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BALSALAZIDE DISODIUM · 2 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | BALSALAZIDE DISODIUM CAPSULES, 750 MG |
| 2 | ACTIVE_COMPARATOR | COLAZAL® Capsules 750 mg |
| Name | Type | Description |
|---|---|---|
| BALSALAZIDE DISODIUM CAPSULES, 750 MG | DRUG | 3x750mg, single dose fed |
| COLAZAL® Capsules 750 mg | DRUG | 3x750mg, single dose fed |
| Balsalazide Disodium Capsules 750 mg | DRUG | 3x750mg, single dose fasting |
Inclusion Criteria: * Age:18 years and older * Sex: Male and/or non-pregnant, non-lactating female * Women of childbearing potential had a negative serum beta human chorionic gonadotropin (β-HCG) pregnancy test performed within 21 days prior to the start of the study and on the evening prior to eac...
Balsalazide disodium is a small molecule drug developed by Viatris Inc. (ticker VTRS). It is being studied in Phase 1 clinical development. The specific therapeutic indication has not been disclosed. It is available in a 750 mg capsule formulation.
Balsalazide disodium targets PPARG, ALOX5, PTGS2, and PTGS1. It acts as an agonist at these targets. PPARG is peroxisome proliferator-activated receptor gamma, ALOX5 is arachidonate 5-lipoxygenase, and PTGS2 and PTGS1 are cyclooxygenase enzymes.
Balsalazide disodium is developed by Viatris Inc., which trades under the ticker symbol VTRS. Viatris is the company responsible for the development of this drug candidate.
Balsalazide disodium is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA for any indication. Two Phase 1 trials have been completed, and no active trials are currently ongoing.
Balsalazide disodium has been studied in two completed Phase 1 trials: NCT00649480, a fed study with 60 healthy volunteers, and NCT00648531, a fasting study with 80 healthy volunteers. Both trials compared balsalazide disodium capsules 750 mg to Colazal capsules 750 mg in the United States.