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An Open-Label, Long-Term Extension Study to Evaluate the Safety and Efficacy of Tapinarof Cream, 1% in Subjects With Atopic Dermatitis

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Trial Profile

An Open-Label, Long-Term Extension Study to Evaluate the Safety and Efficacy of Tapinarof Cream, 1% in Subjects With Atopic Dermatitis

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 17 Jul 2024

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At a glance

  • Drugs Tapinarof (Primary)
  • Indications Atopic dermatitis
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms ADORING 3
  • Sponsors Dermavant Sciences

    • Most Recent Events

    • 25 Jun 2024 According to a Dermavant Sciences media release, company announced that Japan Tobacco has received approval in Japan for tapinarof cream, 1% for the treatment of patients 12 years of age and older with atopic dermatitis.
    • 29 Apr 2024 According to a Dermavant Sciences media release, based on data from ADORING 1, 2, and 3, the U.S. Food and Drug Administration (FDA) accepted the companys Supplemental New Drug Application (sNDA) for VTAMA (tapinarof) cream, 1% for the topical treatment of atopic dermatitis (AD) in adults and children 2 years of age and older. The Prescription Drug User Fee Act action date assigned by the Agency is in Q4 2024
    • 05 Apr 2024 Status changed from recruiting to completed.

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