Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Creon IR · 1 trial · 1 indication
CFA is calculated from fat intake and fat excretion, according to the formula: CFA (%) = 100 \[fat intake - fat excretion\] / fat intake
| Arm | Type | Description |
|---|---|---|
| Creon IR low dose | EXPERIMENTAL | Creon IR 300 Ph. Eur. U lipase/g fat/day, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 30,000 lipase units) |
| Creon IR medium dose | EXPERIMENTAL | Creon IR 1,200 Ph. Eur. U lipase/g fat/day, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 120,000 lipase units) |
| Creon IR high dose | EXPERIMENTAL | Creon IR 2,400 Ph. Eur. U lipase/g fat/day, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 240,000 lipase units) |
| Creon IR maximum dose | EXPERIMENTAL | Creon IR 4,000 Ph. Eur. U lipase/g fat/day, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 400,000 lipase units) |
| Creon® (DR/GR) | ACTIVE_COMPARATOR | Creon® (DR/GR) 4,000 Ph. Eur. U lipase/g fat/day, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 400,000 lipase units) |
| Name | Type | Description |
|---|---|---|
| Creon IR | DRUG | - |
| Creon® (DR/GR) | DRUG | - |
Inclusion Criteria: 1. Subject has voluntarily signed and dated the Informed Consent Form (ICF). For subjects aged less than 18 years, the parents, or a legally acceptable representative, must sign consent and, as required by the Independent Ethics Committee (IEC), assent will be given by the subje...
Creon IR is an investigational small molecule being studied for exocrine pancreatic insufficiency in subjects with cystic fibrosis. It is a gastrointestinal therapeutic developed by Abbott Laboratories. The drug is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
Abbott Laboratories (NYSE: ABT) is developing Creon IR. The company is conducting clinical trials to evaluate the drug's efficacy and safety in patients with exocrine pancreatic insufficiency due to cystic fibrosis. Creon IR is an investigational agent and is not yet commercially available.
Creon IR is in Phase 2 clinical development. A Phase 2 trial has been completed, and the drug remains investigational. It has not received FDA approval or any other regulatory approval, and its safety and efficacy have not been established for the treatment of exocrine pancreatic insufficiency in cystic fibrosis.
Creon IR has one completed Phase 2 clinical trial, NCT02415959, titled "Efficacy and Safety Study of Creon IR in Subjects With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis." The trial enrolled 70 participants across Czechia, Hungary, Poland, and Spain, and included patients aged 12 years and older.
Creon IR is a distinct investigational drug developed by Abbott Laboratories, while Creon is a marketed pancreatic enzyme product. The "IR" designation indicates a different formulation under study. Creon IR is being evaluated in Phase 2 trials for exocrine pancreatic insufficiency in cystic fibrosis, whereas Creon is an established treatment.