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 |
|---|---|
|
Synonyms:
|
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
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
| Dose | Unit | Route |
|---|---|---|
| 6.75 | g | O |
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| 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 |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| July 18, 2000 | FDA | SALIX PHARMS |
FDA Adverse Event Reporting System (Female)
| 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 | 66.61 | 27.96 | 20 | 791 | 16834 | 50587479 |
| Effusion | 43.81 | 27.96 | 9 | 802 | 1594 | 50602719 |
| Pulmonary embolism | 34.54 | 27.96 | 21 | 790 | 101683 | 50502630 |
| Congestive cardiomyopathy | 28.17 | 27.96 | 8 | 803 | 5510 | 50598803 |
FDA Adverse Event Reporting System (Male)
None
FDA Adverse Event Reporting System (Geriatric)
| 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 | 51.30 | 26.04 | 18 | 1087 | 23010 | 64474617 |
| Effusion | 41.35 | 26.04 | 9 | 1096 | 1959 | 64495668 |
| Pulmonary embolism | 32.93 | 26.04 | 24 | 1081 | 146332 | 64351295 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| 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|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| 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 level | Dissociation constant | Type (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 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 |
| 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:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA 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:
| ID | Source |
|---|---|
| 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 |
| DB00244 | DRUGBANK_ID |
| 130137 | MMSL |
| 15641 | MMSL |
| 37855 | MMSL |
| 37856 | MMSL |
| 5056 | MMSL |
| d01031 | MMSL |
| d04700 | MMSL |
| 001600 | NDDF |
| 007156 | NDDF |
| 007157 | NDDF |
| 4019494 | VANDF |
| 4021231 | VANDF |
| 4021232 | VANDF |
| 4075 | PUBCHEM_CID |
| C0127615 | UMLSCUI |
| 387501005 | SNOMEDCT_US |
| 391811002 | SNOMEDCT_US |
| 420306005 | SNOMEDCT_US |
| 420557005 | SNOMEDCT_US |
| 86977007 | SNOMEDCT_US |
Pharmaceutical products:
| 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 | 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 | 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 | 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 |
| 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 |