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toremifene 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| antiestrogens or estrogen receptor modulators, clomifene and tamoxifen derivatives | 2709 | 89778-26-7 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
A first generation selective estrogen receptor modulator (SERM). Like TAMOXIFEN, it is an estrogen agonist for bone tissue and cholesterol metabolism but is antagonistic on mammary and uterine tissue.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
| Dose | Unit | Route |
|---|---|---|
| 60 | mg | O |
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| BDDCS (Biopharmaceutical Drug Disposition Classification System) | 1 | Benet LZ, Broccatelli F, Oprea TI |
| S (Water solubility) | 0.38 mg/mL | Benet LZ, Broccatelli F, Oprea TI |
| EoM (Fraction excreted unchanged in urine) | 0.10 % | Benet LZ, Broccatelli F, Oprea TI |
| MRTD (Maximum Recommended Therapeutic Daily Dose) | 8.20 µM/kg/day | Contrera JF, Matthews EJ, Kruhlak NL, Benz RD |
| BA (Bioavailability) | 99 % | Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H |
Predicted pharmacokinetic/toxicological properties (PK-AZ):
| Property | Description | Value | Unit | Confidence | Similarity |
|---|---|---|---|---|---|
| kinase-safety-class | ACVR2A,ACVR2B,AKT1,AKT2,AKT3,ALK,AURKA,AXL,BRAF,BTK,CAMK2B,CAMK2D,CDK4,CDK5,CDK9,CHEK1,DDR1,DYRK1B,EIF2AK3,EPHB4,ERBB2,FLT3,GRK2,ITK,JAK1,JAK2,JAK3,MAP3K1,MAP3K21,MAP3K7,MAP4K1,MAP4K3,MAPK10,MAPK12,MAPK7,MAPK9,MAPKAPK2,MARK4,MET,MTOR,NTRK2,PAK4,PDK2,PDK4,PDPK1,PIK3CB,PIM2,PRKCD,PRKDC,SIK2,SIK3,STK33,SYK,TEK,TGFBR1,TTK | 56 | |||
| kinase-selectivity-class | CDK4,PDK4 | 2 | |||
| pfas-class | PFAS structural alert (1 = True, 0 = False) | 0 | |||
| pld-class | Phospholipidosis risk class (1 = positive, 0 = negative) | 1 | Moderate | 0.74 |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| May 29, 1997 | FDA | PROSTRAKAN INC |
FDA Adverse Event Reporting System (Female)
| 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 |
|---|---|---|---|---|---|---|
| Osteonecrosis of jaw | 79.02 | 37.15 | 24 | 759 | 39079 | 90588585 |
| Osteomyelitis | 51.56 | 37.15 | 16 | 767 | 27830 | 90599834 |
FDA Adverse Event Reporting System (Male)
None
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 |
|---|---|---|---|---|---|---|
| Osteonecrosis of jaw | 62.53 | 36.64 | 19 | 598 | 47998 | 110540684 |
| Osteomyelitis | 41.34 | 36.64 | 13 | 604 | 36587 | 110552095 |
| General physical health deterioration | 39.08 | 36.64 | 26 | 591 | 425269 | 110163413 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | L02BA02 | ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS ENDOCRINE THERAPY HORMONE ANTAGONISTS AND RELATED AGENTS Anti-estrogens |
| FDA MoA | N0000000168 | Selective Estrogen Receptor Modulators |
| MeSH PA | D000970 | Antineoplastic Agents |
| MeSH PA | D006727 | Hormone Antagonists |
| MeSH PA | D018931 | Antineoplastic Agents, Hormonal |
| MeSH PA | D020845 | Selective Estrogen Receptor Modulators |
| MeSH PA | D050071 | Bone Density Conservation Agents |
| FDA EPC | N0000175826 | Estrogen Agonist/Antagonist |
| CHEBI has role | CHEBI:22587 | antiviral agent |
| CHEBI has role | CHEBI:35610 | antineoplastic agent |
| CHEBI has role | CHEBI:50646 | bone density conservation agent |
| CHEBI has role | CHEBI:50739 | estrogen receptor modulator |
| CHEBI has role | CHEBI:50837 | estrogen antagonist |
| CHEBI has role | CHEBI:149553 | anticoronaviral agent |
Related Drugs by ATC class:
L02BA Anti-estrogens 3 drugs
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Metastatic Breast Carcinoma | indication | ||
| Torsades de pointes | contraindication | 31722008 | |
| Hypokalemia | contraindication | 43339004 | |
| Hypercalcemia | contraindication | 66931009 | DOID:12678 |
| Leukopenia | contraindication | 84828003 | DOID:615 |
| Prolonged QT interval | contraindication | 111975006 | |
| Hypomagnesemia | contraindication | 190855004 | |
| Endometrial hyperplasia | contraindication | 237072009 | |
| Pregnancy, function | contraindication | 289908002 | |
| Thrombocytopenic disorder | contraindication | 302215000 | DOID:1588 |
| Thromboembolic disorder | contraindication | 371039008 | |
| Breastfeeding (mother) | contraindication | 413712001 | |
| Congenital long QT syndrome | contraindication | 442917000 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 8.61 | Basic |
Orange Book patent data (new drug applications)
None
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 |
|---|---|---|---|---|---|---|---|---|---|
| Estrogen receptor | Nuclear hormone receptor | MODULATOR | WOMBAT-PK | CHEMBL | |||||
| 5-hydroxytryptamine receptor 6 | GPCR | Ki | 5.38 | CHEMBL | |||||
| Estrogen-related receptor gamma | Nuclear hormone receptor | WOMBAT-PK | |||||||
| Envelope glycoprotein | Viral envelope protein | Kd | 4.80 | CHEMBL |
External reference:
| ID | Source |
|---|---|
| D00967 | KEGG_DRUG |
| 89778-27-8 | SECONDARY_CAS_RN |
| 4021088 | VANDF |
| 4024102 | VANDF |
| C0076836 | UMLSCUI |
| CHEBI:9635 | CHEBI |
| T0R | PDB_CHEM_ID |
| CHEMBL1655 | ChEMBL_ID |
| CHEMBL1200675 | ChEMBL_ID |
| D017312 | MESH_DESCRIPTOR_UI |
| DB00539 | DRUGBANK_ID |
| 3005573 | PUBCHEM_CID |
| 4325 | IUPHAR_LIGAND_ID |
| 5698 | INN_ID |
| 7NFE54O27T | UNII |
| 155082 | RXNORM |
| 11447 | MMSL |
| 305699 | MMSL |
| 5603 | MMSL |
| d04137 | MMSL |
| 006098 | NDDF |
| 007222 | NDDF |
| 387057008 | SNOMEDCT_US |
| 387588002 | SNOMEDCT_US |
| 96378009 | SNOMEDCT_US |
| 7NFE54O27T | INXIGHT DRUGS |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Fareston | HUMAN PRESCRIPTION DRUG LABEL | 1 | 42747-327 | TABLET | 60 mg | ORAL | NDA | 26 sections |
| toremifene citrate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 64980-404 | TABLET | 60 mg | ORAL | ANDA | 27 sections |
| toremifene citrate | Human Prescription Drug Label | 1 | 72205-050 | TABLET | 60 mg | ORAL | ANDA | 26 sections |