An Open-Label Pilot Study of the Pharmacokinetics and Safety of 50 Mg Oral Testosterone Undecanoate (Kyzatrex) in Menopausal Women with Low Testosterone and Hypoactive Sexual Desire Disorder

This is an unblinded study to be conducted at a single research center, San Diego Sexual Medicine. Eligible subjects will receive 50 mg capsules of Kyzatrax® to be taken orally daily over a 3-month period. Multiple blood samples will be taken at baseline and on days 7, 28 and 56 to assess safety and pharmacokinetics of the testosterone. After the informed consent is signed and for up to 14 days after the last dose of study drug, participants will have serial blood samples collected in addition to other routine study procedures (e.g. vital signs measured, adverse events assessed, validated outcome scales completed).

Start Date01 Jan 2025

Sponsor / Collaborator-

NCT06188767 / Not yet recruitingNot Applicable

Long-term Effects of Anabolic Androgenic Steroids on Muscle Growth Potential: Testosterone-induced Muscle Memory and Underlying Mechanisms

The purpose of this project is to investigate underlying mechanisms of testosterone- and resistance training-induced muscle hypertrophy and muscle memory in humans.

Start Date01 Sep 2024

Sponsor / Collaborator

University of Copenhagen

NCT05964920 / RecruitingPhase 2/3IIT

Does Human Skeletal Muscle Possess an Epigenetic Memory of Testosterone?

This project's primary aim of this double-blinded, randomised, placebo-controlled trial is to investigate whether short-term testosterone administration +/- resistance exercise training induces a muscle memory response that can lead to longer-lasting benefits in aged human skeletal muscle.
The investigators will provide older men with the anabolic hormone, testosterone or placebo, with or without resistance training, followed by a period of testosterone abstinence and detraining, followed by a subsequent repeated period of resistance training (retraining). This will help determine if earlier encounters with short-term testosterone administration can be "remembered" and if adaptation to later retraining can be enhanced as a consequence of encountering testosterone earlier.

Start Date01 Sep 2024

Sponsor / Collaborator

Norges Idrettshogskole

[+1]

100 Clinical Results associated with Testosterone Undecanoate

100 Translational Medicine associated with Testosterone Undecanoate

100 Patents (Medical) associated with Testosterone Undecanoate

686

Literatures (Medical) associated with Testosterone Undecanoate

31 Dec 2024·Aging Male

Testosterone and resistance training improved physical performance and reduced fatigue in frail older men: 1 year follow-up of a randomized clinical trial

Article

Author: Vinther, Anders ; Rashid, Anahita ; Ragle, Anne-Mette ; Østergren, Peter Busch ; Paulin, Tine Kolenda ; Rosendahl, Eva ; Pedersen, Maria ; Karlsson, Linda Katharina ; Pødenphanth, Thea Winther ; Zerahn, Bo ; Overgaard, Karsten ; Midttun, Mette ; Rasmussen, Rune Skovgaard

OBJECTIVE:

To improve health conditions among hypogonadal men ≥70 years of age using testosterone undecanoate (TU) injections, progressive strength training, and oral supplements of vitamin D, calcium, and protein.

METHODS:

This study is a 1-year follow-up of a double-blind RCT lasting 20 weeks, including 148 older men ≥70 years old with low testosterone levels and mobility problems. During 52 weeks, 4 groups received either testosterone therapy (TU) or progressive resistance training (Training), both (Combo), or no intervention (Controls). Physiotherapists supported the training groups until week 20, while these participants continued trained on their own during weeks 21 to 52. The main outcome measure was the 30-s chair stand test.

RESULTS:

The following numbers of participants completed the trial: 20 (Combo), 20 (Controls), 24 (TU), and 14 (Training). When examining 30-s chair stand test performance within each group at baseline, and at weeks 4, 20 and 52, only the Combo group improved (p = 0.001, Friedman Test). Compared to controls, only the Combo group experienced reduced fatigue and tiredness (p < 0.05).

CONCLUSIONS:

Fifty-two weeks of testosterone supplementation combined with progressive resistance training may enhance physical performance, alleviate fatigue, and had no notable detrimental impacts among males aged ≥70 suffering from mobility issues and testosterone insufficiency.Trial registration - Clinical Trials NCT02873559.

31 Dec 2024·Aging Male

Testosterone therapy over 60 months improves aging male symptoms scores in all men with adult-onset testosterone deficiency

Article

Author: Haider, Karim Sultan ; Saad, Farid ; Zitzmann, Michael ; Ramachandran, Pravinath ; Mann, Amar ; Ramachandran, Sudarshan ; König, Carola S. ; Desnerck, Pieter ; Hackett, Geoffrey ; Haider, Ahmad ; Strange, Richard

OBJECTIVE:

We evaluated change (Δ) in AMSS in men with adult-onset testosterone deficiency (TD) on/not on testosterone undecanoate (TU) by analysing a registry of men with adult-onset TD.

METHODS:

Analyses were performed using non-parametric statistics to determine ΔAMSS at 6-12 monthly intervals in men on/not on TU and movement in AMSS. Factors predicting ΔAMSS were established via linear/multiple regression.

RESULTS:

TU was significantly associated with lower AMSS values compared with that at baseline/prior assessment during the initial 42 months treatment; 259 of the 260 men showed improvement. In the 361 men not on TU, AMSS values increased during 60 months of follow-up compared with that at baseline/prior assessment; improvement after 60 months was evident in 1 man, whilst AMSS remained the same or worsened in 213 and 147 men, respectively. In men on TU, baseline AMSS was inversely associated with ΔAMSS (R² = 0.97), with no other factors reaching significance. Baseline AMSS, age, serum total testosterone (TT), waist circumference (WC), and diastolic blood pressure (BP) were associated with ΔAMSS in men not on TU.

DISCUSSION:

We show that TU was associated with lower AMSS in men with adult-onset TD whilst non-treatment led to increased values. Baseline AMSS values inversely predicted ΔAMSS in both groups.

01 Nov 2024·Andrology

TRACK_9: Testosterone replacement assessment: Classical vs. functional hypogonadism‐knowledge from a 9‐year study

Article

Author: Soave, Armin ; Cremers, Jann‐Frederik ; Zitzmann, Michael ; Kliesch, Sabine ; Krallmann, Claudia

Abstract:

Background and objective:

The longitudinal efficacy and clinical utility of Testosterone Therapy (TTh) in ameliorating functional hypogonadism (FH) remain contentious, with long‐term data being scarce. To address this lacuna, a comprehensive long‐term registry study, stratifying patients across a spectrum of hypogonadal etiologies, offers a robust investigative paradigm.

Materials and methods:

This 9‐year registry, encompassing 650 patients (equivalent to 4,362 cumulative years of treatment), included 188 patients diagnosed with FH (mean age 42.3 ± 11.3 years) and 462 individuals with classical hypogonadism (CH). The cohort segregated into 266 men with primary hypogonadism (PH, mean age 34.0 ± 11.7 years) and 196 with secondary hypogonadism (SH, mean age 31.9 ± 12.0 years). Uniform treatment across the cohort involved intramuscular administration of testosterone undecanoate (1,000 mg). A comparative analysis was conducted focusing on anthropometric, metabolic, and safety parameters.

Results:

Serum testosterone levels increased from 6.6 ± 2.4 to 19.3 ± 2.9 nmol/L (p < 0.001). TTh was linked with weight reduction and decreased waist circumference (WC) in both CH and FH cohorts (both p < 0.001). Cox regression and Kaplan–Meier analyses delineated disparities: men with FH demonstrated a higher propensity for losing > 10% body weight and > 5% WC compared to CH (hazard ratio [HR] 1.3 [1.1–1.4], p = 0.008 and HR 1.4 [1.3–1.5], p = 0.001). Increases in hematocrit > 50% were uniform across groups, albeit amelioration of anemia was more pronounced in FH versus CH (p = 0.002). Increments of prostate‐specific antigen (PSA) levels were more likely to occur in FH (HR 1.3 [1.1–1.6], p = 0.003). FH patients exhibited pronounced improvements in metabolic parameters and in aging male symptom score (AMS) and IIEF‐EF questionnaire scores. These effects were markedly modulated by age and initial weight. Subgroup analysis of age‐matched obese patients revealed an accentuated impact of TTh in CH compared to FH.

Discussion and conclusion:

The therapeutic outcomes of TTh across distinct hypogonadal populations demonstrate heterogeneous responses, significantly influenced by diagnostic categorization, age, and baseline risk factor profiles.

128

News (Medical) associated with Testosterone Undecanoate

18 Nov 2024

·www.prnewswire.com

Lipocine Announces Publication and Discussion of LPCN 1148 Manuscript at The Liver Meeting 2024 Editor's Cut Session

SALT LAKE CITY, Nov. 18, 2024 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to augment therapeutics through effective oral delivery, today announced the publication and discussion of a manuscript "Oral LPCN 1148 Improves Sarcopenia and Hepatic Encephalopathy in Male Patients with Cirrhosis: a randomized, placebo-controlled Phase 2 trial" in the journal Hepatology and discussion at The Liver Meeting (AASLD) 2024 Editor's Cut: Clinical Study Session held on November 16, 2024. LPCN 1148 is targeted to be a "First in Class" product candidate with a novel mechanism of action for overt hepatic encephalopathy and sarcopenia indications. A copy of the publication can be accessed here. The publication features the results from a Phase 2 proof-of-concept clinical trial (LPCN 1148-21-001) that evaluated LPCN 1148 in men with cirrhosis and sarcopenia awaiting liver transplantation. The trial was conducted in two stages. Stage 1 was double blind, placebo-controlled with participants randomized 1:1, to receive either oral LPCN 1148 or placebo. This was followed by Stage 2, a 28-week single-arm open label extension. The publication reports the analyses from the Stage 1 readout. The results at 24 weeks showed that LPCN 1148 therapy resulted in a significant improvement in sarcopenia when compared with placebo. Furthermore, despite most participants already on background therapies for HE, participants receiving LPCN 1148 also experienced significantly fewer episodes of overt hepatic encephalopathy (OHE) compared to those on placebo. Additional beneficial effects of LPCN 1148, including improved muscle quality, hemoglobin, and patient reported symptom improvement are also covered in the manuscript. The publication was discussed at The Liver Meeting during 'The Editors Cut: Clinical Studies' session. This session critically discusses the most notable, influential, cutting edge, game changing clinical research papers published during the past year. "We are pleased to publish the results from this important proof-of-concept study of LPCN 1148 in Hepatology, a leading peer-reviewed journal," said Benjamin Bruno, Ph.D., Pharm.D., Vice President of Clinical Development at Lipocine and lead author on the publication. "To our knowledge, LPCN 1148 therapy is the first pharmacologic agent to demonstrate improvements in both sarcopenia and overt HE outcomes in patients with cirrhosis. Our findings support further research on the efficacy of LPCN 1148 in managing cirrhosis complications, a critical unmet medical need." For more information on the study, refer to ClinicalTrials.gov NCT04874350. About Cirrhosis Cirrhosis is an end stage liver disease of varying etiologies such as alcoholic liver disease, chronic viral hepatitis, nonalcoholic fatty liver disease and primary cholangitis. Complications of cirrhosis include decompensation events such as hepatic encephalopathy due to systemic ammonia buildup, variceal bleeding, and ascites, which require frequent hospitalizations. In addition, many patients exhibit sarcopenia (low muscle mass). Over 382,000 patients have been diagnosed with decompensated liver cirrhosis in the US, with few options for managing their disease other than liver transplant. Poor quality of life is common while waiting for a liver transplant. Although there is a limited supply of donor livers, transplant is the only cure for end-stage cirrhosis. About OHE OHE is a frequent complication and one of the most debilitating manifestations of liver disease, severely affecting the lives of patients and their caregivers. For patients with decompensated liver cirrhosis and sarcopenia, clinical outcomes tend to be worse - both sarcopenia and myosteatosis are associated with an increased risk of OHE. OHE is an episodic neurological disorder with a high recurrence rate. Up to 50% of patients with cirrhosis will experience an OHE episode in their lifetime. Patients can exhibit global neurological, psychiatric, and musculoskeletal deficits. HE has a complex pathophysiology that includes impairment of ammonia clearance and increased inflammatory cytokine and HE recurrence is common, despite use of standard-of-care therapies. Options for prevention/treatment are limited, resulting in significant enduring unmet medical need as the 1-year survival for patients with OHE is ~50%. Furthermore, cognitive impairment associated with cirrhosis results in utilization of more health care resources. About LPCN 1148 LPCN 1148 comprises testosterone dodecanoate, a unique androgen receptor agonist. It is targeted as a differentiated intervention option with a novel multimodal MOA to elicit potential benefits in management of cirrhosis and associated comorbidities of cirrhosis. About Lipocine Lipocine is a biopharmaceutical company leveraging its proprietary technology platform to augment therapeutics through effective oral delivery to develop differentiated products. 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 non-cirrhotic NASH. 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 development and commercialization of TLANDO and TLANDO XR (LPCN 1111) by our licensees, the amount of the license fee, milestone payments, and royalty payments we will ultimately receive, the ability of our licensees to grow the TLANDO franchise, our product development efforts, the application of our proprietary platform in developing new treatments for CNS disorders, our product candidates and related clinical trials, our development of our product candidates and related efforts with the FDA, including with respect to LPCN 1148 and LPCN 2401, the timing of our submission of a NDA with the FDA 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 to treat CNS disorders, we may not have sufficient capital to complete the development processes for our product candidates, we may not be able to enter into partnerships or other strategic relationships to monetize our non-core assets, the FDA will 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 2Clinical ResultDrug Approval

14 Nov 2024

·www.globenewswire.com

New Data from Marius Pharmaceuticals Reveals High Prevalence of Low Libido, Energy and Quality of Life in Men

RALEIGH, N.C., Nov. 14, 2024 (GLOBE NEWSWIRE) -- Marius Pharmaceuticals, a pharmaceutical company focused on developing innovative therapies for testosterone deficiency, has released compelling new insights from a recent Androgen Deficiency in Aging Males (qADAM) questionnaire conducted on their KYZATREX® (testosterone undecanoate) CIII capsules website. The data collected from 779 participants highlights significant challenges faced by men regarding energy, libido, strength and overall life satisfaction, underscoring the potential impact of testosterone deficiency on quality of life and well-being. Below are the results from men who responded to the qADAM questionnaire, a validated tool for assessing testosterone deficiency symptoms: 75% rated their libido as poor or terrible76% rated their energy level as poor or terrible66% rated their strength and/or endurance as poor or terrible62% rated their enjoyment of life as poor or terrible46% rated their happiness level as poor or terrible72% rated the strength of their erections as somewhat or extremely weak53% rated their work performance over the past 4 weeks as poor or terrible59% fall asleep at least 3-4x/week after eating dinner72% rated their sports ability over the past 4 weeks as poor or terrible Together, this data reflects a broader pattern of symptoms often associated with low testosterone, highlighting the need for accessible solutions to support men experiencing these challenges. View the infographic for a detailed results breakdown. "This data reinforces the necessity for greater awareness and resources to address men's health concerns, particularly testosterone deficiency, which can profoundly affect physical and emotional well-being," said Amit Shah, Chief Operating Officer of Marius Pharmaceuticals. "At Marius, we are committed to providing safe, effective options for managing low testosterone with products like KYZATREX." KYZATREX is an FDA-approved oral form of testosterone replacement therapy (TRT) indicated for adult males experiencing low or no testosterone due to certain medical conditions. A six-month clinical trial demonstrated that KYZATREX was up to 96% effective at Day 90 at restoring normal testosterone levels in adult men who have low or no testosterone levels due to certain medical conditions.1,2* *Per label, 88% of patients had low testosterone levels at Day 90 (worst-case scenario calculation, excluding Site 104). Based on patients who completed the study (n=127), 96% of patients achieved normal testosterone levels at Day 90.1 Testosterone deficiency, also known as hypogonadism, affects millions of men worldwide and is associated with various chronic conditions, including obesity, diabetes and depression.3,4 As the global demand for men’s health solutions grows, Marius Pharmaceuticals continues to prioritize patient-centered therapies, empowering men to take control of their health and well-being. For more information on KYZATREX, visit www.kyzatrex.com. About Marius PharmaceuticalsMarius 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. Important Safety Information for KYZATREX® KYZATREX can increase blood pressure, which can increase the risk of having a heart attack or stroke and can increase risk of death due to a heart attack or stroke. Your risk may be greater if you have already had a heart attack or stroke or if you have other risk factors for heart attack or stroke. If your blood pressure increases while on KYZATREX, blood pressure medicines may need to be started. If you are currently taking blood pressure medicines, they may need to be changed or new blood pressure medicines may need to be added to control your blood pressure.If your blood pressure cannot be controlled, KYZATREX may need to be stopped.Your healthcare provider will monitor your blood pressure while you are being treated with 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); are allergic to KYZATREX or any of its ingredients; or have low testosterone without certain medical conditions (e.g., do not take KYZATREX if you have low testosterone due to age). 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. References: KYZATREX [prescribing information]. Raleigh, NC: Marius Pharmaceuticals; 2022.Data on file. Raleigh, NC: Marius Pharmaceuticals, 2020.“Hypogonadism in Men.” Endocrine Society, 31 Mar. 2022, www.endocrine.org/patient-engagement/endocrine-library/hypogonadism.Shores MM, Sloan KL, Matsumoto AM, et al. Increased incidence of diagnosed depressive illness in hypogonadal older men. Arch Gen Psychiatry. 2004;61(2):162–167. Media Contact Marius PharmaceuticalsLilly Washburnlilly@mariuspharma.com

Clinical Result

07 Nov 2024

·www.prnewswire.com

Lipocine Announces Financial Results for the Third Quarter Ended September 30, 2024

SALT LAKE CITY, Nov. 7, 2024 /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 and nine months ended September 30, 2024 and provided a corporate update. Neuroactive Steroids LPCN 1154, oral brexanolone, is being developed as a treatment for postpartum depression (PPD). It is targeted to be a highly effective, oral, fast-acting and short duration treatment option. The Company has completed labeling studies such as a food effect study and PK profiling in women with PPD, and is targeting NDA submission for LPCN 1154 by the end of 2024. In October, Lipocine announced positive results from a quantitative electroencephalogram (qEEG) study conducted in healthy subjects administered single doses of LPCN 1154. The results indicated robust central nervous system (CNS) activity of LPCN 1154, with concentration- and time-dependent post-dose changes in qEEG. The study confirmed GABAA positive allosteric modulation and supports future development of LPCN 1154 in neuropsychiatric indications. LPCN 2401 for obesity management LPCN 2401 is an oral formulation comprised of a proprietary anabolic androgen receptor agonist targeted for once daily regimen. In October, Lipocine hosted a virtual key opinion leader (KOL) event on LPCN 2401. The event highlighted positive data from the Phase 2 study of LPCN 2401 and the data support the potential for the product to be used as an adjunct with incretin mimetics (GLP-1/GIP agonists) or as a monotherapy, including post incretin mimetic discontinuation. Frank Greenway, MD (Professor and Chief Medical Officer at Pennington Biomedical Research Center) discussed the unmet needs and current treatment landscape in obesity management with a focus on fat loss and lean muscle mass preservation for patients on incretin therapies. A poster "Oral LPCN 2401 Reduces Fat Mass and Increases Lean Mass in Men With Obesity" featuring the Phase 2 data was presented by Dr. Greenway at the Obesity Society's Annual ObesityWeek® conference on November 5, 2024 in San Antonio, TX. Lipocine plans to meet with the FDA to discuss the study design for a proof-of-concept Phase 2 study for LPCN 2401 and expansion to the female population. LPCN 1148 Management of Cirrhosis Lipocine is evaluating LPCN 1148 for the management of decompensated cirrhosis and has conducted a successful Phase 2 study that met its primary endpoint. The Company plans to request a Type C meeting with the FDA to discuss the clinical development plan for LPCN 1148. TLANDO® In October, Lipocine signed an exclusive supply and distribution agreement with Pharmalink to commercialize TLANDO, its oral testosterone replacement therapy, in the Gulf Cooperation Council (GCC) countries consisting of Saudi Arabia, Kuwait, the United Arab Emirates (UAE), Qatar, Bahrain, and Oman. In September, Lipocine signed an exclusive distribution and license agreement with SPC Korea to commercialize TLANDO in South Korea. The company continues to pursue opportunities for partnering and/or development arrangements for the continued development and/or marketing of our remaining pipeline candidates. Third Quarter Ended September 30, 2024 Financial Results Lipocine reported a net loss of $2.2 million, or ($0.44) per diluted share, for the third quarter ended September 30, 2024, compared with a net loss of $6.7 million, or ($1.27) per diluted share, for the quarter ended September 30, 2023. There were no revenues recorded during the third quarter ended September 30, 2024. In the third quarter of 2023, the company recorded a non-cash revenue reversal of variable consideration for minimum guaranteed royalties of $3.1 million related to the termination of the Antares License Agreement. Research and development expenses were $1.6 million and $2.9 million, respectively, for the quarters ended September 30, 2024 and 2023. The decrease was a result of a decrease in TLANDO related costs, a decrease in contract research organization expense and outside consulting costs related to the wind down of the LPCN 1148 study in 2024, and a decrease in costs related to LPCN 1154 clinical studies, offset by increases in personnel related costs and other research and development related costs and supplies. General and administrative expenses were $1.0 million in each of the quarters ended September 30, 2024 and 2023. As of September 30, 2024, Lipocine had $19.8 million of unrestricted cash, cash equivalents and marketable investment securities compared to $22.0 million at December 31, 2023. Nine Months Ended, September 30 2024, Financial Results Lipocine reported a net loss of $1.8 million, or ($0.33) per diluted share, for the nine months ended September 30, 2024, compared with a net loss of $14.1 million, or ($2.72) per diluted share, for the nine months ended September 30, 2023. Revenues for the nine-month period ended September 30, 2024 were $7.7 million, primarily consisting of licensing revenue received from our Verity License Agreement, in addition to TLANDO royalty revenue of $206,000. During the nine months ended September 30, 2023, the company recognized a non-cash revenue reversal of variable consideration for minimum guaranteed royalties of $3.1 million relating to the termination of the Antares License Agreement offset by licensing revenue of approximately $55,000 for payments received related to the Spriaso license agreement. Research and development expenses were $6.3 million and $8.5 million, respectively, for the nine months ended September 30, 2024 and 2023. The decrease was a result of a decrease in contract research organization expense and outside consulting costs related to the wind down of the LPCN 1148 study in 2024, a decrease in TLANDO related costs, a decrease in personnel related costs, and a decrease in other research and development related costs. These decreases were offset an increase in costs related to the LPCN 1154 clinical studies. General administrative expenses were $4.1 million and $3.8 million respectively, for the nine months ended September 30, 2024 and 2023. The increase in general and administrative expenses was a result of increases in business development expenses, corporate legal fees and director fees, offset by decreases in corporate insurance expense, professional fees, other administrative consulting fees, personnel related costs, and travel related costs. For more information on Lipocine's financial results, refer to Form 10-Q filed by the Company with the SEC. About Lipocine Lipocine is a biopharmaceutical company leveraging its proprietary technology platform to augment therapeutics through effective oral delivery to develop differentiated products. 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 non-cirrhotic NASH. 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 development and commercialization of TLANDO and TLANDO XR by our licensees, the amount of the license fee, milestone payments, and royalty payments we will ultimately receive, the ability of our licensees to grow the TLANDO franchise, our product development efforts, the application of our proprietary platform in developing new treatments for CNS disorders, our product candidates and related clinical trials, our development of our product candidates and related efforts with the FDA, including with respect to LPCN 1148 and LPCN 2401, the timing of our submission of a NDA with the FDA 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 to treat CNS disorders, we may not have sufficient capital to complete the development processes for our product candidates, we may not be able to enter into partnerships or other strategic relationships to monetize our non-core assets, the FDA will 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

Clinical ResultLicense out/inPhase 2Drug ApprovalFinancial Statement

100 Deals associated with Testosterone Undecanoate

External Link

KEGG	Wiki	ATC	Drug Bank
D06087	Testosterone Undecanoate	G03BA03	DB13946

R&D Status

Approved

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Indication	Country/Location	Organization	Date
Low testosterone levels	US	Endo Operations Ltd.	05 Mar 2014
Hypogonadism	AU	Bayer Australia Ltd.	26 Oct 2005

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Testosterone deficiency	NDA/BLA	CA	Marius Pharmaceuticals LLCStartup	30 Jul 2024
Eunuchism	Phase 3	US	Clarus Therapeutics, Inc.	01 Jul 2011
Eunuchism	Phase 3	DE	Clarus Therapeutics, Inc.	01 Jul 2011
Klinefelter Syndrome	Phase 3	US	Endo Pharmaceuticals, Inc.	01 Mar 2006
Multiple Endocrine Neoplasia	Phase 3	US	Endo Pharmaceuticals, Inc.	01 Mar 2006
secondary testicular failure	Phase 3	US	Endo Pharmaceuticals, Inc.	01 Mar 2006
Chronic Kidney Diseases	Phase 2	US	Clarus Therapeutics, Inc.	15 Mar 2022

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


Phase 3 (AUA2024)	Phase 3	Multiple Endocrine Neoplasia	325	Oral Testosterone Undecanoate (316 mg BID)	qteqluelgt(eofczwvhct) = sufrazfyjr qjmmrcfxpc (sjowxsfmkq )	Positive	01 May 2024
NCT03198728 \| NCT04467697 (Pubmed)	Phase 3	Multiple Endocrine Neoplasia \| Eunuchism	155	KYZATREX	(deoahbtaad) = hypertension lzyifnlolr (bmkpucshav ) View more	-	10 Apr 2024
NCT04983940 (CTgov)	Phase 4	Testosterone deficiency	41	Jatenzo	xogzsphzvk(qyfjhzgzau) = tivgiwdlpn ouxdpchzka (rhzoquibia, rqhzqagpnr - kymccrjhty) View more	-	14 Dec 2023
NCT03198728 (###DELETE, CTgov)	Phase 3	Eunuchism	314	AndroGel (Andro-gel™ Treated)	bikhhtlnub(lfmmrngjzw) = vavmrhoypb vamlcblehu (gjgqirbfdg, inmbswktwq - zgwddjaimm) View more	-	28 Jun 2023
NCT03198728 (###DELETE, CTgov)	Phase 3	Eunuchism	314	SOV2012-F1 (SOV2012-F1-Treated)	ynabofywpd(olpvicoitt) = bremtabutb crsiwajvti (iegrnzlkyj, molswwuemc - gdudxsfhuj) View more	-	28 Jun 2023
NCT04120363 (OPS II, CTgov)	Phase 4	Sleep	34	Testosterone Undecanoate (Testosterone)	rbwveumgdw(abmlwqaffh) = uduckdvgvf fogpdkiwyk (rdhwjixalx, hptebzkrhy - axatuuabhd) View more	-	07 Oct 2022
NCT04120363 (OPS II, CTgov)	Phase 4	Sleep	34	sesame oil (Placebo)	rbwveumgdw(abmlwqaffh) = kddrvglmsk fogpdkiwyk (rdhwjixalx, oazephibcq - jtihqhfgtv) View more	-	07 Oct 2022
AUA2022	Phase 4	-	-	Jatenzo®	auhtlkkrcv(xqcphkmkux) = kbjgeidkpc vyohrcuvya (vuwhvbkgys )	-	01 May 2022
NCT03242590 (Pubmed \| Andrology) Manual	Phase 3	-	95	testosterone	oxrtmklfez(hdxgpcvcpp) = tijhdfitjr ffsbgpltau (orvdvvcilz, 72 - 88)	Positive	07 Jan 2022
AUA2021	Not Applicable	Multiple Endocrine Neoplasia	86	Oral Testosterone Undecanoate (TU)	eihnvpfrlw(azspuywkxs) = gcxgnohbyr kjgqdfowtt (pnxgdnjark ) View more	-	01 Sep 2021
Pubmed \| J Clin Hypertens (Greenwich)	Not Applicable	Multiple Endocrine Neoplasia	155	Kyzatrex™	iibjggdbde(uilsrxdaqq) = mxhpjjwvks torwizbkjl (zdifkjiiqv, 0.3 - 3.1)	-	01 Jul 2021
NCT03868059 (Pubmed \| J Cardiovasc Pharmacol Ther)	Phase 3	Multiple Endocrine Neoplasia	138	TLANDO™ 225 mg twice daily	paactivnyb(meehhjybfg) = ahipiifhre duowljsjzw (tiyzijjvup ) View more	-	30 Jun 2021

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