly extremely sPTB) and improve the long-term prognosis of preterm infants. Our PCR method, which is sensitive and free from false positives, accurately identifies whether intra-amniotic infection is present. Appropriate antibiotic therapy against intra-amniotic infection (macrolides against Ureaplasma/Mycoplasma and beta-lactams against bacteria) in preterm labor (PTL) cases effectively prolongs the gestational period by 4 weeks. In contrast, the use of antibiotics shortens the gestational period in cases without intra-amniotic infection. We previously reported that 17-alpha-hydroxyprogesterone caproate (17OHP-C) effectively prolonged pregnancy by 4 weeks in PTL cases with mild intra-amniotic inflammation, but not in those with severe intra-amniotic inflammation. Treatment strategies based on accurate intra-amniotic information is expected to prolong pregnancy. However, obstetrical interventions are limited once severe clinical symptoms appear. In addition to the use of drugs to control uterine contractions, antibiotics and/or 17OHP-C may be necessary in the treatment of PTL cases following the accurate assessment of intrauterine infection and/or inflammation is confirmed.

02 Jul 2025·Cureus Journal of Medical Science

Acute Uterine Torsion Masquerading as Fibroid Degeneration in a High-Risk Pregnancy: A Case of Diagnostic Surprise

Article

Author: Bera, Riya ; Debbarma, Durlabh ; Samanta, Ajanta ; Barua, Medha ; Pande, Arindam

Uterine torsion during pregnancy is a rare and life-threatening condition that is frequently misdiagnosed due to nonspecific symptoms and imaging limitations. This case report describes a 32-year-old third gravida (G3, P0+2) with recurrent pregnancy loss, having a 16.9 cm uterine fibroid and hypertrophic cardiomyopathy (managed with bisoprolol), who presented at 24 weeks with severe abdominal pain. Although her vitals were stable, a markedly elevated C-reactive protein (CRP) (245 mg/dL) raised concern for acute pathology. Initial ultrasound incorrectly localized the fibroid to the left, but exploratory laparotomy revealed a 180-degree uterine torsion with contralateral fibroid position, revising the diagnosis from fibroid degeneration to this rare emergency, leading to detorsion and myomectomy. At 30 weeks' gestation, cervical insufficiency (a short cervix measuring 0.5 cm with funneling) was successfully managed with an Arabin pessary and weekly 500 mg injections of hydroxyprogesterone, prolonging the pregnancy to 34 weeks and resulting in an outlet forceps delivery of a healthy 1.9 kg infant. This case highlights the importance of surgical exploration when clinical suspicion contradicts imaging findings, the feasibility of pregnancy-preserving surgery for uterine torsion, and the effectiveness of combined mechanical-hormonal therapy for cervical insufficiency following complex uterine interventions. Multidisciplinary care was critical to manage overlapping high-risk factors, including fibroids, cardiac disease, and preterm cervical changes, ultimately leading to a favorable outcome.

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.

111

News (Medical) associated with Hydroxyprogesterone Caproate

06 Nov 2025

·www.prnewswire.com

Lipocine Announces Financial Results for the Third Quarter Ended September 30, 2025

SALT LAKE CITY, Nov. 6, 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 third quarter ended September 30, 2025 and provided a corporate update. Neuroactive Steroids (NAS) LPCN 1154 for Postpartum Depression (PPD) LPCN 1154 (oral brexanolone) is a non-invasive, rapid onset, oral formulation of the neuroactive steroid brexanolone that Lipocine is developing for the treatment of PPD. A Phase 3 safety and efficacy study evaluating LPCN 1154 as a treatment for PPD continues to enroll patients and top-line data is expected in the second quarter of 2026. A meeting of the independent Data Safety Monitoring Board (DSMB) overseeing this trial will take place to review safety data from the first one-third of participants who were randomized and completed the day seven follow up visit, and the Company plans to provide a safety update in November 2025 following the DSMB review. Lipocine believes data from the Phase 3 study will be beneficial for potential inclusion in product labeling and for eligibility for clinical investigation exclusivity for a 48-hour, oral treatment option. The Phase 3 trial is expected to support a global registration package for LPCN 1154 in PPD, including a 505(b)(2) New Drug Application (NDA) submission in the U.S. which is expected in 2026. On July 9, 2025, Lipocine hosted a virtual R&D investor event to discuss the current treatment landscape and unmet needs in PPD. The event featured presentations by Kristina M. Deligiannidis, MD (Zucker Hillside Hospital, Northwell Health, New York) and by company management. A replay of the webinar can be accessed here. Lipocine is exploring the possibility of partnering LPCN 1154 with a third party for commercialization. LPCN 2101 for Epilepsy Lipocine is evaluating LPCN 2101, a neuroactive steroid GABA positive allosteric modulator for epilepsy including drug resistant epilepsy (DRE) and women with epilepsy (WWE), both of which pose significant treatment challenges under current standard of care. The Company may initiate a Phase 2 proof-of-concept study to evaluate the safety, tolerability, and efficacy of LPCN 2101, subject to resource prioritization. Pre-clinical and Phase 1 studies have demonstrated promising PK results, safety and tolerability. 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. Oral Toxicokinetics of a Bioidentical GABAA Receptor Modulating Neuroactive Steroid (NAS) Anti-seizure Medication (ASM) Candidate for Women with Epilepsy (WWE) Clinical Pharmacokinetics (PK) and Tolerability of a Novel Oral GABAA Receptor Positive Allosteric Modulating (PAM) Candidate for Epilepsy 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 chronic weight management therapies and/or as a monotherapy post cessation of GLP-1 receptor agonist chronic weight management therapies with demonstrated benefits to the liver. Pending further regulatory guidance, Lipocine may conduct a proof-of-concept Phase 2 study for LPCN 2401 in elderly obese and overweight GLP-1 eligible patients, with possible appropriate body composition and functional end points such as stair climb performance measure. Lipocine may explore the possibility of partnering LPCN 2401 with a third party. TLANDO™ Lipocine has an exclusive License Agreement with Verity Pharma, entered into in 2024, under which Verity Pharma has the rights to market TLANDO, its oral testosterone replacement therapy, in the United States and Canada. Rights to TLANDO have also been licensed to companies in South Korea, the GCC countries, and Brazil. Third Quarter Ended September 30, 2025, Financial Results As of September 30, 2025, Lipocine had $15.1 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 $3.2 million, or ($0.59) per diluted share, for the quarter ended September 30, 2025, compared with net loss of $2.2 million, or ($0.44) per diluted share, for the quarter ended September 30, 2024. Royalty revenue from TLANDO sales was $115,000 during the quarter ended September 30, 2025. No royalty revenue was recorded during the comparable period in 2024. Research and development expenses were $2.7 million and $1.6 million, respectively, for the quarters ended September 30, 2025 and 2024. The increase in research and development expenses was due to an increase in costs primarily related to the ongoing LPCN 1154 Phase 3 clinical trial in addition to other clinical trials, offset by a decrease in other research and development costs. General and administrative expenses were $0.8 million and $1.1 million, respectively, for the quarters ended September 30, 2025 and 2024. The decrease in general and administrative expenses was primarily a result of a decrease in business development fees incurred in 2024, a decrease in Delaware franchise tax, and a decrease in other general and administrative costs, offset by an increase in legal fees. Interest and investment income was $0.2 million and $0.3 million, respectively for the quarters ended September 30, 2025 and 2024. The decrease was due to lower interest rates and lower cash and marketable investment securities balances in 2025 as compared to 2024. Nine Months Ended September 30, 2025, Financial Results Lipocine reported a net loss of $7.3 million, or ($1.35) per diluted share, for the nine months ended September 30, 2025, compared with net loss of $1.8 million, or ($0.33) per diluted share, for the nine months ended September 30, 2024. Lipocine recognized revenue of $831,000 and $7.7 million during the nine months ended September 30, 2025 and 2024, respectively. Revenue during the nine months ended September 30, 2025, consists of license revenue of $500,000 compared to license revenue of $7.5 million resulting from the Verity Licensing Agreement during the same period in 2024. During the nine months ended September 30, 2025, and 2024, the company recognized royalty revenue from TLANDO sales of $331,000 and $207,000, respectively. Research and development expenses were $5.9 million and $6.3 million, respectively, for the nine month periods ended September 30 2025 and 2024. The decrease was a result of lower costs related to the LPCN 1154 Phase 3 clinical study in 2025 as compared to LPCN 1154 studies which occurred in 2024, and a decrease in other research and development related costs and supplies in 2025, offset by an increase in costs related to the initiation of the LPCN 2401 clinical study. General and administrative expenses were $2.8 million and $4.1 million, respectively, for the nine-month period ended September 30 2025 and 2024. The decrease was a result of a decrease in business development fees, a decrease related to fees incurred in 2024 in conjunction with the Verity Pharmaceutical license agreement, a decrease in other general and administrative costs, a decrease in legal fees and a decrease in estimated Delaware franchises taxes. Interest and investment income was $0.6 million and $0.9 million, respectively, for the nine months ended September 30 2025, and 2024. The decrease was due to lower interest rates and lower cash and marketable investment securities balances in 2025 as compared to 2024. For further details on Lipocine's financial results from the three and nine months ended September 30, 2025, refer to Form 10Q filed with the SEC. About Lipocine Lipocine is a biopharmaceutical company leveraging its proprietary technology platform to develop innovative products with effective oral delivery. 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, LPCN 2101, and LPCN 2401, our Phase 3 safety and efficacy study relating to LPCN 1154, the timing and potential results of the safety and efficacy study relating to LPCN 1154, the potential Phase 2 proof-of-concept studies for LPCN 2101 and LPCN 2401, 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 assets, clinical and other 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 and our other product candidates, 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. 21% more press release views with Request a Demo

Phase 1License out/inFinancial StatementDrug ApprovalPhase 2

04 Nov 2025

·www.prnewswire.com

Lipocine Presents LPCN 2401 Clinical Data at ObesityWeek®

SALT LAKE CITY, Nov. 4, 2025 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to develop innovative products with effective oral delivery, today announced the presentation of a poster Treatment with Oral LPCN 2401, a Physiological Regulator of Myostatin, Rapidly Improves Body Composition in Men with Obesity at the ObesityWeek® annual meeting, taking place in Atlanta, Ga., November 4 to 7. The poster features 20-week data from the previously completed Phase 2 trial and highlights the rapid improvement in body composition in participants with obesity taking LPCN 2401. Data from the study also showed LPCN 2401 improves liver health, as measured by reduction in liver fat content and liver injury markers, in an overweight and obese liver compromised population. In this Phase 2 trial, men with BMI ≥27 kg/m2 with metabolic dysfunction associated steatohepatitis were randomized (1:1:1) to one of three treatments:1) LPCN 2401, 2) LPCN 2401 plus vitamin E or 3) placebo, for 36 weeks (NCT04134091). Endpoints included percent change from baseline in lean mass (LM), fat mass (FM), and FM/LM ratio. Other parameters associated with metabolic disorder were also measured. Key findings: As previously disclosed, LPCN 2401 and LPCN 2401+E were shown to increase lean mass, and reduce fat mass and fat to lean mass ratio, at 20 weeks and 36 weeks compared to placebo. Treatment with LPCN 2401 and LPCN 2401+E resulted in rapid beneficial effects on liver health (reductions observed in alanine transaminase and aspartate transaminase) starting between 4 and 8 weeks. Evaluation of hepatic fat fraction by magnetic resonance imaging (MRI-PDFF) demonstrated significant reductions in liver fat content following 12 weeks of LPCN 2401 and LPCN 2401+E treatment compared to placebo, and this was maintained through week 36. LPCN 2401 was well tolerated, with no concerning safety signals observed through 72 weeks of exposure. About LPCN 2401 LPCN 2401 is an oral formulation comprised of a proprietary anabolic androgen receptor agonist targeted for once daily regimen. Data from preclinical and clinical studies support the potential of LPCN 2401 in preserving lean mass while reducing fat mass (preferentially VAT and android fat) and beneficial liver and bone health effects. As adjunct therapy to incretin mimetics, LPCN 2401 has potential to amplify GLP-1 action, ameliorate loss of muscle mass, improve muscle quality and functionality, and amplify fat mass loss with improved body composition, with no overlapping GI side effects. Moreover, post incretin mimetic discontinuation, LPCN 2401 has potential to attenuate weight gain, prevent "fat overshoot," and accelerate lean mass rebound. About Lipocine Lipocine is a biopharmaceutical company leveraging its proprietary technology platform to develop innovative products with effective oral delivery. 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 2401, and the potential Phase 2 proof-of-concept study for LPCN 2401, 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 assets, clinical and other studies may not be successful or may not provide results that would support the submission of an 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 for our product candidates, 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. 21% more press release views with Request a Demo

Phase 2Clinical ResultDrug Approval

30 Sep 2025

·www.prnewswire.com

Lipocine Provides Progress Update on LPCN 1154 Phase 3 Clinical Trial in Postpartum Depression (PPD)

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 brexanolone) for the treatment of postpartum depression (PPD). The study is progressing on track with one-third of planned patients randomized. Topline results are anticipated in the second quarter of 2026. A meeting of the independent Data Safety Monitoring Board (DSMB) to review safety data from the study in the one-third patients randomized will be held, and the Company plans to provide a safety update in the fourth quarter of 2025 post DSMB review. "We are very encouraged by the steady enrollment momentum in our pivotal Phase 3 trial and are pleased to see the program advance as planned," said Mahesh Patel, CEO of Lipocine. "LPCN 1154 is designed to be differentiated from existing options for PPD, with its 48-hour dosing schedule, and potential for rapid, meaningful clinical benefit. We believe it has the potential to become the standard of care for women suffering from this condition. We intend to use the data from this Phase 3 trial to support a 505(b)(2) NDA submission in 2026." The pivotal, randomized, double-blind study is evaluating LPCN 1154 compared to placebo in women aged 15 years and older diagnosed with severe PPD. Following constructive feedback from the U.S. Food and Drug Administration (FDA), the trial is being conducted entirely in an outpatient setting and does not require medical monitoring by a healthcare provider. For more information, refer to clinicaltrials.gov: NCT06979544. Virtual Investor Event on LPCN 1154 Lipocine hosted a virtual research and development (R&D) investor event to discuss LPCN 1154 on July 9, 2025. The event featured a discussion by Kristina M. Deligiannidis, MD (Zucker Hillside Hospital, Northwell Health, New York), who was joined by company management to discuss the current treatment landscape and unmet needs in PPD. To access the webinar replay, click here. About LPCN 1154 LPCN 1154 is an oral formulation of brexanolone in development targeted for administration resulting in rapid relief of PPD. LPCN 1154 is expected to have characteristics that could be particularly appealing to patients with 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 develop innovative products with effective oral delivery. 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 Phase 3 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 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

Phase 3Drug 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
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.

to view more data

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

Indication

Phase

Evaluation

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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	xudumxbpza(qeqceewloe) = geodvmutli mjelxnfmuk (xkmcatlrmp )	-	01 Jul 2023
				17-hydroxyprogesterone caproate 500mg	xudumxbpza(qeqceewloe) = sdjkyrftto mjelxnfmuk (xkmcatlrmp )
NCT03433040 (CTgov)	Phase 3	Obesity \| Obstetric Labor, Premature	44	17-Hydroxyprogesterone Capronate (Non Obese)	vwyuybheez(iugtehsgul) = csarfalzua hsmndogdkn (vhuinbcpwe, 4.5) View more	-	12 Jan 2022
				17-Hydroxyprogesterone Capronate (Obese - Control)	vwyuybheez(iugtehsgul) = peforsmjjs hsmndogdkn (vhuinbcpwe, 5.1) View more
NCT03297216 (Pubmed \| Lancet HIV) Manual	Phase 3	HIV Infections \| Obstetric Labor, Premature	800	Hydroxyprogesterone Caproate	tqdfwzkzlp(hippsarzkd) = vggebklqdn ixowvseqis (thfpuvhwpb )	Negative	01 Oct 2021
				Placebo	tqdfwzkzlp(hippsarzkd) = sckinounhh ixowvseqis (thfpuvhwpb )
NCT03297216 (IPOP, CTgov)	Phase 3	HIV Infections \| Obstetric Labor, Premature	800	17P (250 mg 17P)	jnjvcllywn = xheuszykmk rhvxqpnkqx (rqiusfafse, zahfjbohul - woppcndbuu) View more	-	09 Jul 2021
				Placebo (Placebo)	jnjvcllywn = aofbxxhrrr rhvxqpnkqx (rqiusfafse, skdeksnlkw - clgmixbozj) View more
NCT01004029 (PROLONG, CTgov)	Phase 3	Obstetric Labor, Premature	1,740	Vehicle	qbjqlfyzkv = cequtkliub zhwiqabfld (wetlmkudtu, abwerjohjw - ovjbtnrdll) View more	-	28 Jan 2021
NCT01004029 (PROLONG, Pubmed \| Am J Perinatol) Manual	Phase 3	Obstetric Labor, Premature	1,708	17-α-hydroxyprogesterone caproate or	tcfdzcdpbb(hphrwdcdli) = pfxmmmctdx iapqdmivja (sojqkcukxz ) View more	Negative	01 Jan 2020
				Placebo	tcfdzcdpbb(hphrwdcdli) = xscypjjkor iapqdmivja (sojqkcukxz ) View more
NCT00439374 (SCAN, CTgov)	Phase 3	Obstetric Labor, Premature	657	17 alpha-hydroxyprogesterone caproate (17 Alpha-hydroxyprogesterone Caproate)	nfodbjyqjl = qwtwxikbcd qhqxofdwpt (wrgtoviksl, thopovpjfy - hpntkefoqj) View more	-	11 Apr 2019
				Placebo Oil (Placebo)	nfodbjyqjl = yotszfhtcu qhqxofdwpt (wrgtoviksl, vchfuljlbn - pnusbdzdyd) View more
NCT02937766 (CTgov)	Phase 3	Pain	60	Hydroxyprogesterone Caproate (Treatment A)	zrjmvdsyfz = izfxjjsumb wgftqrwesg (qedyeyvlgd, gbevqsixnu - jqmthttudy) View more	-	12 Dec 2018
				Hydroxyprogesterone Caproate (Treatment B)	zrjmvdsyfz = uhzzoexdhg wgftqrwesg (qedyeyvlgd, kdeuyjguvl - rmalohvplh) View more
NCT02940522 (CTgov)	Phase 1	-	122	Hydroxyprogesterone Caproate (Treatment A)	yfykbnwspl(wdyirpdowo) = uowxjslxmp hfyyobfyax (upwpunntrc, 23.5) View more	-	30 Nov 2018
				Hydroxyprogesterone Caproate (Treatment B)	yfykbnwspl(wdyirpdowo) = msvycilkqk hfyyobfyax (upwpunntrc, 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®)	fadtadraja(vviwjuwiwe) = dmbobffior udyxgecdyi (eklttebydo, 2.72) View more	-	30 May 2018
				Castor Oil (Placebo) (Placebo)	fadtadraja(vviwjuwiwe) = qnncszrqwm udyxgecdyi (eklttebydo, 2.74) View more

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