rezafungin 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | 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
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 |
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 | CIDARA THERAPS | 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 | CIDARA THERAPS | N217417 | March 22, 2023 | RX | POWDER | INTRAVENOUS | 8722619 | March 2, 2032 | TREATMENT OF CANDIDEMIA AND INVASIVE CANDIDIASIS WITH REZAFUNGIN BY INTRAVENOUS ADMINISTRATION |
| EQ 200MG BASE/VIAL | REZZAYO | CIDARA THERAPS | 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 | CIDARA THERAPS | 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 | CIDARA THERAPS | 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 | CIDARA THERAPS | N217417 | March 22, 2023 | RX | POWDER | INTRAVENOUS | March 22, 2028 | NEW CHEMICAL ENTITY |
| EQ 200MG BASE/VIAL | REZZAYO | CIDARA THERAPS | 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 | CIDARA THERAPS | N217417 | March 22, 2023 | RX | POWDER | INTRAVENOUS | March 22, 2033 | GENERATING ANTIBIOTIC INCENTIVES NOW |
| EQ 200MG BASE/VIAL | REZZAYO | CIDARA THERAPS | 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 |
| C586076 | MESH_SUPPLEMENTAL_RECORD_UI |
| DB16310 | DRUGBANK_ID |
| 019349 | NDDF |
| 019383 | NDDF |
| 4042354 | VANDF |
| C4726687 | UMLSCUI |
| CHEMBL3989928 | ChEMBL_ID |
| 10432 | INN_ID |
| 1631754-41-0 | SECONDARY_CAS_RN |
| 78318119 | PUBCHEM_CID |
| 2639155 | RXNORM |
| D11197 | KEGG_DRUG |
| G013B5478J | UNII |
| 368549 | MMSL |
| 41718 | MMSL |
| d10071 | MMSL |
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 | 29 sections |