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

1,304

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

Abstract:

Introduction:

Concerns 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.

Methods:

Transgender 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.

Results:

Thirty‐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).

Conclusions:

Our 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 Number:

NCT04593680.

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

BACKGROUND & AIMS:

Testosterone, 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.

METHODS:

Forty 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.

RESULTS:

In 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.

CONCLUSION:

IF, 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 ; Sato, Mitsuhiko ; Miyamoto, Asami ; Okano, Masato

Abstract:

Testosterone, 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

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

09 Apr 2025

·www.prnewswire.com

European Commission Approved Subcutaneous DARZALEX® (daratumumab)-based Quadruplet Regimen for the Treatment of Patients with Newly Diagnosed Multiple Myeloma, Regardless of Transplant Eligibility

Subcutaneous DARZALEX® is co-formulated with Halozyme's ENHANZE® drug delivery technology SAN DIEGO, April 9, 2025 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) (Halozyme) today announced that Janssen-Cilag International NV, a Johnson & Johnson company, received European Commission (EC) approval for an indication extension of DARZALEX® (daratumumab) subcutaneous (SC) co-formulated with ENHANZE ® in the frontline setting. The approval is for daratumumab SC in combination with bortezomib, lenalidomide, and dexamethasone (daratumumab-VRd) for the treatment of adult patients with newly diagnosed multiple myeloma.1 "The continued expansion of DARZALEX delivered subcutaneously with ENHANZE into additional settings highlights its status as a cornerstone of therapy for multiple myeloma," said Dr. Helen Torley, President and CEO of Halozyme. "This approval means that newly diagnosed patients can receive daratumumab subcutaneous plus VRd and avoid the need for lengthy IV infusions." This approval follows the indication extension approval for daratumumab-VRd in October 2024, for the treatment of newly diagnosed patients with multiple myeloma who are eligible for autologous stem cell transplant, based on the results from the Phase 3 PERSEUS (NCT03652064) study. The study evaluated this daratumumab SC-based quadruplet regimen for induction and consolidation therapy, followed by daratumumab SC and lenalidomide maintenance.2,3 1 European Medicines Agency. DARZALEX (daratumumab) Summary of Product Characteristics. April 2025. 2 Rodríguez-Otero P, et al. Daratumumab (DARA) + bortezomib/lenalidomide/dexamethasone (VRd) in transplant-eligible (TE) patients (pts) with newly diagnosed multiple myeloma (NDMM): Analysis of minimal residual disease (MRD) in the PERSEUS trial. 2024 American Society for Clinical Oncology Annual Meeting. June 3, 2024. 3 Johnson & Johnson Innovative Medicine EMEA. DARZALEX® (daratumumab)-SC based quadruplet regimen approved by the European Commission for patients with newly diagnosed multiple myeloma who are transplant-eligible. Available at: . Last accessed: April 2025. 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 a potential reduction in administration time and broadening the treatment options for the indications 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 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 ApprovalPhase 3ASCOClinical Result

07 Apr 2025

·www.prnewswire.com

European Commission Approves Subcutaneous RYBREVANT® (amivantamab) Co-Formulated with ENHANZE® for the Treatment of Patients with Advanced EGFR-Mutated Non-Small Cell Lung Cancer

SAN DIEGO, April 7, 2025 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) (Halozyme) today announced that Janssen-Cilag International NV, a Johnson & Johnson company, has received European Commission (EC) marketing authorization of the subcutaneous (SC) formulation of RYBREVANT® (amivantamab), in combination with LAZCLUZE® (lazertinib), for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations. Additionally, it is approved as a monotherapy for adult patients with advanced NSCLC with activating EGFR exon 20 insertion mutations after the failure of platinum-based therapy. Subcutaneous amivantamab is co-formulated Halozyme's ENHANZE® drug delivery technology. "We are delighted to announce the European approval of the subcutaneous formulation of amivantamab, developed using our innovative ENHANZE drug delivery technology. This marks our tenth approved partner product," said Dr. Helen Torley, President and CEO of Halozyme. "The data supporting this approval showed a reduced administration time and decrease in infusion-related reactions, which could have a positive impact on the healthcare system." The EC approval is supported by positive results from the Phase 3 PALOMA-3 study (NCT05388669). For detailed information on the study and its findings, please refer to Johnson & Johnson's press release issued today.1 1 Leighl NB et al. Subcutaneous Versus Intravenous Amivantamab, Both in Combination With Lazertinib, in Refractory Epidermal Growth Factor Receptor–Mutated Non–Small Cell Lung Cancer: Primary Results From the Phase III PALOMA-3 Study. ASCO Journal of Clinical Oncology. 2024;42(3):3593-3605. 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 nine 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 a potential reduction in administration time and infusion related reactions and broadening the treatment options for the indications 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. 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 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

Clinical ResultDrug 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.

to view more data

Indication	Country/Location	Organization	Date
Low testosterone levels	United States	Antares Pharma, Inc.	28 Sep 2018
Anemia, Aplastic	Japan	-	10 Feb 1954
Infertility, Male	Japan	-	10 Feb 1954
Primary Myelofibrosis	Japan	-	10 Feb 1954
Delayed Puberty	United States	Endo Pharmaceuticals, Inc.	24 Dec 1953
Hypogonadism	United States	Endo Pharmaceuticals, Inc.	24 Dec 1953
Metastatic breast cancer	United States	Endo Pharmaceuticals, Inc.	24 Dec 1953

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
Contraception	Phase 2	United States	GSK Plc	01 Nov 2006
Cachexia	Phase 1	United States	GSK Plc	05 May 2014

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))	kodcvtjsyt(hrpjsanmcy) = inxfmwuewm fwgajapwly (zstljeaikd, ucuaesgjna - tqwxtlvstc) View more	-	04 Feb 2025
				Supervised exercise training (Exercise + Placebo (EX + P))	kodcvtjsyt(hrpjsanmcy) = gcvgsqrhjq fwgajapwly (zstljeaikd, jvlhfayjph - wermubjeex) View more
NCT02248701 (CTgov)	Phase 2	Hypogonadism \| Genital Diseases, Male \| Spinal Cord Injuries	33	Finasteride+Testosterone Enanthate (Testosterone Enanthate, Finasteride)	caotouxrpq(qnihiydbzw) = akzxxcjnyz fwdumzteif (dyxlomfnkz, 4.7) View more	-	29 Sep 2023
				Placebo pill (Placebo Treatment)	caotouxrpq(qnihiydbzw) = iowshvgscr fwdumzteif (dyxlomfnkz, 2.4) View more
NCT03123913 (STARFISH, CTgov)	Phase 1	Muscular Dystrophy, Facioscapulohumeral	20	Somatropin+Testosterone Enanthate	bezldzuxse = yykhbirxep tzbnrtadms (zvycbysgds, wqlcaivaam - wshqlbhiep) View more	-	16 May 2023
LBODP090 (ENDO2022)	Not Applicable	Penis Agenesis	164	Testosterone Enanthate 100 mg/m2	lqxfbmotbl(atiqxylito) = npqihawucc vcxaijaxma (rqzkyhbwlh, 2.08)	Positive	01 Nov 2022
				Anastrozole 1 mg/day	lqxfbmotbl(atiqxylito) = ggsoincjko vcxaijaxma (rqzkyhbwlh, 2.3)
NCT02090114 (RESTORE, CTgov)	Phase 2	Prostatic Cancer	112	Enzalutamide+Testosterone Enanthate+Testosterone cypionate (Cohort A:Post-enzalutamide)	jtycvnpsmr = qyevwqblzl lgubrntcda (jirmfyyndl, ixvphpgmhn - qlzwnukucj) View more	-	27 Jun 2022
				Testosterone Enanthate+Abiraterone acetate+Testosterone cypionate (Cohort B: Post-abiraterone)	jtycvnpsmr = qlfvumrrds lgubrntcda (jirmfyyndl, xgzfbgbqgq - qpyoheufmq) View more
NCT02159469 (SAT-037, ENDO2020)	Phase 3	Testosterone deficiency	150	50 mg SC TE dose group	wzczuhmvym(rkzjrclsiv) = jikpquvura bndyryijtd (mdonmsiuru ) View more	Positive	08 May 2020
				75 mg SC TE dose group	wzczuhmvym(rkzjrclsiv) = hrzaudlwix bndyryijtd (mdonmsiuru ) View more
NCT02408445 (CTgov)	Phase 4	Klinefelter Syndrome	20	testosterone cypionate 200mg/ml (Testosterone Treatment)	inyghtlmss(ncwdeyjlsh) = zwpumlfhbx cdnwgqriho (boaneeqpkx, 0.65) View more	-	15 Apr 2020
				testosterone (No Treatment)	inyghtlmss(ncwdeyjlsh) = gqjicpqhyp cdnwgqriho (boaneeqpkx, 0.62) View more
NCT02504541 (Pubmed \| J Sex Med)	Phase 3	Hypogonadism	133	SCTE-AI 75 mg	cdsvcczctp(hkrorsbpao) = qvuhunmsre fjqsyhsuzg (aaxfeewnol ) View more	-	01 Nov 2019
ESPE2019	Not Applicable	Eunuchism	18	Testosterone Enanthate	drsraooiyj(zfavrqyaur) = uafsfwtwjh nlpcmjxyei (zaixnblciy )	Positive	19 Sep 2019
NCT02286921 (TRANSFORMER, CTgov)	Phase 2	Metastatic castration-resistant prostate cancer	222	Testosterone Enanthate+Testosterone cypionate (Arm A: Testosterone Cypionate or Testosterone Enanthate)	mnwbmvplrj(tpmzdqtiso) = coxhzzblhh avsvgvfsah (erztiyzkys, zgruvwczwr - tmuuooanqr) View more	-	01 May 2019
				Enzalutamide (Arm B: Enzalutamide)	mnwbmvplrj(tpmzdqtiso) = dppelgibfh avsvgvfsah (erztiyzkys, xhrhfjpspj - ktcipxoxak) View more

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