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Drug ReportsTestosterone enanthate
Testosterone enanthate
Androgel, Azmiro, Depo-testadiol, Ditate, Intrinsa, Livensa, Natesto, Testim, Testopel, Testosterone, Vogelxo, Xyosted (testosterone enanthate) is a small molecule pharmaceutical. Testosterone enanthate was first approved as Depo-testadiol on 1982-01-01. It is used to treat breast neoplasms, delayed puberty, and hypogonadism in the USA. It has been approved in Europe to treat psychological sexual dysfunctions.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
skin and connective tissue diseasesD017437
endocrine system diseasesD004700
mental disordersD001523
Trade Name
FDA
EMA
Testosterone enanthate, Xyosted (discontinued: Delatestryl, Testosterone enanthate)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Testosterone enanthate
Tradename
Company
Number
Date
Products
XYOSTED (AUTOINJECTOR)Antares PharmaN-209863 RX2018-09-28
3 products, RLD, RS
Show 1 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
androgelNew Drug Application2024-09-18
aveedNew Drug Application2021-08-28
axironNew Drug Application2013-11-12
azmiroNew Drug Application2025-01-03
depo-testosteroneANDA2024-01-11
jatenzoNew Drug Application2025-05-16
kyzatrexNew Drug Application2023-10-26
natestoNew Drug Application2025-03-31
striantNew Drug Application2009-11-19
testimNew Drug Application2021-08-25
Show 12 more
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
breast neoplasmsEFO_0003869D001943C50
hypogonadism—D007006E23.0
delayed puberty—D011628E30.0
prostatic neoplasms—D011471C61
menorrhagiaEFO_0003945D008595N92.0
primary ovarian insufficiencyEFO_0004266D016649E28.3
hot flashes—D019584—
premature menopause—D008594E28.31
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Testosterone Cypionate, Testosterone Cypionate, Slayback Pharma Llc
113115542039-03-25DP
116423552039-03-25DP
Testosterone Enanthate, Xyosted (Autoinjector), Antares Pharma Inc
106464952038-08-30DP
99501252036-09-04DPU-2418
97443022035-11-19DP
111919082035-10-18DP
118134352035-02-25DP
102386622035-02-19DPU-2418
109127822035-02-19DPU-2418
111607512034-10-07DPU-2418
108817982034-02-11DP
108210722033-06-04DPU-2418
118448042033-06-04U-2418
103576092031-08-21DP
109058272031-08-21DP
114464402031-08-21DP
102791312031-07-31DP
114977532030-03-19DP
80213352026-10-04DP
85625642026-01-24DP
91802592026-01-24DP
95331022026-01-24DP
96299592026-01-24DP
104785602026-01-24DP
114464412026-01-24DP
Testosterone, Natesto, Acerus
110903122034-03-17U-1616
85746222024-02-04DP
87848692024-02-04DP
87848822024-02-04DPU-1557
88772302024-02-04U-1616
Testosterone, Vogelxo, Upsher Smith Labs
87854262034-02-11DPU-1531
92956752034-02-11DPU-1531
96623402034-02-11DPU-1531
Testosterone, Axiron, Eli Lilly And Co
84359442027-09-27U-1390
84193072027-02-26U-1386
88078612027-02-26DPU-1563
92895862027-02-26U-1390
89935202026-06-02U-1390
91801942026-06-02U-1390
Testosterone, Androgel, Besins Hlthcare
84661362026-10-12DP
84661372026-10-12U-1103
84661382026-10-12U-1103
84869252026-10-12DP
87290572026-10-12DP
87418812026-10-12U-1103
87540702026-10-12DP
87593292026-10-12DP
ATC Codes
G: Genito urinary system and sex hormones
— G03: Sex hormones and modulators of the genital system
— G03B: Androgens
— G03BA: 3-oxoandrosten (4) derivatives
— G03BA03: Testosterone
— G03E: Androgens and female sex hormones in combination
— G03EA: Androgens and estrogens
— G03EA02: Testosterone and estrogen
— G04: Urologicals
— G04C: Drugs used in benign prostatic hypertrophy
— G04CB: Testosterone-5-alpha reductase inhibitors for benign prostatic hypertrophy
HCPCS
Code
Description
J3121
Injection, testosterone enanthate, 1 mg
Clinical
Clinical Trials
892 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
HypogonadismD007006—E23.011—2—4
MenopauseD008593EFO_0003922N95———1—1
Cardiovascular diseasesD002318EFO_0000319I98———1—1
Indications Phases 3
No data
Indications Phases 2
No data
Indications Phases 1
No data
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameTestosterone enanthate
INNtestosterone
Description
Testosterone enanthate is a heptanoate ester and a sterol ester. It has a role as an androgen. It is functionally related to a testosterone.
Classification
Small molecule
Drug classsteroids (androgens, anabolics); antiandrogens
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
CCCCCCC(=O)O[C@H]1CC[C@H]2[C@@H]3CCC4=CC(=O)CC[C@]4(C)[C@H]3CC[C@]12C
Identifiers
PDB—
CAS-ID315-37-7
RxCUI—
ChEMBL IDCHEMBL1200335
ChEBI ID9464
PubChem CID9416
DrugBankDB00624
UNII ID3XMK78S47O (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Striant – Juniper Pharmaceuticals
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Androgel – AbbVie
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Testim – Auxilium Pharmaceuticals
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Testopel – Auxilium Pharmaceuticals
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Tabular view
Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 36,241 documents
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Safety
Black-box Warning
Black-box warning for: Androgel, Aveed, Axiron, Kyzatrex, Testim, Testosterone, Testosterone gel, 1%, Tlando, Undecatrex, Vogelxo
Adverse Events
Top Adverse Reactions
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40,627 adverse events reported
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