Drug ID:Drug57
Drug Name:Balsalazide
CID:54585
DrugBank ID:DB01014
Modality:Small Molecule
Groups:approved|investigational
US Approved:YES
Other Approved:YES
Identifier: NCT00618228, , NCT00618202
Molecular Formula:C17H15N3O6
Molecular Weight:357.32 g/mol
Isomeric SMILES:C1=CC(=CC=C1C(=O)NCCC(=O)O)N=NC2=CC(=C(C=C2)O)C(=O)O
Synonyms:BALSALAZIDE; 80573-04-2; Balsalazido; Balsalazida; Balsalazidum; Balsalazidum [Latin]; (E)-5-((4-(((2-Carboxyethyl)amino)carbonyl)phenyl)azo)-2-hydroxybenzoic acid; CHEBI:267413; P80AL8J7ZP; DTXSID7040653
Phase 0: 0
Phase 1: 4
Phase 2: 0
Phase 3: 2
Phase 4: 0
Description:Balsalazide is an anti-inflammatory drug used in the treatment of Inflammatory Bowel Disease. It is sold under the name "Colazal" in the US and "Colazide" in the UK.The chemical name is (E)-5-[[-4-(2-carboxyethyl) aminocarbonyl] phenyl]azo] -2-hydroxybenzoic acid. It is usually administered as the disodium salt.Balsalazide releases mesalazine, also known as 5-aminosalicylic acid, or 5-ASA, in the large intestine. Its advantage over that drug in the treatment of Ulcerative colitis is believed to be the delivery of the active agent past the small intestine to the large intestine, the active site of ulcerative colitis.

Molecular Structure

2D Molecular Structure

Knowledge Graph

dtIDCIDCompound NameGene IDGene NameSpeciesPubMed IDsAction
dt521 54585 Balsalazide 5468 PPARG Homo sapiens (human) Agonist
dt522 54585 Balsalazide 5743 PTGS2 Homo sapiens (human) Inhibitor
dt523 54585 Balsalazide 5742 PTGS1 Homo sapiens (human) Inhibitor
dt524 54585 Balsalazide 240 ALOX5 Homo sapiens (human) Inhibitor
dt525 54585 Balsalazide None -- Bacillus sp. OY1-2 Substrate
dt526 54585 Balsalazide 5743 PTGS2 Homo sapiens (human) None
dt527 54585 Balsalazide 5468 PPARG Homo sapiens (human) None
dt528 54585 Balsalazide 240 ALOX5 Homo sapiens (human) None
dt529 54585 Balsalazide 5742 PTGS1 Homo sapiens (human) None

  • No data available

Phase Distribution
Phase Description
  • Phase 0: Exploratory trials to assess drug behavior in humans
  • Phase 1: Safety trials to determine safe dosage range
  • Phase 2: Efficacy trials to evaluate therapeutic effects
  • Phase 3: Large-scale trials to confirm efficacy and safety
  • Phase 4: Post-marketing surveillance for long-term safety and efficacy

Trial IDTitlePhaseStatusSponsorIndicationsInterventions
NCT00408174 Balsalazide Disodium vs. Mesalamine in Mildly to Moderately Active Ulcerative Colitis PHASE3 COMPLETED Bausch Health Americas, Inc. Inflammatory Bowel Disease|Ulcerative Colitis DRUG: Balsalazide disodium Details
NCT00269438 New Tablet Formulation and Dosing Regimen of Balsalazide Disodium in Mildly to Moderately Active Ulcerative Colitis PHASE3 COMPLETED Bausch Health Americas, Inc. Ulcerative Colitis DRUG: 5 ASA, enemas, suppositories, corticosteroi… Details
NCT00618228 Bioequivalency Study of Balsalazide Capsules Under Fasting Conditions None COMPLETED Roxane Laboratories Ulcerative Colitis DRUG: Balsalazide Details
NCT00618202 A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Balsalazide Disodium 750 mg Capsules Under Fasting Conditions None COMPLETED Roxane Laboratories Ulcerative Colitis DRUG: Balsalazide Details
NCT00486031 Open-Label, Long-term Balsalziade Disodium Tablet Ulcerative Colitis Study PHASE3 COMPLETED Bausch Health Americas, Inc. Inflammatory Bowel Disease|Ulcerative Colitis DRUG: Balsalazide Disodium Details

Disease IDDisease NameDefinitionCategoryRelated DrugsMechanism
No data available

Strategy IDTherapeutic StrategySynonymsRelated DrugsMechanism
No data available

Radioiodination of balsalazide, bioevaluation, and characterization as a highly…

PMID: 34984721
Year: 2022
Relationship Type: Association Score: 6.5

This work focuses on tracking ulcerative colitis in mice. High labeling yield and radiochemical purity were achieved for the formation of a [(125/131…

Balsalazide-Induced Pneumonitis Causing Dyspnea in a Patient With Inflammatory …

PMID: 32309496
Year: 2020
Relationship Type: Treatment Score: 6.5

Inflammatory bowel disease complications can be related to inflammatory bowel disease-related pulmonary diseases or a form of hypersensitivity pneumo…

Unilateral balsalazide-induced eosinophilic pneumonia in an ulcerative colitis …

PMID: 21127763
Year: 2010
Relationship Type: Treatment Score: 6.1

We report a case of unilateral eosinophilic pneumonia secondary to balsalazide monotherapy for ulcerative colitis. After commencing balsalazide, the …

Role of tyrosine 131 in the active site of paAzoR1, an azoreductase with specif…

PMID: 20057057
Year: 2010
Relationship Type: Mechanism Score: 6.1

Azoreductase 1 from Pseudomonas aeruginosa strain PAO1 (paAzoR1) catalyses the activation of the prodrug balsalazide and reduces the azo dye methyl r…