Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TU-100 · 1 trial · 1 indication
Change in abdominal bloating rating, through comparison of the change in average ratings from the 7 days prior to baseline (Visit 2) to the last 7 days of the 4 week treatment period (Visit 4), between TU-100 15 g and placebo.
| Arm | Type | Description |
|---|---|---|
| TU-100 | EXPERIMENTAL | 15g TU-100 (oral, daily) for 4 consecutive weeks (administered as 5g three times daily) |
| Matching placebo | PLACEBO_COMPARATOR | Matching placebo given 5g three times daily orally for 4 consecutive weeks |
| Name | Type | Description |
|---|---|---|
| TU-100 | DRUG | 15g daily, orally as 5g three times daily for 4 consecutive weeks |
| Placebo | DRUG | Matching placebo given 5g three times daily orally for 4 consecutive weeks |
Inclusion Criteria: * Meet Rome III criteria for IBS (any subtype) * Female aged 18 to 65 years, inclusive * If of childbearing potential, prepared to use suitable forms of contraception throughout the study and for 30 days after the last dose i.e., hormonal contraceptives (such as oral contracepti...
TU-100 is an investigational small molecule being studied for the treatment of Irritable Bowel Syndrome in Females. It is being developed by Icon Plc (ticker: ICLR) and is currently in Phase 2 clinical development. The drug is intended to relieve abdominal bloating in female subjects with irritable bowel syndrome.
TU-100 is a small molecule being studied for irritable bowel syndrome in females. The specific molecular target of TU-100 has not been disclosed in the available information. It is being evaluated for its safety and efficacy in relieving abdominal bloating in this patient population.
TU-100 is being developed by Icon Plc, a company traded under the ticker ICLR. The drug is currently in Phase 2 clinical development for the treatment of Irritable Bowel Syndrome in Females. Icon Plc is conducting clinical trials to evaluate the safety and efficacy of TU-100.
TU-100 is in Phase 2 clinical development. It is an investigational drug being studied for Irritable Bowel Syndrome in Females. The drug has completed one Phase 2 clinical trial, and it is not yet approved by regulatory authorities. Further clinical development may be needed before it can be considered for approval.
TU-100 has been studied in one clinical trial with the identifier NCT02074579. This was a Phase 2, randomized, double-blind, placebo-controlled study titled 'A Safety and Efficacy Study of Daikenchuto (TU-100) to Relieve Abdominal Bloating in Female Subjects With Irritable Bowel Syndrome'. The trial enrolled 101 female participants in the United States and has been completed.
Yes, TU-100 is also known as Daikenchuto. The clinical trial NCT02074579 refers to the drug as Daikenchuto (TU-100). This alternative name is used in the study title and may be encountered in related research literature. Both names refer to the same investigational drug being developed for irritable bowel syndrome in females.