Testosterone Undecanoate

SALT LAKE CITY, Aug. 3, 2026 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to augment therapeutics through effective oral delivery, today announced the appointment of Michael J. Grissinger to its Board of Directors, effective August 3, 2026. "We are pleased to welcome Mike Grissinger to our Board of Directors," said Dana Ono, Ph.D., Chairman of the Board of Lipocine. "Mike brings extensive experience leading pharmaceutical licensing, corporate development, and mergers and acquisitions. As Lipocine works to advance the pipeline and pursue partnerships for our assets, his dealmaking experience and judgment will be invaluable." Mr. Grissinger spent more than two decades at Johnson & Johnson where he served in a variety of senior level management roles, including Vice President and Head of Worldwide Pharmaceutical Licensing and Vice President and Head of Worldwide Pharmaceutical Corporate Development and M&A. At Johnson & Johnson, Mr. Grissinger led the Immunology Therapeutic Area Business Development and Licensing Group and was also a member of the Immunology R&D/Commercial leadership team for Johnson & Johnson's Worldwide Immunology Franchise. Prior to Johnson & Johnson, Mr. Grissinger spent 12 years at Ciba-Geigy in finance, marketing, and business development roles. Mr. Grissinger is an experienced biotech company director serving on boards of public and private companies, including Board Chair roles. He currently serves on the board of directors at Aprea Therapeutics (Nasdaq: APRE) and Adicet Bio (Nasdaq: ACET). He also advises several privately-held biotech companies. Mr. Grissinger holds a B.S. in Chemistry from Juniata College and an M.B.A. from Temple University – Fox School of Business. Mr. Grissinger commented, "I am pleased to join the Board of Lipocine. The company has leveraged its innovative oral delivery technology to build a compelling portfolio of commercial and late-stage clinical assets with the potential to address significant unmet needs. I look forward to working with the Board and management team as they advance these programs to deliver meaningful value for patients and shareholders." 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 development of our products and product candidates and related efforts with the FDA, including the timing of clinical trials and regulatory submissions, the potential uses and benefits of our products and product candidates, the commercial potential for our product candidates, and potential strategic partnerships and other opportunities. 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

Model projects up to $16.2 million in potential annual savings for every 50,000 veterans transitioned from office-administered injectable therapy — while expanding treatment choiceRALEIGH, N.C., July 28, 2026 (GLOBE NEWSWIRE) -- As federal leaders place greater emphasis on identifying and addressing testosterone deficiency across America’s military community, Marius Pharmaceuticals today announced findings from a new pharmacoeconomic analysis identifying a potential path to expand treatment choice for veterans while reducing costs to the U.S. Department of Veterans Affairs (VA). The analysis found that KYZATREX® (testosterone undecanoate) capsules, CIII, could reduce modeled total monthly treatment costs by up to approximately 46% compared with office-administered injectable testosterone. Applied to a modeled population of 50,000 veterans receiving office-administered testosterone replacement therapy (TRT), the analysis projects potential net annual savings to the VA of approximately $16.2 million. “Federal leaders are bringing long-overdue attention to testosterone health and its potential impact on the well-being of those who serve and have served our country,” said Shalin Shah, CEO of Marius Pharmaceuticals. “As that conversation advances, we must ensure that clinically appropriate treatment is not only accessible, but economically sustainable. This analysis suggests KYZATREX could give eligible veterans a convenient oral treatment option while helping the VA use its resources more efficiently — demonstrating that meaningful pharmaceutical innovation does not have to come at a premium.” The Sticker Price Is Not the Real Price Generic injectable testosterone is often perceived as the least expensive TRT option based on drug-acquisition cost alone. The Marius analysis evaluated the fuller cost of office-administered injectable therapy — drug acquisition, injection-administration visits, prescription dispensing and the management of injection-site adverse events — and found that the medication itself is the smallest part of the bill. Under the base-case model, drug acquisition accounted for just $11.22 of injectable therapy’s modeled monthly cost per patient. Injection-administration visits and prescription dispensing added $61.38 per month, and injection-site adverse events added a modeled $24.38 per applicable patient per month. In other words, nearly 90% of the modeled monthly cost of office-administered injectable testosterone stems from how the drug is delivered and managed — not the drug itself. Because KYZATREX is taken orally, it eliminates injection-administration visits entirely and carries no modeled injection-site adverse-event costs — producing the modeled reduction of approximately 46% in total monthly cost of care per patient. When applied to a modeled population of 50,000 veterans receiving office-administered injectable TRT — with injection-site adverse-event costs applied to an estimated 30% of those patients — the analysis projects potential net annual savings of approximately $16.2 million. Because the real-world population of veterans receiving TRT is substantially larger than the modeled population, the broader savings opportunity could be significantly greater, depending on the number of clinically appropriate patients transitioned from office-administered injectable therapy to KYZATREX. The findings suggest that evaluating only the acquisition price of testosterone medication overlooks the substantial costs of administering and managing treatment — and demonstrate the value of a total-cost-of-care lens when evaluating treatment options for veterans. Challenging the Cost Premium of Oral Testosterone The analysis also compared VA drug-acquisition costs for the three FDA-approved oral testosterone undecanoate products, using Federal Supply Schedule pricing and each product’s labeled starting dose. On that basis, KYZATREX’s modeled annual drug-acquisition cost was approximately 95% lower than JATENZO® and approximately 92% lower than TLANDO®: JATENZO’s modeled annual acquisition cost was approximately 20 times that of KYZATREX.TLANDO’s modeled annual acquisition cost was approximately 13 times that of KYZATREX. Testosterone undecanoate products are not substitutable and may differ in dosing, safety, efficacy and other clinical considerations. Treatment and formulary decisions should be based on FDA-approved prescribing information, individual patient needs and independent clinical judgment. “As awareness and screening increase, the next critical question is how to ensure that veterans who are appropriately diagnosed can access treatment without creating an unnecessary financial burden on the federal healthcare system or American taxpayers,” Shah added. “Marius is committed to working toward a future in which affordability, innovation and patient choice are not competing priorities.” Supporting Sustainable Access for Veterans KYZATREX is an FDA-approved oral testosterone replacement therapy that is used to treat adult men who have low or no testosterone levels due to certain medical conditions. As an oral treatment, KYZATREX eliminates the need for injections and the administration visits associated with office-based injectable therapy. The analysis is intended to support continued discussion among policymakers, clinicians, formulary decision-makers and veterans’ health advocates about how to expand access to clinically appropriate testosterone care in an economically responsible manner. Complete modeling inputs and methodology are available to qualified formulary decision-makers and policymakers upon request. Diagnosis of hypogonadism should be confirmed by measuring morning serum testosterone concentrations on at least two separate days. Treatment decisions should be made by qualified healthcare professionals based on each patient’s diagnosis, medical history, clinical needs and the approved prescribing information for the selected therapy. About the Pharmacoeconomic Analysis The analysis compared the modeled costs of KYZATREX with testosterone cypionate administered intramuscularly every two weeks in an office setting. Cost inputs included VA Federal Supply Schedule drug pricing, a resource-based cost proxy for injection administration, VA prescription-dispensing costs and modeled costs associated with injection-site adverse events. The potential $16.2 million annual savings estimate assumes 50,000 veterans receiving office-administered injectable TRT. Actual savings would vary based on the number of eligible veterans, the proportion of patients who self-inject at home, local costs, dosing and the incidence of injection-site adverse events. The analysis excludes laboratory and clinical monitoring common to all testosterone formulations and models treatment at steady state. Acquisition costs evaluated in the analysis do not necessarily reflect the actual prices paid by consumers, pharmacies or third-party payers. The report recommends using local data from individual VA medical centers or Veterans Integrated Service Networks to assess potential annual savings accurately. VA pharmaceutical prices used in the analysis were obtained from the VA National Acquisition Center Pharmaceutical Catalog, accessed in June 2026. Dosing calculations were based on the FDA-approved prescribing information for each product. About Marius Pharmaceuticals Marius Pharmaceuticals strives to better the lives of patients by focusing on therapies designed for hypogonadism or Testosterone Deficiency. The company's vision is to holistically improve metabolic health and mitigate significant unnecessary costs to the global healthcare system. For more information, please visit www.mariuspharma.com. About KYZATREX® (testosterone undecanoate)KYZATREX is a proprietary softgel oral formulation absorbed primarily via the lymphatic system (meaning it is not toxic to the liver) and indicated in adult males for conditions associated with a deficiency or absence of endogenous testosterone. The safety and efficacy of KYZATREX was demonstrated in a phase 3, multi-center, open-label, six-month study in 155 hypogonadal males between 18 and 65 years of age with documented hypogonadism, as defined by a below normal serum testosterone level (≤281 ng/dL) and at least one sign or symptom of testosterone deficiency. In the efficacy population (n=139), 88 percent of hypogonadal men treated with KYZATREX achieved a mean plasma total testosterone concentration (Cavg) over 24 hours within the normal range (222-800 ng/dL) on the final pharmacokinetic (PK) visit of the study at Day 90 (primary endpoint). Based on exploratory endpoints, patients who received KYZATREX reported improvements in symptoms of low testosterone, including quality of life, energy/fatigue, erectile function, sexual intercourse, and mood. The most common side effect reported in ≥2 percent of KYZATREX patients was increased blood pressure (2.6%). The safety and efficacy of KYZATREX in males less than 18 years old have not been established. Please see additional Important Safety Information for KYZATREX below or visit www.kyzatrex.com. What is KYZATREX®KYZATREX® (testosterone undecanoate) is a prescription drug that is used to treat adult men who have low or no testosterone levels due to certain medical conditions. KYZATREX® is a controlled substance (CIII) because it contains testosterone. It is not known if KYZATREX® is safe or effective in males younger than 18 years old. Improper use may affect bone growth in children. It is not known if KYZATREX® is safe or effective in men with “age-related hypogonadism” (also referred to as “late-onset hypogonadism”). KYZATREX® is not meant for use by women. Important Safety Information for KYZATREX® Do not take KYZATREX® if you: have breast cancer; have or might have prostate cancer; are a woman who is pregnant (KYZATREX may harm your unborn baby); or are allergic to KYZATREX® or any of its ingredients. Before you take KYZATREX®, tell your healthcare provider about all of your medical conditions, including if you: have high blood pressure or are treated for high blood pressure; have a history of diabetes; have heart problems; have high red blood cell count (hematocrit) or high hemoglobin laboratory value; have urinary problems due to an enlarged prostate; have liver or kidney problems; or have problems breathing while you sleep (sleep apnea). Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking KYZATREX® with certain other medicines can affect each other. Especially, tell your healthcare provider if you take: insulin; medicines that decrease blood clotting (blood thinners); corticosteroids; or medicines that increase blood pressure, such as some cold medicine and pain medicines. KYZATREX® may cause other serious side effects including: Increase in red blood cell count (hematocrit) or hemoglobin, which can increase the risk of blood clots, strokes, and heart attacks. You may need to stop KYZATREX® if your red blood cell count increases.If you already have an enlarged prostate, your signs and symptoms may worsen while taking KYZATREX®. These may include: increased urination at night; trouble starting your urine stream; urinating many times during the day; urge to go to the bathroom right away; a urine accident; inability to pass urine or weak urine flow.Increased risk of prostate cancer.Blood clots in the legs or lungs. Signs and symptoms of a blood clot in your leg can include pain, swelling or redness. Signs and symptoms of a blood clot in your lungs can include difficulty breathing or chest pain.Abuse. Testosterone can be abused when taken at higher than prescribed doses and when used with other anabolic androgenic steroids. Abuse can cause serious heart and psychological side effects.In large doses, KYZATREX® may lower your sperm count.Liver problems. Symptoms of liver problems may include: nausea or vomiting; yellowing of your skin or whites of your eyes; dark urine; pain on the right side of your stomach area (abdominal pain).Swelling of your ankles, feet, or body (edema), with or without heart failure.Enlarged or painful breasts.Breathing problems while you sleep (sleep apnea). Call your healthcare provider right away if you have any of the serious side effects listed above. The most common side effect of KYZATREX® is high blood pressure. Other side effects may include: headache, joint or back pain, diarrhea, increased red blood cell count, anxiety, constipation, swelling of the legs, and increased prostate specific antigen (PSA) levels. These are not all the possible side effects of KYZATREX®. For more information, ask your healthcare provider or pharmacist. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to Marius [by visiting www.mariuspharma.com]. Keep KYZATREX and all medicines out of the reach of children. See Full Prescribing Information and Medication Guide for KYZATREX®. Media Contact:Lilly Washburnlilly@mariuspharma.com