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Drug ReportsTestosterone
Depo-testadiol, Intrinsa(testosterone)
Androgel, Depo-testadiol, Ditate, Intrinsa, Livensa, Natesto, Testim, Testopel, Testosterone, 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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Clinical
Drug
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Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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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, Natesto, Testim, Vogelxo, Xyosted (generic drugs available since 1982-01-01, discontinued: Androderm, Axiron, Delatestryl, Fortesta, 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
VOGELXOUpsher-Smith LaboratoriesN-204399 RX2014-06-04
2 products
Show 10 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
No data
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
breast neoplasmsEFO_0003869D001943C50
delayed pubertyHP_0000823D011628E30.0
hypogonadismHP_0000044D007006E23.0
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
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
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
887 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
HypogonadismD007006HP_0000044E23.02756413935190
Prostatic neoplasmsD011471—C6114451742196
EunuchismD005058EFO_0007266E29.1510119842
Healthy volunteers/patients———12723628
ObesityD009765EFO_0001073E66.934231122
Polycystic ovary syndromeD011085EFO_0000660E28.263—11222
Psychological sexual dysfunctionsD020018—F52.013121219
Erectile dysfunctionD007172EFO_0004234F52.212227417
Metabolic syndromeD024821EFO_0000195E88.8102343515
Type 2 diabetes mellitusD003924EFO_0001360E111417314
Show 49 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Castration-resistant prostatic neoplasmsD064129——291—113
AdenocarcinomaD000230——182——11
InfertilityD007246HP_0000789—323—511
Spinal cord injuriesD013119EFO_1001919—172—29
Male infertilityD007248EFO_0004248N46112—48
Breast neoplasmsD001943EFO_0003869C50241—28
NeoplasmsD009369—C80—32—27
HemorrhoidsD006484EFO_0009552K64—11—67
Mobility limitationD051346HP_0002355——11—35
Hip fracturesD006620EFO_0003964S72.00—22——4
Show 26 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
ContraceptionD003267——86——112
Insulin resistanceD007333HP_0000855E88.81923——610
DepressionD003863—F33.9—2——68
HyperandrogenismD017588———2——57
Androgen-insensitivity syndromeD013734—E34.513——47
Gonadal disordersD006058——13——25
Gender identityD005783——11——34
Opioid-related disordersD009293EFO_0005611F1112——13
Primary ovarian insufficiencyD016649EFO_0004266E28.312——13
Colorectal neoplasmsD015179——11——23
Show 49 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
HypertensionD006973EFO_0000537I102———35
HivD006678—O98.71———12
PharmacokineticsD010599——2————2
Peanut hypersensitivityD021183EFO_0007425—2————2
Head and neck neoplasmsD006258——1———12
Facioscapulohumeral muscular dystrophyD020391EFO_0000491G71.021————1
Cerebral arterial diseasesD002539EFO_1000859—1————1
HyperparathyroidismD006961EFO_0008506E21.31————1
HypercalcemiaD006934HP_0003072E83.521————1
Endocrine bone diseasesD001849——1————1
Show 10 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Blood pressureD001794EFO_0004325—————33
Delayed pubertyD011628HP_0000823E30.0————33
StrokeD020521EFO_0000712I63.9————33
ParesisD010291HP_0001269—————33
Acne vulgarisD000152EFO_0003894L70————33
Postoperative painD010149—G89.18————22
Hematologic diseasesD006402EFO_0005803D75.9————22
Traumatic brain injuriesD000070642—S06————22
Appetitive behaviorD001070——————22
Depressive disorderD003866EFO_1002014F32.A————22
Show 95 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)Loading
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
RxCUI—
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
367
Protein name
androgen receptor
Protein synonyms
Dihydrotestosterone receptor, Nuclear receptor subfamily 3 group C member 4
Uniprot ID
Q9UD95
Mouse ortholog
Ar (11835)
androgen receptor (P19091)
Alternate
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Testopel – Auxilium Pharmaceuticals
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Testim – Auxilium Pharmaceuticals
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Striant – Juniper Pharmaceuticals
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Androgel – AbbVie
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Estimated US medical usage
Testosterone
+
Estradiol
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Price per prescription (USD)
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Testosterone
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 121,543 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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35,853 adverse events reported
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