Balsalazide
- Generic Name
- Balsalazide
- Brand Names
- Colazal
- Drug Type
- Small Molecule
- Chemical Formula
- C17H15N3O6
- CAS Number
- 80573-04-2
- Unique Ingredient Identifier
- P80AL8J7ZP
- Background
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 works by deliverying mesalazine to the large intestine to act directly on ulcerative colitis. Mesalazine is also known as 5-aminosalicylic acid, or 5-ASA.
- Indication
For the treatment of mildly to moderately active ulcerative colitis.
- Associated Conditions
- Mild Ulcerative Colitis, Moderate Ulcerative colitis
Fasting Study of Balsalazide Disodium Capsules 750 mg and Colazal® Capsules 750 mg
- Conditions
- Healthy
- Interventions
- First Posted Date
- 2008-04-01
- Last Posted Date
- 2024-04-24
- Lead Sponsor
- Mylan Pharmaceuticals Inc
- Target Recruit Count
- 80
- Registration Number
- NCT00648531
- Locations
- 🇺🇸
PRACS Institute, Ltd., Fargo, North Dakota, United States
Fed Study of Balsalazide Disodium Capsules 750 mg and Colazal® Capsules 750 mg
- Conditions
- Healthy
- Interventions
- First Posted Date
- 2008-04-01
- Last Posted Date
- 2024-04-24
- Lead Sponsor
- Mylan Pharmaceuticals Inc
- Target Recruit Count
- 60
- Registration Number
- NCT00649480
- Locations
- 🇺🇸
PRACS Institute Ltd. - Cetero Research, Fargo, North Dakota, United States
Bioequivalency Study of Balsalazide Capsules Under Fasting Conditions
- Conditions
- Ulcerative Colitis
- First Posted Date
- 2008-02-19
- Last Posted Date
- 2018-01-23
- Lead Sponsor
- Roxane Laboratories
- Target Recruit Count
- 52
- Registration Number
- NCT00618228
- Locations
- 🇺🇸
Novum Pharmaceuticals Research Services, Houston, Texas, United States
A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Balsalazide Disodium 750 mg Capsules Under Fasting Conditions
- Conditions
- Ulcerative Colitis
- First Posted Date
- 2008-02-19
- Last Posted Date
- 2018-01-23
- Lead Sponsor
- Roxane Laboratories
- Target Recruit Count
- 52
- Registration Number
- NCT00618202
- Locations
- 🇺🇸
Novum Pharmaceutical Research Services, Houston, Texas, United States
Open-Label, Long-term Balsalziade Disodium Tablet Ulcerative Colitis Study
- Conditions
- Ulcerative ColitisInflammatory Bowel Disease
- Interventions
- First Posted Date
- 2007-06-13
- Last Posted Date
- 2019-08-15
- Lead Sponsor
- Bausch Health Americas, Inc.
- Target Recruit Count
- 443
- Registration Number
- NCT00486031
- Locations
- 🇺🇸
Community Clinical Trials, Orange, California, United States
🇺🇸Premeire Pharmaceutical Research, Tempe, Arizona, United States
🇺🇸Digestive and Liver Disease Specialists, Norfolk, Virginia, United States
Balsalazide Disodium vs. Mesalamine in Mildly to Moderately Active Ulcerative Colitis
- Conditions
- Inflammatory Bowel DiseaseUlcerative Colitis
- First Posted Date
- 2006-12-06
- Last Posted Date
- 2019-11-25
- Lead Sponsor
- Bausch Health Americas, Inc.
- Target Recruit Count
- 400
- Registration Number
- NCT00408174
- Locations
- 🇺🇸
West Gastroenterology Medical Group, Los Angeles, California, United States
🇺🇸Atlanta Gastroenterology Associates, Atlanta, Georgia, United States
🇺🇸University of Illinois at Chicago, Chicago, Illinois, United States
Drug Development Updates
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