Testosterone Undecanoate

SALT LAKE CITY, March 10, 2026 /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 full year ended December 31, 2025 and provided a corporate update. "We believe 2025 was a pivotal year for Lipocine as we continue to advance our pipeline and expand our market presence. The progress we've made, especially with our postpartum depression therapeutic, LPCN 1154, demonstrates the strength of our science and our team's commitment to delivering more effective treatments for patients in need," said Dr Mahesh Patel, Lipocine President and CEO. "We're excited about the near-term milestones ahead and remain committed to advancing our pipeline proficiently." Neuroactive Steroids (NAS) LPCN 1154 for Postpartum Depression (PPD) Lipocine is developing LPCN 1154, a rapid onset, short treatment duration oral product candidate comprising the neuroactive steroid brexanolone for the treatment of postpartum depression. The last patient completed the final study visit (Last Patient/Last Visit) in a confirmatory Phase 3 safety and efficacy study evaluating LPCN 1154 as a treatment for PPD in February 2026. The study enrolled 90 patients in total and top line results are expected early in April 2026. If successful, 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 mid-2026. LPCN 2201 for Major Depressive Disorders (MDD) Lipocine is advancing LPCN 2201, a unique oral brexanolone formulation, as a novel, rapid relief oral treatment option for MDD with the goal of improving outcomes without the limitations of existing therapies. LPCN 2201 is chemically identical to the endogenous human hormone allopregnanolone, a positive allosteric modulator of y-aminobutyric acid (GABAA) receptor. LPCN 2101 for Epilepsy Lipocine is developing 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. Two posters related to LPCN 2101 were presented at the 2025 American Epilepsy Society (AES) Annual Meeting that took place in December 2025 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 Based on FDA review of the protocol and agreement to proceed, the Company plans to 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. 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 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 endpoints 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, if approved. Also in 2024, Lipocine entered into a distribution and license agreement with SPC Korea Limited for the development and commercialization of TLANDO for TRT in South Korea and Lipocine signed an exclusive supply and distribution agreement with Pharmalink to commercialize TLANDO in the Gulf Cooperation Council (GCC) countries. In 2025, Lipocine entered into a license and supply agreement with Aché in Brazil. The Company is exploring further partnerships for TLANDO outside of North America, South Korea, the GCC countries and Brazil. Full year Ended December 31, 2025, Financial Results As of December 31, 2025, Lipocine had $14.9 million of unrestricted cash, cash equivalents and marketable investment securities compared to $21.6 million as of December 31, 2024. Lipocine reported a net loss of $9.6 million, or ($1.69) per diluted share, for the year ended December 31, 2025, compared with net income of $8,352, or ($0.00) per diluted share, for the year ended December 31, 2024. Revenues were $2.0 million during the year ended December 31, 2025, compared to revenue of $11.2 million during the year ended December 31, 2024. Revenue in 2025 primarily consisted of license revenue from the Company's licenses with Verity and Aché of $1.5 million, and royalty revenue from TLANDO sales of $480,000. Revenue in 2024 primarily consisted of $10.9 million in license revenue from licenses with Verity, SPC and Pharmalink and royalty revenue from TLANDO sales of $298,000. Research and development expenses were $8.6 million and $7.4 million, respectively, for the years ended December 31, 2025 and 2024. The increase in research and development expenses during the year ended December 31, 2025 primarily related to an increase in clinical study costs, in addition to other increases in supplies and research costs and in personnel-related costs. General and administrative expenses were $3.8 million and $5.0 million, respectively, for the years ended December 31, 2025 and 2024. The decrease in general and administrative expenses during the year ended December 31, 2025 was primarily due to a decrease in business development, strategic advisory services and corporate legal fees, a decrease in estimated franchise taxes, a decrease in other various professional fees, and a decrease in corporate insurance expense, offset by an increase in personnel related expenses, an increase in patent related fees and an increase in other general and administrative expenses. Interest and investment income was $0.7 million and $1.2 million for the years ended December 31, 2025 and 2024, respectively. The decrease in interest and investment income during the year ended December 31, 2025 was mainly due to declining cash and marketable investment securities balances in 2025 compared to 2024. As of March 6, 2026, the Company had unrestricted cash, cash equivalents and marketable investment securities of approximately $24.7 million. The higher balance compared with the balance at December 31, 2025 was primarily a result of the sale of shares of common stock by means of an "At the Market ("ATM") Offering" under a sales agreement with A.G.P./Alliance Global Partners ("A.G.P") entered into in April 2024. For further details on Lipocine's financial results from the year ended December 31, 2025, refer to Form 10K 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 development pipeline includes: LPCN 1154 for the treatment of postpartum depression, LPCN 2201 for treatment of major depressive disorder, LPCN 2101 for the treatment of epilepsy, LPCN 2203 targeted for the management of essential tremor, LPCN 2401 as an aid for improved body composition in obesity management, LPCN 1148 targeted for the management of symptoms associated with liver cirrhosis, and LPCN 1107 our candidate for prevention of preterm birth. 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, our Phase 3 safety and efficacy study relating to LPCN 1154, including the timing and potential results of the study, the timing of any submission of a NDA 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 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. 21% more press release views with Request a Demo

Bringing medical advances from the lab to the clinic. （👆，征战罕见病，我们一起努力。） 根据卫健委公布的罕见病目录（共两批，207种），美国Healsan恒祥医学科技将持续对所有罕见病进行解读和大数据分析，以其能够为从事罕见病研究的生物制药公司、医生科学家及患者提供一些有用的信息。 编者按：在儿科内分泌和罕见病领域，有一个极易与“先天性肾上腺皮质增生症（CAH）”混淆，但发病机制却截然相反的隐秘杀手先天性肾上腺发育不良（Congenital Adrenal Hypoplasia，简称AHC）。 如果说增生症（CAH）是肾上腺这座工厂“疯狂加班但产错原料”，那么发育不良（AHC）则是这座工厂“从地基开始就遭遇了毁灭性坍塌”。这是一种极其罕见的致死性遗传病，患儿（绝大多数为男婴）在出生后不久，就会因无法合成维持生命必需的皮质醇和醛固酮，陷入严重的失盐性危象、低血糖和休克；而即便侥幸活到青春期，他们又将面临生殖细胞发育停滞的二次打击。 过去数十年，AHC患者家属面临的最大痛点是“掰药片”：将成人的激素药片碾碎、凭感觉估算婴儿的剂量。剂量少了，随时猝死；剂量多了，发育迟缓。 当我们回望过去六年（2020-2026），从FDA首次批准专为婴幼儿设计的精准微粒激素，到干细胞“肾上腺类器官”在实验室里的惊艳突破，再到中国医保对罕见病“救命药”保供与支付的雷霆手段，AHC的诊疗版图已发生了翻天覆地的巨变。 本文将为您全景梳理近六年全球AHC领域的核心新药进展、前沿技术突破以及中国本土的政策红利。无论您是寻找儿科罕见病蓝海的制药先锋、奋战在一线的临床医生，还是在迷茫中前行的患者家属，本文都将为您提供最硬核的行业洞察。一、 破译“生命腺”的坍塌密码：为何AHC如此棘手？ 要理解制药界在AHC领域的研发逻辑，首先要看透其病理根源。 临床上最常见的AHC是X连锁隐性遗传性先天性肾上腺发育不良（X-linked AHC），主要由位于X染色体上的NR0B1（DAX-1）基因突变引起。 DAX-1蛋白是肾上腺和性腺发育过程中的核心转录抑制因子。当这个基因发生突变，胎儿期的肾上腺皮质干细胞无法正常增殖和分化，导致出生时肾上腺皮质极其微小，无法分泌足够的糖皮质激素（皮质醇）和盐皮质激素（醛固酮）。 更残酷的是，DAX-1同样参与下丘脑-垂体-性腺轴（HPG）的调控。因此，这些男孩在步入青春期时，通常会并发低促性腺激素性性腺功能减退症（HH），无法经历正常的青春期发育，并面临终生不育的困境。 研发的终极挑战： AHC是一种“器官级缺失”疾病。这意味着，在基因疗法或器官再生技术成熟之前，患者必须终生依赖极其精准的外源性激素替代治疗。而人体正常皮质醇的分泌具有强烈的“昼夜节律（子夜最低，清晨最高）”，如何用药物完美模拟这一节律，成为了制药界过去十年的攻坚高地。二、 2020-2026 FDA新药审批风向标：告别“盲人摸象”的精准替代时代 在2020年之前，全球没有任何一款专为婴幼儿肾上腺皮质功能减退（包含AHC）设计的精准剂型。直到近几年，两款具有里程碑意义的药物/剂型彻底改变了这一现状。1. Alkindi Sprinkle：终结婴幼儿“掰药片”历史的里程碑 对于新生儿AHC患者而言，2020年9月是一个被载入史册的月份。美国FDA正式批准了Diurnal Group（现已被Neurocrine Biosciences收购）研发的Alkindi Sprinkle（氢化可的松口服颗粒），用于治疗婴幼儿及儿童的肾上腺皮质功能减退症。 技术突破： 这是首个且唯一一个获FDA批准的专为儿科设计的氢化可的松颗粒。它提供了0.5mg、1mg、2mg和5mg四种极低剂量的精准胶囊。家长只需将胶囊打开，将无味的微粒洒在软食（如苹果酱或酸奶）上即可喂服。 临床价值与制药启示： 传统成人药片（通常为10mg或20mg）极难分割，导致婴儿经常面临用药过量的医源性库欣综合征（生长停滞、骨质疏松）或用药不足的肾上腺危象。Alkindi的获批向全球制药界释放了强烈信号：在罕见病领域，通过针对特定年龄段（尤其是儿科）优化剂型（505(b)(2)途径），不仅能迅速解决临床痛点，还能顺利斩获孤儿药资格（ODD）并占据垄断市场。2. Efmody (Chronocort) 与长效制剂的节律重塑 随着AHC患儿逐渐成年，他们面临的挑战转变为：如何模拟正常人体的皮质醇昼夜节律？ 在2021-2025年间，改良释放型氢化可的松硬胶囊 Efmody 在欧洲和英国相继获批（主要针对CAH，但也广泛惠及各种原发性肾上腺功能不全患者）。 机制亮点： 这种双重释放制剂让患者在睡前服药，药物在睡眠期间缓慢释放，在清晨患者醒来时达到血药浓度峰值，完美复刻了健康肾上腺的生物钟。这极大改善了成年AHC患者长期以来的晨起极度疲劳感和代谢综合征风险。三、 下一代疗法暗流涌动：从“终生服药”到“再生治愈”的实验室突围 (2023-2026前沿) 如果说精准激素替代只是“治标”，那么全球顶尖科研机构和Biotech公司正在布局的，则是如何“治本”。近几年，基于诱导多能干细胞（iPSCs）的肾上腺类器官（Adrenal Organoids）技术取得了爆炸性进展。 2024-2025年再生医学高光： 以美国宾夕法尼亚大学（UPenn）及日本顶尖代谢病研究中心为代表的团队，在医学顶刊上连续发文，宣布成功从人类皮肤/血液细胞重编程而来的iPSCs中，体外诱导分化出了具备完整激素分泌功能的“微型肾上腺皮质组织”。 颠覆性意义： 这些类器官在移植到缺乏肾上腺功能的小鼠体内后，成功存活并响应了小鼠脑垂体分泌的ACTH（促肾上腺皮质激素）信号，按需释放皮质酮。对于AHC患者而言，这意味在未来5-10年内，通过自体细胞培养、利用CRISPR技术修复DAX-1基因缺陷，再将健康的肾上腺细胞植回体内，实现彻底的“脱药治愈”已在理论上完全可行。 目前，多家专注于细胞疗法的创新药企正积极筹备该领域的早期IND推进。四、 中国力量：罕见病保供战与医保“护城河”的全面筑牢 视线拉回国内。对于中国的AHC患者群体，过去的六年是见证国家医保体系从“保基本”向“罕见病精准托底”深刻跨越的六年。1. 揪出“隐形杀手”：NGS基因测序下沉与确诊率飙升 过去，大量AHC男婴在满月前因“不明原因休克”夭折，甚至被误诊为败血症。随着2020-2026年间，全外显子组测序（WES）和基因Panel检测在中国三甲医院新生儿重症监护室（NICU）的全面普及，AHC的早期确诊率呈现指数级上升，为患儿抢出了黄金救命时间。2. 打赢“氟氢可的松”保供战与医保全覆盖 AHC患者除了需要补充糖皮质激素（氢化可的松），还必须终生服用盐皮质激素醋酸氟氢可的松（Fludrocortisone）以防止钠流失和致死性低血压。 曾经的断药危机： 几年以前，由于利润极低，国内拥有氟氢可的松批文的药企一度停产，导致全国患者家属陷入恐慌，只能高价寻求海外代购。 国家重拳出击： 近年来，国家卫健委与工信部将醋酸氟氢可的松明确列入《国家短缺药品清单》并实施定点生产保供（如上药信谊等本土老牌药企担当重任）。 医保红利落地： 如今，基础的氢化可的松片和醋酸氟氢可的松片不仅供应稳定，且均稳居国家医保目录（甲类/乙类）。在医保报销后，患者维持基础生命线的月度药物成本仅需数十至百元人民币左右，彻底解决了“因病致贫”的生存危机。3. 商业健康险（惠民保）与睾酮替代的闭环 步入青春期后，AHC男孩需要接受昂贵的长效促性腺激素或睾酮替代治疗（如十一酸睾酮注射液）以维持男性特征和骨密度。2024-2026年，随着各大城市“惠民保”政策的升级，大量原本属于医保目录外或受限的高值内分泌专科用药被纳入了商业补充报销范畴，为AHC患者的“全生命周期管理”补齐了最后一块拼图。五、 结语与洞察：在孤岛上，种下参天大树 致患者与家属：如果您刚刚拿到孩子DAX-1基因突变的确诊报告，请务必从绝望中抬起头。AHC虽然凶险，但它是一种“只要按时按量服药，就能拥有与常人无异的寿命和智力”的罕见病。 请严格遵从儿科内分泌专家的指导，随身携带“肾上腺功能不全急救卡”和氢化可的松注射液。在科学的庇护下，您的孩子完全可以正常上学、工作甚至组建家庭。干细胞治愈的曙光正在加速靠近，你们要做的，就是稳稳地接住当下的每一天。 致制药同仁与临床医生：由于AHC常被误诊为更常见的CAH，临床上的精准基因分型显得尤为关键，这直接关系到孩子青春期的发育干预策略。而对于制药界，儿童专用微粒剂型（如推动Alkindi类产品在国内的商业化落地或国产替代）、长效节律重塑制剂，以及靶向DAX-1/SF1通路的细胞再生疗法，依然是国内罕见病内分泌赛道中极具投资价值的破局点。 生命之腺虽在基因中坍塌，但人类智慧的接力，终将为他们重建起生生不息的屏障。 本公众号由美国Healsan (恒祥医学科技)运营。投稿及商务联系微信号：healsan 提供特惠码MELT99，可以获得优惠。 美国Healsan专长于Healsan医学大数据分析（Healsan™）、及基于大数据的Hanson临床科研服务（HansonCR™）和医学编辑服务（MedEditing™）。主要为医生科学家、生物制药公司和医院科研处等提供文献计量分析和SCI论文润色、编辑、选刊等服务，成为诸多机构的“临床科研外挂”。 网址： https://healsan.com/ （👆，征战罕见病，我们在行动！） ▼ Healsan医路成长更多免费资源： （点击👆图片，进入自己感兴趣的专辑。或点击“资源”，浏览本公众号所有资源）