Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Velusetrag · 3 trials · 2 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Number of subjects who complete the treatment period and are not withdrawn due to adverse events (AEs) or clinically significant findings on vital signs or ECGs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 |
|---|---|---|
| Velusetrag | DRUG | - |
| Placebo | DRUG | - |
| velusetrag dose 1 | DRUG | - |
| velusetrag dose 2 | DRUG | - |
| velusetrag dose 3 | DRUG | - |
Inclusion Criteria: * Symptoms of gastroparesis (eg, nausea, early satiety, fullness, bloating, upper abdominal pain, retching or vomiting) for at least 3 months prior to Screening * Composite score ≥2and \<5 on nausea, bloating, feeling excessively full after meals, and not able to finish a normal...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Vanda Pharmaceuticals Inc. | VNDA | 1 | PHASE4 | Tradipitant |
| United Therapeutics Corporation | UTHR | 1 | PHASE4 | Undisclosed |
Velusetrag is an investigational small molecule being studied for the treatment of gastroparesis and Alzheimer's disease. It has been evaluated in clinical trials for diabetic or idiopathic gastroparesis and in a study of healthy elderly subjects related to Alzheimer's disease. Velusetrag is not approved and remains in clinical development.
Velusetrag is being developed by Theravance Biopharma, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol TBPH. The company has sponsored clinical trials of Velusetrag in the United States for gastroparesis and Alzheimer's disease.
Velusetrag is in clinical development, with completed trials in Phase 1 and Phase 2. It has not been approved by regulatory authorities. The development program includes a Phase 1 study in healthy elderly subjects and two Phase 2 studies in patients with gastroparesis.
Velusetrag has been studied in three completed clinical trials. NCT01467726 was a Phase 1 study in healthy elderly subjects. NCT01718938 was a Phase 2 study in diabetic or idiopathic gastroparesis. NCT02267525, the DIGEST study, was a Phase 2 trial in diabetic and idiopathic gastroparesis with 233 participants.
Velusetrag is a distinct investigational drug developed by Theravance Biopharma. No alternative names for Velusetrag have been reported in the clinical trial information. It is a small molecule being studied for gastrointestinal and neurological conditions.