Methyltestosterone
Android, Methyltestosterone (methyltestosterone) is a small molecule pharmaceutical. Methyltestosterone was first approved as Metandren on 1982-01-01. It is used to treat breast neoplasms, delayed puberty, erectile dysfunction, and hypogonadism in the USA. The pharmaceutical is active against androgen receptor.
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Trade Name
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EMA
Android, Methyltestosterone (discontinued: Android, Metandren, Methyltestosterone, Oreton, Oreton methyl, Testred, Virilon)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Methyltestosterone
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| METANDREN | Novartis | N-003240 DISCN | 1982-01-01 | 4 products |
| ORETON METHYL | Merck & Co | N-003158 DISCN | 1982-01-01 | 2 products |
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Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| covaryx | unapproved drug other | 2020-01-25 |
| covaryx covaryx | unapproved drug other | 2013-02-26 |
| eemt | unapproved drug other | 2020-01-22 |
| eemt eemt | unapproved drug other | 2013-03-01 |
| esterified estrogens and methyltestosterone | unapproved drug other | 2024-12-13 |
| estratest f.s. | unapproved drug other | 2024-09-06 |
| estratest f.s. estratest h.s. | unapproved drug other | 2024-06-15 |
| methitest | ANDA | 2024-10-21 |
| methyltestosterone | ANDA | 2022-02-22 |
Indications
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Agency Specific
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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
— G03BA02: Methyltestosterone
— G03E: Androgens and female sex hormones in combination
— G03EA: Androgens and estrogens
— G03EA01: Methyltestosterone and estrogen
— G03EK: Androgens and female sex hormones in combination with other drugs
— G03EK01: Methyltestosterone
HCPCS
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Clinical
Clinical Trials
501 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 | HP_0000044 | E23.0 | 23 | 45 | 37 | 45 | 18 | 160 |
| Prostatic neoplasms | D011471 | — | C61 | 5 | 34 | 10 | 1 | 5 | 54 |
| Eunuchism | D005058 | EFO_0007266 | E29.1 | 6 | 9 | 12 | 10 | 3 | 38 |
| Healthy volunteers/patients | — | — | — | 9 | 4 | 2 | 3 | 3 | 19 |
| Diabetes mellitus | D003920 | HP_0000819 | E08-E13 | — | 2 | 1 | 7 | 6 | 16 |
| Syndrome | D013577 | — | — | 3 | 2 | 2 | 3 | 5 | 15 |
| Obesity | D009765 | EFO_0001073 | E66.9 | 2 | 2 | 2 | 5 | 5 | 15 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | 1 | 3 | 2 | 6 | 1 | 11 |
| Insulin resistance | D007333 | HP_0000855 | — | 4 | 2 | — | 3 | 2 | 10 |
| Psychological sexual dysfunctions | D020018 | — | F52.0 | 1 | 1 | 5 | 1 | 2 | 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 |
| Neoplasms | D009369 | — | C80 | 1 | 4 | 2 | — | 3 | 10 |
| Carcinoma | D002277 | — | C80.0 | 3 | 5 | 1 | — | — | 9 |
| Infertility | D007246 | HP_0000789 | — | 2 | 1 | 3 | — | 4 | 9 |
| Gender dysphoria | D000068116 | — | — | 1 | 1 | 1 | — | 6 | 8 |
| Spinal cord injuries | D013119 | EFO_1001919 | — | 2 | 7 | 2 | — | — | 8 |
| Menopause | D008593 | EFO_0003922 | N95 | — | 5 | 2 | — | — | 7 |
| Cognitive dysfunction | D060825 | HP_0001268 | G31.84 | — | — | 1 | — | 4 | 5 |
| Aging | D000375 | GO_0007568 | R41.81 | 3 | 1 | 1 | — | — | 5 |
| Critical illness | D016638 | — | — | — | 3 | 1 | — | 2 | 5 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Castration-resistant prostatic neoplasms | D064129 | — | — | 1 | 10 | — | — | — | 11 |
| 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 | HP_0000939 | 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 | HP_0012393 | 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 46 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hypertension | D006973 | EFO_0000537 | I10 | 2 | — | — | — | 3 | 5 |
| Muscular dystrophies | D009136 | HP_0003560 | G71.0 | 1 | — | — | — | 1 | 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 |
| Postmenopause | D017698 | — | — | 1 | — | — | — | — | 1 |
Show 5 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Anxiety | D001007 | EFO_0005230 | F41.1 | — | — | — | — | 7 | 7 |
| Anxiety disorders | D001008 | EFO_0006788 | F41.1 | — | — | — | — | 4 | 4 |
| Sleep initiation and maintenance disorders | D007319 | — | F51.01 | — | — | — | — | 4 | 4 |
| Type 1 diabetes mellitus | D003922 | EFO_0001359 | E10 | — | — | — | — | 3 | 3 |
| Obstructive sleep apnea | D020181 | EFO_0003918 | G47.33 | — | — | — | — | 2 | 2 |
| Sleep apnea syndromes | D012891 | HP_0010535 | G47.3 | — | — | — | — | 2 | 2 |
| Parkinson disease | D010300 | EFO_0002508 | G20 | — | — | — | — | 2 | 2 |
| Sleep wake disorders | D012893 | — | G47 | — | — | — | — | 2 | 2 |
| Respiratory tract infections | D012141 | — | J06.9 | — | — | — | — | 2 | 2 |
| Pneumonia | D011014 | EFO_0003106 | — | — | — | — | — | 2 | 2 |
Show 109 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Methyltestosterone |
| INN | methyltestosterone |
| Description | Methyltestosterone is a 17beta-hydroxy steroid that is testosterone bearing a methyl group at the 17alpha position. It has a role as an antineoplastic agent, an anabolic agent and an androgen. It is a 3-oxo-Delta(4) steroid, a 17beta-hydroxy steroid and an enone. 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) | C[C@]1(O)CC[C@H]2[C@@H]3CCC4=CC(=O)CC[C@]4(C)[C@H]3CC[C@@]21C |
Identifiers
| PDB | — |
| CAS-ID | 58-18-4 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1395 |
| ChEBI ID | 27436 |
| PubChem CID | 6010 |
| DrugBank | DB06710 |
| UNII ID | V9EFU16ZIF (ChemIDplus, GSRS) |
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Methyltestosterone
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Trends
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Safety
Black-box Warning
Black-box warning for: Covaryx, Covaryx covaryx, Eemt, Eemt eemt, Esterified estrogens and methyltestosterone, Estratest f.s., Estratest f.s. estratest h.s.
Adverse Events
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207 adverse events reported
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