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
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 | 3 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 |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| androgel | New Drug Application | 2024-09-18 |
| aveed | New Drug Application | 2021-08-28 |
| axiron | New Drug Application | 2013-11-12 |
| azmiro | New Drug Application | 2025-01-03 |
| depo-testosterone | ANDA | 2024-01-11 |
| jatenzo | New Drug Application | 2025-05-16 |
| kyzatrex | New Drug Application | 2023-10-26 |
| natesto | New Drug Application | 2025-03-31 |
| striant | New Drug Application | 2009-11-19 |
| testim | New Drug Application | 2021-08-25 |
Show 12 more
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
892 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 | 33 | 68 | 55 | 54 | 49 | 250 |
| Prostatic neoplasms | D011471 | — | C61 | 16 | 72 | 27 | 6 | 27 | 141 |
| Eunuchism | D005058 | EFO_0007266 | E29.1 | 6 | 11 | 12 | 11 | 12 | 50 |
| Syndrome | D013577 | — | — | 6 | 5 | 4 | 5 | 20 | 40 |
| Healthy volunteers/patients | — | — | — | 13 | 7 | 2 | 3 | 5 | 28 |
| Obesity | D009765 | EFO_0001073 | E66.9 | 3 | 4 | 3 | 5 | 13 | 27 |
| Infertility | D007246 | EFO_0000545 | — | 7 | 3 | 7 | 1 | 11 | 27 |
| Polycystic ovary syndrome | D011085 | EFO_0000660 | E28.2 | 6 | 4 | 1 | 1 | 15 | 27 |
| Erectile dysfunction | D007172 | EFO_0004234 | F52.21 | 2 | 2 | 2 | 7 | 8 | 21 |
| Psychological sexual dysfunctions | D020018 | — | F52.0 | 1 | 5 | 12 | 1 | 2 | 21 |
Show 87 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Castration-resistant prostatic neoplasms | D064129 | — | — | 3 | 13 | 1 | — | 1 | 18 |
| Adenocarcinoma | D000230 | — | — | 2 | 12 | 3 | — | — | 17 |
| Neoplasms | D009369 | — | C80 | 1 | 5 | 3 | — | 4 | 13 |
| Carcinoma | D002277 | — | C80.0 | 3 | 8 | 1 | — | — | 12 |
| Male infertility | D007248 | EFO_0004248 | N46 | 2 | 2 | 4 | — | 5 | 12 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 3 | 4 | 1 | — | 4 | 11 |
| Spinal cord injuries | D013119 | EFO_1001919 | — | 2 | 7 | 2 | — | 1 | 9 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | — | 3 | 4 | — | — | 7 |
| Delayed puberty | D011628 | — | E30.0 | — | 1 | 1 | — | 5 | 6 |
| Fatigue | D005221 | — | R53.83 | — | 4 | 1 | — | 1 | 6 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Contraception | D003267 | — | — | 8 | 6 | — | — | 1 | 12 |
| Hypersensitivity | D006967 | EFO_0003785 | T78.40 | 2 | 3 | — | — | 3 | 8 |
| Gonadal disorders | D006058 | — | — | 1 | 4 | — | — | 4 | 8 |
| Endocrine system diseases | D004700 | EFO_0001379 | E34.9 | 2 | 3 | — | — | 4 | 8 |
| Hyperandrogenism | D017588 | — | — | — | 2 | — | — | 6 | 8 |
| Androgen-insensitivity syndrome | D013734 | — | E34.5 | 1 | 3 | — | — | 5 | 8 |
| Gender identity | D005783 | — | — | 1 | 1 | — | — | 5 | 6 |
| Primary ovarian insufficiency | D016649 | EFO_0004266 | E28.3 | 1 | 2 | — | — | 3 | 5 |
| Premature menopause | D008594 | — | E28.31 | 1 | 2 | — | — | 3 | 5 |
| Kidney diseases | D007674 | EFO_0003086 | N08 | — | 1 | — | — | 4 | 5 |
Show 68 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 | EFO_0000757 | G71.0 | 1 | — | — | — | 2 | 3 |
| Sleep deprivation | D012892 | — | F51.12 | 2 | — | — | — | — | 2 |
| Hiv | D006678 | — | O98.7 | 1 | — | — | — | 1 | 2 |
| Male breast neoplasms | D018567 | — | — | 1 | — | — | — | 1 | 2 |
| Antibiotic prophylaxis | D019072 | — | — | 1 | — | — | — | — | 1 |
| Facioscapulohumeral muscular dystrophy | D020391 | EFO_0000491 | G71.02 | 1 | — | — | — | — | 1 |
| Cerebral arterial diseases | D002539 | EFO_1000859 | — | 1 | — | — | — | — | 1 |
| Pharmacokinetics | D010599 | — | — | 1 | — | — | — | — | 1 |
| Bone diseases | D001847 | — | M89.9 | 1 | — | — | — | — | 1 |
Show 15 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pituitary diseases | D010900 | — | E23.7 | — | — | — | — | 6 | 6 |
| Acne vulgaris | D000152 | EFO_0003894 | L70 | — | — | — | — | 4 | 4 |
| Blood pressure | D001794 | EFO_0004325 | — | — | — | — | — | 3 | 3 |
| Anxiety disorders | D001008 | EFO_0006788 | F41.1 | — | — | — | — | 3 | 3 |
| Hormone replacement therapy | D020249 | EFO_0003961 | Z79.890 | — | — | — | — | 3 | 3 |
| Endometriosis | D004715 | EFO_0001065 | N80 | — | — | — | — | 3 | 3 |
| Hematologic diseases | D006402 | EFO_0005803 | D75.9 | — | — | — | — | 2 | 2 |
| Beta-thalassemia | D017086 | Orphanet_848 | D56.1 | — | — | — | — | 2 | 2 |
| Thalassemia | D013789 | EFO_1001996 | D56 | — | — | — | — | 2 | 2 |
| Hemorrhage | D006470 | MP_0001914 | R58 | — | — | — | — | 2 | 2 |
Show 136 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
PubMed Central
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Safety
Black-box Warning
Black-box warning for: Androgel, Aveed, Axiron, Kyzatrex, Testim, Testosterone, Testosterone gel, 1%, Tlando, Undecatrex, Vogelxo
Adverse Events
Top Adverse Reactions
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33,516 adverse events reported
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