Testosterone undecanoate
Aveed, Intrinsa, Jatenzo, Kyzatrex, Livensa, Tlando (testosterone undecanoate) is a small molecule pharmaceutical. Testosterone undecanoate was first approved as Intrinsa on 2006-07-28. 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
Therapeutic Areas
Trade Name
FDA
EMA
Aveed, Jatenzo, Kyzatrex, Tlando (discontinued: Kyzatrex)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Testosterone undecanoate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| AVEED | Endo | N-022219 RX | 2014-03-05 | 1 products, RLD, RS |
| KYZATREX | Marius Pharmaceuticals | N-213953 RX | 2022-07-27 | 2 products, RLD, RS |
| JATENZO | Tolmar | N-206089 RX | 2019-03-27 | 3 products, RLD, RS |
| TLANDO | Verity Pharmaceuticals | N-208088 RX | 2022-03-28 | 1 products, RLD, RS |
Show 1 discontinued
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| breast neoplasms | EFO_0003869 | D001943 | C50 |
| hypogonadism | — | D007006 | E23.0 |
| delayed puberty | — | D011628 | E30.0 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
TESTOSTERONE UNDECANOATE, KYZATREX, MARIUS PHARMS LLC | |||
| 2025-07-27 | NP | ||
TESTOSTERONE UNDECANOATE, TLANDO, VERITY | |||
| 2025-03-28 | NP | ||
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Testosterone Undecanoate, Tlando, Verity | |||
| 11464735 | 2041-04-28 | DP | U-1500 |
| 11559530 | 2037-11-28 | U-1500 | |
| 9943527 | 2030-11-30 | U-1500 | |
| 9949985 | 2030-11-30 | U-1500 | |
| 10226473 | 2030-11-30 | U-1500 | |
| 10716794 | 2030-11-30 | U-1500 | |
| 11311555 | 2030-11-30 | U-1500 | |
| 11364249 | 2030-11-30 | U-1500 | |
| 11433083 | 2030-11-30 | U-1500 | |
| 8778922 | 2029-01-08 | DP | U-1500 |
| 8865695 | 2029-01-08 | U-1500 | |
| 11304960 | 2029-01-08 | DP | U-1500 |
| Testosterone Undecanoate, Jatenzo, Tolmar | |||
| 11564933 | 2039-04-12 | U-1103 | |
| 8492369 | 2030-12-20 | DP | U-2506 |
| 8778916 | 2030-04-12 | DP | |
| 10543219 | 2030-04-12 | U-2506 | |
| 10617696 | 2030-04-12 | DS, DP | |
| 11179403 | 2030-04-12 | U-2506 | |
| 11426416 | 2030-04-12 | U-3420 | |
| 8241664 | 2029-03-29 | DP | U-2506 |
| 11331325 | 2027-01-06 | U-2506 | |
| 11179402 | 2026-04-14 | DS, DP | |
| Testosterone Undecanoate, Kyzatrex, Marius Pharms Llc | |||
| 11617758 | 2033-03-15 | DP | U-2506 |
| 10576089 | 2030-12-31 | DP | U-2506 |
| 10576090 | 2030-12-31 | DP | |
| 11590146 | 2030-12-31 | DP | |
| Testosterone Undecanoate, Aveed, Endo Pharms Inc | |||
| 8338395 | 2027-05-08 | U-1500 | |
| 7718640 | 2027-03-14 | 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 |
|---|---|
| J3145 | Injection, testosterone undecanoate, 1 mg |
Clinical
Clinical Trials
348 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 | 21 | 43 | 36 | 47 | 17 | 156 |
| Eunuchism | D005058 | EFO_0007266 | E29.1 | 5 | 8 | 11 | 12 | 2 | 36 |
| Prostatic neoplasms | D011471 | — | C61 | 4 | 19 | 1 | 2 | 2 | 28 |
| Healthy volunteers/patients | — | — | — | 7 | 3 | 2 | 2 | 2 | 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 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | 1 | 3 | 2 | 6 | — | 10 |
| Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | — | 2 | 1 | 7 | — | 10 |
| Syndrome | D013577 | — | — | 2 | 1 | 1 | 3 | 2 | 9 |
| Psychological sexual dysfunctions | D020018 | — | F52.0 | 1 | 1 | 5 | 1 | 1 | 9 |
Show 53 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Gender dysphoria | D000068116 | — | F64 | 1 | 1 | 1 | — | 7 | 9 |
| Infertility | D007246 | EFO_0000545 | — | 1 | — | 2 | — | 3 | 6 |
| Spinal cord injuries | D013119 | EFO_1001919 | — | 2 | 5 | 1 | — | — | 6 |
| Aging | D000375 | GO_0007568 | R41.81 | 3 | 1 | 1 | — | — | 5 |
| Menopause | D008593 | EFO_0003922 | N95 | — | 4 | 1 | — | — | 5 |
| Neoplasms | D009369 | — | C80 | — | 2 | 2 | — | — | 4 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | — | 3 | 1 | — | — | 4 |
| Critical illness | D016638 | — | — | — | 3 | 1 | — | 1 | 4 |
| Muscular atrophy | D009133 | — | — | — | 2 | 3 | — | — | 4 |
| Fatigue | D005221 | — | R53.83 | — | 3 | 1 | — | — | 4 |
Show 29 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 | — | — | 5 | 4 | — | — | — | 6 |
| Gonadal disorders | D006058 | — | — | 1 | 4 | — | — | 1 | 5 |
| Polycystic ovary syndrome | D011085 | EFO_0000660 | E28.2 | 2 | 1 | — | — | 1 | 4 |
| Androgen-insensitivity syndrome | D013734 | — | E34.5 | 1 | 3 | — | — | 1 | 4 |
| Sclerosis | D012598 | — | — | 1 | 4 | — | — | — | 4 |
| Osteoporosis | D010024 | EFO_0003882 | M81.0 | — | 2 | — | — | 1 | 3 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 1 | 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 36 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 | — | — | — | — | 2 |
| Facioscapulohumeral muscular dystrophy | D020391 | EFO_0000491 | G71.02 | 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 |
| Priapism | D011317 | — | N48.3 | 1 | — | — | — | — | 1 |
| Virilism | D014770 | — | — | 1 | — | — | — | — | 1 |
| Squamous cell carcinoma | D002294 | — | — | 1 | — | — | — | — | 1 |
| Squamous cell neoplasms | D018307 | — | — | 1 | — | — | — | — | 1 |
Show 1 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| 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 |
| Liver cirrhosis | D008103 | EFO_0001422 | K74.0 | — | — | — | — | 1 | 1 |
| Fibrosis | D005355 | — | — | — | — | — | — | 1 | 1 |
| Duchenne muscular dystrophy | D020388 | EFO_0000429 | — | — | — | — | — | 1 | 1 |
| Muscular dystrophies | D009136 | EFO_0000757 | G71.0 | — | — | — | — | 1 | 1 |
| Anxiety disorders | D001008 | EFO_0006788 | F41.1 | — | — | — | — | 1 | 1 |
| Anxiety | D001007 | EFO_0005230 | F41.1 | — | — | — | — | 1 | 1 |
| Paraplegia | D010264 | — | G82.2 | — | — | — | — | 1 | 1 |
Show 19 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Testosterone undecanoate |
| INN | testosterone |
| Description | Testosterone undecanoate is a steroid ester. |
| Classification | Small molecule |
| Drug class | steroids (androgens, anabolics); antiandrogens |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CCCCCCCCCCC(=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 | 5949-44-0 |
| RxCUI | — |
| ChEMBL ID | CHEMBL2107067 |
| ChEBI ID | — |
| PubChem CID | 65157 |
| DrugBank | DB13946 |
| UNII ID | 3XMK78S47O (ChemIDplus, GSRS) |
Target
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Variants
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Financial
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Trends
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Safety
Black-box Warning
Black-box warning for: Aveed
Adverse Events
Top Adverse Reactions
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1,654 adverse events reported
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