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Aveed, Intrinsa(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
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
TLANDOAntares PharmaN-208088 RX2022-03-28
1 products, RLD, RS
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
Labels
FDA
EMA
Brand Name
Status
Last Update
aveedNew Drug Application2020-06-30
jatenzoNew Drug Application2021-01-11
kyzatrexNew Drug Application2022-08-17
tlandoNew Drug Application2022-03-28
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
breast neoplasmsEFO_0003869D001943C50
delayed pubertyHP_0000823D011628E30.0
hypogonadismHP_0000815D007006E23.0
Agency Specific
FDA
EMA
Expiration
Code
TESTOSTERONE UNDECANOATE, KYZATREX, MARIUS PHARMS LLC
2025-07-27NP
TESTOSTERONE UNDECANOATE, TLANDO, ANTARES PHARMA INC
2025-03-28NP
Patent Expiration
Patent
Expires
Flag
FDA Information
Testosterone Undecanoate, Tlando, Antares Pharma Inc
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
7 clinical trials
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Mock data
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Vulvovaginal candidiasisD002181EFO_0007543B37.3———123
Indications Phases 3
No data
Indications Phases 2
No data
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
VaginitisD014627EFO_0005757N761————1
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)
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
RxCUI37864
ChEMBL IDCHEMBL2107067
ChEBI ID—
PubChem CID65157
DrugBankDB13946
UNII ID3XMK78S47O (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
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Additional graphs summarizing 109,989 documents
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Safety
Black-box Warning
Black-box warning for: Aveed, Jatenzo, Kyzatrex, Tlando
Adverse Events
Top Adverse Reactions
Mock data
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261 adverse events reported
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