Testosterone

New Drug Submission filed by Lipocine's licensing partner Verity Pharma Over 700,000 total prescriptions written annually for testosterone replacement therapy (TRT) in Canada, representing large commercial opportunity SALT LAKE CITY, June 9, 2025 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to enable effective oral delivery of therapeutics, today announced that its licensing partner, Verity Pharma, filed a New Drug Submission (NDS) for TLANDO® in Canada. TLANDO is the first and only oral testosterone replacement therapy (TRT) option approved by the US Food and Drug Administration (FDA) that does not require dose titration. "Canada represents an attractive market for TLANDO and the filing of the NDS by Verity Pharma represents an important next step in making the product available there," said Mahesh Patel, CEO of Lipocine. "We believe that, if approved, the introduction of this new and highly differentiated oral TRT option has the potential to drive significant market gains." There are over 700,000 prescriptions written annually in Canada for TRT, and approximately 50% of this patient population is covered through private insurance. In addition, there are limited promotional activities surrounding currently available TRTs, which could provide an opportunity for TLANDO to capture a significant share of this large and growing market. In January 2024, Lipocine and Verity Pharma entered into an exclusive license agreement under which Verity Pharma gained the commercial rights to TLANDO® in the United States and Canada. About TLANDO TLANDO is approved by the US FDA as a testosterone replacement therapy (TRT) in adult males indicated for conditions associated with a deficiency or absence of endogenous testosterone: primary hypogonadism (congenital or acquired) and hypogonadotropic hypogonadism (congenital or acquired). It was developed using Lipocine's proprietary Lip'ral drug delivery technology platform. For full prescribing information, please visit . About Lipocine Lipocine is a biopharmaceutical company leveraging its proprietary technology platform to enable effective oral delivery of therapeutics. Lipocine has drug candidates in development as well as drug candidates for which we are exploring partnerships. Our drug candidates represent enablement of differentiated, patient friendly oral delivery options for favorable benefit to risk profile which target large addressable markets with significant unmet medical needs. Lipocine's clinical development candidates include: LPCN 1154, oral brexanolone, for the potential treatment of postpartum depression, LPCN 2101 for the potential treatment of epilepsy, LPCN 2203 an oral candidate targeted for the management of essential tremor, LPCN 2401 an oral proprietary anabolic androgen receptor agonist, as an adjunct therapy to incretin mimetics, as an aid for improved body composition in obesity management and LPCN 1148, a novel androgen receptor agonist prodrug for oral administration targeted for the management of symptoms associated with liver cirrhosis. Lipocine is exploring partnering opportunities for LPCN 1107, our candidate for prevention of preterm birth, LPCN 1154, for rapid relief of postpartum depression, LPCN 2401 for obesity management, LPCN 1148, for the management of decompensated cirrhosis, and LPCN 1144, our candidate for treatment of metabolic dysfunction-associated steatohepatitis (MASH). TLANDO, a novel oral prodrug of testosterone containing testosterone undecanoate developed by Lipocine, is approved by the FDA for conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism, in adult males. For more information, please visit . Forward-Looking Statements This release contains "forward-looking statements" that are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and include statements that are not historical facts regarding our product candidates and related clinical trials, our development of our product candidates and related efforts with the FDA, including with respect to LPCN 1154, our P3 safety and efficacy study relating to LPCN 1154, the timing and potential results of the safety and efficacy study relating to LPCN 1154, potential partnering of our product candidates with third parties, and the potential uses and benefits of our product candidates. Investors are cautioned that all such forward-looking statements involve risks and uncertainties, including, without limitation, the risks that we may not be successful in developing product candidates, we may not have sufficient capital to complete the development processes for our product candidates or we may decide to allocate our available capital to other product candidates, we may not be able to enter into partnerships or other strategic relationships to monetize our non-core assets, safety and efficacy studies, including those relating to LPCN 1154, may not be successful or may not provide results that would support the submission of a NDA, the FDA may not approve any of our products, risks related to our products, expected product benefits not being realized, clinical and regulatory expectations and plans not being realized, new regulatory developments and requirements, risks related to the FDA approval process including the receipt of regulatory approvals and our ability to utilize a streamlined approval pathway for LPCN 1154, the results and timing of clinical trials, patient acceptance of Lipocine's products, the manufacturing and commercialization of Lipocine's products, and other risks detailed in Lipocine's filings with the SEC, including, without limitation, its Form 10-K and other reports on Forms 8-K and 10-Q, all of which can be obtained on the SEC website at . Lipocine assumes no obligation to update or revise publicly any forward-looking statements contained in this release, except as required by law. SOURCE Lipocine Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

New Research Highlights DHT’s Role in Prostate Health and Emerging Therapies to Manage Hormone Imbalance Understanding the role of dihydrotestosterone (DHT) is essential for those undergoing testosterone replacement therapy.” — Chris Rue, FNP-C NEW ORLEANS, LA, UNITED STATES, June 6, 2025 / EINPresswire.com / -- Dihydrotestosterone (DHT), a potent androgen derived from testosterone, plays a critical role in the development and maintenance of male characteristics. However, medical experts and researchers are sounding the alarm about its potential impact on prostate health, especially when levels become elevated. DHT is primarily synthesized in the prostate, liver, skin, and hair follicles through the enzymatic conversion of testosterone by 5-alpha reductase. While essential for male development, excessive DHT levels have been strongly linked to benign prostatic hyperplasia (BPH) and an increased risk of prostate enlargement, which can lead to urinary problems and decreased quality of life in aging men. Effects of Elevated DHT on the Prostate: • Prostate Enlargement: Elevated DHT stimulates excessive growth of prostate tissue, contributing to BPH. • Urinary Symptoms: Increased prostate volume can compress the urethra, causing frequent urination, difficulty starting urination, and weak urinary flow. • Potential Cancer Risk: Though the relationship is complex, some studies suggest high DHT levels may influence prostate cancer progression. According to recent clinical reviews, men over the age of 50 are especially vulnerable, with over 50% developing some form of prostate enlargement by age 60. Treatment Options to Lower Elevated DHT Levels: Medical professionals emphasize early intervention and hormone regulation as key strategies. The most common treatments include: 1. 5-Alpha Reductase Inhibitors: Medications such as finasteride (Proscar) and dutasteride (Avodart) block the conversion of testosterone to DHT, reducing prostate size and alleviating symptoms. 2. Natural DHT Blockers: Compounds like saw palmetto extract, pumpkin seed oil, and green tea catechins are under investigation for their mild DHT-lowering effects. 3. Lifestyle Changes: A diet rich in anti-inflammatory foods, regular exercise, and weight management may help regulate hormone levels. 4. Hormonal Monitoring: Regular blood tests to track testosterone and DHT levels can aid in early detection and intervention. Dr. Michael Reynolds, a board-certified urologist, commented, “DHT is essential, but when imbalanced, it can become a catalyst for prostate issues. We now have evidence-based strategies to bring levels back to a healthier range.” About the Prostate Health Initiative The Prostate Health Initiative is a nationwide educational campaign aimed at raising awareness about male hormone balance and its effects on long-term urological health. Through collaboration with healthcare providers and research institutions, the initiative seeks to empower men to make informed choices about their prostate health. ________________________________________ Chris Rue Metairie Optimal Performance Enhancement +1 504-265-5491 info@mopeclinic.com Visit us on social media: LinkedIn Facebook Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.