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Testosterone Enanthate

Generic Name
Testosterone Enanthate
Brand Names
Delatestryl, Xyosted
Drug Type
Small Molecule
Chemical Formula
C26H40O3
CAS Number
315-37-7
Unique Ingredient Identifier
7Z6522T8N9

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
2024/09/19
Phase 2
Recruiting
Australian and New Zealand Urogenital and Prostate Cancer Trials Group
2020/10/23
Phase 4
Not yet recruiting
2020/07/08
Phase 2
Recruiting
2020/04/27
Phase 2
Recruiting
2019/07/19
Phase 3
Withdrawn
2018/09/17
Phase 2
Withdrawn
2018/05/04
Phase 2
Completed
2017/04/21
Phase 1
Completed
2016/04/12
Phase 4
Completed
2016/03/03
Phase 2
Completed

FDA Drug Approvals

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