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VTP-38543 · 1 trial · 1 indication
An Adverse Event is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The number of participants with AEs related to treatment are reported.
Clinical Laboratory tests included chemistry, hematology and urinalysis tests collected during the study. The investigator determined if the changes in laboratory results were clinically significant.
Vital signs included blood pressure, pulse, respiration rate and body temperature. The investigator determined if the changes in vital sign results were clinically significant.
A standard 12-lead ECG was performed. The investigator determined if the changes in ECG results were clinically significant.
| Arm | Type | Description |
|---|---|---|
| VTP-38543 0.05% | EXPERIMENTAL | VTP-38543 0.05% administered topically every 12 hours for 28 days. |
| VTP-38543 0.15% | EXPERIMENTAL | VTP-38543 0.15% administered topically every 12 hours for 28 days. |
| Vehicle without Transcutol®P | PLACEBO_COMPARATOR | Vehicle without Transcutol®P administered topically every 12 hours for 28 days. |
| VTP-38543 1% | EXPERIMENTAL | VTP-38543 1% administered topically every 12 hours for 28 days. |
| Vehicle with Transcutol®P | PLACEBO_COMPARATOR | Vehicle with Transcutol®P administered topically every 12 hours for 28 days. |
| Name | Type | Description |
|---|---|---|
| VTP-38543 | DRUG | VTP-38543 topical cream |
| Vehicle with Transcutol®P | OTHER | Vehicle matching VTP-38543 cream with Transcutol®P |
| Vehicle without Transcutol®P | OTHER | Vehicle matching VTP-38543 cream without Transcutol®P |
Inclusion Criteria: * Mild to moderate atopic dermatitis with a minimum of 3 to a maximum of 15% body surface area (BSA) involvement * Investigator Global Assessments (IGA) score of 2 or 3 * Body Mass Index (BMI) = 18 - 35 kg/m\^2 * Negative Pregnancy test for females Exclusion Criteria: * Treatm...
VTP-38543 is an investigational small molecule being developed for the treatment of atopic dermatitis, also known as eczema. It is intended for adult patients with mild to moderate forms of the condition. The drug is currently in clinical development and has not been approved by regulatory authorities.
The specific molecular target of VTP-38543 has not been disclosed. It is a small molecule therapeutic being studied for its potential to treat atopic dermatitis, a chronic inflammatory skin condition. The mechanism of action is not publicly detailed in available clinical trial information.
VTP-38543 is being developed by Syndax Pharmaceuticals, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol SNDX. The company is conducting clinical research to evaluate the safety and efficacy of this investigational drug for atopic dermatitis.
VTP-38543 is in Phase 1 clinical development. A Phase 1 trial has been completed, which studied the drug in adult participants with mild to moderate atopic dermatitis. The drug remains investigational and has not received FDA approval for any use.
VTP-38543 has one completed clinical trial registered as NCT02655679, titled "An Ascending Multiple Dose Study of VTP-38543 in Adult Participants With Mild to Moderate Atopic Dermatitis." This Phase 1 study enrolled 104 participants and was conducted in the United States and Canada.
No alternative names for VTP-38543 have been disclosed. The drug is identified solely by its development code VTP-38543 in clinical trial registrations and company communications. It is not known to be marketed under any other brand name.