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Drug ReportsTestosterone undecanoate
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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Clinical
Drug
Target
Variants
Financial
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Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
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FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
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Primary completion date
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Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
skin and connective tissue diseasesD017437
endocrine system diseasesD004700
mental disordersD001523
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
AVEEDEndoN-022219 RX2014-03-05
1 products, RLD, RS
KYZATREXMarius PharmaceuticalsN-213953 RX2022-07-27
2 products, RLD, RS
JATENZOTolmarN-206089 RX2019-03-27
3 products, RLD, RS
TLANDOVerity PharmaceuticalsN-208088 RX2022-03-28
1 products, RLD, RS
Show 1 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
aveedNew Drug Application2025-07-15
jatenzoNew Drug Application2025-09-15
kyzatrexNew Drug Application2025-10-02
tlandoNew Drug Application2025-07-01
undecatrexNew Drug Application2024-09-17
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
breast neoplasmsEFO_0003869D001943C50
hypogonadism—D007006E23.0
delayed puberty—D011628E30.0
Agency Specific
FDA
EMA
Expiration
Code
TESTOSTERONE UNDECANOATE, KYZATREX, MARIUS PHARMS LLC
2025-07-27NP
TESTOSTERONE UNDECANOATE, TLANDO, VERITY
2025-03-28NP
Patent Expiration
Patent
Expires
Flag
FDA Information
Testosterone Undecanoate, Tlando, Verity
114647352041-04-28DPU-1500
115595302037-11-28U-1500
99435272030-11-30U-1500
99499852030-11-30U-1500
102264732030-11-30U-1500
107167942030-11-30U-1500
113115552030-11-30U-1500
113642492030-11-30U-1500
114330832030-11-30U-1500
87789222029-01-08DPU-1500
88656952029-01-08U-1500
113049602029-01-08DPU-1500
Testosterone Undecanoate, Jatenzo, Tolmar
115649332039-04-12U-1103
84923692030-12-20DPU-2506
87789162030-04-12DP
105432192030-04-12U-2506
106176962030-04-12DS, DP
111794032030-04-12U-2506
114264162030-04-12U-3420
82416642029-03-29DPU-2506
113313252027-01-06U-2506
111794022026-04-14DS, DP
Testosterone Undecanoate, Kyzatrex, Marius Pharms Llc
116177582033-03-15DPU-2506
105760892030-12-31DPU-2506
105760902030-12-31DP
115901462030-12-31DP
Testosterone Undecanoate, Aveed, Endo Pharms Inc
83383952027-05-08U-1500
77186402027-03-14DP
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
346 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
HypogonadismD007006—E23.0———2—2
Cardiovascular diseasesD002318EFO_0000319I98———1—1
Indications Phases 3
No data
Indications Phases 2
No data
Indications Phases 1
No data
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameTestosterone undecanoate
INNtestosterone
Description
Testosterone undecanoate is a steroid ester.
Classification
Small molecule
Drug classsteroids (androgens, anabolics); antiandrogens
Image (chem structure or protein)Loading
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-ID5949-44-0
RxCUI—
ChEMBL IDCHEMBL2107067
ChEBI ID—
PubChem CID65157
DrugBankDB13946
UNII ID3XMK78S47O (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 1,656 documents
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Safety
Black-box Warning
Black-box warning for: Aveed, Undecatrex
Adverse Events
Top Adverse Reactions
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1,603 adverse events reported
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