anidulafungin 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
antifungal antibiotics	4357	166663-25-8

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: anidulafungin ecalta eraxis LY 303366 LY-303366	Echinocandin antifungal agent that is used in the treatment of CANDIDEMIA and CANDIDIASIS. Molecular weight: 1140.25 Formula: C58H73N7O17 CLOGP: 2.80 LIPINSKI: 3 HAC: 24 HDO: 14 TPSA: 377.42 ALOGS: -4.31 ROTB: 14 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

anidulafungin
ecalta
eraxis
LY 303366
LY-303366

Echinocandin antifungal agent that is used in the treatment of CANDIDEMIA and CANDIDIASIS.

Molecular weight: 1140.25
Formula: C58H73N7O17
CLOGP: 2.80
LIPINSKI: 3
HAC: 24
HDO: 14
TPSA: 377.42
ALOGS: -4.31
ROTB: 14

Status: OFP

Legend:
OFP - off patent
OFM - off market
ONP - on patent

Drug dosage:

Dose	Unit	Route
0.10	g	P

ADMET properties:

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Property	Value	Reference
MRTD (Maximum Recommended Therapeutic Daily Dose)	6.30 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
t_half (Half-life)	40 hours	Lombardo F, Berellini G, Obach RS
BDDCS (Biopharmaceutical Drug Disposition Classification System)	2	Benet LZ, Broccatelli F, Oprea TI
Vd (Volume of distribution)	0.57 L/kg	Lombardo F, Berellini G, Obach RS
EoM (Fraction excreted unchanged in urine)	0.50 %	Benet LZ, Broccatelli F, Oprea TI
CL (Clearance)	0.21 mL/min/kg	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	0.16 %	Lombardo F, Berellini G, Obach RS
S (Water solubility)	0.05 mg/mL	Benet LZ, Broccatelli F, Oprea TI

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Approvals:

Date	Agency	Company	Orphan
Feb. 17, 2006	FDA	VICURON
Sept. 20, 2007	EMA

FDA Adverse Event Reporting System (Female)

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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
Pathogen resistance	71.17	43.61	18	1260	6380	63481364
Multiple organ dysfunction syndrome	69.51	43.61	30	1248	56722	63431022
Morganella infection	56.12	43.61	10	1268	661	63487083
Haemodynamic instability	55.64	43.61	16	1262	9174	63478570
Haemostasis	51.00	43.61	8	1270	242	63487502
Septic shock	46.77	43.61	24	1254	66605	63421139

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FDA Adverse Event Reporting System (Male)

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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
Multiple organ dysfunction syndrome	132.38	40.56	74	2179	76492	34878186
Candida infection	96.64	40.56	38	2215	17677	34937001
Septic shock	83.83	40.56	54	2199	71780	34882898
Geotrichum infection	83.28	40.56	16	2237	488	34954190
Drug ineffective	65.92	40.56	110	2143	456641	34498037
Enterococcal infection	65.26	40.56	24	2229	9282	34945396
Fungaemia	61.97	40.56	17	2236	2551	34952127
Aortoenteric fistula	60.95	40.56	10	2243	119	34954559
Sepsis	56.28	40.56	61	2192	166500	34788178
Scedosporium infection	52.32	40.56	12	2241	870	34953808

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FDA Adverse Event Reporting System (Geriatric)

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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
Multiple organ dysfunction syndrome	191.99	37.51	97	3399	120149	79620743
Septic shock	133.98	37.51	77	3419	122724	79618168
Candida infection	101.73	37.51	44	3452	38170	79702722
Haemodynamic instability	92.26	37.51	33	3463	17349	79723543
Sepsis	81.68	37.51	78	3418	269350	79471542
Enterococcal infection	76.63	37.51	28	3468	15632	79725260
Drug ineffective	74.15	37.51	152	3344	1080761	78660131
Geotrichum infection	72.89	37.51	15	3481	966	79739926
Pathogen resistance	67.79	37.51	25	3471	14317	79726575
Fungaemia	67.66	37.51	19	3477	4572	79736320

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	J02AX06	ANTIINFECTIVES FOR SYSTEMIC USE ANTIMYCOTICS FOR SYSTEMIC USE ANTIMYCOTICS FOR SYSTEMIC USE Other antimycotics for systemic use
FDA CS	M0519359	Lipopeptides
FDA EPC	N0000175507	Echinocandin Antifungal
MeSH PA	D000890	Anti-Infective Agents
MeSH PA	D000935	Antifungal Agents

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Drug Use | Suggest Off label Use Form| |View source of the data|

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Disease	Relation	SNOMED_ID	DOID
Candidiasis of the esophagus	indication	20639004	DOID:13146
Disseminated candidiasis	indication	70572005
Candidemia	indication	432261003
Candida Peritonitis	indication
Intra-Abdominal Candida Abscess	indication
Oropharyngeal Candidiasis	off-label use
Liver function tests abnormal	contraindication	166603001
Disease of liver	contraindication	235856003	DOID:409

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🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

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Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	9.55	acidic
pKa2	11.98	acidic
pKa3	13.18	acidic
pKa4	13.53	acidic
pKa5	13.86	acidic

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Orange Book patent data (new drug applications)

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Orange Book exclusivity data (new drug applications)

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Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
100MG/VIAL	ERAXIS	VICURON HOLDINGS	N021632	Nov. 14, 2006	RX	POWDER	INTRAVENOUS	Sept. 22, 2023	NEW PATIENT POPULATION
50MG/VIAL	ERAXIS	VICURON HOLDINGS	N021632	Feb. 17, 2006	RX	POWDER	INTRAVENOUS	Sept. 22, 2023	NEW PATIENT POPULATION

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Bioactivity Summary:

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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		O13428_CANAX	INHIBITOR	IC50	7.75		CHEMBL	CHEMBL

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External reference:

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ID	Source
011233	NDDF
166548	PUBCHEM_CID
21218	MMSL
341018	RXNORM
4025092	VUID
4025092	VANDF
421904007	SNOMEDCT_US
422157006	SNOMEDCT_US
7795	INN_ID
80828	MMSL

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
ERAXIS	HUMAN PRESCRIPTION DRUG LABEL	1	0049-0114	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	50 mg	INTRAVENOUS	NDA	32 sections
ERAXIS	HUMAN PRESCRIPTION DRUG LABEL	1	0049-0114	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	50 mg	INTRAVENOUS	NDA	32 sections
ERAXIS	HUMAN PRESCRIPTION DRUG LABEL	1	0049-0116	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	100 mg	INTRAVENOUS	NDA	32 sections
ERAXIS	HUMAN PRESCRIPTION DRUG LABEL	1	0049-0116	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	100 mg	INTRAVENOUS	NDA	32 sections

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