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]

NCT06312761 / Not yet recruitingPhase 1/2IIT

Single-Dose Pharmacokinetics of Oral Testosterone Undecanoate With and Without Concomitant Inhibition of UGT2B17 With Oral Curcumin in Normal Men With Experimental Hypogonadism

This study will be performed in normal men whose endogenous testosterone production has been temporarily suppressed by the administration of a single dose of 120 mg of the oral GnRH antagonist Relugolix, which is approved for the treatment of prostate cancer, and can suppress endogenous testosterone biosynthesis for 48-72 hours after a single dose.

Start Date01 Jun 2024

Sponsor / Collaborator

University of Washington

[+1]

100 Clinical Results associated with Testosterone Undecanoate

100 Translational Medicine associated with Testosterone Undecanoate

100 Patents (Medical) associated with Testosterone Undecanoate

692

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: Saad, Farid ; Haider, Karim Sultan ; Zitzmann, Michael ; König, Carola S ; Ramachandran, Pravinath ; Mann, Amar ; Ramachandran, Sudarshan ; 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·JCEM case reports

5α Reductase Deficiency-a Rare Cause of Ambiguous Genitalia and Gender Dysphoria.

Article

Author: Jayadev, Veena ; Wall, Ellen

We present a case of pseudovaginal perineoscrotal hypospadias, secondary to 5α-reductase deficiency presenting as gender dysphoria. This particular enzyme deficiency accounts for only a small number of disorders of sexual development cases worldwide. A feature of this disorder is the presence of ambiguous genitalia at birth followed by the development of male secondary sexual characteristics during puberty when testicular production of testosterone can compensate for previous low circulating levels of 5-dihydrotestosterone (DHT). Our described patient, raised female, presented with gender dysphoria with no male secondary sexual features given a bilateral orchidectomy in infancy. Initial testing showed biochemical primary hypogonadism and whole-genomic sequencing demonstrated pathogenic compound heterozygous variants in the SRD5A2 gene. Treatment was commenced with injectable testosterone undecanoate leading to development of desired male secondary sexual characteristics.

123

News (Medical) associated with Testosterone Undecanoate

31 Oct 2024

·www.prnewswire.com

HALOZYME REPORTS THIRD QUARTER 2024 FINANCIAL AND OPERATING RESULTS

Total Revenue Increased 34% YOY to $290 million and Royalty Revenue Increased 36% YOY to $155 million Net Income Increased 67% YOY to $137 million and Adjusted EBITDA Increased 60% YOY to $184 million GAAP Diluted EPS Increased 72% YOY to $1.05 and Non-GAAP Diluted EPS Increased 69% YOY to $1.271 Raised 2024 Financial Guidance Ranges for Total Revenue of $970-$1,020 million, Representing YOY Growth of 17%-23%, Adjusted EBITDA of $595-$625 million, Representing YOY Growth of 40%-47%, and Non-GAAP Diluted EPS of $4.00-$4.20, Representing YOY Growth of 44%-52% SAN DIEGO, Oct. 31, 2024 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme" or the "Company") today reported its financial and operating results for the third quarter ended September 30, 2024, and provided an update on its recent corporate activities and outlook. "Our robust third quarter financial results highlight the strong execution and accelerating momentum we have across our business and exceeded expectations with total revenue growth of 34% and adjusted EBITDA growth of 60%. Based on the strong performance year-to-date, we have raised our 2024 guidance ranges and expect the advancement of our ENHANZE pipeline and new nominations from two global licensing agreements to support our future growth trajectory," said Dr. Helen Torley, president and chief executive officer of Halozyme. "In the quarter, the announcement of two highly anticipated partner approvals in the U.S. for Roche's TECENTRIQ HYBREZA and OCREVUS ZUNOVO reinforces ENHANZE's track record of 100% phase 3 study and subsequent regulatory success. The new nominations for ENHANZE from argenx, for a total of six targets, and ViiV Healthcare, for an additional undisclosed target, further demonstrate the value of our leading technology for rapid, large volume subcutaneous delivery." Recent Partner Highlights: In October 2024, argenx initiated two studies evaluating VYVGART® Hytrulo with ENHANZE®, a Phase 3 study for adult patients with ocular myasthenia gravis ("oMG") and a Phase 2 study for kidney transplant recipients with antibody mediated rejection ("AMR"). In October 2024, Janssen announced the European Commission approved DARZALEX® SC for the treatment of patients newly diagnosed with multiple myeloma ("NDMM") who are eligible for autologous stem cell transplant ("ASCT") in combination with bortezomib, lenalidomide, and dexamethasone ("D-VRd"). In September 2024, argenx expanded its global collaboration and license agreement nominating four additional targets that provides them exclusive access to our ENHANZE® drug delivery technology for a total of six targets. Under the terms of the expanded exclusive agreement, we received upfront payments of $7.5 million per target nomination for a total of $30.0 million. argenx is obligated to make future milestone payments of up to $85.0 million per new nominated target, subject to achievements of specified development, regulatory and sales-based milestones. We are also entitled to receive royalties on net sales of commercialized products with our ENHANZE® technology. In September 2024, ViiV expanded its global collaboration and license agreement providing ViiV the ability to exclusively access our ENHANZE® drug delivery technology for one additional undisclosed target. In September 2024, Roche announced the U.S. Food and Drug Administration ("FDA") approved OCREVUS ZUNOVO™ with ENHANZE® as a twice a year ten-minute subcutaneous ("SC") injection for the treatment of relapsing multiple sclerosis and primary progressive multiple sclerosis. In September 2024, Roche announced the FDA approved TECENTRIQ HYBREZA™ with ENHANZE® for all approved adult indications of intravenous ("IV") TECENTRIQ® and was made available to patients, resulting in a $12.0 million milestone payment. In September 2024, Janssen announced the submission of a supplemental Biologic License Application to the FDA for approval of a new indication of DARZALEX FASPRO® in combination with D-VRd for the treatment of adult patients with NDMM for whom ASCT is deferred or who are ineligible for ASCT. In August 2024, the FDA designated Janssen's Biologics License Application ("BLA") priority review status for amivantamab SC in combination with LAZCLUZE™ for currently approved or submitted indication of IV in certain patients with non-small cell lung cancer. In August 2024, Takeda submitted a New Drug Application in Japan seeking approval for TAK-771 with ENHANZE® for treatment of chronic inflammatory demyelinating polyneuropathy/Multifocal Motor Neuropathy. In July 2024, Janssen announced the FDA approved DARZALEX FASPRO® for an additional indication in NDMM patients who are eligible for ASCT in combination with D-VRd. In July 2024, argenx announced the National Medical Products Administration approved the BLA of efgartigimod SC for generalized myasthenia gravis in China. In July 2024, Acumen initiated a Phase 1 study of sabirnetug ("ACU193") co-formulated with ENHANZE® for the treatment of early Alzheimer's disease. Third Quarter 2024 Financial Highlights: Revenue was $290.1 million, compared to $216.0 million in the third quarter of 2023. The 34% year-over-year increase was primarily driven by royalty revenue growth and an increase in milestone revenue. Revenue for the quarter included $155.1 million in royalties, an increase of 36% compared to $114.4 million in the third quarter of 2023, primarily attributable to increases in revenue of DARZALEX® SC and Phesgo®, and the prior year launch of VYVGART® Hytrulo. Cost of sales was $49.4 million, compared to $54.8 million in the third quarter of 2023. The decrease was primarily due to lower device and bulk rHuPH20 sales. Amortization of intangibles expense was $17.8 million, compared to $20.3 million in the third quarter of 2023. The decrease was primarily due to an impairment charge of $2.5 million recognized in the prior year to fully impair the TLANDO® product rights intangible asset. Research and development expense was $18.5 million, compared to $17.3 million in the third quarter of 2023. The increase was primarily due to increased compensation expense. Selling, general and administrative expense was $41.2 million, compared to $35.3 million in the third quarter of 2023. The increase was primarily due to increased compensation expense and consulting and professional service fees. Operating income was $163.2 million, compared to $88.3 million in the third quarter of 2023. Net Income was $137.0 million, compared to $81.8 million in the third quarter of 2023. EBITDA was $183.6 million, compared to $124.6 million in the third quarter of 2023. Adjusted EBITDA was $183.6 million, compared to $114.9 million in the third quarter of 2023.1 GAAP diluted earnings per share was $1.05, compared to $0.61 in the third quarter of 2023. Non-GAAP diluted earnings per share was $1.27, compared to $0.75 in the third quarter of 2023.1 Cash, cash equivalents and marketable securities were $666.3 million on September 30, 2024, compared to $336.0 million on December 31, 2023. The increase was primarily a result of cash generated from operations. Financial Outlook for 2024 The Company is raising its financial guidance for 2024. For the full year 2024, the Company expects: Total revenue of $970 million to $1,020 million, representing growth of 17% to 23% over 2023 total revenue primarily driven by increases in royalty revenue, collaboration revenue and growth in product sales from XYOSTED®. Revenue from royalties of $550 million to $565 million, representing growth of 23% to 26% over 2023. Adjusted EBITDA of $595 million to $625 million, representing growth of 40% to 47% over 2023. Non-GAAP diluted earnings per share of $4.00 to $4.20, representing growth of 44% to 52% over 2023. The Company's earnings per share guidance does not consider the impact of potential future share repurchases. Table 1. 2024 Financial Guidance Webcast and Conference Call Halozyme will host its Quarterly Update Conference Call for the third quarter ended September 30, 2024 today, Thursday, October 31, 2024 at 1:30 p.m. PT/4:30 p.m. ET. The conference call may be accessed live with pre-registration via link: . The call will also be webcast live through the "Investors" section of Halozyme's corporate website and a recording will be made available following the close of the call. To access the webcast and additional documents related to the call, please visit Halozyme.com. About Halozyme Halozyme is a biopharmaceutical company advancing disruptive solutions to improve patient experiences and outcomes for emerging and established therapies. As the innovators of ENHANZE® drug delivery technology with the proprietary enzyme rHuPH20, Halozyme's commercially-validated solution is used to facilitate the subcutaneous delivery of injected drugs and fluids, with the goal of improving the patient experience with rapid subcutaneous delivery and reduced treatment burden. Having touched more than 800,000 patient lives in post-marketing use in eight commercialized products across more than 100 global markets, Halozyme has licensed its ENHANZE® technology to leading pharmaceutical and biotechnology companies including Roche, Takeda, Pfizer, Janssen, AbbVie, Eli Lilly, Bristol-Myers Squibb, argenx, ViiV Healthcare, Chugai Pharmaceutical and Acumen Pharmaceuticals. Halozyme also develops, manufactures and commercializes, for itself or with partners, drug-device combination products using its advanced auto-injector technologies that are designed to provide commercial or functional advantages such as improved convenience, reliability and tolerability, and enhanced patient comfort and adherence. The Company has two commercial proprietary products, Hylenex® and XYOSTED®, partnered commercial products and ongoing product development programs with Teva Pharmaceuticals and Idorsia Pharmaceuticals. Halozyme is headquartered in San Diego, CA and has offices in Ewing, NJ and Minnetonka, MN. Minnetonka is also the site of its operations facility. For more information visit and connect with us on LinkedIn and Twitter. Note Regarding Use of Non-GAAP Financial Measures In addition to disclosing financial measures prepared in accordance with U.S. generally accepted accounting principles ("GAAP"), this press release and the accompanying tables contain certain non-GAAP financial measures. The Company reports earnings before interest, taxes, depreciation, and amortization ("EBITDA"), adjusted EBITDA and Non-GAAP diluted earnings per share, and guidance with respect to those measures, in addition to, and not as a substitute for, or superior to, financial measures calculated in accordance with GAAP. The Company calculates non-GAAP diluted earnings per share excluding share-based compensation expense, amortization of debt discounts, intangible asset amortization, one-time changes in contingent liabilities, inventory adjustments, impairment charges, and certain adjustments to income tax expense. The Company calculates non-GAAP diluted shares excluding the dilutive impact of convertible notes which is used in calculating non-GAAP diluted earnings. The Company calculates EBITDA excluding interest, taxes, depreciation and amortization. The Company calculates adjusted EBITDA excluding one-time items such as changes in contingent liabilities and inventory adjustments. Reconciliations between GAAP and Non-GAAP financial measures are included at the end of this press release. The Company does not provide reconciliations of forward-looking adjusted measures to GAAP due to the inherent difficulty in forecasting and quantifying certain amounts that are necessary for such reconciliation, including adjustments that could be made for changes in share-based compensation expense and the effects of any discrete income tax items. The Company evaluates other items of income and expense on an individual basis for potential inclusion in the calculation of Non-GAAP financial measures and considers both the quantitative and qualitative aspects of the item, including (i) its size and nature, (ii) whether or not it relates to the Company's ongoing business operations and (iii) whether or not the Company expects it to occur as part of the Company's normal business on a regular basis. Non-GAAP financial measures do not have any standardized meaning and are therefore unlikely to be comparable to similarly titled measures presented by other companies. These non-GAAP financial measures are not meant to be considered in isolation and should be read in conjunction with the Company's consolidated financial statements prepared in accordance with GAAP, and are not prepared under any comprehensive set of accounting rules or principles. In addition, from time to time in the future there may be other items that the Company may exclude for purposes of its non-GAAP financial measures, and the Company may in the future cease to exclude items that it has historically excluded for purposes of its non-GAAP financial measures. The Company considers these non-GAAP financial measures to be important because they provide useful measures of the operating performance of the Company, exclusive of factors that do not directly affect what the Company considers to be its core operating performance, as well as unusual events. The non-GAAP measures also allow investors and analysts to make additional comparisons of the operating activities of the Company's core business over time and with respect to other companies, as well as assessing trends and future expectations. The Company uses non-GAAP financial information in assessing what it believes is a meaningful and comparable set of financial performance measures to evaluate operating trends, as well as in establishing portions of our performance-based incentive compensation programs. Safe Harbor Statement In addition to historical information, the statements set forth in this press release include forward-looking statements including, without limitation, statements concerning the Company's financial performance (including the Company's financial outlook for 2024) and expectations for future growth, profitability, total revenue, royalty revenue, EBITDA, Adjusted EBITDA, and non-GAAP diluted earnings-per-share. Forward-looking statements regarding the Company's ENHANZE® drug delivery technology may include the possible benefits and attributes of ENHANZE®, its potential application to aid in the dispersion and absorption of other injected therapeutic drugs and facilitating more rapid delivery and administration of higher volumes of injectable medications through subcutaneous delivery. Forward-looking statements regarding the Company's business may include potential growth and receipt of royalty and milestone payments driven by our partners' development and commercialization efforts, potential new clinical trial study starts and clinical data, regulatory submissions and product launches, the size and growth prospects of our partners' drug franchises, potential new or expanded collaborations and collaborative targets and regulatory review, and potential approvals of new partnered or proprietary products, and the potential timing of these events. These forward-looking statements are typically, but not always, identified through use of the words "expect," "believe," "enable," "may," "will," "could," "intends," "estimate," "anticipate," "plan," "predict," "probable," "potential," "possible," "should," "continue," and other words of similar meaning and involve risk and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. Actual results could differ materially from the expectations contained in these forward-looking statements as a result of several factors, including unexpected levels of revenues, expenditures and costs, unexpected results or delays in the growth of the Company's business, or in the development, regulatory review or commercialization of the Company's partnered or proprietary products, regulatory approval requirements, unexpected adverse events or patient outcomes and competitive conditions. These and other factors that may result in differences are discussed in greater detail in the Company's most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission. Except as required by law, the Company undertakes no duty to update forward-looking statements to reflect events after the date of this release. Contacts: Tram Bui VP, Investor Relations and Corporate Communications 609-359-3016 [email protected] Samantha Gaspar Teneo 212-886-9356 [email protected] Footnotes: 1. Reconciliations between GAAP reported and non-GAAP financial information for actual results are provided at the end. SOURCE Halozyme Therapeutics, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

License out/inDrug ApprovalPhase 1Phase 3Financial Statement

31 Oct 2024

·www.prnewswire.com

Lipocine Announces Distribution and License Agreement with SPC Korea to Commercialize TLANDO® in South Korea

SALT LAKE CITY, Oct. 31, 2024 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to augment therapeutics through effective oral delivery, today announced a license, development and supply agreement with to SPC Korea granting exclusive rights to market TLANDO® in South Korea. Under the terms of the distribution and license agreement, Lipocine will receive an upfront payment and is also eligible to receive certain regulatory and sales milestone payments, including a payment upon regulatory approval of TLANDO in South Korea. Lipocine is entitled to royalties on net commercial sales. Lipocine will supply TLANDO to SPC Korea and will receive a supply price. SPC Korea will assume responsibility for obtaining regulatory approval within the territory. "We are very pleased to partner TLANDO with SPC Korea," said Dr. Mahesh Patel, President and Chief Executive Officer of Lipocine. "This license agreement represents a strategic opportunity to expand the global reach of TLANDO and to address the significant unmet medical need in South Korea. It underscores Lipocine's commitment to strategic partnerships that have the potential to drive growth and create value for our shareholders while advancing our goals to deliver innovative therapies to patients." 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 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 combination of anabolic androgen receptor agonist and α-tocopherol, an antioxidant, as an adjunct therapy to incretin mimetics, as an aid for improved body composition in chronic weight 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 chronic weight 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 our product development efforts, our strategic plans for developing products, our ability to monetize product candidates, including through entering into partnering arrangements, our product candidates and related clinical trials, the achievement of milestones within and completion of clinical trials, the timing and completion of regulatory reviews, outcomes of clinical trials of our product candidates, 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, 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

License out/inDrug Approval

25 Oct 2024

·www.mobihealthnews.com

Telehealth firm UpScriptHealth partners with pharma company Tolmar

Pharmaceutical company Tolmar has partnered with direct-to-consumer telehealth company UpScriptHealth to provide telehealth consultations for Jatenzo, an oral testosterone-replacement therapy (TRT) for adult men. Tolmar, which acquired Jatenzo in 2022, is positioning the TRT treatment as suited for patients who lack testosterone or have low testosterone levels due to hypogonadism or other medical conditions. The treatment protocol for patients seeking testosterone, including Jatenzo, includes a series of lab tests to determine whether testosterone is the correct treatment for the patient. Peter Ax, founder and CEO of UpScriptHealth, told MobiHealthNews that the streamlined digital experience lets patients connect with licensed providers to receive treatment and ongoing care management from home. "By making the entire process more accessible and convenient, we expect better adherence rates for patients receiving testosterone replacement therapy," he explained. He said the collaboration with Tolmar was representative of a broader shift in how treatments for complex conditions can reach more patients. "Patients increasingly expect healthcare to fit their lifestyle, not the other way around," Ax said. "There's growing recognition that telehealth can provide more consistent monitoring and support than traditional models." THE LARGER TREND UpScriptHealth has launched more than 50 partnerships with pharma and has been expanding into rare diseases and complex care models, including on-site diagnostic testing for esophageal cancer, infusion care and the coordination of care with Alternative Sites of Care. The company works in a complicated regulatory environment, having to comply with fifty state laws and various federal laws regarding the delivery of care, patient safety and privacy, steering and other areas of regulation. "Compliance is fundamental to everything we do at UpScriptHealth," Ax said. "We have prioritized adherence since its inception and helped shape many of the regulations now guiding the industry." He explained that patient safety and data privacy are paramount and that focusing on compliance is critical in building trust with patients and partners. "UpScriptHealth’s clinicians are not incentivized to write prescriptions or to encourage the use of a specific therapy," he said. The company also offers treatments for hair loss and erectile dysfunction, and Ax noted that men who historically avoided seeking treatment due to stigma or inconvenience are now actively engaging with their health through UpScriptHealth’s platform. "Our goal is to make UpScriptHealth the comprehensive digital home for men's health, where patients can access the full spectrum of care they need with the convenience they expect," Ax said. In July, Axena Health and UpScriptHealth partnered to offer women online consultations with UpScriptHealth providers. This allows them to receive prescriptions for Axena’s Leva Pelvic Health System. The company has teamed up with medical device companies, including Spark Biomedical, to provide telehealth for its FDA-cleared opioid-withdrawal wearable, and Lucid Diagnostics, to expand access to esophageal pre-cancer testing, while it also enables telehealth consultations for Spark Biomedical's Sparrow Ascent wearable.

100 Deals associated with Testosterone Undecanoate

External Link

KEGG	Wiki	ATC	Drug Bank
D06087	Testosterone Undecanoate	G03BA03	DB13946

R&D Status

Approved

10 top approved records.

to view more data

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.

to view more data

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

View All Results

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)	egbqowdkhw(eobcrqryan) = okfapabriz enhzjuzwno (ouoxhethky )	Positive	01 May 2024
NCT04467697 (NCT03198728, Pubmed)	Phase 3	Multiple Endocrine Neoplasia \| Eunuchism	155	KYZATREX	lztpiukclo(mwgotzldea) = hypertension cywzixitxc (ydxqfjfxjk ) View more	-	10 Apr 2024
NCT04983940 (CTgov)	Phase 4	Testosterone deficiency	41	Jatenzo	chyohikpge(qkzhlambjk) = yqzpqszbnw wbvloymfke (kkouhzdwez, nfhbyyahoy - jnahaaxaqb) View more	-	14 Dec 2023
NCT03198728 (CTgov)	Phase 3	Eunuchism	314	AndroGel (Andro-gel™ Treated)	cmmvreuhot(ejmtncwbhf) = jxffzjybpq atnnrfywiv (jenklulpbt, enycfcxoju - gbszardwfe) View more	-	28 Jun 2023
NCT03198728 (CTgov)	Phase 3	Eunuchism	314	SOV2012-F1 (SOV2012-F1-Treated)	vaqlelfkla(duvyfoxlno) = rzddtrralj elhucewtwl (ysbsakxkcb, gnsxogmdao - qlcvdulssr) View more	-	28 Jun 2023
NCT04120363 (OPS II, CTgov)	Phase 4	Sleep	34	Testosterone Undecanoate (Testosterone)	izrlfmxuxg(oltowovfcj) = qekyfqlymn epvkugqryg (yneejtsucm, oxtlbjalxm - mnenyzdaul) View more	-	07 Oct 2022
NCT04120363 (OPS II, CTgov)	Phase 4	Sleep	34	sesame oil (Placebo)	izrlfmxuxg(oltowovfcj) = oizupywdvx epvkugqryg (yneejtsucm, rvxbpcnbfh - qpivrzjyvh) View more	-	07 Oct 2022
AUA2022	Phase 4	-	-	Jatenzo®	gtqyxjqugu(mifnrjfhyh) = tbqknwmybv fncakoppue (bpnjgqnsck )	-	01 May 2022
AUA2021	Not Applicable	Multiple Endocrine Neoplasia	86	Oral Testosterone Undecanoate (TU)	twoebitzfw(azhswpaqdo) = jzltgqqvhg hwkumbojbu (rbznhlardh ) View more	-	01 Sep 2021
Pubmed \| J Clin Hypertens (Greenwich)	Not Applicable	Multiple Endocrine Neoplasia	155	Kyzatrex™	bahsdftbal(vtynbmkxee) = rnpxzlbjrt glwidvtrxc (ivthnosagt, 0.3 - 3.1)	-	01 Jul 2021
NCT03868059 (Pubmed \| J Cardiovasc Pharmacol Ther)	Phase 3	Multiple Endocrine Neoplasia	138	TLANDO™ 225 mg twice daily	ilntmdisvv(wjcklqchpt) = mberzonrmi ciryzylvbo (hbcftmoqhw ) View more	-	30 Jun 2021
NCT00695110 (CTgov)	Phase 2	Hypogonadism	29	testosterone enanthate (TE) (300 mg T equivalents/dose)+Oral testosterone undecanoate (TU) (200 mg T equivalents/dose	uobshuhvkz(ndqexrlqwb) = pzipffhiqo macwsjsadb (gpirtctqma, vzbtdwekup - bfwvfjrikm) View more	-	24 Jun 2021

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