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

734

Literatures (Medical) associated with Hydroxyprogesterone Caproate

01 Sep 2026·Drug Research

The Real-World Safety Profile of Hydroxyprogesterone: A Pharmacovigilance Study Based on the Food and Drug Administrationʼs Adverse Event Reporting System Database

Article

Author: Fang, Yuan ; Fan, Tingting ; Liu, Meiyou ; Zhang, Juanli ; Ding, Likun ; Ren, Danjun ; Zhang, Di

Abstract:

This study aimed to explore the spectrum of adverse events associated with hydroxyprogesterone and provide a comprehensive understanding of the drug’s safety profile based on the Food and Drug Administrationʼs Adverse Event Reporting System database.Adverse events associated with hydroxyprogesterone were extracted from the Food and Drug Administrationʼs Adverse Event Reporting System database, covering the period from the first quarter of 2004 to the second quarter of 2025. Disproportionality analysis methods were used to detect potential safety signals related to hydroxyprogesterone. We further analyzed the demographic characteristics of the population and the onset time of adverse events.A total of 40,450 adverse event reports related to hydroxyprogesterone were included, corresponding to 197 significant preferred terms categorized into 21 system organ classes per Medical Dictionary for Regulatory Activities criteria. In addition to commonly observed adverse events, several clinically relevant adverse events not previously documented were identified, including fetal distress syndrome, abnormal fetal heart rate deceleration, neonatal jaundice, neonatal respiratory distress, and low birth weight infant. The median time to the onset of hydroxyprogesterone-induced adverse events was 20 days (interquartile range: 0–72 d), with 57.8% of adverse events occurring within the initial 30 days following hydroxyprogesterone administration.In this study, we identified both clinically observed adverse events and potential safety signals associated with hydroxyprogesterone. These results provide valuable evidence to support clinical monitoring, safety risk identification, and the development of subsequent safety investigations.

05 Aug 2026·AMERICAN JOURNAL OF EPIDEMIOLOGY

Clarifying contradictions: transportability in 17OHP-C trials and preterm birth outcomes using doubly debiased machine learning

Article

Author: Dalynn Willis ; Eric Tchetgen Tchetgen ; Sean Blackwell ; Sunni Mumford ; Enrique F Schisterman ; Kristin D Gerson ; Samuel Parry ; Lisa D Levine ; Brandie D Taylor ; Stephen R Cole ; Beth Pineles ; Arti V Virkud ; Alan Peaceman ; Maria T Johnson ; Ellen C Caniglia ; Stefanie N Hinkle

Abstract:

Following the Meis et al. trial that identified a benefit of 17-alpha-hydroxyprogesterone caproate (17OHP-C) in reducing the risk of recurrent preterm birth (PTB) (risk difference (RD) −18.6%; 95% CI, −28.2%, −9.2%), a confirmatory trial (PROLONG) identified no benefit of 17OHP-C (RD, 1.2%; 95% CI, −3.0%, 5.3%). The leading hypothesis is that the difference was due to the heterogeneity in PTB risk. We implemented state-of-the-art methods, using doubly debiased machine learning for transportability to investigate whether the conflicting trial results could be explained by measured differences between trial populations. The estimated RD when transporting the effect in Meis to the PROLONG trial population was −18.6% (95% CI, −55.9%, 8.8%) comparing 17OHP-C to placebo. The estimated RD when transporting PROLONG to Meis was 5.2% (95% CI, −17.3%, 18.1%) comparing 17OHP-C to placebo. Transporting from PROLONG to Meis did not recover the protective effect observed in Meis, which we hypothesize is due to a hidden violation of one or more causal assumptions for transportability, such as the presence of unmeasured effect measure modifiers. Transporting from Meis to PROLONG did not recover the null point estimate observed in PROLONG, though the confidence interval was wide. Future studies should explore effect heterogeneity by PTB.

01 Aug 2026·BJOG-AN INTERNATIONAL JOURNAL OF OBSTETRICS AND GYNAECOLOGY

Prenatal 17‐Alpha‐Hydroxyprogesterone Caproate Exposure in Twins and Childhood Outcomes: 14‐Year Follow‐Up of a Randomised Trial

Article

Author: van Limburg Stirum, Emilie V. J. ; Lim, Arianne C. ; de Boer, Marjon A. ; Leemhuis, Aleid G. ; van Baar, Anneloes L. ; Ravelli, A. C. J. ; Aarnoudse‐Moens, Cornelieke S. H. ; Painter, Rebecca C. ; Mol, Ben W. ; van 't Hooft, Janneke ; Finken, Martijn J. J. ; Pajkrt, Eva ; Simons, Noor E. ; van Eekelen, Rik ; Oudijk, Martijn A.

ABSTRACT:

Objective:

Long‐term child outcomes after intra‐uterine exposure to 17‐alpha‐hydroxyprogesterone caproate (17‐OHPC) versus placebo.

Design:

Follow‐up of the AMPHIA randomised controlled trial assessing neonatal outcomes after weekly 17‐OHPC injections compared to placebo in multiple pregnancies.

Setting:

Multicentre.

Population or Sample:

Children born in the AMPHIA study.

Methods:

Children were assessed at 11–14 years of age by record linkage and through self‐reported, parental and teacher questionnaires. Mean differences or odds ratios (OR) with 95% confidence intervals (95% CI) were calculated with cluster robust standard errors for twins and adjustment for confounders using inverse probability weighting (IPW).

Main Outcome Measures:

Child mortality, educational attainment, cognition, behaviour, gender identity, general health, and a composite of abnormal development.

Results:

Up to 14 years, 60/1356 children had died ( n = 24 17‐OHPC and n = 36 placebo (OR 0.75 95% CI 0.36–1.53)). Record linkage was completed for 1027/1296 (79%) surviving children ( n = 517 17‐OHPC and n = 510 placebo). No significant difference was found regarding educational attainment. Detailed developmental outcomes through questionnaires were collected for 303/1296 (23%) surviving children ( n = 159 17‐OHPC and n = 144 placebo). No differences in cognition, behaviour, gender identity, and general health up to 14 years of age were found between both groups. The composite of abnormal development did not differ between 17‐OHPC (23.3%) and placebo (20.1%) groups (OR 1.31 95% CI 0.66–2.56).

Conclusion:

In offspring of women with a multiple pregnancy, the use of 17‐OHPC in pregnancy is unlikely to provide positive or negative effects on child outcome related to mortality, educational attainment, cognition and behaviour.

112

News (Medical) associated with Hydroxyprogesterone Caproate

13 May 2026

·www.businesswire.com

Osel Inc. and March of Dimes Announce Groundbreaking Phase 2b Trial of Microbiome-based Therapy Targeting Preterm Birth Prevention

MOUNTAIN VIEW, Calif. & ARLINGTON, Va. & LONDON--(BUSINESS WIRE)--Osel Inc., a clinical‑stage biopharma leader in live biotherapeutic products (LBPs), in partnership with the Imperial Clinical Trials Unit at Imperial College London, and March of Dimes, a national leader in maternal and infant health research, today announced the launch of FLIP‑2, a Phase 2b clinical trial that will evaluate the efficacy and safety of LACTIN‑V in pregnant women at high risk of preterm birth (PTB). "We are excited to work with Imperial and March of Dimes on this groundbreaking clinical trial addressing a major unmet need in pregnancy." LACTIN-V is a live biotherapeutic product (LBP) containing the beneficial bacterium Lactobacillus crispatus, which has been designed to restore a healthy vaginal microbiome. Imbalance in the vaginal microbiome is thought to be a major underrecognized risk factor for poor pregnancy outcomes, including preterm birth and late miscarriage. The FLIP‑2 trial will be led by Dr. Lynne Sykes (Chief Investigator), Professor Phillip Bennett (Principal Investigator), and Dr. Ryan Love (Associate PI) at the March of Dimes Prematurity Research Center (PRC) at Imperial College London. “For families facing the fear of preterm birth, the absence of effective treatments for microbiome imbalance in the reproductive tract is devastating. This trial represents a truly unique opportunity to test an intervention that targets a clearly defined cause of PTB, rather than a one‑size‑fits‑all solution,” said Dr. Sykes, Parasol Foundation Clinical Associate Professor in Obstetrics at Imperial College London. “If successful, it could move us toward a far more personalised and precise approach to preventing preterm birth, giving women a better chance to deliver their babies safely at the right time.” “This exciting trial represents a paradigm change in the prevention of PTB, targeting activation of host immune responses to the reproductive tract microbiome,” said Professor Bennett, Professor of Obstetrics and Gynaecology and Acting Head of the Department of Metabolism, Digestion and Reproduction at Imperial College London. “It is the first new treatment for preterm birth in decades, and unlike previous therapies, aims to prevent the activation of the mechanisms causing preterm labor, rather than trying to stop preterm labour once it has started.” The FLIP‑2 study represents the most advanced clinical trial to date of a microbiome‑based therapy aimed at preventing PTB, marking a major step forward in women’s health and microbiome science. It follows the encouraging results from the prior FLIP‑1 Phase 1 study conducted at the March of Dimes PRC at Imperial College London by Professor Bennett, Dr. Sykes and Professor David MacIntyre. This open‑label pilot showed that LACTIN‑V is safe, well‑tolerated, and highly acceptable to pregnant women at high risk of preterm birth. Importantly, the study observed a lower rate of preterm birth compared with historical controls, providing strong rationale for advancing LACTIN‑V into this larger, placebo-controlled Phase 2b trial.¹ “We are excited to work with Imperial and March of Dimes on this groundbreaking clinical trial addressing a major unmet need in pregnancy,” said Peter P. Lee, MD, Founder and Executive Chairman of Osel. “Professor Bennett and Dr. Sykes are world-renowned experts on the impact of vaginal microbiome disruption and inflammation on the risk of PTB. We are honored to work with them to further explore the potential of LACTIN-V in this vulnerable population.” The double‑blind study evaluating LACTIN‑V against a matching placebo aims to enroll 360 pregnant patients at high risk of early birth across four maternity units in the United Kingdom. Imperial College London is sponsoring the study, with funding support from the March of Dimes and the NIHR Imperial Biomedical Research Centre, underscoring the strong international commitment to advancing new solutions for preterm birth. “After nearly a decade supporting this incredible research team working to understand and mitigate microbiome-driven preterm birth, we are thrilled to be at the doorstep of the first randomized controlled trial of a live biotherapeutic to prevent early labor,” said March of Dimes Chief Scientific Advisor Dr. Emre Seli. “Not only is this a historic trial, it’s also a very promising one, with potential to dramatically reduce preterm birth rates in our lifetime.” For more information about the FLIP‑2 study, visit: https://www.isrctn.com/ISRCTN13610566 About LACTIN-V LACTIN-V is a powder delivered vaginally utilizing a proprietary applicator. By delivering L. crispatus directly to the vagina, LACTIN‑V supports stable colonization of this protective bacterium, ‘flipping the flora’, and helps reduce vaginal inflammation, addressing a key biological pathway linked to preterm birth. Women with high levels of L. crispatus have a significantly lower risk of preterm birth, while those with low levels and high microbial diversity experience greater vaginal inflammation, placing them at increased risk of premature rupture of membranes (PPROM), early delivery, and low‑birthweight infants. Osel holds an exclusive worldwide license with ICL for intellectual property covering the use of LACTIN-V, a live biotherapeutic product, in PTB. About Preterm Birth (PTB) Preterm birth (PTB) is the leading cause of death in children under five worldwide, claiming nearly one million lives every year. Survivors often face lifelong challenges, including disability and developmental delays, making PTB one of the most urgent global threats to child health and wellbeing. The economic impact is equally profound: PTB costs tens of billions of dollars annually in medical care, lost productivity, and long‑term support services, with expenses rising sharply for babies born before 28 weeks of gestation. Against this backdrop, treatment options remain extremely limited. In April 2023, the FDA withdrew approval of Makena® (hydroxyprogesterone caproate) after post‑market studies failed to confirm its effectiveness in preventing preterm birth. As a result, there are no FDA‑approved therapies available to prevent PTB. About Osel Inc. Osel Inc., headquartered in Mountain View, California, is a privately held biopharmaceutical company dedicated to developing and commercializing live biotherapeutic products aimed at preventing or treating major medical conditions by modulating the human microbiome. As a pioneer in the field of LBPs, Osel focuses primarily on oncology and women’s health. For more information, visit oselinc.com. About Imperial College London We are Imperial – a world-leading university for science, technology, engineering, medicine and business (STEMB), where scientific imagination leads to world-changing impact. As a global top ten university in London, we use science to try to understand more of the universe and improve the lives of more people in it. Across our 10 campuses and throughout our Imperial Global network, our 22,000 students, 8,000 staff, and partners work together on scientific discovery, innovation and entrepreneurship. Their work navigates some of the world’s toughest challenges in global health, climate change, AI, business leadership and more. Founded in 1907, Imperial’s future builds on a distinguished past, having pioneered penicillin, holography and fibre optics. Today, Imperial combines exceptional teaching, world-class facilities and a habit of interdisciplinary practice to unlock scientific imagination. About March of Dimes March of Dimes leads the fight for the health of all moms and babies. We support research, education, and advocacy, and provide programs and services so that every family can have the best possible start. Since 1938, we’ve built a successful legacy to support every pregnant person and every family. Visit marchofdimes.org or nacersano.org for more information. Find us on Facebook and follow us with #marchofdimes and @marchofdimes. References: 1. Bayar E, MacIntyre DA, Sykes L, Mountain K, Parks TP, Lee PP, Bennett PR. Safety, tolerability, and acceptability of Lactobacillus crispatus CTV-05 (LACTIN-V) in pregnant women at high-risk of preterm birth. Benef Microbes. 2023 Mar 14;14(1):45-56. doi: 10.3920/BM2022.0084. Epub 2023 Feb 23. PMID: 36815494.

Phase 1Phase 2License out/inMicrobial therapy

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

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.

to view more data

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

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	gbythoromq(fwjfmutasa) = znkuuepkjw cgydycshcw (toxjbltewo )	-	01 Jul 2023
				17-hydroxyprogesterone caproate 500mg	gbythoromq(fwjfmutasa) = hsfacsslto cgydycshcw (toxjbltewo )
NCT03433040 (CTgov)	Phase 3	Obesity \| Obstetric Labor, Premature	44	17-Hydroxyprogesterone Capronate (Non Obese)	gqyotlqpvv(otaerotexb) = hkdqniiqia untkdjuqjy (zevusihdbv, 4.5) View more	-	12 Jan 2022
				17-Hydroxyprogesterone Capronate (Obese - Control)	gqyotlqpvv(otaerotexb) = roxjjkgarx untkdjuqjy (zevusihdbv, 5.1) View more
NCT03297216 (Pubmed \| Lancet HIV) Manual	Phase 3	HIV Infections \| Obstetric Labor, Premature	800	Hydroxyprogesterone Caproate	fnughjevjl(iavpyqfmxm) = zibojiqwxf uotzjpwfug (gwdccfldyd )	Negative	01 Oct 2021
				Placebo	fnughjevjl(iavpyqfmxm) = nvdfgvlwse uotzjpwfug (gwdccfldyd )
NCT03297216 (IPOP, CTgov)	Phase 3	HIV Infections \| Obstetric Labor, Premature	800	17P (250 mg 17P)	oornikiozg = hdsuneibmj sscfnlzxeh (hjgahcjqan, lshcpewpnz - ewzhhuqnku) View more	-	09 Jul 2021
				Placebo (Placebo)	oornikiozg = dzrhrcamqu sscfnlzxeh (hjgahcjqan, frxogfjsyf - pllojwccdn) View more
NCT01004029 (PROLONG, CTgov)	Phase 3	Obstetric Labor, Premature	1,740	Vehicle	hndzfftqsb = norofxypwy setglhygxt (tchakqtmjz, rjuvqsrxgk - ehpcfyocio) View more	-	28 Jan 2021
NCT01004029 (PROLONG, Pubmed \| Am J Perinatol) Manual	Phase 3	Obstetric Labor, Premature	1,708	17-α-hydroxyprogesterone caproate or	pdevnmhpge(nrhujzeubf) = bvervarang tjztfkoubb (suptfpuags ) View more	Negative	01 Jan 2020
				Placebo	pdevnmhpge(nrhujzeubf) = qhfucyxabg tjztfkoubb (suptfpuags ) View more
NCT00439374 (SCAN, CTgov)	Phase 3	Obstetric Labor, Premature	657	17 alpha-hydroxyprogesterone caproate (17 Alpha-hydroxyprogesterone Caproate)	pvawnhvivw = nrggkuvvry jvndbqesph (yzwhbudcvy, ffxcymuqea - lezdiglxfe) View more	-	11 Apr 2019
				Placebo Oil (Placebo)	pvawnhvivw = vbzyrwiejb jvndbqesph (yzwhbudcvy, bmmelzaarn - kiuosisnzo) View more
NCT02937766 (CTgov)	Phase 3	Pain	60	Hydroxyprogesterone Caproate (Treatment A)	ehphyjfsbf = zidrkygplf fjuefgwndf (poklcujgfx, sqmuyzxril - ligmkrtsgn) View more	-	12 Dec 2018
				Hydroxyprogesterone Caproate (Treatment B)	ehphyjfsbf = wqxjlpbgna fjuefgwndf (poklcujgfx, woqrrmdojt - rpyztaymqo) View more
NCT02940522 (CTgov)	Phase 1	-	122	Hydroxyprogesterone Caproate (Treatment A)	hcooubrzeq(ndwrsfnwcy) = bzxtmkeydw lcftbrlbmu (gdvzaiktne, 23.5) View more	-	30 Nov 2018
				Hydroxyprogesterone Caproate (Treatment B)	hcooubrzeq(ndwrsfnwcy) = dljivhleoy lcftbrlbmu (gdvzaiktne, 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®)	klmyzzrvnk(ddwbxhilrx) = lhimohkjla jhqvpyhgao (grgrymqgrm, 2.72) View more	-	30 May 2018
				Castor Oil (Placebo) (Placebo)	klmyzzrvnk(ddwbxhilrx) = yoaascgriu jhqvpyhgao (grgrymqgrm, 2.74) View more

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