PharmaKB logo
Company Reports
Company Reports
Drug Reports
Drug Reports
Disease Reports
Disease Reports
Sets
Sets
Favorites
Favorites
Log in
Log in
AboutPricing
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.
Download report
Favorite
Events Timeline
Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
Plot placeholder
Mock data
Subscribe for the real data
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
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
3 products, RLD, RS
JATENZOTolmarN-206089 RX2019-03-27
3 products, RLD, RS
TLANDOVerity PharmaceuticalsN-208088 RX2022-03-28
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
androgelNew Drug Application2024-09-18
aveedNew Drug Application2021-08-28
axironNew Drug Application2013-11-12
azmiroNew Drug Application2025-01-03
depo-testosteroneANDA2024-01-11
jatenzoNew Drug Application2023-08-15
kyzatrexNew Drug Application2023-10-26
natestoNew Drug Application2022-12-19
striantNew Drug Application2009-11-19
testimNew Drug Application2021-08-25
Show 12 more
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
breast neoplasmsEFO_0003869D001943C50
hypogonadismHP_0000044D007006E23.0
delayed pubertyHP_0000823D011628E30.0
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
875 clinical trials
View more details
Plot placeholder
Mock data
Subscribe for the real data
Indications Phases 4
No data
Indications Phases 3
No data
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Prostatic neoplasmsD011471—C61—1———1
Indications Phases 1
No data
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
View more details
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:
Plot placeholder
Mock data
Subscribe for the real data
Additional graphs summarizing 30,490 documents
View more details
Safety
Black-box Warning
Black-box warning for: Androgel, Aveed, Axiron, Jatenzo, Kyzatrex, Testim, Testosterone gel, 1%, Tlando, Undecatrex, Vogelxo, Xyosted
Adverse Events
Top Adverse Reactions
Plot placeholder
Mock data
Subscribe for the real data
33,263 adverse events reported
View more details
© 2020-2024 Collaborative Drug Discovery Inc. (CDD) | Terms of Use