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A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Mavorixafor in Patients With WHIM Syndrome With Open-Label Extension

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Trial Profile

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Mavorixafor in Patients With WHIM Syndrome With Open-Label Extension

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 27 Mar 2024

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At a glance

  • Drugs Mavorixafor (Primary)
  • Indications WHIM syndrome
  • Focus Adverse reactions; Biomarker; Registrational; Therapeutic Use
  • Acronyms 4WHIM
  • Sponsors X4 Pharmaceuticals

    • Most Recent Events

    • 26 Feb 2024 Results assessing changes in lymphocyte subpopulations, particularly T and B cells of the adaptive immune system, during the randomized control period presented at the 2024 Annual Meeting of the American Academy of Allergy, Asthma and Immunology
    • 31 Oct 2023 According to a X4 Pharmaceuticals media release,the FDA granted Priority Review of the mavorixafor NDA, establishing a goal of six months review from the date of acceptance and assigning a Prescription Drug User Fee Act (PDUFA) target action date of April 30, 2024.NDA supported by positive results fromthis clinical trial
    • 31 Oct 2023 According to a X4 Pharmaceuticals media release, the United States Food and Drug Administration (FDA) has accepted for filing the companys New Drug Application (NDA) , oral mavorixafor to treat individuals aged 12 and older with WHIM (Warts, Hypogammaglobulinemia, Infections, and Myelokathexis) syndrome.
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