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Depo-testadiol, Intrinsa(testosterone enanthate)
Androgel, Depo-testadiol, Ditate, Fortesta, Intrinsa, Livensa, Natesto, Testim, 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
Androgel, Fortesta, Natesto, Testim, Vogelxo, Xyosted (generic drugs available since 1982-01-01, discontinued: Androderm, Axiron, Delatestryl, Striant, Testoderm)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Estradiol cypionate
+
Testosterone cypionate
Tradename
Company
Number
Date
Products
DEPO-TESTADIOLPharmacia & UpjohnN-017968 DISCN1982-01-01
1 products
Hide discontinued
Testosterone
Tradename
Company
Number
Date
Products
NATESTOAcerus Pharmaceuticals CorporationN-205488 RX2014-05-28
1 products, RLD, RS
TESTIMAuxilium PharmaceuticalsN-021454 RX2002-10-31
1 products, RLD, RS
ANDROGELBESINS HLTHCAREN-022309 RX2011-04-29
1 products, RLD, RS
FORTESTAEndoN-021463 RX2010-12-29
1 products, RLD, RS
VOGELXOUpsher-Smith LaboratoriesN-204399 RX2014-06-04
2 products
Show 9 discontinued
Testosterone cypionate
Tradename
Company
Number
Date
Products
TESTOSTERONE CYPIONATESlayback PharmaN-216318 PEND2022-06-02
1 products, RLD
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
androdermNew Drug Application2020-05-18
androgelNew Drug Application2023-03-07
axiron New Drug Application2013-11-12
fortestaNew Drug Application2022-01-19
natesto New Drug Application2021-12-22
striantNew Drug Application2009-11-19
testimNew Drug Application2021-08-25
testopelANDA2018-08-24
vogelxoNew Drug Application2020-07-09
xyostedNew Drug Application2020-11-18
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
breast neoplasmsEFO_0003869D001943C50
delayed pubertyHP_0000823D011628E30.0
hypogonadismHP_0000815D007006E23.0
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
102386622035-02-19DPU-2418
109127822035-02-19DPU-2418
111607512034-10-07DPU-2418
108817982034-02-11DP
108210722033-06-04DPU-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
87848782023-07-13DPU-1545
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
Testosterone, Testim, Auxilium Pharms Llc
73209682025-01-18U-843
76086052023-04-21U-1009
76086062023-04-21U-1009
76086072023-04-21U-1009
76086082023-04-21U-1009
76086092023-04-21U-1009
76086102023-04-21U-1009
79356902023-04-21U-1009
80630292023-04-21U-843
81785182023-04-21DP
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
3 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
TranssexualismD014189F64.0———1—1
Indications Phases 3
No data
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Precocious pubertyD011629E22.8—2———2
Polyostotic fibrous dysplasiaD005359Orphanet_562Q78.1—1———1
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)
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
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
Androgel - AbbVie
$
€
£
₣
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Testopel - Auxilium Pharmaceuticals
$
€
£
₣
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Mock data
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Striant - Juniper Pharmaceuticals
$
€
£
₣
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Testim - Auxilium Pharmaceuticals
$
€
£
₣
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 110,045 documents
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Safety
Black-box Warning
Black-box warning for: Androgel, Axiron , Fortesta, Testim, Vogelxo, Xyosted
Adverse Events
Top Adverse Reactions
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4 adverse events reported
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