Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Velusetrag, velusetrag dose 1, velusetrag dose 2, velusetrag dose 3
TD-5108 · 4 trials · 3 indications
Number of subjects who complete the treatment period and are not withdrawn due to adverse events (AEs) or clinically significant findings on vital signs or ECGs
| Arm | Type | Description |
|---|---|---|
| Velusetrag 5mg | EXPERIMENTAL | Velusetrag 5mg capsules QD (once daily) x 12 weeks |
| Velusetrag 15mg | EXPERIMENTAL | Velusetrag 15mg capsules QD x 12 weeks |
| Velusetrag 30mg | EXPERIMENTAL | Velusetrag 30mg capsules QD x 12 weeks |
| Placebo | PLACEBO_COMPARATOR | Placebo capsules QD x 12 weeks |
| Sequence 1 | EXPERIMENTAL | 3-way crossover of velusetrag or placebo |
| Sequence 2 | EXPERIMENTAL | 3-way crossover of velusetrag or placebo |
| Sequence 3 | EXPERIMENTAL | 3-way crossover of velusetrag or placebo |
| Sequence 4 | EXPERIMENTAL | 3-way crossover of velusetrag or placebo |
| Dose regimen 1 | EXPERIMENTAL | Varied doses |
| Dose regimen 2 | EXPERIMENTAL | Varied doses |
| Name | Type | Description |
|---|---|---|
| TD-5108 | DRUG | - |
| Velusetrag | DRUG | - |
| Placebo | DRUG | - |
| velusetrag dose 1 | DRUG | - |
| velusetrag dose 2 | DRUG | - |
| velusetrag dose 3 | DRUG | - |
Inclusion Criteria: * Meet ROME III Criteria Exclusion Criteria: * Constipation caused by:colonic etiology, pelvic floor dysfunction, metabolic disturbances, neurologic disturbances,concomitant medications affecting bowel function * Chronic treatment with anticholinergics, narcotic analgesics * I...
TD-5108 is an investigational small molecule being developed for the treatment of chronic constipation. It has been studied in a Phase 2 clinical trial in adults with this gastrointestinal condition. TD-5108 is not approved for any indication and remains in clinical development.
TD-5108 targets the 5-HT4 receptor, a serotonin receptor. It acts as a 5-HT4 agonist, meaning it activates this receptor. This receptor-targeted mechanism is being investigated for its effects in chronic constipation.
TD-5108 is being developed by Theravance Biopharma, Inc., which trades under the ticker TBPH. The company is responsible for the clinical development of this small molecule for chronic constipation.
TD-5108 is in Phase 2 clinical development. It has completed one Phase 2 trial in chronic constipation. The drug is investigational and has not been approved by the FDA for any indication.
TD-5108 has been studied in one completed Phase 2 trial, NCT00391820, titled the ACCORD Trial. This randomized, double-blind study evaluated the safety and efficacy of a 5-HT4 agonist in chronic constipation and enrolled 360 participants in the United States.