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Also known as velusetrag dose 1, TD-5108
Velusetrag · 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Number of subjects who complete the treatment period and are not withdrawn due to adverse events (AEs) or clinically significant findings on vital signs or ECGs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...
Top 1 of 2 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Vanda Pharmaceuticals Inc. | VNDA | 1 | PHASE4 | Tradipitant |
Velusetrag is an investigational small molecule being studied for gastroparesis and Alzheimer's disease. It has been evaluated in completed Phase 2 trials in diabetic and idiopathic gastroparesis, and in a Phase 1 study in healthy elderly subjects. It is not approved for any indication and remains in clinical development.
Velusetrag targets HTR4, the serotonin 5-HT4 receptor, and acts as an agonist. By activating this receptor, it is designed to stimulate gastrointestinal motility, which is the rationale for studying it in gastroparesis. The target class is agonist.
Velusetrag is being developed by Theravance Biopharma, Inc., which trades under the ticker TBPH. The company is the sponsor of the clinical program evaluating the drug in gastroparesis and Alzheimer's disease.
Velusetrag is in Phase 1 development. The program includes completed Phase 2 trials in gastroparesis and a completed Phase 1 study in healthy elderly subjects. It is investigational and has not been approved by the FDA for any indication.
Velusetrag has been studied in completed trials including NCT02267525, the Phase 2 DIGEST study in diabetic and idiopathic gastroparesis with 233 participants; NCT01718938, a Phase 2 study in diabetic or idiopathic gastroparesis with 34 participants; and NCT01467726, a Phase 1 study in healthy elderly subjects with 40 participants.
Yes, velusetrag dose 1 is an alternative name for Velusetrag. Both refer to the same investigational small molecule developed by Theravance Biopharma, Inc. (TBPH) that targets HTR4 and is being studied in gastroparesis and Alzheimer's disease.