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VLY-686 · 3 trials · 3 indications
The Gastroparesis Core Symptom Daily Diary (GCSDD) is a patient reported diary that asks patients to rate the worst occurrence of each cardinal symptom of gastroparesis (nausea severity, early satiety, postprandial fullness, bloating, and abdominal pain) in the past 24 hours on a Likert scale from 0 (no symptoms) to 5 (very severe). Change from baseline in average nausea severity score is calculated as the weekly average post value minus baseline value of the daily nausea severity score from the GCSDD. A negative change indicates improvement.
Responses were measured on a 100-mm Visual Analogue Scale (VAS), where the left end point was marked "no itch" (0 mm) and in the right end point was marked "worst imaginable itch" (100 mm).
| Arm | Type | Description |
|---|---|---|
| Study Drug | EXPERIMENTAL | VLY-686 (Tradipitant) oral capsule for 4 weeks. |
| Placebo | PLACEBO_COMPARATOR | Placebo oral capsule for 4 weeks. |
| VLY-686 | EXPERIMENTAL | - |
| VLY-686 20 mg | EXPERIMENTAL | Single dose, 20 mg VLY-686, administered as two 10 mg VLY-686 oral capsules |
| VLY-686 50 mg | EXPERIMENTAL | Single dose, 50 mg VLY-686, administered as one 50 mg VLY-686 oral capsule and one placebo capsule mimicking the VLY-686 50 mg capsule |
| VLY-686 100 mg | EXPERIMENTAL | Single dose, 100 mg VLY-686, administered as two 50 mg VLY-686 oral capsules |
| Name | Type | Description |
|---|---|---|
| VLY-686 (Tradipitant) | DRUG | oral capsule |
| Placebo | OTHER | placebo oral |
| VLY-686 | DRUG | - |
Inclusion Criteria: 1. Diagnosed with gastroparesis; 2. Subjects must agree to the use of contraception 3. Ability and acceptance to provide written informed consent; 4. Willing to participate in the pharmacogenomics sample collection; 5. Willing and able to comply with all study requirements and r...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Vanda Pharmaceuticals Inc. | VNDA | 1 | PHASE4 | Tradipitant |
| United Therapeutics Corporation | UTHR | 1 | PHASE4 | Undisclosed |
VLY-686 is an investigational small molecule being studied for treatment-resistant pruritus associated with atopic dermatitis, gastroparesis, and pruritus. It has been evaluated in clinical trials for these conditions, though it remains in clinical development and is not yet approved.
VLY-686 is being developed by Vanda Pharmaceuticals Inc., a biopharmaceutical company traded on NASDAQ under the ticker VNDA. The company has sponsored clinical trials of VLY-686 in the United States, Germany, and Switzerland.
VLY-686 is in Phase 2 clinical development. It has completed Phase 2 trials for treatment-resistant pruritus associated with atopic dermatitis and gastroparesis, as well as a Phase 1 trial in healthy volunteers. It is investigational and not FDA approved.
VLY-686 has completed three clinical trials: NCT01919944, a Phase 1 study in healthy volunteers with pruritus; NCT02004041, a Phase 2 proof-of-concept study in treatment-resistant pruritus associated with atopic dermatitis; and NCT02970968, a Phase 2 study in gastroparesis. All trials are completed.
VLY-686 is also known as tradipitant. It is a neurokinin-1 receptor antagonist being developed by Vanda Pharmaceuticals. The drug has been studied under the name VLY-686 in clinical trials for pruritus and gastroparesis.