| Drug ID: | Drug176 |
|---|---|
| Drug Name: | Balsalazide Disodium |
| CID: | 135413496 |
| DrugBank ID: | DB01014 |
| Modality: | Small Molecule |
| Groups: | approved|investigational |
| US Approved: | YES |
| Other Approved: | YES |
| Identifier: | NCT00486031, , NCT00408174 |
| Molecular Formula: | C17H13N3Na2O6 |
| Molecular Weight: | 401.28 g/mol |
| Isomeric SMILES: | C1=CC(=CC=C1C(=O)NCCC(=O)[O-])N=NC2=CC(=C(C=C2)[O-])C(=O)O.[Na+].[Na+] |
| Synonyms: | Balsalazide Disodium; 213594-60-6; 82101-18-6; Balsalazide sodium; BX-661A; Balsalazide disodium anhydrous; Giazo; Balsalazide disodium salt hydrate; disodium;3-[[4-[(3-carboxy-4-oxidophenyl)diazenyl]benzoyl]amino]propanoate; Balsalazide Disodium Salt |
| 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
Knowledge Graph
| dtID | CID | Compound Name | Gene ID | Gene Name | Species | PubMed IDs | Action |
|---|---|---|---|---|---|---|---|
| dt1286 | 135413496 | Balsalazide Disodium | 240 | ALOX5 | Homo sapiens (human) | Arachidonate 5-lipoxygenase inhibitor | |
| dt1287 | 135413496 | Balsalazide Disodium | 5468 | PPARG | Homo sapiens (human) | Peroxisome proliferator-activated receptor gamma agonist | |
| dt1288 | 135413496 | Balsalazide Disodium | 4353 | MPO | Mus musculus (house mouse) | 19296261 | Balsalazide results in decreased activity of MPO protein |
- 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 ID | Title | Phase | Status | Sponsor | Indications | Interventions | |
|---|---|---|---|---|---|---|---|
| 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 |
| 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 ID | Disease Name | Definition | Category | Related Drugs | Mechanism | |
|---|---|---|---|---|---|---|
| No data available | ||||||
| Strategy ID | Therapeutic Strategy | Synonyms | Related Drugs | Mechanism | |
|---|---|---|---|---|---|
| No data available | |||||
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