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rezafungin 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| antifungal antibiotics | 5716 | 1396640-59-7 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
Rezafungin is a semi-synthetic echinocandin. Rezafungin inhibits the 1,3-beta-D glucan synthase enzyme complex, which is present in fungal cell walls but not in mammalian cells. This results in inhibition of the formation of 1,3-beta-D-glucan, an essential component of the fungal cell wall of many fungi, including Candida species (spp.). Inhibition of 1,3-beta-D-glucan synthesis results in concentration-dependent in vitro fungicidal activity against Candida spp., however, the clinical significance of this activity is unknown.
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 |
|---|---|---|---|---|---|
| azlogd74 | LogD at pH 7.4 | 0.694 | High | 0.88 | |
| caco2-efflux | Caco-2 efflux ratio (BA/AB) | 9.977 | High | 0.88 | |
| caco2-intrinsic-papp | Caco-2 intrinsic apparent permeability | 0.100 | 10^-6 cm/s | High | 0.88 |
| dh-clint | Dog hepatocyte intrinsic clearance | 2.296 | uL/min/10^6 cells | High | 0.88 |
| dppb | Dog plasma protein binding (% unbound) | 11.020 | % | High | 0.88 |
| fcs-ppb | Fetal calf serum protein binding (% unbound) | 18.120 | % | High | 0.88 |
| herg | hERG pIC50 | 4.558 | pIC50 | High | 0.88 |
| hh-clint | Human hepatocyte intrinsic clearance | 2.884 | uL/min/10^6 cells | High | 0.88 |
| hlm-clint | Human liver microsomal intrinsic clearance | 3.819 | uL/min/mg protein | High | 0.88 |
| hppb | Human plasma protein binding (% unbound) | 6.770 | % | High | 0.88 |
| kinase-safety-class | ACVR2B,EIF2AK3,GRK2,ITK,PDK1,PDK2,PDK4 | 7 | |||
| mdck-mdr1-efflux | MDCK-MDR1 efflux ratio | 4.305 | High | 0.88 | |
| mh-clint | Mouse hepatocyte intrinsic clearance | 3.811 | High | 0.88 | |
| mppb | Mouse plasma protein binding (% unbound) | 3.870 | High | 0.88 | |
| nih-mdck-mdr1-efflux | NIH MDCK-MDR1 efflux ratio | 6.109 | High | 0.88 | |
| pfas-class | PFAS structural alert (1 = True, 0 = False) | 0 | |||
| pppb | Pig plasma protein binding (% unbound) | 9.800 | % | High | 0.88 |
| rh-clint | Rat hepatocyte intrinsic clearance | 3.177 | uL/min/10^6 cells | High | 0.88 |
| rh-fuinc | Rat hepatocyte fraction unbound in incubation | 16.730 | % | High | 0.88 |
| rppb | Rat plasma protein binding (% unbound) | 3.520 | % | High | 0.88 |
| solubility-dd | Solubility at pH 7.4 in DMSO | 127.938 | uM | High | 0.88 |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| March 22, 2023 | FDA | CIDARA THERAPEUTICS, 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 | J02AX08 | ANTIINFECTIVES FOR SYSTEMIC USE ANTIMYCOTICS FOR SYSTEMIC USE ANTIMYCOTICS FOR SYSTEMIC USE Other antimycotics for systemic use |
| MeSH PA | D000890 | Anti-Infective Agents |
| MeSH PA | D000935 | Antifungal Agents |
| FDA CS | M0519359 | Lipopeptides |
| FDA EPC | N0000175507 | Echinocandin Antifungal |
Related Drugs by ATC class:
J02AX Other antimycotics for systemic use 5 drugs
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Disseminated candidiasis | indication | 70572005 | |
| Candidemia | indication | 432261003 |
🐶 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 |
|---|---|---|---|---|---|---|---|---|---|---|
| EQ 200MG BASE/VIAL | REZZAYO | MUNDIPHARMA | N217417 | March 22, 2023 | RX | POWDER | INTRAVENOUS | 11654196 | March 2, 2032 | TREATMENT OF CANDIDEMIA AND INVASIVE CANDIDIASIS WITH REZAFUNGIN BY INTRAVENOUS ADMINISTRATION |
| EQ 200MG BASE/VIAL | REZZAYO | MUNDIPHARMA | N217417 | March 22, 2023 | RX | POWDER | INTRAVENOUS | 10702573 | March 14, 2033 | TREATMENT OF CANDIDEMIA AND INVASIVE CANDIDIASIS WITH REZAFUNGIN BY INTRAVENOUS ADMINISTRATION |
| EQ 200MG BASE/VIAL | REZZAYO | MUNDIPHARMA | N217417 | March 22, 2023 | RX | POWDER | INTRAVENOUS | 9526835 | March 14, 2033 | TREATMENT OF CANDIDEMIA AND INVASIVE CANDIDIASIS WITH REZAFUNGIN BY INTRAVENOUS ADMINISTRATION |
| EQ 200MG BASE/VIAL | REZZAYO | MUNDIPHARMA | N217417 | March 22, 2023 | RX | POWDER | INTRAVENOUS | 8722619 | May 9, 2036 | TREATMENT OF CANDIDEMIA AND INVASIVE CANDIDIASIS WITH REZAFUNGIN BY INTRAVENOUS ADMINISTRATION |
| EQ 200MG BASE/VIAL | REZZAYO | MUNDIPHARMA | N217417 | March 22, 2023 | RX | POWDER | INTRAVENOUS | 11712459 | March 15, 2037 | TREATMENT OF CANDIDEMIA AND INVASIVE CANDIDIASIS WITH REZAFUNGIN BY INTRAVENOUS ADMINISTRATION |
| EQ 200MG BASE/VIAL | REZZAYO | MUNDIPHARMA | N217417 | March 22, 2023 | RX | POWDER | INTRAVENOUS | 11819533 | July 11, 2038 | TREATMENT OF CANDIDEMIA AND INVASIVE CANDIDIASIS WITH REZAFUNGIN BY INTRAVENOUS ADMINISTRATION |
| EQ 200MG BASE/VIAL | REZZAYO | MUNDIPHARMA | N217417 | March 22, 2023 | RX | POWDER | INTRAVENOUS | 11197909 | July 14, 2038 | TREATMENT OF CANDIDEMIA AND INVASIVE CANDIDIASIS WITH REZAFUNGIN BY INTRAVENOUS ADMINISTRATION |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| EQ 200MG BASE/VIAL | REZZAYO | MUNDIPHARMA | N217417 | March 22, 2023 | RX | POWDER | INTRAVENOUS | March 22, 2028 | NEW CHEMICAL ENTITY |
| EQ 200MG BASE/VIAL | REZZAYO | MUNDIPHARMA | N217417 | March 22, 2023 | RX | POWDER | INTRAVENOUS | March 22, 2030 | FOR USE IN PATIENTS 18 YEARS OF AGE OR OLDER WHO HAVE LIMITED OR NO ALTERNATIVE OPTIONS FOR THE TREATMENT OF CANDIDEMIA AND INVASIVE CANDIDIASIS |
| EQ 200MG BASE/VIAL | REZZAYO | MUNDIPHARMA | N217417 | March 22, 2023 | RX | POWDER | INTRAVENOUS | March 22, 2033 | GENERATING ANTIBIOTIC INCENTIVES NOW |
| EQ 200MG BASE/VIAL | REZZAYO | MUNDIPHARMA | N217417 | March 22, 2023 | RX | POWDER | INTRAVENOUS | March 22, 2035 | GENERATING ANTIBIOTIC INCENTIVES NOW |
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Beta-1,3-glucan synthase catalytic subunit 1 | Enzyme | INHIBITOR | UNKNOWN | DRUG LABEL |
External reference:
| ID | Source |
|---|---|
| CHEMBL3989945 | ChEMBL_ID |
| C000629634 | MESH_SUPPLEMENTAL_RECORD_UI |
| DB16310 | DRUGBANK_ID |
| 1363063002 | SNOMEDCT_US |
| 1363064008 | SNOMEDCT_US |
| 4042354 | VANDF |
| C4726687 | UMLSCUI |
| CHEBI:230470 | CHEBI |
| CHEMBL3989928 | ChEMBL_ID |
| 1631754-41-0 | SECONDARY_CAS_RN |
| 78318119 | PUBCHEM_CID |
| 368549 | MMSL |
| 41718 | MMSL |
| d10071 | MMSL |
| 019349 | NDDF |
| 019383 | NDDF |
| D11197 | KEGG_DRUG |
| G013B5478J | UNII |
| 10432 | INN_ID |
| 2639155 | RXNORM |
| C586076 | MESH_SUPPLEMENTAL_RECORD_UI |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| REZZAYO | HUMAN PRESCRIPTION DRUG LABEL | 1 | 70842-240 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 200 mg | INTRAVENOUS | NDA | 31 sections |