Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 an investigational small molecule being studied in healthy volunteers. It is currently in Phase 1 clinical development, with completed trials evaluating its pharmacokinetics under fasting and fed conditions. The drug is being developed by Viatris Inc. (VTRS) and is not yet approved for any indication.
BALSALAZIDE DISODIUM is being developed by Viatris Inc., a global healthcare company traded on the NASDAQ under the ticker VTRS. The company is conducting Phase 1 clinical trials to evaluate the drug's pharmacokinetic profile in healthy subjects.
BALSALAZIDE DISODIUM is in Phase 1 clinical development. Two Phase 1 studies have been completed, both involving healthy volunteers. The drug remains investigational and has not received FDA approval. Further clinical development phases have not been publicly disclosed.
BALSALAZIDE DISODIUM has two completed Phase 1 trials: NCT00648531, a fasting study comparing the drug to Colazal capsules in 80 healthy subjects, and NCT00649480, a fed study in 60 healthy subjects. Both trials were conducted in the United States with participants aged 18 years and older.
BALSALAZIDE DISODIUM is being studied as a potential generic equivalent to Colazal, a brand-name drug. The Phase 1 trials were designed to compare the pharmacokinetics of Balsalazide Disodium Capsules 750 mg with Colazal Capsules 750 mg under fasting and fed conditions.