Open-Label, Multiple-Dose, 52-Week Study to Evaluate the Safety, PK, & Efficacy of XYOSTED® for Testosterone Replacement in Male Adolescents With Deficiency or Absence of Endogenous Testosterone Due to Primary or Secondary Hypogonadism

This is a 52-week open label single arm study to investigate the effects of XYOSTED, as testosterone replacement therapy, on adolescent males with either primary or secondary hypogonadism.
The study aims to determine the effectiveness of XYOSTED measured by continuation or induction of puberty in addition to XYOSTED dosage, safety and testosterone levels.

Start Date05 Feb 2025

Sponsor / Collaborator

Halozyme Therapeutics, Inc.

NCT06670053

/ RecruitingNot ApplicableIIT

Effect of Testosterone on Brain Imaging and Headache in Transmasculine Adolescents

Transmasculine youth (female sex assigned at birth, male gender identity) who begin clinical gender affirming hormone therapy (GAHT) with testosterone (T) may experience changes in headache. Researchers think this because studies published on effects of giving testosterone to cisgender females (female sex, female gender identity) and transmasculine adults seem to show an effect on pain.
This research will help us learn more about changes in headache and in brain structure and function in transmasculine youth during the first two years of T. Youth who will be starting T within 6 months, either on puberty blocker or not, as part of their regular medical care can participate and will be asked to attend 4 visits:
* before starting T
* after 6 months on T
* after 1 year on T
* after 2 years on T
At the visits, they will be asked to:
* answer questions and surveys about their health
* have a brain MRI done
* give a small sample of blood
and at their first visit, complete a physical exam. Some participants can also do a brief test of pain sensitivity. All participants will be asked to complete a headache diary for the first 6 months, for 1 month after the 1 year visit, and for 1 month after the 2 year visit.

Start Date31 Dec 2024

Sponsor / Collaborator

University of Colorado Denver

100 Clinical Results associated with Testosterone Enanthate

100 Translational Medicine associated with Testosterone Enanthate

100 Patents (Medical) associated with Testosterone Enanthate

1,307

Literatures (Medical) associated with Testosterone Enanthate

01 Apr 2025·Journal of the International AIDS Society

Exploring potential drug−drug interactions between masculinizing hormone therapy and oral pre‐exposure prophylaxis (F/TDF and F/TAF) among transgender men (iMACT study): a randomized, open‐label pharmacokinetic study in Thailand

Article

Author: Boonruang, Jakkrapatara ; Janamnuaysook, Rena ; Cressey, Tim R. ; Anderson, Peter L. ; Hiransuthikul, Akarin ; Trichavaroj, Rapee ; Nonenoy, Siriporn ; Kerr, Stephen ; Phanuphak, Nittaya ; Hongchookiat, Piranun ; Thammajaruk, Narukjaporn ; Teeratakulpisarn, Nipat ; Tawon, Yardpiroon

AbstractIntroductionConcerns regarding potential drug−drug interactions (DDIs) between hormone therapy and pre‐exposure prophylaxis (PrEP) may hinder PrEP use among transgender persons. Transgender men have often been overlooked in biomedical HIV research, and potential DDIs between masculinizing hormone therapy (MHT) and PrEP have not been addressed. We aimed to assess the potential DDIs between MHT and daily oral PrEP among transgender men.MethodsTransgender men without HIV who never underwent oophorectomy were enrolled between May and October 2022. Participants were randomly assigned to receive emtricitabine‐tenofovir disoproxil fumarate (F/TDF) or emtricitabine‐tenofovir alafenamide (F/TAF) for daily oral PrEP. Intramuscular testosterone enanthate 200 mg was administered every 2 weeks from baseline to week 12, while oral PrEP was initiated at week 6 and continued until week 16. Pharmacokinetic (PK) sampling was conducted at weeks 4 and 12 to assess the impact of PrEP on MHT and at weeks 12 and 16 to evaluate the impact of MHT on PrEP. Plasma total testosterone, TAF, tenofovir (TFV) and FTC; tenofovir‐diphosphate (TFV‐DP) and emtricitabine‐triphosphate (FTC‐TP) concentrations in peripheral blood mononuclear cells (PBMCs) were measured in all participants. Cervical and rectal tissues were obtained in a subset of 20 participants (10 per group) to measure TDF‐DP and FTC‐TP.ResultsThirty‐nine participants (19 F/TDF and 20 F/TAF) completed the PK visits. No significant changes in the PK parameters of plasma total testosterone, TFV, FTC and TAF (for F/TAF group); urine TFV and FTC; and PBMC and rectal tissue TFV‐DP and FTC‐TP were observed when MHT and PrEP were administered together. Both TFV‐DP and FTC‐TP concentrations in cervical tissue were significantly lower when MHT was co‐administered with F/TAF (TFV‐DP: median [IQR] of 12.9 [6.78–14.56] fmol/mg at weeks 12 vs. 20.63 [7.47–53.43] fmol/mg at week 16, p = 0.04; and FTC‐TP: 67.05 [27.24–77.24] fmol/mg vs. 120.43 [65.98–245.76] fmol/mg, p = 0.02).ConclusionsOur findings across multiple anatomical compartments suggest that oral PrEP should not affect the effectiveness of MHT and that F/TDF‐based PrEP should be effective when taken with MHT. However, further research is needed to assess the effectiveness of TAF‐based PrEP in transgender men.Clinical Trial NumberNCT04593680.

01 Feb 2025·Clinical Nutrition ESPEN

Effects of time-restricted feeding and weight-loaded swimming test on androgen levels and androgen receptor expression in orchiectomized male Wistar rats

Article

Author: Mohd Esa, Norhaizan ; Yaacob, Azhar ; Abu Saad, Hazizi ; Liow, Chun Hung

BACKGROUND & AIMSTestosterone, vital for reproductive health and muscle development, declines with age, increasing susceptibility to conditions like diabetes, obesity and sarcopenia. Conventional hormone therapy carries risks, including elevated prostate-specific antigens and prostate cancer risk, prompting exploration of safer options like intermittent fasting (IF) and physical training (PT) which potentially boost androgen in certain cases. However, their combined impacts on testosterone remain underexplored. This study aimed to assess the individual and combined effects of IF and PT on androgen and androgen receptor (AR) levels.METHODSForty male Wistar rats were divided into five groups (n = 8 each): negative control (NC) receiving food ad libitum without orchiectomized, positive control (PC) receiving daily testosterone enanthate injections, IF with 16/8 time-restricted feeding, PT with 1-h forced swimming sessions, and combined IF + PT. After 8 weeks, DHEA and testosterone levels, AR expression, gastrocnemius muscle histology, and body weight were assessed.RESULTSIn comparison to the NC group (429.40 ± 26.86 g), body weight in the IF (348.90 ± 15.94 g, PT (391.40 ± 16.35 g), and IF + PT groups, (360.90 ± 29.90 g) was significantly lowered (p < 0.05) after 8 weeks of study. The muscle fiber cross-sectional area in the IF (2968 μm²; IQR 1995-4053 μm²), PT (2956 μm²; IQR 2089-4371 μm²), and IF + PT groups, (3389 μm²; IQR 2260-4596 μm²) was significantly greater than the NC group (2508 μm²; IQR 1800-3567 μm². p < 0.05) after the study. DHEA levels significantly increased in the PT and IF + PT groups (375.01 ± 32.55 ng/μL and 420.00 ± 24.50 ng/μL, respectively) compared to the NC group (257.09 ± 67.79 ng/μL, p < 0.05). However, neither IF nor PT, alone or in combination, resulted in improvements in testosterone levels or AR expression in the gastrocnemius muscle. with testosterone levels remained unchanged.CONCLUSIONIF, PT, and IF + PT demonstrated potential effects on improving androgen levels, managing weight, and enhancing muscle growth, with IF + PT emerging as the most effective intervention. Despite these positive outcomes, the lack of impact on AR expression and testosterone levels suggests the need for further research to elucidate the underlying mechanisms and potential clinical applications for managing androgen deficiency through these interventions.

01 Jan 2025·Drug Testing and Analysis

Simultaneous detection of testosterone, nandrolone, and boldenone esters in dried blood spots for doping control in sports by liquid chromatography–tandem mass spectrometry

Article

Author: Ota, Masanori ; Okano, Masato ; Miyamoto, Asami ; Sato, Mitsuhiko

AbstractTestosterone, nandrolone, and boldenone, which are listed as doping substances on the World Anti‐Doping Agency Prohibited List, are mostly available commercially in esterified forms. Isotope ratio mass spectrometry (IRMS) represents a key tool for identifying these substances, as they are hydrolyzed and discharged in the urine as pseudo‐endogenous substances. However, IRMS, which comprises a complicated process, cannot achieve the direct detection of steroid esters in blood samples. These substances can be detected using dried blood spots (DBSs), reducing the impact of esterase hydrolysis. Here, a simultaneous liquid chromatography–tandem mass spectrometry method for detecting 28 steroid (13 testosterone, nine nandrolone, and six boldenone) esters was developed using three DBS types of samples, including a cellulose paper and polymer. The substances were first derivatized with methyloxime to increase their sensitivities (the limits of detection were <0.1–0.4, <0.1–0.9, and <0.1–0.9 ng/mL for the testosterone, nandrolone, and boldenone esters, respectively). Further, the DBS absorbents were verified since the effect of interferences depended on it. Next, a study involving seven participants was conducted to detect intramuscularly administered testosterone enanthate (100 mg). Polymer and cellulose papers were used to collect blood from their upper arms and fingertips, respectively, and testosterone enanthate was identified and detectable at both blood‐collection sites for up to 144 and 216 h, respectively. Furthermore, testosterone enanthate was detectable in the DBS samples stored under refrigeration after 6 months, indicating the stable nature of DBS.

News (Medical) associated with Testosterone Enanthate

28 Apr 2025

·www.prnewswire.com

Halozyme Announces argenx Received Positive CHMP Opinion for VYVGART® (efgartigimod alfa) Subcutaneous Injection with ENHANZE® for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

European Commission (EC) decision on marketing authorization application expected within approximately two months SAN DIEGO, April 28, 2025 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) (Halozyme) today announced that argenx received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency recommending European Commission (EC) approval of VYVGART® 1000mg (efgartigimod alfa) developed with ENHANZE®, Halozyme's proprietary recombinant human hyaluronidase enzyme (rHuPH20) for subcutaneous (SC) injection as a monotherapy for the treatment of adult patients with progressive or relapsing active chronic inflammatory demyelinating polyneuropathy (CIDP) after prior treatment with corticosteroids or immunoglobulins. The SC injection of VYVGART® is available as a vial or prefilled syringe and can be administered by a patient, caregiver, or healthcare professional. VYVGART is the first and only targeted IgG Fc-antibody fragment for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) and the first novel mechanism of action for CIDP treatment in more than 30 years. "We are delighted that the subcutaneous injection of VYVGART® co-formulated with our ENHANZE drug delivery technology, has been recommended for approval in the European Union. The positive CHMP opinion moves argenx closer to offering patients throughout Europe a groundbreaking new treatment option. We are proud to support argenx achieve their vision of developing innovative, targeted treatments for patients with rare and severe autoimmune diseases," said Dr. Helen Torley, president and chief executive officer of Halozyme. The CHMP recommendation is based on positive results from the ADHERE clinical trial, the largest study of CIDP patients to date. For more information on the CHMP recommendation, and the ADHERE study and its findings, please view argenx's press release issued on April 28, 2025. The EC is expected to make a decision following CHMP recommendation and the decision will apply to all 27 European Union Member States, and also to Iceland, Norway and Liechtenstein. 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 one million patient lives in post-marketing use in ten commercialized products in at least one major region and 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 McDermott Laboratories Limited, an affiliate of Viatris Inc. 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. Safe Harbor Statement In addition to historical information, the statements set forth above include forward-looking statements including, without limitation, statements concerning the possible activity, benefits and attributes of ENHANZE®, the possible method of action of ENHANZE®, its potential application to aid in the dispersion and absorption of other injected therapeutic drugs, and statements concerning certain other potential benefits of ENHANZE® including facilitating more rapid delivery of injectable medications through subcutaneous delivery and potentially lowering the treatment burden for patients, including a potential reduction in administration time and broadening the treatment options for the indication referred to in this press release. Forward-looking statements may also include statements regarding the product development efforts of Halozyme's ENHANZE® partner and the potential approval of an extension of marketing authorization for the subcutaneous formulation referred to in this press release and the timing of such potential approval. These forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. The 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. Actual results could differ materially from the expectations contained in forward-looking statements as a result of several factors, including uncertainties concerning whether the extension of marketing authorization for the subcutaneous formulation referred to in this press release is delayed or ultimately approved, unexpected results or delays in the launch or commercialization of our partner's product for the indication referred to in this press release, unexpected adverse events or patient experiences or outcomes from being treated with the ENHANZE® co-formulated treatment referred to in this press release, and competitive conditions. These and other factors that may result in differences are discussed in greater detail in Halozyme's most recent Annual and Quarterly Reports filed with the Securities and Exchange Commission. Except as required by law, Halozyme 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 609-333-7668 [email protected] Samantha Gaspar Teneo 212-886-9356 [email protected] 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

Drug ApprovalClinical Result

22 Apr 2025

·www.globenewswire.com

Marius Pharmaceuticals Welcomes John "Shrek" Mcphee as Kyzatrex® (testosterone undecanoate) CIII Capsules Patient Ambassador

The U.S. Army Special Operations Veteran and Tactical Fitness Personality Champions a Non-Invasive Testosterone SolutionRALEIGH, N.C., April 22, 2025 (GLOBE NEWSWIRE) -- Marius Pharmaceuticals, a pharmaceutical company focused on developing innovative therapies for testosterone deficiency, announces its partnership with John “Shrek” McPhee, widely recognized in tactical and fitness communities as the “Sheriff of Baghdad,” who joins KYZATREX® (testosterone undecanoate) CIII capsules as a patient ambassador. McPhee is known for his strong advocacy of testosterone health and his clear preference for non-invasive treatment options. “This is a great solution, I hate injections. Period,” said McPhee. “Finding KYZATREX means I can be on TRT without sticking myself with a needle or more likely, not being on testosterone at all. It’s effective, easy, and doesn’t screw up my routine.” McPhee, a veteran with extensive experience in active military combat and pistol training—having trained over 15,000 individuals on the use of firearms—is a familiar voice on platforms such as the Joe Rogan and Shawn Ryan podcasts. McPhee has also appeared on the Power Athlete podcast, where he introduces the treatment and how KYZATREX has helped to improve his overall health. Marius Pharmaceuticals applauds individuals who raise awareness about testosterone deficiency, particularly among veterans who often face challenges related to low testosterone. Research indicates that testosterone deficiency is a prevalent concern within veteran communities, highlighting the need for effective and patient-friendly treatment solutions. By joining the KYZATREX ambassador program, McPhee is helping to bring more attention to these important health issues. “Partnering with John ‘Shrek’ McPhee, reinforces our commitment to making testosterone therapy accessible and effective,” said Marius Pharmaceuticals CEO Shalin Shah, adding, “With KYZATREX’s innovative, non-invasive formulation, we’re breaking away from outdated injection-based therapies and offering a more patient-friendly solution.” For more information on the Sheriff of Baghdad please visit the SOB Tactical website linked here. About KYZATREX® (testosterone undecanoate) KYZATREX is a proprietary softgel oral formulation absorbed primarily via the lymphatic system (meaning it is not toxic to the liver) indicated in adult males for conditions associated with a deficiency or absence of endogenous testosterone. The safety and efficacy of KYZATREX was demonstrated in a phase 3, multi-center, open-label, six-month study in 155 hypogonadal males between 18 and 65 years of age with documented hypogonadism, as defined by a below normal serum testosterone level (≤281 ng/dL) and at least one sign or symptom of testosterone deficiency. In the efficacy population (n=139), 88 percent of hypogonadal men treated with KYZATREX achieved a mean plasma total testosterone concentration (Cavg) over 24 hours within the normal range (222-800 ng/dL) on the final pharmacokinetic (PK) visit of the study at Day 90 (primary endpoint). Based on exploratory endpoints, patients who received KYZATREX reported improvements in quality of life, energy/fatigue, erectile function, intercourse satisfaction, and positive mood. The most common side effect reported in ≥2 percent of KYZATREX patients was increased blood pressure (2.6%). The safety and efficacy of KYZATREX in males less than 18 years old have not been established. Please see additional Important Safety Information below, including Boxed Warning for potential increased blood pressure, for KYZATREX or visit www.kyzatrex.com. About Marius Pharmaceuticals Marius Pharmaceuticals strives to better the lives of men and women by focusing on therapies designed for hypogonadism or Testosterone Deficiency. Their 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® (testosterone undecanoate) Use KYZATREX (testosterone undecanoate) is a prescription drug that is used to treat adult men who have low or no testosterone levels due to certain medical conditions. KYZATREX is a controlled substance (CIII) because it contains testosterone. It is not known if KYZATREX is safe or effective in males younger than 18 years old. Improper use may affect bone growth in children. KYZATREX is not meant for use by women. Important Safety Information for KYZATREX® (testosterone undecanoate) 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 calling 1-833-949-5040. Keep KYZATREX and all medicines out of the reach of children. See Full Prescribing Information and Medication Guide for KYZATREX. Media Contacts: Lucky Break PR marius@luckybreakpr.com

Clinical ResultPhase 3

10 Apr 2025

·www.prnewswire.com

Halozyme Announces FDA Approval of argenx's VYVGART® Hytrulo Prefilled Syringe Co-Formulated with ENHANZE® for Self-Injection for Generalized Myasthenia Gravis and Chronic Inflammatory Demyelinating Polyneuropathy

SAN DIEGO, April 10, 2025 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) (Halozyme) today announced that argenx has received U.S. Food and Drug Administration (FDA) approval of VYVGART® Hytrulo prefilled syringe for self-injection (efgartigimod alfa and hyaluronidase-qvfc) for the treatment of adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive and adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP). VYVGART® Hytrulo prefilled syringe for self-injection is approved as a 20-to-30-second subcutaneous injection administered by a patient, caregiver, or healthcare professional. Patients are able to self-inject after proper instruction in subcutaneous injection technique. The single dose prefilled subcutaneous injection was developed as part of argenx's exclusive partnership with Halozyme on their ENHANZE® drug delivery technology, which enables rapid, high-volume delivery of biologics "The FDA approval of VYVGART Hytrulo prefilled syringe represents a significant advancement in treatment options for gMG and CIDP patients, enabling self-administration by patients and potentially further reducing the burden of treatment," said Dr. Helen Torley, president and chief executive officer of Halozyme. "We are delighted that argenx continues to expand use of Halozyme's proven ENHANZE technology to support patient independence and convenience." The approval of VYVGART® Hytrulo prefilled syringe for self-injection is supported by data from studies evaluating its bioequivalence to VYVGART® Hytrulo in a vial. In addition, human factors validation studies demonstrated that participants with gMG or CIDP, or their caregivers, safely and successfully prepared and administered VYVGART® Hytrulo with the prefilled syringe. Previous FDA approval of VYVGART® Hytrulo for patients with gMG and CIDP was based on the global Phase 3 ADAPT, ADAPT-SC and ADHERE trials. 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 one million patient lives in post-marketing use in ten 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. Safe Harbor Statement In addition to historical information, the statements set forth above include forward-looking statements including, without limitation, statements concerning the possible activity, benefits and attributes of ENHANZE®, the possible method of action of ENHANZE®, its potential application to aid in the dispersion and absorption of other injected therapeutic drugs, and statements concerning certain other potential benefits of ENHANZE® including facilitating more rapid delivery of injectable medications through subcutaneous delivery and potentially lowering the treatment burden for patients, including offering flexibility to receive treatment in more convenient locations by enabling self-administration and broadening the treatment options for the indication referred to in this press release. These forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. The 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. Actual results could differ materially from the expectations contained in forward-looking statements as a result of several factors, including unexpected results or delays in launch or commercialization of our partner's product referred to in this press release, unexpected adverse events or patient experiences or outcomes from being treated with the ENHANZE® co-formulated treatment referred to in this press release, and competitive conditions. These and other factors that may result in differences are discussed in greater detail in Halozyme's most recent Annual and Quarterly Reports filed with the Securities and Exchange Commission. Except as required by law, Halozyme 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 609-333-7668 [email protected] Samantha Gaspar Teneo 212-886-9356 [email protected] 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

Drug ApprovalPhase 3

100 Deals associated with Testosterone Enanthate

External Link

KEGG	Wiki	ATC	Drug Bank
D00958	Testosterone Enanthate	G03BA03	DB13944

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Low testosterone levels	United States	Antares Pharma, Inc.	28 Sep 2018
Anemia, Aplastic	Japan	-	10 Feb 1954
Hypogonadism	Japan	-	10 Feb 1954
Infertility, Male	Japan	-	10 Feb 1954
Primary Myelofibrosis	Japan	-	10 Feb 1954

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Eunuchism	Phase 3	United States	Halozyme Therapeutics, Inc.	05 Feb 2025
Cachexia	Preclinical	United States	GSK Plc	05 May 2014
Contraception	Preclinical	United States	GSK Plc	01 Nov 2006
Hypogonadism	Preclinical	United States	Endo Pharmaceuticals, Inc.	24 Dec 1953

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02938923 (STEP-HI, CTgov)	Phase 3	Hip Fractures \| Femoral Neck Fractures \| Sarcopenia	129	Supervised exercise training+Testosterone (Exercise + Testosterone (EX + T))	zvqxrgsueg(uarnxvtwva) = rxjdgcpufu wgdyfncpsu (cjsampqzji, qbatldftgk - ovybvqykch) View more	-	04 Feb 2025
				Supervised exercise training (Exercise + Placebo (EX + P))	zvqxrgsueg(uarnxvtwva) = shlxnnngqy wgdyfncpsu (cjsampqzji, fkkeemvjpz - qoyrwkwfxk) View more
NCT02248701 (CTgov)	Phase 2	Hypogonadism \| Genital Diseases, Male \| Spinal Cord Injuries	33	Finasteride+Testosterone Enanthate (Testosterone Enanthate, Finasteride)	ilkuhhqaoi(gzhjdxqjyg) = asauhytbxp uvmvhgdbns (zbeynvspev, dberhtkhnj - iicoxmqigx) View more	-	29 Sep 2023
				Placebo pill (Placebo Treatment)	ilkuhhqaoi(gzhjdxqjyg) = pegjkkletn uvmvhgdbns (zbeynvspev, qielcxukyn - oubwmprufm) View more
NCT03123913 (STARFISH, CTgov)	Phase 1	Muscular Dystrophy, Facioscapulohumeral	20	Somatropin+Testosterone Enanthate	kvpkenzkqs(bjxsxjcwex) = euiamudpwr uoxqrkemjf (ytwieqydsy, afdfwmfmvb - xdljesfbyf) View more	-	16 May 2023
LBODP090 (ENDO2022)	Not Applicable	Penis Agenesis	164	Testosterone Enanthate 100 mg/m2	bfhgeuyyfx(aavyrtvlxp) = cuhneumsrb bhnvotewaa (ohenqyvoed, 2.08)	Positive	01 Nov 2022
				Anastrozole 1 mg/day	bfhgeuyyfx(aavyrtvlxp) = knedpfoqvw bhnvotewaa (ohenqyvoed, 2.3)
NCT02090114 (RESTORE, CTgov)	Phase 2	Prostatic Cancer	112	Enzalutamide+Testosterone Enanthate+Testosterone cypionate (Cohort A:Post-enzalutamide)	kjhgelaamv(klrtoxiwvk) = ygjaxmwlgr gsypkyrffd (omwtlwlgrs, mqvbtmabnq - rhouzffxib) View more	-	27 Jun 2022
				Testosterone Enanthate+Abiraterone acetate+Testosterone cypionate (Cohort B: Post-abiraterone)	kjhgelaamv(klrtoxiwvk) = vgofvcjsxy gsypkyrffd (omwtlwlgrs, mexmoncioc - veotectimo) View more
NCT03516812 (CTgov)	Phase 2	Castration-Resistant Prostatic Cancer \| Metastatic castration-resistant prostate cancer \| Adenocarcinoma of prostate	36	Survey Administration+Olaparib+Testosterone Enanthate+Testosterone Cypionate	zchcdtdiya(pxxiraulbp) = qshrrkylbo bjppfdtemg (pzhycivhan, hhpzhqwrae - ksqecqjhud) View more	-	18 May 2022
ESPE2021	Not Applicable	Penis Agenesis	45	Androstanolone	(rfvnimefdl) = fkomvczink gbemhbzucf (fepuafjnrh ) View more	Positive	22 Sep 2021
				Testosterone Enanthate	(rfvnimefdl) = ydszznxayh gbemhbzucf (fepuafjnrh ) View more
AUA2021	Not Applicable	Multiple Endocrine Neoplasia serum total testosterone (TT) \| hematocrit (HCT) \| estradiol (E2) ... View more	263	Intramuscular Testosterone Cypionate	fqvoyzjnkt(muspttuyfh) = yfdjmxnqme ddahppbgjc (bihbpakaaa )	-	01 Sep 2021
				Subcutaneous Testosterone Enanthate	fqvoyzjnkt(muspttuyfh) = mzhxxqijto ddahppbgjc (bihbpakaaa )
NCT02408445 (CTgov)	Phase 4	Klinefelter Syndrome	20	testosterone cypionate 200mg/ml (Testosterone Treatment)	bdgadkezra(vramamgbdg) = ijxiztqtld escxaemfwt (jomenqcogv, isukecqbwk - rgtoqnunyy) View more	-	15 Apr 2020
				testosterone (No Treatment)	bdgadkezra(vramamgbdg) = psyqymspnt escxaemfwt (jomenqcogv, nkxfomcbpz - lueyojepza) View more
ESPE2019	Not Applicable	Eunuchism	18	Testosterone Enanthate	hebzvidore(socpfubuhj) = uzhrvikkzi xtdafmblgh (nxwxkaxjjk )	Positive	19 Sep 2019

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