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doxercalciferol 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| Vitamin D analogues/derivatives | 957 | 54573-75-0 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
decrease of bone density caused by prednisolone was prevented by above cpd; decreases number of osteoclast areas in normal rats; RN given refers to (1alpha,3beta,5Z,7E,22E)-isomer
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
None
ADMET properties:
None
Predicted pharmacokinetic/toxicological properties (PK-AZ):
| Property | Description | Value | Unit | Confidence | Similarity |
|---|---|---|---|---|---|
| kinase-safety-class | ACVR2B,BRAF,CAMK2D,CDK5,EIF2AK3,ERBB2,GRK2,ITK,NTRK2,PDK1,PDK2,PDK4,PRKDC,TEK | 14 | |||
| pfas-class | PFAS structural alert (1 = True, 0 = False) | 0 |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| June 9, 1999 | FDA | GENZYME CORP |
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 |
|---|---|---|---|---|---|---|
| Drug hypersensitivity | 367.52 | 42.44 | 136 | 604 | 463473 | 90164234 |
| Pruritus | 62.60 | 42.44 | 44 | 696 | 541481 | 90086226 |
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 |
|---|---|---|---|---|---|---|
| Drug hypersensitivity | 281.03 | 46.66 | 89 | 562 | 99300 | 42521384 |
| Pruritus | 56.07 | 46.66 | 35 | 616 | 188736 | 42431948 |
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 |
|---|---|---|---|---|---|---|
| Drug hypersensitivity | 620.76 | 46.26 | 224 | 1173 | 453866 | 110134036 |
| Pruritus | 108.27 | 46.26 | 75 | 1322 | 581485 | 110006417 |
| Dyspnoea | 68.06 | 46.26 | 76 | 1321 | 1106796 | 109481106 |
| Flushing | 59.04 | 46.26 | 28 | 1369 | 104708 | 110483194 |
| Unresponsive to stimuli | 51.72 | 46.26 | 22 | 1375 | 63768 | 110524134 |
| Feeling hot | 47.21 | 46.26 | 23 | 1374 | 91083 | 110496819 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | H05BX03 | SYSTEMIC HORMONAL PREPARATIONS, EXCL. SEX HORMONES AND INSULINS CALCIUM HOMEOSTASIS ANTI-PARATHYROID AGENTS Other anti-parathyroid agents |
| FDA CS | M0007651 | Ergocalciferols |
| MeSH PA | D014815 | Vitamins |
| MeSH PA | D018977 | Micronutrients |
| MeSH PA | D050071 | Bone Density Conservation Agents |
| CHEBI has role | CHEBI:35610 | antineoplastic agent |
| CHEBI has role | CHEBI:50188 | provitamin |
| CHEBI has role | CHEBI:50646 | bone density conservation agent |
| CHEBI has role | CHEBI:50748 | antipsoriatic |
| CHEBI has role | CHEBI:71212 | prohormone |
| FDA EPC | N0000175907 | Vitamin D2 Analog |
Related Drugs by ATC class:
H05BX Other anti-parathyroid agents 5 drugs
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Hyperparathyroidism Secondary to Chronic Renal Failure with Dialysis | indication | ||
| Hyperparathyroidism Secondary to Chronic Renal Failure | off-label use | ||
| Hyperphosphatemia | contraindication | 20165001 | DOID:0050459 |
| Hypervitaminosis D | contraindication | 27712000 | DOID:9971 |
| Hypoparathyroidism | contraindication | 36976004 | DOID:11199 |
| Hypercalcemia | contraindication | 66931009 | DOID:12678 |
| Disease of liver | contraindication | 235856003 | DOID:409 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 13.7 | acidic |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 0.5MCG | HECTOROL | SANOFI | N020862 | April 23, 2004 | DISCN | CAPSULE | ORAL | June 11, 2028 | ADDITIONAL CLINICAL TRIAL INFORMATION ADDED TO PEDIATRIC USE SUBSECTION |
| 1MCG | HECTOROL | SANOFI | N020862 | July 13, 2009 | DISCN | CAPSULE | ORAL | June 11, 2028 | ADDITIONAL CLINICAL TRIAL INFORMATION ADDED TO PEDIATRIC USE SUBSECTION |
| 2.5MCG | HECTOROL | SANOFI | N020862 | June 9, 1999 | DISCN | CAPSULE | ORAL | June 11, 2028 | ADDITIONAL CLINICAL TRIAL INFORMATION ADDED TO PEDIATRIC USE SUBSECTION |
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Vitamin D3 receptor | Nuclear hormone receptor | AGONIST | UNKNOWN | CHEMBL |
External reference:
| ID | Source |
|---|---|
| 4021201 | VUID |
| N0000179007 | NUI |
| D01009 | KEGG_DRUG |
| 4021201 | VANDF |
| C0043668 | UMLSCUI |
| CHEBI:4712 | CHEBI |
| V2H | PDB_CHEM_ID |
| CHEMBL1200810 | ChEMBL_ID |
| DB06410 | DRUGBANK_ID |
| 5281107 | PUBCHEM_CID |
| 2790 | IUPHAR_LIGAND_ID |
| C042533 | MESH_SUPPLEMENTAL_RECORD_UI |
| 7878 | INN_ID |
| 3DIZ9LF5Y9 | UNII |
| 11516 | RXNORM |
| 211288 | MMSL |
| 30992 | MMSL |
| 8230 | MMSL |
| d04435 | MMSL |
| 007891 | NDDF |
| 116094003 | SNOMEDCT_US |
| 126234006 | SNOMEDCT_US |
| 3DIZ9LF5Y9 | INXIGHT DRUGS |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Doxercalciferol | HUMAN PRESCRIPTION DRUG LABEL | 1 | 23155-538 | CAPSULE | 0.50 ug | ORAL | ANDA | 22 sections |
| Doxercalciferol | HUMAN PRESCRIPTION DRUG LABEL | 1 | 23155-539 | CAPSULE | 1 ug | ORAL | ANDA | 22 sections |
| Doxercalciferol | HUMAN PRESCRIPTION DRUG LABEL | 1 | 23155-540 | CAPSULE | 2.50 ug | ORAL | ANDA | 22 sections |
| DOXERCALCIFEROL | HUMAN PRESCRIPTION DRUG LABEL | 1 | 43598-850 | INJECTION | 4 ug | INTRAVENOUS | ANDA | 24 sections |
| Doxercalciferol | Human Prescription Drug Label | 1 | 55150-357 | INJECTION, SOLUTION | 2 ug | INTRAVENOUS | ANDA | 24 sections |
| Doxercalciferol | Human Prescription Drug Label | 1 | 55150-357 | INJECTION, SOLUTION | 2 ug | INTRAVENOUS | ANDA | 24 sections |
| Doxercalciferol | Human Prescription Drug Label | 1 | 55150-358 | INJECTION, SOLUTION | 4 ug | INTRAVENOUS | ANDA | 24 sections |
| Doxercalciferol | Human Prescription Drug Label | 1 | 55150-358 | INJECTION, SOLUTION | 4 ug | INTRAVENOUS | ANDA | 24 sections |
| Doxercalciferol | Human Prescription Drug Label | 1 | 55150-359 | INJECTION, SOLUTION | 4 ug | INTRAVENOUS | ANDA | 24 sections |
| Doxercalciferol | Human Prescription Drug Label | 1 | 55150-359 | INJECTION, SOLUTION | 4 ug | INTRAVENOUS | ANDA | 24 sections |
| Doxercalciferol | HUMAN PRESCRIPTION DRUG LABEL | 1 | 62135-450 | CAPSULE | 0.50 ug | ORAL | ANDA | 17 sections |
| Doxercalciferol | HUMAN PRESCRIPTION DRUG LABEL | 1 | 62135-451 | CAPSULE | 1 ug | ORAL | ANDA | 17 sections |
| Doxercalciferol | HUMAN PRESCRIPTION DRUG LABEL | 1 | 62135-452 | CAPSULE | 2.50 ug | ORAL | ANDA | 17 sections |
| Doxercalciferol | Human Prescription Drug Label | 1 | 62332-690 | INJECTION, SOLUTION | 4 ug | INTRAVENOUS | ANDA | 23 sections |
| Doxercalciferol | Human Prescription Drug Label | 1 | 68083-300 | INJECTION, SOLUTION | 4 ug | INTRAVENOUS | ANDA | 24 sections |
| Doxercalciferol | Human Prescription Drug Label | 1 | 68083-359 | INJECTION, SOLUTION | 4 ug | INTRAVENOUS | ANDA | 24 sections |
| Doxercalciferol | HUMAN PRESCRIPTION DRUG LABEL | 1 | 70518-4642 | CAPSULE | 0.50 ug | ORAL | ANDA | 22 sections |
| Doxercalciferol | HUMAN PRESCRIPTION DRUG LABEL | 1 | 71288-802 | INJECTION, SOLUTION | 4 ug | INTRAVENOUS | ANDA | 25 sections |