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

Stem definitionDrug idCAS RN
phenylazosalicylic acid derivatives antibacterial 284 80573-04-2

Description:

MoleculeDescription

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:

DoseUnitRoute
6.75 g O

ADMET properties:

PropertyValueReference
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
S (Water solubility) 87 mg/mL Bocci G, Oprea TI, Benet LZ
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Bocci G, Oprea TI, Benet LZ

Approvals:

DateAgencyCompanyOrphan
July 18, 2000 FDA SALIX PHARMS

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients 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

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients 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

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients 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

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC A07EC04 ALIMENTARY TRACT AND METABOLISM
ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS
INTESTINAL ANTIINFLAMMATORY AGENTS
Aminosalicylic acid and similar agents
FDA CS M0000971 Aminosalicylic Acids
MeSH PA D000700 Analgesics
MeSH PA D018712 Analgesics, Non-Narcotic
MeSH PA D000893 Anti-Inflammatory Agents
MeSH PA D000894 Anti-Inflammatory Agents, Non-Steroidal
MeSH PA D018501 Antirheumatic Agents
MeSH PA D005765 Gastrointestinal Agents
MeSH PA D018373 Peripheral Nervous System Agents
MeSH PA D018689 Sensory System Agents
CHEBI has role CHEBI:35475 non-steroidal anti-inflammatory agent
FDA EPC N0000175781 Aminosalicylate
CHEBI has role CHEBI:49201 anti-ulcer drugs
CHEBI has role CHEBI:55324 gastrointestinal drugs
CHEBI has role CHEBI:50266 Prodrugs

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

DiseaseRelationSNOMED_IDDOID
Ulcerative colitis indication 64766004 DOID:8577
Kidney disease contraindication 90708001 DOID:557
Pyloric obstruction contraindication 244815007




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 2.28 acidic
pKa2 4.08 acidic
pKa3 11.45 acidic
pKa4 12.18 acidic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent 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
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
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

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Prostaglandin G/H synthase 2 Enzyme INHIBITOR WOMBAT-PK CHEMBL
Prostaglandin G/H synthase 1 Enzyme INHIBITOR WOMBAT-PK CHEMBL
Arachidonate 5-lipoxygenase Enzyme INHIBITOR CHEMBL CHEMBL
Peroxisome proliferator-activated receptor gamma Nuclear hormone receptor AGONIST CHEMBL CHEMBL
NAD-dependent protein deacylase sirtuin-5, mitochondrial Enzyme IC50 5.41 CHEMBL

External reference:

IDSource
4021231 VUID
N0000148675 NUI
D02715 KEGG_DRUG
150399-21-6 SECONDARY_CAS_RN
153718 RXNORM
C0052940 UMLSCUI
CHEBI:267413 CHEBI
CHEBI:6775 CHEBI
BLQ PDB_CHEM_ID
CHEMBL1201346 ChEMBL_ID
DB01014 DRUGBANK_ID
CHEMBL1200760 ChEMBL_ID
C038637 MESH_SUPPLEMENTAL_RECORD_UI
54585 PUBCHEM_CID
11569 IUPHAR_LIGAND_ID
5221 INN_ID
P80AL8J7ZP UNII
130137 MMSL
15641 MMSL
37855 MMSL
37856 MMSL
5056 MMSL
d01031 MMSL
d04700 MMSL
387501005 SNOMEDCT_US
391811002 SNOMEDCT_US
420306005 SNOMEDCT_US
420557005 SNOMEDCT_US
86977007 SNOMEDCT_US
C0127615 UMLSCUI
DB00244 DRUGBANK_ID
4019494 VANDF
4021231 VANDF
4021232 VANDF
4075 PUBCHEM_CID
001600 NDDF
007156 NDDF
007157 NDDF

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
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
Colazal HUMAN PRESCRIPTION DRUG LABEL 1 65649-101 CAPSULE 750 mg ORAL NDA authorized generic 22 sections
Colazal HUMAN PRESCRIPTION DRUG LABEL 1 65649-101 CAPSULE 750 mg ORAL NDA authorized generic 22 sections
Colazal HUMAN PRESCRIPTION DRUG LABEL 1 65649-101 CAPSULE 750 mg ORAL NDA authorized generic 22 sections
balsalazide disodium HUMAN PRESCRIPTION DRUG LABEL 1 68682-750 CAPSULE 750 mg ORAL NDA authorized generic 23 sections
balsalazide disodium HUMAN PRESCRIPTION DRUG LABEL 1 70710-1626 CAPSULE 750 mg ORAL ANDA 24 sections
balsalazide disodium HUMAN PRESCRIPTION DRUG LABEL 1 70771-1841 CAPSULE 750 mg ORAL ANDA 24 sections
Balsalazide Disodium HUMAN PRESCRIPTION DRUG LABEL 1 72789-149 CAPSULE 750 mg ORAL ANDA 24 sections
Balsalazide Disodium HUMAN PRESCRIPTION DRUG LABEL 1 72789-149 CAPSULE 750 mg ORAL ANDA 24 sections
Balsalazide Disodium HUMAN PRESCRIPTION DRUG LABEL 1 72789-149 CAPSULE 750 mg ORAL ANDA 24 sections