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
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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 Pharma | N-209863 RX | 2018-09-28 | 3 products, RLD, RS |
Show 1 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| azmiro | New Drug Application | 2025-01-03 |
| testosterone enanthate | ANDA | 2025-06-02 |
| xyosted | New Drug Application | 2025-03-04 |
Indications
FDA
EMA
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 | |
| 11813435 | 2035-02-25 | 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 |
| 11844804 | 2033-06-04 | 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 | |
| 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 | |
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
419 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 | 23 | 45 | 38 | 45 | 19 | 162 |
| Prostatic neoplasms | D011471 | — | C61 | 5 | 38 | 13 | 1 | 5 | 58 |
| Eunuchism | D005058 | EFO_0007266 | E29.1 | 6 | 9 | 12 | 10 | 3 | 38 |
| Healthy volunteers/patients | — | — | — | 9 | 4 | 2 | 2 | 2 | 17 |
| Syndrome | D013577 | — | — | 3 | 2 | 2 | 4 | 3 | 14 |
| Obesity | D009765 | EFO_0001073 | E66.9 | 2 | 2 | 2 | 5 | 3 | 13 |
| Insulin resistance | D007333 | EFO_0002614 | E88.819 | 4 | 2 | — | 3 | 2 | 10 |
| Psychological sexual dysfunctions | D020018 | — | F52.0 | 1 | 1 | 5 | 1 | 2 | 10 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | 1 | 3 | 2 | 6 | — | 10 |
| Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | — | 2 | 1 | 7 | — | 10 |
Show 59 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Adenocarcinoma | D000230 | — | — | 1 | 10 | 2 | — | — | 13 |
| Carcinoma | D002277 | — | C80.0 | 3 | 5 | 1 | — | — | 9 |
| Infertility | D007246 | EFO_0000545 | — | 2 | 1 | 3 | — | 3 | 8 |
| Gender dysphoria | D000068116 | — | F64 | 1 | 1 | 1 | — | 6 | 8 |
| Spinal cord injuries | D013119 | EFO_1001919 | — | 2 | 7 | 2 | — | — | 8 |
| Neoplasms | D009369 | — | C80 | 1 | 4 | 2 | — | — | 7 |
| Menopause | D008593 | EFO_0003922 | N95 | — | 5 | 2 | — | — | 7 |
| Aging | D000375 | GO_0007568 | R41.81 | 3 | 1 | 1 | — | — | 5 |
| Delayed puberty | D011628 | — | E30.0 | — | 1 | 1 | — | 4 | 5 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | — | 3 | 1 | — | — | 4 |
Show 36 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Castration-resistant prostatic neoplasms | D064129 | — | — | 1 | 11 | — | — | — | 12 |
| Contraception | D003267 | — | — | 6 | 4 | — | — | — | 7 |
| Gonadal disorders | D006058 | — | — | 1 | 4 | — | — | 1 | 5 |
| Polycystic ovary syndrome | D011085 | EFO_0000660 | E28.2 | 2 | 1 | — | — | 1 | 4 |
| Osteoporosis | D010024 | EFO_0003882 | M81.0 | — | 2 | — | — | 2 | 4 |
| Androgen-insensitivity syndrome | D013734 | — | E34.5 | 1 | 3 | — | — | 1 | 4 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 2 | 1 | — | — | 2 | 4 |
| Hypersensitivity | D006967 | EFO_0003785 | T78.40 | — | 2 | — | — | 1 | 3 |
| Non-alcoholic fatty liver disease | D065626 | EFO_0003095 | K75.81 | — | 3 | — | — | — | 3 |
| Endocrine system diseases | D004700 | EFO_0001379 | E34.9 | 1 | 3 | — | — | — | 3 |
Show 42 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Muscular dystrophies | D009136 | EFO_0000757 | G71.0 | 1 | — | — | — | 1 | 2 |
| Hypertension | D006973 | EFO_0000537 | I10 | 2 | — | — | — | — | 2 |
| Male breast neoplasms | D018567 | — | — | 1 | — | — | — | 1 | 2 |
| Facioscapulohumeral muscular dystrophy | D020391 | EFO_0000491 | G71.02 | 1 | — | — | — | — | 1 |
| Pharmacokinetics | D010599 | — | — | 1 | — | — | — | — | 1 |
| Breast density | D000071060 | — | — | 1 | — | — | — | — | 1 |
| Urologic neoplasms | D014571 | — | C64-C68 | 1 | — | — | — | — | 1 |
| Urologic diseases | D014570 | — | N39.9 | 1 | — | — | — | — | 1 |
| Urination disorders | D014555 | — | — | 1 | — | — | — | — | 1 |
| Sickle cell anemia | D000755 | EFO_0000697 | D57 | 1 | — | — | — | — | 1 |
Show 4 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Covid-19 | D000086382 | — | U07.1 | — | — | — | — | 2 | 2 |
| Migraine disorders | D008881 | EFO_0003821 | G43 | — | — | — | — | 2 | 2 |
| Endometriosis | D004715 | EFO_0001065 | N80 | — | — | — | — | 2 | 2 |
| Drug interactions | D004347 | — | — | — | — | — | — | 1 | 1 |
| Obstructive sleep apnea | D020181 | EFO_0003918 | G47.33 | — | — | — | — | 1 | 1 |
| Sleep apnea syndromes | D012891 | EFO_0003877 | G47.3 | — | — | — | — | 1 | 1 |
| Vulvovaginitis | D014848 | EFO_1001240 | N76.0 | — | — | — | — | 1 | 1 |
| Pregnancy | D011247 | EFO_0002950 | Z33.1 | — | — | — | — | 1 | 1 |
| Liver cirrhosis | D008103 | EFO_0001422 | K74.0 | — | — | — | — | 1 | 1 |
| Fibrosis | D005355 | — | — | — | — | — | — | 1 | 1 |
Show 18 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Testosterone enanthate |
| INN | testosterone |
| 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 class | steroids (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-ID | 315-37-7 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1200335 |
| ChEBI ID | 9464 |
| PubChem CID | 9416 |
| DrugBank | DB00624 |
| UNII ID | 3XMK78S47O (ChemIDplus, GSRS) |
Target
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Variants
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Financial
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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
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Trends
PubMed Central
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Safety
Black-box Warning
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Adverse Events
Top Adverse Reactions
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40,955 adverse events reported
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