testosterone undecanoate Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| androgens/anabolic steroids | 2608 | 5949-44-0 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
None
ADMET properties:
None
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| March 5, 2014 | FDA | ENDO PHARMS INC |
FDA Adverse Event Reporting System (Female)
None
FDA Adverse Event Reporting System (Male)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| MeSH PA | D000728 | Androgens |
| MeSH PA | D006728 | Hormones |
Drug Use (View source of the data)
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Hypogonadotropic hypogonadism | indication | 33927004 | |
| Primary hypogonadism | indication | 370999003 |
Acid dissociation constants calculated using MoKa v3.0.0
None
Orange Book patent data (new drug applications)
None
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 158MG | JATENZO | CLARUS | N206089 | March 27, 2019 | RX | CAPSULE | ORAL | March 27, 2022 | NEW PRODUCT |
| 198MG | JATENZO | CLARUS | N206089 | March 27, 2019 | RX | CAPSULE | ORAL | March 27, 2022 | NEW PRODUCT |
| 237MG | JATENZO | CLARUS | N206089 | March 27, 2019 | RX | CAPSULE | ORAL | March 27, 2022 | NEW PRODUCT |
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Androgen receptor | Nuclear hormone receptor | AGONIST | CHEMBL | CHEMBL |
External reference:
| ID | Source |
|---|---|
| 4033172 | VUID |
| N0000190487 | NUI |
| D06087 | KEGG_DRUG |
| 4033172 | VANDF |
| C0076195 | UMLSCUI |
| CHEBI:135741 | CHEBI |
| CHEMBL2107067 | ChEMBL_ID |
| C010792 | MESH_SUPPLEMENTAL_RECORD_UI |
| DB13946 | DRUGBANK_ID |
| H16A5VCT9C | UNII |
| 65157 | PUBCHEM_CID |
| 37864 | RXNORM |
| 15462 | MMSL |
| 004105 | NDDF |
| 395900004 | SNOMEDCT_US |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Aveed | HUMAN PRESCRIPTION DRUG LABEL | 1 | 67979-511 | INJECTION | 250 mg | INTRAMUSCULAR | NDA | 29 sections |
| Jatenzo | HUMAN PRESCRIPTION DRUG LABEL | 1 | 69087-158 | CAPSULE, LIQUID FILLED | 158 mg | ORAL | NDA | 32 sections |
| Jatenzo | HUMAN PRESCRIPTION DRUG LABEL | 1 | 69087-198 | CAPSULE, LIQUID FILLED | 198 mg | ORAL | NDA | 32 sections |
| Jatenzo | HUMAN PRESCRIPTION DRUG LABEL | 1 | 69087-237 | CAPSULE, LIQUID FILLED | 237 mg | ORAL | NDA | 32 sections |