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A Multicenter, Open Label Study of QRX003 Lotion in Subjects With Netherton Syndrome

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Trial Profile

A Multicenter, Open Label Study of QRX003 Lotion in Subjects With Netherton Syndrome

Status: Recruiting
Phase of Trial: Phase II/III

Latest Information Update: 17 Nov 2025

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At a glance

  • Drugs QRX 003 (Primary)
  • Indications Netherton Syndrome
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Sponsors Quoin Pharmaceuticals

Most Recent Events

  • 21 Oct 2025 According to a Quoin Pharmaceuticals media release, enrollment in this pivotal study is expected to be completed in Q1 2026, top-line data is anticipated in the second half of 2026, and NDA submission is planned later in the year
  • 10 Oct 2025 According to a Quoin Pharmaceuticals media release, the Company has received Type C meeting minutes from the FDA indicating openness to baseline-controlled pivotal studies for QRX003 for the treatment of Netherton Syndrome, with regulatory exclusivity of five years from the date of issuance.
  • 07 Aug 2025 According to a Quoin Pharmaceuticals media release, NDA filing anticipated later in 2026.

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