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Depo-testadiol, Intrinsa(testosterone)
Androgel, Depo-testadiol, Ditate, Fortesta, Intrinsa, Livensa, Natesto, Testim, Vogelxo, Xyosted (testosterone) is a small molecule pharmaceutical. Testosterone 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. The pharmaceutical is active against androgen receptor.
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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 Application2020-06-30
natestoNew Drug Application2020-11-12
striantNew Drug Application2009-11-19
testimNew Drug Application2020-11-29
testopelANDA2018-08-24
vogelxoNew Drug Application2020-07-09
xyostedNew Drug Application2021-12-21
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
J1071
Injection, testosterone cypionate, 1 mg
J3121
Injection, testosterone enanthate, 1 mg
J3145
Injection, testosterone undecanoate, 1 mg
S0189
Testosterone pellet, 75 mg
Clinical
Clinical Trials
460 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
HypogonadismD007006E23.02242333615142
EunuchismD005058EFO_0007266E29.148109334
Healthy volunteers/patients10422319
Psychological sexual dysfunctionsD020018F52.012121117
ObesityD009765EFO_0001073E66.92313311
SarcopeniaD055948EFO_1000653M62.84324110
Erectile dysfunctionD007172EFO_0004234F52.211116110
Metabolic syndromeD024821EFO_0000195E88.812333110
AgingD000375GO_0007568R41.814211210
Type 2 diabetes mellitusD003924EFO_0001360E111369
Show 37 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Prostatic neoplasmsD011471C615121422
Spinal cord injuriesD013119EFO_100191917218
InfertilityD007246EFO_000054521226
Breast neoplasmsD001943EFO_0003869C5023116
MenopauseD008593EFO_0003922N954116
Mobility limitationD051346HP_00023551135
TranssexualismD014189F64.0224
NeoplasmsD009369C80224
Hip fracturesD006620EFO_0003964S72.00123
Physiological sexual dysfunctionD012735112
Show 21 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
ContraceptionD0032678611
Castration-resistant prostatic neoplasmsD064129167
Polycystic ovary syndromeD011085EFO_0000660E28.22125
Insulin resistanceD007333EFO_00026142225
Androgen-insensitivity syndromeD013734E34.51314
DepressionD003863F33.9224
DyspareuniaD004414HP_0030016N94.12113
Gonadal disordersD006058213
CachexiaD002100HP_0004326R64213
HypertensionD006973EFO_0000537I10112
Show 34 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Male infertilityD007248EFO_0004248N46112
PharmacokineticsD01059922
Peanut hypersensitivityD021183EFO_000742522
Facioscapulohumeral muscular dystrophyD020391EFO_0000491G71.0211
Cerebral arterial diseasesD002539EFO_100085911
Allergic rhinitisD065631J30.911
Allergic conjunctivitisD003233EFO_0007141H10.4411
Breast densityD00007106011
PostmenopauseD01769811
Sickle cell anemiaD000755EFO_0000697D5711
Show 3 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
StrokeD020521EFO_0000712I63.933
ParesisD010291HP_000126933
HemorrhoidsD006484EFO_0009552K6422
Liver cirrhosisD008103EFO_0001422K74.022
Delayed pubertyD011628HP_0000823E30.022
Postoperative painD010149G89.1811
Obstructive sleep apneaD020181EFO_0003918G47.3311
ThalassemiaD013789EFO_1001996D5611
Stress urinary incontinenceD014550HP_001099211
HysterectomyD007044EFO_000388111
Show 34 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameTESTOSTERONE
INNtestosterone
Description
Testosterone is an androstanoid having 17beta-hydroxy and 3-oxo groups, together with unsaturation at C-4-C-5.. It has a role as an androgen, a human metabolite, a Daphnia magna metabolite and a mouse metabolite. It is a 17beta-hydroxy steroid, an androstanoid, a C19-steroid and a 3-oxo-Delta(4) steroid.
Classification
Small molecule
Drug classsteroids (androgens, anabolics); antiandrogens
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
C[C@]12CC[C@H]3[C@@H](CCC4=CC(=O)CC[C@@]43C)[C@@H]1CC[C@@H]2O
Identifiers
PDB
CAS-ID58-22-0
RxCUI10379
ChEMBL IDCHEMBL386630
ChEBI ID17347
PubChem CID6013
DrugBankDB00624
UNII ID3XMK78S47O (ChemIDplus, GSRS)
Target
Agency Approved
AR
AR
Organism
Homo sapiens
Gene name
AR
Gene synonyms
DHTR, NR3C4
NCBI Gene ID
Protein name
androgen receptor
Protein synonyms
Dihydrotestosterone receptor, Nuclear receptor subfamily 3 group C member 4
Uniprot ID
Mouse ortholog
Ar (11835)
androgen receptor (P19091)
Alternate
No data
Variants
Clinical Variant
No data
Financial
Androgel - AbbVie
$
£
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Testim - Auxilium Pharmaceuticals
$
£
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Testopel - Auxilium Pharmaceuticals
$
£
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Striant - Juniper 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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25,487 adverse events reported
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