Trial Profile
A Phase 3 Efficacy and Safety Study of Tapinarof for the Treatment of Moderate to Severe Atopic Dermatitis in Children and Adults
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 08 Nov 2024
Price :
$35 *
At a glance
- Drugs Tapinarof (Primary)
- Indications Atopic dermatitis
- Focus Registrational; Therapeutic Use
- Acronyms ADORING 2
- Sponsors Dermavant Sciences
- 05 Nov 2024 According to an Organon media release, As part of its review process, the FDA requested the final datasets and clinical study report from the long-term extension study for VTAMA. After receiving the datasets, the FDA determined that the additional information requested constitutes a major amendment to the sNDA resulting in a standard three-month extension to the original target action date.
- 05 Nov 2024 According to an Organon media release, the U.S. Food and Drug Administration (FDA) extended by three months the target action date of its review of the supplemental New Drug Application (sNDA) for VTAMA (tapinarof) cream, 1% as a treatment for atopic dermatitis (AD) in adults and children two years of age and older. The new target date is March 12, 2025, revised from the original target action date of December 12, 2024.
- 24 Oct 2024 According to a Dermavant Sciences media release, data from the study will be presented at the American College of Allergy, Asthma and Immunology Annual Meeting, being held in Boston, MA, October 24-28, 2024.