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
FDA
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 | 2025-02-10 |
| esterified estrogens and methyltestosterone full strength esterified estrogens and methyltestosterone half strength | unapproved drug other | 2025-03-10 |
| estratest f.s. | unapproved drug other | 2024-09-06 |
| estratest f.s. estratest h.s. | unapproved drug other | 2024-06-15 |
| estratest fs estratest hs | unapproved drug other | 2025-03-10 |
| methitest | ANDA | 2024-10-21 |
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Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| breast neoplasms | EFO_0003869 | D001943 | C50 |
| erectile dysfunction | EFO_0004234 | D007172 | F52.21 |
| hypogonadism | — | D007006 | E23.0 |
| delayed puberty | — | D011628 | E30.0 |
Agency Specific
FDA
EMA
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Patent Expiration
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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
753 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 | 37 | 45 | 18 | 160 |
| Prostatic neoplasms | D011471 | — | C61 | 5 | 38 | 13 | 1 | 5 | 58 |
| Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | 1 | 3 | 2 | 7 | 33 | 45 |
| Eunuchism | D005058 | EFO_0007266 | E29.1 | 6 | 9 | 12 | 10 | 3 | 38 |
| Obesity | D009765 | EFO_0001073 | E66.9 | 2 | 2 | 2 | 5 | 11 | 21 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | 1 | 4 | 3 | 6 | 10 | 21 |
| Healthy volunteers/patients | — | — | — | 9 | 4 | 2 | 3 | 3 | 19 |
| Depression | D003863 | — | F33.9 | 1 | 1 | — | 1 | 15 | 18 |
| Syndrome | D013577 | — | — | 3 | 2 | 2 | 4 | 6 | 17 |
| Metabolic syndrome | D024821 | EFO_0000195 | E88.810 | 2 | 1 | 1 | 4 | 4 | 11 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | — | C80 | 1 | 4 | 2 | — | 11 | 18 |
| Adenocarcinoma | D000230 | — | — | 1 | 10 | 2 | — | — | 13 |
| Cognitive dysfunction | D060825 | — | G31.84 | — | — | 1 | — | 12 | 13 |
| Spinal cord injuries | D013119 | EFO_1001919 | — | 2 | 7 | 2 | — | 2 | 10 |
| Carcinoma | D002277 | — | C80.0 | 3 | 5 | 1 | — | — | 9 |
| Infertility | D007246 | EFO_0000545 | — | 2 | 1 | 3 | — | 4 | 9 |
| Gender dysphoria | D000068116 | — | F64 | 1 | 1 | 1 | — | 6 | 8 |
| Menopause | D008593 | EFO_0003922 | N95 | — | 5 | 2 | — | — | 7 |
| Malnutrition | D044342 | EFO_0008572 | E40-E46 | — | — | 2 | — | 4 | 6 |
| Fatigue | D005221 | — | R53.83 | — | 3 | 1 | — | 2 | 6 |
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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 | 11 | — | — | — | 12 |
| Endocrine system diseases | D004700 | EFO_0001379 | E34.9 | 1 | 3 | — | — | 4 | 7 |
| Contraception | D003267 | — | — | 6 | 4 | — | — | — | 7 |
| Metabolic diseases | D008659 | EFO_0000589 | E88.9 | 1 | 1 | — | — | 5 | 6 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 2 | 1 | — | — | 4 | 6 |
| Polycystic ovary syndrome | D011085 | EFO_0000660 | E28.2 | 2 | 1 | — | — | 2 | 5 |
| Gonadal disorders | D006058 | — | — | 1 | 4 | — | — | 1 | 5 |
| Osteoporosis | D010024 | EFO_0003882 | M81.0 | — | 2 | — | — | 2 | 4 |
| Androgen-insensitivity syndrome | D013734 | — | E34.5 | 1 | 3 | — | — | 1 | 4 |
| Hiv infections | D015658 | EFO_0000764 | B20 | — | 1 | — | — | 3 | 4 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Type 1 diabetes mellitus | D003922 | EFO_0001359 | E10 | 1 | — | — | — | 27 | 28 |
| Hypertension | D006973 | EFO_0000537 | I10 | 3 | — | — | — | 8 | 11 |
| Muscular dystrophies | D009136 | EFO_0000757 | G71.0 | 1 | — | — | — | 2 | 3 |
| Hypoglycemia | D007003 | — | E16.2 | 1 | — | — | — | 2 | 3 |
| Facioscapulohumeral muscular dystrophy | D020391 | EFO_0000491 | G71.02 | 1 | — | — | — | 1 | 2 |
| Sickle cell anemia | D000755 | EFO_0000697 | D57 | 1 | — | — | — | 1 | 2 |
| Male breast neoplasms | D018567 | — | — | 1 | — | — | — | 1 | 2 |
| Pharmacokinetics | D010599 | — | — | 1 | — | — | — | — | 1 |
| Breast density | D000071060 | — | — | 1 | — | — | — | — | 1 |
| Urologic neoplasms | D014571 | — | C64-C68 | 1 | — | — | — | — | 1 |
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Anxiety | D001007 | EFO_0005230 | F41.1 | — | — | — | — | 18 | 18 |
| Asthma | D001249 | EFO_0000270 | J45 | — | — | — | — | 14 | 14 |
| Anxiety disorders | D001008 | EFO_0006788 | F41.1 | — | — | — | — | 12 | 12 |
| Sleep initiation and maintenance disorders | D007319 | — | F51.01 | — | — | — | — | 8 | 8 |
| Smoking cessation | D016540 | EFO_0004319 | — | — | — | — | — | 7 | 7 |
| Parkinson disease | D010300 | EFO_0002508 | G20 | — | — | — | — | 5 | 5 |
| Sleep wake disorders | D012893 | — | G47 | — | — | — | — | 5 | 5 |
| Stroke | D020521 | EFO_0000712 | I63.9 | — | — | — | — | 5 | 5 |
| Pediatric obesity | D063766 | — | — | — | — | — | — | 5 | 5 |
| Nursing care | D009732 | — | — | — | — | — | — | 5 | 5 |
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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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Additional graphs summarizing 32,271 documents
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Safety
Black-box Warning
Black-box warning for: Covaryx, Covaryx covaryx, Eemt, Eemt eemt, Esterified estrogens and methyltestosterone, Esterified estrogens and methyltestosterone full strength esterified estrogens and methyltestosterone half strength, Estratest f.s., Estratest f.s. estratest h.s., Estratest fs estratest hs
Adverse Events
Top Adverse Reactions
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222 adverse events reported
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