Testosterone Enanthate

Overview

Testosterone enanthate is an esterified variant of testosterone that comes as an injectable compound with a slow-release rate. This slow release is achieved by the presence of the enanthate ester functional group attached to the testosterone molecule. This testosterone derivative was first approved on December 24, 1953. In 2017, about 6.5 million retail prescriptions for testosterone therapy were filled . The majority of the prescriptions written were for injectable (66%) and topical (32%) testosterone products. As recent as 1 October 2018, the US FDA approved Antares Pharma Inc.'s Xyosted - a subcutaneous testosterone enanthate product for once-weekly, at-home self-administration with an easy-to-use, single dose, disposable autoinjector . As the first subcutaneous autoinjector product designed for testosterone replacement therapy, this innovative formulation removes transfer concerns commonly associated with testosterone gels and potentially reduces the need for in-office/in-clinic injection procedures that may inconvenience patients with frequent visits to the clinic .

Indication

⑴男性性功能低减替代疗法；⑵绝经后女性晚期乳腺癌姑息性治疗；⑶男性青春期发育迟缓。⑷再生障碍性贫血。

Associated Conditions

Congenital Hypogonadotropic Hypogonadism
Hypergonadotropic Hypogonadism
Idiopathic Hypogonadotropic Hypogonadism

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Working Out M0 Bipolar Androgen Therapy	2024/09/19	NCT06594926	Phase 2	Recruiting	Australian and New Zealand Urogenital and Prostate Cancer Trials Group
Testosterone Treatment for Erectile Dysfunction and Multiple Sclerosis	2020/10/23	NCT04601233	Phase 4	Not yet recruiting	Tulane University
Locomotor Training With Testosterone to Promote Bone and Muscle Health After Spinal Cord Injury	2020/07/08	NCT04460872	Phase 2	Recruiting	North Florida Foundation for Research and Education
Sequential Testosterone and Enzalutamide Prevents Unfavorable Progression	2020/04/27	NCT04363164	Phase 2	Recruiting	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Testosterone Effects on Pelvic Floor Muscles	2019/07/19	NCT04026880	Phase 3	Withdrawn	Brigham and Women's Hospital
Cycled Testosterone Administration During Pulmonary Rehabilitation in Early Stage COPD	2018/09/17	NCT03674320	Phase 2	Withdrawn	The University of Texas Medical Branch, Galveston
Testosterone and Olaparib in Treating Patients With Castration-Resistant Prostate Cancer	2018/05/04	NCT03516812	Phase 2	Completed	University of Washington
Study of Testosterone and rHGH in FSHD	2017/04/21	NCT03123913	Phase 1	Completed	University of Rochester
Physiological and Psychological Effects of Testosterone During Severe Energy Deficit and Recovery	2016/04/12	NCT02734238	Phase 4	Completed	Pennington Biomedical Research Center
Pilot Pharmacokinetic Study of Oral Testosterone Ester Formulations in Hypogonadal Men	2016/03/03	NCT02697188	Phase 2	Completed	Clarus Therapeutics, Inc.

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
TESTOSTERONE ENANTHATE	Hikma Pharmaceuticals USA Inc.	0143-9750	INTRAMUSCULAR	200 mg in 1 mL	11/12/2021
XYOSTED	Antares Pharma, Inc.	54436-250	SUBCUTANEOUS	50 mg in 0.5 mL	8/1/2023
TESTOSTERONE ENANTHATE	Eugia US LLC	55150-336	INTRAMUSCULAR	200 mg in 1 mL	9/19/2018
XYOSTED	Antares Pharma, Inc.	54436-200	SUBCUTANEOUS	100 mg in 0.5 mL	8/1/2023
XYOSTED	Antares Pharma, Inc.	54436-275	SUBCUTANEOUS	75 mg in 0.5 mL	8/1/2023

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
MALOGEX LA200 LIQ 200MG/ML	Germiphene Corporation	02027054	Liquid - Intramuscular	200 MG / ML	12/31/1995
TESTOSTERONE ENANTHATE INJECTION, USP	hikma canada limited	02536315	Solution - Intramuscular	200 MG / ML	1/30/2024
PMS-TESTOSTERONE ENANTHATE INJ 200MG/ML USP	Pharmascience Inc	00739944	Liquid - Intramuscular	200 MG / ML	12/31/1991
DELATESTRYL	bausch health, canada inc.	00029246	Solution - Intramuscular	200 MG / ML	12/31/1955
TESTOSTERONE ENANTHATE INJ 200MG/ML	Taro Pharmaceuticals Inc	00716936	Liquid - Intramuscular	200 MG / ML	12/31/1988
NEO PAUSE INJECTION	neolab inc	00147567	Solution - Intramuscular	100 MG / ML	12/31/1970

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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