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

Stem definition	Drug id	CAS RN
	987	60-00-4

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: edetate disodium edetic acid EDTA edathamil endrate ethylenedinitrilotetraacetic acid edetate calcium disodium calcium disodium versenate	A chelating agent that sequesters a variety of polyvalent cations such as CALCIUM. It is used in pharmaceutical manufacturing and as a food additive. Molecular weight: 292.24 Formula: C10H16N2O8 CLOGP: -1.92 LIPINSKI: 0 HAC: 10 HDO: 4 TPSA: 155.68 ALOGS: -1.50 ROTB: 11 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

edetate disodium
edetic acid
EDTA
edathamil
endrate
ethylenedinitrilotetraacetic acid
edetate calcium disodium
calcium disodium versenate

A chelating agent that sequesters a variety of polyvalent cations such as CALCIUM. It is used in pharmaceutical manufacturing and as a food additive.

Molecular weight: 292.24
Formula: C10H16N2O8
CLOGP: -1.92
LIPINSKI: 0
HAC: 10
HDO: 4
TPSA: 155.68
ALOGS: -1.50
ROTB: 11

Status: OFP

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

Drug dosage:

None

ADMET properties:

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Property	Value	Reference
EoM (Fraction excreted unchanged in urine)	95 %	Benet LZ, Broccatelli F, Oprea TI
S (Water solubility)	91 mg/mL	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	66.03 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BDDCS (Biopharmaceutical Drug Disposition Classification System)	3	Benet LZ, Broccatelli F, Oprea TI

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Approvals:

Date	Agency	Company	Orphan
July 16, 1953	FDA	MEDICIS

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
Gastrointestinal toxicity	387.06	99.62	81	2021	7660	63479260
Pulmonary toxicity	365.32	99.62	80	2022	9375	63477545
Neoplasm malignant	278.41	99.62	81	2021	29780	63457140
Joint injury	274.74	99.62	80	2022	29492	63457428
Hepatotoxicity	261.18	99.62	81	2021	36960	63449960
C-reactive protein abnormal	227.82	99.62	77	2025	46019	63440901
Joint stiffness	203.11	99.62	69	2033	41800	63445120
Therapy non-responder	200.81	99.62	80	2022	75821	63411099
Musculoskeletal pain	189.01	99.62	81	2021	92196	63394724
Musculoskeletal stiffness	135.78	99.62	81	2021	184537	63302383

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FDA Adverse Event Reporting System (Male)

None

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
Gastrointestinal toxicity	224.43	84.61	48	1600	8061	79734679
Pulmonary toxicity	202.19	84.61	48	1600	12866	79729874
Joint injury	160.01	84.61	48	1600	31287	79711453
Neoplasm malignant	159.30	84.61	48	1600	31762	79710978
Joint stiffness	143.44	84.61	47	1601	40783	79701957
Hepatotoxicity	136.70	84.61	48	1600	51304	79691436
C-reactive protein abnormal	124.09	84.61	44	1604	48323	79694417
Therapy non-responder	106.13	84.61	47	1601	92258	79650482
Musculoskeletal pain	104.62	84.61	48	1600	102306	79640434

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
CHEBI has role	CHEBI:38161	Chelating agent
CHEBI has role	CHEBI:50247	antidotes
CHEBI has role	CHEBI:50249	anticoagulants
CHEBI has role	CHEBI:166831	copper chelator
CHEBI has role	CHEBI:176497	geroprotectors
FDA EPC	N0000175963	Lead Chelator
FDA EPC	N0000175980	Anti-coagulant
FDA MoA	N0000175089	Calcium Chelating Activity
FDA MoA	N0000175962	Lead Chelating Activity
FDA PE	N0000008556	Decreased Coagulation Factor Activity

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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
Digitalis toxicity by EKG	indication	6412007
Hypercalcemia	indication	66931009	DOID:12678
Accidental poisoning by lead and its compounds and fumes	indication	216777009
Cerebral edema	contraindication	2032001
Anuria	contraindication	2472002	DOID:2983
Hypocalcemia	contraindication	5291005
Dehydration	contraindication	34095006
Hypokalemia	contraindication	43339004
Chronic heart failure	contraindication	48447003
Acute nephropathy	contraindication	58574008

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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	0.96	acidic
pKa2	1.56	acidic
pKa3	2.15	acidic
pKa4	2.75	acidic
pKa5	10.12	Basic
pKa6	6.12	Basic

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Orange Book patent data (new drug applications)

None

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
200MG/ML	EDETATE CALCIUM DISODIUM	CASPER PHARMA LLC	A216435	May 3, 2023	RX	INJECTABLE	INJECTION	Jan. 8, 2024	COMPETITIVE GENERIC THERAPY

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Bioactivity Summary:

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Target	Class	Pharos	UniProt	Type	Activity value (-log[M])	Bioact source
Angiotensin-converting enzyme	Enzyme	P12821	ACE_HUMAN	IC50	4.85	CHEMBL
Ceramide glucosyltransferase	Enzyme	Q16739	CEGT_HUMAN			WOMBAT-PK
Amyloid beta A4 protein	Unclassified	P05067	A4_HUMAN	IC50	5.11	CHEMBL
Eyes absent homolog 2	Enzyme	O00167	EYA2_HUMAN	IC50	4.19	CHEMBL
Beta-lactamase	Enzyme		Q79MP6_PSEAI	IC50	4.55	CHEMBL
Beta-lactamase VIM-1; Class B carbapenemase VIM-1; Metallo-beta-lactamase; Metallo-beta-lactamase VIM-1; Metallobeta-lactamase; VIM-1; VIM-1 metallo-beta lactamase; VIM-1 metallo-beta-lactamase; VIM-1	Unclassified		Q9XAY4_PSEAI	IC50	5.03	CHEMBL
cAMP-specific 3',5'-cyclic phosphodiesterase 4B	Enzyme		J3SE37_CROAD	IC50	4.13	CHEMBL

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External reference:

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ID	Source
001090	NDDF
001091	NDDF
002560	NDDF
003785	NDDF
1903	RXNORM
23	MMSL
30988	MMSL
3413	MMSL
387418006	SNOMEDCT_US
387428002	SNOMEDCT_US

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Anubis Barcelona	HUMAN OTC DRUG LABEL	12	83021-495	CONCENTRATE	0 g	TOPICAL	OTC monograph final	9 sections
Anubis Barcelona	HUMAN OTC DRUG LABEL	12	83021-495	CONCENTRATE	0 g	TOPICAL	OTC monograph final	9 sections
Anubis Barcelona	HUMAN OTC DRUG LABEL	13	83021-839	CONCENTRATE	0 g	TOPICAL	OTC monograph final	9 sections
Anubis Barcelona	HUMAN OTC DRUG LABEL	13	83021-839	CONCENTRATE	0 g	TOPICAL	OTC monograph final	9 sections
Calcium Disodium Versenate	HUMAN PRESCRIPTION DRUG LABEL	1	99207-240	INJECTION	200 mg	INTRAMUSCULAR	NDA	25 sections
Clinplant	HUMAN OTC DRUG LABEL	1	47649-0002	GEL, DENTIFRICE	24 g	DENTAL	unapproved drug other	7 sections
Edetate Calcium Disodium	Human Prescription Drug Label	1	64980-588	INJECTION	200 mg	INTRAMUSCULAR	ANDA	23 sections
Edetate Calcium Disodium	Human Prescription Drug Label	1	70199-034	INJECTION	200 mg	INTRAMUSCULAR	ANDA	23 sections
MIIN FOOT	HUMAN OTC DRUG LABEL	4	72988-0014	LIQUID	0.05 g	TOPICAL	OTC monograph not final	7 sections
Miracle FootCream Lavender	HUMAN OTC DRUG LABEL	4	82145-0005	CREAM	0.05 g	TOPICAL	unapproved drug other	7 sections

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