Balsalazide
Colazal (balsalazide) is a small molecule pharmaceutical. Balsalazide was first approved as Colazal on 2000-07-18. It is used to treat ulcerative colitis in the USA.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| digestive system diseases | D004066 |
Trade Name
FDA
EMA
Colazal (generic drugs available since 2007-12-28, discontinued: Giazo)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Balsalazide disodium
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| COLAZAL | Bausch Health Companies | N-020610 RX | 2000-07-18 | 1 products, RLD, RS |
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Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| balsalazide disodium | ANDA | 2023-03-29 |
| colazal | NDA authorized generic | 2019-06-21 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| ulcerative colitis | EFO_0000729 | D003093 | K51 |
Agency Specific
FDA
EMA
No data
HCPCS
No data
Clinical
Clinical Trials
52 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Burns | D002056 | T30.0 | 1 | 1 | 1 | 1 | 2 | 5 | |
| Dental pulp necrosis | D003790 | K04.1 | 3 | — | — | 1 | — | 4 | |
| Sinusitis | D012852 | EFO_0007486 | J32 | — | — | — | 1 | 1 | 2 |
| Periapical abscess | D010482 | EFO_1001202 | — | — | — | 1 | — | 1 | |
| Chronic kidney failure | D007676 | EFO_0003884 | N18.6 | — | — | — | 1 | — | 1 |
| Arteriovenous fistula | D001164 | Q27.3 | — | — | — | 1 | — | 1 | |
| Surgical wound infection | D013530 | — | — | — | 1 | — | 1 | ||
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | — | — | — | 1 | — | 1 |
| Diabetic foot | D017719 | EFO_1001459 | — | — | — | 1 | — | 1 | |
| Type 1 diabetes mellitus | D003922 | EFO_0001359 | E10 | — | — | — | 1 | — | 1 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Sick sinus syndrome | D012804 | EFO_0004275 | I49.5 | — | — | 1 | — | 1 | 2 |
| Systolic heart failure | D054143 | EFO_1001207 | I50.20 | — | — | 1 | — | — | 1 |
| Syncope | D013575 | HP_0001279 | G90.01 | — | — | 1 | — | — | 1 |
| Heart block | D006327 | I45.89 | — | — | 1 | — | — | 1 | |
| Cardiac arrhythmias | D001145 | EFO_0004269 | I49.9 | — | — | 1 | — | — | 1 |
| Edema | D004487 | R60.9 | — | 1 | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Heart failure | D006333 | EFO_0003144 | I50 | — | 1 | — | — | 1 | 2 |
| Skin neoplasms | D012878 | EFO_0004198 | C44 | — | 1 | — | — | — | 1 |
| Paranasal sinus diseases | D010254 | — | 1 | — | — | — | 1 | ||
| Allergic contact dermatitis | D017449 | L23 | — | 1 | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Gestational diabetes | D016640 | HP_0009800 | O24.4 | — | — | — | — | 1 | 1 |
| Hiv infections | D015658 | EFO_0000764 | B20 | — | — | — | — | 1 | 1 |
| Herpes simplex | D006561 | B00 | — | — | — | — | 1 | 1 | |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | — | — | — | — | 1 | 1 |
| Finger injuries | D005383 | — | — | — | — | 1 | 1 | ||
| Traumatic amputation | D000673 | — | — | — | — | 1 | 1 | ||
| Infectious skin diseases | D012874 | — | — | — | — | 1 | 1 | ||
| Pituitary neoplasms | D010911 | — | — | — | — | 1 | 1 | ||
| Uterine rupture | D014597 | — | — | — | — | 1 | 1 | ||
| Premature birth | D047928 | EFO_0003917 | O60 | — | — | — | — | 1 | 1 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | BALSALAZIDE |
| INN | balsalazide |
| Description | Balsalazide is an anti-inflammatory drug used in the treatment of inflammatory bowel disease. It is sold under the brand names Giazo, Colazal in the US and Colazide in the UK. It is also sold in generic form in the US by several generic manufacturers.
|
| Classification | Small molecule |
| Drug class | anti-inflammatory agents (salicylic acid derivatives) |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | O=C(O)CCNC(=O)c1ccc(/N=N/c2ccc(O)c(C(=O)O)c2)cc1 |
Identifiers
| PDB | — |
| CAS-ID | 80573-04-2 |
| RxCUI | 18747 |
| ChEMBL ID | CHEMBL1201346 |
| ChEBI ID | 267413 |
| PubChem CID | 5362070 |
| DrugBank | DB01014 |
| UNII ID | P80AL8J7ZP (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 684 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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1,685 adverse events reported
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