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

Stem definition	Drug id	CAS RN
phenylazosalicylic acid derivatives antibacterial	284	80573-04-2

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: balsalazide balsalazide disodium balsalazide sodium	a mesalamine 5-aminosalicylate prodrug; 99% of ingested drug remains intact through the stomach and is delivered to and activated in the colon; used for inflammatory bowel disease, ulcerative colitis and radiation-induced proctosigmoiditis but avoided in patients with known hypersensitivity reaction to salicylates or mesalamine Molecular weight: 357.32 Formula: C17H15N3O6 CLOGP: 3.31 LIPINSKI: 0 HAC: 9 HDO: 4 TPSA: 148.65 ALOGS: -3.76 ROTB: 7 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

balsalazide
balsalazide disodium
balsalazide sodium

a mesalamine 5-aminosalicylate prodrug; 99% of ingested drug remains intact through the stomach and is delivered to and activated in the colon; used for inflammatory bowel disease, ulcerative colitis and radiation-induced proctosigmoiditis but avoided in patients with known hypersensitivity reaction to salicylates or mesalamine

Molecular weight: 357.32
Formula: C17H15N3O6
CLOGP: 3.31
LIPINSKI: 0
HAC: 9
HDO: 4
TPSA: 148.65
ALOGS: -3.76
ROTB: 7

Status: OFP

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

Drug dosage:

Dose	Unit	Route
6.75	g	O

ADMET properties:

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Property	Value	Reference
S (Water solubility)	87 mg/mL	Bocci G, Oprea TI, Benet LZ
MRTD (Maximum Recommended Therapeutic Daily Dose)	269.86 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability)	1 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
BDDCS (Biopharmaceutical Drug Disposition Classification System)	1	Bocci G, Oprea TI, Benet LZ

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Approvals:

Date	Agency	Company	Orphan
July 18, 2000	FDA	SALIX PHARMS

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
Colitis ulcerative	64.97	28.62	21	856	26070	63462075
Effusion	50.52	28.62	10	867	1708	63486437
Congestive cardiomyopathy	42.60	28.62	11	866	6171	63481974
Pulmonary embolism	34.74	28.62	21	856	116663	63371482
Left ventricular dysfunction	31.23	28.62	10	867	11978	63476167

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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
Lactobacillus infection	63.80	32.69	10	708	296	34955917
Bacterial translocation	55.00	32.69	9	709	351	34955862
Subacute endocarditis	52.27	32.69	7	711	65	34956148
Gastrointestinal bacterial infection	39.79	32.69	7	711	422	34955791

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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
Colitis ulcerative	52.50	27.64	20	1247	34722	79708399
Effusion	46.57	27.64	10	1257	2204	79740917
Lactobacillus infection	42.16	27.64	7	1260	387	79742734
Subacute endocarditis	40.22	27.64	6	1261	165	79742956
Bacterial translocation	38.53	27.64	7	1260	655	79742466
Congestive cardiomyopathy	34.04	27.64	11	1256	11769	79731352
Pulmonary embolism	31.10	27.64	24	1243	171630	79571491
Gastrointestinal bacterial infection	29.91	27.64	6	1261	949	79742172
Left ventricular dysfunction	28.70	27.64	11	1256	19350	79723771

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	A07EC04	ALIMENTARY TRACT AND METABOLISM ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS INTESTINAL ANTIINFLAMMATORY AGENTS Aminosalicylic acid and similar agents
CHEBI has role	CHEBI:35475	non-steroidal anti-inflammatory agent
CHEBI has role	CHEBI:49201	anti-ulcer drugs
CHEBI has role	CHEBI:55324	gastrointestinal drugs
CHEBI has role	CHEBI:50266	Prodrugs
FDA CS	M0000971	Aminosalicylic Acids
FDA EPC	N0000175781	Aminosalicylate
MeSH PA	D000700	Analgesics
MeSH PA	D018712	Analgesics, Non-Narcotic
MeSH PA	D000893	Anti-Inflammatory 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
Ulcerative colitis	indication	64766004	DOID:8577
Kidney disease	contraindication	90708001	DOID:557
Pyloric obstruction	contraindication	244815007

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🐶 Veterinary Drug Use

None

🐶 Veterinary products

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Acid dissociation constants calculated using MoKa v3.0.0

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Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	2.28	acidic
pKa2	4.08	acidic
pKa3	11.45	acidic
pKa4	12.18	acidic

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Orange Book patent data (new drug applications)

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Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
1.1GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GIAZO	VALEANT PHARMS INTL	N022205	Feb. 3, 2012	DISCN	TABLET	ORAL	9192616	Aug. 2, 2026	TREATMENT OF MILDLY TO MODERATELY ACTIVE ULCERATIVE COLITIS IN MALE PATIENTS
1.1GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GIAZO	VALEANT PHARMS INTL	N022205	Feb. 3, 2012	DISCN	TABLET	ORAL	7452872	Aug. 24, 2026	TREATMENT OF MILDLY TO MODERATELY ACTIVE ULCERATIVE COLITIS IN MALE PATIENTS
1.1GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GIAZO	VALEANT PHARMS INTL	N022205	Feb. 3, 2012	DISCN	TABLET	ORAL	7625884	Aug. 24, 2026	TREATMENT OF MILDLY TO MODERATELY ACTIVE ULCERATIVE COLITIS IN MALE PATIENTS
1.1GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GIAZO	VALEANT PHARMS INTL	N022205	Feb. 3, 2012	DISCN	TABLET	ORAL	8497256	June 23, 2031	TREATMENT OF MILDLY TO MODERATELY ACTIVE ULCERATIVE COLITIS IN MALE PATIENTS
750MG	COLAZAL	VALEANT PHARMS INTL	N020610	July 18, 2000	RX	CAPSULE	ORAL	7452872	Aug. 24, 2026	TREATMENT OF ULCERATIVE COLITIS
750MG	COLAZAL	VALEANT PHARMS INTL	N020610	July 18, 2000	RX	CAPSULE	ORAL	7625884	Aug. 24, 2026	TREATMENT OF ULCERATIVE COLITIS

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Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

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Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Prostaglandin G/H synthase 2	Enzyme	P35354	PGH2_HUMAN	INHIBITOR			WOMBAT-PK	CHEMBL
Prostaglandin G/H synthase 1	Enzyme	P23219	PGH1_HUMAN	INHIBITOR			WOMBAT-PK	CHEMBL
Arachidonate 5-lipoxygenase	Enzyme	P09917	LOX5_HUMAN	INHIBITOR			CHEMBL	CHEMBL
Peroxisome proliferator-activated receptor gamma	Nuclear hormone receptor	P37231	PPARG_HUMAN	AGONIST			CHEMBL	CHEMBL
NAD-dependent protein deacylase sirtuin-5, mitochondrial	Enzyme	Q9NXA8	SIR5_HUMAN		IC50	5.41	CHEMBL

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External reference:

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ID	Source
BLQ	PDB_CHEM_ID
001600	NDDF
007156	NDDF
007157	NDDF
11569	IUPHAR_LIGAND_ID
130137	MMSL
150399-21-6	SECONDARY_CAS_RN
153718	RXNORM
15641	MMSL
37855	MMSL

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Balsalazide Disodium	HUMAN PRESCRIPTION DRUG LABEL	1	0054-0079	CAPSULE	750 mg	ORAL	ANDA	24 sections
Balsalazide Disodium	HUMAN PRESCRIPTION DRUG LABEL	1	0054-0079	CAPSULE	750 mg	ORAL	ANDA	24 sections
Balsalazide Disodium	HUMAN PRESCRIPTION DRUG LABEL	1	42291-157	CAPSULE	750 mg	ORAL	ANDA	24 sections
Balsalazide Disodium	HUMAN PRESCRIPTION DRUG LABEL	1	50268-102	CAPSULE	750 mg	ORAL	ANDA	24 sections
Balsalazide Disodium	HUMAN PRESCRIPTION DRUG LABEL	1	50268-102	CAPSULE	750 mg	ORAL	ANDA	24 sections
Balsalazide Disodium	HUMAN PRESCRIPTION DRUG LABEL	1	51407-820	CAPSULE	750 mg	ORAL	ANDA	24 sections
Balsalazide Disodium	HUMAN PRESCRIPTION DRUG LABEL	1	54868-6137	CAPSULE	750 mg	ORAL	ANDA	25 sections
Balsalazide Disodium	HUMAN PRESCRIPTION DRUG LABEL	1	60505-2575	CAPSULE	750 mg	ORAL	ANDA	25 sections
Balsalazide Disodium	HUMAN PRESCRIPTION DRUG LABEL	1	60505-2575	CAPSULE	750 mg	ORAL	ANDA	25 sections
Balsalazide Disodium	HUMAN PRESCRIPTION DRUG LABEL	1	63629-8301	CAPSULE	750 mg	ORAL	ANDA	24 sections

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