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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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-TESTADIOL | Pharmacia & Upjohn | N-017968 DISCN | 1982-01-01 | 1 products |
Hide discontinued
Testosterone
Tradename | Company | Number | Date | Products |
---|---|---|---|---|
NATESTO | Acerus Pharmaceuticals Corporation | N-205488 RX | 2014-05-28 | 1 products, RLD, RS |
TESTIM | Auxilium Pharmaceuticals | N-021454 RX | 2002-10-31 | 1 products, RLD, RS |
ANDROGEL | BESINS HLTHCARE | N-022309 RX | 2011-04-29 | 1 products, RLD, RS |
FORTESTA | Endo | N-021463 RX | 2010-12-29 | 1 products, RLD, RS |
VOGELXO | Upsher-Smith Laboratories | N-204399 RX | 2014-06-04 | 2 products |
Show 9 discontinued
Testosterone cypionate
Tradename | Company | Number | Date | Products |
---|---|---|---|---|
TESTOSTERONE CYPIONATE | Slayback Pharma | N-216318 PEND | 2022-06-02 | 1 products, RLD |
Testosterone enanthate
Tradename | Company | Number | Date | Products |
---|---|---|---|---|
XYOSTED (AUTOINJECTOR) | Antares Pharma | N-209863 RX | 2018-09-28 | 3 products, RLD, RS |
Show 1 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
---|---|---|
androderm | New Drug Application | 2020-05-18 |
androgel | New Drug Application | 2023-03-07 |
axiron | New Drug Application | 2013-11-12 |
fortesta | New Drug Application | 2020-06-30 |
natesto | New Drug Application | 2020-11-12 |
striant | New Drug Application | 2009-11-19 |
testim | New Drug Application | 2020-11-29 |
testopel | ANDA | 2018-08-24 |
vogelxo | New Drug Application | 2020-07-09 |
xyosted | New Drug Application | 2021-12-21 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
---|---|---|---|
breast neoplasms | EFO_0003869 | D001943 | C50 |
delayed puberty | HP_0000823 | D011628 | E30.0 |
hypogonadism | HP_0000815 | D007006 | E23.0 |
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent | Expires | Flag | FDA Information |
---|---|---|---|
Testosterone Cypionate, Testosterone Cypionate, Slayback Pharma Llc | |||
11311554 | 2039-03-25 | DP | |
11642355 | 2039-03-25 | DP | |
Testosterone Enanthate, Xyosted (Autoinjector), Antares Pharma Inc | |||
10646495 | 2038-08-30 | DP | |
9950125 | 2036-09-04 | DP | U-2418 |
9744302 | 2035-11-19 | DP | |
11191908 | 2035-10-18 | DP | |
10238662 | 2035-02-19 | DP | U-2418 |
10912782 | 2035-02-19 | DP | U-2418 |
11160751 | 2034-10-07 | DP | U-2418 |
10881798 | 2034-02-11 | DP | |
10821072 | 2033-06-04 | DP | U-2418 |
10357609 | 2031-08-21 | DP | |
10905827 | 2031-08-21 | DP | |
11446440 | 2031-08-21 | DP | |
10279131 | 2031-07-31 | DP | |
11497753 | 2030-03-19 | DP | |
8021335 | 2026-10-04 | DP | |
8562564 | 2026-01-24 | DP | |
9180259 | 2026-01-24 | DP | |
9533102 | 2026-01-24 | DP | |
9629959 | 2026-01-24 | DP | |
10478560 | 2026-01-24 | DP | |
11446441 | 2026-01-24 | DP | |
Testosterone, Natesto, Acerus | |||
11090312 | 2034-03-17 | U-1616 | |
8574622 | 2024-02-04 | DP | |
8784869 | 2024-02-04 | DP | |
8784882 | 2024-02-04 | DP | U-1557 |
8877230 | 2024-02-04 | U-1616 | |
Testosterone, Vogelxo, Upsher Smith Labs | |||
8785426 | 2034-02-11 | DP | U-1531 |
9295675 | 2034-02-11 | DP | U-1531 |
9662340 | 2034-02-11 | DP | U-1531 |
Testosterone, Axiron, Eli Lilly And Co | |||
8435944 | 2027-09-27 | U-1390 | |
8419307 | 2027-02-26 | U-1386 | |
8807861 | 2027-02-26 | DP | U-1563 |
9289586 | 2027-02-26 | U-1390 | |
8993520 | 2026-06-02 | U-1390 | |
9180194 | 2026-06-02 | U-1390 | |
8784878 | 2023-07-13 | DP | U-1545 |
Testosterone, Androgel, Besins Hlthcare | |||
8466136 | 2026-10-12 | DP | |
8466137 | 2026-10-12 | U-1103 | |
8466138 | 2026-10-12 | U-1103 | |
8486925 | 2026-10-12 | DP | |
8729057 | 2026-10-12 | DP | |
8741881 | 2026-10-12 | U-1103 | |
8754070 | 2026-10-12 | DP | |
8759329 | 2026-10-12 | DP | |
Testosterone, Testim, Auxilium Pharms Llc | |||
7320968 | 2025-01-18 | U-843 | |
7608605 | 2023-04-21 | U-1009 | |
7608606 | 2023-04-21 | U-1009 | |
7608607 | 2023-04-21 | U-1009 | |
7608608 | 2023-04-21 | U-1009 | |
7608609 | 2023-04-21 | U-1009 | |
7608610 | 2023-04-21 | U-1009 | |
7935690 | 2023-04-21 | U-1009 | |
8063029 | 2023-04-21 | U-843 | |
8178518 | 2023-04-21 | DP |
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
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 |
---|---|---|---|---|---|---|---|---|---|
Hypogonadism | D007006 | E23.0 | 22 | 42 | 33 | 36 | 15 | 142 | |
Eunuchism | D005058 | EFO_0007266 | E29.1 | 4 | 8 | 10 | 9 | 3 | 34 |
Healthy volunteers/patients | — | 10 | 4 | 2 | 2 | 3 | 19 | ||
Psychological sexual dysfunctions | D020018 | F52.0 | 1 | 2 | 12 | 1 | 1 | 17 | |
Obesity | D009765 | EFO_0001073 | E66.9 | 2 | 3 | 1 | 3 | 3 | 11 |
Sarcopenia | D055948 | EFO_1000653 | M62.84 | — | 3 | 2 | 4 | 1 | 10 |
Erectile dysfunction | D007172 | EFO_0004234 | F52.21 | 1 | 1 | 1 | 6 | 1 | 10 |
Metabolic syndrome | D024821 | EFO_0000195 | E88.81 | 2 | 3 | 3 | 3 | 1 | 10 |
Aging | D000375 | GO_0007568 | R41.81 | 4 | 2 | 1 | 1 | 2 | 10 |
Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | 1 | 3 | — | 6 | — | 9 |
Show 37 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Prostatic neoplasms | D011471 | C61 | 5 | 12 | 1 | — | 4 | 22 | |
Spinal cord injuries | D013119 | EFO_1001919 | 1 | 7 | 2 | — | 1 | 8 | |
Infertility | D007246 | EFO_0000545 | 2 | 1 | 2 | — | 2 | 6 | |
Breast neoplasms | D001943 | EFO_0003869 | C50 | 2 | 3 | 1 | — | 1 | 6 |
Menopause | D008593 | EFO_0003922 | N95 | — | 4 | 1 | — | 1 | 6 |
Mobility limitation | D051346 | HP_0002355 | — | 1 | 1 | — | 3 | 5 | |
Transsexualism | D014189 | F64.0 | — | — | 2 | — | 2 | 4 | |
Neoplasms | D009369 | C80 | — | 2 | 2 | — | — | 4 | |
Hip fractures | D006620 | EFO_0003964 | S72.00 | — | 1 | 2 | — | — | 3 |
Physiological sexual dysfunction | D012735 | — | 1 | 1 | — | — | 2 |
Show 21 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Contraception | D003267 | 8 | 6 | — | — | — | 11 | ||
Castration-resistant prostatic neoplasms | D064129 | 1 | 6 | — | — | — | 7 | ||
Polycystic ovary syndrome | D011085 | EFO_0000660 | E28.2 | 2 | 1 | — | — | 2 | 5 |
Insulin resistance | D007333 | EFO_0002614 | 2 | 2 | — | — | 2 | 5 | |
Androgen-insensitivity syndrome | D013734 | E34.5 | 1 | 3 | — | — | 1 | 4 | |
Depression | D003863 | F33.9 | — | 2 | — | — | 2 | 4 | |
Dyspareunia | D004414 | HP_0030016 | N94.1 | 2 | 1 | — | — | 1 | 3 |
Gonadal disorders | D006058 | — | 2 | — | — | 1 | 3 | ||
Cachexia | D002100 | HP_0004326 | R64 | 2 | 1 | — | — | — | 3 |
Hypertension | D006973 | EFO_0000537 | I10 | — | 1 | — | — | 1 | 2 |
Show 34 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Male infertility | D007248 | EFO_0004248 | N46 | 1 | — | — | — | 1 | 2 |
Pharmacokinetics | D010599 | 2 | — | — | — | — | 2 | ||
Peanut hypersensitivity | D021183 | EFO_0007425 | 2 | — | — | — | — | 2 | |
Facioscapulohumeral muscular dystrophy | D020391 | EFO_0000491 | G71.02 | 1 | — | — | — | — | 1 |
Cerebral arterial diseases | D002539 | EFO_1000859 | 1 | — | — | — | — | 1 | |
Allergic rhinitis | D065631 | J30.9 | 1 | — | — | — | — | 1 | |
Allergic conjunctivitis | D003233 | EFO_0007141 | H10.44 | 1 | — | — | — | — | 1 |
Breast density | D000071060 | 1 | — | — | — | — | 1 | ||
Postmenopause | D017698 | 1 | — | — | — | — | 1 | ||
Sickle cell anemia | D000755 | EFO_0000697 | D57 | 1 | — | — | — | — | 1 |
Show 3 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Stroke | D020521 | EFO_0000712 | I63.9 | — | — | — | — | 3 | 3 |
Paresis | D010291 | HP_0001269 | — | — | — | — | 3 | 3 | |
Hemorrhoids | D006484 | EFO_0009552 | K64 | — | — | — | — | 2 | 2 |
Liver cirrhosis | D008103 | EFO_0001422 | K74.0 | — | — | — | — | 2 | 2 |
Delayed puberty | D011628 | HP_0000823 | E30.0 | — | — | — | — | 2 | 2 |
Postoperative pain | D010149 | G89.18 | — | — | — | — | 1 | 1 | |
Obstructive sleep apnea | D020181 | EFO_0003918 | G47.33 | — | — | — | — | 1 | 1 |
Thalassemia | D013789 | EFO_1001996 | D56 | — | — | — | — | 1 | 1 |
Stress urinary incontinence | D014550 | HP_0010992 | — | — | — | — | 1 | 1 | |
Hysterectomy | D007044 | EFO_0003881 | — | — | — | — | 1 | 1 |
Show 34 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common name | TESTOSTERONE |
INN | testosterone |
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 class | steroids (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-ID | 58-22-0 |
RxCUI | 10379 |
ChEMBL ID | CHEMBL386630 |
ChEBI ID | 17347 |
PubChem CID | 6013 |
DrugBank | DB00624 |
UNII ID | 3XMK78S47O (ChemIDplus, GSRS) |
Target
Variants
Clinical Variant
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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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Trends
PubMed Central
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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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