This study is a continuation of previous studies done in healthy volunteers to prove the efficacy of delivering Testosterone, the male hormone, rapidly across intact skin in s series of doses from low to high in men with low-to-no natural testosterone production to measure their response to the varying doses. The results of this study will inform further studies which will be longer in length, as to the starting doses. The study will be conducted in London, U.K. at the Advanced Therapies Centre, The London Clinic.

Start Date01 Jun 2025

Sponsor / Collaborator

Transdermal Delivery Solutions Corp.

NCT06733350

/ RecruitingPhase 4IIT

Investigating the Effect of Testosterone Replacement Therapy Among Hypogonadal Men With Localized Prostate Cancer on Active Surveillance

This phase IV trial studies the effects of testosterone replacement therapy (TRT) on treatment outcomes in hypogonadal men with prostate cancer that has not spread to other parts of the body (localized) and who are on active surveillance (AS). AS in prostate cancer involves closely watching the patient's condition through regular physical exams and blood tests, but not giving treatment unless there are changes in test results. It can be a practical alternative to treatment in localized prostate cancer. Hypogonadal men have low testosterone associated with symptoms such as low libido and erectile problems. TRT can be used to treat hypogonadism by increasing testosterone levels, which may improve associated symptoms. TRT is often not used in men with prostate cancer due to concerns it may lead to the cancer growing or spreading. This may lead hypogonadal men to have a poor quality of life or to discontinue AS. TRT may improve treatment and quality of life outcomes in hypogonadal men with localized prostate cancer on active surveillance.

Start Date15 Jan 2025

Sponsor / Collaborator

Roswell Park Comprehensive Cancer Center

RBR-8xtsgvv

/ Not yet recruitingNot ApplicableIIT

Evaluation of Metabolic, Inflammatory, Cardiovascular and Endothelial Risk markers in transgender men on Testosterone therapy

Start Date15 Dec 2024

Sponsor / Collaborator-

100 Clinical Results associated with Testosterone

100 Translational Medicine associated with Testosterone

100 Patents (Medical) associated with Testosterone

116,445

Literatures (Medical) associated with Testosterone

31 Dec 2025·Italian Journal of Animal Science

A comparative study to estimate three commercial products of human chorionic gonadotropin (hCG) on blood biochemistry, sexual hormones concentrations, reproductive indices, and larvae production of African catfish Clarias gariepinus brood-stock

Author: Ahmed, Mohammad Z. ; Abdel-Aziz, Mohamed F. A. ; Saleh, Hamed H. E. ; Attia, El-Sayed I. ; Arai, Takaomi ; Hassan, Habib Ul

Hormonal induction is an effective method for spawning African catfish, especially the use of human chorionic gonadotropin (hCG)Hormonal treatment is an essential factor in the cost of seed productionThere are many types of hCG products used in Egypt but Choriomon is the best in efficiency of reproduction and economic

01 Jun 2025·GENE EXPRESSION PATTERNS

Pre-gestational restraint stress affects reproductive outcomes in adult rats by modulating ovarian and uterine function

Article

Author: Paul, Jeyakumari ; Srinivasan, Divya ; Rajan, Ravindran ; Raghavendhira, Harini ; Bhaskaran, Ravi Sankar

The impact of gestational stress on reproductive outcomes is well-established, but the effects of pre-gestational stress remain inconclusive. Using female Wistar rats, we demonstrated that pre-gestational stress negatively affects fertility and pregnancy outcomes. The rats were subjected to restraint stress (RS) for 15 days, with 3 h of stress each day, before mating. The RS group exhibited higher levels of corticosterone and prolactin, along with lower levels of adrenocorticotropic hormone (ACTH), indicating a successful stress model. Stressed rats showed reduced fertility and fecundity indices, longer conception times, and decreased levels of ovarian steroids, such as progesterone, testosterone, and estradiol. Additionally, the ovaries of the RS group had fewer antral follicles and more ovarian cysts. Elevated protein levels of cytochrome P450 side-chain cleavage enzyme (CYP11A1) and aromatase (CYP19A1), along with decreased levels of 17β-hydroxysteroid dehydrogenase (17β-HSD), indicating impaired ovarian steroidogenesis in stress exposed rats. In the RS group, there was a significant increase in proteins associated with folliculogenesis, specifically octamer-binding transcription factor 4 (OCT 4) and growth differentiation factor 9 (GDF 9). Additionally, proteins linked to ovulation, such as the prolactin receptor (PRLR), peroxisome proliferator-activated receptor-γ (PPAR-γ), and cyclooxygenase 2 (COX 2), were elevated. The increased levels of PRLR, progesterone receptor (PR), androgen receptor (AR), and estrogen receptor (ER) combined with heightened oxidative stress in the uteri of the RS group, suggest a potential disruption in uterine function. Overall, this research indicates that pre-gestational stress can significantly impact reproductive health by altering gonadotrophin and ovarian steroid dynamics in the female reproductive tract.

01 May 2025·Journal of Environmental Sciences

The effects of 17β-trenbolone and bisphenol A on sexual behavior and social dominance via the hypothalamic-pituitary-gonadal axis in male mice

Article

Author: Sun, Minghe ; Luan, Jialu ; Zhao, Qili ; Zhang, Shuhui ; Feng, Xizeng ; Bai, Huijuan ; Sun, Mingzhu ; Zhao, Xin ; Yu, Qian ; Fu, Zhenhua ; Zuo, Xiang

17β-Trenbolone (17-TB) is well documented as an environmental endocrine disruptor in aquatic biological studies, but its effects on mammals remain poorly understood. Furthermore, 17-TB acts as a hormone with properties similar to testosterone, and the consequences of juvenile exposure on adult social behavior remain uncertain. Bisphenol A (BPA) acts as an estrogen-like hormone, compared to 17-TB. Three-week-old male Balb/c mice were exposed orally to 17-TB (100 µg/(kg·day)) and BPA (4 mg/(kg·day)) for 28 days. Assessments of social interactions and a three-chamber test showed that 17-TB increased virility in male mice, intensified both male and female sexual behavior, and attracted and accepted female mice. It also increased social dominance through tube tests in male mice and markedly activated the c-Fos⁺ immune response in the medial prefrontal cortex (mPFC) and basal amygdala (BLA). ELISA data showed that 17-TB and BPA exposure significantly affected serum gonadotropin-releasing hormone (GnRH), growth hormone (GH), estradiol (E2), and luteinizing hormone (LH) levels, as well as testicular lesions and androgen receptor (ARβ) and estrogen receptor (ERα) synthesis. Testicular transcriptomic analysis further confirmed that could disrupt steroid synthesis and linoleic acid-related biometabolic processes. These findings suggest the influence of 17-TB and BPA exposure on sexual behavior and fertility in male mice, possibly through modulation of the hypothalamic-pituitary-gonadal axis. This study provides insights relevant to human reproductive health and neuro-social behavioral research, and the potential risk of environmental disturbances should not be overlooked.

169

News (Medical) associated with Testosterone

13 Mar 2025

·www.prnewswire.com

Lipocine Announces Financial Results for the Full Year Ended December 31, 2024

SALT LAKE CITY, March 13, 2025 /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 year ended December 31, 2024, and provided a corporate update. Oral Brexanolone LPCN 1154 is an oral formulation of the neuroactive steroid brexanolone that Lipocine is developing for the rapid treatment of postpartum depression (PPD). Lipocine held a meeting with the U.S. Food and Drug Administration (FDA) in the first quarter of 2025 to discuss the NDA submission package for LPCN 1154 (oral brexanolone) as a treatment for PPD. In the meeting, Lipocine was advised that the FDA believes that, in addition to the previously completed PK bridge data, a safety and efficacy study of oral LPCN 1154 in the target population will be required for 505(b)(2) NDA submission. Based on observed comparable exposure of LPCN 1154 and the reference drug in the PK bridge study, the company is initiating a phase 3 safety and efficacy study with expected first patient dosed in the second quarter of 2025. The Company has completed registration stability studies required for NDA submission. A Phase 3 safety and efficacy study will provide the opportunity to generate safety and depression symptom relief data with LPCN 1154. Lipocine believes this data will be beneficial for potential inclusion in product labeling and for eligibility for clinical investigation exclusivity for a 48-hour, oral treatment option. In addition, the planned study will investigate the potential of oral brexanolone to treat anxiety disorders, representing another attractive commercial opportunity with a high unmet need. In October 2024, Lipocine announced positive data from a quantitative EEG (qEEG) study of oral brexanolone. The results indicate robust central nervous system (CNS) activity of oral brexanolone, with concentration- and time-dependent post-dose changes in qEEG. These results confirm GABAA positive allosteric modulation and support future development of oral brexanolone in neuropsychiatric indications. Lipocine is exploring the possibility of partnering LPCN 1154 with a third party. LPCN 2401 for Obesity Management LPCN 2401 is targeted to be a once daily oral formulation comprising a proprietary anabolic androgen receptor agonist for obesity management. It is expected to have a favorable benefit to risk profile as an oral option for use as an adjunct to GLP-1 receptor agonist chronic weight management therapies and/or as a monotherapy post cessation of GLP-1 receptor agonist therapies, with demonstrated benefits to the liver. Lipocine is exploring the possibility of partnering LPCN 2401 with a third party. LPCN 2401 was featured in a virtual key opinion leader (KOL) event hosted by Lipocine in October 2024 The event highlighted positive data from the Phase 2 study of LPCN 2401 which support the potential for the product to be used as an adjunct with incretin mimetics (GLP-1/GIP agonists) or as a monotherapy post incretin mimetic discontinuation. 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. Frank Greenway (Chief Medical Officer at Pennington Biomedical Research Center) at the Obesity Society's Annual Obesity Week conference in November 2024, in San Antonio, TX. LPCN 1148 LPCN 1148 is targeted to be a "First in Class" product candidate with a novel mechanism of action for the management of decompensated cirrhosis. A manuscript "Oral LPCN 1148 Improves Sarcopenia and Hepatic Encephalopathy in Male Patients with Cirrhosis: a randomized, placebo-controlled Phase 2 trial" was published in the journal Hepatology and also discussed at The Liver Meeting (AASLD) 2024 Editor's Cut: Clinical Study Session in November 2024. The publication and conference discussion highlighted updated results from Lipocine's Phase 2 proof-of-concept clinical trial (LPCN 1148-21-001) that evaluated LPCN 1148 in men with decompensated cirrhosis and sarcopenia awaiting liver transplantation. The results at 24 weeks showed that LPCN 1148 therapy resulted in a significant improvement in sarcopenia when compared with placebo. Participants receiving LPCN 1148 also experienced significantly fewer episodes of overt hepatic encephalopathy (OHE) compared to those on placebo, even though most participants were already on background therapies for HE. The US FDA granted fast track designation to LPCN 1148 as a treatment for sarcopenia in patients with decompensated cirrhosis in December 2024. Lipocine is exploring the possibility of partnering LPCN 1148 with a third party. TLANDO™ Lipocine entered into an exclusive License Agreement with Verity Pharma in January 2024 under which Verity Pharma has the rights to market its oral testosterone replacement therapies TLANDO and, if approved, TLANDO XR, in the United States and Canada. Under the terms of the License Agreement, Verity Pharma agreed to pay Lipocine license fees totaling $11 million. Of this amount, Lipocine received payments totaling $10 million during 2024 and is to receive a further payment of $1 million in 2025. Lipocine is entitled to receive up to $259 million in development and sales-based commercial milestone payments, as well as tiered royalty payments ranging from 12% up to 18% on net sales of TLANDO franchise products. In September 2024, we entered into a distribution and license agreement with SPC Korea Limited for the development and commercialization of TLANDO for TRT in South Korea. In October 2024, Lipocine signed an exclusive supply and distribution agreement with Pharmalink to commercialize TLANDO in the Gulf Cooperation Council (GCC) countries consisting of Saudi Arabia, Kuwait, the United Arab Emirates (UAE), Qatar, Bahrain, and Oman. The Company is exploring further partnerships for TLANDO outside of North America, South Korea and the GCC countries. Testosterone On February 28, 2025, the FDA informed sponsors of testosterone products about new labeling changes following the agency's review of the findings from the Testosterone Replacement Therapy for Assessment of Long-term Vascular Events and Efficacy Response in Hypogonadal Men (TRAVERSE) clinical trial and the results from required post-market ambulatory blood pressure (ABPM) studies. The changes include adding the TRAVERSE trial results to testosterone products, retaining "Limitation of Use" language for age-related hypogonadism, and removal of language from the Boxed Warning related to an increased risk of adverse cardiovascular outcomes for all testosterone products, in addition to other changes led by results of the ABPM studies. Year Ended December 31, 2024 Financial Results As of December 31, 2024, Lipocine had $21.6 million of unrestricted cash, cash equivalents and marketable investment securities compared to $22.0 million as of December 31, 2023. Lipocine reported a net income of approximately $8,400 for the year ended December 31, 2024, compared with a net loss of $16.4 million, or ($3.14) per diluted share, for the year ended December 31, 2023. The company recognized revenue of $11.2 million during the year ended December 31, 2024, compared to a net reversal of variable consideration revenue of $2.9 million during the year ended December 31, 2023. Revenue in 2024 primarily consisted of license revenue from the company's licensees, Verity Pharma, SPC Korea and Pharmalink and royalty revenue from TLANDO sales. Research and development expenses were $7.4 million and $10.2 million, respectively, for the years ended December 31, 2024 and 2023. The decrease in research and development expenses in 2024 compared with the prior year was primarily due to completion of patient dosing expenses in the LPCN 1148 Phase 2 POC study in male patients with cirrhosis in 2023, a decrease in TLANDO related costs, and a decrease in personnel related costs. These decreases were offset by an increase in LPCN 1154 clinical studies, an increase in other lab supplies and research costs, and an increase in LPCN 2401 costs. General and administrative expenses were $5.0 million and $4.9 million, respectively, for the years ended December 31, 2024 and 2023. Interest and investment income was $1.2 million and $1.4 million, respectively, for the years ended December 31, 2024 and 2023. 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 metabolic dysfunction-associated steatohepatitis (MASH). TLANDO, a novel oral prodrug of testosterone containing testosterone undecanoate developed by Lipocine, is approved by the FDA for conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism, in adult males. For more information, please visit . Forward-Looking Statements This release contains "forward-looking statements" that are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and include statements that are not historical facts regarding our product candidates and related clinical trials, our development of our product candidates and related efforts with the FDA, including with respect to LPCN 1154, our current intention to conduct a safety and efficacy study relating to LPCN 1154, the timing and potential results of the safety and efficacy study relating to LPCN 1154, potential partnering of our product candidates with third parties, and the potential uses and benefits of our product candidates. Investors are cautioned that all such forward-looking statements involve risks and uncertainties, including, without limitation, the risks that we may not be successful in developing product candidates, we may not have sufficient capital to complete the development processes for our product candidates or we may decide to allocate our available capital to other product candidates, we may not be able to enter into partnerships or other strategic relationships to monetize our non-core assets, safety and efficacy studies, including those relating to LPCN 1154, may not be successful or may not provide results that would support the submission of a NDA, the FDA may not approve any of our products, risks related to our products, expected product benefits not being realized, clinical and regulatory expectations and plans not being realized, new regulatory developments and requirements, risks related to the FDA approval process including the receipt of regulatory approvals and our ability to utilize a streamlined approval pathway for LPCN 1154, the results and timing of clinical trials, patient acceptance of Lipocine's products, the manufacturing and commercialization of Lipocine's products, and other risks detailed in Lipocine's filings with the SEC, including, without limitation, its Form 10-K and other reports on Forms 8-K and 10-Q, all of which can be obtained on the SEC website at . Lipocine assumes no obligation to update or revise publicly any forward-looking statements contained in this release, except as required by law. SOURCE Lipocine Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultPhase 2License out/in

24 Feb 2025

·medcitynews.com

The HRT Club Launches to Expand Access to Hormonal Care - MedCity News

About 85% of women and 30% of men will experience hormonal challenges in their lifetime. Recognizing this, The HRT Club is stepping up by providing consumers access to hormone replacement therapies, treatments that replace lost hormones and are commonly used for menopause. The Bridgewater, New Jersey-based company announced the commercial release of its solution last week following an April soft launch. Members pay $99 a year and gain access to a network of over 700 healthcare providers that partner with The HRT Club and can prescribe hormone treatments. Members don’t require insurance for the company’s services. The HRT Club bypasses pharmacy benefit managers and has direct agreements with drug manufacturers and independent wholesalers, allowing them to provide patients with discounts on prescribed treatment options. These treatments include estrogen therapies, progesterone therapies, testosterone therapies and sexual health treatments. For some medications, members can receive up to 90% in savings, the company claimed. Sponsored Post Tips for Greater Healthcare Practice Success in 2025 Join us on February 26 at 3 pm ET, and we’ll dive into the key areas where practices are losing time and money and provide solutions to overcome them. By Elation Health and MedCity News “We created The HRT Club to address a pressing public health crisis: two out of three Americans with hormone deficiencies cannot access the medications they need. The root of the problem lies with middlemen — pharmacy benefit managers and wholesalers — who inflate prices and restrict access,” said Cyrille Labourel, CEO of The HRT Club, in an email. “As a result, hormone replacement therapy (HRT) treatments in the U.S. cost, on average, five times more than in other countries. The HRT Club is here to change that.” Labourel isn’t the only one who has a bone to pick with PBMs. The pharmacy middlemen — specifically CVS Caremark, Optum Rx and Express Scripts — have come under fire recently from legislators and the Federal Trade Commission. The latter has released two reports on PBMs, which declare that the market has become too concentrated and that PBMs hike up the cost of life-saving drugs. Several other companies are cutting out PBMs in order to make prescriptions cheaper, including Mark Cuban Cost Plus Drug Company and DiRx, though these companies don’t focus on HRT medications. The HRT Club already has more than 3,000 members across 42 states. About 90% of its customers are women, though more men are seeking testosterone replacement therapy, and the company has a growing population of patients undergoing gender transition, according to Labourel. The HRT Club is backed by a $10 million investment from its parent company Besins Healthcare, a manufacturer of HRT products. In 2025, The HRT Club hopes to reach 50,000 members nationwide, the announcement stated. In addition, it aims to expand to other hormonal therapies in the future, such as GLP-1 medications. It also plans to create tech solutions for prescription tracking and refills, as well as a community platform for members to share their experiences. Exclusive Improving the Healthcare Financial Experience to Help Care Flow Zelis CEO Amanda Eisel shares her perspective on how the company is solving the problems of a fragmented health financial system to benefit all. By Stephanie Baum “We aim to be the go-to destination for hormonal health, driven by our mission to democratize access to hormone treatments,” Labourel said. “Our focus extends beyond sex hormones; our ultimate goal is to redefine the healthcare model — putting patients first by bypassing the traditional insurance, PBM, and wholesaler systems.” Other companies that offer HRT products include Winona and MyAlloy, though these don’t offer testosterone products, according to Labourel.

06 Feb 2025

·www.prnewswire.com

Lipocine Receives Updated Regulatory Guidance on LPCN 1154

SALT LAKE CITY, Feb. 6, 2025 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to augment therapeutics through effective oral delivery, today announced receipt of revised regulatory guidance for LPCN 1154 which the Company is developing for postpartum depression (PPD) treatment. As previously disclosed, the Company was scheduled to meet with the U.S. Food and Drug Administration (FDA or the Division) in Q1 2025 to discuss the NDA submission package of LPCN 1154. Following the meeting, the Company was advised that the Division believes, in addition to the previously completed PK bridge data, an efficacy and safety study of oral LPCN 1154 in the target population will be required for 505(b)(2) NDA submission. Lipocine remains committed to advancing a rapid relief treatment for postpartum depression. Based on the guidance received and observed comparable exposure of LPCN 1154 and the reference drug in the completed PK bridge study, Lipocine is planning next steps toward the execution of a phase 3 safety and efficacy study. "The regulatory guidance regarding a safety and efficacy study provides an opportunity to generate safety and depression symptom relief data with LPCN 1154, which we believe will be beneficial for potential inclusion in product labeling and eligibility for clinical investigation exclusivity for a 48-hour, oral treatment option," said Mahesh Patel, CEO of Lipocine. "Furthermore," Dr. Patel added, "the planned study will investigate the potential of oral brexanolone to treat anxiety disorders, representing another attractive commercial opportunity with a high unmet need." About LPCN 1154 LPCN 1154 is an oral formulation of brexanolone in development targeted for administration resulting in rapid relief of PPD. Brexanolone is a bioidentical to naturally occurring neuroactive steroid, allopregnanolone, a positive allosteric modulator of y-aminobutyric acid (GABAA) receptor. LPCN 1154 is expected to have characteristics that could be particularly appealing to patients with severe PPD, acutely elevated suicide risk, and in whom rapid improvement is a priority while presenting no significant risk of adverse reactions to breastfed infants from exposure to brexanolone. About Postpartum Depression and Unmet Needs PPD is a major depressive disorder with onset either during pregnancy or within four weeks of delivery, with symptoms persisting up to 12 months after childbirth. Hormonal changes leading to GABA dysfunction are common in depression and pregnancy. Symptoms of PPD include hallmarks of major depression, including, but not limited to, sadness, depressed mood, loss of interest, change in appetite, insomnia, sleeping too much, fatigue, difficulty thinking/concentrating, excessive crying, fear of harming the baby/oneself, and/or thoughts of death or suicide. Results from a recent survey (Truist Securities Research, January 2024) show that obstetricians believe approximately 20-40% of their patients may suffer from PPD. Further, obstetricians are comfortable making a diagnosis and prescribing antidepressants for PPD. Traditional antidepressants, not approved for PPD, have slow onset of action, side effects such as weight gain, and do not demonstrate adequate remission post-acute treatment. 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 our product candidates and related clinical trials, our development of our product candidates and related efforts with the FDA, including with respect to LPCN 1154, our current intention to conduct a safety and efficacy study relating to LPCN 1154, the timing and potential results of the safety and efficacy study relating to LPCN 1154, 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, we may not have sufficient capital to complete the development processes for our product candidates or we may decide to allocate our available capital to other product candidates, we may not be able to enter into partnerships or other strategic relationships to monetize our non-core assets, safety and efficacy studies, including those relating to LPCN 1154, may not be successful or may not provide results that would support the submission of a NDA, the FDA may not approve any of our products, risks related to our products, expected product benefits not being realized, clinical and regulatory expectations and plans not being realized, new regulatory developments and requirements, risks related to the FDA approval process including the receipt of regulatory approvals and our ability to utilize a streamlined approval pathway for LPCN 1154, the results and timing of clinical trials, patient acceptance of Lipocine's products, the manufacturing and commercialization of Lipocine's products, and other risks detailed in Lipocine's filings with the SEC, including, without limitation, its Form 10-K and other reports on Forms 8-K and 10-Q, all of which can be obtained on the SEC website at . Lipocine assumes no obligation to update or revise publicly any forward-looking statements contained in this release, except as required by law. SOURCE Lipocine Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Drug ApprovalNDA

100 Deals associated with Testosterone

External Link

KEGG	Wiki	ATC	Drug Bank
D00075	Testosterone	G03BA03	DB00624

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
secondary testicular failure	United States	Endo Operations Ltd.	29 Dec 2010
Sexual Dysfunctions, Psychological	European Union	Warner Chilcott Ltd.	28 Jul 2006
Sexual Dysfunctions, Psychological	European Union	Teva NI Ltd.	28 Jul 2006
Sexual Dysfunctions, Psychological	Iceland	Warner Chilcott Ltd.	28 Jul 2006
Sexual Dysfunctions, Psychological	Iceland	Teva NI Ltd.	28 Jul 2006
Sexual Dysfunctions, Psychological	Liechtenstein	Warner Chilcott Ltd.	28 Jul 2006
Sexual Dysfunctions, Psychological	Liechtenstein	Teva NI Ltd.	28 Jul 2006
Sexual Dysfunctions, Psychological	Norway	Teva NI Ltd.	28 Jul 2006
Sexual Dysfunctions, Psychological	Norway	Warner Chilcott Ltd.	28 Jul 2006
Low testosterone levels	United States	Endo Operations Ltd.	31 Oct 2002
Testosterone deficiency	Australia	Teva Pharmaceuticals Australia Pty Ltd	10 Apr 2002
Hypogonadism	United States	AbbVie, Inc.	29 Sep 1995

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Klinefelter Syndrome	Phase 3	United States	Amneal Intermediate, Inc.	01 Mar 2014
Arthralgia	Phase 3	United States	National Cancer Institute	10 Sep 2013
Arthralgia	Phase 3	Puerto Rico	National Cancer Institute	10 Sep 2013
Breast Cancer	Phase 3	United States	National Cancer Institute	10 Sep 2013
Breast Cancer	Phase 3	Puerto Rico	National Cancer Institute	10 Sep 2013
Hot Flashes	Phase 3	United States	National Cancer Institute	10 Sep 2013
Hot Flashes	Phase 3	Puerto Rico	National Cancer Institute	10 Sep 2013
Musculoskeletal Abnormalities	Phase 3	United States	National Cancer Institute	10 Sep 2013
Musculoskeletal Abnormalities	Phase 3	Puerto Rico	National Cancer Institute	10 Sep 2013
Alzheimer Disease	Phase 3	United States	Solvay Pharmaceuticals, Inc.	01 Jul 2009

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04456296 (CTgov)	Phase 4	secondary testicular failure \| Eunuchism	673	AVEED (AVEED® (Testosterone Undecanoate Injection))	hjvawemugu(msxtmejnbw) = pqeymmmrjw ybvqxhmazl (fcrgcbcuck, bsthxpcuje - hdonbttsqi) View more	-	14 Mar 2025
				FORTESTA (FORTESTA® (Testosterone Gel))	hjvawemugu(msxtmejnbw) = sijfanwghb ybvqxhmazl (fcrgcbcuck, wrdfffttby - ezfedmndfp) View more
NCT02432261 (CTgov)	Phase 1	-	44	Nestorone® /testosterone gel (Group 1)	utlxadovqi = gducobghvw ubwcnlevhy (wqmvhkqyws, vdnytoejoe - wpguqjqbye) View more	-	13 Feb 2025
				Testosterone only gel (Group 2)	utlxadovqi = ckllcohblj ubwcnlevhy (wqmvhkqyws, vsmdghisrr - bxtnoakqmb) View more
NCT02938923 (STEP-HI, CTgov)	Phase 3	Hip Fractures \| Sarcopenia	129	Testosterone+Supervised exercise training (Exercise + Testosterone (EX + T))	cyzpemwwfh(xsbnqsfobf) = ygqnycdczf hldfzvjhmp (tgavgxunfm, vnrfqhejli - iyoubeqrfs) View more	-	04 Feb 2025
				Supervised exercise training (Exercise + Placebo (EX + P))	cyzpemwwfh(xsbnqsfobf) = mngcuhcnku hldfzvjhmp (tgavgxunfm, fmdyzpnioq - kovpvthlfc) View more
UEGW2024	Not Applicable	Primary Malignant Liver Neoplasm testosterone \| estradiol \| tumor necrosis factor receptor superfamily member 9 (TNFRS9) ... View more	-	TESTOSTERONE (Estradiol levels)	rilskrpucu(nndylwbesj) = bunhptpfwz kpgcdpctoa (jknbriwqfc ) View more	Positive	13 Oct 2024
NCT05781685 (CTgov)	Early Phase 1	Acute Pain	20	Testosterone+Placebo Syrup (Testosterone)	ggmynghxic(lpppsfcsne) = pykmafrpmo ziwvlxibcm (rursvvuowh, 91.144110) View more	-	05 Aug 2024
				Testosterone+Placebo Syrup (Placebo)	ggmynghxic(lpppsfcsne) = tmhekbhjkm ziwvlxibcm (rursvvuowh, 94.080395) View more
ADA2024	Not Applicable	Obesity	-	Testosterone Replacement Therapy (TRT)	dlorjcniky(ylslorbynp) = vochanmfei tklvtzawuq (kfubwezrbo ) View more	-	14 Jun 2024
Near Term Cardiometabolic Outcomes in Transgender Boys and Men (ENDO2024)	Not Applicable	E2	51	Transgender Men on Testosterone Therapy	kbyysuytgs(rmqsxkxjrd) = phvswoulhy bacqnfgjkj (tinnvmzsma ) View more	-	01 Jun 2024
Testosterone II (TSTII) (ENDO2024)	Not Applicable	Renal Cell Carcinoma testosterone	-	Testosterone II (TSTII) Immunoassay (Atellica IM Testosterone II (TSTII) assay)	smeenyqdfm(cafpgcidfc) = meneyctfej oifuprbdud (lwjuudzqfm )	-	01 Jun 2024
				Testosterone II (TSTII) Immunoassay (ADVIA Centaur Testosterone II (TSTII) assay)	smeenyqdfm(cafpgcidfc) = yxbefodcdw oifuprbdud (lwjuudzqfm )
Testosterone Modulation of Muscle Transcriptome Profile (ENDO2024)	Not Applicable	Hypogonadism \| Obesity early AM testosterone	83	Testosterone Replacement + Lifestyle Therapy	afcynbcdfo(jbtobdqloj) = tekcgmceif xmgganmbxa (qprogdcysf ) View more	Positive	01 Jun 2024
				Placebo + Lifestyle Therapy	afcynbcdfo(jbtobdqloj) = ztfeifursi xmgganmbxa (qprogdcysf ) View more
ATS2024	Not Applicable	Acute Lung Injury	-	Anabolic Testosterone Isocaproate	dzkmlabjkd(phxmwkovgb) = Our patient is a 46-year-old smoker who presented with two days of progressively dyspnea preceded by two weeks of cough. His history was significant for polysubstance use disorder. In the emergency department, he was found to be hypoxic to 60% with diffuse crackles and expiratory wheezes on exam, so he was given a dose of systemic steroids and started nebulizers. Chest radiograph and chest CT scan (figure 1) showed diffuse bilateral ground glass opacities. His respiratory status deteriorated rapidly, and he was intubated, then he was ultimately admitted to the MICU for acute hypoxemic respiratory failure. All infectious work-up including sputum culture and rapid respiratory pathogen PCR were negative. Over the next three days, he continued to have higher oxygen requirements, so empiric steroids were given then flexible bronchoscopy was performed with BAL demonstrating eosinophils of 14%, and lymphocytes of 3%. BAL bacterial and fungal cultures were negative. He was started on IV methylprednisolone, responded very well and after 3 days he was extubated. Following extubation, he reported using non-prescribed anabolic testosterone isocaproate for bodybuilding over the past several months and had three similar presentations with respiratory distress with chest CT also showing bilateral ground glass opacities and negative infectious workup. In all of them, he exhibited clinical improvement following each of these presentations with normal chest radiographs in between. He was followed in pulmonary clinic and was advised to stop using anabolic steroids with no recurrence to date. shfutaxhpg (vaswirabxl )	-	19 May 2024

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