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testosterone enantate 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| androgens/anabolic steroids | 4609 | 315-37-7 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
None
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| BA (Bioavailability) | 4 % |
Predicted pharmacokinetic/toxicological properties (PK-AZ):
| Property | Description | Value | Unit | Confidence | Similarity |
|---|---|---|---|---|---|
| azlogd74 | LogD at pH 7.4 | 4.766 | High | 0.80 | |
| caco2-efflux | Caco-2 efflux ratio (BA/AB) | 0.798 | High | 0.80 | |
| caco2-intrinsic-papp | Caco-2 intrinsic apparent permeability | 22.542 | 10^-6 cm/s | High | 0.80 |
| dh-clint | Dog hepatocyte intrinsic clearance | 145.881 | uL/min/10^6 cells | High | 0.80 |
| dppb | Dog plasma protein binding (% unbound) | 0.270 | % | High | 0.80 |
| fcs-ppb | Fetal calf serum protein binding (% unbound) | 0.420 | % | High | 0.80 |
| herg | hERG pIC50 | 4.973 | pIC50 | High | 0.80 |
| hh-clint | Human hepatocyte intrinsic clearance | 129.718 | uL/min/10^6 cells | High | 0.80 |
| hlm-clint | Human liver microsomal intrinsic clearance | 128.529 | uL/min/mg protein | High | 0.80 |
| hppb | Human plasma protein binding (% unbound) | 0.290 | % | High | 0.80 |
| mdck-mdr1-efflux | MDCK-MDR1 efflux ratio | 0.082 | High | 0.80 | |
| mh-clint | Mouse hepatocyte intrinsic clearance | 311.172 | High | 0.80 | |
| mppb | Mouse plasma protein binding (% unbound) | 0.440 | High | 0.80 | |
| nih-mdck-mdr1-efflux | NIH MDCK-MDR1 efflux ratio | 0.143 | High | 0.80 | |
| pfas-class | PFAS structural alert (1 = True, 0 = False) | 0 | |||
| pppb | Pig plasma protein binding (% unbound) | 1.110 | % | High | 0.80 |
| rh-clint | Rat hepatocyte intrinsic clearance | 291.743 | uL/min/10^6 cells | High | 0.80 |
| rh-fuinc | Rat hepatocyte fraction unbound in incubation | 3.370 | % | High | 0.80 |
| rppb | Rat plasma protein binding (% unbound) | 0.340 | % | High | 0.80 |
| solubility-dd | Solubility at pH 7.4 in DMSO | 1.208 | uM | High | 0.80 |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Dec. 24, 1953 | FDA | ENDO PHARMS |
FDA Adverse Event Reporting System (Female)
None
FDA Adverse Event Reporting System (Male)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Device dislocation | 150.99 | 32.66 | 38 | 1422 | 7793 | 42612082 |
| Device malfunction | 143.00 | 32.66 | 40 | 1420 | 12287 | 42607588 |
| Product dose omission issue | 117.57 | 32.66 | 70 | 1390 | 154295 | 42465580 |
| Faecal calprotectin increased | 44.91 | 32.66 | 12 | 1448 | 3082 | 42616793 |
| Pharyngitis streptococcal | 42.16 | 32.66 | 12 | 1448 | 3888 | 42615987 |
| Drug ineffective | 41.00 | 32.66 | 75 | 1385 | 630122 | 41989753 |
| Product use in unapproved indication | 38.67 | 32.66 | 39 | 1421 | 184417 | 42435458 |
| Accidental exposure to product | 34.88 | 32.66 | 16 | 1444 | 20377 | 42599498 |
| Migraine | 34.48 | 32.66 | 17 | 1443 | 25397 | 42594478 |
| Hot flush | 33.48 | 32.66 | 16 | 1444 | 22335 | 42597540 |
| Focal segmental glomerulosclerosis | 32.84 | 32.66 | 9 | 1451 | 2539 | 42617336 |
FDA Adverse Event Reporting System (Geriatric)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Device malfunction | 164.18 | 32.84 | 46 | 2062 | 25512 | 110561679 |
| Device dislocation | 154.38 | 32.84 | 46 | 2062 | 31658 | 110555533 |
| Product dose omission issue | 102.64 | 32.84 | 68 | 2040 | 321714 | 110265477 |
| Ear congestion | 55.05 | 32.84 | 13 | 2095 | 3652 | 110583539 |
| Faecal calprotectin increased | 42.64 | 32.84 | 12 | 2096 | 6707 | 110580484 |
| Migraine | 39.92 | 32.84 | 30 | 2078 | 171622 | 110415569 |
| Thyroid disorder | 39.12 | 32.84 | 14 | 2094 | 16955 | 110570236 |
| Secondary hypogonadism | 35.40 | 32.84 | 7 | 2101 | 856 | 110586335 |
| Pharyngitis streptococcal | 34.59 | 32.84 | 12 | 2096 | 13265 | 110573926 |
| Focal segmental glomerulosclerosis | 33.72 | 32.84 | 9 | 2099 | 4136 | 110583055 |
| Bronchitis | 33.32 | 32.84 | 26 | 2082 | 157006 | 110430185 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| FDA CS | M0001109 | Androstanes |
| FDA MoA | N0000000146 | Androgen Receptor Agonists |
| MeSH PA | D000728 | Androgens |
| MeSH PA | D006728 | Hormones |
| FDA EPC | N0000175824 | Androgen |
| CHEBI has role | CHEBI:35610 | antineoplastic agent |
| CHEBI has role | CHEBI:50113 | androgen |
| CHEBI has role | CHEBI:74518 | anti-obesity agent |
| CHEBI has role | CHEBI:35480 | analgesic |
| CHEBI has role | CHEBI:35554 | cardiovascular drug |
| CHEBI has role | CHEBI:35620 | vasodilator agent |
| CHEBI has role | CHEBI:35705 | immunosuppressive agent |
| CHEBI has role | CHEBI:50779 | appetite enhancer |
| CHEBI has role | CHEBI:50864 | insulin-sensitizing drug |
| CHEBI has role | CHEBI:75771 | mouse metabolite |
| CHEBI has role | CHEBI:77746 | human metabolite |
| CHEBI has role | CHEBI:83056 | <em>Daphnia magna</em> metabolite |
| CHEBI has role | CHEBI:176497 | geroprotector |
| CHEBI has role | CHEBI:231911 | renoprotective agent |
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Deficiency of testosterone biosynthesis | indication | 38825009 | |
| Male hypogonadism | indication | 48723006 | |
| Menopausal flushing | indication | 198436008 | |
| Undescended testicle | indication | 204878001 | DOID:11383 |
| Delayed puberty | indication | 400003000 | |
| Klinefelter's syndrome, XXY | indication | 405769009 | |
| Hormone receptor positive malignant neoplasm of breast | indication | 417181009 | |
| LHRH Deficiency | indication | ||
| Hyperlipoproteinemia | contraindication | 3744001 | DOID:1168 |
| Gynecomastia | contraindication | 4754008 | DOID:12698 |
| Hypocalcemia | contraindication | 5291005 | |
| Hypercholesterolemia | contraindication | 13644009 | |
| Myocardial infarction | contraindication | 22298006 | DOID:5844 |
| Chloasma | contraindication | 36209000 | |
| Migraine | contraindication | 37796009 | DOID:6364 |
| Hypertensive disorder | contraindication | 38341003 | DOID:10763 |
| Disorder of gallbladder | contraindication | 39621005 | DOID:0060262 |
| Hypothyroidism | contraindication | 40930008 | DOID:1459 |
| Body fluid retention | contraindication | 43498006 | |
| Thrombosis of retinal vein | contraindication | 46085004 | |
| Humoral hypercalcemia of malignancy | contraindication | 47709007 | |
| Chronic heart failure | contraindication | 48447003 | |
| Dementia | contraindication | 52448006 | |
| Hepatic porphyria | contraindication | 55056006 | DOID:3133 |
| Systemic lupus erythematosus | contraindication | 55464009 | DOID:9074 |
| Heart disease | contraindication | 56265001 | DOID:114 |
| Thrombophlebitis | contraindication | 64156001 | DOID:3875 |
| Intermenstrual bleeding - irregular | contraindication | 64996003 | |
| Diabetes mellitus | contraindication | 73211009 | DOID:9351 |
| Sleep apnea | contraindication | 73430006 | DOID:0050847 |
| Epilepsy | contraindication | 84757009 | DOID:1826 |
| Breast lump | contraindication | 89164003 | |
| Kidney disease | contraindication | 90708001 | DOID:557 |
| Uterine leiomyoma | contraindication | 95315005 | DOID:13223 |
| Neoplasm of prostate | contraindication | 126906006 | DOID:10283 |
| Deep venous thrombosis | contraindication | 128053003 | |
| Endometriosis | contraindication | 129103003 | |
| Mammography abnormal | contraindication | 168750009 | |
| Asthma | contraindication | 195967001 | DOID:2841 |
| Cerebrovascular accident | contraindication | 230690007 | |
| Pulmonary thromboembolism | contraindication | 233935004 | |
| Thrombophilia | contraindication | 234467004 | DOID:2452 |
| Disease of liver | contraindication | 235856003 | DOID:409 |
| Endometrial carcinoma | contraindication | 254878006 | DOID:2871 |
| Benign prostatic hyperplasia | contraindication | 266569009 | |
| Edema | contraindication | 267038008 | |
| Chorea | contraindication | 271700006 | |
| Pregnancy, function | contraindication | 289908002 | |
| Hypertriglyceridemia | contraindication | 302870006 | |
| Functional visual loss | contraindication | 313165001 | |
| Malignant tumor of ovary | contraindication | 363443007 | DOID:2394 |
| Thromboembolic disorder | contraindication | 371039008 | |
| Cardiovascular event risk | contraindication | 395112001 | |
| Breastfeeding (mother) | contraindication | 413712001 | |
| Chronic lung disease | contraindication | 413839001 | |
| Disorder of coronary artery | contraindication | 414024009 | |
| Obesity | contraindication | 414916001 | DOID:9970 |
| Estrogen receptor positive tumor | contraindication | 416053008 | |
| Family history of malignant neoplasm of breast | contraindication | 429740004 | |
| Hypertensive urgency | contraindication | 443482000 | |
| Carcinoma of female breast | contraindication | 447782002 | |
| Smokes tobacco daily | contraindication | 449868002 | |
| Breast Carcinoma in Males | contraindication |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
None
Orange Book patent data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
|---|---|---|---|---|---|---|---|---|---|---|
| 100MG/0.5ML (100MG/0.5ML) | XYOSTED (AUTOINJECTOR) | ANTARES PHARMA INC | N209863 | Sept. 28, 2018 | RX | SOLUTION | SUBCUTANEOUS | 10821072 | June 4, 2033 | METHOD OF ADMINISTERING TESTOSTERONE ENANTHATE SUBCUTANEOUSLY |
| 100MG/0.5ML (100MG/0.5ML) | XYOSTED (AUTOINJECTOR) | ANTARES PHARMA INC | N209863 | Sept. 28, 2018 | RX | SOLUTION | SUBCUTANEOUS | 11844804 | June 4, 2033 | METHOD OF ADMINISTERING TESTOSTERONE ENANTHATE SUBCUTANEOUSLY |
| 50MG/0.5ML (50MG/0.5ML) | XYOSTED (AUTOINJECTOR) | ANTARES PHARMA INC | N209863 | Sept. 28, 2018 | RX | SOLUTION | SUBCUTANEOUS | 10821072 | June 4, 2033 | METHOD OF ADMINISTERING TESTOSTERONE ENANTHATE SUBCUTANEOUSLY |
| 50MG/0.5ML (50MG/0.5ML) | XYOSTED (AUTOINJECTOR) | ANTARES PHARMA INC | N209863 | Sept. 28, 2018 | RX | SOLUTION | SUBCUTANEOUS | 11844804 | June 4, 2033 | METHOD OF ADMINISTERING TESTOSTERONE ENANTHATE SUBCUTANEOUSLY |
| 75MG/0.5ML (75MG/0.5ML) | XYOSTED (AUTOINJECTOR) | ANTARES PHARMA INC | N209863 | Sept. 28, 2018 | RX | SOLUTION | SUBCUTANEOUS | 10821072 | June 4, 2033 | METHOD OF ADMINISTERING TESTOSTERONE ENANTHATE SUBCUTANEOUSLY |
| 75MG/0.5ML (75MG/0.5ML) | XYOSTED (AUTOINJECTOR) | ANTARES PHARMA INC | N209863 | Sept. 28, 2018 | RX | SOLUTION | SUBCUTANEOUS | 11844804 | June 4, 2033 | METHOD OF ADMINISTERING TESTOSTERONE ENANTHATE SUBCUTANEOUSLY |
| 100MG/0.5ML (100MG/0.5ML) | XYOSTED (AUTOINJECTOR) | ANTARES PHARMA INC | N209863 | Sept. 28, 2018 | RX | SOLUTION | SUBCUTANEOUS | 11160751 | Oct. 7, 2034 | METHOD OF ADMINISTERING TESTOSTERONE ENANTHATE SUBCUTANEOUSLY |
| 50MG/0.5ML (50MG/0.5ML) | XYOSTED (AUTOINJECTOR) | ANTARES PHARMA INC | N209863 | Sept. 28, 2018 | RX | SOLUTION | SUBCUTANEOUS | 11160751 | Oct. 7, 2034 | METHOD OF ADMINISTERING TESTOSTERONE ENANTHATE SUBCUTANEOUSLY |
| 75MG/0.5ML (75MG/0.5ML) | XYOSTED (AUTOINJECTOR) | ANTARES PHARMA INC | N209863 | Sept. 28, 2018 | RX | SOLUTION | SUBCUTANEOUS | 11160751 | Oct. 7, 2034 | METHOD OF ADMINISTERING TESTOSTERONE ENANTHATE SUBCUTANEOUSLY |
| 100MG/0.5ML (100MG/0.5ML) | XYOSTED (AUTOINJECTOR) | ANTARES PHARMA INC | N209863 | Sept. 28, 2018 | RX | SOLUTION | SUBCUTANEOUS | 10238662 | Feb. 19, 2035 | METHOD OF ADMINISTERING TESTOSTERONE ENANTHATE SUBCUTANEOUSLY |
| 100MG/0.5ML (100MG/0.5ML) | XYOSTED (AUTOINJECTOR) | ANTARES PHARMA INC | N209863 | Sept. 28, 2018 | RX | SOLUTION | SUBCUTANEOUS | 10912782 | Feb. 19, 2035 | METHOD OF ADMINISTERING TESTOSTERONE ENANTHATE SUBCUTANEOUSLY |
| 50MG/0.5ML (50MG/0.5ML) | XYOSTED (AUTOINJECTOR) | ANTARES PHARMA INC | N209863 | Sept. 28, 2018 | RX | SOLUTION | SUBCUTANEOUS | 10238662 | Feb. 19, 2035 | METHOD OF ADMINISTERING TESTOSTERONE ENANTHATE SUBCUTANEOUSLY |
| 50MG/0.5ML (50MG/0.5ML) | XYOSTED (AUTOINJECTOR) | ANTARES PHARMA INC | N209863 | Sept. 28, 2018 | RX | SOLUTION | SUBCUTANEOUS | 10912782 | Feb. 19, 2035 | METHOD OF ADMINISTERING TESTOSTERONE ENANTHATE SUBCUTANEOUSLY |
| 75MG/0.5ML (75MG/0.5ML) | XYOSTED (AUTOINJECTOR) | ANTARES PHARMA INC | N209863 | Sept. 28, 2018 | RX | SOLUTION | SUBCUTANEOUS | 10238662 | Feb. 19, 2035 | METHOD OF ADMINISTERING TESTOSTERONE ENANTHATE SUBCUTANEOUSLY |
| 75MG/0.5ML (75MG/0.5ML) | XYOSTED (AUTOINJECTOR) | ANTARES PHARMA INC | N209863 | Sept. 28, 2018 | RX | SOLUTION | SUBCUTANEOUS | 10912782 | Feb. 19, 2035 | METHOD OF ADMINISTERING TESTOSTERONE ENANTHATE SUBCUTANEOUSLY |
| 100MG/0.5ML (100MG/0.5ML) | XYOSTED (AUTOINJECTOR) | ANTARES PHARMA INC | N209863 | Sept. 28, 2018 | RX | SOLUTION | SUBCUTANEOUS | 9950125 | Sept. 4, 2036 | METHOD OF ADMINISTERING TESTOSTERONE ENANTHATE SUBCUTANEOUSLY |
| 50MG/0.5ML (50MG/0.5ML) | XYOSTED (AUTOINJECTOR) | ANTARES PHARMA INC | N209863 | Sept. 28, 2018 | RX | SOLUTION | SUBCUTANEOUS | 9950125 | Sept. 4, 2036 | METHOD OF ADMINISTERING TESTOSTERONE ENANTHATE SUBCUTANEOUSLY |
| 75MG/0.5ML (75MG/0.5ML) | XYOSTED (AUTOINJECTOR) | ANTARES PHARMA INC | N209863 | Sept. 28, 2018 | RX | SOLUTION | SUBCUTANEOUS | 9950125 | Sept. 4, 2036 | METHOD OF ADMINISTERING TESTOSTERONE ENANTHATE SUBCUTANEOUSLY |
Orange Book exclusivity data (new drug applications)
None
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 |
|---|---|
| D00958 | KEGG_DRUG |
| 4017482 | VUID |
| N0000179264 | NUI |
| 4017482 | VANDF |
| 4017484 | VANDF |
| TES | PDB_CHEM_ID |
| CHEMBL1200335 | ChEMBL_ID |
| C004648 | MESH_SUPPLEMENTAL_RECORD_UI |
| DB13944 | DRUGBANK_ID |
| DB00624 | DRUGBANK_ID |
| 10379 | RXNORM |
| 2966 | MMSL |
| 3019 | MMSL |
| 399960 | MMSL |
| 5552 | MMSL |
| 5554 | MMSL |
| d00558 | MMSL |
| 001245 | NDDF |
| 001247 | NDDF |
| 109033004 | SNOMEDCT_US |
| 116071004 | SNOMEDCT_US |
| 43688007 | SNOMEDCT_US |
| C0076189 | UMLSCUI |
| C0039601 | UMLSCUI |
| CHEBI:6980 | CHEBI |
| 9416 | PUBCHEM_CID |
| 6013 | PUBCHEM_CID |
| 1900 | INN_ID |
| D013739 | MESH_DESCRIPTOR_UI |
| 7Z6522T8N9 | UNII |
| CHEBI:17347 | CHEBI |
| 7Z6522T8N9 | INXIGHT DRUGS |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| TESTOSTERONE ENANTHATE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0143-9750 | INJECTION, SOLUTION | 200 mg | INTRAMUSCULAR | ANDA | 28 sections |
| XYOSTED | HUMAN PRESCRIPTION DRUG LABEL | 1 | 54436-200 | INJECTION | 100 mg | SUBCUTANEOUS | NDA | 34 sections |
| XYOSTED | HUMAN PRESCRIPTION DRUG LABEL | 1 | 54436-250 | INJECTION | 50 mg | SUBCUTANEOUS | NDA | 34 sections |
| XYOSTED | HUMAN PRESCRIPTION DRUG LABEL | 1 | 54436-275 | INJECTION | 75 mg | SUBCUTANEOUS | NDA | 34 sections |
| TESTOSTERONE ENANTHATE | Human Prescription Drug Label | 1 | 55150-336 | INJECTION, SOLUTION | 200 mg | INTRAMUSCULAR | ANDA | 26 sections |