Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SYN-010 · 2 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| High Dose SYN-010 | EXPERIMENTAL | 42-mg SYN-010 |
| Low Dose | ACTIVE_COMPARATOR | 21 mg SYN-010 |
| High Dose | ACTIVE_COMPARATOR | 42 mg SYN-010 |
| Placebo | PLACEBO_COMPARATOR | Placebo |
| Name | Type | Description |
|---|---|---|
| SYN-010 | DRUG | - |
| SYN-010 21 mg | DRUG | - |
| SYN-010 42 mg | DRUG | - |
| Placebo | DRUG | - |
Inclusion Criteria: * Subject has completed Study SB-2-010-001. * Subject must be willing to abstain from or discontinue the use of any laxatives and any prescription and over-the-counter medications or supplements intended to treat constipation from the time of Screening to the end of the study, e...
SYN-010 is being developed for irritable bowel syndrome with constipation, or IBS-C. It is a small molecule therapeutic candidate studied in adults 18 years and older with this gastrointestinal condition. Both of its Phase 2 clinical trials enrolled participants with IBS-C in the United States.
SYN-010 is being developed by Theriva Biologics, Inc., which trades under the ticker TOVX. The company is the sponsor of the clinical program evaluating the drug in irritable bowel syndrome with constipation.
SYN-010 is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. Two Phase 2 trials have been completed, and neither is currently active. Together those trials enrolled 117 participants with IBS-C.
SYN-010 has been studied in two completed Phase 2 trials. NCT02495623 was a randomized, double-blind, placebo-controlled study of SYN-010 in IBS-C that enrolled 63 subjects. NCT02493036 was a single-dose, open-label study evaluating the sustainability of the drug's effects in 54 patients with IBS-C. Both were conducted in the United States.
The Phase 2 program for SYN-010 included a randomized, double-blind, placebo-controlled trial, NCT02495623, and a single-dose, open-label trial, NCT02493036. Both enrolled adults with IBS-C in the United States, and both have been completed. No biomarker-based patient selection was used in these studies.