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 exocrine pancreatic insufficiency, including in patients with chronic pancreatitis and after pancreatectomy. It is designed to treat pancreatic exocrine insufficiency, a condition where the pancreas does not produce enough digestive enzymes. SA-001 is currently in Phase 3 clinical development.
SA-001 is being developed by Abbott Laboratories, a company traded on the New York Stock Exchange under the ticker ABT. Abbott is conducting clinical trials of SA-001 for the treatment of exocrine pancreatic insufficiency.
SA-001 is in Phase 3 clinical development. It has completed two Phase 3 trials in Japan, one randomized, double-blind, placebo-controlled study and one open-label long-term safety study. SA-001 is not yet approved and remains investigational.
SA-001 has completed two Phase 3 trials in Japan. NCT00400842 was a randomized, double-blind, placebo-controlled study with 274 participants with exocrine pancreatic insufficiency and chronic pancreatitis. NCT00401076 was an open-label study of 80 participants with pancreatic exocrine insufficiency, chronic pancreatitis, or post-pancreatectomy, assessing long-term oral safety.
No alternative names for SA-001 have been disclosed. It is referred to solely as SA-001 in clinical trial records and development information from Abbott Laboratories.