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oteseconazole 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| systemic antifungal agents, miconazole derivatives | 5510 | 1340593-59-0 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
Oteseconazole is an azole metalloenzyme inhibitor targeting the fungal sterol, 14alpha demethylase(CYP51), an enzyme that catalyzes an early step in the biosynthetic pathway of ergosterol, a sterol required for fungal cell membrane formation and integrity. Inhibition of CYP51 results in the accumulation of 14-methylated sterols, some of which are toxic to fungi. Through the inclusion of a tetrazole metal-binding group, oteseconazole has a lower affinity for human CYP enzymes.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
| Dose | Unit | Route |
|---|---|---|
| 21 | mg | O |
ADMET properties:
None
Predicted pharmacokinetic/toxicological properties (PK-AZ):
| Property | Description | Value | Unit | Confidence | Similarity |
|---|---|---|---|---|---|
| azlogd74 | LogD at pH 7.4 | 4.020 | High | 1 | |
| caco2-efflux | Caco-2 efflux ratio (BA/AB) | 2.065 | High | 1 | |
| caco2-intrinsic-papp | Caco-2 intrinsic apparent permeability | 36.058 | 10^-6 cm/s | High | 1 |
| dh-clint | Dog hepatocyte intrinsic clearance | 3.499 | uL/min/10^6 cells | High | 1 |
| dppb | Dog plasma protein binding (% unbound) | 0.770 | % | High | 1 |
| fcs-ppb | Fetal calf serum protein binding (% unbound) | 2.890 | % | High | 1 |
| herg | hERG pIC50 | 5.442 | pIC50 | High | 1 |
| hh-clint | Human hepatocyte intrinsic clearance | 2.812 | uL/min/10^6 cells | High | 1 |
| hlm-clint | Human liver microsomal intrinsic clearance | 3.365 | uL/min/mg protein | High | 1 |
| hppb | Human plasma protein binding (% unbound) | 0.770 | % | High | 1 |
| kinase-safety-class | ACVR2B,EIF2AK3,GRK2,PDK1,PDK2,PDK4,PIK3CG | 7 | |||
| mdck-mdr1-efflux | MDCK-MDR1 efflux ratio | 2.729 | High | 1 | |
| mh-clint | Mouse hepatocyte intrinsic clearance | 4.295 | High | 1 | |
| mppb | Mouse plasma protein binding (% unbound) | 0.820 | High | 1 | |
| nih-mdck-mdr1-efflux | NIH MDCK-MDR1 efflux ratio | 6.397 | High | 1 | |
| pfas-class | PFAS structural alert (1 = True, 0 = False) | 1 | |||
| pppb | Pig plasma protein binding (% unbound) | 1.370 | % | High | 1 |
| rh-clint | Rat hepatocyte intrinsic clearance | 2.065 | uL/min/10^6 cells | High | 1 |
| rh-fuinc | Rat hepatocyte fraction unbound in incubation | 6.650 | % | High | 1 |
| rppb | Rat plasma protein binding (% unbound) | 0.560 | % | High | 1 |
| solubility-dd | Solubility at pH 7.4 in DMSO | 16.866 | uM | High | 1 |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| April 26, 2022 | FDA | MYCOVIA PHARMACEUTICALS INC |
FDA Adverse Event Reporting System (Female)
None
FDA Adverse Event Reporting System (Male)
None
FDA Adverse Event Reporting System (Geriatric)
None
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | J02AC06 | ANTIINFECTIVES FOR SYSTEMIC USE ANTIMYCOTICS FOR SYSTEMIC USE ANTIMYCOTICS FOR SYSTEMIC USE Triazole and tetrazole derivatives |
| MeSH PA | D000890 | Anti-Infective Agents |
| MeSH PA | D000935 | Antifungal Agents |
| FDA CS | M0002083 | Azoles |
| FDA EPC | N0000175487 | Azole Antifungal |
| FDA MoA | N0000190113 | Breast Cancer Resistance Protein Inhibitors |
| CHEBI has role | CHEBI:35718 | antifungal agent |
| CHEBI has role | CHEBI:86327 | antifungal drug |
Related Drugs by ATC class:
J02AC Triazole and tetrazole derivatives 5 drugs
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Recurrent vulvovaginal candidiasis (RVVC) | indication | 708126004 | |
| Lactation | contraindication | 63158009 | |
| Pregnancy, function | contraindication | 289908002 |
🐶 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 |
|---|---|---|---|---|---|---|---|---|---|---|
| 150MG | VIVJOA | MYCOVIA PHARMS | N215888 | April 26, 2022 | RX | CAPSULE | ORAL | 8754227 | April 22, 2031 | VIVJOA IS INDICATED TO REDUCE THE INCIDENCE OF RECURRENT VULVOVAGINAL CANDIDIASIS (RVVC) IN FEMALES WITH A HISTORY OF RVVC WHO ARE NOT OF REPRODUCTIVE POTENTIAL |
| 150MG | VIVJOA | MYCOVIA PHARMS | N215888 | April 26, 2022 | RX | CAPSULE | ORAL | 11247981 | May 9, 2033 | VIVJOA IS INDICATED TO REDUCE THE INCIDENCE OF RECURRENT VULVOVAGINAL CANDIDIASIS (RVVC) IN FEMALES WITH A HISTORY OF RVVC WHO ARE NOT OF REPRODUCTIVE POTENTIAL |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 150MG | VIVJOA | MYCOVIA PHARMS | N215888 | April 26, 2022 | RX | CAPSULE | ORAL | April 26, 2027 | NEW CHEMICAL ENTITY |
| 150MG | VIVJOA | MYCOVIA PHARMS | N215888 | April 26, 2022 | RX | CAPSULE | ORAL | April 26, 2032 | GENERATING ANTIBIOTIC INCENTIVES NOW |
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Cytochrome P450 3A4 | Enzyme | INHIBITOR | IC50 | 4.19 | SCIENTIFIC LITERATURE | ||||
| Cytochrome P450 2C9 | Enzyme | INHIBITOR | IC50 | 4 | SCIENTIFIC LITERATURE | ||||
| Cytochrome P450 2C19 | Enzyme | INHIBITOR | IC50 | 4.14 | SCIENTIFIC LITERATURE | ||||
| Lanosterol 14-alpha demethylase | Enzyme | INHIBITOR | Kd | 7.41 | SCIENTIFIC LITERATURE | DRUG LABEL |
External reference:
| ID | Source |
|---|---|
| CHEBI:188153 | CHEBI |
| VT1 | PDB_CHEM_ID |
| CHEMBL3311228 | ChEMBL_ID |
| C000599187 | MESH_SUPPLEMENTAL_RECORD_UI |
| DB13055 | DRUGBANK_ID |
| 4041587 | VANDF |
| C4519300 | UMLSCUI |
| D11785 | KEGG_DRUG |
| 10138 | INN_ID |
| 77050711 | PUBCHEM_CID |
| 40649 | MMSL |
| d09883 | MMSL |
| 019048 | NDDF |
| VHH774W97N | UNII |
| 2602577 | RXNORM |
| VHH774W97N | INXIGHT DRUGS |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| VIVJOA | HUMAN PRESCRIPTION DRUG LABEL | 1 | 74695-823 | CAPSULE | 150 mg | ORAL | NDA | 32 sections |