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Colazal (BALSALAZIDE)
Colazal works by reducing inflammation in the gut by modulating the immune response.
At a glance
| Generic name | BALSALAZIDE |
|---|---|
| Sponsor | Valeant Pharms Intl |
| Drug class | Aminosalicylate |
| Target | Prostaglandin G/H synthase 1 |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | FDA-approved |
| First approval | 2000 |
Mechanism of action
Balsalazide disodium is delivered intact to the colon where it is cleaved by bacterial azoreduction to release equimolar quantities of mesalamine, which is the therapeutically active portion of the molecule, and the 4-aminobenzoyl-ss-alanine carrier moiety. The carrier moiety released when balsalazide disodium is cleaved is only minimally absorbed and is largely inert.The mechanism of action of 5-ASA is unknown, but appears to be local to the colonic mucosa rather than systemic. Mucosal production of arachidonic acid metabolites, both through the cyclooxygenase pathways, i.e., prostanoids, and through the lipoxygenase pathways, i.e., leukotrienes and hydroxyeicosatetraenoic acids, is increased in patients with chronic inflammatory bowel disease, and it is possible that 5-ASA diminishes inflammation by blocking production of arachidonic acid metabolites in the colon.
Approved indications
- Ulcerative colitis
Common side effects
- headache
- abdominal pain
- diarrhea
- nausea
- vomiting
- respiratory infection
- arthralgia
- rhinitis
- insomnia
- fatigue
- flatulence
- fever
Key clinical trials
- Fed Study of Balsalazide Disodium Capsules 750 mg and Colazal® Capsules 750 mg (PHASE1)
- Fasting Study of Balsalazide Disodium Capsules 750 mg and Colazal® Capsules 750 mg (PHASE1)
- Assessment of 5-Aminosalicylic Acid Prescription Patterns and Treatment Outcomes in Patients With Ulcerative Colitis in Korea
- Balsalazide Disodium vs. Mesalamine in Mildly to Moderately Active Ulcerative Colitis (PHASE3)
- New Tablet Formulation and Dosing Regimen of Balsalazide Disodium in Mildly to Moderately Active Ulcerative Colitis (PHASE3)
- Randomized Placebo-Controlled Trial of Budesonide Multi-Matrix System (MMX®) 9 Milligrams (mg) in Participants With Ulcerative Colitis Currently on a 5-Aminosalicylic Acid (5-ASA) (PHASE3)
- Open-Label, Long-term Balsalziade Disodium Tablet Ulcerative Colitis Study (PHASE3)
- A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Balsalazide Disodium 750 mg Capsules Under Fasting Conditions (NA)
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Colazal CI brief — competitive landscape report
- Colazal updates RSS · CI watch RSS
- Valeant Pharms Intl portfolio CI