Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SA-001 · 2 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | - |
| L | EXPERIMENTAL | - |
| H | EXPERIMENTAL | - |
| P | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| SA-001 | DRUG | 0.25 g of SA-001 pellets/capsule, 12 capsules/day for 52 weeks |
| Placebo | DRUG | Placebo |
Inclusion Criteria Subjects who complete the S245.3.122 clinical study (excluding discontinued subjects). Exclusion Criteria Subjects who are assessed to be inappropriate for continuing long-term use of SA-001, at the discretion of the investigator or the sub-investigator, because they experienced ...
SA-001 is an investigational small molecule being developed for pancreatic exocrine insufficiency, a condition that can occur in chronic pancreatitis and after pancreatectomy. It is intended to treat the digestive problems caused by insufficient pancreatic enzyme output. The drug is in Phase 3 clinical development.
SA-001 is being developed by Abbott Laboratories, a company publicly traded under the ticker symbol ABT. The drug is an investigational small molecule in Phase 3 clinical trials for gastrointestinal conditions related to pancreatic exocrine insufficiency.
SA-001 is in Phase 3 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. Two Phase 3 trials have been completed, including a randomized, double-blind, placebo-controlled study and an open-label long-term safety study.
SA-001 has been studied in two completed Phase 3 trials in Japan. NCT00400842 was a randomized, double-blind, placebo-controlled study with 274 participants. NCT00401076 was an open-label study of 80 participants assessing long-term oral safety. Both enrolled adults aged 20 years and older.
SA-001 is the primary name for this investigational drug. No alternative names have been reported in the clinical trial data. It is being studied specifically for pancreatic exocrine insufficiency related to chronic pancreatitis and pancreatectomy.